Open Innovative Partnerships by Ochre Media Pvt. Ltd.

Sp e c ia l issue on Partnerships

Issue 18 2013

On the Partnering Path from the US to Asia How far, how fast for university-industry collaborations?

Open Innovative Partnerships A working model for the future of drug discovery and development

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Foreword

Pharma Partnerships The changing model Cross-industry partnerships have changed the

development partners, service providers, indus-

way pharmaceutical companies approach drug

try and academic groups, and Public-Private

research and manufacturing. Factors such as

Partnerships. In order to remain successful and

expiring patents, paucity of blockbuster drugs,

sustainable the partnerships will require proper

need for cost cutting and more targeted cures has

infrastructure and systems alongside organised

forced pharma companies to look beyond their

business processes.

own reserves of knowledge and capabilities.

We believe this emerging flexible model

Multinational companies are looking eastward

of partnerships will drive the future growth in

in their endeavor to create new therapeutics by

pharma industry. In this special issue of Pharma

partnering with emerging pharma companies

Focus Asia on Pharma Partnerships, with their

from China, India and other south east Asian

extensive experience, many industry leaders

economies. Big pharma companies are also

have shared their insights into the emerging

investing in large scale R&D facilities; a recent

model of partnerships in pharma industry. Hope

example of this being Novartis' announcement

you enjoy reading the magazine.

to invest US$1 billion in a R&D facility in China. They are also partnering with Indian pharma

I thank all the authors for their support and contribution in making this issue possible.

companies to penetrate and capture a larger share of the potential opportunity there. These partnerships between pharma, biotech and the academia are expected to address particular near-term challenges by utilising different skills and capabilities across organisations and geographies. These partnerships have taken several forms such as between independent contract research and manufacturing

Prasanthi Potluri

solution providers, CROs and other external

Editor

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Contents

Special issue on Partnerships

04 Open Innovative Partnerships A working model for the future of drug discovery and development

Kai Bindseil, Managing Director, Biotop Berlin-Brandenburg, Germany

08 Innovative Partnership Model Translating research into products and best practices for spinal cord injury

John Barclay, Manager, Commercialisation & Industry Relations

Bill Barrable, Chief Executive Officer

Rick Hansen Institute, Canada

14 Success Factors for a Strong Drug Development Partnership

Maulik Mehta, Senior Director, Corporate Development, Quintiles, USA

Andrew Bentley, Corporate Development Director, Quintiles, USA

Prasad Velisetty, Senior Director, Therapeutic Strategy Lead, Quintiles, UK

24 M&A and Partnerships in Pharma Rising opportunities

Sujay J Shetty, Associate Director, Pharma Life Sciences Advisory Corporate Finance, PriceWaterhousecoopers, India

26 M&A and Partnerships in Pharma Indian scenario

Ganesh Nayak, Executive Director, Zydus Cadila, India

30 Strategic Partnerships and External Innovation

Andrew A Parsons, Director, Reciprocal Minds Limited, UK

Catherine Carr D, Founder, Catherine Carr and Associates, UK

40 On the Partnering Path from the US to Asia How far, how fast for university-industry collaborations?

Christopher-Paul Milne, Director, Research, Center for the Study of Drug Development, Tufts University Medical School, US

46 The Role of ICH-E5 Enhancing product value and accelerating global drug development

Melton B Affrime, Sr. VP, Translational Medicine, WCCT Global, US

51 New FIPNET Paradigm Powered by technology and innovation

Alan S Louie, Research Director, Health Industry Insights, IDC Company, USA

54 Industry Reports

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Advisory Board

Editor Prasanthi Potluri Alan S Louie Research Director, Health Industry Insights an IDC Company, USA

Christopher-Paul Milne Associate Director, Tufts Center for the Study of Drug Development, Tufts University, USA

Douglas Meyer Senior Director, Aptuit Informatics Inc., USA

Frank A Jaeger Director, New Business Development Solvay Pharmaceuticals, Inc., USA

Georg C Terstappen Chief Scientific Officer, Siena Biotech S.p.A., Italy

Kenneth I Kaitin Director and Professor of Medicine, Tufts Center for the Study of Drug Development, Tufts University, USA

Laurence Flint Associate Director, Clinical Research Schering-Plough Research Institute, USA

Neil J Campbell CEO, Mosaigen Inc. and Partner Endeavour Capital Asia Ltd., USA

Copy Editors V Rashmi Divakar Rao Jenny Jones Art Director M A Hannan Product Managers Prabha Nandikanti Breiti Roger Khaja Ameeruddin Jeff Kenney Product Associate Vineetha G Vinay Kumar M Ben Johnson Veronica Wilson Compliance Team P Bhavani Prasad P Shashikanth Sam Smith Steven Banks CRM Yahiya Sultan Naveen M Subscriptions incharge Vijay Kumar Gaddam IT Team Ifthakhar Mohammed Azeemuddin Mohammed T Krishna Deepak Yadav D Upender Sankar Kodali Head-Operations S V Nageswara Rao

Pharma Focus Asia is published by

In Association with

A member of

Phil Kaminsky Founder, Center for Biopharmaceutical Operations University of California, Berkeley, USA

Rustom Mody Director, Quality and Strategic Research Intas Biopharmaceuticals Limited, India

Confederation of Indian Industry

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Sanjoy Ray Director, Technology Innovation Merck Research Laboratories, USA Sasikant Misra Management Consultant and Ex-Deputy Director CII, Drugs and Pharma Sector

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Special issue on Partnerships

Open

Innovative

Partnerships

A working model for the future of drug discovery and development

Although investment in pharmaceutical research and development has increased substantially in the last decade, the lack of a corresponding output in terms of new approved drugs indicates that therapeutic innovation has become extremely challenging. Kai Bindseil, Managing Director, BioTOP Berlin-Brandenburg, Germany

he pharmaceutical industry’s long successful strategy of placing big bets on a few molecules, promoting them heavily and turning them into blockbusters worked well for many years, but its Research and Development (R&D) productivity has now plummeted and the environment is changing. According to the Pharmaceutical Research and Manufacturers of America (PhRMA) the industry spends roughly US$50 billion per year today on R&D. Despite this massive R&D investment, the number of new drugs approved each year over the past 40 years has remained fairly constant, averaging at roughly 25 to 30 per year. Thus, spending more money on R&D initiatives has not been helping to improve innovation or drug development productivity in the life sciences industry. In addition to this lack of innovation, today’s pharmaceutical industry faces several major financial and business challenges. First, longer R&D cycles and increasing regulatory scrutiny are

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causing R&D costs to spiral out of control. Second, the impending patent expiry of many blockbuster drugs threatens to cut total drug sales revenues by as much as 41 per cent by 2015. By the end of 2012, 20 per cent of big pharma’s current sale revenues were already susceptible to generic drug encroachment. Third, a growing number of healthcare payers are measuring the pharmacoeconomic performance of different medicines. A widespread use of electronic medical records will give them the data they need to enforce outcomes-based pricing. Thus, generic prescriptions drugs are predicted to represent 17 per cent of total global pharmaceutical sales by 2014, up from 10 per cent in 2008. Finally, healthcare reform legislation and increasing downward pricing pressures imposed by insurance companies and third-party payors are driving down drug reimbursement costs and squeezing the margins of many branded prescription drugs.

Drug makers have attempted to adjust to these conditions by controlling costs through job cuts, corporate restructuring, and M&As. For example, over the past four years alone, the world’s 10 largest pharmaceutical companies have eliminated over 200,000 jobs or 18 per cent of the 2010 aggregate, global pharmaceutical workforce. During the same period, M&A activity has skyrocketed with several major acquisitions (Pfizer / Wyeth and Merck / Schering Plough) as big pharma companies scurry to bolster their biotechnology product offerings. While both strategies are likely to help to control costs and bolster company stock prices in the short term, neither is likely to help to improve productivity nor spark the innovation that is drastically needed at most big pharmaceutical companies. From closed innovation to partnering

Historically, the pharma industry has operated by using a ‘closed innovation’

business model where ideas are generated internally and ultimately commercialised using vertically integrated internal corporate resources. This process was mainly driven and protected by patents and IP, and product development has frequently been done internally and secretly without much input from external sources. Due to the fact that several deals did not pay off in the following years, we are

unlikely to see many (if any) additional megadeals involving big pharma in the foreseeable future, as most companies have announced their intention to focus on smaller ‘tuck-in’ deals (acquisitions of products and technologies). In addition this model was working as long as the biotech industry was able to attract sufficient VC to finance product development and to create full pipelines.

In the past decade, as their biggest products started to go off-patent, companies have had to overcome the blockbuster model and responded to the innovation gap in the post-blockbuster world by vertical approaches and decentralisation. They have set up more autonomous and flexible R&D units and were increasingly relying on partnerships and in-licensing drug candidates from the biotechnology sector to supplement its pipelines. This has lead to a situation where the relationship between pharma and biotech is one of licensing, mergers and acquisitions. Of late, several megadeals have been closed such as the acquisition of Medimmune by AstraZeneca and Organon by Schering-Plough. The peak of this development was the acquisition of Genzyme by Sanofi in 2011.

From partnering to open innovation

In a changing market environment and financially difficult times big pharma has to realize that to remain in the business of drug discovery, they need to become more innovative and long-term focused. The new approach includes more emphasis on corporate venture capital, an increased number of collaborations with academia, the establishment of infrastructure and incubators, crowdsourcing techniques to provide grants and the involvement from other industries. Public-private infrastructure

Ultimately, the scientists are the ones innovating and they need the tools to make it happen. Thus the industry is investing in science where it happens. In the past, clinics and pharmaceutical companies have often worked on the same projects, but not necessarily together. Data was exchanged, and in the end the results too, but there was rarely real cooperation. That’s in the process of changing: The Charité - Universitätsmedizin Berlin and

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public organisations offering promising new targets for drug discovery screening. These target proposals will be selected through competitive calls. Incubators

Last year, Johnson & Johnson established Janssen Labs in San Diego, while Bayer HealthCare Pharmaceuticals opened an incubator at the University of California San Francisco and announced that is planning to open a second CoLaborator in Berlin, Germany. Industry backed incubators take into account that innovation is a collaborative process and focus on sharing risks and rewards, thus stepping beyond the confines of a traditional life science incubator. Benefits for SMEs include access to resources and infrastructure of global players and day to day contact with potential customers and markets. This concept can be expanded by including a VC fund model. Crowdsourcing

Over the past few years, several big pharma companies including Eli Lilly, GSK, Merck, and Pfizer have begun to apply the crowdsourcing concept to early drug discovery and development. Lilly has been the most active in this area and has helped to create or spin out several projects that form the basis of Lilly’s Fully Integrated Pharmaceutical Network (FIPNet) model, which is designed to access ideas, resources, and talents beyond ‘its walls’ through collaboration with external academic research scientists, nonprofits, and biotechnology firms. In addition Lilly recently opened together with TVM and Teralys a Canadian unit of Chorus in Montréal. Chorus, an autonomous unit of Lilly, is a global-early-phase drug development network that focuses on designing and executing lean and highly-focused A u t h o r BIO

Sanofi pharmaceuticals embarked on a new path in June 2010. Joint ideas and topics, joint research, joint day-to-day work—that is the framework for their cooperation. And the partners have just recently opened their first joint laboratory, near the Charité hospital in Berlin. Over the next years, Merck will invest US$90 million in a non-profit institute, the California Institute for Biomedical Research (Calibr), with up to 150 staff doing early drug research in immunology, cardiovascular disease, regenerative medicine, cancer, and other diseases. Merck has an option to obtain an exclusive commercial license to any proteins or small molecule therapeutic candidates derived from work conducted by Calibr. In addition to bilateral collaboration, there is a trend towards broad technology platforms. Pharmaceutical companies have vast libraries of compounds which can be screened in the hunt for potential medicines. Until now, access to these compound libraries was highly restricted. To overcome this limitation large pharmaceutical companies have joined forces with Small and Medium-sized Enterprises (SMEs) and academia in an Innovative Medicines Initiative (IMI)-supported Public Private Partnership (PPP) to enhance early drug discovery and so address the ever-increasing need for innovative therapeutics to tackle unmet medical needs. The European Lead Factory, a novel platform for innovative drug discovery, was launched early February by an international consortium of 30 partners. As part of the European Lead Factory, seven participating pharmaceutical companies will contribute at least 300,000 chemical compounds from their corporate chemical collections. A library of an estimated additional 200,000 novel compounds will be developed jointly by academia and SMEs. Together, the two libraries will form a Joint European Compound Collection consisting of up to half a million compounds that will be accessible to all project partners and to

development plans that cost-effectively progress potential medicines from candidate selection to clinical proof-of-concept. GSK is attempting to remove patents and intellectual property as barriers to new drug discovery. In a first step, GSK has released 800 compound and process patents into the public domain and last year offered 13,000 potential antimalarial NMEs to academic researchers to encourage identification of promising lead candidates. Conclusion

Big innovation requires new and open minded thinking. In the past there were very different cultures in the pharma industry, biotech and academia. The future of drug discovery will depend on the ability to establish fair partnerships between these different players, based on novel approaches to capitalise on the potential of excellent basic research for the discovery of new therapies. To achieve this goal of open innovation, new infrastructure and financing tools have to be created within academia and the industry through public private partnerships. Sometimes you need to spend money to make money. In addition, certain barriers from patents and intellectual property must be removed by the industry to create new engines for successful biopharmaceutical innovation. In the future, drug companies will compete and collaborate with not just the denizens of the current ecosystem—biotech and medtech firms, CROs / CMOs, academic organisations, other pharma companies—but entirely new classes of non-traditional entrants: from IT companies to large to non-profit organisations. They can only be successful if they learn from their entire network.

Kai Bindseil is responsible for the life sciences and health activities within the TSB Innovationsagentur GmbH. He studied chemistry at Göttingen University, worked at Ciba, was head of drug discovery and development of AnalytiCon AG in Berlin and served as COO at AnalytiCon Discovery GmbH.

Special issue on Partnerships

Innovative Partnership Model Translating research into products and best practices for spinal cord injury The Rick Hansen Institute (RHI) is a Canada-based not-for-profit organisation committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries (SCI). RHI is developing innovative partnerships and programmes to support the commercialisation of therapeutics and medical devices with application to SCI. John Barclay, Manager, Commercialisation & Industry Relations Bill Barrable, Chief Executive Officer Rick Hansen Institute, Canada

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pinal Cord Injury (SCI) is one of the greatest survivable catastrophes experienced by a human being. Regardless of cause or age at injury, SCI has a devastating impact on an injured person’s health and well-being, and far reaching consequences for individuals, their families and the healthcare system. There is currently no approved treatment for paralysis following SCI beyond surgery and rehabilitation. Furthermore, required care is highly specialised and complex—including costs for acute, Twenty five years ago, Canadian Rick Hansen—paralysed from the waist down in an accident at the age of 15—had a dream: to make the world more accessible and inclusive and to find a cure for paralysis after SCI. Inspired by a deep-seated belief that anything is possible, Rick’s ‘big dream’ took shape in the form of the Man In Motion World Tour. For 26 months, he and his team wheeled more than 40,000 km through 34 countries, raising awareness of the potential of people with disabilities. Following the tour, Rick established the Rick Hansen Foundation (RHF) to continue his quest for an accessible

rehabilitative, emergency, primary, mental health, home and long term care and adaptive equipment—resulting in substantial financial costs for governments. The worldwide annual incidence and prevalence of SCI is conservatively estimated at 130,000 and 2,500,000, respectively. In Canada alone, a country with a population of approximately 35 million people, the cost of care for people with traumatic SCI is now estimated at approximately US$2.7 billion a year. and inclusive society and a cure for paralysis after SCI. Under Rick’s leadership RHF functions as a social innovator, finding collaborative solutions to challenges in the community and the resources necessary to implement those solutions. Rick Hansen has also nurtured a dream of true collaboration across the SCI community. In 2003 his dream began to be realised when the SCI Network was established with funding from the federal government (Western Economic Diversification) invested through RHF. Three initiatives evolved—the SCI Solutions Alliance, the Rick Hansen SCI Registry, and the SCI Translational Research Network, which was funded by a US$30 million investment from Health Canada. In April 2008, a decision was made to combine these three entities into a single organisation, which is more effectively and efficiently addressing priority needs and generating solutions for people with SCI. The Rick Hansen Institute (RHI) became incorporated in March, 2009. RHI received charitable status from Canada Revenue Agency (CRA) in January, 2010 and now operates as an independent charitable organisation.

Today RHI is a Canada-based notfor-profit organisation committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries. It does this by leading the collaboration of researchers, healthcare professionals and service providers across Canada and internationally. RHI has matched leadership and research collaboration with government funding to facilitate one of the largest interdisciplinary spinal cord injury research programmes in the world. At its core, RHI is essentially a network. The network is formed through a variety of partnerships with governments, researchers, clinicians, granting agencies, corporations, research and healthcare organisations and accreditation agencies. RHI considers people who have suffered an SCI, SCI patients and consumers, to also be effective partners in achieving its mission. Therefore, the innovation in RHI’s partnership model is not necessarily represented by a specific partnership; however, the innovation in the partnership model is derived more from the breadth and variety of the partnerships. This partnership model allows RHI and its network to provide a total value that is greater than the sum of its individual parts. Scarcity of research funding

In this economic climate, research funding is scarce. There are more researchers and organisations searching for funding than there are funds available. It is a function of competition over scarce resources. This aspect of competition should be familiar to all those involved in just about any aspect of research and development. Researchers compete for grant funding; charities, foundations and not-for-profit organisations compete for donations and government funding; early-stage and emerging companies compete for investment funding; and more mature companies with approved products compete for actual customers. Therefore, in order to facilitate the

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John Barclay is responsible for the development, implementation and management of RHI’s commercialisation strategy. John has over eight years of experience in the life sciences industry in both profit and non-profit sectors with a focus on strategic relationship management in order to connect innovative ideas to the resources that will help advance them.

implementation of new therapeutics and medical devices into the delivery of healthcare for people with SCI, there is a need to secure more funding into the space. Specifically, there is a need to draw more investment capital into the commercialisation of innovations with application to SCI. However, in order to do so, the investment must be sufficiently de-risked so that it becomes an attractive investment opportunity. In terms of partnership models to de-risk early-stage investment into research, this is often represented by a not-for-profit organisation providing resources towards the development or commercialisation of a technology rele-

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vant to its mission. The recipient uses these resources to advance the commercialisation process of the technology to the point in which it can reach a tangible commercialisation outcome, such as an investment or licensing event. The implication is that through providing resources the not-for-profit assumes some of the risks involved in the development and the investment is effectively de-risked for a third party, such as an investor or commercial partner. RHI is in a unique position to perform a similar de-risking for investment into therapeutics and medical devices with application to SCI under development by an early-stage or emerging company.

Ideally this will result in increased investment into technologies with application to SCI and thus increase investor and industry participation in the space. Successfully commercialised therapeutics and medical devices will improve outcomes or decrease the cost of outcomes for people with SCI and the various stakeholders, ideally both. However, RHI’s core programmes have largely focused on initiatives within the public healthcare system and researchbased institutions. Although RHI has provided grant funding to a few projects associated with the commercialisation of a technology, it has not specifically targeted the commercialisation process within the activities of its core programmes. In other words, RHI has lacked specific mechanisms to support the commercialisation of innovations with the potential to improve outcomes for people with SCI that are under development by early-stage and emerging companies.This represents a proverbial hole in RHI’s portfolio of activities as translating research into products requires risk-taking and the entrepreneurs that run these companies are typically more likely to take the necessary risks. RHI is addressing this need with the development of its Commercialisation Strategy (CS)1. The overall goal of RHI’s CS is to facilitate the development of innovative pre-commercial therapeutics and medical devices that will improve the lives of those living with SCI. However, the capital required in order to shepherd a new therapeutic or medical device all the way through the commercialisation pathway from idea to regulatory approval is well beyond the resources of RHI. The CS must account for these limitations and seek innovative ways of partnering with organisations in order to leverage available resources. Thus, the goals of the strategy include: • The implementation of innovative therapeutics and medical devices into 1 http://www.rickhanseninstitute.org/en/publications/newsarchive/360-ceo-update-february-2013

RHI operates three interconnected core programme areas that represent a unique model in which to translate research into products and best practices for people who have suffered an SCI Translational Research (TR) RHI’s TR programme focuses on applying discoveries generated during laboratory research and preclinical studies to the development of trials and studies in humans, and, where success has been determined, preparing that knowledge for implementation into clinical practice. Projects supported through the TR programme are carefully selected through strategic investment or calls for proposals, based on their potential impact against three objectives: reduce the incidence and severity of paralysis after SCI; improve healthcare outcomes in the treatment of people with SCI and reduce long-term costs in the care of people with SCI. Examples of projects sponsored through RHI’s TR programme include an acute-phase multi-centre clinical trial for the use of minocycline as a neuro-protective therapeutic treatment for traumatic SCI, and a clinical study that monitors Cerebrospinal Fluid (CSF) pressure and will validate biomarkers with the intent of limiting secondary damage to the spinal cord by developing a procedure to help drain the CSF and stratify injury severity and predict neurological recovery based on the presence of specific biomarkers.

the delivery of healthcare for people with SCI • Increasing investor and industry engagement and participation in SCI research and development • Increasing the pipeline of potential innovative therapeutics and medical devices for SCI and the secondary complications • Accelerating the commercialisation process for innovative therapeutics

Best Practices Implementation (BPI) Through its BPI programme, RHI works translate knowledge from its TR programme in order to affect the changes in clinical practices necessary to achieve the best possible health outcomes for people with SCI, from acute care to community integration. RHI is committed to improving the development, validation, dissemination and adoption of best practices in spinal cord injury care. Examples of projects supported through RHI’s BPI programme include an initiative with Accreditation Canada that will create standards for hospitals that provide acute and rehabilitation care services for individuals with SCI, and another initiative with the Canadian Medical Association that is developing incentive mechanisms for Canada’s more than 50,000 family physicians to adopt evidence-based best practices for care of individuals with SCI. Rick Hansen SCI Registry (RHSCIR) RHSCIR is an unprecedented, nation-wide project that is collecting critical information on SCI at 31 major Canadian acute care and rehabilitation hospitals. RHSCIR was established in Vancouver, BC in 2004 and since has expanded to 31 facilities across Canada, effectively creating a clinical research network. The network includes governments, granting bodies, corporations, research and healthcare organisations, and accreditation agencies. Among this network are many key opinion leaders in SCI research and care. This collaboration—largely due to the need to increase the number of participants available for clinical trials, and to enable interactions between researchers world-wide—is now expanding internationally.

and medical devices for paralysis and the secondary complications following SCI and • Development of new therapeutics and medical devices for SCI to the point in which they are ready for licensing, investor or industry investment, or spin-out. RHI’s CS aims to address a common challenge for an early-stage or emerging company in the life sciences and

biotechnology field–securing bridge funding to test an idea through proof of concept to the point in which it is able to secure the investment necessary to continue its development. This is often described as the commercial ‘Valley of Death’2 and is an even larger challenge for companies developing therapeutics 2 http://www.rickhanseninstitute.org/en/publications/newsarchive/360-ceo-update-february-2013

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Bill Barrable has been the Chief Executive Officer of the Rick HansenInstitute since January 2010. Previously, Bill was the Chief Executive of BC Transplant from 1994 to 2009, during which time it was honoured with the Canada Award for Excellence from the National QualityInstitute.

and medical devices for SCI for a variety of reasons, including: • Treating paralysis and the secondary complications following SCI is scientifically challenging and complex • SCI is an ‘Orphan Disease’–the incidence and prevalence of SCI is much smaller than other chronic health conditions • Finding a cure is a long-term prospect • Programmes and mechanisms that specifically address the commercialisation pathway for new therapeutics and medical devices have largely been absent from the SCI research community. Partnerships will be critical to the success of RHI’s CS. Ideally, the 12

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partnerships will leverage RHI’s domain expertise in SCI research and care with the commercialisation process expertise and resource of other organisations. Therefore, RHI will seek to partner with pharmaceutical, biotechnology and medical device companies that have the resources to invest and continue the commercialisation of technologies to regulatory approval and implementation into the delivery of healthcare. The first step for RHI’s CS has been to pilot the RHI SCI Global Investment Forum.3 The Forum is intended to facilitate connections between early-stage 3 http://www.rickhanseninstitute.org/en/what-we-do/ global-investment-forum

and emerging companies, developing therapeutics and medical devices with application to SCI and the secondary complications, to investors and partners. This is done by providing these companies the opportunity to pitch their company and SCI-related technology at an event that is attended by potential investors and partners from the biotechnology and life sciences community. RHI has hosted two forums to date. The first was held at the Interdependence 2012 Global SCI Conference4 in May 2012 in Vancouverand the second was held at Biotech Showcase™5 2013 in January in San Francisco. RHI acknowledges that the RHI SCI Global Investment Forum alone will be insufficient to accomplish the goals of its commercialisation strategy. RHI must implement mechanisms that actually de-risk investment into earlystage and emerging companies in the SCI space. Therefore, RHI is in the process of developing other opportunities for earlystage and emerging companies that are commercialising an innovative therapeutic or medical device for SCI. De-risking early-stage investment and translating research into products is challenging in life sciences, particularly for a complex and costly condition such as SCI. Innovative partnerships are required in order to be able to accomplish these goals. RHI’s innovative partnership model is evidenced in its network that includes a variety of different stakeholders involved in the SCI research and development continuum from both the public and private sectors. Governments, researchers, clinicians, granting agencies, corporations, research and healthcare organisations, accreditation agencies, and SCI patients and consumers are all critical in translating research into products that improve outcomes and decrease the cost of outcomes for people with SCI.

4 http://www.rickhanseninstitute.org/en/what-we-do/ global-investment-forum/events/356-interdependence-2012 5 http://www.rickhanseninstitute.org/en/what-we-do/ global-investment-forum/events/352-biotech-showcase2013-sci-investment-opportunities-and-challenges

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Special issue on Partnerships

Success Factors for a Strong Drug Development Partnership Successful partnerships require a commitment to change, and a reevaluation of core competencies across both organisations. Through the application of a clear strategy, committed leadership, and a high degree of flexibility, strong and sustainable sponsor-CRO partnerships can help maximise portfolio value by minimising development cost and time and enhancing resource productivity. Maulik Mehta, Senior Director, Corporate Development, Quintiles, USA Andrew Bentley, Corporate Development Director, Quintiles, USA Prasad Velisetty, Senior Director, Therapeutic Strategy Lead, Quintiles, UK

linical Research Organisations (CROs) and drug development sponsor organisations such as biopharmaceutical companies, academic organisations, and Non-Governmental

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Organisations (NGOs) have collaborated for more than 30 years in an effort to enhance the clinical development process for new medicines. Although the scale and scope of these collaborations

have substantially increased over time, it is notable that the vast majority of sponsor / CRO relationships have been tactical in nature. CROs are commonly sought out to help achieve â&#x20AC;&#x2DC;quick winâ&#x20AC;&#x2122; benefits based on flexible resourcing, the application of low-cost resources (particularly in emerging markets), and the utilisation of focused scientific and technical skills to address particular near-term challenges. Rarely have these engagements focused on the longer-term investment horizon and extended beyond individual functions or compound outsourcing decisions, and as a result the benefits from these collaborations have been fairly limited and transitory. This is unfortunate. Considering the scientific, operational and financial challenges facing drug development organisations today, the need to maximise the benefits of these relationships is greater than ever. Driving change and realising these types of benefits is hard work, and making this type of an alliance

Making a long-term development alliance successful requires a clear understanding of strategic objectives and strong sense of shared ownership in the success of partnered development programmes. In our experience, a number of steps are critical in creating this environment. These steps are reviewed in the next section. Critical steps in creating an environment of shared ownership

Our experience in this field has allowed us to identify six critical steps that need to be taken when creating an environment of shared ownership in the success of partnered development programmes. 1. Identify priorities

successful can be particularly difficult as the business goals of drug development sponsors and service organisations may appear to be contradictory. However, drug development does not need to be a zero-sum game. With the proper focus on successful outcomes and ‘value drivers,’ there are ways to concentrate partnerships on behaviours and models of work that generate returns for both the organisations. Doing so requires change and strong commitment from both organisations, clarity of roles and responsibilities, clear decision-making rights for both companies, and mechanisms for oversight that align each organisation to shared and measurable objectives that are clearly understood and managed on an ongoing basis. In addition to such a commitment and focus on outcomes, it is critical to structure these relationships in a way that the CRO has sufficient levels of empowerment and motivation to truly ‘own’ the accountability for delivering targeted cost and timeline benefits.

It is vital that partners clearly understand, state, and rank the target priorities for the alliance (e.g. cost savings, timeline reductions, quality standards, flexibility, etc.), as this will drive decision making and ongoing partnership initiatives. Having a clear statement of priorities helps drive internal communication within both organisations and makes it possible to develop strategies that address these goals. Examples of these priorities and the resulting expectations are described in Table 1.

2. Establish clear roles and responsibilities

One of the main drivers of clinical development cost (and frustration) is duplicative and misplaced activity. A critical aspect of any alliance is to identify what functions and responsibilities are ‘core’ to each organisation, and to use this information to create a set of joint business processes and/ or rules that eliminate duplication and leverage the strengths of each company. The identification of what is ‘core’ vs. ‘non-core’ can be fluid and applied either broadly across a partnership or very specifically at the molecule level. In numerous situations, we have found that continuous engagement early on in the development process involving collaborative protocol development, country and site selection, and general development of trial operational plans can produce significant savings in time and cost of development. Furthermore, such an understanding and clarity of responsibilities has enabled sponsor organisations to focus on critical regulatory and commercial initiatives (e.g. working with both central and regional / country-level affiliates, getting buy-in from these affiliates,

Pharma Partnering Deals in China – by Stage

Mostly pre-clinical stage & marketed products deals; trending toward late stage clinical deals, esp. phase II Source: ChinaBio® Consulting

Greg B. Scott President and Founder, ChinaBio® LLC

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Special issue on Partnerships

Table 1: Expectations from the clinical development provider Priority

Expectation from Clinical Development Provider • Ensure provision of flexible access to trained, low-cost resources across multiple functions

Near-term cost benefits

• Leverage Functional Service Provider (FSP) and or Business Process Outsourcing (BPO) models where possible to work at scale • Utilise integrated program / study planning and design to optimise studies and enable CRO to accept greater accountability • Leverage autonomy / empowerment to innovate and improve processes

Mid- to long-term cost benefits

• Apply supplier tools, processes and systems where possible / appropriate • Support lean sponsor management and oversight approach

• Simplify study budgeting and contracting process Simplification of process

Increased predictability and incentive alignment

Transparency to support oversight and compliance

Minimize disruption / risk to ongoing projects

Access innovative technologies

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• Reduce handoffs and support clear decision-making responsibilities

• Consider application of outcomes-driven pricing approach, supported by transparent contracting processes and budgeting tools • Utilise incentive payments to align partnership around key sources of value (timelines, quality, etc) • Accept accountability for quality and operational outcomes • Utilise technology platform(s) that integrates data feeds and links supplier and sponsor systems / platforms • Leverage existing third party models / partnerships where appropriate (including FSPs / BPOs and other suppliers, etc) • Utilise integration / transition team with change management expertise • Apply systems, integration tools, and program/trial planning and simulation tools to reduce technology costs and increase probability of clinical / operational success

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and leveraging local knowledge in the context of a global alliance, etc.) in ways that maximise the capabilities of both sponsor and CRO personnel and resources. 3. Build trust and support via transparency

Building an alliance that drives significant productivity improvements requires both sides to trust each other. This trust is earned over time, and built and supported through mutual commitment to the alliance, shared risks and rewards, and a high degree of transparency in the delivery of work (supported by information systems, metrics / Key Performance Indicators [KPIs], and alliance management). Early goal setting is essential so that all constituents are keenly aware of not only short-term milestones, but also the correlated impact these have on longterm needs for the health of the partnership. These predetermined goals should address both individual and commonly identified mutual goals combined with joint oversight to ensure that performance metrics are achieved. An effective approach used in partnerships involves the adoption of a Balance Scorecard system. The balanced scorecard process and application of the Alliance Strategy Map, developed by Robert S Kaplan and David P Norton is a wellknown, overarching management system that works to integrate and align strategy and operations. The process begins by jointly developing strategic goals for the partnership. Metrics are then developed to measure the progress against partnership goals. Finally, initiatives are implemented to help achieve the metrics and, ultimately, the strategic goals for the partnership. The combined strategy map/ balanced scorecard process then helps to create the agenda for ongoing joint governance meetings (Figure 1). Transformational results can and have been realised in partnerships where this balanced scorecard methodology has been applied. In one partnership, the following efficiencies were achieved and documented:

Special issue on Partnerships

Figure 1: Partnership Team Charter Partner Companies: Partnership History and Background

Partnership Focus (Mission, Spirit of partnership, High-Level Objectives/Milestones)

Roles and Responsibilities (Company Roles and Key Individual Roles)

Partnership Working Guidelines (Addressing Collaborative Processes)

Relationship Performance Measurement (Measuring and Monitoring Relationship Performance)

• Overall clinical cycle time was reduced by 40 per cent, enabling our partner to focus on bringing new products to market at a faster pace • A new methodology was developed to eliminate approximately 50 per cent of non-performing investigators, which then was reapplied for more effective expenditures • The shared objectives on the joint strategy map empowered alliance members to make strategic and scientific decisions earlier in trial design, allowing the sponsor to focus on development priorities and transfer more ownership for delivery priorities. 4. Dedicate a management team

To successfully execute alliance initiatives, leadership and clear accountability for performance are required. In our experience, we have found that managing the transition and execution of work is best accomplished by a dedicated team from both the sponsor and the CRO.

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This team can leverage expertise from across both organisations and be held accountable for meeting performance goals and objectives. In nearly all successful partnerships, the first year of the relationship can be especially challenging for both companies. There is often a great deal of change and uncertainty involved with moving to a new model of work, even if the scope of the partnership is initially small but potentially transformational. During this first year, it is critically important that the leadership teams from both companies clearly demonstrate their commitment to the partnership and its objectives. This commitment begins with the initial ‘launch’ of the partnership and carries through the transition and implementation activities. Related to the need for strong and supportive senior management is the support of highly capable operational teams from both companies. In most

successful partnership models, the individuals responsible for programme direction/leadership tend to be critical in building networks within organisations, shaping processes to fit the partnership, and making sure that key objectives are achieved. In particular, effective operational leadership and engagement with key sponsor stakeholders is central to helping shape a streamlined approach to programme oversight, while duplicative activities and unnecessary handoffs are avoided. A specific example of this management approach and the creation of a ‘biotech-like’ mentality within the alliance is as follows: A recent long-term partnership agreement involving a portfolio of programmes was formed between a sponsor and a CRO, and governed in a very strategic and streamlined manner, with one ‘Representative Officer’ empowered to serve as the primary leader and point of contact for each company. The CRO’s representative functioned effectively as the ‘CEO of a Biotech company,’ with responsibility for the operational and financial management of the portfolio of studies and accountability to a small Executive Oversight Committee (three members from each company) that provided strategic direction and oversight for the model. The objective of the alliance was the successful achievement of proof-of-concept for as many indications as possible, and governance was focused on supporting this objective while ensuring regulatory compliance and patient safety as studies were conducted in a highly externalised way. 5. Focus on all sources of costs and productivity

With the right people and processes in place, it is possible to create an integrated partnership that can address all components/variables (internal and external) contributing to the ‘fully-loaded’ costs of development on a comprehensive basis. In our experience, programme-driven sourcing produces financial benefits driven by the following:

• Collaboration in trial planning activities, which produces study plans that are informed by a broader set of data and perspectives and are more effectively managed and operationalised • Improved management and utilisation of staff, who can be trained and deployed across multiple (often similar) studies in an efficient way • Standardisation of databases, templates and forms, which can be designed for the program and frequently applied across multiple studies • Efficient pharmaceutical company oversight, made possible by having a central point of supplier contact with responsibility across the programme and using consistent systems and processes to deliver the programme. Accelerating time to market is also a key driver of product value and a major source of potential cost savings. In our experience, the most important driver of timeline benefits involves the

Pharma Partnering Deals in China – by Stage

Changing to meet China’s medical needs #1 Oncology, #2 CVD, #3 Infectious Disease Source: ChinaBio® Consulting

Greg B. Scott President and Founder, ChinaBio® LLC

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6. Conduct comprehensive transition planning supported by change management with both organisations

Successful engagement between sponsor companies and CROs must involve a well thought-out transition and change management plan. The plan must focus on assessing risks, mobilising leaders in both companies, supporting positive communication, and providing tools and staff training for successful results. In our experience, having a strategy to prepare for change, proactively identifying and communicating with groups / individuals impacted by the process, and executing the transition plan using training materials and performance metrics plays an important role in supporting alliances and ensuring that productivity targets are met.

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This strategy should involve the use of a joint planning process, based on collaborative efforts using teams that are chartered to develop a detailed transitional project plan as a working document. The content and sections may be adjusted and agreed upon based on potential transfer of work and is approved by both parties. Once this collaborative process is adopted, team members may reach out to counterparts with any concerns or establish additional planning session’s necessary for their work stream. A key deliverable of the transition planning process is a joint communication plan. This plan should identify all key touch points in each organisation and develop key messages for broad distribution, with a proposed timeline and clear delivery owners. Communications should also consider any potential transition risks and draft an escalation and response plan accordingly.

to recognise that they have a somewhat ‘fragmented’ approach to development that relies on many different internal and external suppliers working in inconsistent ways, and focused on activities rather than successful outcomes. There are certainly many challenges involved in working with CROs and other external development partners, but if done effectively the potential financial, operational, and scientific benefits can be substantial. With this in mind, it is imperative for sponsors to both carefully select an appropriate development partner(s) and maximise the value of these relationships in ways that meet operational, financial, and commercial needs. While it is impossible to prepare for every challenge, our experience suggests that following the key steps outlined in this paper makes achieving the goals of such a clinical development alliance much more likely.

Concluding comments

1.Kaplan SR, Norton PD, Rudelsjoen B. (2010). Managing alliances with the balance scorecard. Harvard Business Review. 2010. 2-9. 2.Poddy, Daniel. “Eisai’s Venture-Like R&D Starts to Produce Results, And Shorter Development Timelines.” PharmaAsia News July 2011: Print

We recognise that many biopharmaceutical organisations procure external development capabilities and resources with the intent to serve many different therapeutic areas in a large variety of functions and geographies. As the industry has evolved, many sponsor organisations have come

References

Maulik Mehta is a Sr. Director of Corporate Development for Quintiles. He has over 16 years of international experience across numerous corporate leadership roles. He currently serves as the lead financial and business transaction architect on investment proposals, business transformation projects, and economic / new market development activities globally.

A u t h o r BIO

closing of ‘white spaces’ or gaps in the development cycle that result from handoffs between groups and the review/ reconsideration of previous decisions. This is difficult to accomplish in a projectbased outsourcing approach, where there is limited consistency in the way that development activities are conducted both within and across stages of development. In contrast, the application of consistent outsourcing, oversight, and execution processes across a large set of studies and over a long period of time can result in substantial reductions in study cycle times. For example, in a large-scale partnership between Solvay Pharmaceuticals and Quintiles1 reductions in study cycle times of approximately 40 per cent were realised. Similarly, in an alliance between Eisai Pharmaceuticals and Quintiles, Eisai management noted that the speed at which a number of Phase Ib/II proof-of-concept studies were conducted in partnership with Quintiles allowed Eisai to develop certain compounds at ‘half the level budgeted.’2. While these particular examples and levels of improvement may be exceptional, our experience suggests that these types of broad development collaborations can help pharmaceutical companies generate significant value.

Andrew Bentley is a Director of Corporate Development for Quintiles responsible for conducting non-traditional business development activities and developing partnership-based solutions for Quintiles’ strategic customers. As part of this role, Andrew develops business models and structures that meet customer needs and supports coordination within Quintiles to deliver these solutions. Prasad Velisetty is Senior Director and Therapeutic Strategy Lead for Allergy, Respiratory, Infectious diseases and Vaccines at Quintiles UK. He has 12 years experience of working in clinical research. Practising infectious disease physician with global medical monitoring expertise serves as a strategic therapeutic expert to drug development opportunities.

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Special issue on Partnerships

Where do the current partnering opportunities lie for Pharma and biotech? Because R&D productivity is a problem for pharma the partnering opportunities are basically seen in licensing and acquisitions. There are many opportunities because this year itself you have seen the speed of deal making in the US and in Europe between all kind of companies on one side. You have seen Roche, Merck, GSK, all deals were best which were based on this. With more multinational companies showing interest, the M&A activity in India is expected to go up in the near future. What does this mean for the Indian pharma sector? Do you think it was long overdue? I donâ&#x20AC;&#x2122;t think it is long overdue. It is just that now after Daiichi Sankyo bought Ranbaxy a lot of Indian promoters began to think about should we sell or should we hold on. Because if we hold on, it would

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require a lot of investment and in far away future generics may become increasingly difficult to make money from. It is a big business, but may be if the big pharma enter, the returns may go down. So it is better to sell now when the value is high than later. So one thinking like that has come. In terms of foreign multi-national companies, they also have started thinking last two to three years that India and China are the most attractive markets. And they need to do more to increase the size of their companies here which is actually small. So both from MNCs who want to increase the size in India, and from Indian promoters who may want to cash in, that means that there is a likelihood that the deal may be done. With smaller firms being targeted, where does this leave the big pharma acquisitions that were so rampant not so long ago? Both small and large firms are being

targeted. If you see in recent days there was lot of talk about Wockhardt, Nicholas Piramal in the press. Talking from an Indian perspective, those are large firms. And in the global level, you have seen some billion dollar mega mergers between Pfizer and Wyeth, Merck and Schering Plough. On the contrary, big firms are equally in demand India, along with other developing countries in the Asia-Pacific region, holds huge potential for drug makers. Do you think market is finally getting ready for major players? I think it is getting ready because lot of developments are taking place which, for example, will enable more investment in infrastructure, better quality of pharmacy retail, there are a lot of regulations and legislations in IP that the government is promoting in order to give more IP protection such as in

M&A and Partnerships in Pharma Rising opportunities

Sujay J Shetty Associate Director Pharma Life Sciences Advisory Corporate Finance PriceWaterhousecoopers, India

data exclusivity, clinical trail establishment which will afford more protection and more transparency to outsource and compete in pharmaceutical sector. The environment is and enabling environment at the policy level and at the infrastructural level it is getting much better.

gone up in the last few days, they will continue to expect very high valuations. Indian firms are very richly valued or highly valued. That is one of the reasons why as many deals as should have taken place have not taken place due to promoters wanting excessive valuation / big valuation.

Compared to their European and American counterparts, Indian firms are considered to be undervalued. Do you think this is one of the major factors in bringing multinationals to India? Not at all. I don’t think Indian firms are undervalued. In fact, we are hearing that the valuations are rich. So that is actually one of the reasons for the deals have not been done as much as they should have been done. So, we feel the opposite of this question is true, that, Indian firms are highly valued. In fact because promoters expect unrealistic valuations and now sensex have been

From any Indian biotech / pharma company’s point-of-view, what is better, a partnership or an acquisition? It is difficult to answer because it is different for each company. It depends on the strategies and the objectives of the acquirer. If they feel they have specific skills that they can tap into which can be better addressed in partnership, for example drug discovery, if they want to do drug discovery then may be partnership is better. But if they want to gain scale and gain size in India, then may be acquisition is better. So it is directed towards the objective.

Has the global recession had any effect on this trend? No, because pharmaceutical companies are kind of defensive and anti-cyclical. So they have been seen in a safe bets in this economy. And we have seen that even big mergers like Pfizer-Wyeth, Merck-Schering Plough, which are tens of billions of dollars, have had no problems in raising money for those acquisitions. So, we haven’t seen that much of an impact. Any other comments you would like to make? I think this is very fertile time for M&A environment in India because the market is growing and there is a lot of interest from MNCs both in India and in generic companies. While the pace of deal making may be slow, it can’t be denied that Daiichi and Ranbaxy was a watershed event and we do expect such deals in due course of time.

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Where do the current partnering opportunities lie for Pharma and biotech? Partnering opportunities exist across all segments of the industry, namely, drug discovery, development, clinical trials, data management (IT), manufacturing and marketing. With more multinational companies showing interest, the M&A activity in India is expected to go up in the near future. What does this mean for the Indian pharma sector? Do you think was long overdue? Historically, Indian pharma companies have been founded and managed by owner-entrepeneurs. Consequently, Indian pharma companies are costconscious and responsive organisations. The growth trajectory of the Indian pharma companies began with establishment of Indian Patents Act 1970. However, most companies

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India's growing respect and legal / regulatory framework for IPR, favourable economic policies resulting into attractive investment destination and availability of huge talent pool for sustaining and growing operations is making India an attractive destination for multinationals now.

remained essentially domestic players till 1990. Thereafter, the Indian economy started opening up, and the industry made efforts to integrate with its global counterparts. Increased M&A activity is the consequence. Indian pharma companies have acquired companies abroad and multinationals have made acquisitions in India. To the Indian pharma companies, this brings an opportunity to play on a much bigger turf, and learn to acquire skills to play on a much wider turf. The acquired organisations will expect to see quantum jump in the volume of activities, since most acquirers would like to leverage the cost advantage to supply to global markets. The acquirers would have to learn to â&#x20AC;&#x2DC;quickly digest the acquisitionsâ&#x20AC;&#x2122; and operate in different, challenging and rapidly changing environments.

M&A and Partnerships in Pharma Indian scenario

Ganesh Nayak Executive Director Zydus Cadila, India

With smaller firms being targeted, where does this leave the big pharma acquisitions that were so rampant not so long ago? Large or small, companies are valued for their strategic worth. There has been a healthy debate on ‘sense’ of Big Bang Acquisitions in Pharma Industry for a while. Big Bang acquisitions are difficult to digest. Going forward, wisdom shall prevail. However, as of now, many large pharma companies have made their intent public by announcing that they would stay away from Big acquisitions. India, along with other developing countries in the Asia-Pacific region, holds huge potential for drug makers. Do you think market is finally getting ready for major players? Certainly. With signing of the WTO, and larger part of population agreeing

to honour IPR, markets in Asia Pacific are ready to be a pert in global play. Apart from India and China, countries like Indonesia and Bangladesh have large population bases, varied disease profiles and, now, growing potential to pay. Compared to their European and American counterparts, Indian firms are considered to be undervalued. Do you think this is one of the major factors in bringing multinationals to India? Valuation is one consideration. Indian pharma companies are undervalued and that makes them interesting targets. Acquirers are prepared to pay higher multiples for undervalued assets with huge strategic upside. In addition, what makes India an attractive destination for multinationals now, is, her growing respect—and legal / regulatory framework—for IPR, favourable economic

policies resulting into attractive investment destination and availability of huge talent pool for sustaining and growing operations. From any Indian biotech / pharma company’s point-of-view, what is better, a partnership or an acquisition? Partnering is always a better option from Indian perspective. Has the global recession had any effect on this trend? The ‘Healthcare costs’ feature as the top most concern for most governments in developed world. When their economies are heading southward, healthcare costs have become all the more important. Therefore, recession would only accelerate the need for more efficient players in the healthcare industry, so that, inclusive care can be provided to a wider section of population at lower costs.

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Nanonization of Active Pharmaceutical Ingredients

Illustration 1: DELTAVITAÂŽ 600 with CIP and SIP

The comminution or desagglomeration of Active Pharmaceutical Ingredients (API) is called micronization. Nanonization is a term for reducing particle size to the nanometer range and brings about several advantages. It further increases the surface area of APIâ&#x20AC;&#x2122;s which could result in enhanced solubility and drug bioavailability. Reducing the particle size of an API possessing poor solubility characteristics can lead 28

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to higher specific surface area, thereby increasing bioavailability and dissolution rate. Due to the increased bioavailability a lower amount of API is required which in turn leads to a more cost-efficient product with less risks and side effects for the patient. NETZSCH is an international, successful family-owned German company. The Business Unit Grinding & Dispersing offers equipment for all process

engineering tasks in the fields mixing, dispersing, deaeration, wet- and dry grinding and classifying. Based on comprehensive experience with GMP-conform production of pharmaceutical products all sizes of NETZSCH machines ranging from small laboratory- to production-size machines, illustration 1 shows a medium-size laboratory mill, excel by the following specific features:

• All product wetted parts are manufactured and certified according to FDA standards • Material-, production- and calibration certificates are supplied together with the machine • Optional Sterilization in Place (SIP) • All direct and indirect productwetted surfaces are made of stainless steel • Optional data recording and formulation management. • Password protection operator management providing different levels of security • Laboratory mills can be used with variable grinding chamber sizes • Variable ZrO2, stainless steel 316 or nylon grinding chamber designs on offer • Splash-proof machine stand • Comprehensive testing and qualification documentation including FAT, IOQ, FRS, SDS • Production of GMP compliant machines in the USA • Trainings and seminars. Besides the machine design there are other essential conditions for the successful comminution or dispersion of solids. These are the right formulation of the product suspension as well as the selection of the best grinding media and the optimal operating parameters of the mill. The development of the formulation and the optimisation of the operating parameters can be conducted in laboratory mills. In particular when it comes to the selection of the operating parameters of the mill NETZSCH-Feinmahltechnik GmbH can revert to a pool of experience of more than 6 decades. Illustration 2 shows the development of the particles size distribution of APIs during a grinding test on a laboratory bead mill. The customer aimed at a close particle size distribution with x99,3 < 400 nm. Moreover, the

Illustration 2: Development of the particle size distribution obtained during a grinding test in a laboratory bead

Illustration 3: Results of the scale-up from a laboratory agitator bead mill to a production-size mill

parameters had to be optimised to ensure that the product suspension would not exceed a defined maximal temperature during the comminution process. Once the operating parameters have been optimised the results can be transferred to productionsize mills. An essential parameter for the scale-up is the specific

energy input, which states the energy input with reference to the product quantity produced. Illustration 3 shows the results of the scale-up from a laboratory agitator bead mill to a production-size mill. The illustration clearly shows that the results of the laboratory test can be exactly transferred to the production-size plant.

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Strategic Partnerships and External Innovation

Partnerships and collaborations to create external innovation are an increasing part of the industry landscape. This article highlights some examples of emerging trends in partnership and outlines key areas that can impact performance. We propose that these areas represent the â&#x20AC;&#x2DC;howâ&#x20AC;&#x2122; of external innovation and to maximise success, need an active focus, review and appropriate skill development. Andrew A Parsons, Director, Reciprocal Minds Limited, UK Catherine Carr D, Founder, Catherine Carr and Associates, UK

he last 15 years have seen tremendous changes in the pharmaceutical industry. The significant amount of public and private investment made into sequencing the genome, have brought about some important medical and scientific advances. However, these advances have not resulted in an increase in productivity across the industry. Other industries have undertaken transformative changes to their cycles of productivity. A key change noted in the automotive, telecommunications and other industries is the move to harnessing external innovation as a driver for R&D productivity. As with other industries, an increased reliance on external innovation is emerging to create future value within

R&D pipelines. Following a review of how technology industries changed to meet the difficulties of maintaining growth, Henry Chesborough (2003) coined the term ‘Open Innovation’. This was a way of describing how companies were combining their efforts to harness scientific advances and utilise new technologies to get commercial products to market faster. Strategic partnerships now appear to operate during all aspects of the R&D cycle and a number of different collaboration frameworks have been described within the pharmaceutical industry (Roberston and Mayr, 2011). Collaborations between industry and academic groups have flourished over the past decade with a number of public-private partnerships being formed to provide a kick start to innovation by pooling expertise and knowledge. A change in leadership culture and mindset combined with flexible approaches to portfolio and project management are required (Robertson and Mayr, 2011) to maximise the benefits of these collaborations (Hunter 2010). The scope of strategic partnerships are rapidly changing as a number of independent contract research / manufacturing

solution providers emerge. The growth of the contract research market is striking. One Pharma Magazine report states that the European contract research market reached revenues of US$6 billion in 2011 and is set for growth to nearly US$12 billion by 2018. If strategic collaboration is the new framework for operations within the biopharmaceutical industry, how has the industry changed in recent years and what new capabilities need to be embedded to facilitate growth?

with more local decision making and the solution provider producing products according to agreed milestones. As collaborative partnerships evolve even further to shared risk, the skills needed to work in this co-creative environment and distributed value network require a high level of competency in innovation and communication skills. A key feature of a co-creative collaboration is perhaps developing an engaged and empowered joint culture to equally contribute around a common purpose.

Outsourcing and offshoring

Risk sharing

A focus on reducing cost has supported the growth of the contract research and manufacturing business. The outsourcing or offshoring of activities to a third party supplier has resulted in expansion of the R&D system to evolve core relationships between those who hold or access the intellectual property rights to the product and those who provide a service for its development. The past ten years have seen a change in the way outsourcing initiatives have moved from a service provision model to a more co-creative partnership especially in chemistry and early drug discovery. As a result there is now an increased integration of activities

A frequently used model of risk sharing is setting up Joint Ventures (JV). A JV creates a new entity that may have its own legal and governance framework and its own employees. Examples are numerous and also happening within Asia. These include MedImmune’s development collaboration with WuXi App Tec and AstraZeneca’s JV with Pharmeron to supply chemistry, early discovery and compound screening. Risk sharing between organisations offers companies the advantage of setting up integrated units with an aligned work culture that in turn develops innovative products and ensures cost optimisation.

Changing Face of Partnerships There has been an evolution in the types of collaborations offered with service providers from basic fee-for-service, to dedicated headcount to milestone and finally, to risk sharing deals. At a recent 2013 Bio Asia Outsourcing conference, John Ellingboe from GVKbio discussed how the move to shared risk has driven greater value but also required Contract Research Organisations (CRO) to use different skills and capabilities to develop more integrated collaborations. Partnerships have long been the mainstay of innovation, however there may be many different kinds of partnerships that fall along a continuum. On the one side there is a transfer of a service or commodity; on the other side of the continuum is a joint building of the product co-creatively.

These partnership types necessitate varying skills and capabilities required within the relationship to maximise efficiency and effectiveness. For example, a service provider relationship is one where one or more partners provide a service or commodity to the other(s). This may involve high volume and cost, which will drive a needed capability and skill focus on efficient, highly organised and streamlined business processes. Communication between the partners ensures that there are no preventable delays in delivery of the work product. In contrast, a co-creative collaboration is one where both partners contribute to technological innovation in a more bespoke manner, providing adaptive skills and expertise in partnership with the other to produce what neither can do alone.

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Special issue on Partnerships

Opportunities & Challenges Collaboration and strategic partnerships are becoming the new norm. Each company will need to identify its strategy and develop appropriate management systems to allow flexible collaborations. Furthermore, companies must develop staff to ensure the right mix of skills and attitudes to maximise output. There are a number of challenges to overcome still. With large pharma companies are focussing their internal investments and placing more bets on collaboration within a From service provision to co-creation

Alternative approaches to sharing risk are also being developed within the pharmaceutical and investment community. Many multinationals have their own corporate venture funds However, some are now contributing R&D dollars into venture funds such as Index Ventures and Sanderling Venture. These co-creative collaborations in sharing the risks of early stage biotech will hopefully result in a more productive use of early R&D funding. There is also an opportunity to develop the co-creation model even further. Innovation is certainly coming of age as pharma, academia, biotech and the investment community approach risk sharing opportunities that foster an environment for growth. Innovation: Internal vs. External The past decade has seen a consolidation of external innovation across the bio-pharma industry with an increased balance between home grown and licenced projects progressing through pharma pipelines. The industry will likely consolidate even further into one that leverages external investment, resources and expertise. The dissolution of the larger R&D organisations has also led to a diffused network of knowledge across service providers. Different values and

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diminishing venture capital system, will the return on investment be maintained for all parties? How will players in the ecosystem realise both short and long term value with access to the marketplace becoming based on value? One bright possibility on the near horizon is personalised medicine initiatives that bring the right medicines to the right people but we must ask, at what cost? It is likely that with more complexity in the innovation cycle these issues will be addressed as each partnership develops.

beliefs or mindsets are now required for those working in an independent service or solution provider to those of a scientist working within an internal organisation. Champions of projects are now multi-fold and complex. Projects begin with an initial ‘idea’, leading to a start-up company through to optimisation and various investment stages into development and finally, late stage development. The skills of scientists working in the industry now need to flex beyond deep technical skills to include ability to

access technology from multiple sources. Harnessing diversity is a key competency in scientists that work in this environment (Holtzman and Anderberg, 2011). Further these technical leaders must focus on the common goals and move away from monetary rewards (Antikainen et al., 2010; Pink 2010). Recent work has demonstrated that connection and building trust or shared experience is a vital part of generating creativity across cultural domains. Therefore, the skills of building and maintaining trust and

Pharma Partnering Deals in China – by Stage

2012 bounced back after 2011 slowdown Deal value more than doubled to US$32 million Source: ChinaBio® Consulting

Greg B. Scott President and Founder, ChinaBio® LLC

an interpersonal competence are likely to be necessary as the cultural diversity of an innovation ecosystem grows (Chua et al., 2012). As the industry continues down this track of balanced internal and external innovation there will be key challenges to overcome. One of these will be how to ensure focus on making co-creative collaborative working environments maximise efficiency and growth for those involved in innovation systems. Delivering the strategy

Partnership teams today need to be both internally responsive, at the same time adapt to and partner well with other teams. Thus, companies are learning to collaborate in co-creative partnerships to achieve mutually desired outcomes. Effective management of the collaboration has been a traditional focus of effort within strategic partnerships (Hughes and Weiss 2007) and even seen as a source

of competitive advantage (Ireland et al., 2002). Key areas of the skills needed for success in strategic partnership or collaboration are outlined below with high performing team and co-creative group traits. Trust

It takes a long time to build trust and a moment to destroy it. However, trust is critical to high performing co-creative groups and teams that must come together quickly, work in somewhat ambiguous circumstances, assume good intent, and be collaborative in style. Trust is built through being consistent and reliable, respectful, open, and honest (Larson and LaFasto, 1989). Once these basics are in place, team members will be more likely to cooperate, share knowledge and be able to generate business results as a shared vision, clear roles and responsibilities and processes will develop (Hackman and Wageman, 2005).

Resilience

Change is constant in co-creative partnerships and thus individuals must find ways to cope with letting go of the familiar. As change is stressful, one protective factor to keep in mind is peer support. Peer support has been shown to reduce health problems, decrease personal stress, and is a leading driver of team engagement and performance (Corporate Leadership Council, 2011). Motivation and engagement

Engagement is an essential prerequisite for high performance. The Gallup Q12, which studied over one million employees and y (xx), identified 12 key expectations that were predictive of engagement. Gallop emphasised that peer support and feedback was a key motivator for what makes work worthwhile. Building mechanisms for feedback and support are therefore a vital consideration for co-creative

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Leadership and management

Leaders need to see the way, show the way and walk the way. These attributes and behaviours are critical to building a shared purpose amongst team members and developing the best approach to execution of its work. Research has demonstrated that high performance is linked to well-rounded teams. This is a challenge given that teams are typically assembled quickly rather than carefully constructed. Therefore, it becomes critical for the collaboration team to be aware of where there are gaps in its knowledge and experience base. The big three leadership competencies of results focus, people orientation and thought leadership are needed. Some specific competencies sought after include high emotional intelligence, creative and strategic thinking, agility, change management and entrepreneurial courage. Emotional intelligence is particularly predictive of leadership ability (Offermann, et al., 2004). Carefully selected for and developed across the leadership team, competencies reflect, communicate, and foster the evolution of that organisationâ&#x20AC;&#x2122;s culture. Professional and developmental growth

Invest in strengths rather than focus on areas to improve. A focus on only improving faults results in a low engagement score of the workforce. However, a focus on building on the strengths of the team significantly increases engagement to nearly 3 out of 4 members (Gallop Q12 study in Buckingham and Coffman, 1999).Â From an organisational perspective, team members who develop their emotional intelligence ability are known to improve performance (Naseer et al., 2011). Constructive communication across cultures

Building on strengths does not mean ignoring differences or discouraging disparate 34

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views. On the contrary, healthy teams are strong enough to withstand some task conflict, are open about alternative possibilities for viewing and doing and know that the best answers include many minds thinking in different directions. These high performing teams also extend these skills to their engagement with other stakeholders and parties in the ecosystem. Culturally intelligent individuals and teams that are capable of communicating across cultural differences are essential. Characteristics of these individuals and teams are to be curious, open, willing to learn and appreciative of differences. Also an ability to exercise clear communication with sensitivity to differing cultural preferences, including organisational, ethnic, age, geographical location and gender differences to name a few. Team processes

Team processes are ever changing in todayâ&#x20AC;&#x2122;s environment. After over 20 years of studying teamwork, Edmondson (2011) concluded that the focus needs to be on how teams and groups work together, in a dynamic environment, and build abilities of adapting to dynamic environments. The skills needed include: interpersonal awareness, appropriate skillful inquiry, and an ability to teach others what you know. Team processes to maximise collaboration should focus on sharing crucial knowledge quickly, asking questions clearly and frequently to make small adjustments through which different skills and knowledge are woven together into an effective and dynamic process.

A u t h o r BIO

collaborations as peer factors lead to greater engagement, motivation and productivity.

Risk and innovation

Co-creative teams must mitigate risk carefully to prevent actual threats while encouraging innovative opportunities. Clear articulation of risks allows them to be avoided, reduced or accepted. At the same time teams want to encourage innovation. Risk and innovation go hand in hand and an understanding of the strategic and practical needs of the customer is integral to success. Team networks often include a broader group of stakeholders to oversee the whole innovation to market process. Teams need to be permeable and engage in the broader community. Conclusions

Strategic partnerships are continuing to evolve within the pharmaceutical industry and collaborations need to align different work values and cultures to maximise the collective intelligence. To support this approach, the authors are making available an open source tool called the Adaptive Team Assessment (ATA). This tool supports co-creative groups to assess their functioning in six domains as outlined above. Success in the new world of partnership will require individuals and organisations to flex their existing cognitive and emotional intelligence skills and strengthen all skills to ensure a focus on not only the technical but people element of the collaboration. References are available at www.pharmafocusasia.com

Andrew A Parsons is the Director of Reciprocal Minds Limited and an Executive and Collaboration Coach. Formerly he was a Research Pharmacologist and Vice-President External Development. He was a founding member of the Centre of Excellence for External Drug Discovery in GlaxoSmithKline and currently a Non-Executive Director for Start-up Biotech. Catherine is a Professional Certified Coach and Consultant with Catherine Carr and Associates. She holds a doctorate in leadership and coaching from Middlesex University, UK, and is considered an expert on team coaching. She is the author of an upcoming journal article on team coaching in the International Coaching Psychology Review.

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CHINA-PHARM 2013 Back to Shanghai

Opportunities lie ahead for the pharmaceutical industry Co-organiszed by China Center for Pharmaceutical International Exchange and Messe Düsseldorf (Shanghai) Co., Ltd., China International Pharmaceutical Industry Exhibition (hereinafter referred to as CHINA-PHARM) is an annual event held in Beijing and Shanghai alternatively. Following last year’s success in Beijing National Convention Center, CHINA-PHARM 2013 will return to Shanghai and be staged from October 29th to November 1st at Shanghai New International Expo Center. Covering a space of around 25,000 sqm, CHINAPHARM 2013 is expected to attract over 400 leading Chinese and international brands as well as over 20,000 trade visitors, 15 per cent of which come from overseas. At the beginning of this year, exhibitor recruitment of CHINA-PHARM 2013 is off to a good

start. Since application for regular exhibitors kicked off on January 1st, Hall W5 has been booked out within just one month and only limited space is available at Hall W4 at present. This shows not only the exhibitors’ satisfaction with outcome of participation in the previous events, but also rosy prospects for the Chinese economy and a booming pharmaceutical industry. To increase popularity and present a more international and professional event, CHINA-PHARM 2013 places special focus on communication and exchanges with exhibitors and visitors. In order to provide exhibitors with top services, organiszers of the event actively visited major exhibitors in Shanghai, Beijing, Hunan Province and Guangzhou, among other places, to identify their needs, exchange latest

For more information, please visit: www.china-pharm.net Media Contact: Flora Zhu, Messe Düsseldorf (Shanghai) Co., Ltd Tel: (86 21) 6169 8300 Fax: (86 21) 6169 8301 Email: press@mds.cn Bridget Hao , China Center for Pharmaceutical International Exchange Tel: (86 10) 82212866 Fax: (86 10) 82212857 Email: chinapharm@ccpie.org

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industry trends and share preparation progress of the event. In the meantime, organiszers also devoted more efforts to attracting visitors. Around 10 promotional campaigns will be launched in China to learn about suggestions and advice from potential visitors through face-to-face communication. This will help attract more enterprises and potential target visitors to participate in the event. Over the recent years, the China pharmaceutical industry has experienced rapid growth and formed a huge market with wide circulation and extensive development. According to statistics, the annual growth rate of the pharmaceutical industry reached 23.3 per cent during the 11th Five Year Plan period. RMB 1.5 trillion yuan of total output in 2011 demonstrated strong momentum in the industry. In November 2012, the National Development and Reform Commission announced an output value for the first 10 months of nearly RMB 1.46 trillion yuan, an increase of 20.7 per cent year-on-year. During the 12th Five Year Plan period (2011-2015), the annual growth rate of China pharmaceutical industry is estimated to be over 20 per cent. By 2015, China will become the worldâ&#x20AC;&#x2122;s second largest pharmaceutical consumption market. CHINA-PHARM 2013 will closely follow the latest trends in the pharmaceutical industry and enhance communication with exhibitors and visitors to further promote the event. Being a customer- and service- oriented event, CHINA-PHARM 2013 will also serve as a platform for all pharmaceutical companies to communicate

and cooperate with each other. This platform will showcase leading technologies and products and offer authoritative information that help create more business opportunities for the pharmaceutical industry. CHINA-PHARM 2013 strives to become the top industry exhibition not just in Asia, but also around the world. The auspicious Year of Snake harbingers prosperity and a fresh start. As we bid farewell to 2012, we sincerely invite all established and potential customers and industry friends to join us in Shanghai for CHINA-PHARM 2013 that brimming with opportunities and challenges.

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Choose very carefully Pharmaceutical-Tech.com is the online platform of choice for pharma decision makers seeking to create fruitful partnerships and stay abreast of the day-to-day developments in the pharmaceutical industry. 38

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Suppliers who made the right choice A Choksey Chemical Industries 0091 22 22673868 / 22674006 achokseychemical@rediffmail.com ACE Chemicals 0091 080 51240325 / 26, 22273541 / 42 bhavyadoshi@acechemicalsindia.com www.acechemicalsindia.com Ace Process Equipment 0091 22 4021850 sales@aceeqpt.com www.aceeqpt.tradeindia.com Anil Printers Limited 0091 0253 2382388 / 2382488 anilprintersltd@rediffmail.com www.anilprintersltd.com Anish Pharma Equip. Pvt. Ltd. 0091 253 2381831 ravi_samant@rediffmail.com www.anish.org Aseptic Projectss 0091 22 2374 1072 / 2372 2064 info@asepticprojectss.com www.asepticprojectss.com Bang & Olufsen Medicom a / s 0045 96 84 58 00 medicom@bang-olufsen.dk www.medicom.bang-olufsen.com BIT Life Sciences, Inc 0086 411 84799609–827 charles@bitlifesciences.com www.bitlifesciences.com Bharat Box Group 0091 11 22528066 rachit_agg@rediffmail.com www.bbfgroup.com Biocultr BV 0031 71 521 5443 biocult@sandtcourses.nl www.biocult.com BIT Life Sciences, Inc 0086 411 84799609 leo@bitlifesciences.com www.bitlifesciences.com Bonfiglioli Engineering 00356 2148 2206 h.carbone@bonfiglioliengineering.com www.bonfiglioliengineering.com Brevetti Angela Srl 0039 0444 474200 info@brevettiangela.com www.brevettiangela.com Chemische Werke Hommel GmbH & Co KG 0049 2591 2305-0 info@hommel-pharma.com hommel-pharma@directbox.com Choksi Laboratories Limited 0091 731 2493592 / 3 info@choksilab.com www.choksilab.com Crystal Pharmatech Co Ltd 0086 512 69369978 alex_chen@crystalpharmatech.com www.crystalpharmatech.com DeltaT GmBH 0049 641 48092 40 info@deltaT.de www.deltaT.de Dr. Lauterbach & Partner 0049 0 6332 / 485 0 sales@dr-lauterbach.de www.dr-lauterbach.de EFD Inc., 00401-434-1680 ETS Nederland BV 0031 0 575 545500 info@toxicology.nl www.toxicology.nl Fem Care Pharma Ltd 0091 0253 2390278 / 2375886 fempmt@yahoo.co.in www.femcareworld.com

GleneaglesCRC Pte Ltd 0065 6317 2363 dy_sadasivan@gleneaglescrc.com www.gleneaglescrc.com GMP Technical Solutions 0091 22 6608 3700 enquiry@gmptech.net www.gmptech.net Guava Technologies 001 510 576 1400 info@guavatechnologies.com www.guavatechnologies.com Haldies Chemicals Pvt. Ltd. 0091 2117-235356 / 235661 info@halides-pltd.com Health Protection Agency 0044 1980 612100 business@hpa.org.uk www.hpa.org.uk / business / High Class Art Intl Co Ltd 00886 4 2371 5313 info@highclassintl.com www.highclassintl.com HMG India 0091 22 28549059 / 28408699 response@hmgind.com www.hmgind.com Hrushikesh Water Sciences Pvt. Ltd 0091 20 27451031 / 46703689 info@watersciences.biz www.watersciences.biz Isuta (Malaysia) Sdn.Bhd 00604 3982 770 enquiry@isuta.com www.isuta.com J K Industries 0091 2764 227975 info@jkindus.com www.jkindus.com Kores (India) Limited 0091 22 27613444 korescd@vsnl.com www.korescd.com Lao Soung Machinery Co, Ltd 00886 229900668 laosoung@ms10.hinet.net www.laosoung.com.tw Lomapharm® Rudolf Lohmann GmbH KG 0049 51 55 63 208 sales@lomapharm.de www.lomapharm.de Lotus Labs Pvt Ltd 0091 80 22370912 / 13 / 14 ychugh@lotuslabs.com www.lotuslabs.com M.H. Material Handling S.r.l. 0039 02 96720176 info@mhmaterialhandling.com www.mhmaterialhandling.com MachinePlatform 0031 0 79 3317121 info@machineplatform.com www.machineplatform.com Madison Communications Pvt Ltd 0091 11 40551500 / 1600 rawat@del.madisonindia.com www.madisonindia.com Matrix Laboratories Limited 0091 40 27700363 / 30496427 mbsugar_nsk@sancharnet.in www.matrixlabsindia.com MB Sugars & Pharmaceuticals Ltd. 0091 2554 251 883 mbho@mbsugars.com www.mbsugars.com Mercury Manufacturing Company Ltd 0091 44 2262 8002 / 2262 8593 info@mercuryfurniture.com www.mercuryfurniture.com Meridian Enterprises Private Ltd. 0091 22 66084200 / 66084210 office@meridianentp.com www.meridianentp.com

Merck and Co Inc 001 215 652-2937 janet_schneider@merck.com www.merck.com Messe Dusseldorf 0049 211 / 4560-01 contact@ppccro.com www.messe-duesseldorf.de Micro Therapeutic Research Labs Pvt. Ltd 0091 44 2223 8846 / 56 / 65 info@microtheraps.com www.microtheraps.com Morepen Laboratories Ltd 0091 11 233 24443 / 237 12025 sales@morepen.com www.morepen.com Nitika Chemicals 0091 712 2641001 rskhurana@nitikachemicals.com www.nitikachemicals.com Notox B.V. 0031 (0) 73 640 67 00 notox@notox.nl www.notox.nl Pack Cheon Machinery Co. Ltd 0082 32 517 8014 packon@packon.com www.packon.com Padm Industries 0091 22 28593909 / 28520271 vaibhav_cjp@yahoo.co.in www.indiamart.com / padmindustries Palam Pharma Pvt. Ltd 0091 79 25831892 / 25890579 palam@icenet.net www.palampharma.com Pall India Pvt Ltd 0091 80 40164100 anand_subramanian@ap.pall.com www.pall.com Panoli Intermediates India Pvt. Ltd 0091 11 26174227, 26196368 varmasamir@yahoo.comwww. panoliindia.com Parag Exports 0091 265 2641098 parag_exports@yahoo.co.in www.paragexports.com Parth Engineers & Consultant 0091 79 25841154 info@parthec.com www.parthec.com Parexel International 001 781 434 5305 Sean.McIntosh@parexel.com www.parexel.com PG Foils Limited 0091 2937 2871151–55 pgfoils@pgfoils.in www.pgfoils.in Plus Creations (P) Ltd 0091 130 2366516 sales@pluscreations.org www.pluscreations.org Prachi Pharmaceuticals Private Ltd 0091 22 24132411 prachint@bom7.vsnl.net.in prachint@vsnl.com Pratham Technologies Pvt. Ltd. 0091 20 24355765 prathamtech@vsnl.com www.prathamtech.com Precikot Pharma Pvt. Ltd. 0091 250 2457011 info@precikot.com www.precikot.com Prime Pharmaceutical Sdn Bhd 00604 5074787 / 5074788 primep@streamyx.com www.primepharma.com.my

Protech Pharmaservices Corporation 00886 2 2657 7777 contact@ppccro.com www.ppccro.com PRTM 0081 3.5326.9090 infojp@prtm.com www.prtm.com Radpharm Scientific 0061 2 6251 6533 www.radpharm.com.au Recon Machine Tools Pvt. Ltd. 0091 22 26875931 sales@reconmachine.com www.reconmachine.com Romaco AG info@romaco.com www.romaco.com Royal Artist 0091 22 28320800 response@royalartist.com www.royalartist.com S.Zhaveri Pharmakem Pvt Ltd 0091 22 66 60 7756 / 57 vikas@szhaveri.net www.szhaveri.com Saeplast 00354 460 5000 saeplast@saeplast.is www.saeplast.com Samex 0091 261 2590950 / 25934203 info@samexoverseas.com mehul_jhaveri@hotmail.com www.samexoverseas.com Santapet Polymers Limited 0091 22 2342 0381 info@santapetpolymers.com www.santapetpolymers.com Saz Boilers 0091 20 26970840 saz@vsnl.com www.sazboilers.com Servotex Engineers 0091 22 28454982 servotex_engineers@yahoo.com www.indiamart.com / servotexengineers Shakti Pharmatech Pvt. Ltd. 0091 2717 250405 sales@shaktipharmatech.com. www.shaktipharmatech.com Shiv Shakti Process Equipment Pvt. Ltd. 0091 22 26768480 office@shivshaktiequipments.com www.shivshaktiequipments.com Sigpack Systems AG 0041 52 674 65 00 www.sigpack.com Skan AG 0041 61 485 44 44 info@skan.ch www.skan.ch Speciality Meditech Pvt. Ltd 0091 141 5105136 speciality_meditech@yahoo.com www.indiamart.com Spectrum Pharmatech Consultants Pvt. Ltd. 0091 22 25977000 hemant.lokare@spectrumpharmatech.com www.spectrumpharmatech.com Srinidhi Engineers 0091 22 28497424 / 32964483 srinidhirk@gmail.com www.srinidhiengineers.com Stamfag Punching Tools 0041 44 914 35 35 info@stamfag.ch www.stamfag.ch Starcom Mediavest Group 00971 4 4276435 Samar.jalil@dubai.starcomworldwide.com www.smvgroup.com

Sujyot Engineering 0091 79 25856044 / 26639686 info@boxstrappingmachine.com www.boxstrappingmachine.com Superlite Lighting Co. Pvt. Ltd 0091 22 26852822 info@superliteindia.com www.superliteindia.com Swami Vessels Pvt. Ltd 0091 257 2211294 / 2211447 response@swamivessels.com www.swamivessels.com Syngene International Pvt. Ltd. 0091 80 2808 2808 / 2783 2169 arun.nataraj@biocon.com www.biocon.com Trebing & Himstedt Prozessautomation GMBH & Co 0049 385 39572-0 sinkmann@t-h.de www.t-h.de Turchette Advertising Agency 001 73 227 8080 rsiciliano@turchette.com www.turchette.com Tyagi Air-Wave Equipments Pvt. Ltd 0091 120 2820548 / 2829333 tyagiairwave@yahoo.co.in www.airwaveindia.com UBM India Pvt Ltd 0091 22 66122600 bhaskar-chivukula@ubm.com www.ubm.com Uma Brothers 0091 22 25004510 / 25004579 umabros@vsnl.com www.umabrothers.com UPM-Kymmene India Pvt. Ltd. 0091 22 2767 0031 Santosh.Kumar@upmraflatac.com www.upmraflatac.com Vertis Biotechnologie AG 0049 8161 141 12 11 www.vertis-biotech.com Wintech Pharmachem Equipments Pvt. Ltd. 0091 250 2456495 winpharma@vsnl.net www.wintechpharmachem.com WLE Technology Sdn Bhd 0060 3-7845 0598 / 0798 enquiry@wengloong.com www.wengloong.com Yogesh Pharma Machinery Pvt. Ltd. 0091 79 40233800 to 804 bizypmpl@gmail.com www.pharmaequip.in Zenithmedia GmbH (Siemens) 0049 89 71 05 18 0 Henning.Kittner@zenithmediamuenchen.de www.zenithmediamuenchen.de

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Special issue on Partnerships

On the Partnering Path from the US to Asia How far, how fast for universityindustry collaborations?

In the US, the expansion of partnerships was a natural outgrowth of the historical trends of biotech spinoffs arising from university labs and researchers at academic medical centers already being engaged in industry-sponsored drug and device clinical trials. The origins of university-industry collaboration in Asia were more varied in terms of when and why they came about, as reflected in the subsequent diversity of their roles in shaping the regionâ&#x20AC;&#x2122;s evolving biomedical R&D landscape. Christopher-Paul Milne, Director, Research, Center for the Study of Drug Development, Tufts University Medical School, US

espite decades of success in bringing new medicines to market, the industry, comprised of Multinational Companies (MNCs) producing brand name biopharmaceuticals, has been increasingly challenged since the turn of this century to maintain that level of success. The challenges occur at every stage of R&D and continue throughout a productâ&#x20AC;&#x2122;s life cycle. At the discovery stage, there has been an explosion of knowledge in the basic biological

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sciences that has outpaced the capacity in the applied sciences leading to escalating difficulty in bringing promising investigational compounds from the discovery and preclinical stages into exploratory clinical development. This in turn has led to high attrition rates for molecules in development and low success rates for product approvals. This has occurred while R&D spending has approximately doubled every 8.5 years since 1970. With better and more rapid means for iden-

tifying safety risks, there are increasing regulatory requirements for quantifying these risks pre-approval and for managing them during the post-approval period. A growing emphasis on maximising the medical utility of products has resulted in heightened reimbursement thresholds and increasing demands from payers to demonstrate cost and comparative effectiveness both pre- and post-approval. Shrinking revenues as a result of patent losses of top-selling products and the shift

toward increased utilisation of generic medicines has exacerbated an already challenging business environment, in which the top 10 per cent of new drugs account for more than 50 per cent of the value of all new drugs launched in the same period, and only two out of ten medicines cover the average costs of new drug R&D. With the increasing focus on addressing complex, and challenging diseases the need to pursue novel strategies has never been greater. Strategies adopted by industry to improve productivity are both extrinsic and intrinsic in nature. Among the extrinsic strategies that industry pursues are Mergers and Acquisitions (M&A), joint ventures and licensing to increase access to promising markets, technology platforms, and products. On the intrinsic side, they are implementing such measures as portfolio optimisation (i.e., balancing research projects to minimise risk while maximising potential for return on investment), integration of new technologies and development tools, and selection of appropriate milestones for assessing success of projects in progress. All this in the pursuit of better decision-making â&#x20AC;&#x201C; about which targets to pursue, when and how to terminate specific development programmes, how to efficiently allocate resources, and what type of development portfolio to build.

Breakdown of grant types 11% 14% 75%

Figure 1

Joint clinical trials by type (per cent of trials) 0.31% 0.69% 0.43% 0.77% 2.92%

5.56%

7.69% 12.38%

71.54%

Note that the data for this figure was drawn from an analysis of postings on <ClinicalTrials.gov> for the same AMCs during the same time period, and is likely representative of the breakdown of intervention types in the Joint Clinical Trials subset of the CSDD database. Figure 2

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Evolution of AMC-Industry Partnership Models Emerging in the future Risk-sharing Competition grants Increasingly popular in the present Corporate venture capital funds Academic drug discovery centers Commonly used in the past Unrestricted grants Fee-for-service Figure 3

Academia-industry partnerships in the US

While the litany of challenges faced by innovative biopharmaceutical companies continued to increase over the last decade, academic institutions in the US have faced their own fiscal challenges from reductions in state and federal funding. Among the approaches taken by industry and academia to adapt to the new R&D environment is to increasingly engage in academic-industry partnerships. To examine this rapidly changing facet of the evolving R&D paradigm, the Center for the Study of Drug Development at Tufts University School of Medicine in Boston (Tufts CSDD) conducted a study of grants provided by industry to Academic Medical Centers (AMCs) in the US. The two primary goals of the Tufts CSDD study were: 1) to examine a sample of primary data and typify the kinds of research projects that academicindustry partnerships actually entail— ‘the what’; and 2) to review secondary data from the trade and professional literature as well as public and private

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sector websites to describe and categorise the organisational nature of these partnerships—‘the how.’ In terms of ‘the what,’ CSDD reviewed primary data from 3,278 grants (2008-2010) involving close to 450 industry sponsors and 22 medical schools in 15 states and determined that they fell into three major classifications: conventional clinical trials focused on new drugs / indications (75 per cent ); studies targeting public health priorities (14 per cent); and, health research and education projects (11 per cent), as shown in Figure 1. The majority of grants (75 per cent) were termed joint clinical trials that were by-and-large conventional clinical studies or trials conducted by AMCs with industry support for a particular investigational compound or device. Of those grants, over 90 per cent pertained to drug, device or biologics as shown in Figure 2. Approximately one-sixth (14 per cent ) of grants were comprised of four categories of clinical studies that Tufts CSDD researchers recognised as public

health priorities in the US: • Comparative clinical studies in which two or more treatments are compared with one another • Oversight studies (long-term, registry, and pre-clinical) in which privacy, patient care and open science concerns dictate that AMCs are the most appropriate venue in which to conduct such efforts • Vulnerable population studies for which AMCs can provide the optimum environment for patient care (compassionate access, elderly, neonatal, and minority patients) • Breakthrough investigations (nanotechnology, translational, and pharmacogenomics) in which AMCs can provide an environment for precompetitive collaboration and cross-disciplinary fertilisation. HR&E projects (11 per cent) were collaborations that were not clinical trials or studies focusing on a particular product, but involved a range of activities listed below: • Basic Medicine: Foundational studies of disease or drug impacts on patients) • Education (full spectrum of teaching and learning opportunities beyond basic medical school curriculum • Patient-Centered: Focuses especially on vulnerable or underrepresented patient populations utilising direct measures of patient response, e.g., patient preferences, patient-reported-outcomes, quality-of-life, etc. • Translational: Translation of basic to applied research, especially involving biomarkers, bioimaging and bioinformatics projects • New Technology: In particular pharmacogenomics, novel diagnostic tools and nanotechnology • Training and Services: Broad-based or specific programs for utilisation and / or training related to specialised equipment, laboratory and/or medical services. Secondary data from a variety of sources including company websites, newspaper articles, academic arti-

University-industry collaborations in Asia

While the US is still the global leader in terms of R&D investment, the economic contribution of biomedical innovation, particularly biopharmaceutical R&D, is increasingly seen as an area of opportunity for other countries. China and India, in particular, are investing billions to build an R&D infrastructure modeled after the US system. In similar vein, the academic-industry partnership model in the US is increasingly being viewed as a necessary correlate in the calculus of global competitiveness. The major industrial countries of Asia have a variable history when it comes to what are typically termed University-Industry Collaborations (UIC) in the region, as exemplified by the course of UIC development in the following countries. Japan Although Japan never really developed a biotech sector and utilised academia as its source for certain areas of biopharmaceutical innovation, it did not become serious about UIC until the 1990s when it began to lose competitiveness with the US in Information Technology (IT) and biotechnology. It also felt that South Korea and China were beginning to threaten its global competitiveness. On the part of the university sector, they felt that they were falling behind foreign academia because they were not interacting with industry, but still exhibited caution regarding any compromise of their educational and scholarship mission for the sake of commercial enterprise. In 2004, however, public universities experienced a change of legal status in which they became independent administrative agencies. While this resulted in greater control to manage their own affairs, it also necessitated greater accountability for ensuring efficient operations and contributing to the social good and hence to participate in UIC. China From the beginning of the communist regime in the 1950s universities were required to freely transfer their knowledge for the benefit of the struggling economy without much regard for â&#x20AC;&#x2DC;ownership.â&#x20AC;&#x2122; Once a certain plateau had been achieved, however, and the state of shortage abated, China enacted a reform law in 1985. This was a turning point for their policy on science and technology. Universities would be allowed to make their own decisions based on market conditions regarding organising R&D programs and transferring

technologies, while the government shifted its role away from command-and-control to one of guidance and oversight. Korea Korea took yet another path by jumping quickly from a labor-intensive economy to one based on high-tech and IT, implementing laws to foster UIC as a means to more efficiently playing catch-up in addition to focusing its own resources on basic R&D and opening its innovation system to foreign R&D. Singapore Singapore was competitive in the international marketplace early on, and by the 1990s had already reached a high level of industrial development. However, it soon found that its strategy of utilising cheap manufacturing labor was becoming unsustainable long-term. To facilitate the transition to a more knowledge-based economy it used its existing academic powerhouses, the National University of Singapore and Nanyang Technological University, to expand and exploit UIC. India Over the past ten years, India has moved from a planned and closed economy to a more open and deregulated one. In the area of science and technology, the vehicle for this transition was the implementation of the S&T policy of 2003, which resulted in gradual development of UIC, but overall there were few of them, and most were consultancies, not involving large-scale projects. India R&D is still mostly skewed towards basic research and the majority of quality application-oriented R&D is being done by big MNCs in-house for their own benefit. Yet, the number of R&D centers and R&D talent pool have experienced a CAGR of 30 per cent and 16 per cent respectively from 2004 to 2010, and though the total R&D spending in India is about 0.95 of the national GDP ($1.73B), Âž of it comes from the public sector. Thailand Thailand has experienced a high level of economic development in recent years, especially owing to foreign direct investment in manufacturing. However, its indigenous private sector does not invest greatly in R&D, so UIC has a limited history and there is no overarching policy framework for how UIC should work.

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Examples of university-industry collaborations in Asia-Pacific Country/University

Industry Partner

Area of Research

Australia / Queensland University

J&J

spider venom for chronic pain

University of Hong Kong, Nat’l Univ. of Singapore

Lilly, Merck & Pfizer

role of Hepatitis B in liver cancer

China / Peking University Cancer Hospital

Aushon Biosystems

biomarkers in cancer

Sichuan University West China School of Stomatology

C3 Jian

clinical research in stomatology

USA / University of California-Davis

Beijing Genomics Institute (BGI)

genomics

Japan / Kyoto University

Takeda Pharmaceuticals

endocrine and neurology

USA / Columbia University

China Institute of Strategy & Management Lanmeng Investment

autoimmune disorders

UK / University of Edinburgh

BGI (China) in Q3 2012

genomics and bioinformatics

Japan / Hirosaki University

Ezose Sciences (USA)

biomarkers for prostate and other urological cancers

China / Tsinghua University’s School of Life Sciences

BMS

oncology, immune-science and discovery research focusing on mapping 3D protein structures of biological molecular targets

China / Fudan University School of Pharmacy

HUYA Bioscience International

drug design and synthesis through the computer modeling of 3-dimensional structures of enzymes such as sphingomyelin synthase (SMS)

China / Bio-X Center of Shanghai Jiao Tong University

Qiagen (Germany)

translational medicine collaboration for biomarker validation and analysis

cles, investor analyses, and consultant reports were employed to describe ‘the how,’ i.e., the actual ways and means of the working relationships between of Academic Medical Centers (AMCs) and their industry partners. The landscape of partnerships and alliances funded through grants is highly diverse, with partnerships varying greatly in size and scope, depending on the nature of the agreement as well as the individual biopharmaceutical company or university involved. As Figure 3 indicates, there has also been an evolution in the scope and nature of these partnerships over time. Anecdotal reports suggest that the ‘old model’ of unrestricted grants and fee-for-service, which generally constituted the mainstay

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of academic-industry partnerships historically, are actually on the wane in the US. While it is generally accepted that these partnerships have become an increasingly favoured approach both to promote public health objectives and to produce healthcare innovations, many also believe that their full potential have yet to be realised, and there must be wider adoption of newer risk-sharing, resource-sparing partnership models. Currently, popular trends involve Corporate Venture Capital (CVC) funds, which are established by but organisationally distinct from the MNC, as well as academic drug discovery centers, in which the prime mover is the academic institution itself. Competition grants are an emerging format for

Table 1

partnering that encourages universities to allow a company to assess the potential of their investigational compound for further development and have the right of first refusal for ones selected. Similarly on the upswing are risk-sharing arrangements in which companies and academic institutions share the control of a research project and split the contribution of resources and assets. Despite coming at it from different perspectives and variable speeds, there is a general awareness in the region of the value and necessity of UIC. Over the past 20 years, Asian governments have paid increasing attention to the effectiveness of their national innovation systems, in particular, UIC, regardless

Pharma Partnering Deals in China – by Stage

Number of cross-border deals rising rapidly, up 48%; 87% of deals in 2012 are cross-border Source: ChinaBio® Consulting

Greg B. Scott President and Founder, ChinaBio® LLC

venture development, and material transfer agreements. Yet, a brief litany of UICs from the 2011-2012 issues of The Burrill Report indicate the geographic breadth of partners and the topical depth of recent collaborations (see Table 1). Also, the emerging economies sometimes benefit from ironic ‘skipping’ phenomena while rushing to embrace the brave new world of technology. For example, China is the largest user of the latest generation of mobile phones even though just a halfgeneration ago most people in China didn’t even have landlines, while South Korea is the most advanced user of broadband technology even though it never produced mainframe computers. Conclusion

Maintaining productivity in medical research is critical for the health of the economy as well as competitiveness in A u t h o r BIO

of their per capita income that ranges from $35k in Japan to as little as 1/10 of that for other countries in the region. Three macro level drivers of this imperative are: globalisation; increasing global competitiveness; and the need to take full advantage of the advent of the knowledge-based economy. At a more micro level, industry motivation is similar to the US: access to academic labs, equipment and fresh talent with new perspectives without having to spend their own funds on capital investment and training, and without competing with their core area of business. Universities are motivated by the need for funding, to keep abreast of practical problems and latest trends in industry, and to help attract quality students because of the nexus to industry. There is still a long way to go as a McKinsey survey notes that even in the BRIC countries such as China and India indigenous private sector R&D comes from the following sources: 59 per cent in-house; 18 per cent collaboration with service suppliers; 13 per cent UIC; and 10 per cent other / outsourced. Moreover, an index of so-called PPC intensity which corresponds significantly with the extent to which universities and industry collaborate on R&D show a wide variability among Asian countries (using the US figure of 6.4 per cent for comparison): Japan – 8.8 per cent; South Korea – 6.8 per cent ; Singapore – 3.4 per cent ; Taiwan – 2.6 per cent ; China & India – 1.8 per cent. Also as expected, the forms of UIC in countries more recently embarked on the path like India have a tendency to mimic earlier, perhaps less efficient forms, experienced in the US such as co-publication of research results, informal exchanges between scientists, consultancies or sponsored research. At the other extreme, those further along on the path to UIC like Singapore evidence more sophisticated UIC relationships in the form of seminars and cross-specialist training, industrial attachment programs, technology licensing and commercialisation, formation of spin-off companies,

the global marketplace. There was already a long-standing relationship between AMCs and biopharmaceutical companies in the US that made the development of UICs naturally complementary. In fact, about half of all biotechnology firms were founded by university scientists, most of whom have maintained their academic affiliations, and over half of AMC researchers already conduct drug and device clinical trials in the US. Today, the value of the UIC model is well-appreciated by the emerging economies as well. Countries in the Asia-Pacific region such as India and China are mixing their burgeoning investment in R&D, increasing by 10 per cent a year, with their vast intellectual capital through the auspices of UICs to formulate a potent brew for innovation. References are available at www.pharmafocusasia.com

Christopher Milne joined the faculty at Tufts CSDD over 15 years ago and has published over 70 book chapters, journal articles, center reports and white papers. Currently, his research interests include: academic-industry collaborations; disease, demographic and market access factors in the emerging markets; and, tracking the progress of new regulatory and research initiatives.

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The Role of ICH-E5

Enhancing product value and accelerating global drug development ICH-E5 was established largely in response to a drug approval ‘lag’ in Japan relative to the US and Europe. The main goal of the Guidance was to eliminate the need to duplicate full clinical development programs in various regions of the world. However, the most important outcome would be the public health benefits derived from more timely patient access to new medicines. Melton BAffrime, Sr. VP, Translational Medicine, WCCT Global, US

he possibility that ethnic differences exist in different populations with regards to drug metabolism and distribution has been documented for many years. These observed differences may be manifest in alterations in safety, efficacy and/or labeled dosages, or in terms of adverse event profiles in patients residing in different geographic regions created the perceived necessity to fully and separately develop new medicines for each geographic market. This development practice evolved into a trend such that drug development was initiated in the USA or Europe and development in other geographic regions followed such as Japan, South Korea and Taiwan. Development in Canada, Australia, New Zealand, South Africa and South America generally kept pace with development in the US and Europe. Consequently, throughout the 1980’s and early 1990’s there was an acknowledged 7 to 10 year ‘drug approval lag’ in Japan, South Korea and Taiwan. Thus, these populations suffered delayed access to new therapies even though ‘safety and

efficacy’ had already been established in other regions of the world. Consequently, it was difficult to explain to the people residing in these regions why they had to wait so many years beyond the rest of the world to get access to these medications. Also at this stage, the drug regulatory bodies in these regions had already

created laws requiring ‘full development’ in their individual region or country which also served to perpetuate the drug lag. The urgent need to rationalise and harmonise regulations was also prompted by concerns over rising costs of healthcare and escalation of the cost of pharmaceutical R&D.

The ICH-E5 guideline three-step process for judging the acceptability of foreign clinical data

Step 1 Assess complete-ness of the foreign data Complete?

Step 2 Assess product sensitivity to Ethnic Factors

Extrapolate?

Step 3 Judge the requirement for a Bridging Study

Bridging Trial?

Figure 1

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Examples of successful extrapolation of foreign clinical data utilising ICH-E5 concepts in Japan Drug

Bridging Study in Japan

Sample Size (n)

Approval Date

fexofenadine

Dose - Response (single dose)

September, 2000

oseltamovir

Controlled Clinical Trial

316

December, 2000

Dose - Response (single dose)

Controlled Clinical Trial

sumatriptin

Dose - Response (single dose)

June, 2001

zolmitriptin

Dose - Response (single dose)

June, 2001

anastrozole

December, 2000

Table 1

Along comes ICH-E5

Based on the premise that one should not have to repeat an entire clinical drug development program in each region of the globe, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), published a document entitled ‘Ethnic Factors in the Acceptability of Foreign Clinical Data’ (E-5) on 5 Feb 1998. The ICH-E5 guideline provided a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective of minimising duplication of clinical data, and it also described the requirement of bridging studies for extrapolation of foreign clinical data to a new region. The ICH-E5 guideline basically suggested a three-step process for judging

Inclusion of Asian Volunteers in early development US IND in the US FIH SAD

Japan, Korea, Taiwan

China

Skip phase I studies in Japan, Kerea and Taiwan 1. Cost down 2. Shorten time line to NDA in Japan, Kerea and Taiwan

Include Chinese NDA in your global strategy without delay (After negotiation with SFDA, it is possible to concurrently conduct a required Chinese phase 1 and Global Phase III study in China)

Japanease PMDA accepts a NDA as long as approximately 15% of entire patients population in the global study is Asian (Chinese, Japanese, Korean and Teaiwanese).

MAD Chinese / Japenese / Koreen Bridging study

IND in Japan,Korea and Taiwan

Phase II

IND in Japan, Korea and Taiwan

Global Phase III (1) include Chinese, Japanese, Korean and Taiwanese patients

NDA in the US & Europe

NDA in Japan

NDA in Korea

NDA in Taiwan

Phase I In China

NDA in China Figure 2

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morphism, age, gender, weight, lean body mass. The guidance pointed out that, cumulatively, all of these factors can have potentially profound effects on drug distribution, metabolism and elimination and even individual target receptor sensitivity. This, in turn could affect the pharmacokinetics, pharmacodynamics, and therefore the safety and efficacy of drugs in different ethnic populations. As per ICH-E5, the innovator company should first submit the clinical data package for review. Clinical data generated in foreign regions would be evaluated for ‘completeness’, with the acceptability of the data depending on whether it could be accurately extrapolated to the new region. Extrapolation is the key concept behind accepting foreign clinical data and is highly contingent on the comprehensiveness of the package. The clinical data package would be assessed by the regional regulatory

authority regarding the nature and quality of the data, irrespective of its geographic origin. A clinical data package would be defined as a ‘complete’ clinical data package for submission and potential approval if it could meet all of the regional regulatory requirements for the prospective region. The package would be expected to contain adequate characterisation of pharmacokinetics (PK), pharmacodynamics (PD), dose-response, efficacy, and safety in the population of the foreign region(s). Clinical trials should be designed and conducted according to regulatory standards in the new region. These trials should be adequate and well-controlled and utilize endpoints that are considered appropriate for assessment of treatment in the prospective region. Also, clinical disorders should be evaluated using medical and diagnostic definitions that are acceptable to the new region.

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the acceptability of foreign clinical data. (Figure 1) The first step is assessment of completeness of clinical data package of the medicine and if the clinical data package is found to be complete, then second step is to assess the product’s sensitivity to ethnic factors and third and final step is to judge the requirement of bridging study (if needed) based on medicine’s sensitivity to ethnic factors and on the possibility that extrinsic ethnic factors could affect the medicine’s safety, efficacy, and dose-response. The concepts of ‘extrinsic’ and ‘intrinsic’ ethnic factors were defined in the guidance. Extrinsic factors are factors associated with the environment and culture in which a person resides. Examples of extrinsic factors include diet, use of tobacco and alcohol, exposure to environmental pollutants and sunshine, local normal bacterial and viral flora. Intrinsic factors include genetic poly-

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OTHER REGULATORY BODIES ATTENDING:

UPDATES FROM REGULATORY BODIES INCLUDING: Dr. Wenmin Du Executive Director, Shanghai Centre for Adverse Drug Reaction Monitoring, SFDA Dr Y K Gupta National Scientific Coordinator Pharmacovigilance program of India

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Researched and developed by:

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Recent global clinical trials approved in Japan Drug

Indication

Approval

tolterodine

Overactive bladder with symptoms of urge urinary incontinence, urgency and frequency

April, 2006

losartan

Diabetic nephropathy with proteinuria and hypertension inpatients with Type 2 Diabetes Mellitus

April, 2006

trastuzumab

Adjuvant therapy for HER2-positive breast cancer

February, 2008

insulin glulisine

Diabetes Mellitus

April, 2009

tadalafil

Pulmonary artery hypertension

October, 2009

peramivir

Type A & Type B Influenza virus infection

January, 2010

everolimus

Metastatic renal cell carcinoma

January, 2010

panitumumab

Metastatic colorectal carcinoma with wild-type KRAS tumors

April, 2010

temsirolimus

Advanced renal cell carcinoma

July, 2010

laninamivir

Type A & Type B Influenza virus infection

September, 2010

nilotinib

Newly diagnosed chronic myeloid leukemia in chronic phase

November, 2010

dabigatran

Stroke and systemic embolism in patients with non-valvular atrial fibrillation

January, 2011

trastuzumab

HER-2 positive metastatic gastric cancer

February, 2011 Table 2

If the foreign data do not meet these stringent standards, the regulatory authority may require additional clinical trials—‘Bridging Trial’. These bridging trials may focus on different subsets of the population (for example, including patients with renal or hepatic impairment), distinct comparator groups at clearly specified dosages or dose regimens, or drug–drug interactions. ICH-E5 in Action

Over the past 15 years since ICH-E5’s publication, several important therapies have been made available to the Japanese population through extrapolation of foreign data along with some

additional clinical trials being required. (Table 1) However, there is still a perceptible drug lag in Japan. Even though the PMDA has taken steps to streamline their review process and has publically committed to more expeditiously get important medicines to the market there are factors outside of the PMDA review process that also impact the time it takes to get a drug on the market, such as: • Language–all trial documents must be translated • Physicians do not receive incentives for participating in clinical trials • Overall lack of understanding by patients of the clinical research process

• Extended time for patient enrollment into clinical trials • Media coverage seems to negatively characterise participation in clinical trials. Whether intentional or not, this valuable instrument (ICH-E5) which was crafted by its authors in response to a dilemma (Drug Lag in Japan) has become the foundation for ‘globalisation’ of drug development. The drug development planning process has begun to consider the E5 ‘bridging concepts’ as a central theme: • Intrinsic and extrinsic (to a lesser extent) ethnic factors and regional cultural needs are factored into dosage selection for the global development plan • Key opinion leaders from Asia and the West are consulted during the protocol development process to insure that the disease is correctly characterised for the region and that the correct comparative agents are chosen • Regional cultural considerations are integrated into the global protocol • Sample size is calculated to ensure that each region will provide adequate statistical power. In order to prepare for participation of key regions in a global Phase II dose ranging and / or Phase III safety and efficacy trials early, the sponsoring firm must begin to gather ethnic sensitivity information with their first IND filing in the West. One common strategy is to include an Asian Cohort in the SAD or MAD study or in both. The specific Asian population to be included depends upon the region(s) that the Sponsor wishes to include in their Phase II/III global development programs. It should be pointed out that the study objective would be to characterise primarily intrinsic ethnic sensitivity (genetic polymorphism, age, gender, lean body mass); therefore, subjects should confirm that parents and grandparents are Japanese, Taiwanese, Chinese or Korean. Even though it has been documented that extrinsic ethnic factors can impact

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adequate drug exposure information for IND submissions in support of Asian participation in Global dose ranging or even Phase III clinical trials. The PMDA has already approved several drugs that have used the Global Clinical Trial Development strategy. (Table 2) This is also a valuable strategy for a small biotech company. ‘Biotechs’ generally only have enough funding to support early clinical development through proof of concept demonstration. At that point they must identify a development partner or investor(s) with the financial strength to fund Phase II and Phase III development A u t h o r BIO

drug behaviour, the most meaningful differences are associated with genetic differences in drug disposition. Based upon this author’s experience, Japanese, Korean, Taiwanese and Chinese cohorts are most often included. (Figure 2) If the pharmacokinetics and tolerability are demonstrated to be similar between the groups, then these results can be used for submission to the target region’s regulatory authority in order to enable Phase II/III clinical testing to proceed in that region. However, in the event that drug exposure is different between the Asian and Western treatment groups there is often adequate time to evaluate the comparative pharmacodynamics in the target patient population. This additional testing would provide information in support of the specific dosing strategy chosen for that region. The information gleaned from these ‘imbedded’ Asian cohorts provides

programme. Those biotech firms that have the insight to include one or two important Asian cohorts into their Phase I studies have better negotiating power. They may choose to separately outlicense their compound for the rights to Japan, South Korea and China separate from the US and European development rights. But most assuredly the biotech with both Western and Asian Phase I data can command a better market value and milestone payments for their drug from a global pharmaceutical company or a venture capital investment firm. References are available at www.pharmafocusasia.com

Mel Affrime has an extensive background in Clinical Pharmacology and Global Drug development. His career spans academia, Pharma and the Global Contract Research enterprise arenas. He joined ICON Development Solutions as Sr. VP and Chief Scientific Officer in 2006. Mel is presently Sr. VP, R&D at WCCT Global.

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ISSUE - 18 2013

New FIPNET Paradigm Powered by technology and innovation

The drive for industry transformation in the shadow of blockbuster drug patent expirations has fundamentally changed industry best practices as companies have pursued increased operational efficiency, agility, and accelerated R&D. Technological innovation is enabling this transformation, empowering new collaborative business models while maintaining both full information control and global regulatory compliance in this new distributed ecosystem. Alan S Louie, Research Director, Health Industry Insights, IDC Company, USA

s a critical effort that has been ongoing for the last several years, the pharmaceutical industry continues to pursue transformational change in anticipation (or in the shadow) of lost blockbuster drug revenue due to patent expirations. At the same time, it is becoming increasingly difficult, more complex, and costly to bring new drugs to market. The ratio of new drug approvals to R&D spending continues to decline; clinical trials are getting larger, more costly and more complex; and key stakeholders are taking an ever more critical eye when considering new drug approval or reimbursement. The stakes have never been higher and it is becoming increasingly clear that the future industry will likely look dramatically different than it looked during rosier times. Having already trimmed excess capacity, leading life science companies are continuing their pursuit of optimal operational efficiency and excellence through regular critical assessment of virtually every process along their organisational value chain. Processes that are deemed non-core competencies are being routinely outsourced to

external partners as companies seek near term cost savings and / or process agility. Externalisation of non-core competencies is now the norm and preferred partnership arrangements are redefining what was historically called the FIPNET model [the Fully Integrated Pharmaceutical Network]. At the same time, the boundaries of the life science ecosystem are expanding and collaborations and partnerships have grown to include academic medical centers, healthcare providers, and healthcare payers under the umbrella of translational research / medicine. Driving the shift to the new FIPNET ecosystem

There are a number of attractive features that are driving the industry to move forward in this new direction. In discovery research, the shift to acquire promising, late stage new drug candidates (albeit at a price premium) allows companies to leverage external life science investments and only pay for successful efforts. For those research areas that companies are continuing to pursue directly, external collaborations

(especially in the form of translational research) are providing direct data and insights that are helping to reduce the risk in future development and commercialisation. This new external data is providing valuable insights early in the process in a number of useful areas that may include: anticipated efficacy in humans, expected market opportunity, and data suggesting likelihood of healthcare insurer reimbursement. With this data in hand, organisations hope to more effectively allocate their resources and improve the likelihood that ongoing R&D efforts will be fruitful. Moreover, top life science companies are increasingly interacting with multiple stakeholders that may be distributed to all corners of the world. In addition to effectively managing their own facilities around the world, successful companies are increasingly interacting with partners with their own geographically diverse organisations. While this complex network provides tremendous opportunities to efficiently and effectively achieve common goals, there is also the significant potential for confusion and missteps.

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Pharma Partnering Deals in China â&#x20AC;&#x201C; by Stage

Pharma dominated major life science transactions with 54% pharma related Source: ChinaBioÂŽ Consulting

Greg B. Scott President and Founder, ChinaBioÂŽ LLC

Empowering the New FIPNET Ecosystem

Information transparency will be critical to enabling and empowering the new FIPNET approach to life science R&D. With process efforts increasingly residing outside of organisational boundaries, infrastructure supporting information transparency allow companies to more actively monitor progress in real-time, reducing the potential for efforts to go severely off course while concurrently eliminating logistical and geographic barriers to optimal process performance. Successfully delivering information transparency in the life science industry will not be as simple as developing analytical dashboards on top of a single, study-specific consolidated data warehouse. In addition to addressing practical information sharing and security concerns, regulatory and logistical hurdles abound that complicate effective data, information, and knowledge sharing between key stakeholders. Clinical development, in particular, is awash with a myriad of regulatory restrictions that include requirements for maintaining

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ISSUE - 18 2013

patient privacy (e.g. HIPAA requirements in the United States) as well as other more specialised limitations (for example, some country-specific requirements that their clinical trial patient data reside in-country). The Role of Technological Innovation the New FIPNET Ecosystem

Global Internet connectivity, the IT cloud, big data analytics, and collaboration infrastructure will all play major roles in this new ecosystem. As an increasingly information-centric industry, successful companies will be those organisations that are able to best exploit available resources and translate their efforts into new drug approvals, expanded markets, and optimal market penetration. As a foundational capability, global Internet connectivity provides the realtime interconnectivity that has enabled organisations to work efficiently and effectively in a geographically-agnostic environment. Whether it is down the street or half way around the world, it is now possible for teams to work together

like never before. Bringing together best-of-breed expertise, regardless of geography or traditional organisational boundaries will be a key driver of the FIPNET model. With data, information, and knowledge as a foundational resource, the IT cloud (either public or private) provides the industry with a virtual data storage and computational resource that can deliver full and controlled access to data across geographical and organisational boundaries. The ability of an IT cloud to provide a common accessible location for data sharing and analysis will be especially important for collaborative efforts, including the ability to integrate additional data resources, including publically funding research and development data (for example, the genome data from the 1000 Genomes project currently accessible on Amazon Web Services cloud). While still relatively small in comparison with practical applications in both the retail and financial industries, big data analytics is only now beginning to become important in the life science industry. With the anticipated arrival of the $1000 genome and growing access to healthcare provider and payer data, it will be increasingly important for organisations to implement processes to more routinely extract key insights from these data sources on an ongoing basis. As the industry continues the shift from big market treatments to more targeted therapeutics, big data analytics will be an important contributor to identifying the biomarkers and other key therapeutic differentiators that will help to determine specific drug efficacy and safety on a more individualised basis. By definition, the emerging FIPNET model is built on collaboration. Empowering collaboration within the life science industry is a tightly controlled endeavor, requiring specific tools to provide a secure interaction environment to share both ideas and data; capture intellectual property, where applicable;

Looking forward

While still relatively early in its adoption, the emerging new FIPNET model is built on a foundation of secure information transparency. Given the current business climate, this approach will only succeed if it continues to incrementally deliver measurable near term value. As both science and technology continue to advance, relevant innovations must be seamlessly integrated into the enterprise, allowing new approaches and insights to add to the arsenal of tools driving progress. As discussed already, information transparency will be critical to meaningful par tner interactions, since the distributed par tner network will be core to the broader organisational

progress in both the consumer space and best practices in other industries, the ability to better engage all industry stakeholders (looking inwards) as well as the eventual final buyer (patients and consumers, looking outwards) will be increasingly important as individuals become better informed and more information-centric. From a mobile technologies perspective, the shift to BYOD (bring-yourown-device) remains at an early stage of adoption in the life science industry. Acceptance of the iPhone and iPad as acceptable mobile platforms within the industry is growing and applications are being rapidly developed and adopted across the life science value chain, ranging from laboratory equipment interfaces to data viewing / analysis platforms to sales force productivity tools. At some point it is not unimaginable that devices such as the iPad will eventually replace the computer laptop from the laboratory workbench through to the C-suite. A u t h o r BIO

and provide a trackable and traceable record of the collaboration. Within the broader collaboration toolset, it will be important to be able to access data and information that may be located across the ecosystem, including both public and private data stores. Effective collaboration tools should be able to empower this access, although the development and adoption of available collaboration tools in the life sciences have achieved mixed success. While Microsoft SharePoint is the dominant collaboration platform at present, its use remains primarily at the level of top tier pharmaceutical companies due to cost. Several other collaborations platforms are currently in use, including the legacy EMC Documentum application, tranSMART, and Accelrys HEOS. It remains to be seen which collaboration platform(s) will become the de facto standard in the future. For most top life science organisations today, enabling access to data outside of organisational firewalls remains a significant mindset change and this transition is both ongoing with different levels of progress depending on the specific organisation involved. To a lesser extent, advances in mobile technologies and social media are also expected to contribute to the emerging FIPNET model. In following

enterprise moving forward. The ability to share data, insights, and interactions simply and easily, with clear visualisation of status and outcomes in real-time will equip all key stakeholders with the tools and knowledge needed to systematically and efficiently advance the new therapies and diagnostics on the path to knowledgebased medicine. IDC anticipates that significant medical progress will be made over the next five to ten years, built on a secure, effective, reliable and regulated technology infrastructure that, like the advent of the smartphone, will change the way drugs are developed, medicine delivered and value achieved.

In following consumer trends, social media technologies have achieved early acceptance within the life science industry as a productivity tool in the form of instant messaging, blogging, and networking. While these informal tools have expanded as organisational collaborations and partnering has grown, they remain only a minor contributor to the broader, more systematic approach to partner interactions. From an externally facing perspective, however, social media technologies are becoming of major importance as organisations such as the Alzheimer's Foundation and Patients LikeMe provide life science companies with direct access to patients and diseasecentric advocacy group resources directly. Social media technologies are extending the life science / healthcare value chain directly to patients and consumers, enabling life science companies to extend their reach to those with the greatest interest in bringing new treatment solutions to market.

Alan Louie is Research Director at IDC Health Insights. He is spearheading IDC research covering innovation and best practices in pharmaceutical R&D and personalized medicine. Louie is a recognised thought leader in both the health and life sciences industries and has written and spoken extensively in these areas.

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Special issue on Partnerships

Industry Reports

Contract Research Organizations (CROs) Market to 2018 - Public-Private Partnerships to Strengthen Research Capacities and Advance Clinical Development Programs 1

Summary Contract Research Organizations (CROs) Market to 2018 - PublicPrivate Partnerships to Strengthen Research Capacities and Advance Clinical Development Programs report by GBI Research provides key data, information and analysis of CRO industry. The report provides a comprehensive insight into the size of the CRO market, and includes forecasts, key reasons for outsourcing, technology developments affecting CRO’s, public private partnerships, profiles of top CROs, drivers and restraints and deals analysis. This report is built using data and information sourced from proprietary databases, primary and secondary research and uses in-house analysis from GBI Research’s team of industry experts. CRO industry market revenues were estimated to total US$21.4 billion in 2010. In 2009 the revenues recorded were US$19.1 billion. From 2009 to 2010 the industry grew at the rate of 12 per cent which is considered to be very healthy in comparison to the other R&D industry growth. According to clinicaltrials.gov by November 2011, 43.9 per cent of the clinical trials were carried out in the US. 22.9 per cent of the trials were carried out in Europe. 11.6 per cent of the trials were carried out in

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Asia and the rest of the clinical trials were carried out in Canada, Mexico, Australia, Middle East and Africa approximating 21.4 per cent of the total clinical trials. GBI research estimates that the global R&D outsourcing market in 2010 was 25.3 per cent of the total pharmaceutical R&D expenditure. The expenditure is estimated to increase at the rate of 5 per cent annually and is expected to reach 37.1 per cent of the total R&D expenditure by 2018. All the companies are looking to cut down the time for launch of drugs along with a reduction in the expenditure on R&D.

Partnerships, Licensing, Investments and M&A Deals and Trends in Pharmaceuticals – Q4 2012 2

Summary Partnerships, Licensing, Investments and M&A Deals and Trends in Pharmaceuticals – Q4 2012 report by GlobalData is an essential source of data and trend analysis on partnerships, licensing, mergers and acquisitions (M&A) and financing in the pharmaceutical and healthcare market. The report provides detailed information on partnerships, licensing agreements, M&As, equity/debt offerings, private equity and venture financing transactions recorded in the pharmaceutical and healthcare industry in Q4 2012. The report presents detailed comparative data on the number of deals and their value in the last five quarters, categorized into deal types, segments, and geographies. The report also provides information on the top venture capital and advisory

firms in the pharmaceutical and healthcare industry. GlobalData derived the data presented in this report from proprietary in-house Pharma eTrack deals database and primary and secondary research.

Bigpharma Partnering Yearbook 2013 3

Summary The Bigpharma Partnering Yearbook 2013 report series provides comprehensive understanding and unprecedented access to the partnering deals and agreements entered into by the world’s leading healthcare companies during 2012. Using these reports, dealmakers will effectively and efficiently gain insight into the partnering activities of the past year. The report series allows you to view all the partnering and alliances deals announced worldwide. The initial chapters of this report provide an orientation of 2012’s dealmaking and business activities. Chapter 1 provides an overview of the trends in dealmaking during 2012 covering trends by deal type, stage of development, technology type and therapeutic indication. Chapter 2 provides a review of the leading deals during 2012. Deals are listed by headline value, signed by bigpharma and bigbiotech, and most active bigpharma. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 3 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary

followed by a comprehensive listing of 2012 deals, as well as contract documents available in the public domain. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 4 provides a comprehensive directory of all partnering deals announced during 2012. The chapter is organised by company A-Z, stage of development at signing, deal type (collaborative R&D, copromotion, licensing etc), therapy area and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The report series also includes numerous tables and figures that illustrate the trends and activities in bigpharma partnering and dealmaking during 2012. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of technologies and products during 2012.

Partnerships, Licensing, Investments and M&A Deals and Trends For December 2012 In Pharmaceuticals 4

Summary Partnerships, Licensing, Investments and M&A Deals and Trends For December 2012 In Pharmaceuticals report by GlobalData is an essential source of data and trend analysis on partnerships, licensing, mergers

and acquisitions (M&As) and financings in the pharmaceuticals industry. The report provides detailed information on partnership and licensing transactions, M&As, equity/debt offerings, private equity, and venture financing registered in the pharmaceuticals industry in December 2012. The report portrays detailed comparative data on the number of deals and their value in the last six months, subdivided by deal types, various therapy areas, and geographies. Additionally, the report provides information on the top financial advisory firms in the pharmaceuticals industry. Data presented in this report is derived from GlobalDataâ&#x20AC;&#x2122;s proprietary in-house deals database and primary and secondary research.

Bigbiotech Partnering Yearbook 2013 5

Summary The Bigbiotech Partnering Yearbook 2013 report series provides comprehensive understanding and unprecedented access to the partnering deals and agreements entered into by the worldâ&#x20AC;&#x2122;s leading healthcare companies during 2012. Using these reports, dealmakers will effectively and efficiently gain insight into the partnering activities of the past year. The report series allows you to view all the partnering and alliances deals announced worldwide. The initial chapters of this report provide an orientation of 2012â&#x20AC;&#x2122;s dealmaking and business activities. Chapter 1 provides an overview of the trends in dealmaking during 2012 covering trends by deal type, stage

of development, technology type and therapeutic indication. Chapter 2 provides a review of the leading deals during 2012. Deals are listed by headline value, signed by bigpharma and bigbiotech, and most active bigpharma. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 3 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary followed by a comprehensive listing of 2012 deals, as well as contract documents available in the public domain. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 4 provides a comprehensive directory of all partnering deals announced during 2012. The chapter is organized by company A-Z, stage of development at signing, deal type (collaborative R&D, copromotion, licensing etc), therapy area and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The report series also includes numerous tables and figures that illustrate the trends and activities in bigpharma partnering and dealmaking during 2012. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialisation of technologies and products during 2012. www.pharmafocusasia.com

Special issue on Partnerships

Reducing Uncertainty, Increasing Confidence Q. Can you describe about your responsibility for TSI in Asia Pacific? Iâ&#x20AC;&#x2122;m the Managing Director in charge of the business operations in Asia Pacific. My mandate is to drive all TSI product lines so that our products effectively serve the needs of our markets. Our Asia headquarter is located in Singapore and for the time being, we have local offices in Beijing, Shanghai, and Bangalore. Our products reach all the countries within the region, which includes major economies such as China, India, Australia, Japan and Korea, etc. to name a few. At the moment, my key focuses are to strengthen and to build our core businesses rapidly in existing marketplace, and at the same time we are aggressively cultivating both new markets and innovative applications of our products within the region. The Asia Pacific market has great potentials for the precision instrument industry because of the regionâ&#x20AC;&#x2122;s unique characteristics that may be different from the other regions. Another area of my focus is to build high performance teams in Asia so that we not only outpace the growth rate of the market, but also substantially increase our market share for the region.

Edward Chow Managing Director TSI Inc.

TSI Inc. serves a global market by investigating, identifying and solving issues that require quantitative measurement precisions. As an industry leader in the design and production of precision measurement instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, indoor air quality, fluid dynamics and biohazard detections. With headquarters based in the US and field offices throughout Europe and Asia, TSI has established a worldwide presence in the markets we serve. Every day, our dedicated employees turn research into reality.

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Q. What are the plans & activities of TSI in Asia?

Since my joining the company a little over three years ago, our businesses in Asia has grown over 60 percent and in some of our segments we are seeing triple digit growth, for example, our products in Contamination Control. Last year we launched a new Contamination Control product , BioTrak. The product uses our patented Laser Induced Fluorescence (LIF) technology that provides the most accurate viable measurement for real-time Rapid Microbial Method (RMM). At the moment, we focus on developing the pharmaceutical manufacturing market with the Contamination Control products. The goals of these products

are to help our customers to increase productivity and to safe guard the manufacturing process. We are installing BioTrak in our customers’ manufacturing premises so that we are able to demonstrate to the customers how their production efficiency can be improved from this product of advanced technology. The benefit of BioTrak is when contamination excursions occurs, the customers may respond right away by segregating potentially contaminated products and at the same time immediately locating the source of contamination. As such, loss on production wastage may be minimised and product safety may be enhanced. Besides BioTrak, we are going to introduce a completely new product line this year with our Laser Induce Breakdown Spectrometer (LIBS). LIBS offers rapid chemical analysis for virtually every element in the periodic table. In addition to bringing new products to Asia, we are going to increase our physical presence in Asia Pacific through channel development as well as setting up new offices with both technical and service support structures for different countries With this infrastructure in place, we will have wider market reach and therefore we are able to expand our application offerings to different vertical markets.

Q. What is your view on the current market?

According to The Economist, if I may quote from the report -Asia’s pharmaceutical market has been growing rapidly, in line with the regions strong Economic growth, demographic changes like aging & population growth. Several broad trends, including rising household incomes, increased government expenditure on healthcare, higher life expectancies, consumer health awareness, and the growing incidence of chronic developed-world diseases associated with changing lifestyles have all boosted demand for pharmaceutical products in the region. Global pharmaceutical firms have been moving into Asia to tap its flourishing market, and to lower their production costs by shifting capacity from higher-cost countries to the region. Additionally, while Asia was once considered as an attractive destination only for simple outsourced production, the region is increasingly seen as a key R&D hub. (Source: Asia Competition Barometer – Pharmaceuticals by The Economist)

In the discussions with our customers and partners, we are seeing the same trend as outlined by The Economist’s report. We do expect to see a few bumps along the way but the overall trend is still upwardly positive in the long run.

Q. What are the solutions that TSI specialises in?

Since 1966, TSI has developed and manufactured state-of-the-art instrumentation for a variety of aerosol research applications ranging from atmospheric and climate studies to engine emissions to inhalation toxicology. Today, over 50 years later, TSI is the trusted leader in particle research measurement solutions, offering a catalog of particle measurement instruments for a broad range of aerosol science applications that are truly second to none. We have branched out into several solutions like Air Quality Monitoring for Indoors & Outdoors; Occupational Health & Safety Monitoring for Workers; Pressure Monitoring for Isolation & Operating Rooms ; Viable Particle Detection for Cleanrooms & Hospitals; Chemical, Biological, Radiological or Nuclear (CBRN) detection for Defense; HVAC Testing Instruments for Commercial Buildings, and Particle sizing for nanotechnology research applications. At this current moment, we have over 250 products granted with over 50 patents and we have a proven record of developing instruments that are the first, the only, and the best of their kind. We continue to identify and to provide performance measurement solutions by taking on difficult measuring challenges and providing the tools needed to overcome such challenges. As long as there is need for quantitative measurements in any industry, TSI will strive to accelerate the actualization of the technologies in accommodation for our customers’ needs.

Q. How do you stay ahead in product development?

We invest heavily in product developments. We are committed to be innovative with products that are superior in quality; we try to get our products faster to market; and we make sure our products have high flexibility in design so that their functionalities can be modified in accommodating both our customers’ immediate business needs and the subsequent evolvement of such needs. We are able to achieve

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A u t h o r BIO

this by carefully listening to our customers and that gives us the ability to assess both what is required of our products and the applications such products will provide. Understanding our customers’ needs is by far the most important aspect for both our R&D efforts and the roadmaps that we take in shaping our product planning. Knowing what the market needs and providing the right products and solutions on a timely manner to meet such market needs is critical to our company’s success. For example, we have made significant investments in developing the new BioTrak™ Real-Time Viable Particle Counter for monitoring pharmaceutical cleanroom facilities. This unique product detects airborne viable particles by utilising TSI’s patented fluorescence detection technology. Such technology is derived from TSI’s 20 years’ experiences of biological threat detection instrumentations. By minimizing false positives, the BioTrak Particle Counter delivers with more confidence and assurance to Quality Assurance Professionals in instant detection and identification of viable particles. The BioTrak Particle Counter provides end users with meaningful data when detecting unwanted events and as a result, it supports root cause investigations. To ensure TSI is always at the front line of cutting edge technologies, TSI collaborates with worldwide leading institutions to develop and to manufacture the highest quality of instruments that are used for aerosol sciences, air flow measurement, indoor air quality, health and safety, contamination control, fluid dynamics and biohazard detection. For example, we have close partnerships with Dr. David Pui from University of Minnesota. Dr. David Pui is a Distinguished McKnight Professor at the University of Minnesota. Dr. David Pui holds the LM Fingerson/TSI Inc. chair in mechanical engineering and currently serves as director of the Particle Technology Laboratory. Dr. David Pui is widely recognised throughout the world for his significant contributions to aerosol and nanoparticle researches, he is credited with over 220 publications, twenty patents, and

Edward joined TSI Inc. in 2009 as Managing Director, and has been instrumental in transforming the Asia business to preceded level of market coverage and penetration. UnderEdward’s leadership, TSI Inc. has achieved over 80% profitability growth in Asia and has built ahigh performance team covering all territories. Edward holds a MBA from University of Toronto, he is a Chartered Financial Analyst (CFA) andalso a Professional Engineer.

nine commercialised aerosol instruments. By working closely with Dr. David Pui and other highly skilled professors in University of Minnesota, we are able to provide leading edge technology to the real world of precision measurements. By the same token, we work with research institutions around the world in turning brilliant ideas into realities.

Q. How does TSI seek to position & differentiate?

With over 50 years of experiences in this highly specialized field, we have earned a reputation as an industry performance leader. Our experts work handin-hand with the scientific and industrial community to develop technically sophisticated instruments that meets evolving precision measurement requirements. On the manufacturing side, we continue to make investments so that our products are ensured to be of optimal quality during production processes. These investments also allow us to design our production processes in such a way that requires shorter lead time for delivery to our customers. We are currently in the process of adding a two-story facilities at TSI’s headquarter in Minneapolis USA. One of the new floors will house TSI’s engineering labs, and the other floor will provide additional manufacturing space. The addition building of 58,000-sq.-ft. is expected to be completed in June 2013, and with this addition, it will bring the building’s total square footage to more than 200,000 sq. ft. The new manufacturing facilityis also expected to be readiedby June 2013. We never turn away from difficult measuring challenges; we tackle them head on so that we will provide our customers with the most suitable solutions. TSI has always been regarded as one of the leading global authorities on performance measurement and precision instruments because our instruments always deliver consistent and reliable quantitative measurement that allows our customers to save both precious time and cost of operations. We strive to accelerate the actualization of our customer’s goals by extending unprecedented level of understanding of their requirements and needs. This is why we do not just observe and react to measurement trends. We set the trend by collaborating with leading specialized pioneers around the world. For more than half a century, we have investigated, identified and provided performance measurement solutions by taking on the difficult measuring challenges and by providing the necessary tools to overcome such challenges.

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Product Showcase Priorclave, established for more than 25 years, is one of the UK’s most successful autoclave manufacturers producing an extensive range of standard steam sterilisers with chamber capacities from 40 to 700 litres – the range includes compact top and front autoclaves suitable for bench-top, free-standing medium to high capacity top and front loading autoclaves as well as power door and passthrough double entry machines. In addition to this comprehensive range which features over 40 different models Priorclave is able to design and build autoclaves to suit specific requirements. All Priorclaves, built to the highest of standards, comply with the latest international standards and undergo full inspection and tests prior to despatch. Contact Details: Tel: +44 (0) 20 8316 6620 Email: sales@priorclave.co.uk, web:www.priorclave.co.uk

Russell Finex is a sieves and filter specialist that enhances the reputation of companies in the pharmaceutical industry throughout the world. Our extensive market research and working partnerships with the world’s major pharmaceutical manufacturers ensures we understand how to meet your high standards of design, usability and performance. All Russell pharmaceutical equipment is manufactured using the highest possible quality 316L grade stainless steel, ensuring metal impurities are reduced to a minimum. In addition, our specialist polishing techniques allow us to offer the highest standard mirror polished finish to a documented Ra 0.1. This, combined with easily dismantled parts, ensures all equipment can be easily and thoroughly cleaned Please contact: Tel: +44 (0) 208-818-2000 Email: enquiries@russellfinex.com Web: www.russellfinex.com

Granulation technology will convert poorly soluble APIs into highly soluble granules. The technique can be applied for the production of human and veterinary medicines. The manufacturing technology is twin screw extrusion of the API in a proprietary matrix. The process works at low temperature (45-50°C), and is continuous. Laboratoria Smeets N.V. is a Belgian Pharmaceutical company specializing in the blending and packaging of powders. As a contract manufacturing organisation, we also offer innovative product concepts to our customers who are interested to develop markets for these products. Please contact: Tel: +32 (0) 3 830 77 33 Email: JefVerplaetse@labosmeets.be Web: www.labosmeets.be

SuppliersGuide

Special issue on Partnerships

Company........................................................ Page No. Bachem........................................................................ 50 www.bachem.com BOSCH......................................................................OBC www.boschpackaging.com Fluid-Bag...................................................................... 13 www.fluid-bag.com India Lab Expo............................................................. 17 www.indialabexpo.com IQPC Worldwide Pte Ltd.............................................. 48 www.iqpc.com.sg Laboratoria Smeets N.V............................................... 59 www.labosmeets.be Messe D端sseldorf (Shanghai) - China Pharma..... 07, 36 www.china-pharm.net NETZSCH..............................................................IFC, 28 www.netzsch.com OPTIMA packaging group GmbH............................... 33 www.optima-pharma.com Priorclave..................................................................... 59 www.priorclave.co.uk Russell Finex................................................................ 59 www.russellfinex.com Scavenging Technologies............................................ 19 www.scavengingtechnologies.com TSI Instruments Singapore Pte Ltd........................ 22, 56 www.tsi.com UBM India Pvt Ltd...................................................... IBC www.cphi-india.com

To receive more information on products & services advertised in this issue, please fill up the "Info Request Form" provided with the magazine and fax it, or fill it online at www.pharmafocusasia.com by clicking "Request Client Info" link. 1.IFC: Inside Front Cover 2.IBC: Inside Back Cove 3.OBC: Outside Back Cover

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Join pharma professionals from all over the world to network and do business with pharma ingredients suppliers @ CPhI India 2013!

3-5 December 2013

Bombay Exhibition Centre, Mumbai, India This event is an excellent opportunity to keep abreast with new developments in the pharma industry. Dr Prakash U. Tahiliani, Prime Ever Ayurvedic Research Laboratories

CPhI India is part of the largest and most comprehensive pharmaceutical industry event in South Asia. Focused on pharmaceutical ingredients, machinery, equipment, outsourcing and bio-solutions, this is your ultimate one stop pharma shop! As the pharma industry is increasingly looking towards India to source low cost, high quality pharma solutions, CPhI India and co-located events provide the perfect place to initiate and explore partnerships with key pharma companies from India and abroad.

www.cphi-india.com

Co-located with:

Organised By:

Processing equipment and packaging machinery from Bosch achieve the agreed performance. Day after day. Year after year. GMP-compliant systems ensure the required pharmaceutical product quality. Simple validation, cleaning and sterilization processes and low maintenance requirements increase production efficiency. Experienced employees with extensive know-how guarantee professional service worldwide. Learn more at www.boschpackaging.com

schwarzspringer

Processed and packaged as promised. Bosch.