Express Pharma (Vol.12, No.23) October 1-15, 2017 by Indian Express

CONTENTS

REDEFINING ELDERLY CARE

Vol.12 No.23 October 1-15, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury*

Holistic and multi-disciplinary healthcare approaches are an urgent need to tackle complex challenges posed by an increasing elderly population and ensure effective social and economic development | P18

Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

8TH ANNUAL PHARMA SCM SUMMIT HELD IN MUMBAI

PHARMATECH EXPO AND LABTECH EXPO 2017 CONCLUDES

RESEARCH

National Design Editor Bivash Barua Asst. Art Director Pravin Temble

MARKET

P11: PRE EVENT

MANAGEMENT

Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

PFIZER, ASTELLAS PROSTATE CANCER DRUG PROMISING IN LATE-STAGE TRIAL

IMMUNO-ONCOLOGY LOOKS SET TO BECOME THE FIFTH PILLAR OF CANCER TREATMENT

PURDUE RESEARCHERS CREATE DEVICE TO IDENTIFY RISKS FOR BREAST CANCER

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Nirav Mistry Rajesh Bhatkal Sunil Kumar PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

Express Pharma to host first edition of Pharma CXO Summit in Goa and Express Pharma Excellence in Exports Awards

P30: INTERVIEW Taher Abbasi, CEO and Co-Founder, Cellworks

P50: APPOINTMENT A Vaidheesh elected President of OPPI

INTEGRATIVE CARDIOLOGY: WHERE CAN AYURVEDA CONTRIBUTE?

SUSTAINABLE GROWTH OF PHARMA IN INDIA

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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October 1-15, 2017

EDITOR’S NOTE

What ails India’s pharma exports?

t is no secret that declining pharmaceuticals exports have been worrying not just pharma honchos but the Prime Minister’s Office as well. The slide has not been sudden. Trading Economics’ data shows that pharma exports decreased to $2086.32 million in 2016 from $6488.40 million in 2015. They averaged $3902.05 million from 1996 until 2016, reaching an all time high of $11140.5 million in 2013 and a record low of $672 million in 1996. According to the Directorate General of Commercial Intelligence & Statistics, Government of India, Ministry of Commerce, exports of drugs & pharma de-grew by 5.8 per cent in the first four months of this financial year from $5588.24 million in April–July 2016 to $5264.13 million in the corresponding period this year. It may be a good sign that imports of medical and pharma products de-grew -0.7 per cent during the same period, from $1678.68 million in April–July 2016 to $666.86 million in the corresponding period this year. Interestingly, this July saw a drop of 15.5 per cent, from $449.56 million in July 2016 to $379.9 million. While India Brand Equity Foundation's estimates put pharma exports from India at $16.4 billion in 2016-17, and estimate exports to reach $20 billion by 2020, there are more sobering projections. For instance, according to Trading Economics’ global macro models and analysts expectations, in the long-term, India’s pharma exports is projected to trend around $1551.86 million in 2020, as per their econometric models. While one reason for this drop could be that Indian pharma companies are increasing manufacturing activities in their overseas locations, exports are still a sizeable slice of their revenues. The US alone accounts for approximately a third of total Indian pharma exports,and this has been in a slide for various reasons. A CARE Ratings report dated August 31 has identified four primary contributors for the decline in margins from the US exports: consolidation of pharma distributors in the US, mergers among major drug players, significant increase in Abbreviated New Drug Application (ANDA) approvals and lastly heightened scrutiny by US Food and Drug Administration (US FDA). It is interesting to note that while faster processing of ANDAs, thanks to the Generic Drug User Fee Act (GDUFA), has increased ANDA approvals for India based pharma companies, it has also raised approvals for competitors with ANDAs for the same products. This has increased pricing pressure in the US market in the medium term, especially on plain vanilla products. The recently released Earth Security Report (ESR) 2017 had a section on India's pharma sector which points to another headwind on the exports

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The recently released Earth Security Report (ESR) 2017 had a section on India’s pharma sector which points to another headwind on the exports side: poor environmental norms which delay permissions for pharma exporters

side: poor environmental norms which delay permissions for pharma exporters. The report points out how untreated wastewater from pharma factories is not just polluting water bodies in India but also adding to anti microbial resistance. Not just in Indians, but also foreigners who spend time in India and take back superbugs when they return home. While the ESR looks at the issue from a sustainability perspective, the pressure on global pharmaceutical to clean up its supply chain, will impact Indian companies as well. According to the ESR, investors like BNP Paribas and Nordea Asset Management are increasingly pressuring international pharma companies to address water pollution in their supply chains. In 2016, Nordea revealed that hundreds of drug companies operating in Hyderabad and Visakhapatnam, were still discharging wastewater from factories linked to the supply chains of the largest global pharma companies in its portfolio, including Sanofi, Novartis, and Roche. Considering that these two states, Telengana and Andhra Pradesh, together account for roughly 20 per cent of India’s pharma exports, there is no doubt that Indian pharma exporters will feel the heat soon from their clients. In fact, the ESR quotes from media reports that India’s bulk drug exporters had warned the commerce ministry that stricter environmental requirements were creating delays in production and clearances. The then commerce minister Nirmala Sitharaman had promised to take up the complaints of API manufacturers with her counterparts in the environment and chemicals and fertilizers ministries. The ESR points out that while larger manufacturers/exporters, including Dr Reddy’s, Hetero, Aurobindo, Matrix (Mylan), Divis, Natco, all report to having zero liquid discharge (ZLD) technology and waste processing facilities onsite, common effluent treatment plants for the smaller production plants are over-burdened and under-equipped to process many chemical effluents. Worse, more expensive ZLD equipment is seen as prohibitively expensive for smaller manufacturing facilities. This lack of waste water treatment and other environmental norms would then be a barrier to these smaller companies approaching global clients and accessing global markets. Thus, it is high time that the sector does a deep dive to find a holistic and sustainable prescription to arrest the slide in pharma exports.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENTS

Express Pharma to host first edition of Pharma CXO Summit in Goa To be held in association with Optel Vision, this year’s theme for the event is,‘Beyond 2017 - Leveraging global traceability for sustainable business and growth’

erialisation, combined with track and trace mechanisms, are being seen as an important solution to ensure that substandard or counterfeit medicines are discovered and recalled from global markets. Over 40 countries across the globe are already implementing or set to enforce track & trace and serialization mandates by 2018. Indian companies too are realising that it is strategic business sense to make traceability the cornerstone of sustainable future growth. Therefore, the Pharma CXO Summit, organised by Express Pharma and the Indian Express Group, will bring together leading pharma CEOs, COOs and Division Heads who are leading the way for Indian pharma exports the world over to share their learnings and experiences on implementing serialisation.

The conference will present insights from regulators and policy makers, as well as case studies from the early adopters of traceability technologies. The case studies will be both from global as well as Indian experts who have headed serialisation strategies in their companies. Some of the broad topics which would be covered at the conference are: ◗ Leveraging global traceability for sustainable business and growth ◗ Learning from serialisation stalwarts: Global case studies ◗ Serialisation strategies for biologics ◗ Serialisation strategies for pharmaceuticals ◗ Serialisation strategies for CMOs ◗ Opportunities and challenges in India's serialisation journey

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The other highlights at the event will be: Express Pharma Excellence in Exports Awards: It seeks to recognise the untiring efforts of pharma exporters. It will acknowledge and celebrate the resounding successes of Indian pharma companies, and the vital roles they have played in establishing India as a leading export destination. The Express Pharma CXO Handbook: It will feature interviews, in-depth articles and strategies that Indian pharma exporters have adopted to create an unassailable edge and leading positions. While some have chosen to excel in a particular category, others have crafted their geographical footprint with great care. EP News Bureau

ISPE to organise Europe Pharma 4.0 Conference in Italy The conference will focus on preparing the pharma and biopharma industry for a full transition to an end-to-end integrated computerised system throughout the manufacturing process THE INTERNATIONAL Society for Pharmaceutical Engineering (ISPE) with its Italy Affiliate will organise Europe Pharma 4.0 Conference in Verona, Italy from November 23-24, 2017. The conference will focus on preparing the pharma and biopharma industry for a full transition to an end-to-end integrated computerised system throughout the manufacturing process. The two-day event will feature an education programme focussed on core topics, including automation, analytics, endto-end integration, and workforce 4.0. Attendees will gain insight into a new world of manufacturing, engaging in dialogue with peer groups and senior industry leaders, and learning new manufacturing applications, models, and solutions. The introduction of advance automation and the increasing interconnectivity of Industry 4.0 is not only revolu-

tionising the pharma industry, but also introducing many new challenges and production roadblocks. “Shifting the paradigm to Pharma 4.0 and focusing on the issues specifically surrounding pharma priorities will lead to improvements in productivity, quality, and security of the supply chain,” said John Bournas, CEO and President, ISPE. The ISPE 2017 Europe Pharma 4.0 Conference stems from the ISPE Europe Affiliates’ newly founded special interest group (SIG): ‘From Industry 4.0 to Pharma 4.0.’ The Pharma 4.0 SIG started discussions around the issues that the new ‘automation’ factors are causing in the pharma production chain. Their goal is to specify and differentiate Pharma 4.0 from the common ‘Industry 4.0’ concept, with the focus on maturity level models integrated in the programme. EP News Bureau

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October 1-15, 2017

MARKET POST EVENTS th

8 Annual Pharma SCM Summit held in Mumbai Discussions were held on issues related to pharma supply chain and impact of GST THE 8 TH edition of Pharma SCM Summit was recently organised by UBM India in Mumbai which witnessed more than 150+ industry leaders gather to network, exchange ideas and latest innovations, form future alliances and shape the future of the pharma supply chain. The sessions focussed on various aspects of pharma supply chain including impact of GST introduction, strategies for digitalisation in Pharma SCM, warehouse automation, cold chain and inventory management. There were innovative networking sessions during the day like speed networking which

helped interact and build contacts with industry leaders. The day one of the event covered topics like India— Complexity in pharma cold chain logistics and increasing integration with stakeholders by Rajesh Vij, Associate VP Export & Import, Wockhardt; Building a risk mitigated supply chain to avoid supply disruptions by Nihar Medh, VP and Global Procurement Head, Cipla; Discussing the impact and challenges in understanding the change post introduction of GST for the pharma industry as a whole (API, fromulations) by Bimal Jain, Independent Practioner; Temperature-controlled

logistics – Solutions for India and Tropical Countries by Samit Jain, MD, Pluss Advanced Technologies; Supply Chain Challenges in Emerging Markets – an European perspective by Chris Wallace, Senior Director - International Supply Chain, Sanofi Genzyme; Challenges in Pharmaceuticals Cold Chain Management by Virendra Chaudhary, Director, Algor Supply Chain Solutions. Two panel discussions were held on way forward post implementation of GST for the pharma sector and increasing importance of maintaining data visibility and forecasting data accurately.

Day two covered topics like overview of global pharma market and adopting Internet of Things (IoT) for smoother supply chains and ensuring visibility and access to accurate data by Avinash Talwar, Director - Supply Chain Management (Strategic & Plant Sourcing), Dr Reddy’s Laboratories Express Transportation Solutions for the pharma industry by Abhik Mitra, MD, SPOTON Logistics; Implementing end-to-end integrated supply chain business process solutions by Chris Wallace, Senior Director - International Supply Chain, Sanofi Genzyme; Forecasting and demand

planning in pharma supply chain by Dr Rakesh Singh, Dean Academics, Amity University; Efficient Manufacturing supporting agile Supply Chain by Naveen Pilania, GMOperational Excellence, Zydus Cadila Healthcare; Supply chain interventions to boost R&D pipeline and handling new launches bySandhya Shenoy, Associate VP, FDC; and Ensuring Supply chain security identifying major threats in supply chain that impact patient safety and loss of business by Yogesh Lawania, Head - API Planning & Global Logistics, Biocon. EP News Bureau

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MARKET

PharmaTech Expo and LabTech Expo 2017 concludes PharmaTechnologyIndex.com and Indo African Chamber of Commerce and Industry enter into an MoU to promote pharma business in Africa SIXTH PHARMATECH Expo and LabTech Expo 2017 recently concluded in Gujarat University Convention Centre, Ahmedabad. At the inaugural address, Rameshbhai Shah, Chairman, KNS Group said, â&#x20AC;&#x153;Roaring success of all efforts of government and entrepreneur support has made Gujarat a preferred destination for business and platform for procurement of machinery and materials for the industry under the Prime Minister's Make in India programme.â&#x20AC;? The exhibition was spread across 7,500 square metres, with about 200 exhibitors displaying machinery and equipment for producing drugs and pharma products. The event was attended by about 7,000 visitors. Indo-Africa Chamber of Commerce and Industry (IACCI) organised a seminar on 'Doing Business with Africa', bringing in buyers from African countries Burkina Faso, Mali, Lesotho, Niger and Togo. Kanyi Galley LOGOSU-TEKO, Ambassador of Togo and Ali Illiassou, Ambassador of Niger were present as special invitees for the event. About 250 delegates attended the seminar. Entrepreneurs / industrialists and ambassadors from African countries took part in discussions. The Secretary General of IACCI was present during the event where around 500 one to one meetings were organised with exhibitors / entrepreneurs during the event. BV Patel, PERD Centre was Knowledge Partner of the event. A seminar on 'Impact of Analytical Technology on Quality Production of Pharmaceuticals' was organised which was attended by 200 delegates. During the event, PharmaTechnologyIndex.com, Ahmedabad and Indo African Chamber of Commerce and Industry, Mumbai signed an MoU to promote Pharma Machinery and

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Pharmaceutical Business in Africa. The objective of MoU is to

exchange of information related to organising of exhibitions in India and in African

member countries of IACCI for display of catalogue, machinery and equipment and

organising technical seminars. It is also for one to one meetings which needs to be

MARKET organised for development of trading of pharma industry and products and machinery and equipment between two geographical areas. The MoU was signed to bring in and out business delegation, trade promotion and other industrial development activity. Indo African Chamber of Commerce is having activities of bi-lateral promotion between India and Africa. Dr Manish Nivsarkar, Director, BV Patel, PERD Centre, Ahmedabad said, “It is a unique idea of having a seminar along with the expo. Our last experience and their efforts at Chandigarh event has given us a lot of confidence and encouragement and today we have come up with a halfday seminar on Impact of Analytical Technology and quality production of pharma.” PK Jha, Zonal General Manager, The National Small Industries Corporation (NSIC) said, “Technology, engineering, integration and automation are the prime drivers of the pharma industry across the globe. The Indian pharma industry is one of the most rapidly expanding industry, both economically and technologically. The pharma industry is increasingly looking towards India for high quality, low cost pharma solutions.,The event is the perfect place for companies to pick up on the latest trends and innovations the market has to offer.” Guest of Honour Sunanda Rajendran, Secretary General, IACCI said, “There are more than 3,500 pharma manufacturing units in Gujarat and growth in pharma sector has been very significant. The Indian pharma industry has grown at a compounded growth rate of 17.46 per cent from 2000 to 2016. From a $6 bn industry in 2005, it has grown to $36.7 billion in 2016, which is a remarkable achievement and it is expected to increase at 15.82 per cent by 2020. Indian manufacturers can showcase our African ambassadors what Indians has to offer and where India can go. As far as investments are concerned, the government has already announced100 per cent Foreign

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Entrepreneurs / industrialists and ambassadors from African countries took part in discussions. The Secretary General of IACCI was present during the event where around 500 one to one meetings were organised with exhibitors / entrepreneurs during the event Direct Investment in medical devices, equipment etc. Drugs and pharma sector has attracted investments worth $14.53 bn from 2000 to 2016.” Ali Illiassou, Ambassador of the Republic of Niger said, “We are here to strengthen the relations, business and commercial between the dynamic state of Gujarat and African countries. We are here to show how Africa is transforming and offers many opportunities for Asian and particularly Indian companies in the pharma sector. Africa is now a new frontier. Six of the worlds 10 fastest growing economies are African and the continent has been grow-

ing at average of five per cent per annum offering host of opportunities.” Further he said, “By 2020, India is likely to be among the top three pharma markets by incremental growth and sixth largest market globally in absolute size. To ensure world class quality and adherence to international standards and regulations in the manufacturing of pharma drugs, it is necessary that the Indian and Asian pharma manufacturers and laboratories move to shop floor to top floor integration. This growth in the pharma industry and its increasing need for the latest technology in automation, engineering,

artificial intelligence and robotics has motivated Pharma Tech Expo 2017 to provide an exclusive platform to the pharma machinery manufacturers and automation service providers from core automation and manufacturing IT sector for the pharma Industry.” Amit Thakkar, President, Drug Marketing and Manufacturers Association (DMMA) said, “Since long Gujarat has been known as pharma hub. Gujarat pharma market was affected due to the price disparity between the companies enjoying tax benefits from tax-free zones and others. However, post

GST the scenario has changed and once again Gujarat is moving towards becoming big pharma manufacturing hub.” Shailesh Patwari, President, Gujarat Chamber of Commerce and Industry, Chief Guest on the occasion said, “We have good relations with Africa. They have been very humble to us. African Development Bank has its presence here in India and therefore Africa should be our destination and I am sure the pharma industry can very well surpass China by doing good business in Africa.” Dr Arvind Kukrety, Deputy Drug Controller, CDSCO Zonal office, Ahmedabad in his address said, “ As a regulator our aim is to see quality, efficacy and safety is maintained throughout the life cycle of the drugs. I am proud that we are the first country in the world to produce biosimilars in the world and two of the companies are from Gujarat. Gujarat has been leading as far as the latest technology adoption is concerned.” EP News Bureau

MARKET DEAL TRACKER

M&Aactivity in August records 58 transactions worth $15 bn The top two transactions recorded in August 2017 were related to oncology assets and accounted for about 88 per cent of the total activity in value terms M&A ACTIVITY in the pharmaceuticals and healthcare industry was focussed on oncology assets. The top two transactions recorded in August 2017 were related to oncology assets and accounted for about 88 per cent of the total activity in value terms. In volume terms, the M&A activity during the month witnessed a marginal increase of 7 per cent when compared to July 2017 and 9

The top two transactions recorded in August 2017 were related to oncology assets per cent over the average of previous five months. In value terms though, the increase was 61 per cent over the fivemonth average. August recorded a total of 58 transactions worth $15 billion. One of the major deals in August includes Gilead Sciencesâ&#x20AC;&#x2122; definitive agreement to acquire Kite Pharma, a biopharmaceutical company engaged in the development of cancer immunotherapies, for purchase consideration of approximately $11.9 billion. Gilead Sciencesâ&#x20AC;&#x2122; offer price represents a 29 per cent premium to Kite Pharma's closing price on August 25, 2017 and a 50 per cent premium to its 30-day volume weighted average stock price. The transaction is expected to help Gilead to strengthen its position in oncology and

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MARKET M&A DEAL ACTIVITY WAS FOCUSED ON ONCOLOGY ASSETS

The venture capital (VC) market recorded a decrease, in both deal volume and value terms, with 51 deals worth $747.4 million in August as compared to 70 deals worth $945.4 million in the previous month Source: GlobalData

cell therapy. Some other notable transactions in August include Bristol-Myers Squibb’s proposed acquisition of IFM Therapeutics for $1.3 billion; Mallinckrodt’s proposed acquisition of InfaCare Pharma for up to $425 million; and CSL Behring’s proposed acquisition of Calimmune for $416 million. The venture capital (VC) market recorded a decrease, in both deal volume and value terms, with 51 deals worth $747.4 million in August as compared to 70 deals worth $945.4 million in the previous month. Some of the notable VC deals in August include Homology Medicines raising $83.5 million in series B financing round, ARMO Biosciences raising $67 million in series C-1 financing round, and CF PharmaTech raising $65 million in series D financing round.

Source: GlobalData

VENTURE CAPITAL TRANSACTIONS DECLINED IN AUGUST 2017 Deal Date

Acquirer (s)

Target

Deal value (US$ m)

27-Aug-17

Gilead Sciences Inc (US)

Kite Pharma Inc (US)

11,900.0

3-Aug-17

Bristol-Myers Squibb Company (US)

IFM Therapeutics Inc (US)

1,310.0

4-Aug-17

Mallinckrodt Plc (UK)

InfaCare Pharmaceutical Corp (US)

425.0

28-Aug-17

CSL Behring Australia Pty Ltd (Australia)

Calimmune Inc (US)

416.0

24-Aug-17

Karo Pharma AB (Sweden)

Weifa ASA (Norway)

162.2

Deal Date

Acquirer (s)

1-Aug-17

Temasek Holdings (Private) Limited; 5AM Venture Management LLC; Vida ventures Ltd.; Vivo Capital; Alexandria Venture Homology Medicines Inc (US) 83.5 Investments; Deerfield Management Company LP; ARCH Venture Partners LP; Novartis AG; Maverick Ventures; HBM Healthcare Investments AG; Fidelity Management and Research LLC; Rock Springs Capital Management LP

29-Aug-17

DAG Ventures, LLC; Quan Management LLC; HBM Healthcare Investments (Cayman) Ltd.; GV ; RTW Investments, LLC; Decheng ARMO Biosciences Inc (US) Capital LLC; NanoDimension AG; Qiming Venture Partners; Celgene Corp; OrbiMed Advisors LLC; Kleiner Perkins Caufield & Byers; Sequoia Capital; Undisclosed Investor(s)

67.0

28-Aug-17

Future Industry Investment Fund; Undisclosed Investor(s)

65.0

10-Aug-17

Vivo Capital; F-Prime Inc; Sectoral Asset Management, Inc.; venBio; Sofinnova Ventures Inc; Morningside Ventures; Clough Capital Apellis Pharmaceuticals Inc 60.0 Partners, LP; Epidarex Capital Partners LLC; Cormorant Asset Management, LLC (US)

8-Aug-17

Bank of Hangzhou Co Ltd; Temasek Holdings (Private) Limited; Taikang Life Insurance Co., Ltd.; Bank of China Limited; Lilly Asia Hangzhou Just ventures; Hangzhou Economic and Technological Development Zone; ARCH Venture Partners Biotherapeutics Ltd (China)

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Target

CF PharmaTech Inc. (China)

Deal value (US$ m)

57.0

MARKET EVENT BRIEF 6TH ANNUAL PHARMA LEGAL & COMPLIANCE SUMMIT 2017 Date: October 6, 2017 Venue: Mumbai Summary: The Lex Witness 6th Annual Pharma Legal & Compliance Summit 2017 will have power packed discussions on regulatory rides, technological advancements, IPR, smart contracts, combat counterfeiting, pharmaceutical pricing in India. The event will showcase the latest developments in the pharma industry in the arena of legal and compliance and forays further into the horizon of big data analytics, digitisation of healthcare, forensics and all the challenges, risks and opportunities associated with these. Contact details Bhupinder Kaur Sr Manager – Brand Innovation Lex Witness -India’s 1st Magazine on Legal & Corporate Affairs Handphone:+91.9654155065 Deskphone:+91.11- 66569793 Address: #426, 2nd Floor, MG Road, Ghitorni New Delhi – 110030

Markets, will organise a seminar on Proactive & Sustainable Compliance Workshop. The seminar will

have a panel of international experts who will shed light on recent compliance challenges confronting the biopharma

industry worldwide with a special focus on the Indian industry. Contact details

Amit Shelke Email: amit.shelke@ marketsandmarkets.com Phone no: +91 20 30108 270

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INNOVATION – THE BRIDGE & PLATFORM FOR PROGRESS Date: October 16, 2017 Venue: Thiruvananthapuram Summary: Centre for Intellectual Property Management (CIPROM) with Gopakumar Nair Associates and Gnanlex will organise a workshop on ‘INNOVATION – The Bridge & Platform for Progress.’ Contact details Sajeevkumar Gopakumar Nair Associates 3rd Floor, Shivmangal Next to Big Bazaar Akurli Road, Kandivli (East) Mumbai – 400101, (India) Tel: 91-22-4089 5403/ 2887 2058/ 2885 0805 Fax: 91-22-28462455 Website: www.gnaipr.com

PROACTIVE & SUSTAINABLE COMPLIANCE WORKSHOP

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Date:December 7-8, 2017 Venue: Mumbai, India Summary: Markets and

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(

THE MAIN FOCUS

Holistic and multi-disciplinary healthcare approaches are an urgent need to tackle complex challenges posed by an increasing elderly population and ensure effective social and economic development

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Safeguarding the golden years Geriatric care and health management raises unique social, economic, and clinical challenges in India. From a pharma perspective, tackling their medication needs for complex health issues require special attention to protect their sunset years By Usha Sharma

apan, the country with the highest number of old people, is also home to 117-yearold Nabi Tajima of Japan, now the oldest living person in the world whose age has been documented. He took over this slot from Violet Brown, another 117-year-old from Japan who died recently, on September 15, 2017. Yet, we have a contender from India as well. Almost a year back, Swami Sivananda from Varanasi claimed to be 120 years old and was in the process of applying for the Guinness World Record. Thus, lifespans in India too have increased significantly and thereby so has the number of older people in the country. According to United Nations estimates, India has the largest youth population, but a report released by the Ministry of Statistics also reveals that the number of citizens over the age of 60 jumped 35.5 per cent — from 7.6 crores in 2001 to 10.3 crores in 2011. The growing number of

20 EXPRESS PHARMA October 1-15, 2017

senior citizens in India have also created the need for healthcare methods which are suited for this population. Speaking in his personal capacity, As Utkarsh Palnitkar Partner and Head, Infrastructure, Government and Healthcare, Life Sciences KPMG India points out, “India's population is expected to grow from 1.32 billion in 2016 to 1.51 billion by 2030, an increase of 14 per cent. This is likely to, in turn, lead to a growing elderly population (aged 60 years above) which is projected to rise from 121 million in 2016 to 190 million by 2030, an increase of 56.2 per cent. This demographic shift will serve as a key driver for the demand of medicines in the country.”

Special attention for senior citizens This necessitates the need for specially designed medication and treatment protocols to suit the needs of this population. There are several factors that need to be considered during formulation of medicines, drug

delivery and treatment of the geriatric population. Palnitkar informs, “The prevalence of chronic disease in the geriatric patient population such as asthma and heart disease are more prevalent amongst Indian men, whereas ailments like arthritis, hypertension, cataract and diabetes are more prevalent amongst women. India's epidemiological profile would, thus, become increasingly favourable for pharma companies as the burden imposed by chronic diseases grows.” Nishant Vaidya, Senior Product Manager, Bliss GVS Pharma also states, “The major concern for the elderly population are, loco motor disabilities, irritable bowel syndrome, heart diseases, skin disorders and mental disorders due to ageing brain.” So, how do we handle the special and specific needs of this special population? Depicting the Indian scenario, Palnitkar informs, “In India, elderly patients have a traditional mind-set and prefer

( conventional formulations such as oral and injectable. Doctors also find it challenging to explain the administration of suppositories and pessaries to elderly patients. Hence, promoting these dosage forms would be an ambitious task for pharma companies.” However, Nishant Vaidya highlights the challenges and shortcomings in the traditional and conventional dosage and delivery methods and states, significance of identifying disease profiles and states, “In elderly population, pharmacokinetics are strongly influenced by co-morbidity, polypharmacy or impaired organ functions. Though oral formulation is widely accepted in the Indian market, these dosage formulations come with their own set of problems when used in elderly population.”

Are suppositories the answer? Pharma companies like Sun Pharma, Cipla, Zydus Cadila, Abbott Laboratories, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline, Merck & Company, Novartis, Pfizer, and Sanofi are some of the major players operating in the global geriatric medicines market for older group of population, however, there is still a void when it comes to providing specific treatment options suitable for geriatrics. For older population, pharma companies need to offer solution which has minimal side effects and effective treatments procedures. Nishant Vaidya opines that suppositories could be the solution. He informs that globally, the suppository route represents a promising administration route for a wide range of therapeutic categories such as anti-malarial, laxative, contraceptive, anti-haemorrhoidal, anti-spasmodic, and anti-fungal. Globally, these forms are well accepted and assumed to be a possible treatment solution for the geriatrics in the near future. Suppositories and pessaries provide several advantages such

EXPRESS PHARMA

October 1-15, 2017

as avoidance of gastrointestinal irritation, provision of local effect on rectal mucosa, avoidance of first pass metabolism, reducing the chances of nausea, and vomiting and free from issue of taste.

However, not everyone holds these views. Anwar Daud, MD, ZIM Laboratories says, “Although suppositories are popular in Europe and North Africa and provide an acceptable solution to oral delivery

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parenteral delivery and further provide reduction of adverse effects, they have never been acceptable well in the Asian countries because of cultural perception issues. Also, there is some amount of inconvenience

as a majority of the patients in the population under discussion, will find it difficult to self-administer and cannot be administered ‘on the go’ in public while carrying out routine activity but needs private enclosures

cover ) In India, elderly patients have a traditional mindset and prefer conventional formulations such as oral and injectable Utkarsh Palnitkar Partner and Head, Infrastructure, Government and Healthcare, Life Sciences KPMG

We expect effervescence to gain a lot more traction in the coming months

like bathrooms to be available at the right time.” Vinod Arora, Principal Advisor, IGMPI, is another person who doesn’t completely agree that suppositories is the answer. He says, “In the West, suppositories delivery format is well accepted but in India its acceptance is poor. Bliss has been manufacturing suppositories for the last 15 years or more and have tapped many Big Pharma companies. However, to the best of my knowledge not a single product has touched the 100 crore mark.” He further narrates, “I worked on anti-malarial FDC suppositories for paediatric and during this time I also visited Bliss’ suppositories manufacturing facility for contract manufacturing. Later the product was dropped as there was a change in the business plan. We also debated on developing other molecules in suppositories dosage form for geriatric/paediatric but, the management decided was not to go ahead with this delivery format due to the following reasons: ◗ Inserting suppositories is a messy affair and is not patient friendly Suppositories Base Wax/Polyethylene/Polymer base melts at ~450C which creates a

challenge for storage /transportation ◗ Market Intelligence - Value wise sales of suppositories were not in line with organisation expectation. Thus, it seems that presently Indian pharma companies are not offering enough suppositories- and pessariesbased therapeutic solutions to patient due to several reasons, such as patients comfort in taking oral formulations, low awareness of safety and efficacy of suppositories, traditional mind-set of patients and doctors finding it difficult to explain the administration of suppositories to patients. If these social behaviours are going to continue in future too then Indian pharma manufacturer needs to look for some alternate treatment options. Beside social psychology, cost also plays an important role in this. Daud explains, “The Indian market is price sensitive and many companies do not have the technical capabilities to formulate such complex or differentiated products targeted towards special populations convenience and adherence. Companies which use branded prescription based marketing have traditionally dependent

upon fixed dose combinations for differentiation and providing multiple drug ingestion convenience and affordability.” So, what are the other solutions to ensure good quality and effective medication and treatment to our senior citizens?

A quest for alternate solutions Palnitkar shares his views on the alternate treatment methods Indian pharma companies should look for and suggests, “Novel Drug Delivery Systems (NDDS) products such as sustained released tablets, controlled released tablets, transdermal patches, etc. provide several clinical advantages for the geriatric patient population such as increase in safety, efficacy, a controlled and predictable release; decrease in dosing frequency; minimisation of side effects; and increase in patient compliance.” Daud gives his opinion and says, “The other medicinal dosage forms include multi-particulates in capsules, transdermal patches, orally dispersible tablets and granules, oral films (the last three requiring good taste-masking etc).” Dr Himadri Sen, Chairman, STEERLife suggests,

In the West, suppositories delivery format is well accepted but in India its acceptance is poor Vinod Arora Principal Advisor, IGMPI

If we are able to prevent most of the apparent disorders, these very people will enable us to augment our society SR Vaidya Director, Bliss GVS Pharma

Dr Himadri Sen Chairman, STEERLife

The other medicinal dosage forms include multi-particulates in capsules, transdermal patches, orally dispersible tablets and granules, oral films

Oral dosage formulations come with their own set of problems when used in elderly population Nishant Vaidya Senior Product Manager, Bliss GVS Pharma

22 EXPRESS PHARMA October 1-15, 2017

Anwar Daud Source: KPMG India

MD, ZIM Laboratories

( “Effervescent dosage in the form of tablets that rapidly becomes a fizzy solution in water is a well suited oral dosage forms for geriatric patients. Effervescent tablets takes away the pain of swallowing large tablets by providing a convenient alternative of sipping a flavoured drink.” However, these solutions are not very commonly used today. On being quizzed why Indian pharma companies are not offering such solutions to the Indian population, he says, “Effervescent manufacturing has been very cumbersome and very difficult to manage. However, there is a new effervescent platform technology from STEERLife that is called the ‘eximious technology’, which offers

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treating chronic ailments. In senior citizens, the problem of full term continuance of treatment is even more pronounced and such measures help ensure better adherence to treatment and medication protocols.

A brighter future

Source: KPMG India

the ease of continuous granulation process for effervescent manufacture. We expect effervescence to gain a lot more traction in the coming months.” Yet, the drugs and the delivery systems are only a part of

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the whole. Geriatric care needs to be looked at in a broader, comprehensive and holistic manner. Fortunately, recognising this fact, some pharma companies are exploring the combination of patient service while administer-

ing drugs. For example; a multinational company is offering complimentary counselling service to diabetic patients who are on its insulin based drug. Adherence to protocols is an essential factor when it comes to

As we near the World Elderly Day, observed on October 1 each year, it is to be hoped to that the lifesciences industry would continue to make strides in geriatric care. Afterall as SR Vaidya points out, “If we are able to prevent most of the apparent disorders in the geriatric population of our country, these very people will enable us to augment our society in terms of passing their valuable experiences in various fields.” u.sharma@expressindia.com

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October 1-15, 2017

cover )

24 EXPRESS PHARMA October 1-15, 2017

(

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October 1-15, 2017

MANAGEMENT INSIGHT

Integrative cardiology: Where can Ayurveda contribute? Dr M Vijayakumar, Clinical Professor,Adult Cardiology,Amrita Institute of Medical Sciences, Kochi, Kerala and Dr P Ram Manohar, Research Director, Amrita Centre for Advanced Research in Ayurveda,Amrita School of Ayurveda, Kollam, Kerala, share insights on blending traditional medicine and modern science to develop a holistic approach for cardiovascular healthcare

Dr M Vijayakumar, Clinical Professor, Adult Cardiology at Amrita Institute of Medical Sciences, Kochi, Kerala

here is no question about the miraculous impact of advanced medical knowledge in saving millions of human lives. Specially so, when it comes to diseases that afflict a vital organ like the heart, which can create life and death situations demanding complex interventions. New pharmaceutical drugs, bypass surgery, angioplasty, heart transplantation, pacemakers and the list is endless when it comes to discussing about the path breaking developments that have revolutionised medical interventions in the field of

26 EXPRESS PHARMA October 1-15, 2017

cardiology. Cardiology has become increasingly technology intensive and while these advances are life saving in many situations, there is growing concern that such interventions are sometimes being used out of context and become the cause of economic burden to the public. Worldwide, there is growing dissatisfaction with conventional treatments as they can at times be not effective or cause side effects or be prohibitively expensive. People are searching for less invasive, cost effective and safer solutions where it is

warranted. While the advancements in modern cardiology cannot be undermined in any way, complementing it with alternative approaches can perhaps reduce drug dependence, minimise surgical procedures and improve quality of life where it is reasonably possible to do so. In many parts of the first world, Integrative Cardiology has emerged as a clinical discipline that attempts to integrate the best of both worlds in the bid to provide the best care for the patient. Many cardiologists are

beginning to consider alternatives to conventional treatment for management of a wide range of conditions including angina, arrhythmia and congestive heart failure. Apart from surgery and pharmaceutical drugs, Integrative Cardiologists are keen to prescribe diet and lifestyle modifications along with standard care. Integrative Cardiology is developing around the world by incorporating many practices from complementary and clternative Medicine. However, the role that Ayurveda can play in Integrative Cardiology is yet to

Dr P Ram Manohar, Research Director, Amrita Centre for Advanced Research in Ayurveda, Amrita School of Ayurveda, Kollam, Kerala

be widely recognised. Ayurveda uses at least 1200 medicinal plants and about 25,000 herbal formulations. Many of these plants and formulations have been found to be potentially beneficial in the management of cardiovascular diseases in preclinical and clinical studies. However, sufficient translational work has not been done to integrate Ayurveda into mainstream clinical practice for management of cardiovascular diseases.

Terminalia arjuna, Desmodium gangeticum and Sida cordifolia are herbs that have shown promise in the management of chronic heart failure. T. arjuna may also have benefits in pulmonary hypertension. While Bacopa monnieri has been shown to increase rat coronary blood flow conferring protection against myocardial ischemic injury, Tinospora cordifolia has been found to have benevolent effects on physical and cardivascular performance induced by physical stress. Commiphora mukul or Guggulu continues to be studied for lipid lowering activity. When it comes to hyperlipidemia herbs like Terminalia chebula and procedures like lekhana vasti and virecana have also been found to be beneficial. Many classical formulations remain unexplored for their potential benefits in management of dyslipidemia. There are strong indications that Shirodhara, a specialised

therapy in which medicated oils are dripped on the forehead in rhythmic back and forth movement can influence the autonomous nervous system and stabilise cardiovascular function. Kalpamrita, Arogyavardhini Vati and Mustadi Ghanavati are formulations that have been studied for their efficacy in cardiovascular diseases. Saussurea lappa, Inula racemosa, Terminalia chebula and even Withania somnifera have been studied for their benefits in ischemic heart disease. There is preliminary evidence that a number of herbs, formulations and therapies from Ayurveda can be beneficial in management of heart diseases. Clinical experience suggests that Ayurveda could be considered as an option in Severe Peripheral Vascular Diseases, No option coronary disease as well left ventricular dysfunction.

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There are reports from clinical practice in Ayurveda of successful reduction or weaning of antihypertensives and lipid lowering agents with adjuvant Ayurvedic therapy. However, lack of safety data and concerns about herb drug interactions come in the way of such combination therapies being accepted in mainstream clinical practice, especially by the physicians of modern medicine. While adoption of modern methods of research can generate data to enhance its acceptability amongst practitioners of modern medicine, the introduction of Ayurvedic genomics and biology can also refine our understanding of diseases and open new avenues in drug discovery and therpeutics. Modern research is also shedding new light on the significance of some of the traditional dietary practices in India. A study conducted by cardi-

ologists at Amrita Institue of Medical Sciences, Kochi with Dr M Vijayakumar showed that coconut oil, though rich in saturated fatty acids when used for cooking, in comparison to sunflower oil, did not change the lipid-related cardiovascular risk factors in those who received standard medical care. Similarly, integration of Ayurvedic treatment along with conventional management of ischemic heart disease could potentially enhance quality of life and reduce mortality. Collaborative studies have to be conducted with the participation of Allopathic and Ayurvedic physicians to generate the kind of evidence that will enable development of treatment guidelines for Integrative Cardiology. Integrative Cardiology is not merely the supplementation of some herbs, formulations or treatments from Alternative Medicine for better outcomes in some selected cardiovascular

diseases. On the other hand, Integrative Cardiology means the active participation of practitioners of other medical systems in the assessment and decision making process potentially in all Cardiovascular diseases. In other words, we have to look at Integrative Cardiology as the collaboration of a multimodal team of clinicians who will deal with the patient in a wholesome manner integrating the body, mind and self. Intelligent synthesis of conventional medicine and Ayurveda medicine will definitely fill the gap in patient care India has a high incidence of heart disease and needs to develop approaches to prevent and manage heart diseases with deeper understanding of the causes that stem from socio cultural and other factors. In this context, blending of traditional wisdom and modern science has the potential to develop effective approach to holistic cardiovascular health.

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MANAGEMENT REPORT

Sustainable growth of pharma in India The overuse of antibiotics and water pollution in India undermine the global pharma industry, says The Earth Security Report 2017. The report put forth a practical method for business and investors to define the issues, metrics and actions that matter to their sustainable growth. Excerpts from the report THE WORLD’S focus on antimicrobial resistance (AMR) in India is increasing the scrutiny on global pharmaceutical companies to address complex social and environmental imperatives in its global supply chains. Indian pharma must get ahead of this challenge by creating an industry alliance in global fight against AMR. India is one of the world’s largest suppliers of antibiotics and the largest consumer worldwide and is now becoming an epicentre and focus of global attention for antibiotic resistance as over-use of antibiotics is having global effects. Globally deaths caused by antibiotic-resistant infections are expected to rapidly grow from 700,000 today to 10 million by 2050. Companies are being asked to use the power of innovation, investment, marketing and global value chains as a solution to entrenched social inequality and environmental degradation. Achieving this change will require business and governments to work together, translating global aspirations into practical actions. The Sustainable Development Goals (SDGs) have provided a common framework for these aspirations.

SDG 3: Good Health and Well-being India’s government spends only 4.7 per cent of its GDP on healthcare, less than half of government spend in Brazil, China and Russia. Poor public health infrastructure, high levels of infectious disease, such as TB, and cheap unregulated over-the-counter sale of antibiotics have led to a rapid rise in resistant infections in India.

28 EXPRESS PHARMA October 1-15, 2017

57,000 newborn babies are estimated to die annually from drug-resistant infections in India, the highest figure globally. At the same time, on average, only 36 per cent of key generic medicines are available in public hospitals in comparison to 76 per cent in the private sector facilities. The government and industry campaign on the safe use of antibiotics must integrate sustainable access to and usage of antibiotics, as well as other key generic drugs, particularly for poor rural populations that lack access to doctors.

SDG 6: Clean water and sanitation The number of polluted rivers in India doubled from 2010 to 2015, exacerbating the growing water supply crisis for 600 million Indians that are already at high risk of freshwater supply disruptions. The contamination of waterways and the potential impact of untreated wastewater from antibiotic factories on antibiotic resistance, will require the industry to work with state governments and other industries to strengthen stewardship practices, as well as address water pollution challenges with suppliers as a central component of industry’s response to the AMR crisis.

REGIONAL SDG HIGHLIGHTS The Earth Security Index diagram for the pharmaceuticals industry in India provides pharmaceutical companies and policy makers with a view of the SDG pressures that are material to the long-term growth of the sector in the country. Pharma companies, industry associations, investors in pharma and development finance institutions, and government policy makers, should consider the risks and opportunities they face in relation to the following SDGs, and the imperatives for action:

MANAGEMENT SDG 8: Decent work and economic growth Only 1,500 drug inspectors are responsible for monitoring good manufacturing practices for drug quality across the entire pharmaceutical industry in India. The Pollution Control Boards that monitor water pollution are chronically understaffed and underfunded. New partnerships with state governments must support investments in building up the skills and capacities of the Pollution Control Boards in order to create a more level playing field.

SDG 9: Industry, innovation and infrastructure Research and development costs in India can be up to 20 to 30 per cent lower than those in the US and Europe, driving many companies to outsource both production and clinical trials to India. As the government looks to boost competitiveness and respond to India’s water crisis with stricter environmental regulations, companies that have already invested in effectively managing their wastewater emissions and being compliant with government regulations will be better positioned to grow in a more tightly regulated market.

SDG 12: Responsible consumption and production Over 21 per cent of diseases in India are water-related due to high levels of biological and chemical contamination, leading to a drastic rise in respiratory diseases in populations where industry is concentrated. Scientists are also concerned that chemical pollution containing extremely high levels of antibiotics is a driver of AMR. Sound management strategies of industrial chemicals and wastes in the pharma supply chain and other key industries must meet international standards.

SDG 15: Life on land India is one of the most biodiverse countries on earth, hosting 8 per cent of all documented species, including over 45,000 species of plants. High levels of land degradation and biodiversity loss in India will require pharma companies to consider integrating a pharma value of biodiversity into bio-prospecting agreements with the government and form new partnerships with NGOs and communities to better protect species and habitats while ensuring fair and equitable benefit sharing from the utilisation of genetic resources as per international standards.

SDG 16: Peace and justice strong institutions A chronic lack of enforcement of industry regulations and lack of capacity of

government inspectors has allowed a number of industry transgressions in the supply chain to persist, from water pollution to unethical marketing practices. As the government calls for stricter penal action against unethical practices and making the ‘Uniform Code of Pharmaceutical Marketing Practices’ mandatory, pharma companies must ramp up their efforts to agree to providing pricing guidelines to thirdparty sales agents and monitoring and auditing sales agents.

The sustainable growth of pharmaceuticals in India India has become a major global player in the pharma industry as a lowcost manufacturing destination for the global pharma across all categories of pharmaceutical production: finished dosage, active pharmaceutical ingredients (APIs) and intermediates as well as research and development activities. Alongside China, India is now one of the world’s two largest suppliers of antibiotics. However, India is now also the largest user of antibiotics for human health globally. The industry faces multiple social and environmental challenges to its sustainable growth. Access to healthcare and affordable medicines remains a challenge at the bottom of the pyramid, as government investment in healthcare remains low in comparison to other large emerging markets. The large-scale overuse of antibiotics in humans, as well as animal farming, is a primary driver of human resistance to antibiotics (known as antimicrobial resistance – AMR), which is emerging as a highly complex issue. Another significant contributor to the spread of AMR in India is water pollution from antibiotic factories. Globally, deaths caused by drug-resistant infections are expected to rapidly grow from 700,000 today to 10 million by 2050. India is a global hotspot for AMR, which is becoming one of the greatest threats to modern medicine. This is increasing scrutiny on global pharmaceutical companies to address protracted social and environmental challenges in global supply chains.

Recommendations Indian pharma companies should adopt sustainable financing strategies to develop zero-wastewater facilities. The national antibiotic campaign in India should deploy proven crowdsourcing technologies to enable citizens to control water pollution. Indian industry associations – FICCI, CII and OPPI – should create a business action hub as a local partner of the global AMR Industry Alliance.

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RESEARCH I N T E R V I E W

â&#x20AC;&#x2DC;Our current development work is focussed to oncologyâ&#x20AC;&#x2122; Taher Abbasi, COO and Co-Founder, Cellworks, shares with Prathiba Raju, how precision medicine is gaining momentum in healthcare and how simulation technology is able to identify right treatment for a patient and identify right patient for a clinical trial

From a background of semiconductor business in the automation engineering business to healthcare, how and why was the transformation? Automation technologies and methodologies enables semiconductor business to shorten product development time, handle higher product complexity and achieve success rates of over 98 per cent. Computer simulation was one of the enabling technologies. In healthcare, the drug development cycle is 10 years, drug approval success rate is less than 8 per cent and response rate of approved drugs is below 30 per cent. The idea for Cellworks is to apply the best practices and successes from an orthogonal domain to healthcare.

Our underlying product is a simulation model representing cancer physiology

Can you explain to us how do use the simulation technology to minimise or lower the deployment cost in the healthcare industry? Simulation technology can identify right treatment for a patient and identify right patient for a clinical trial. Computer simulations can predict patient clinical responses to specific drug treatments thereby eliminating adverse events and costs of ineffective treatments. Simulations can identify novel treatments the patient is more likely to respond to. Why precision medicine would be apt for cancer and oncology treatments? Cancer is a disease where every patient's tumour characteristics are different. Hence one-size-fits-all treatments have low response rate. Precision medicine is apt for cancer

30 EXPRESS PHARMA October 1-15, 2017

if one can predict prior to treatment if the patient would respond to a drug and alternatively what treatments would impact the disease. Your company is now designing a range of drugs via computer modelling. How did you work or come out with a mathematical model which work out the chances of creating a successful drug or personal care product? Our underlying product is a simulation model representing cancer physiology. This simulation model has been developed over 1000 man years of effort with continuous enhancements and validations. We do not create new chemicals. We build digital models of existing drug agents. These digital drug agents are simulated on computational patient models to match with the best therapeutic options for a patient. What are the challenges you face as an information broker and trying to integrate data and biology? The key Cellworks differentiator and opportunity is building a multidisciplinary skillset team of sciences, mathematics and software. The platform development requires interpreting biology from research, modelling biology using mathematical equations and software coding, testing and validation. How does Cellworks Group crunch a huge volume of biological data and conduct a predictive analysis of drugs and diseases?

Elaborate. There are two classes of biological data which are used for building a digital model of patient and precision medicine. One is the biological data of the underlying signalling and metabolic pathways to build the computational simulation model. The other class of biological data is the genomic measurements and clinical data for each patient. This is used for customisation per patient. The representation of biology using mathematical equations allow predictions to be made. Can you update on your current work on testing virtual prototyping systems such as oncology, auto-immune disorders, infectious diseases, dermatology and metabolic syndrome, including type II diabetes? Our current development work is focussed to oncology. Our product is a software engineering medical device which creates a digital model of a patientâ&#x20AC;&#x2122;s cancer using tumor genomic measurements. This digital model can be simulation-tested with targeted drug agents individually and in combination to predict the likelihood of cancer response and mechanistic insights into the scientific rationale. We continue to validate this product across clinical datasets. Are big MNCs like Siemens, GE and Biocon guiding you and how? We collaborate mainly with clinical partners at academic medical centres and co-author presentations and publications with them. prathiba.raju@expressindia.com

UPDATE

Pfizer,Astellas prostate cancer drug promising in late-stage trial Pfizer is pinning its growth on approvals and success of 15 drugs, including Xtandi and breast cancer drug Ibrance, over the next five years PFIZER AND Japan’s Astellas Pharma said their blockbuster prostate cancer drug met the main goal of a key study that tested it for treating the disease in its early stages. The positive data sets the stage for an earlier-than-expected approval of the drug, which is already cleared to treat metastatic castration-resistant prostate cancer (CRPC) - where the cancer has spread to other parts of the body. Pfizer said the drug, Xtandi, in combination with an anti-hormone therapy, was statistically significant in improving survival in men with non-metastatic CRPC without their cancer spreading, compared with the standalone anti-hormone therapy.

“It increases the target market size by perhaps more than double,” Evercore ISI analyst Umer Raffat said. There is no FDAapproved treatment for non-metastatic CRPC, according to Deutsche Bank analysts. The drug, which Pfizer gained access to after it bought Medivation in a $14 billion deal last year, generated global sales of more than $600 million in the April-June period. Pfizer and Astellas jointly sell Xtandi in the US, while Astellas owns the rights

to develop and sell Xtandi outside the United States. Analysts said the early success of the trial, which was originally set to be completed in 2019, validates Pfizer’s decision to buy Medivation. “(This) data will serve as an important catalyst for Xtandi, while also improving sentiment on the Medivation deal,” Credit Suisse analysts wrote in a research note. Pfizer is pinning its growth on approvals and success of 15 drugs, including Xtandi and breast cancer drug

GSK’s three-in-one inhaler gets positive opinion from EU agency Three different mechanisms wil be used to help open airways of patients with severe chronic obstructive pulmonary disease GLAXOSMITHKLINE said that an European Medicines Agency (EMA) panel has recommended the company’s three-inone inhaled lung drug. GSK’s once-daily triple inhaler combines the drugs fluticasone furoate, umeclidinium and vilanterol. The idea is to use three different mechanisms to help open airways of patients with severe chronic obstructive pulmonary disease (COPD). GSK and US-listed Innoviva received a positive opinion for the treatment from the EMA’s Committee for Medicinal Products for Human Use (CHMP), GSK said in a statement.

A CHMP positive opinion is one of the final steps before marketing authorisation from the European Commission. A final decision is expected around the end of 2017, the company said. GSK’s former blockbuster lung drug Advair, which has generated more than $1 billion in an-

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nual sales for the company since 2001, has already been facing generic competition in Europe. However, the company is likely to escape generic competition in the US this year as, so far, generic competitors have failed to win US approval for the cutprice equivalent form of the medicine. Approval is expected by mid-2018. GSK’s new chief executive announced plans in July to allocate 80 per cent of its R&D budget in the future to respiratory and HIV/infectious diseases, along with two other potential areas of oncology and immuno-inflammation. Reuters

Ibrance, over the next five years. Earlier this month, the US Food and Drug Administration approved the company’s Mylotarg for certain patients with acute myeloid leukemia, re-clearing a drug that had been pulled off the market in 2010. The positive Xtandi trial comes three months after data showed Johnson & Johnson’s rival drug, Zytiga, reduced chances of death for men newly diagnosed with high-risk prostate cancer that had spread to other parts of the body. According to the American Cancer Society, more than 161,000 men are estimated to be diagnosed with prostate cancer this year in the US. Reuters

US FDAapproves Bayer drug to treat follicular The drug, Aliqopa, known also as copanlisib, is a kinase inhibitor that blocks certain enzymes that promote cell growth THE US Food and Drug Administration said on Thursday it has approved Bayer's treatment for follicular lymphoma, a cancer of the lymph system. The drug, Aliqopa, known also as copanlisib, is a kinase inhibitor that blocks certain enzymes that promote cell growth. It is designed for patients who have received at least two prior treatments. Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma. An estimated 72,240 people in the US will be diagnosed with some form of non-Hodgkin lymphoma this year. The FDA granted Aliqopa accelerated approval, meaning clinical data suggests it will be beneficial, but further trials will be needed to prove that. In a trial of 104 patients, 59 per cent experienced a complete or partial shrinkage of their tumors for a median 12.2 months. Reuters

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RESEARCH

Immuno-oncology looks set to become the fifth pillar of cancer treatment According to GlobalData, the report predominantly focusses on developments in active immunotherapy products based on their molecular targets and molecule types IMMUNO-ONCOLOGY (IO) looks set to become the fifth pillar of cancer treatment alongside surgery, radiotherapy, chemotherapy, and other targeted treatments according to GlobalData, a recognised leader in providing business information and analytics. The company’s health team analysed over 4,000 clinical trials and more than 800 IO products in Phase I–III clinical trials to generate a number of unique actionable insights in their latest report: 'Pharma Focus Visual Analysis of Immuno-Oncology Development and Opportunities'. The report predominantly focusses on developments in active immunotherapy products based on their molecular targets and molecule types. The team also assessed immune checkpoint modulators (based on 21 individual targets) together with a total of 18 solid tumour types and eight blood cancers. A large selection of treatments within immune-oncology focus on utilising the immune system to induce an anti-tumour response, leading to tumour stabilisation and potential remission from the disease. These treatments achieve their effects through the inhibition, or blockade, of immune checkpoint proteins (ICPs) such as CTLA-4 and PD-1. PD-(L)1 inhibitors are rapidly adopted in indications receiving approval due to significant survival benefit and relatively good safety profiles in comparison with other Standard Of Care (SOC) treatments. The number of regulatory designations generally correlates with the number of first-to-market indications. Maxime Bourgognon, Senior Healthcare Analyst, GlobalData, commented, ‘‘Beyond PD-(L)1 and CTLA-4, 18 other IO targets are currently being explored in Phase I–III clinical

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October 1-15, 2017

The company’s health team analysed over 4,000 clinical trials and more than 800 IO products in Phase I–III clinical trials to generate a number of unique actionable insights in their latest report: 'Pharma Focus Visual Analysis of ImmunoOncology Development and Opportunities' trials. However, agents targeting emerging checkpoint targets will not represent a threat to the uptake of existing PD(L)1 checkpoint modulators, as most agents will be combined with already marketed immune checkpoint modulators.’’ Of the big advances in cancer care over recent years, excitement around the clinical and market potential of IO has been driven by IO’s ability to harness the natural processes of the body’s immune system to search for, examine and eradicate foreign particles. IO teaches the immune system to recognise and destroy cancer cells and thereby enable the body to regain control. The future of IO looks brighter than ever, and IO drugs are now in a position to compete as monotherapies against traditional SOC chemotherapy regi-

mens in the first line of the metastatic setting. In addition, these treatments have shown efficacy in a wide variety of indications offering a less toxic treatment alternative. Bourgognon continued, ‘‘Despite all the initial setbacks and challenges in IO, researchers and drug developers have now found innovative ways to successfully augment the immune response against cancer. In the near future, it is hoped that the combination of IO agents with other IO agents, targeted therapies, or chemotherapy regimens will lead to improved long-term survival outcomes for even more cancer patients.'’ Key topics covered in the report include: ◗ Immune checkpoint modulators – Trends in clinical trial

development ◗ Competitive Assessment of Marketed PD-(L)1 Checkpoint Modulators ◗ Emergence of new immune checkpoint targets ◗ Clinical and commercial opportunities for highly anticipated CAR cell therapies ◗ Cell Vaccines: Steady development stimulated by prior IO Success ◗ Promising IO-IO combinations utilising oncolytic viruses Bourgognon, added, ‘‘This report consists of a highly-visual slide deck that is intended to facilitate the dissemination of aggregated data and insights. Types of graphical analyses include cumulative plots, aggregated bubble plots, pie charts, and matrix analyses.’’ EP News Bureau

Roche cancer immunotherapy Tecentriq wins EU approval ROCHE immunotherapy Tecentriq has won European Union approval for treating advanced lung and bladder cancer, the Swiss drugmaker said. The European Commission approved Tecentriq, also known as atezolizumab, as a monotherapy for locally advanced or metastatic nonsmall cell lung cancer (NSCLC) after patients have been treated with chemotherapy. The Commission also approved the drug as a monotherapy for treating people with locally advanced or metastatic urothelial carcinoma (mUC) who have been treated with a platinum-containing chemotherapy or who are considered ineligible for cisplatin chemotherapy, Roche said. “We are delighted that the European Commission has approved Tecentriq, the first anti-PD-L1 cancer immunotherapy approved in the EU, as a monotherapy in both advanced bladder and advanced lung cancer,” Chief Medical Officer Sandra Horning said in a statement. The therapy is already approved in the US and several other countries for people with metastatic NSCLC, people with mUC who are not eligible for cisplatin chemotherapy, or those whose disease progresses during or after platinumcontaining therapy. Roche is counting on the immunotherapy to help offset the loss of sales from biologic cancer drugs facing cut-throat competition from so-called biosimilar rivals. It generated first-half sales of 237 million Swiss francs ($245 million). Reuters

RESEARCH

Purdue researchers create device to identify risks for breast cancer The device, known as risk-on-a-chip, is a small plastic case with several thin layers and an opening for a piece of paper where researchers can place a portion of tissue RESEARCHERS AT Purdue University are creating a device that they hope will help identify risk factors that cause breast cancer. The device, known as risk-ona-chip, is a small plastic case with several thin layers and an opening for a piece of paper where researchers can place a portion of tissue. This tiny environment produces risk factors for cancer and mimics what happens in a living organism. “We want to be able to understand how cancer starts so that we can prevent it,” said Sophie Lelièvre, a professor of cancer pharmacology at Purdue. The key to preventing cancer is understanding how it starts, but people generally don’t want to be prodded with potential carcinogens. Cancer is a disease of gene expression, and organisation of genes is specific to a particular species and organ, which means it wouldn’t be useful to perform this study on rats or mice. Thus, Lelièvre needs a model that will mimic the organ in question. She teamed up with Babak Ziaie, a professor of electrical and computer engineering at Purdue, to create the device. “Unlike conventional 2-D monolayer cell culture platforms, ours provides a 3-D cell culture environment with engineered gradient generators that promote the biological relevance of the environment to real tissue in the body,” said Rahim Rahimi, a graduate student in Ziaie’s lab. The risk-on-a-chip is based on an earlier cell culture device developed by Lelièvre and Ziaie to study cancer progression. To modify it for prevention, Ziaie plans to add nanosensors that measure two risk factors: oxida-

The risk-on-achip will simulate oxidative stress by producing those molecules in a cell culture system that mimics the breast ducts where cancer starts tive stress and tissue stiffness. Oxidative stress is a chemical reaction that occurs as the result of diet, alcohol consumption, smoking or other stressors, and it alters the genome of the breast, aiding cancer development. The risk-on-a-chip will simulate oxidative stress by pro-

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ducing those molecules in a cell culture system that mimics the breast ducts where cancer starts. Tissue stiffness refers to the stiffness of breast tissue, which has been found to contribute to onset and progression of breast cancer. The research team will measure stiffness within a tunable matrix made of fibres, whose density is relative to stiffness. Breast cancer is particularly difficult to prevent because multiple risk factors work independently or in combination to promote disease onset. To account for this, the risk-on-a-chip will be tailorable to different groups of women at risk. “We need to see if there’s a difference in primary cells from black women or Asian women or white women, because that matters,” Lelièvre said. “The way our genome is organised depends on an individual’s ancestry and lifestyle; it’s very complex. That’s why cancer is so difficult to treat.” The research team believes the risk-on-a-chip could be used to study additional risks by adding more cell types and biosensors. They estimate that optimisation for each new condition will take between six months and a year. Lelièvre and Ziaie have received a joint grant from the Department of Defense (W81XWH-17-1-0250) to create and test the device with structures that mimic the mammary gland, which will provide more than $500,000 over the next two years. This project is part of the international breast cancer and nutrition collaboration. EP News Bureau

Lilly/Incyte pill beats placebo in mid-stage eczema trial Side effects included upper respiratory tract infections and headache ELI LILLY and Co and Incyte Corp said a mid-stage trial of their oral drug baricitinib showed that at the highest dose it worked better than placebo for people with moderate-to-severe atopic dermatitis. The finding could be a boost for the drug’s prospects, which suffered a setback earlier this year after US regulators turned down an application for its use in rheumatoid arthritis, saying that more data was needed. Baricitinib, in a class of drugs known as Jak inhibitors, is sold in the European Union under the brand name Olumiant for treating rheumatoid arthritis. Atopic dermatitis is a chronic type of skin inflammation also known as eczema, which in severe cases causes constant itching. The Phase II eczema trial found that after 16 weeks, 61 per cent of patients on the highest dose of baricitinib and a topical corticosteroid had at least a 50 per cent reduction in symptoms, compared to 37 per cent of patients treated with just a steroid. At the lower dose, there was not a significant difference between the groups. Side effects included upper respiratory tract infections and headache. The study, presented at the

European Academy of Dermatology and Venereology annual meeting in Geneva, involved patients who had failed to achieve adequate relief after four weeks of using a mid-potency topical corticosteroid. Baricitinib has the potential for use as an oral treatment for eczema patients who are unable to control the disease with a steroid, Dr Emma GuttmanYassky, Vice Chair of the department of dermatology at Mount Sinai Hospital in New York, said in a statement. Lilly and Incyte said they plan to launch a Phase III clinical programme for atopic dermatitis later this year. Rival AbbVie last week said its experimental Jak inhibitor, upadacitinib, was shown in a mid-stage study to significantly improve the severity of eczema. The US medicines regulator, the Food and Drug Administration, earlier this year approved Regeneron Pharmaceuticals and Sanofi's Dupixent for moderate-to-severe atopic dermatitis. However, sales of the drug, which has a list price of $37,000 a year, have so far disappointed investors. Eczema affects an estimated two per cent of US adults, and as many as 20 per cent of children. Reuters

EXPRESS PHARMA

October 1-15, 2017

RESEARCH

FDAdeclines to approve J&J arthritis drug sirukumab Panelists were concerned about an imbalance in the number of deaths in patients taking sirukumab compared with those taking a placebo THE US Food and Drug Administration has declined to approve Johnson & Johnson’s rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. The FDA’s decision is in keeping with an advisory panel’s recommendation in August that the FDA reject the drug. Panelists were concerned about an imbalance in the number of deaths in patients taking sirukumab compared with those taking a placebo. The most common causes of death were major heart problems, infection and malignancies.

“We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab,” said Dr Newman Yeilding, head of immunology, J&J’s Janssen subsidiary. He added that the company is seeking to “gain a full understanding of FDA requirements for US approval” and plans to have a follow-up discussion with the agency. Sirukumab blocks a cytokine in the body known as interleukin 6 that can contribute to the inflammation associated with rheumatoid arthritis, an autoimmune disorder that affects more than 23 million peo-

ple worldwide. Other drugs in the same class include Roche Holding's Actemra and Sanofi and Regeneron Pharmaceuticals' Kevzara. Analysts on average had expected sirukumab, which would be known as Plivensia if ultimately approved, to generate annual global sales of $426 million by 2020. J&J originally developed sirukumab with GlaxoSmithKline but GSK recently said it would end the programme and return all rights to J&J. GSK had rights to the drug in North, Central and South America. In April the FDA declined to approve a rheumatoid arthritis

drug made by Eli Lilly and Co and partner Incyte Corp, saying additional clinical data was needed to determine the most appropriate doses of the drug, baricitinib, and to further char-

acterise safety concerns. Baricitinib belongs to a class of drugs known as Jak inhibitors that include Pfizer's Xeljanz and AbbVie's Humira. Reuters

Stopping antidepressants tied to increased relapse risk The study found that overall, relapse occurred in about 36 per cent of people who switched to placebo and 16 per cent of those who remained on antidepressants PEOPLE TAKING antidepressants for anxiety, obsessivecompulsive disorder (OCD) and post-traumatic stress disorder (PTSD) are more likely to relapse when they stop using these drugs than when they remain on medication, a research review confirms. Researchers analysed the combined results from 28 previously published studies with a total of 5,233 participants who had been on antidepressants for up to one year. Patients were randomly assigned to either continue medication or switch to placebo, or dummy, pills. Over the next year, patients who discontinued treatment were roughly three times more likely to relapse than people who remained on antidepressants, researchers report in The BMJ. “Patients and their doctors

34 EXPRESS PHARMA October 1-15, 2017

should be aware that discontinuing antidepressants within a year is associated with increased relapse risk,” said lead study author Dr Neeltje Batelaan of the VU University Medical Center in Amsterdam. “This should be taken into account when discussing discontinuation,” Batelaan said by email. “It does not imply that all patients should remain on antidepressants for the rest of their lives.” That’s because the majority of patients who discontinue antidepressants do not relapse, and because relapse sometimes occurs even when patients are still taking these medications, Batelaan added. Overall, relapse occurred in about 36 per cent of people who switched to placebo and 16 per cent of those who remained on

antidepressants, the study found. And among the patients who did relapse, this happened more than three times faster for people switched to placebo than for individuals kept on antidepressants. It’s not exactly clear why some patients relapsed, but it’s unlikely to have been caused by withdrawal symptoms among the people who discontinued treatment, Batelaan said. Many antidepressants work by altering the way certain chemicals in the brain such as serotonin, dopamine and norepinephrine transmit signals involved in controlling emotions and moods. Stopping antidepressants is thought to change how these brain chemicals function, which may lead to relapse in some people. Side effects of antidepres-

sants can include nausea, weight gain, sexual dysfunction, insomnia, blurred vision and constipation. One limitation of the study is that it included only patients who had been taking these medications for up to a year, making it likely that all or most of the participants didn’t need to halt treatment due to side effects. Another drawback of the study is its reliance primarily on published studies funded by drug companies, which the authors note might bias the results toward showing the benefits of continuing antidepressant treatment. Even so, the results add to a large body of evidence already suggesting that patients on antidepressants may be more prone to relapse when they discontinue treatment than when

they remain on medication, said Dr Ronald Pies, a psychiatry researcher at SUNY Upstate Medical University in Syracuse, New York, and Tufts University School of Medicine in Boston. “If the patient has a fairly severe or recurrent anxiety disorder that has not responded to cognitive-behavioral therapy alone, the use of an antidepressant for up to a year and possibly longer can be justified, owing to the risk of relapse with medication - so long as the patient is tolerating the treatment reasonably well,” Pies, who wasn’t involved in the study, said by email. “Not all patients will need long-term medication,” Pies added. “In fact, the study found that most patients do well when discontinuing treatment.” Reuters

PHARMA ALLY I N T E R V I E W

India is considered to be one of the fastest growing regions for the company Amit Bansal, MD, Corning India talks about his company’s focus areas, growth strategies, its plans for the Indian market and more, in an exclusive interaction with Viveka Roychowdhury

What is the revenue mix between the five business segments that Corning is present in: consumer electronics, telecom, automotive, life sciences and display? Corning is one of the world’s leading innovators in materials science. For more than 165 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people’s lives. Corning operates in five reportable segments: Display Technologies, Optical Communications, Environmental Technologies, Specialty Materials and Life Sciences, and manufactures products at 98 plants across 17 countries. Globally, the Display Technologies segment that manufactures glass substrates for active matrix liquid crystal displays, primarily in LCD televisions, notebook computers and flat panel desktop monitors, represented 34 per cent of Corning's sales in 2016, the Optical Communications segment offering optical fibre, cable and connectivity solutions, represented 32 per cent, Environmental Technologies segment that manufactures ceramic substrates and filter products for emissions control in mobile and stationary applications around the world, represented 11 per cent, Specialty Materials segment that manufactures products

36 EXPRESS PHARMA October 1-15, 2017

that provide more than 150 material formulations for glass, glass ceramics and fluoride crystals to meet demand for unique customer needs, represented approximately 12 per cent and life sciences segment that offers tools and solutions to researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process, represented approximately nine per cent of Corning's sales in 2016. Corning India revenue is not publicly disclosed, but contributes to AP emerging market sales which recorded $363 million in 2016 vs. $331 million in 2015. What has been the growth in the life sciences segment? Corning has been the leading developer, manufacturer and global supplier of scientific laboratory products for over 100 years. We are also the trusted suppliers to life scientists seeking new approaches to increase efficiencies, reduce costs and compress timelines in cell culture and bioprocessing, drug discovery, molecular biology and genomics, microbiology and quality testing, and chemistry fields. Today, a revolution in drug development is underway-driving life science progress into new and innovative areas all centered around growing cells. Globally, Corning Life Sciences grew five per cent in 2016 compared to expected

A revolution in drug development is underway which is driving life science progress not only into new and innovative areas of research, but new markets as well

market growth of 2.5 per cent. Globally, drug production continues to grow, and in addition to the chemicallybased treatments we’ve always known, we now see a proliferation of highly effective biologic therapies. In fact, eight of the top 10 drugs on the market today are biologics. Currently, Corning is investing and focussing in cell research. With an ageing population and the rise of lifestyle-related diseases and global healthcare, spending is projected to increase by over five per cent annually in the coming years (Deloitte Report). Corning has established itself as the market leader in the moving liquids, adherent cell bioprocessing and growing cells segments. Currently, bioprocess and cell therapy are driving single digit growth for Corning Life Sciences. In India, the growing population creates a huge demand for existing vaccines and for the development of new vaccines, Corning Life Sciences offers a comprehensive range of innovative, high-quality labware products and solutions for life science research and bio-production. Corning’s bioprocessing tools are already helping Indian biopharma companies to develop and produce vaccines. Additionally, the acquisition of BD’s Discovery Labware business in 2012 has expanded the Corning Life Sciences product portfolio and enhanced its access to an

extensive dealer network to serve customers in India. As per IBEF research, India is among the top 12 biotech destinations in the world and ranks third in the Asia-Pacific region. India has the second-highest number of US Food and Drug Administration (USFDA)–approved plants, after the USA and is the largest producer of recombinant Hepatitis B vaccine. Out of the top 10 biotech companies in India (by revenue), seven have expertise in bio-pharmaceuticals and three specialties in agribiotech. The Indian biotech industry holds about 2 per cent share of the global biotech industry. The biotechnology industry in India, comprising about 800 companies, is valued at $11 billion and is growing at a Compound Annual Growth Rate (CAGR) of 20 per cent. The government has to invest $5 billion to develop human capital, infrastructure and research initiatives if it is to realise the dream of growing the sector into a $100 billion industry by 2025. Biopharma is the largest sector contributing about 64 per cent of the total revenue followed by bio services (18 per cent), bioagri (14 per cent), bio industry (three per cent), and bioinformatics contributing (one per cent). The upward trend in Indian life sciences market will provide Corning with an immense growth opportunity in the country. As per the internal reports of

Corning, the company has successfully doubled its revenues and India is considered to be one of the fastest growing regions for the company, thus contributing to Corning’s success. Which are the geographic markets showing promising growth? What are the growth drivers? A revolution in drug development is underway which is driving life science progress not only into new and innovative areas of research, but new markets as well. Asia Pacific region has consistently proven to be a dynamic market in terms of growth and opportunity available. The primary development has notably been experienced in the healthcare segment like vaccine production and immunotherapy. This increase is driven by a large and aging population along with the need for preventive healthcare which goes hand in hand with Corning’s expertise of developing, manufacturing and supplying products to life scientists seeking new approaches to increase efficiencies, reduce costs and compress timelines in cell culture and bioprocessing, drug discovery, molecular biology and genomics, to name a few. Asia Pacific has been one of the key focus regions for Corning Life Sciences, and Corning is committed to Asia’s vaccine industry by providing more professional and technical support to the customers to optimise their processes and improve yield. Apart from the segments where Corning is already active, we are also working on capturing an exciting opportunity for next–generation glass packaging for drug storage and delivery. Corning Pharmaceutical Glass is uniquely suited to supply highquality pharma glass tubing to meet the rigorous needs of the pharma packaging industry. Corning Pharmaceutical Glass manufacture a variety of clear and amber borosilicate glass tubing, which is converted by our global customers into glass

vials, cartridges, ampules and syringes for drug storage and delivery. In addition, a new era of medicines, based on biologically-derived drugs or 'biologics', has started to show significant growth, with an estimate of it accounting for up to 80 per cent of all drugs that are being developed or launched, hence becoming another of our key focus areas. Corning continues to develop and produce innovative technologies aimed at the growing biologic drug production markets. What is your market share in the products and services for this division? The Indian pharma market is currently at $25 billion and it is expected to grow at a CAGR of 12 per cent till 2020, giving Corning Life Sciences a platform for immense growth opportunities. Notably, the year 2016 witnessed the strongest performance in Corning Life Sciences history in India. Where does India fit into the company's global strategy for the future? Corning, as a market leader in the life sciences industry globally, has footprints in cell culture, bio-process, microbiology, drug discovery, genomics, molecular biology, small lab equipment and chemistry. India is one of the fastest growing markets for Corning Life Sciences in the Asia-Pacific region and shows great potential for business. India’s life science market is the third largest by incremental growth and the seventh largest by volume. In India, Corning Life Sciences provides solutions to academic institutions, R&D, contract research organisations and pharma industry. India’s growing population (expected to reach 1.4 billion in 2022 as per the 2015 UN Report), creates the demand for not only large scale production of vaccines but also extensive research for newer ones; Corning’s expertise in providing the this service, provides for strong potential

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to deliver solutions for this demand, making India one of its potentially biggest markets for Corning, outside the US. Corning’s major focus areas in India have been bioprocess, cell culture and molecular biology/genomics. In the future, we are looking forward to increase our product offering by introducing cell culture media and innovative scale-up technologies like CellCube which is an integral, encapsulated, sterile, singleuse device that is 100 per cent pressure-hold tested before shipment that comprises of a series of parallel, styrene plates joined to create thin, sealed, laminar flow spaces between adjacent plates and HYPERStack, a new product line combines the best of two Corning products; the CellSTACK Culture Chamber and HYPERFlask vessel. The utilisation of the proprietary gas-permeable film technology provided in the format of the CellSTACK Culture Chamber allows the HYPERStack vessel to be the most efficient, scalable cell culture vessel for adherent cell culture available today. These technologies will provide efficient processing. How does Corning score over your peer solutions providers in the life sciences sector? Corning seeks to maintain a competitive advantage by emphasising product quality, global distribution, supply chain efficiency, superior product attributes and by offering a world- class customer experience Corning is a market leader in the industry in which we operate. For over 100 years, Corning Life Sciences has been developing, manufacturing and supplying high quality, innovative products and solutions. Corning offers range of life science applications, accelerating the industry’s discovery of new drugs, treatments, and breakthroughs that saves and change lives. Our trusted brands, backed by technical expertise, provide researchers with better ways

to advance their research from the beginning of their process to the end. Corning has developed technologies that change the way researchers work, including optimised synthetic surfaces for cell culture and assays, biological surfaces, single-use products and closed system solutions for more efficient scale-up and downstream bioprocess, automation solutions, and Next-Generation Sequencing solutions to simplify genomics sample preparation and library construction. These technologies are bringing new efficiencies and improved results to scientists around the world. With our local warehouse in Mumbai, it’s easy for researchers in India to access to all the Corning Life Sciences products. Our end-to-end total solutions enable researchers to make breakthrough discoveries easier and faster. Corning has been the most trusted supplier to life scientists seeking new approaches to increase efficiencies, reduce costs, and compress timelines. Using our unique expertise in the combined fields of materials science, surfaces, molecular biology and biochemistry, we provide a full range of innovative solutions that improve productivity, enable breakthrough discoveries and save and change lives. Corning has grown in India through acquisitions and collaborations. What kind of acquisitions, collaborations are you currently pursuing and in which part of the portfolio? India is one of our biggest and most promising markets, we will continue to explore our growth opportunities in the country. What are the revenue targets, growth targets for the life sciences business in Corning in India and what are the strategies to achieve these targets? Globally, we are expecting low single digit sales growth from

our life science business in 2017, ahead of forecasted market growth rates driven by demand for bioprocessing, cell therapy and 3D cell culture applications. Corning expanded their ADME/Tox product offering in April to include Corning TransportoCells HEK293derived ABC transporter membrane vesicles and Corning Supersomes Ultra Human Aldehyde Oxidase (AO) enzyme. Building on its large line of Corning Gentest in vitro transporter models, TransportoCells provide an innovative cell model for solute carrier (SLC) transporter studies. Corning’s new ABC transporter vesicles are made from HEK cells transiently transfected to over-express a single human ABC transporter protein. Using this mammalian expression system, the new products avoid many disadvantages associated with insect cell expression systems. The product portfolio now includes four human ABC transporter vesicles and a control vesicle. Corning also extended its line of Corning Gentest Supersome recombinant metabolic enzymes using a mammalian expression system. Corning Supersome Ultra Human AO is a stable and reliable in vitro tool for the study of AO-mediated metabolism, which has increasing importance in drug development. As a robust and consistent screening platform, Corning Supersomes Ultra Human AO delivers significantly higher (three-tofour-fold higher) activity as compared to bacterial expression systems. Corning Life Sciences brings new and innovative laboratory technologies to researchers worldwide and helps customers succeed by providing innovative, high quality products and services in the areas of polymer science, biochemistry and molecular biology, glass melting and forming, surface modification, and characterisation science. viveka.r@expressindia.com

EXPRESS PHARMA

October 1-15, 2017

PHARMA ALLY

VENDOR NEWS

HERMApartners with OPTEL To show serialisation-ready labeller at Pack Expo HERMA US, a subsidiary of HERMA, a Germany-based provider of labelling machinery and self-adhesive labels and materials for the global packaging marketplace – has partnered with track and trace solutions provider OPTEL to offer a serialisation-ready version of its popular 152E Wraparound Labeller. Outfitted with a sophisticated OPTEL camera system to complement the labeller’s premium-level print and application performance, the new module will make its debut at HERMA’s booth #N324 at Pack Expo Las Vegas. Pack Expo marks the first time this equipment combina-

tion has been shown at a US exhibition, and follows a number of successful projects completed between HERMA and OPTEL on both tamper-evident and bottle labelling applications. The latest module offers US pharmaceutical companies and CMOs a straightforward path to DSCSA compliance with minimal production disruption. The 152E Wraparound Labeller is suitable for a wide range of cylindrical containers, is capable of speeds of up to 150 bottles per minute, and can be supplied within 12 weeks of order. The machine features the same heavy-duty label applica-

tor platform as Herma’s premium 'M' (Master) series, allowing for simple installation of printers and vision systems.

The 152E can handle substrate diameters from ½” to 4”, and can be fitted with either an Allen-Bradley or Siemens PLC

controller, depending on customer preference. At Pack Expo, HERMA also will showcase its unique laseractivated label material. Specifically developed for use with C02 lasers, the substrate gives a clear, crisp print and is both smudge- and scratch-proof. The material will be demonstrated using a Domino D-Series Laser Printer complementing HERMA’s signature, servo-driven H400 Label Applicator. Also on display will be the HERMA 132M high speed bottle labeller, as well as the versatile 362M front, back and wraparound labelling machine. EP News Bureau

Valicare offers consulting in GMPcompliant development of cancer therapies The company ensures that all laboratory processes are standardised in compliance with GMP, the guideline for quality assurance of production processes and their environments BOSCH SUBSIDIARY Valicare, a wholly-owned subsidiary of Bosch Packaging Technology, has expanded its consulting services for Good Manufacturing Practices (GMP) to include biotech companies. Amongst others, Valicare is currently supporting the Swedish start-up polybiocept in establishing new cancer therapies. In a long-term project, the company ensures that all laboratory processes are standardised in compliance with GMP, the guideline for quality assurance of production processes and their environments. It plays an especially important role in the pharmaceutical industry, as quality defects in drugs can

38 EXPRESS PHARMA October 1-15, 2017

impact patients’ health. Valicare also offers comprehensive qualification and documentation services for pharma research laboratories. The polybiocept group develops new types of cell therapies for the treatment of pancreatic carcinoma and glioblastoma. Pancreatic cancer has the highest mortality rate with approximately 90 per cent of all patients dying from the disease within five years and more than 70 per cent within the first year following diagnosis. Glioblastoma represents approximately 15 per cent of all primary, and the majority of all malignant brain tumours. Patients have an average sur-

vival rate of 14.6 months; 95 per cent of patients die within five years. Following successful approval, these cell therapies will be produced and applied at many different specialised centres. “For this reason, we recommended that polybiocept use a decentralised production concept,” explains Dr Hans-Georg Eckert, Senior Project Manager and GMP consultant, Valicare. It is especially Page 2 of 3 important that the method of production complies with international pharmaceutical requirements. “The transfer of the cellculturing processes developed at the research laboratory to a GMP-compliant manufactur-

ing process requires an especially high degree of standardisation. Biotech companies can profit from the long-standing experience of Valicare in GMP consulting for pharmaceutical companies,” says Dr Eckert. In the approach developed by polybiocept, cells from the patient’s own immune system are extracted from the tumour, isolated in a cell culture dish, multiplied and subsequently used to attack the tumour. “Our collaboration with Valicare is an essential building block to ensure that many patients are given the chance to benefit from these innovative therapies in the future,” says Prof Dr Markus Maeurer, physician and Chief Scientific

Officer, polybiocept. Together with Dr Ernest Dodoo, neurosurgeon and Chief Development Officer, Polybiocept, he plays a decisive role in the clinical development of new cell therapies. For many years, the entire Bosch group has played an active part in the fight against cancer. In 2016 the Robert Bosch initiated the 'Alliance Against Cancer' together with the Bosch Foundation and the Robert Bosch Hospital. The laboratory and manufacturing equipment from Bosch Packaging Technology is also suited for the development and production of anti-cancer drugs. EP News Bureau

PHARMA ALLY

LANXESS accelerates profitable growth The group is to become even more stable, with less volatility in the operating result SPECIALTY CHEMICALS company LANXESS intends to accelerate measures for profitable growth. The company plans to further improve its stability and profitability over the next years and has set new medium-term financial targets accordingly. From 2021, the operating margin – measured in terms of EBITDA pre exceptionals – is expected to be between 14 and 18 per cent. In fiscal 2016 the margin was at 12.9 per cent. At the same time, the group is to become even more stable, with less volatility in the operating result. In terms of volume, LANXESS intends to consistently grow above global gross domestic product. “LANXESS is back on solid footing and has embarked on a profitable growth path. In the coming years, we intend to

reach our full potential and transform LANXESS into an even stronger company with a highly balanced and stable platform, increased profitability and, last but not least, a company team-culture based on dedication and motivation,” says Matthias Zachert, CEO, LANXESS. In order to achieve these new targets, LANXESS will continue to develop its current portfolio based on clear criteria. The group will only include business operations in its portfolio that can achieve leading market positions and generate attractive margins sustainably. Organic investments – around EUR 400 million between 2016 and 2020 – involve projects that generate an average return on capital employed (ROCE) of 20 per cent on aver-

age. In comparison, Group ROCE was 6.9 per cent for fiscal 2016. In addition, LANXESS is pursuing even greater regional and industrybased balancing to further reduce the effects of market volatilities. This includes an increased share of sales in growth markets such as Asia and North America and an expanded presence in attractive customer industries such as electrical/electronics or energy with innovative product applications. A key factor in achieving the new financial targets includes synergies stemming from the acquisition of Chemtura, which is the largest acquisition in the company’s history. The company expects about EUR 100 million in annual cost savings by 2020. Cost savings for fiscal

2017 are already expected to amount to approx. EUR 25 million. An estimated EUR 140 million in associated one-time costs will be incurred for this. Approximately half of the expected EUR 100 million in synergies are attributable to production and procurement. For instance, LANXESS will be expanding its 'Manufacturing Excellence' initiative to the previous Chemtura production sites to further optimise their processes and technologies. Furthermore, the combined purchase volume of both companies for raw materials of about EUR 2.5 billion can be reduced by harmonising supply contracts and increasing backward integration. Additional savings can be realised in the area of transportation and logistics. For example, the com-

bined business units currently still operate more than 200 warehouses globally. Around 30 per cent of all synergies can be achieved in administration, primarily in North America. The costs and structures for the former Chemtura Board of Directors, the former headquarters in Philadelphia and the Chemtura stock exchange listing are no longer necessary. Furthermore, administrative locations in close proximity will be merged and duplicated functions eliminated. Altogether some 40 projects have been initiated to standardise administration in North America. A further 20 per cent of the synergies are expected to come from streamlining global marketing and sales structures. EP News Bureau

PRODUCTS

VACUUBRAND chooses LAUDALOOP THE NEW, innovative LOOP L 250 thermoelectric circulation thermostat by LAUDA is proving its performance as an elegant all-rounder in quality assurance at VACUUBRAND. VACUUBRAND, from Wertheim, Germany, manufactures the most comprehensive range of vacuum generation, vacuum measurement and vacuum control products worldwide for coarse and fine vacuums in laboratories. When certain workpieces are measured for dimensional accuracy during quality assurance, the temperature must remain constant to ensure comparability. Since the ambient temperature in the production hall varies considerably at different times

of the year, the measuring equipment and workpieces are maintained at a constant temperature of 19 °C on a copper plate with water flowing through it. For this purpose, the LAUDA LOOP L 250 is switched on via an external timer at five am to

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pre-heat the plate. The device is switched off automatically at six pm. The LAUDA LOOP has been available on the market since spring 2017, making it the most recent product development from LAUDA in LaudaKönigshofen.

This external thermostatic circulator was developed for the requirements of modern laboratory work processes: The highly flexible thermoelectric circulation thermostat accurately maintains a constant temperature between 4 and 80 °C. The air-cooled LAUDA LOOP is ideal for laboratories with limited space, thanks to its compact design and low noise emissions, whilst still achieving impressive cooling performance. The smaller version, the L 100, has an output of 120 Watts at 8 kilogram, while the larger L 250 offers 250 Watts at 12 kilogram. With the LAUDA LOOP, LAUDA is the first leading manufacturer of thermostatic circulators to

employ Peltier technology without the use of refrigerant. This provides benefits in operation and maintenance, in safety of the work processes and the environment. The LAUDA LOOP is used primarily in laboratory applications in a wide variety of industries: from bio-technology to life sciences, as well as the chemical industry, pharmaceuticals and medical technology, and even production. Contact details José-Antonio Morata Marketing-Kommunikation Leiter Medien und Events Tel: +49 (9343) 503-380 Fax: +49 (9343) 503-4380 E-Mail: jose.morata@lauda.de

EXPRESS PHARMA

October 1-15, 2017

PHARMA ALLY

Gandhi rolling shutters: Quality engineered GANDHI AUTOMATIONS, India’s number one entrance automation and loading bay equipment company, is the only manufacturer of rolling shutters certified to ISO 9001 2008 quality management system. This has resulted in the implementation of continuous improvement in personnel training, production, inspection, equipment calibration, machinery maintenance, logistics and customer relations. The product engineering team uses the latest software combined with technologically advanced machinery to offer to the customer a well-engineered product. Over years of meticulously working on the design, fabrication and installation, Gandhi Automations has developed technical expertise in manufacturing various kinds of automated rolling shutters. The research and development team with its extensive knowhow and experience are able to produce specific types of

rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of Gandhi Automations' manufacturing process right through installation to after sales service. Gandhi rolling shutters are ideal for situations where side room is at a premium and security is required. The rolling shutters require little head-

room above the structural opening. They combine strength with elegance along with durability and are designed for both external and internal applications. Gandhi rolling shutters are fabricated of interlocking galvanized insulated and non insulated, stainless steel, patented aluminum or polycarbonate profiles and patented MS Rolling Grills.

Each of the rolling shutters is designed to the clients specifications conforming to IS 6248 and solidly constructed to promote trouble-free operation and long life. Gandhi rolling shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300(200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in http://www.geapl.co.in/ rolling-shutters.html

BOGE advances development of its C series ENGINEERING TO the customer’s wishes – based on this principle, BOGE KOMPRESSOREN is developing a new, oillubricated screw compressor in the performance class of up to 22 kW. The C 22-2 LFR compressor, presented to the public for the first time at the trade fair, will be available both with and without a receiver as well as with the option of an attached compressed air dryer. Further development will focus on ease of maintenance, noise reduction, and efficiency accross the entire C series. One of these developments is a new, optimised airend for the 7.5 to 11 kW range. The market launch of the new C-2 series should be completed in 2018. Machines on receivers and those with dryers have a large share in this performance segment. Thus, in its redesigned version of the series of compres-

40 EXPRESS PHARMA October 1-15, 2017

sors up to 22 kW, the Bielefeldbased family enterprise gives highest priority to the technological development of the C-2 machines. These are suitable for receiver and floor assembly and will be available with an optional dryer. In this way, easy setup of a complete compressed air station will be possible in the smallest of spaces. The control system can be mounted variably: at the top or at the front for floor or receiver installation, respectively. This ensures that ergonomic criteria are fulfilled. In the frequency-controlled C-2 screw compressors, BOGE is replacing the belt drive with a direct drive in order to improve system features and meet increasing efficiency standards. For further energy savings, the company also offers an optional frequency-controlled fan and IE4 motors. As a result, sound

level and power consumption are reduced. Thanks to a new component arrangement, annual maintenance can be conducted easily from one side of

the machine. Additionally, a variable cooling air outlet enables flexible connection to the exhaust air duct for use of discharged heat. BOGE is devoting

special attention to its performance range of 7.5 to 11 kW. As a result, it has specially created a new airend which will satisfy the highest efficiency requirements, providing a very good free air delivery-efficiency ratio. Further goals are improved performance, quiet running, and reduced power consumption. This airend, like many other C-2 models, should also be eligible for BAFA incentives. Contact details BOGE Press contact BOGE India #216, Third Link Street Nehru Nagar Industrial Area, Kottivakkam, Chennai - 600041 Jayanta Ghosh, Country Manager Tel: +91 44 4359 3454 Fax: +91 44 4359 3452 E-mail: j.ghosh@boge.com www.boge.com/en

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October 1-15, 2017

PHARMA LIFE APPOINTMENT

AVaidheesh elected President of OPPI Office bearers for 2017-18 were also elected

he Organisation of Pharmaceutical Producers of India (OPPI), which represents researchbased pharmaceutical companies in India, has unanimously elected A Vaidheesh, VP, South Asia and MD, GlaxoSmithKline Pharmaceuticals as President for the year 2017-18. He takes over from Dr Shailesh Ayyangar, MD, India & Head South Asia, Sanofi who held this position since 2013. The four elected Vice Presidents are Sharad Tyagi, MD, Boehringer Ingelheim; Sanjiv Navangul, MD, Janssen India (Pharmaceutical Companies of Johnson & Johnson); S Sridhar, MD, Pfizer and Anand Nambiar, MD, Merck India. Speaking on his appointment, Vaidheesh said, “I am honoured to be taking over the responsibility as President OPPI. Today, we are at the in-

tersection of technology and medicine and the future of healthcare seems to be progressing towards ‘personalised’ medicines and ‘personalised’ patient-care. The pharma industry has an important role to play in delivering responsible healthcare and we look forward to partnering with the government and other stakeholders in realising the collective dream of a healthy India. This dream can become a reality only when science and research deliver new cures for the unmet medical needs; thereby fostering an environment of innovation. On the policy front, I am sure that the National Health Policy and the National IPR Policy will lead the way for better health outcomes. Along with an inclusive ecosystem, in the coming years, healthcare financing will also play its role in improving

access to healthcare. I believe we at the OPPI have clear priorities and along with the OPPI Secretariat led by Kanchana TK, Director General, OPPI, we will together work towards serving more patients in India.”

Dr Ayyangar, the outgoing President, said, “It has been a privilege to represent OPPI as its President over the past four years. The member companies of OPPI have played a very important and responsible role in collaborating with the government and various stakeholder groups to ensure that high quality, innovative and essential medicines are available at affordable prices across our country. Our industry depends on cutting-edge research and development to bring new innovative solutions for the unmet needs of the patients. It is the responsibility of our government to make India a safe and reliable destination for research investments.” He further said, “OPPI will continue to hold dialogues and create common coalition amongst stake holders to encourage research and develop-

ment in our country through transparent and unambiguous IPR policy. At the same time, OPPI members are willing and ready to address the access issues around these innovative medicines. Our industry continues to play a stellar role in advancing science and in building patient support programmes to help healthcare professionals achieve predictable and holistic outcomes for the patients. As the government takes the lead in strengthening our country’s healthcare infrastructure at the primary healthcare centre, I am very confident that under the experienced leadership of Vaidheesh, OPPI member companies will raise the bar especially through innovative and technologically enabled solutions, and support the national agenda on healthcare.” EP News Bureau

Lupin appoints Jim Loerop as Chief Corporate Development Officer He will be responsible for the company’s global M&A and business development functions LUPIN HAS appointed Jim Loerop as Chief Corporate Development Officer. Loerop will lead Lupin’s overall corporate development efforts and will be responsible for the company’s global M&A and business development functions. He will integrate Lupin’s business development, licensing and M&A teams to drive the company’s global M&A and business

50 EXPRESS PHARMA October 1-15, 2017

development strategy. A professional with over 27 years of experience in the pharma industry, Loerop joins Lupin from Alexion Pharmaceuticals, where he served as senior VP, Global Business Development. Prior to Alexion, he held multiple leadership positions at leading pharma companies such as GlaxoSmith Kline, Stiefel (a GSK Company), KV Pharmaceutical

and Curatek Pharmaceuticals. Loerop graduated from Western Michigan University with a major in marketing following which he began his career as a sales representative with Solvay Pharmaceuticals. Commenting on the appointment, Vinita Gupta, CEO, Lupin said, “We are delighted to welcome Loerop at a crucial time as we accelerate our transition into complex

generics and specialty brand segments. Loerop’s rich experience in both branded and generic business will be invaluable in helping us navigate our business towards new growth opportunities.” Jim will be based at Naples, Florida in the US, and he will report to Vinita Gupta, CEO, Lupin. EP News Bureau

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