Express Pharma (Vol.12, No.21) September 1-15, 2017 by Indian Express

VOL. 12 NO. 21 PAGES 64

www.expresspharmaonline.com

Market

India is an important, big market for us

1-15 SEPTEMBER 2017, ` 40

CONTENTS As the pharma landscape continues to evolve and transform, teachers will have to lead from the classrooms to create next generation leaders and accelerate progress | P24

Vol.12 No.21 September 1-15, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana

MARKET

New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar 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 Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

INDIA IS AN IMPORTANT, BIG MARKET FOR US

‘WE HAVE THE POTENTIAL TO ADDRESS AT LEAST $1 BN OF THE SSI MARKET’

MANAGEMENT

P21: PRE EVENT ISPE to organise Europe Pharma 4.0 Conference in Italy

P29: INTERVIEW 'Revival of pharmacy education in India is the need of the hour'

PAST INTO THE FUTURE?

RESEARCH

P41: VENDOR NEWS Sanner invests in Bensheim production facility

P56: APPOINTMENTS Kiran Mazumdar-Shaw joins Keck Graduate Institute's Board of Trustees

‘DISCOVERY AND INNOVATION IS NOW THRIVING IN SMES LIKE BUGWORKS’

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.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

EDITOR’S NOTE

Draft pharma policy: Old wine in a new bottle?

he Draft Pharma Policy 2017 which was released for comments in midAugust, has an ambitious intent: to make drug pricing 'more poor oriented while retaining its industry friendliness'. Health activists point out that the intent to balance the needs of the poor and the private sector can never be realised as long as the Department of Pharmaceuticals (DoP) crafts the pharma policy, because the DoP’s primary mandate is not patient healthcare but the health of the pharma sector. Industry too has panned the Draft. It has been dubbed 'a bunch of Stalinist contradictions' as well as being 'more a product of perceptions than evidence'. Is this a case of old wine in a new bottle? A meeting organised by the DoP on August 30, where various Ministries are expected to present relevant aspects of the policy, is sure to be a stormy one. The perennial tug of war between the Health Ministry and the Fertilizers and Chemicals Ministry once again promises to take centre stage as they each wrest for control of the DoP, which is currently placed under the latter. While the National List of Essential Medicines has been prepared so far by the Health ministry, the Draft Pharma Policy 2017 proposes that this duty be handed over to the DoP. The health ministry has strongly objected to the proposal that 'all the regulators/commissions pertaining to pharma industries/sector will be brought within the ambit of one department.' The draft policy is sure to go through many revisions, and one hopes that middle ground will be found. For instance, the draft policy recommends that a ‘one company – one drug – one brand name – one price’ stance which is impractical as many companies use the same molecule in different formulations for different therapeutic areas. Similarly, the draft policy intends to phase out the practice of loan licensing, except in biopharma, by propagating a 'one manufacturer, one salt, one brand name and one price' mandate. This could hit the margins of both pharma MNCs, who would lose a cost effective manufacturing option, as well as SME manufacturers, for whom this is a major source of revenue. The positives include the thumbs up for epharmacies, (of course with adequate safeguards), and advocating skilling programmes for pharmacists. Against the backdrop of China's recent aggressive moves on the border and the impact on API supplies, the draft policy proposes that formulations produced from indigenously produced API and its intermediates be given preference in government procurements. Moreover, such formulations would be out of

10 EXPRESS PHARMA September 1-15, 2017

Intent is one thing, implementation quite another story.And once again,the emphasis is on cost,not quality and access of medicines

price control for five years and, after that, prices would be linked to indigenous content of the formulations. On the R&D front, the government proposes to allow a concessional rate of customs duty of 0 to 5 per cent on import of specified goods and services required for R&D in pharma industry. All novel drug delivery systems (NDDS) would be considered as ‘new drugs’, unless certified otherwise by the licensing authority. But isn’t this too little, too late? Are these sops enough to incentivise the huge cost of long gestation R&D? Also, while the Drugs Prices Control Order, (DPCO) to be implemented by the National Pharmaceutical Pricing Authority (NPPA) will apply to off patent medicines only, the threat of compulsory licensing will still apply to ‘in-patent’ medicines. Will this threat act as a brake on R&D into innovative medicines? On a slightly more positive note, experts have pointed out that this is perhaps the first pharma policy which also attaches some importance to quality. The government proposed to ensure that World Health Organisation’s Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) are adopted by all manufacturing units. As a first step, all national/central government level procurements as well as the state government level procurements done out of National Health Mission funds would be mandatorily from GMP and GLP compliant manufacturing units. SSIs would be given incentives to upgrade. Given the planned roll out and scale up of Jan Aushadi stores, as well as the huge procurement budgets of PSUs like the railways, armed forces, etc this mandate should be a huge incentive for pharma companies to upgrade their quality standards. The proposal to shorten and standardise the approval process of the Central or State drug regulator to within three months, extendable by another three months, too will be very welcome, provided of course that the regulator delivers on this promise. The Draft Pharma Policy 2017 also proposes to crack down on trade margins, and make the code for pharma marketing practices, which is at present voluntary, mandatory. These are all worthy intentions, but as I've said before, in relation to previous policies, intent is one thing, implementation quite another story. And once again, the emphasis is on cost, not quality and access of medicines. Let us hope that the final Pharma Policy 2017 will be more realistic and not a hurried attempt to cross off one more promise on the checklist for the 2019 general elections.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

India is an important, big market for us As Merck prepares for its 350th anniversary due next year, we're 'Fit for 2018' says Dr Stefan Oschmann, Chairman of the Executive Board and CEO, Merck. While the Sigma-Aldrich acquisition gave the company a global leadership position in the lifesciences sector, Anand Nambiar, MD, Merck India tells Viveka Roychowdhury that the focus for the India market in the next 18 months is to reach out directly to consumers post the recent integration of the consumer health and biopharma segments. Edited excerpts ... Since 2011, Merck has been through a transformation as part of the Fit for 2018 initiative. What are the next stages in this evolution? Dr Stefan Oschmann: Historically, Merck is the oldest chemical and pharmaceutical company in the world. We were founded in 1668, and next year we will celebrate our 350th anniversary which is something really unusual. Moreover, the founding family still has majority stakes in the company, with 250 family members, about 150 of whom are partners, as part of the company globally. This gives it a very long-term perspective. That's fascinating. We are also a bold and vibrant science and technology company and our branding is an expression of that. Our business portfolio has changed dramatically over the last 10 years plus. We have moved about Euro 40 billion in assets, in either buying or selling businesses. So we're a very active company. Right now, we have three main pillars of our business: healthcare, lifesciences, performance materials; which are very different but also have a lot in common. What they share is that they are very much science and innovation based, so we are very happy with this transformation. We are not going to be complacent about the future and we're working on quite a few things that will define our future but so far we are very happy with the transformation process. When I joined the company

EXPRESS PHARMA

September 1-15, 2017

Our lifesciences business is now a global powerhouse. With the recent integration of Sigma-Aldrich, we have become a leader in this business

in 2011, there were serious doubts about the long term vitality of our healthcare business but today, nobody has doubts any more. We understand that this is a business with very good momentum, with the in line products as well as a very promising pipeline. And we've had some major regulatory successes recently. Our lifesciences business is now a global powerhouse. With the recent integration of Sigma-Aldrich, we have become a leader in this business. In our performance materials business, when we had acquired AZ Electronic Materials in 2014, now has very comprehensive offerings for our customers in the display and semi conductor industry. So we're very happy with where we are. There was a lot of cost optimising as part of the early 2018 plan. Is that all over now? And should we expect more such transformative moves from Merck? Oschmann: We colleagues always think that, “once we get this done, then maybe we can relax a little bit.” But in my experience of 30 years, once you get something done, you will be onto something new. So yes, while we are happy with where we are right now, it (the transformation) will never stop.

We want to get closer to consumers, especially for the vitamin products, so you'll see more of us reaching out to consumers over the next 18 months

Dr Stefan Oschmann Chairman of the Executive Board and CEO, Merck

Merck’s FY/Q4 2016 results show that net sales were €15 billion, and EBITDA pre was €4.49 billion. What is India’s fitment and role in the ‘Fit for

Anand Nambiar MD, Merck India

2018’ growth and transformation programme? What is the country's value proposition to a global biopharma major like Merck? How much do Emerging Markets (EM) contribute to the revenue mix right now? Oschmann: We stopped referring to them as EM. India is not emerging. India is there. India is a high growth market for us, both for healthcare as well as for lifesciences. We refer to these markets as Growth Markets and they have very different profiles so we don't call them Emerging Markets any more. If you look at the regional distribution (our our revenues), compared to many other companies, we have a very global profile, where at a corporate level, the No 1 revenue contributor is Asia Pacific. The three major regions we have (Asia Pacific, the Americas and EU) contribute about one third each. So we’re quite globally balanced. We used to have a dedicated EM market strategy for a while like many other companies. We now believe that markets like India have reached a level of maturity which does not need this logic anymore. India is an important, big market for us and we have a dedicated team in India which is developing strategies for India within the business and above. The Indian market has very little in common with the Chinese or Brazilian markets. So we don't think this EM logic makes a lot of sense any more these days.

When Merck India was set up in 1967, it was the company's first Asian subsidiary. What is the employee strength today? Where does India rank within the APAC region, in terms of revenues? We have around 4000 employees in India across all businesses. Merck doesn't publish figures per country or per business. Of the 10 largest countries in Merck's growth markets segment, India ranks fifth. A large proportion of our APAC business is in the display field, under performance materials. So as we do not have display manufacturing facilities in India, as yet, India doesn't rank so high in that business. India has a very prominent position in the region in the healthcare and lifesciences businesses. In the lifesciences

India has a very prominent position in the region in the healthcare and lifesciences businesses. In the lifesciences segment, given the prominence of the Indian pharma biotech and vaccines business, it’s actually fairly large segment, given the prominence of the Indian pharma biotech and vaccines business, it’s actually fairly large. So is the size of our healthcare business from India, given the progress of the Indian healthcare sector. What’s the plan for 2017-2018 for India in terms of product launches, etc? What will be the strategies to grow the business further in India? You have two partnerships with

Lupin and Dr Reddy Laboratories (DRL), how are these proceeding? Oschmann: The DRL partnership for oncology biosimilars proceeded nicely but will end soon as we are in the process of selling our biosimilars business to Fresenius Kabi, because we are now confident of our research based pipeline. Nambiar: The Lupin partnership goes beyond

India. The deal was to take some of Lupin's products and market it in some of the other emerging markets. There are a couple of countries where this is at pilot stage. Oschmann: The main current drivers of our portfolio in India is our biotech portfolio (Erbitux for colorectal cancer; Rebif in multiple sclerosis, and Gonal-f and other products in fertility.) We also have our cardio metabolic portfolio (with

products such as Concor, Euthyrox, etc.) We have a fairly large portfolio of small molecule products that we sometimes refer to as our Classics. We also have the consumer health space. All that is growing well. The bio processes business is a significant driver in the lifesciences portfolio, where we are supporting India based customers in biologics and vaccine manufacturing. Our research solutions portfolio is also very prominent in India. Given the huge efforts in quality control in the food and other industries, we have our applied solutions business which is yet another driver. Are you looking at more alliances with Indian companies, to grow the revenue stream from India?

NICOMAC CLEAN ROOMS NICOMAC CLEAN ROOM SYSTEM is the most advanced technology for

Pharmaceutical, API, Biotechnology & Electronic Industries. We offer Clean Room Panels, Doors, Windows & False Ceilings. We combine our top quality product with skilled installation team. High quality, attractive appearance & competitive price. Only first class materials are used, highquality finishes are applied on all surfaces.

Nicomac Clean Rooms Far East Pvt Ltd

Plot No: 116, IDA Bollaram, Near Miyapur, Hyderabad 502325. Ph: +91 8978388004; Email: sales@nicomacfareast.com ; www.nicomac.com

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

MARKET Nambiar: We're always looking for opportunities but none to speak of at the moment. Oschmann: I've been working in India for many years. I have a lot for respect for India and the large corporations and what they have achieved. If you look at the success stories of some of them, like Sun Pharma, Zydus Cadila, Lupin, DRL, and so on; its impressive what they've achieved. We do cooperate with such companies on the manufacturing side, on product development and many other areas. My friends tell me that the dream is the India-based research breakthrough. We would be delighted to see that happening because the Indian healthcare system needs to evolve. When we talk about intellectual property (IP) standards, we have good material, in practice we have good enforcement standards in India. So we think as the

Indian industry continues to evolve, it will also strengthen the IP protection. The Indian industry has made significant achievements when it comes to process optimisation to ensure that generics manufacturing is at a very low cost base. We also hope that the Indian industry will contribute to enhancing access of the poor to such products. Some people see a dichotomy between researchbased and generic companies. I think we depend on each other. Both have an important role to play. Is India still so price sensitive that we cannot afford innovation? Oschmann: Access is a big issue in India. People in rural areas do not even have access to very cheap generics which could also be on the essential medicines list. India invests a bit more than one per cent of GDP into healthcare and that is

fairly low if we look at other comparable markets. We applaud efforts that show that India is gradually investing more in healthcare, that India is expanding insurance coverage, and that India is making efforts to achieve some of the Sustainable Development Goals. When it comes to market access of innovative patented products, I think both sides need to be flexible. Industry needs to be open to innovative schemes. Tier pricing is one example. Governments and other stakeholders also need to be flexible on partnering. At the end of the day, in my experience, partnering approaches have always yielded the best results. Even if one disagrees on a couple of things, if one can agree on doing something that enhances access to products and at the same time rewards innovation, that would be a very good thing.

There are so many examples in the world where this is possible. India completes 70 years of Independence this year. What do you think our policy makers, pharma fraternity needs to do to create an ecosystem to work towards the first Innovated in India molecule? Oschmann: India has an incredible output of engineers, scientists and the like. And it would be intellectually inconceivable that this will not yield substantial progress. We see that there are so many emerging players in India. If you allow me to compare India with China for a moment, I see that over the last decade or so, when it comes to R&D based output, China is gaining somehow. My personal view is that this is related to the Chinese government putting more of an emphasis on balancing IP

protection and access. So that would be my advice. Yes, the Indian government has to make sure that they ensure access to the broad population, that they look at industrial policy, employment etc. At the same time, strong IP protection will continue to drive economic development in India. An enhanced effort will be good for India, and I repeat, we would be delighted to see a highly successful and globally competitive Indian research based biopharmaceutical industry. And given the talent base that India has, I think India has no excuse but to deliver on that! What's the strategy for the India market? Nambiar: We have a global strategy, referred to as the 3x3 strategy, which is to have three brands with three per cent (local) market share. We've already surpassed this in India

The Standard of Comparison

Pharmaceutical Grade Crystalline, Spray Dried, Anhydrous, and Inhalation Lactose • For more than 70 years, we have delivered the industry's most extensive Lactose portfolio

www.SheffieldBioScience.com

• The original patent for Anhydrous Direct Tabletting (DT) Lactose • Batch to Batch Consistency • Global technical service, regulatory and application expertise to ensure regional and global market compliance

EXPRESS PHARMA

September 1-15, 2017

Registered Oﬃce Address: 17th Floor, Nirmal Building, Nariman Point, Mumbai - 400021 Corporate Identiﬁcation Number: U15400MH2010PTC202946 Tel.: +91 22 27815003, Fax Number ; (022- 27815989) Email: Kerry-India.Info@kerry.com

MARKET where we have four - five brands, which are near to or have surpassed the three per cent mark. In some brands we have 70 per cent market share, some five per cent. That is the global framework that we operate within but we have passed that already. What is going to be Merck's next goal, the next level of transformation after reaching the 2018 milestone? Oschmann: At the global level, we are still digesting the Sigma-Aldrich acquisition. We currently have debt of Â¤ 11 billion on the balance sheet so we need to focus on deleveraging. And even if we had a lot of imagination, we need to deliver on that. Within the lifesciences business, the direction is fairly clear. Within the healthcare business, we're investing heavily in R&D and its about creating results in this area. In performance materials, we have very different businesses. We see a very thriving integrated circuits business, a highly successful pigment business. We are facing some challenges on the display side so we are fighting to maintain global market and technology leadership. So over the next couple of years, its really about these couple of things. Nambiar: On the India front, we just went through a major transformation, where we integrated our consumer health and our biopharma businesses and primarily a huge portfolio of vitamins, minerals products from biopharma going OTC. So that's the major transformation that we are going through right now. The integration of the organisation is now complete. Now itâ&#x20AC;&#x2122;s about taking these products directly to consumers and you''ll start seeing efforts on that front over the next couple of months. So that journey will go thru over the next year/year and a half. We want to get closer to consumers, especially for the vitamin products, so you'll see more of us reaching out to consumers over the next 18 months. In our specialty business, our branded generics business is growing above market (rates). The IMS reports also

EXPRESS PHARMA

September 1-15, 2017

show that from a market share as well as growth standpoint, we're beating market growth. In our oncology and fertility business, we don't publish it openly, but again, significantly over market, especially on the fertility franchise. Oncology is a very difficult space. We're the only single molecule player in the cituximab (Erbitux) area.

With Erbitux, for colorectal and head and neck, especially in head and neck, we're the market leaders. So it'll be about how to defend ourselves from biosimilars coming into the market over the next 3-4 years. Dr Oschmann, before joining Merck, you were with US MSD. Do you think that the

battle for the 'Merck' brand, between the US Merck and the founder company from Germany has been finally settled? In India, there's one Merck and that's us! There are 193 United Nations member states and we are Merck in 191 of them. If you look at the population of the world, we're

living in a world of 11 billion people. Five billion will be Asian, four billion will be African and two billion will be Europe and the Americas. So our rough estimate is that in a world of 11 billion, 10.5 billion will know us as Merck. So we're very relaxed about this! viveka.r@expressindia.com

MARKET I N T E R V I E W

‘We have the potential to address at least $1 bn of the SSI market’ Recently, CHD Bioscience signed a global licensing agreement with Dr Reddy's Laboratories for developing and commercialising its phase III candidate DFA-02. Michael Handley, CEO, CHD Bioscience, talks about the plans for clinical trials of the molecule, with Usha Sharma

What is the progress on DFA-02 clinical studies? Tell us more about its prospects. DFA-02 is positioned to enter into a phase III clinical study for mitigation of complex abdominal infections in high risk patient populations. CHD Bioscience is currently in discussions with the FDA on the biostatistical powering and the study design. We will have a Type C meeting in the coming months to determine study design and study size. CHD believes DFA-02 has a place in the acute care setting beyond complex abdominal infections and we will be exploring other indications in cardiovascular surgeries and complex bone fixation surgeries. When will DFA-02 enter phase III studies? When is it likely to commence? Initiation of the phase III study is dependent on several factors, the most important being FDA approval of the study design and study size. We anticipate enrolling the first patient in the first half of 2018.

Furthermore, as our understanding of the human microbiome has improved, we now understand that most of our intrinsic microbiome has a supportive effect in the maintenance of a healthy immune system

EXPRESS PHARMA

September 1-15, 2017

Can you elaborate on your strategy to become a leader in prevention and treatment of drug-resistant infections? We have performed extensive analysis of the antimicrobial landscape and determined that approximately 30 per cent of the population has comorbidities that make it difficult to safely dose these patients with large quantities of systemic antibiotics. To fight resistance, it is important to kill all microbes where they live. Systemics are challenged by this and it leads to increased resistance (can’t kill what you can’t reach). By using targeted therapies, we can safely increase to localised drug concentration where the microbes are while lowering systemic drug exposure. Furthermore, as our understanding of the human microbiome has improved, we now understand that most of our intrinsic microbiome has a supportive effect in the maintenance of a healthy immune system. By using systemic antibiotics, you run the risk of wiping out all the beneficial bacteria, potentially exposing the patient to a weakened immune

system and re-population of pathogenic microbes like C. diff that can cause prolonged illness and even death. As a result, we have made the decision to focus on this subset of the patient population, one on which no other company is currently focussed. Consequently, we are developing a pipeline of products that fit our product target profile (localised targeted delivery, low systemic exposure, high concentrations to destroy even the most drug resistant bacteria). How big is the surgical site infection market? By most market estimates, the surgical site infection (SSI) market is the largest of the HAI market. With an estimated 300,000 cases of SSI per year in the US, this would represent a very large market potential for CHD. With our current products in development, we have the potential to address at least $1 billion of that market.

We have made the decision to focus on the subset of patient population, one on which no other company is currently focussed Do you want to increase your focus on hospital business? CHD is increasing the focus on the acute care side of the business as we feel hospital CEOs are subject to ever increasing pressure to lower costs. One of the easier ways for hospital CEOs to reduce cost is to mitigate or lower the number of HAIs that occur at their facilities as HAIs subject them to reimbursement penalties and additional costs. u.sharma@expressindia.com

MARKET DEAL TRACKER

Pharma industry records 53 deals worth $5.8 bn in July 2017 The US, Israel, France and the UK were the top destinations for cross-border activity, while the US, Canada, Japan and Switzerland where active acquirer countries CROSS-BORDER activity witnessed a significant increase in July 2017, accounting for 54 per cent of the M&A activity recorded during the month, in volume terms. The US, Israel, France and the UK were the top destinations for crossborder activity, while the US, Canada, Japan and Switzerland where active acquirer countries. The industry recorded 53 deals worth $5.8 billion in July 2017, of which $5.4 billion was contributed by the cross-border deal activity. Laboratory Corp of America’s proposed acquisition of Chiltern, a UK-based specialty CRO, for $1.2 billion was the top transaction recorded in July 2017. The pharmaceutical and healthcare industry reported three deals over $1 billion in July 2017: Laboratory Corporation of America Holdings’ proposed acquisition of Chiltern International; Mit-

Cross-border activity witnessed a significant increase in July 2017

Source: GlobalData

The Next-Gen, Best-in-Class

Cole-Parmer

Latex & Nitrile Gloves

Request Your

Free Sample Glove Today!

Perfectly Engineered for Pharmaceutical Applications From laboratory bench to production floor, we’ve a Glove for You – manufactured under strict GMP, complying with ISO, EN and ASTM standards. Available in Sterile-to-Non-Sterile, S to XL, 9.5” to 18”. Contact for Placing Orders/Sampling Requests:

022-6139-4444

response@coleparmer.in

To subscribe: bpd.subscription@expressindia.com

For More Details, Visit:

www.coleparmer.in

EXPRESS PHARMA

September 1-15, 2017

MARKET subishi Tanabe Pharma Corp proposed acquisition of Neuroderm, a pharma company that develops drug-device combinations for central nervous system (CNS) disorders, for a total consideration of diluted equity value of $1,100 million in cash; and Konica Minoltaâ&#x20AC;&#x2122;s proposed acquisition of Ambry Genetics Corp, a genetics testing company, for a purchase consideration of $1 billion. The venture capital market recorded a decrease in terms of volume and value with 57 deals worth $0.9 billion in July 2017, compared to 94 deals worth $1.2 billion in June 2017. Companies based in the US raised $.73 billion of the total $0.9 billion in July 2017.

Venture capital transactions declined in July 2017

Source: GlobalData

Deal Date

Acquirer (s)

Target

Deal Value (US$ m)

29-Jul-17

Laboratory Corp of America Holdings (US)

Chiltern International Ltd (UK)

1,200.0

24-Jul-17

Mitsubishi Tanabe Pharma Corp (Japan)

NeuroDerm Ltd (Israel)

1,100.0

06-Jul-17

Konica Minolta, Inc. (Japan)

Ambry Genetics Corp (US)

1,000.0

11-Jul-17

Sanofi (France)

Protein Sciences Corp (US)

750.0

26-Jul-17

Canada Pension Plan Investment Board (Canada)

Partial royalty rights for Venetoclax from Walter and Eliza Hall Institute of Medical Research (Australia)

325.0

Source: GlobalData

Deal Date

Acquirer (s)

Target

Deal Value (US$ m)

14-Jul-17

3Ă&#x2014;5 RiverVest Fund II LP; Arix Bioscience PLC; BioMed Ventures; Lundbeckfond Ventures; New Enterprise Associates Inc; Pappas Capital, LLC; RiverVest Venture Partners LLC; Sofinnova Venture Partners

Amplyx Pharmaceuticals Inc (US)

67.0

26-Jul-17

Edmond de Rothschild Investment Partners; HBM Healthcare Investments AG; JAFCO Co., Ltd.; New Enterprise Associates Inc; Pfizer Venture Investments

Complexa Inc (US)

62.0

20-Jul-17

Aperture Venture Partners LLC; Lundbeckfond Ventures; New Enterprise Associates Inc; Omega Fund; TPG Biotech

Trevi Therapeutics Inc (US)

50.5

25-Jul-17

AJU IB Investment Co., Ltd.; Bay City Capital LLC; Cormorant Asset Management, LLC; Cowen Group, Inc.; EcoR1 Capital, LLC; Morningside Ventures; Omega Fund Management, LLC; Pappas Ventures; Qiming Venture Partners

Kezar Life Sciences Inc (US)

50.0

18-Jul-17

Aisling Capital; Bay City Capital LLC; F-Prime Capital Partners; Novo Holding A/S; Presidio Partners LLC; Remeditex Ventures, LLC; Rock Springs Capital LP; venBio; Vivo Capital

Menlo Therapeutics Inc (US)

50.0

11-Jul-17

Alexandria Venture Investments; Celgene Corp; Flagship Pioneering Inc; Google Ventures; Mayo Clinic

Evelo Biosciences Inc (US)

50.0

Source: GlobalData

20 EXPRESS PHARMA September 1-15, 2017

MARKET PRE EVENT

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, in-

cluding automation, analytics, end-to-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 revolutionising the pharma industry, but also introducing many new challenges and pro-

To subscribe: bpd.subscription@expressindia.com

Their goal is to specify and differentiate Pharma 4.0 from the common ‘Industry 4.0’ concept

duction 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 conference will explore the effects of this shift and how the industry will prepare for this next generational challenge.” 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.

EXPRESS PHARMA

September 1-15, 2017

MARKET

Hyderabad to host 10th edition of analytica Anacon India and India Lab Expo Alongside the event, the analytica Anacon India conference 2017 will focus on regulatory aspects for pharma labs, bioanalysis and bio-pharma, food safety and clinical diagnosis THE 10TH edition of analytica Anacon India and India Lab Expo, the International trade fairs for Laboratory Technology, Analysis, Biotechnology and Diagnostics will be held in Hyderabad from September 21 to 23, 2017 at HITEX Exhibition Centre in Hyderabad. analytica Anacon India 2017 and India Lab Expo will bring together internationally renowned manufacturers, laboratory users, consultants and key government officials on one platform to discuss best practices and seek solutions to some of the most pressing challenges related to the industry and research. Bhupinder Singh, CEO, Messe Muenchen India says, “We are pleased to come back with the yet another path breaking editions of analytica Anacon India and India Lab Expo. This year is special as we are adding one more feather in our cap by successfully completing 10 years. analytica Anacon India and India Lab Expo have always stood out in terms of its approach, execution and implementation. Along with analytica Anacon India and India Lab Expo, the fifth edition of

EXPRESS PHARMA

September 1-15, 2017

analytica Anacon India and India Lab Expo aim at creating a platform for knowledge exchange and bring manufacturers, vendors, laboratory users, experts, consultants, sellers and buyers under one roof PHARMA Pro & Pack Expo will also be held at the same venue. This is to give our visitors an opportunity to expand their business prospects in India and explore the international pharma industry.” analytica Anacon India and India Lab Expo aim at creating a platform for knowledge exchange and bring manufacturers, vendors, laboratory users, experts, consultants, sellers and buyers under one roof. Reportedly, more than 250 exhibitors will come from 11 countries and occupy 10,500 sq m of exhibition space. These include massive players from the biotechnology, diagnostics, analysis and lab technology industries. These exhibitors include Agilent Technologies India, Avantor Perfor-

mance Materials, Borosil Glass Works, Elabscience Biotechnology, Hindustan Platinum, Shimadzu Analytical (India), Thermo Fisher Scientific India, Thermolab Scientific Equipments and Titan Biotech to name a few. Alongside the event, the analytica Anacon India conference 2017 will focus on regulatory aspects for pharmaceutical laboratories, bioanalysis and bio-pharmaceuticals, food safety and clinical diagnosis. The conference will therefore throw light on audits and regulatory affairs, data integrity, extractable and leachable, emerging technologies for pharma laboratories. analytica Anacon will be implementing Live Labs for ‘Food & Pharma Analysis’ in 2017. This

concept was first introduced at analytica 2012 in Munich which also witnessed great success. Visitors will be experiencing features like progress live and in person wherein a person can be a part of innovative experiments while they are carried out. A workshop will be organised on ‘Practice-orientated seminar for laboratory users—Introduction to the laboratory’ and addressed by Christian Lipok, Faculty of Chemistry, University Duisburg-Essen. The workshop will be a blend of presentations and a practical section for visitors to offer an overview of important methods of working in a laboratory. This year will also witness the third edition of the buyerseller forum which generated

huge interest and reported strong participation in the previous year by conducting 750 face-to-face meetings. The Buyer Seller Forum is a very prominent stage for exhibitors, decision makers and VIPs to network directly and interact with clients. They also get a chance to converse with industry delegates from international and domestic markets for exchanging information on new equipment, technologies and solutions. analytica Anacon India and India Lab Expo highlight the huge potential Indian Laboratory technology, analysis and biotechnology market. The fair has positioned itself as the leading industry platform on the Indian subcontinent. It is a global gathering that profits exhibitors and visitors alike – the event stands for profitable new ideas, concrete business transactions and promising collaboration opportunities. Media Contact for Messe Muenchen India: Siddharth Narain +91-9971600355 siddharth.narain@mm-india.in

MARKET EVENT BRIEF 21

India Lab Expo 2017/ analytica Anacon India

Proactive & Sustainable Compliance Workshop

INDIA LAB EXPO 2017/ ANALYTICA ANACON INDIA Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific, analytical and biotechnology sector will see international as well as Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India.

MIX. MELT. PERFORM.

Contact details MMI India INIZIO 507 & 508, 5th Floor, Cardinal Gracias Road, Opp P&G building, Chakala, Andheri (E), Mumbai - 400099 Tel : +91 22 42554710 Mob: +91 9820668393 Fax: +91 22 42554719 Email: info@mmi-india.in

Enhance API solubility with Parteck® MXP excipient. Our new Parteck® MXP is specifically designed for application in hot melt extrusion to increase solubility and allow for stable, high drug loads for a broad range of APIs. High thermostability Ease of use Flexible release kinetics of final oral dosage form

PROACTIVE & SUSTAINABLE COMPLIANCE WORKSHOP Date:December 7-8, 2017 Venue: Mumbai, India Summary: Markets and 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@marketsandmar kets.com Phone no: +91 20 30108 270

Find out more: MerckMillipore.com/parteckmxp

The life science business of Merck operates as MilliporeSigma in the U.S. and Canada. Merck, the Vibrant M and Parteck are trademarks of Merck. SAFC is a trademark of Sigma-Aldrich Co. LLC. or its affiliates. Copyright © 2017 Merck KGaA. All rights reserved. 05/2017

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

cover )

INSIDE 24 EXPRESS PHARMA September 1-15, 2017

PHARMA EDUCATION: IN NEED OFA REVAMP

'REVIVAL OF PHARMACY EDUCATION IN INDIA IS THE NEED OFTHE HOUR'

‘A CONTEMPORARY AND RELEVANT PHARMACY CURRICULUM IS THE NEED’

HOMAGE TO THE GURUS

(

THE MAIN FOCUS

Pharma education: In need of a revamp An analysis of the current state of pharma education in India, its successes and shortcomings, as well as measures needed to bridge the gap between the industry and academia By Swati Rana

he pharmacy profession in India began in the early 20th century and since then, has undergone several transformations. These changes have had an impact on pharmaceutical education as well.

Tracing the beginnings The systematic implementation of pharma education in India commenced from 1948, with the enforcement of Pharmacy Act-1948, to set standards and regulate pharmacy education, profession and practice in India. Provisions of the Pharmacy Act are implemented through the Pharmacy Council of India (PCI), a statutory body established in 1949. Thus, formal pharma education in India has been prevalent for several decades. Since the late 1980s, due to rapid industrialisation in the pharma sector, privatisation, and economic growth, pharmacy education has been developing faster in India than anywhere in the world. Yet,

EXPRESS PHARMA

September 1-15, 2017

cover ) even today, the pharma education system in India is criticised by industry for lack of regular revision of the syllabus to ensure students are industry ready. Another grouse is that though the use of technology in the pharma industry is growing at a rapid pace, academia finds it difficult to match the pace of industry via revisions of the curriculum. As a result, there is a noticeable gap between industry and academia. To address this issue, the Pharmacy Council of India (PCI) recently revised and introduced a uniform B Pharm and M Pharm syllabus to meet the needs and expectations of the industry.

PHARMA EDUCATION

Challenges galore According to Dr B Suresh, President, PCI, pharmacy education in India is presently in a very challenging phase. Due to an increase in the growth of the industry, there is growing need for qualified and highly knowledgeable human resources. As a result, there is now a sudden spurt of interest from students to pursue pharmacy in India. The sudden interest and consequent increase in demand has resulted in a rush to start new pharmacy colleges in India, in an already overcrowded space. This sudden growth has precipitated issues related to the quality of education being delivered at these institutions.” Dr Mayur Yergeri, Associate Dean and Professor, SPPSPTM also reiterates, “There are more than 1000 institutions that admit more than 50,000 students to the B Pharm degree programme and more than 700 institutions that train more than 34,000 students in the D Pharm programme. To add to this, we have the Pharm D and M Pharm Programmes where more than 15,000 students are added in these courses. For a country of more than 1.3 billion people, we need this number of healthcare professionals to meet the demands of the healthcare industry for a

26 EXPRESS PHARMA September 1-15, 2017

highly populated country.” “In India, pharma education is still more focused towards pharma sciences, manufacturing quality medicines at affordable prices unlike many developed countries where the focus is more towards pharma practice, preparing them for a direct role in patient care. For example, in the US, Pharm D is the minimum qualification for practicing the profession of pharmacy. Students are trained to be a part of a multidisciplinary healthcare team,” informs Dr G Parthasarathi, Dean, Global Engagement and Professor, Pharmacy Practice, JSS University. Pointing out major concerns related to pharma education, Dr Bharani S Sogali, Professor and HOD, Department of Pharmaceutics, Krupanidhi College of Pharmacy said, “Some of the drawbacks of pharma education (in India) includes, entry of unqualified and non-meritorious students into the course, non focused and unspecialised way of learning, lack of industrial and clinical exposure, unskilled ways of practical and lab training in the institutes. Research output from Indian educational labs rarely lead to commercialisation and revenue generation. Given the market

needs for trained man power, teaching takes total priority over research in our universities. Institutional base of research in India is extremely narrow and serious research is limited to a few ‘elite’ institutes. Lack of encouragement from government research funding organisations to private institutes and gaps in institution governing policies for research priorities as well as limited funds for research and development facilities/ equipment by institutes or governing bodies are other concern areas.”

Winds of change The PCI has tried to has address the challenge of quality in pharmacy education through a strategy involving three domains of action: quality assurance, academic and institutional capacity building and more emphasis on experiential education and competency building. Moreover, pharma education is heading towards a lot of change after the introduction of uniform PCI syllabus for pharmacy across the country. Dr Mahesh Burande, Director, IPER gives an overview of the Indian situation vis-a-vis the global scenario and says, “In developed countries, Pharm

D schools are producing pharmacists and they work in the healthcare sector, especially hospitals and pharmacy chains. This job is highly respected and rewarded. In some other countries, science graduates contribute more to pharma manufacturing and research and development. Pharm D programmes in India started 10 years back under the leadership of Dr B Suresh, President, PCI. In India, students today have the choice to select a industry career or a healthcare career due to availability of two programmes i.e. B. Pharm or Pharm D after 12 th (grade) science.

Industry – academia gap Nevertheless, there exists an undeniable gap between industry and academia. Some of the major reasons for the gap are: ◗ Academia often fails to adopt technology changes as compared to the industry. ◗ The faculty involved in the design, development and delivery of the course content lacks industry experience and exposure which also reflects in the overall outcomes of the course. ◗ The lack of proper representation/contribution

In India, pharma education is still more focused towards pharma sciences, manufacturing quality medicine at affordable price unlike many developed countries where the focus is more towards pharma practice, preparing them for direct role in patient care Dr G Parthasarathi Dean, Global Engagement and Professor, Pharmacy Practice, JSS University

The regulatory needs of pharmacy education should change and it should move towards surprise inspection and see that the poor performing institutes are weeded out Dr Mayur Yergeri Associate Dean and Professor, SPPSPTM

(

THE MAIN FOCUS

In India, students todayhave the choice to select a industry career or a healthcare career due to availability of two programmes i.e. B. Pharm or Pharm D after 12th (grade) science Dr Mahesh Burande Director, IPER

by subject experts from industry while framing the syllabus. ◗ Minimum industry-institution collaboration in grooming future pharmacists. “An improved educational system will enable pharmacy graduates to satisfy the requirements of the pharma industry, which is currently missing. As the industry’s demand for competency is constantly increasing, the educational domain will have to undergo changes to match industry requirements. Each college should tie up with industry, by working on mutual exchange programmes like collaborative projects, R&D and training,” said Dr Sogali. Dr Burande said that while industry is growing at a tremendous speed with new technology and new regulations at par with global standards, the syllabus for B Pharm and M Pharm is not updated at the same pace. Even if it is updated, teachers are not groomed or oriented to pass on these changes and skills at the earliest to students, creating a knowledge gap. He further suggested that in order to bridge this gap, a pharma industry panel should suggest new changes in the syllabus each year. Experienced teachers should be certified to deliver these changes and these teachers should orient their juniors to deliver it to students. The minimum skills required in manufacturing should be identified and developed in students who wish to make a career in the pharma industry. Students should be

certified for these skills before receiving D. Pharm, B.Pharm, M.Pharm or Pharm D degrees. There should also be formal agreements between a pharma company and a pharmacy college, to enable training of students. The licence of the comppany and approval of the college should not continue, if this active association doesn’t happen and specific outcomes are measured. India has 1,300 pharmacy colleges and more than 10,000 pharma companies and this is easily achievable. For Pharm D holders, a hospital is already attached before giving approval to the programme by PCI. 30 per cent of the syllabus related to identified skills should be taught by industry experts on weekends. Teachers should undergo a one month training once every two years in the industry related to his/her subject , accompanied by a certification from the company. This would make them eligible for promotions and pay hikes as they would then impart better skills to students. Similarly, he recommends a six month industrial training and project report for B.Pharm students before raduation. Thus one semester in a four-year programme should be for training ina pharma company. Soft skills along with at least one foreign language should be taught to students in the college. India exports drugs and medicines to 212 countries, hence such skills are in demand. This approach will definitely bridge the gap between academia and industry. Fortunately, PCI has taken note of these needs and has taken certain measures. In an interview with Express Pharma, Dr Suresh informs that the PCI has made it mandatory for pharmacy teachers to undergo continuing education and quality improvement programmes and update themselves, both with the pedagogy of teaching as well as advances in relevant fields. The other step that can help address the gap would be the use of technology for disseminating information and knowledge which the PCI intends to do over a period of time by providing online modules of learning to teachers through its web portal. PCI has also revised the B Pharm and M Pharm syllabi as per industry requirements. PCI has brought out five regulations and a national curriculum for making a paradigm shift in the pharma education, training and research. These regulations will not only provide much needed direction, growth and leadership for creation, sharing and offering advances in the curriculum, but also help identify and create partnerships between institutions and industry

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

cover ) for the required transition and bring about a cultural change, not only in the educational programmes, but also the profession.

Future trends in pharma education Industry veterans also share their views on the upcoming trends in pharmacy education. Dr Burande of IPER opines that the future trend in pharma education is digitalisation. Experts lectures are available on the web and even demonstrations through video. It will be virtual learning and simulation models to develop skills. Online education to develop skills will be preferred worldwide and those institutes well equipped with these facilities will drive growth and quality teaching. “Inspired teachers will build the brand of such institutes and cater to the needs of industry and students. There should be marketing and training departments in every pharmacy college,” further states Burande. According to Dr Parthasarthi, “The need for every institution involved in imparting pharmacy education is to seek national and international accreditation to bench mark the quality necessary. The future trend is going to be more learner-centric as implementing innovative pedagogy to engage students actively in the learning process is important. Adopting Information and Communication and Technologies (ICT) enabled teaching and learning process is essential.” Whereas, Dr Sogali believes, every college should give students an atmosphere to nourish internal skills and qualities. A system should be devised so that each student gets an opportunity to freely think and develop skills to the maximum. Professionalism can be cultivated only through rational ways of thinking and performing. Students should come out with their ideas and suggestions in any aspect of education and especially be focused on innovative re-

28 EXPRESS PHARMA September 1-15, 2017

search. Most of our students lack an initial pull, which should be given by the teachers or the college. Students should also be trained to improve their soft skills, she opines. She further states, “Coming to the educational aspect, much emphasis should be given to industrial and practical exposure. Clinical and practical training should be given more importance and included as a part of the curriculum. Research-oriented ways of learning are more effective rather than limiting students to theory. One should be updated on current and continuous changes in the pharma field. Also, in the current competitive market, everyone should strive to be ahead of the curve with latest updates and higher knowledge levels.” The pharma sector is undergoing a sea change in terms of meeting the healthcare needs of the country. In a world which is getting constantly disrupted, we have to keep pace with the changing scenario. Luckily, the pharma

education sector is taking the necessary steps to do so. For example, the change in the B Pharm and M Pharm syllabi by the PCI is one such change as the country will now have a uniform pharma education system. It has its advantages and disadvantages— the advantage is that the quality of pharmacy schools will improve as we gear up to meet the needs of the new healthcare system. I expect an exit exam in the near future for the benefit of all stake holders and the students themselves, says Yergeri.

Making students industry ready The professors unanimously believe that there is need to strengthen industry-academia collaborations in terms of education, training and research, through continuous interaction with the pharma industry leaders and involving them in the framing of the pharmacy curriculum. ◗ Firstly, students can be made industry ready by training them within pharma companies and in community phar-

macy practice to keep abreast of the demand and supply gap in the health industry. ◗ Keeping pace with the industry needs and continuous technology upgradation, thinking out-of-the-box for solving problems, both for pharma industry and healthcare needs are other ways towards this goal. ◗ Regular faculty exposure to the changing scenario in the industry would help them understand industry needs as would periodic skill and competency based evaluation ◗ Industry sponsored projects, enhanced alumni engagement ◗ Starting practice schools/ finishing school for pharmacy profession are also important initiatives. ◗ Campus recruitment and training would be the final step in this endeavour. It is hoped that India wil soon be able to build a robust pharma education system which would be instrumental in fortifying the sector and making India a global leader in this sphere. swati.rana@expressindia.com

PCI has made it mandatory that pharmacy teachers need to undergo continuing education programmes and quality improvement programmes and get themselves updated, both with the pedagogy of teaching as well as the advances that have happened in the relevant field Dr B Suresh President, PCI

Most of our students lack an initial pull, which should be given by the teachers or the college. Students should also be trained to improve their soft skills Dr Bharani S Sogali Professor and HOD, Department of Pharmaceutics, Krupanidhi College of Pharmacy

(

THE MAIN FOCUS

I N T E R V I E W

'Revival of pharmacy education in India is the need of the hour' Over 33 years of experience as a pharmacy professor and five years as President of APTI has empowered Dr Pramod Yeole, Pro Vice-Chancellor, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur with traditional and modern teaching arts. In an interview with Usha Sharma, Dr Yeole suggests partnering with pharmacy programmes in other nations for teaching and research Tell us about your roles and responsibilities at the R.T.M. Nagpur University? How does your past experience as APTI President empower you in the present role? I feel proud to be the first pharmacist to be a Pro Vice Chancellor of any Public University in the state of Maharashtra. When I embraced the office of the Pro Vice Chancellor of the University on June 30, 2015, the public universities in Maharashtra state were governed by Maharashtra University Act 1994 in which the duties and responsibilities of Pro Vice Chancellor of the University were not prescribed. During the last two years of my tenure, I brought a lot of reforms in the examination system of the university by using advanced technology. As a consequence, results of all 1250 examinations conducted by the university in summer 2017 were declared in the stipulated time, which is a record in the state. I upgraded the standards of Ph.D. and D.Lit degrees of the universit and established state-of-theart answer book centre and on- screen valuation centre in the university, which is the largest in the country. While executing all these, my 33 years of experience as a pharmacy teacher and five years as a President of APTI undeniably empowered me in the present role.

Tell us the five major problems in pharmacy education? What role can be played by teachers to mitigate it? In this era of specialisation and globalisation, pharmacy education in India is suffering from serious setbacks and flaws. There is an urgent need to initiate an academic exercise aimed at revamping of curriculum and keeping pace with current and emerging trends in the field of pharmacy. Unfortunately all these years, adequate emphasis was not laid on strengthening the components of 'Community Pharmacy', Hospital and Clinical pharmacy, while designing curriculum at diploma and degree levels of teaching. The curriculum followed by almost all universities in India does not match up to the world standards and students are still getting 20-30 years older compounding practical exposure in labs during the graduation level. Application of Total Quality Management (TQM) to the educational system can improve the present situation. An emphasis on the concept of quality teacher must be included. Revival of the pharmacy education in India is the need of the hour, which in turn will pave the way for upgradation of the pharmacy profession in the country. Existent flaws in the system:

To subscribe: bpd.subscription@expressindia.com

There is an urgent need to initiate an academic exercise aimed at revamping of curriculum and keeping pace with current and emerging trends in the field of pharmacy

◗ Entry of unqualified and nonmeritorious students into the course ◗ Outdated curriculum and educational regulations ◗ Lack of industrial exposure ◗ Unskilled ways of practical and lab training in the institutes ◗ Research output from Indian educational labs rarely lead to commercialisation and revenue generation ◗ Non focused and unspecialised way of learning ◗ Given the market needs for trained manpower, teaching takes total priority over research in our universities ◗ Institutional base of research in India is extremely narrow; serious research is limited to a few ‘elite’ institutes These imperfections need to be strictly eliminated for upgrading our current education system into a perfect world class structure. What can pharmacy professors in India learn from our counterparts? Definitely the pharmacy professors in India have to learn many things from their counterparts specially teaching learning methods, advance curriculum, research and development. Pharmacy professors should consider the opportunities to partner with pharmacy programmes in other nations for teaching and research, as well as to better prepare students for practice in an increasingly diverse

ethnic population. In many abroad universities each professor has 15 to 20 patents and each university has five to six noble laurels. We have to analyse where we stand? In India, professors are involved in too many nonacademic activities resulting in poor research output. There are only a handful of universities and institutions with a serious focus on research. However, in the US and Europe there is a strong bond between industry and academia with the industry sponsoring many projects in universities and institutions as a consequence of which many universities have undertaken pioneering research project. In India, research academia and industry lack patent awareness and are mostly dependent on research that is done abroad. According to you, why are students not opting for pharmacy teaching as a career option? Those days are gone when rank holders from our colleges used to join the teaching profession. Today, the rank holders have better options and are least interested to join the teaching profession. Most of them prefer teaching not out of interest but as a last resort in there career choice. They are least motivated for the job. Institution has only Continued on Page 31

EXPRESS PHARMA

September 1-15, 2017

cover ) I N T E R V I E W

â&#x20AC;&#x2DC;A contemporary and relevant pharmacy curriculum is the needâ&#x20AC;&#x2122; Dr B Suresh, President, Pharmacy Council of India, speaks on various issues related to pharma education in India and elaborates on the initiative taken by Pharmacy Council of India (PCI) to bridge the gap between industry and academia, in an interview with Swati Rana

Brief us on the current scenario of pharma education in India. The pharmacy education in India is presently in a very challenging phase. Due to an increase in the growth of the pharma industry, there is a growing need for qualified and highly knowledgeable human resource. As a result, there is now a sudden spurt of interest from the students to pursue pharmacy programme in India. Further, job opportunities for engineeringbased programmes are on the downslide, making it less attractive for students to pursue engineering as a first choice of career option. The sudden influx of interest and consequent increase of demand has resulted in the rush to start new pharmacy colleges in India in an already overcrowded space. This sudden growth has precipitated issues relating to the quality of education being delivered at these institutions. The Pharmacy Council of India (PCI) has addressed this challenge of quality in pharmacy education through a strategy involving three domains of action: quality assurance, academic and institutional capacity building and more emphasis on experiential education and competency building. What are the issues faced by PCI? PCI faces a major challenge with regards to dual regulation

30 EXPRESS PHARMA September 1-15, 2017

status? I would like to reiterate that dual regulation is greatly impacting the pharmacy education system. Efforts to overcome this by the PCI are ongoing and has to be considered by the government as changes require amendment to various acts.

PCI has made it mandatory that pharma teachers need to undergo continuing education programmes and quality improvement programmes and get themselves updated both with the pedagogy of teaching as well as the advances that has happened in the relevant fields of pharmacy education, i.e. by the PCI and All India Council for Technical Education (AICTE). This dual regulation has led to institutions exploiting structural and procedural mechanisms of regulation to their advantage, resulting in a number of litigations. Though the PCI and AICTE have worked out strategies to harmonise their

regulations it still does precipitate regulatory challenges that result in not being able to bring about quality advancement. Besides this, the major challenge for pharmacy education in the country relates to the availability of qualified and competent pharmacy teachers that can carry forward the vision of PCI in preparing a

pharmacist workforce that is competent, current and relevant. Pharma education is regulated by two bodies, PCI and AICTE in India. How is it impacting the education system? There was also an attempt by PCI to bring complete pharma education under its roof. What is the

The gap between academia and industry is a major concern. How is PCI bridging the gap? There has been a steady change in the pharma sector approach to drug discovery and development. A contemporary and relevant pharmacy curriculum is the need to address this gap. Emerging and growing scientific areas in pharma sciences such as modelling and simulation training, clinical and translational science as well as nano technology should become available for both basic and advanced training. The faculty should be developed and supported to lead and contribute to fields such as cell and system biology, genomics, proteomics and nano technology. PCI has brought out five regulations and a national curriculum to usher a paradigm shift in pharma education, training and research. This will not only provide much needed direction, growth and leadership for the cusrriculum advances, creation, sharing and offering, but also help identify creation of

( partnerships with institution and industry. Thus, it will lead to development of required transition and bring about a cultural change, not only in the educational programmes, but also the profession. There has been a demand to abolish D.Pharm course and make B.Pharm as a minimum qualification. What are your views? The views of making the minimum registered qualification for pharmacy profession in the country as B.Pharm have been on discussion for more than 10 years now. However, on the other side, there is also the observation being made on the need for diploma pharmacists in drug stores and hospitals, which is on great demand and any step to stop D.Pharm programme would result in shortage of pharmacists to manage the pharmacies and the pharmaceutical care. In this regard, I am of the view that perhaps this is still the not the right time to state that D.Pharm programme is no longer required. May be 5-10 years down the line, the profession may revisit this issue and make the right decision. Recently PCI has revised B.Pharm and M.Pharm syllabus, how it is going to help students be more industry ready? PCI has brought out for the first time a national syllabus for its B.Pharm and M.Pharm programmes and has been well received by most of the academia, the students and the industry. This effort would result in: i) Developing well qualified knowledgeable skilled and competent and pharma scientists ii) Support efforts in the drug discovery development and delivery iii) Providing high quality pharma care services in healthcare system.

Pharm D was introduced to meet the international level of pharma education. The first batch of Pharm D passed out in 2014. What are the opportunities available for them? The Pharm D programme was introduced in 2008 to meet the needs of pharmacists playing their roles in clinical settings and helping in advancing the pharma care and healthcare delivery system of the country. The first batch of the Pharm D students who have passed out in 2014 have now been able to make their mark in the healthcare team through their knowledge and expertise in medicines and the supportive role they can play with the physicians. These students have been able to find opportunities for themselves both in India and abroad in the segments of hospital and clinical pharmacy services, pharmacy education and also in pharma industry in the area of pharmacovigilance and clinical research. What are the measures taken by PCI to address deficit in teaching staff, both in terms of quality and quantity? Availability of the number of faculty for teaching at pharmacy institutions is no longer a challenge as almost 70 per cent of the pharmacy institutions in our country offer post graduate programmes in pharmacy and almost 30 per cent of the institutions also are recognised for conducting research leading to the award of PhD. What really is the concern relates to the quality of teaching and learning process being delivered at the institutions and updation of knowledge by the existing faculty. To address these challenges, PCI has made it mandatory that pharmacy teachers need to undergo continuing education programmes and quality improvement programmes and get themselves updated

To subscribe: bpd.subscription@expressindia.com

both with the pedagogy of teaching as well as the advances that has happened in the relevant fields. The other step that can help bridge this gap would be the use of technology for disseminating information and knowledge which the PCI intends to do over a period of time by providing modules of learning to teachers, online through its web portal. What are the pre-requisites of a great teacher? Share some learnings from your experience. The most important prerequisite to become a great teacher is to give your best to the students without any expectations. The pleasure of sharing your knowledge with another person that will help him shape his career is the greatest reward which a teacher can get. If the teacher has indeed impacted and helped shape the career of a student, he will be the recipient of unstinted respect and affection that he will receive from the student throughout his life. I have experienced this and continue to enjoy the love and respect from my students when I meet them. Tell us about a teacher who changed your life. I convey my greetings to all my fellow teacher colleagues on the occasion of ‘Teacher's Day’ during which period this issue is going to be released. I have thoroughly enjoyed being a teacher and even now the most joyous moment for me is always when I speak to the young students and motivate them in their careers. To speak about any one of my teachers who had played an important role in my life would be doing injustice to other teachers. I on this day, acknowledge and pay my respects to all my teachers who have shaped me and helped me reach where I am today. swati.rana@expressindia.com

THE MAIN FOCUS

'Revival of the pharmacy... Continued from Page 29 one option now, to select those who are available and train them to be competent and committed teachers. They need regular training in subject updating, educational technology, teaching methods and management aspects. The low level of attraction among students towards a teaching career can be linked to factors like uncertainty regarding the future of the profession; poor salaries, especially in private institutions; limited possibilities for personal ascension and precarious working conditions. There is still a gap between industry and academia, how to bridge these gaps? In India, over the years the industry and academia have been seen as the north pole and the south pole rather than being viewed as two sides of the same coin – the economy. Some may argue that academia exists only for knowledge creation and dissemination which has no connection with wealth and that industry exists only for wealth, and has no connection with knowledge. The fact remains that both are interwoven!! India has the potential of becoming a global hub for providing high-end manufacturing services to the world. There is still a need to have a clear and unambiguous perception in the direction of leveraging strength towards actualisation of excellence. This can be nurtured and nourished by a fulfilling academia-industry interaction. The apprehension over academia-industry interaction has been widely discussed by all concerned many a times. This needs to be done full-fledged and to make up for the lost time. The public funded R&D

(Protection, Utilisation and Regulation of Intellectual Property) Bill 2007 is one such step, which can go a long way in better utilisation of government- funded research work. Other steps required in increasing academia-industry collaborations are greater alignment of curricula with the requirements of industry and more practical training sessions for the students in all streams. So far it has only been students on the technical side who have been taking up internship in the industry. While basic research will continue to require government support, applied R&D will have to be supported more actively by the industry. On Teachers' Day what message would you like to give to pharmacy students? Although many milestones have been crossed in the development of pharma profession in the country, but more heights need to be scaled. My quest has been the one for principles to orient the reformation of higher education in the third millennium. This is because, I strongly believe this millennium will be that of: ‘Change being the only thing constant’. In this era of constant change, of enhanced internationalism; education and training needs to be adequately imparted to deal with knowledge society which can be done only if our students are amply trained. Finally, I would like to say, if you are prepared to think big and act in time with conviction, you will be rewarded. You should hold on to your goals even if you stumble here and there, and learn your lessons. In all that lies before you, may God grant you wisdom, success and true sense of fulfillment of your cherished ideals and goals. u.sharma@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

cover ) HOMAGE TO THE GURUS

Ajit Singh Chairman, ACG Worldwide

person whose wisdom changed my life, in its own way, was the late Nobel Laureate, Sir James Black, the Research Scientist at GSK, UK whose work led to the development of Propranolol and Cimetidine. I learnt that a recognition by the Nobel Prize Committee is not given only for expertise and new frontiers development in the narrow area of specialisation of the award winner. It is also for a broad and humanitarian view of our planet. I learnt that one could talk to Sir James on almost every subject. For example, we even discussed about marriage and divorce, right down to how to avoid bureaucracy creeping into a growing organisation. He said that his recipe for attacking bureaucracy would not be found in any book on Management. It was simply that, within an organisation, authority should never be given to a person to say No to any proposal

unless that person has the authority to say Yes. I had to really ponder over it, to understand this deep, original concept. My other substantial learning was from the late Professor Arnold Beckett who was Professor at Chelsea School of Pharmacy, London, U.K. He visited India to lecture more than once. The presentation of his lectures were far ahead of his time, illustrated with beautifully composed slides and delivered in a powerful tone of voice that engaged attention of and enthused the audience. He was like an actor on the stage, and I learnt how active body movements and a varied modulation and tone of voice creates excitement in what could otherwise be a drab scientific lecture. During one of his visits, Prof Arnold Beckett inaugurated a Scientific Pharmacy Museum that SciTech Centre/Associated Capsules set up at the Principal K.M. Kundnani College of Pharmacy, Mumbai.

Dr Mahesh Burande Director, Institute of Pharma Education and Research (IPER)

y favourite Teacher in Pharmacy is Dr JK Lala who was the Principal K.M.Kundanani College of Pharmacy Ulhasnagar. He was taking our subject Drug Store Management. While taking this subject, without any PPP during that time (1979), he was literally taking our mind to the Drug Store by illustrating suitable examples, live situations, case studies,involving us and taking suggestions from us and I think it was learning by participation and problem-based learning with command over language and humour. I am also inspired by the teaching style of Dr Chandrakant Kokate, the first Pharmacy Teacher who became Vice Chancellor of University. His lectures would be full of information and statistics without any paper in front of him and wonderful quotes to start and end his speech. Currently, I am impressed with my friend Dr B Suresh, President, PCI, for the way he controls the crowd with humour and delivers new thoughts and concepts. Their styles of teaching inspired me to become a teacher and I am trying to teach and talk like them as a teacher ,trainer and consultant who is appreciated today by pharma industries and pharma profession.

Dr Mayur Yergeri Associate Dean and Professor, SPPSPTM

32 EXPRESS PHARMA September 1-15, 2017

had some amazing teachers who taught me and some of these teachers went on to teach at universities in US. As naming one teacher will be bias on my part, I will take the some names of teachers who impacted my future and career — Dr VN Sonar, Dr RH Udupi, my PhD supervisor Dr KN Thimmaiah and Dr GJ Peters. One teacher who did not teach me but inspired was Dr Yellapragada Subbarow, a pioneer who discovered medicines like Tetracycline, Folic acid, Methotrexate, Aureomycin and Diethyl Carmabamzepine, we live longer today because of these medicines. Our Late President Dr Abdul Kalam’s Wings of Fire was inspiring for me and I brought and read this beautiful book five times. I also got an opportunity recently to be a Visiting Scientist with Dr GJ Peters who is a pioneer in Preclinical studies in cancer at the VU University Medical Center, Amsterdam, Netherlands on a sabbatical for a year to keep abreast the research happening in the field of cancer. It was a rewarding experience and I was a Postdoc with him a few years ago.

Dr Dinesh Dua Vice Chairman, Pharmexcil, Chairman,Higher Education, CII North India

n Teacher’s Day on, I very fondly recall my Dronacharya Guru, Dr Ahmed, HoD Pharmacology. Early on in 1972, he saw a spark in me from the chemistry perspective besides potential in extracurricular activities and sports. With his continuous mentoring for five years of my academic career, I excelled in pharmacology. He encouraged me to prepare and qualify for MBA from the Indian Institute of Management, Ahmedabad during 1977-79 which gave a great fillip to my career. Dr Ahmed strongly ingrained in me a huge significance for culture and a value system which I’m very proud of. Whatever I’m today, a huge credit goes to Dr Ahmed's mentoring.

(

THE MAIN FOCUS

Dr N Udupa Professor and Research Director (Health Sciences), Manipal University, Manipal

salute my great teacher, Dr G P Srivasatav. He motivated all students, mentored and largely was responsible for his students being gainfully engaged in the pharma industry. His letter of recommendations in 1970s were enough to fetch jobs in any place, in any industry, in any city, even abroad. Dr G P Srivastav was a popular teacher and always smiling, interacting with students in laboratories, class rooms. Under his mentorship, his students achieved great positions in national and international institutions in the pharma industry. We were fortunate to learn a lot of talents and technologies relevant to the pharma industry in those days. He helped us to dispose the dog from the laboratory after pharmacological experiment when technician was not available and the laboratory was stinking. He gave us a lesson and educated us that even if the technician is not available, we can go ahead with our experiment and research. Even during strikes and student unrest, he was the one allowing the students like me to come and enter from the backdoor to work in the laboratory and use the library. We will not get such great teachers these days. However, he passed away in Varanasi in the year 1976 when I had just completed my M Pharm. I cannot forget my teacher of pharmacy, Dr Srivasatav who is responsible for making me and shaping me as a pharmacy teacher and researcher.

n Teachers’ Day I always talk about my favourite teacher, Anne Warrior. She was a fascinating person who taught me to think for myself, to excel in everything I do and to do things differently and creatively in order to make a difference. Once, she got us to creatively spruce up a wilting garden patch in school into a designer cactus garden over a weekend to win our class ‘The Garden Patch of the Year’ award! Now when I look back, I realize that her unconventionality rubbed off on me and led me later in life to break convention and do many of the things that were considered pioneering for young women in the 1970s.

Kiran Mazumdar Shaw

Dr Arun Garg General Secretary – IPGA, Prof. & Dean, School of Medical & Allied Sciences KR Mangalam University, Gurgaon

rof B Suresh, the Honourable Vice-Chancellor of JSS University, Mysore, was my Ph.D supervisor and is my ideal teacher! Prof Suresh has been actively involved in uplifting the quality and standards of pharmacy education and profession in India for the past 30 years. It was Prof B Suresh who gave me the opportunity and encouraged me to indulge myself in pharma research especially on drug utilisation to ensure and improve the safety and quality of the life of diabetic patients. It was this humanitarian concern of my teacher that has made me become fully committed to indulge in the issues and problems of diabetic patients around. On the very first day in JSS College of Pharmacy, Ooty, Prof Suresh introduced Dr David Kosh from Adelaide, Australia, to me and encouraged me to interact with him. With utmost care, Dr Kosh went through my concepts and improved my understanding of the drug utilisation studies. It is this generous and selfless attitude of my teacher that enabled me to have a wider circle of pharmacy related academicians. Prof Suresh’s nurturing and encouragement has helped me a lot to enrich my professional career. Last, but not the least, I would like to share with you that Prof Suresh as a human being is very supportive and always gives right guidance and suggestion with clear objectives and aims.

CMD, Biocon

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

MANAGEMENT INSIGHT

Past into the future? Shailesh Gadre, MD, Gencoval Strategic Services shares his views on some of the key revolutionary/evolutionary alterations in the pharma industry

he heading 'Indian pharmaceutical industry faces growth pains' caught my attention, not only because it dealt with my interest area, the Indian pharma industry, but also for the sharp contradiction to an almost constant feature of this sector. In my last 20 years of being in this industry, I had almost got used to double digit growth in this domestic market. In all my strategy workshops that I held for corporate marketing teams, the aspiration never rested at matching the double digit growth but always aimed at surpassing the industry momentum. Today I see this very youthful industry reeling under pressure of multiple stress situations arising from pricing constraints, tighter regulatory scrutiny, competitive forces of patented molecules, GST compliances and generic threats, to just name a few. Generous, time tested strategies of geographical expansion, CRM models of doctor enticement and trade push industry are somehow failing to help tide the industry through these changing times.

New game, new rules I strongly believe that the industry is at an inflection point of transformation and likely to go through a complete structural change. In line with this, each and every aspect of the existing structure will get questioned and challenged. My endeavour is to put forth my views on some of the key revolutionary/evolutionary alterations in the industry through a series of articles. Today, I am going to take up one of the most important, strategic point – territory prioritisation and expansion,

34 EXPRESS PHARMA September 1-15, 2017

which definitely calls for moulting ahead of the others. While the complete environmental spectrum is going through an overhaul, the territory potential mapping strategies seem to have stuck in the past. How else can we explain the following ‘real’ observations ◗ Top 100 cities account for more than 80 per cent of the therapy potential, but field numbers exploding over 1,000 in numbers and 30 per cent or more are deployed beyond the top 100 cities. ◗ Large companies have expanded into cities beyond top 100, which swing as per the therapeutic segments, but missed out on the top 100. ◗ Many of the national level brand leaders are not at the top in over 50 per cent of high potential cities. ◗ Limited patient consumer overlap. Pharma market is not aligned to growing consumerism and infrastructure progress

◗ Target setting is still skewed, it is based on past performance within the territory and not on the potential of the territory. Let me support my view of the frozen strategic mindset prevailing across companies by giving a simple analogy. Ask a brand manager to define the potential for the market, instant will be the response of quantum and growth from audits. Ask the regional sales manager about the market potential of the city and he will draw our attention to the number of medical representatives of competitors. Ask the area manager and he will tell us that the number of doctors and chemists within the territory determine the territory potential. Undoubtedly, these datapoints have more or less driven results in the past, but are they exhaustive enough to steer the future? Increasingly, when the game itself has taken up a new outlook, the rules of the game are bound to change. Will these drivers alone be able to hold onto the growth trajectory across changed turfs?

Does the equation driving territory potential hold true in current times? High potential territories = fn (stronghold cities of self + highly deployed cities of competition + city doctor population) This equation sums up the territory potential mapping exercise for most of the companies. The variables in the potential equation are decisive but surely not exhaustive. This statement is backed by my experience of working with data and data sciences to scrutinise the growth patterns across geographies for multiple therapeutic categories and brands.

Our analytical offering 'Contour' helped me to dissect the emerging patterns and also dismantled my strong perceptions viz. larger the target population of the doctors, higher is the value potential of the territory. Market share of the new molecule is largely dependent on the existing market of the older molecule. Growth of a market is directly proportional to the demographic profile of the consumer. I wouldn’t underestimate the

gent that survives. It is the one that is most adaptable to change.” By bringing the past into the future, we create a future just like our past. It is time that we let go of the past to create the future. Territory potential mapping is just one of the many aspects which surely need a revisit. Let me put in a few questions from my antidiabetic market Contour Insights to you as food for thought “Will Indore continue to be

By bringing the past into the future, we create the future just like our past. It is time that we let go the past to create the future. acumen of the marketing teams to gauge the need of going beyond the obvious for reinstituting the territory potential equation but lack the analytical tools, expertise and experience to scientifically connect the dots. Increasing volumes of data but depleting insights is the emerging scenario across most of the companies. With building costs pressures, I believe that one of the quick fix which would have a significant impact on both top line and bottom line is to redefine the territory focus backed by strong territory potential algorithm.

Bringing the past into the future The pharma industry is witness to the reality of the most popular maxim of all times – “It is not the strongest of the species that survives, nor the most intelli-

half of Coimbatore for the gliptins market when both score almost similar in population size, the city potential and identified as a ‘smart city’”? Why does Calicut stands at 28th position and Kochi at 49th position for the industry inspite of a similar population, but yetare almost similar in size for the gliptins market? What are the key factors impacting the current growth, adoption and evolution of the gliptins market across the cities? The list could be endless. The intent is to drive deep the thought that one needs to go beyond the past to tackle problems of the future. In my subsequent articles, I will bring forth my views across other aspects that need to be rebuilt as we tread the path of uncertainty.

RESEARCH I N T E R V I E W

‘Discovery and innovation is now thriving in SMEs like Bugworks’ Bugworks Research India is developing a new class of antibiotics and has received a grant from CARB-X, a global initiative to address the gap in antibiotic R&D. V Balasubramanian, Co-founder and President R&D, Bugworks Research India, shares more details about their research, tackling the AMR menace and more, in an exclusive interaction with Lakshmipriya Nair Tell us about the research project which has secured you the Carb X grant? Bugworks has unlocked a new paradigm to discover novel antibiotics. Through our innovative approaches, we have developed a stealth strategy by which antibiotics can successfully by-pass efflux pumps, which are a key defense barrier present on the bacterial cell envelope. Our current lead chemical series target the WHO 2017 Critical, Serious and Concerning infection threats. We are progressing a first-inclass novel chemical entity (NCE) that exhibits potent killing of pan-resistant superbugs such as those resistant to colistin, betalactams, cephalosporins, carbapenems, fluroquinolones, and difficult to treat pathogens such as Acinetobacteri baumannii, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Klebsiella pneumoniae etc. We will deliver a clinical candidate that will progress through proof of concept studies in human patients by 2020. How will your project reduce risk of AMR, lower costs associated with resistance and address a public health challenge? Bacteria evolve continuously and have the ability to break defuse - avoid - expel the antibiotics developed in the earlier decades. The Bugworks team has developed a new paradigm that allows its antibiotics to overcome the bacterial defense and rapidly

kill the organism. We have successfully validated our paradigm through the discovery of multiple novel chemical series. The successful outcome of our discovery efforts will result in the introduction of a brand new class of antibiotics, which will be effective on all known resistant bacterial strains. This will not only saves millions of lives who are otherwise perishing due to infections that are resistant to all known classes of antibiotics, but also save millions of dollars in extended hospital costs. When would your project be ready to be commercialised? We are in pre-clinical development and likely to initiate Phase 1 studies in 2019. Given the push and pull mechanisms for novel antibiotics, we expect an accelerated development timeline and the product in the market within seven years. How will this grant help you? How have you deployed the investment of $2.6 million ? The grant is valuable for many reasons: one, since it was a globally competitive grant with less than five per cent success in terms of the final award, it is a vindication of the science that is emanating out of our small biotech operation in Bangalore, India. And to be the only company from Asia is indeed a matter of great distinction. Two, it brings non-dilutive funding, covering nearly 75 per cent of the total costs to deliver one candidate drug. Three, it

To subscribe: bpd.subscription@expressindia.com

pockets to develop and deliver the final drug.

The successful outcome of our efforts will result in of a brand new class of antibiotics, which will be effective on all known resistant bacterial strains brings with it an ecosystem of the best minds in antibiotic development from a global pool who will provide critical feedback and steer the team. Four, it opens up several investor networks and access to large pharma who have deeper

What is preventing investment and innovation in tackling superbug infections? The failure to develop novel antibiotics by big pharma in the past decades are well documented. Problems in science are not always solved by infusing vast sums of money. In fact, recent history has shown that the industrialised, proces- driven discovery engines of big pharma has failed spectacularly in yielding novel antibiotics to combat bacterial infections. Innovation happens in creative environments, which are not shackled by the process driven cultures of big pharma. Hence in recent times, discovery and innovation has exited Big Pharma and is now thriving in SMEs like Bugworks. This not only unshackles the creative mind, but also significantly lowers the cost. Investments into antibiotic discovery are still a trickle compared to other therapy areas such as oncology and cardiovascular diseases. Even though antibiotics are life saving in most situations, since they have been around for several decades, the common mindset is to pay extremely small sums of money for a course of antibiotics. And a typical course of a successful antibiotic for a patient is a few weeks as opposed to life-long consumption in the case of antihypertensive and anti-diabetic medications. Hence the traditional volume-based

pharma business model has become less attractive This has had a spiral effect in terms of investor friendliness as well. What should be the blueprint to tackle AMR? AMR is a problem that affects the entire spectrum of clinical practice and is not only a problem when someone contracts infections. This is not easily intuitive to most, who still view AMR as a problem of the infectious disease (ID) specialists in the clinic and microbiologists in the diagnostic labs. Thanks to AMR, simple surgical procedures will become untenable. The most advanced cardio thoracic surgeries to treat heart ailments will be derailed due to the humble drug-resistant bacteria. Cancer treatments, which offer life extensions and improved quality of life, will become useless when the patient now succumbs to infection and not cancer. The point of all this is to shift the focus of AMR from the purview of ID specialists alone to the purview of the entire medical fraternity. It is everyone’s problem and not just the microbiologist’s problem! This will not only increase the awareness, but also increase the investments into the area. The true implementation of the responsible use of antibiotics is a must if we are to succeed in our quest to tackle AMR. Tackling AMR is a combination of scientific innovation, responsible social behavior and strong political will. lakshmipriya.nair@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

RESEARCH UPDATE

Bayer,J&J in the frame for bigger anti-clotting market opportunity Their clot-prevention drug Xarelto could potentially be used on 30 million additional patients in its largest national markets once regulators give their go ahead for atherosclerosis indication BAYER AND Johnson & Johnson’s blockbuster clot prevention drug Xarelto was shown to cut the risk of potentially deadly strokes and heart attacks in patients with severe atherosclerosis by 24 per cent, raising the prospects of billions more in sales. Xarelto is already approved for a number of cardiovascular conditions and prevention of strokes caused by atrial fibrillation, a type of irregular heart beat common among the elderly, is the main profit driver. Now the drug could potentially be used on 30 million additional patients in its largest national markets, once regulators give their go-ahead for the atherosclerosis indication, Bayer said. That would come on top of a population of roughly 25 million patients in atrial fibrillation. In the irregular heart beat market, Xarelto is head to head with rival pill Eliquis, owned by Pfizer and BristolMyers Squibb, and also competes with Boehringer Ingelheim’s Pradaxa, but none of them have been tested in the atherosclerosis setting, mainly because of concerns over side effects. The results strengthen Bayer’s drugs division, which some investors say could be drained of funding amid the planned $66 billion takeover of US seeds maker Monsanto. But the trial success still leaves Bayer exposed to a major slump in sales when Xarelto’s US patent runs out in 2024. So far there is no strong

36 EXPRESS PHARMA September 1-15, 2017

contender in its drug pipeline to step in after two setbacks in earlier stages of development over the past few years. Detailed results presented at the European Society of Cardiology Congress in Barcelona over the weekend showed that a combination of Xarelto and aspirin was 24 per cent more effective at preventing strokes, heart attacks and cardiovascular deaths than the standard treatment of aspirin alone. The odds of suffering a stroke alone was slashed by 42 per cent.

Xarelto competes with rival pills Eliquis, from Pfizer and Bristol-Myers Squibb, as well as Boehringer Ingelheim’s Pradaxa

Investors had a glimpse of Xarelto’s bigger potential when independent supervisors of the trial in February said the drug’s efficacy was so evident that control patients in the trial who were on aspirin only should also be given Xarelto one year ahead of schedule. On the down-side, major internal bleeding that required medical treatment occurred 70 per cent more often when compared to the aspirin-only group, though Bayer said the risk of that happening to a patient was

still low. Bayer added that the difference was mainly due to more gastrointestinal bleeding and that there were no signs that patients on the Xarelto-aspirin combination were exposed to a bigger risk of potentially deadly bleeding in the brain or other vital organs. “In total, the benefits outweigh the side effect risks by far. You can see it from the clearly lowered mortality rate and that number also takes the cases of fatal bleeding into account,” said Frank Misselwitz, Head of Cardiovascular Drug Development, Bayer. The risk of dying from any cause during the four-year trial was 18 per cent lower in the Xarelto-plus-aspirin arm. Participants suffered from coronary artery disease (CAD) or peripheral artery disease (PAD), which are common forms of gradually constricting arteries in the legs, neck and around the heart. They are typically given much cheaper aspirin to prevent cardiovascular knock-on diseases. Bayer, which invented aspirin, raised its annual peak sales potential estimate for Xarelto last year to more than 5 billion euros ($5.3 billion) and on Sunday said it would keep that unchanged for now. The pill generated 2.9 billion euros in 2016 sales for Bayer, up 30 per cent from a year earlier, while partner J&J, which gets a majority of US revenues, booked sales of $2.3 billion, up 23 per cent. Reuters

RESEARCH

FDAclears Novo Nordisk's diabetes drug to reduce cardiovascular risk The FDA has cleared a diabetes drug for reducing risks of heart attack, stroke and cardiovascular deaths in patients with type II diabetes for the first time NOVO NORDISK has announced that US Food and Drug Administration (FDA) has approved an expanded use of its diabetes drug to reduce the risk of cardiovascular events such as heart attack and stroke. This is the first time the FDA has cleared a diabetes drug for reducing risks of heart attack, stroke and cardiovascular deaths in patients with type II diabetes, the company said in a statement. In December, the FDA had approved Eli Lilly and Co and

Boehringer Ingelheim Pharmaceuticals' drug, Jardiance, to reduce the risk of cardiovascular death in patients with type II diabetes. Novo Nordisk’s Victoza, which was approved in 2010 to treat patients with type II diabetes, brought in 11.5 billion Danish crown ($1.84 billion) in the first six months of 2017. Type II diabetes, closely linked to obesity, accounts for more than 90 per cent of all diabetes cases, the company said. Victoza’s expanded label follows a successful trial that

showed the drug significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13 per cent when compared to a placebo. Heart disease is the leading cause of death in the US, killing about 610,000 people every year, according to the Centers for Disease Control and Prevention. Adults with type II diabetes are up to four times more likely to develop cardiovascular disease, the company said. Reuters

Adamas Pharma secures approval for Parkinson's dyskinesia drug The company said the drug is expected to be available in the fourth quarter, and formally launched in January 2018 THE US Food and Drug Administration (FDA) said it had approved Adamas Pharmaceuticals' treatment for a side effect caused by a commonly prescribed Parkinson’s drug. A majority of patients diagnosed with Parkinson’s are treated with levodopa, whose use often leads to dyskinesia involuntary movements that are non-rhythmic, purposeless and unpredictable. Parkinson’s disease is a debilitating disorder in which brain cells progressively die causing patients to experience tremors, rigidity, extreme slowness of movement, impaired balance, and difficulties in swallowing and speaking. Adamas’ Gocovri, previously ADS-5102, is the first drug cleared by the FDA to control levodopa-induced dyskinesia (LID). The long-acting therapy is taken once-daily at

bedtime. An estimated 90 per cent of levodopa-treated patients, about 200,000 people in the US, suffer from LID, the company said. Fluctuating levels of lev-

To subscribe: bpd.subscription@expressindia.com

odopa result in erratic periods of muscular control and involuntary movements throughout the day, disrupting activity at least half a dozen times a day. As Parkinson’s progresses, patients are dyskinetic just af-

ter taking levodopa but increasingly exhibit ‘off time’, or worsening symptoms, as it wears off. These patients have little recourse, other than opting for deep brain stimulation, a surgical procedure that involves

blocking electrical signals from targeted areas in the brain. With Gocovri, which targets both dyskinesia and off time, patients will be able to reclaim about 3.6 hours of their day, CEO Gregory Went said in an interview ahead of the decision. About 50,000 people are diagnosed with Parkinson’s in the US each year, according to the National Institutes of Health. The main ingredient of Gocovri, amantadine, has been available in the market as an antiviral drug for several decades. The company said the drug is expected to be available in the fourth quarter, and formally launched in January 2018. Adamas is also testing the drug to treat walking impairment in patients with multiple sclerosis. Reuters

EXPRESS PHARMA

September 1-15, 2017

IT PHARMA

Life science sector: Future and cyber risk landscape Prashansa Daga, Asia Leader Life Sciences, Marsh, looks at new technological advancements that affect different stakeholders of the life science sector—manufacturers, distributors, and consumers—and the risks associated with such changes

ife science companies have always operated in a world of uncertainty. Challenges around cost and pricing, clinical and operational innovation, customer and consumer engagement, and regulatory compliance issues have existed for decades. In addition, new and evolving technologies and processes, including blockchain, digital supply networks (DSN), and data analytics have meant that the life science sector is a prime candidate for disruption. Most life science companies face the challenge of focussing on cutting edge research and development and innovation. At the same time, they need to keep costs low, without compromising on patient safety in all the geographies that they operate in. They also have to be compliant with local and global regulations. How should life science companies invest and operate to thrive in today’s world of uncertainty? What capabilities do they need to leverage the large (and growing) electronic health information data across the enterprise, from R&D through product commercialisation? How can they develop incremental and breakthrough strategies that de-risk clinical, business, and operating models and create added value for patients, manufacturers, and shareholders?

are likely to adopt are the following:

Manufacturers and suppliers 1. Digital supply network: The DSNs integrate information from different sources and locations to drive production and distribution. Many life science organisations are now trying to use DSNs to focus more holistically on how the supply chain can better achieve business objectives, while informing corporate, business unit, and portfolio strategies. 2. Blockchain: Blockchain technology has the potential to drive life science innovation, strengthen security efforts, and increase company and industry accountability. As drugs are manufactured, patents filed,

and clinical trials carried out, blockchain technology could be used across the product lifecycle and provide visibility among pharmaceutical companies, clinical research organisations, regulators, distributors, and

38 EXPRESS PHARMA September 1-15, 2017

rapid commercialisation of new drugs and devices, and create a competitive advantage. 6. Digital platforms: Digital platforms have the potential to substantially lower the cost of patient-physician engagement.

Consumers of life science products and health care services Social media: Peer-to-peer reviews through closed groups and open groups of friends and relatives, as well as social media platforms open to all, are rapidly emerging as a useful tool in consumers’ choices of life science companies’ offerings. Almost everyone uses these platforms to inform their decision making on almost each field of the life science sector, from drugs to which doctor to consult.

Life science companies may need to adapt to the new reality Given these trends, life science companies need to strengthen their interaction with the users of their products and services by developing online information resources, mobile applications, and personal health devices. In addition, streamlining and harmonising all their digital channels to provide a consistent customer experience and reduce costs is important.

Other strategies driven by emerging technologies

Emerging technologies and strategies in the life science sector Some of the technologies that manufacturers in the life science and healthcare industries

patients. 3. Health care digitalisation: The collection and electronic exchange of vital biological and clinical data (e.g., disease statistics, patient population statistics, electronic patient dossiers) among life science companies, providers, health plans, and patients can improve drug and device R&D, manufacturing, distribution, adoption, and use. 4. Artificial intelligence (AI): Technical advances by collaborating robotics and medtech companies are enabling semiautonomous patient care and robot-assisted surgeries. 5. Big data and analytics: Sophisticated data sharing, processing, and mining techniques can support the development of personalised medicines,

1. Evidence management model: An insight-driven E2E (end-to-end) evidence manageSource: Marsh India life science team Continued on Page 39

Astep into the future: Collaborative robots in the pharma sector Pradeep David, General Manager, South Asia, Universal Robots highlights how pharma industry is adopting robotics to improve efficiency and efficacy pharma industry too has begun adopting robotics AUTOMATION IN its broadest sense has expanded from its original industrial manufacturing base to laboratories and businesses. The application of robotics and automation has been successfully achieved in a wide range of industries dealing with well-defined processes and products like the manufacturing industry, FMCG, automotive industry, the healthcare industry, the pharmaceutical industry, to name a few. Technological advancements have revolutionised automation to the current level of complexity and flexibility; even so, the pharma industry faces a few issues. As the commercial environment is getting harsher, the healthcare payers impose newcost constraints on healthcare providers who scrutinise the value medicines offer, much more carefully. This leads to a sharp rise in the customer expectations for newer therapies, which are economically better than existing alternatives, while being medically superior. The industry output has remained at a stable level for the past decade. Using the same discovering and developing processes, there’s little reason to think its productivity will suddenly soar. Lastly, the prevailing management culture, mental models and strategies on which the industry relies are traditional, even though they’ve been eclipsed by innovative ways of doing business, leaving a huge margin for human error. Automation improves compliance and minimises deviations by connecting instruments to electronic systems, so users don’t have to manually enter data. Cloud- based software, with appropriate security protocols can be adopted to facilitate integration and automation. This reduces the paper work of

the companies, making data manageable. The other benefits of automation include efficiency, saving workers from hazardous environments or repetitive tasks, reducing training overhead, eliminating human error, increasing repeatability, reproducibility, and in clean-rooms, removing the potential for human contamination. Robots, as are being introduced into every industry, the pharma industry too has begun adopting robotics in production and distribution. A study by the Association for Packaging and

robotic arms from Denmark. Their latest technological advancement in collaborative robots or ‘Cobots’ was brought out in the international market with a peculiar intention which is in line with Industrial 4.0; which is also in sync with the automated revolution in the pharma industry. Robotic arms from Universal Robots are designed to meet the pharma industry's specifications for accuracy, precision and hygiene. Robotics in the pharma industry is performing a wide range of tasks: from packaging of medical devices and implants as well as assisting in surgeries.

A study by PMMI found that robots are expected to handle 34 per cent of primary pharma packaging operations in the US by 2018, compared with 21 per cent in 2013 Processing Technologies (PMMI) found that robots are expected to handle 34 per cent of primary pharma packaging operations in the US by 2018, compared with 21 per cent in 2013. An increase in the use of robots is seen in dispensing, sorting, kit assembly, and light machinetending as well as in more traditional applications associated with packaging. The global use of robotics in the pharma sector has invariably increased in the past couple of years. With the idea of higher production rate and the need for human interaction with machine automation, the Collaborative robots were first developed in 2008 by Universal Robots. Universal Robots are the leading manufacturers of advanced user-friendly and light industrial

To subscribe: bpd.subscription@expressindia.com

The robot arms from Universal Robots can be used for mixing, counting, dispensing and inspection to deliver consistent results for business-critical products. They can also be used for sterile handling and assembly of the small, delicate parts that are used in prosthetics, implants and medical devices. Three robotic arms from Universal Robots namely UR3, UR5 and UR10 can be incorporated into the processes so that engineers could easily adapt the software to the specific needs of the drugs and the required tasks. The easy programming, installation and collaborative nature of the industrial robot arms allow them to work side-by-side with the workforce for the production of efficient, high-quality medicines.

Automation has been an indispensable part of the Indian manufacturing industry for decades now and has seen remarkable improvements in the efficiency and productivity of the industry. According to IBEF, the domestic Indian pharma industry was estimated to be $36 billion in 2016 growing at nearly 20 per cent and is expected to reach nearly $55 billion in 2020. It is evident that a lot of internal factors are responsible for the growing Indian pharma industry. There are more than 200 companies’ medicines for the largest population in the world which adds to the prevailing competition on the domestic front. The Indian pharma industry is a success story in developing countries because within a span of three decades, India has become one of the world’s largest manufacturers of medicines. The past decade has seen a change in the mindset of most pharma companies and a digital wave has swept the $36 billion Indian pharma industry. The industry is now keen in adopting technology in every aspect of their operations. Thus, the incorporation of collaborative robots will be a timely introduction to revolutionise the Indian pharma industry which will bring optimisation of processes, reduce waste, improve yield in production, with higher efficiency and precision. The functions that have already embraced automation will continue to prevail with incremental improvements from the normal cycle of technological innovation. Areas that are likely to witness quantum leaps will be in the integration between development work and manufacturing, efficiency and optimum utilisation of robotics in the industry.

Life science... Continued from Page 38 ment model is becoming a necessary operating strategy in the life science sector. The advantages include better data transparency; the design of less expensive, targeted clinical trials; and the acceleration of product approvals. 2. Lifetime patient data management: Lifetime patient datasets can be used to develop an integrated understanding of patients and help de-risk the process of discovery through a better focus on unmet needs; improve selection of biomarkers/sub-populations; and support earlier/ faster identification of trial patients. 3. Collaborative product development: Life science industry is joining other industries in which companies have turned to open innovation (OI) and other collaborative models as a way to fill in-house capability gaps and overcome R&D and marketplace challenges by externally sourcing innovative ideas, knowledge, skills, and technologies. It has become an effective way for biopharma and medtech companies to offset mounting R&D costs, funding shortfalls, increasing disease complexity, and rapid-fire technology advances.

Reference: 1. Cybercrime in the pharmaceutical industry: a booming business, Pharmaceutical technology”, http://www.pharmaceutical-technology.com/features (assessed on August 1, 2016), and https://www.mcafee. com/in/resources/reports/ rp-economic-impact-cybercrime2.pdf “Net Losses: Estimating the global cost of cybercrime”, Mcafee, http:// www.mcafee.com/inhttps://ww w.mcafee.com/in/resources/ reports/rp-economic-impactcybercrime2.pdf (assessed on August 1, 2016). 2. Economic times 3. 2017 Deloitte Life Sciences outlook; https://www2.deloitte.com/us/e n/pages/life-sciences-andhealth-care/articles/life-sciences-outlook.html.

EXPRESS PHARMA

September 1-15, 2017

PHARMA ALLY VENDOR NEWS

Sanner invests in Bensheim production facility 14 new injection-molding machines will significantly increase efficiency and energy savings SANNER, manufacturer of high-quality primary plastic packaging and medical devices, has successfully completed the expansion of its production facility in Bensheim. 14 new, state-of-the-art injection-molding machines were installed to improve production processes. With an investment of close to three million euros, Sanner has paved the way for future-oriented manufacturing at its headquarters. One year after its start, Sanner has successfully completed the 'future project production area South.' During the project, the entire machine park in

this area was replaced with 14 injection-molding machines of the latest generation. The Sanner team completed the project

on schedule and within the designated budget. “Our goal was to further automatise production and consequently increase

capacities and efficiency,” says Dirk Mähr, MD, Sanner. “A goal we have definitely achieved”, he futher says. With this expansion, the company is taking another important step towards futureoriented production at its headquarters in Bensheim. The new injection molding machines ensures faster processes and can be further automatised at any time. The packaging specialist is thus optimally equipped for the challenges of industry 4.0, as well as for further optimisation projects. Over the next few years, Sanner will also consequently expand its portfolio in

the areas of capsules and desiccant packaging. “During the modification, we were also able to significantly reduce energy consumption in production in line with the Sanner sustainability concept,” Mähr adds. This includes, amongst others, a renewed media supply for cooling water and compressed air, a better raw material supply and the installation of new cranes. Thanks to new lighting and a reduced noise level, Sanner employees also benefit from easier workflows and better working conditions. EP News Bureau

Lonza acquires Micro-Macinazione To create the global leader in micronisation capacity and capabilities LONZA HAS acquired Micro-Macinazione, one of Europe’s leading contract manufacturers providing micronisation of active ingredients for the pharmaceutical and fine chemical industries. Micro-Macinazione, which had sales of ~ CHF 20 million in 2016, has 120 employees and is based in Monteggio, Switzerland. Micro-Macinazione was purchased from Cross and the acquisition was completed recently. Financial details of the deal were not disclosed. The acquisition of MicroMacinazione creates the global leader in the field of micronisation services by building on Lonza/Capsugel’s existing micronisation clinical and commercial manufacturing capabilities that are based in Quakertown, PA (USA). Lonza/Capsugel strengthened its micronisation offering to

40 EXPRESS PHARMA September 1-15, 2017

customers in January 2016, when it acquired Powdersize and has since invested in significant additional capacity at this site which came on stream in early 2017. Marc Funk, Pharma & Biotech COO, Lonza, commented, “With the acquisition of Micro-Macinazione, Lonza becomes the largest and most diversified provider of micronisation services to the pharma industry. Micronisation is an attractive technology for Lonza given its applications across many high growth areas of the pharma market. Micro-Macinazione provides micronisation technology and expertise that complements our existing US capabilities and provides significant additional capacity to support our growth. Its micronisation technology can also add value to other areas of Lonza’ business, including

A key focus for the new combined business will be highly potent APIs (HPAPIs) health and nutrition ingredients and excipients, enhancing the appeal of this bolt-on acquisition, which strengthens our position across the healthcare continuum.” Lonza’s pharma andbiotech customers are increasingly looking for external partners to help them assess early-stage compounds

and to improve product design by using micronisation and sub-micronisation to address key challenges of active pharmaceutical ingredients (API) development. A key focus for the new combined business will be highly potent APIs (HPAPIs) where MicroMacinaziones’s pilot to commercially scale HPAPI offerings and Lonza’s recent HPAPI capacity expansion at Quakertown, provide the capacity and expertise needed to serve this growing area of the pharmaceutical market. Micronisation via jet milling is an established technique for enhancing the overall bioavailability of drug products by reducing or controlling the particle size of the API. By improving bioavailability, lower drug doses can be prescribed, potentially reducing a patient’s side effects. Markus Arigoni, CEO, Mi-

cro-Macinazione, commented, “Micro-Macinazione was founded in 1970 and has been a pioneer in the development of jet mill equipment and contract micronisation services. We operate in a niche market with high growth expectations. Micronisation is often seen as key to improving the bioavailability of the growing number of highly potent and complex APIs, which an increasing number of pharma and biotech companies are looking to develop. By combining with Lonza, we are creating a global leader with the ability to provide customers both in the US and Europe with access to the micronisation technologies and manufacturing capabilities that they need to bring novel drugs to market faster and more efficiently.” EP News Bureau

Gerresheimer to attend Pharmed & Healthcare in Vietnam To showcase high-quality packaging made from tubular glass for medicines GERRESHEIMER WILL present its primary packaging made from tubular glass to Pharmed & Healthcare visitors for the first time from September 20 to 23 in Ho Chi Minh City. The specialist in primary packaging will showcase its vials, ampoules, and dental cartridges at booth H4 at the Saigon Exhibition and Convention Center.

amber glass that can hold between 1 and 50 ml. The range of tubular glass vials on offer in Asia includes clear and amber glass types I and II. All manner of different shapes are available, either with or without blowback and compliant with either international standards or the customer’s own specifications. Gerresheimer offers a wide

Gerresheimer’s trade fair booth will focus on injection vials, also known as Gx vials. They are amongst the world’s most popular pharma packaging solutions “Vietnam is a key market for Gerresheimer,” says David Tsoe, Sales Director at Gerresheimer Shuangfeng in China. “We will be making our debut at Pharmed & Healthcare. Existing and potential customers will have the chance to discover all there is to know about Gerresheimer’s highquality primary packaging made from tubular glass from the glass experts at booth H4”, Tsoe adds. Gerresheimer’s trade fair booth will focus on injection vials, also known as Gx vials. They are amongst the world’s most popular pharma packaging solutions and Gerresheimer produces versions in clear and

range of pharma ampoules made from pharma glass type I. The standard rangeincludes ampoules made from clear and amber glass that can hold between 1 and 30 ml. Among these products are straightstem, funnel-type, and closed ampoules that comply with the relevant ISO standards (types B, C, and D) with various break systems such as OPC (one point cut), CBR (colour break ring), and score ring. Customer-specific requirements can also be applied in conjunction with the current ISO standards. Gerresheimer produces premium-quality cartridges that hold between 1.5 and 3.0 ml

To subscribe: bpd.subscription@expressindia.com

and are geared toward the specific requirements of various different drugs. Our range of products boasts both clear and amber borosilicate glass cartridges in hydrolytic class I. Additional individual options are also available, for example hardening with aluminum sulfate, which further enhances the quality of the glass and thus the compatibility of the cartridges. At its two Chinese sites, Danyang I and II and Zhenjiang, and in the In-dian city of Kosamba, Gerresheimer produces ampoules, injection vials, cartridges, laboratory vials (threaded vials), siliconised vials, and specialty products made from tubular glass. Having a uniform global standard for its state-of-the-art machinery and employees who are trained in the production process ensures that all the workflows in all the plants meet the same standards. Gerresheimer’s zero-defect strategy draws on the ‘product by process’ principle and aims to achieve a consistently high level of product quality around the world. All of its glass production sites consistently apply the principles of Good Manufacturing Practice (CGMP) and are certified in accordance with DIN EN ISO 9001 and 15378. Gerresheimer products comply with the regulations of the applicable pharmacopeias (Pharm. Eur., USP, and JP) and meet all requirements. EP News Bureau

LANXESS doubles membrane production capacity New Lewabrane ULP line launched for removing micropollutants in water treatment SPECIALTY CHEMICALS company LANXESS – as announced previously in mid-2017 – has doubled its membrane capacities. “We have expanded the capacity of our plant in Bitterfeld so that we can continue meeting the rising demand for reverse osmosis membrane elements. This step makes us even more attractive as a supplier to major customers,” says JeanMarc Vesselle, head of the Liquid Purification Technologies business unit at LANXESS. The market for reverse osmosis membrane elements is currently projected to continue growing at an above-average annual rate of 10 per cent (CAGR 2015-2020) in the years ahead. Because the plant was already operating almost at the limit of its capacity, LANXESS decided to double it. Production of membrane elements for the Lewabrane line is a multi-stage process. It begins with the fabrication of a thinfilm composite membrane comprising several individual layers. A polysulfone base layer and an active filter layer are applied on a nonwoven base substrate. The filter layer is made of polyamide and applied in a complex coating process. Produced as flat components, the reverse osmosis membranes are then wound by fully automated autowinders into spiral-shaped elements. This design helps to conduct untreated water towards the membrane surface and to collect the permeate (filtrate). In addition to the membrane elements plant, LANXESS also operates the world’s largest plant for monodisperse ion exchange resins in Bitterfeld. LANXESS has been continuously expanding its line of membrane elements since pro-

The reverse osmosis membrane elements market is growing at 10 per cent duction began in September 2011 and the products were introduced to the market in early 2012. Today, numerous types of Lewabrane elements are available in different sizes, which can be optimised for high fouling resistance, high energy efficiency or high performance. The new Lewabrane RO ULP line is the latest addition. These 'Ultra Low Pressure' elements display higher water permeability than the standard elements, while offering the same high level of rejection of critical substances. The operating pressure required in the pressure vessel is 40 per cent lower, which reduces operating costs. Furthermore, the new membranes are a good option for removing micropollutants from wastewater and drinking water. As an exhibitor at Aquatech 2017, from October 31 to November 3 in Amsterdam, The Netherlands, LANXESS will be showcasing its Lewatit-brand ion exchangers, its Lewabrane line of reverse osmosis membrane elements and its Bayoxide iron oxide adsorbers for water treatment. Exhibits will include the new Lewabrane RO ULP line of membrane elements. EP News Bureau

EXPRESS PHARMA

September 1-15, 2017

PHARMA ALLY PRODUCTS

AB Sea Container launches refurbished shipping containers IN LINE with the Make in India and Swatch Bharat campaigns, AB Sea Container has introduced refurbished shipping/transportation containers as affordable and convenient solutions for hospitals/first aid centres, home, office, accommodations, toilets, portable cabins, etc., which are usable immediately after installation. One of their customers, Leighton Welspun Contractors, an Australian-based company, had a project in India with DLF. As per their safety protocol, they required hospitals at three to four of their construction sites, available 24x7. The requirement was to establish a

shelter for quick response teams, with all emergency and first aid equipment for immediate initial procedures. AB Sea Container provided them with insulated containers with all the basic humane necessities, like

beds, toilets, segregated cabins, curtains, proper ventilation, electrical points, fans, television sets and such other accessories which were required by the concerned team. Beyond the project duration of three years,

which is now completed, AB Sea Containers has secured repeat orders from the same customers. The company feels that containerised medical/first aid clinics could be a used for mo-

bile health camps, which currently exists as mobile ambulances and also require the transporation and set up of medical staff, temporary shelter and equipment from location to location. With a containerised hospital, the shelter with all required medical accessories needs to be transported to the desired location. Once the container is offloaded, and plugged into electricity, the medical team is ready for execution. Contact details Ashish Budhiraja CEO, Ashish@abseacontainer.com

ACE Technologies' FEDEGARI launches autoclaves and sterilisers ACE TECHNOLOGIES has launched autoclaves and sterilisers from FEDEGARI, the trend setters in the manufacture of sterilisers and plants for processes using dense-phase fluids. Each one of FEDEGARI's products is the result of research, design and manufacturing work done since the last 50 years. With a Fedegari sterilizer, a user, having the required knowhow, is aware of obtaining a performance unattainable with other machines. This is why our best clients are also the most demanding. The overall performance of a machine or of a system is not the logical consequence of a set of components itemised according to relevant standard features, but rather the result of the people whose minds and hands are designed and built them. The skilful alchemy created by many human talents, co-ordinated and

42 EXPRESS PHARMA September 1-15, 2017

guided towards an apparently simple goal: ‘Manufacturing the best sterilisers in the world’. Each Fedegari product is the result of extensive research, design and manufacturing that is, done with professionalism and dedication of the last 50 years. Being considered one of today’s leading steriliser manufacturers worldwide stems from the distinguishing features imposed by the founders from the company’s very start, in the early 1950s. Over half a century later, we

have retained the “craftsman’s spirit” of our early days, the care for detail in giving shape to matter, without neglecting the rigour of those days, combining these factors with the requirements of industrial production. Fedegari was the first to introduce an absolutely innovative strategy in the field of sterilisation: to exclusively design machines according to specific user operating requirements. The sterilisers are highly customised industrial products,

designed to satisfy the needs of the customers. They are based on specifically engineered functional modules minimising risks connected to production of ever-differing machines, while guaranteeing top performances. Precisely thanks to constant collaboration with our customers, we have been able to develop and increase our company’s know-how, something without which we would never have achieved today’s results.

Contact details ACE Technologies 223,Blue Rose Industrial Premises CHSL, Western Express Highway, Opp Magathane Bus Depot, Borivali (E),Mumbai Phone: +91-22- 42089270 Mob: +91 9819858299Fax:+9122- 28700281 / 26855738 /28116196 E-Mail: marcom@acetechnologiesgroup.com Website: www.acetechnologiesgroup.com

PHARMA ALLY

High speed doors by Gandhi Automations ideal for medium and large entrances HIGH SPEED doors designed and manufactured by Gandhi Automations are sturdy, dependable and are the ideal solu-

reliable doors are needed in industrial and commercial contexts. High speed doors are versatile and solid ensuring

width window panels ensure a safer traffic and allow more light in. Their fast and easy replacement, in case of accidental tear-

fectively operate in any situation, even when strong winds are blowing and in rooms with high volume traffic. Sturdy and

loads and curtain stability. Contact details Gandhi Automations Chawda Commercial Centre

tion for medium and large entrances. The doors are manufactured with European collaboration and technology with innovative and creative engineering. Fast moving functional and

long-lasting reliability. The modular structure of the curtains, assembled and joined by anodised aluminium extrusions, provides for a wide range of polyester sections available in a variety of colours. Wide, full-

ing, saves money and time. The alternating metal tubular structure there inserted ensures high wind-resistance. Prime high speed doors are the ideal solution for internal and external entrances and ef-

dependable, prime is the intelligent door for medium and large entrances. High speed doors for external entrance are equipped with spring steel wind lock in curtain pocket that ensures silent door travel, higher wind

Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph. Preferably in colour, postcard size and with a good contrast.

To subscribe: bpd.subscription@expressindia.com

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021. Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

PHARMA ALLY VALUE AD

Biopharmax: Turn your vision into reality Atul Pabalkar, Sr GM Engineering and Projects of Biopharmax, recalls the journey of Biopharmax and talks about its increasing global presence Mission: Design, build and validate, tailor made biopharmaceutical manufacturing facilities. The company was established in 1978, with a unique design build, turnkey approach and timely delivery of custom manufacturing solutions. Since 1998, Biopharmax deepened its capabilities in biotechnology manufacturing technologies. Biopharmax, a global design and construction provider of manufacturing facilities and systems for biotechnology, and pharmaceutical manufacturers, has experience to cater industry leaders around the world. The company's turnkey execution assures its clients a high-end production facility completed on time. In order to enhance this expertise, Biopharmax India arm was established in 2006, which now forms the core design part of Biopharmax group. Biopharmax’s in-house team of engineers has years of experience in each discipline involved in the design, construction and validation of the facility. The team has been able to identify the regulatory challenges from a very early stage, and accordingly offers an optimal solution based on its diverse industry experience. Biopharmax is dedicated to design and execution of biotechnological, API and pharma manufacturing facilities. Biopharmaceutical unique manufacturing processes require specialised tailor-made solutions with dedicated knowhow and industry experience. In order to support manufacturing process integrity, repeatability and compliance with global and local cGMP requirements, Biopharmax developed state-of-the-art design methods and tools for lean and efficient manufacturing facilities. The company is committed

44 EXPRESS PHARMA September 1-15, 2017

clients with all scales of manufacturing, including commercial scale, pilot and R&D, designed and built on greenfield sites or within an existing envelope. Client’s facilities are upgraded to increase capacities, improve cGMP level, and automate production or other plant modifications as required.

Biotechnology

to maintain strictest standards and to comply with latest cGMP requirement per global and local authorities (FDA, EMEA, SFDA, Indian cGMP, local MoH etc.).

One stop shop solutions It is uncommon in the Biopharmaceutical industry to find a partner that commits to: ◗ Design to supply, commissioning and qualification ◗ Conceptual, basic and detail engineering ◗ Process skids and system expertise- CIP/SIP, fermentation, PW/WFI ◗ cGMP gap analysis and gap closure ◗ Project management consultancy (PMC) services ◗ Project execution ◗ Validation ◗ Technology sourcing

Products and services Design to validation Design to validation with four decades of industry experience and hundreds of successes, Biopharmax has positioned itself as one of the world leaders in design and validation of biopharma facilities. By utilising its in-house capabilities, Biopharmax provides the complete design and validation range to comply with manufacturing facility requirements.

The company's global staff includes seasoned designers with unique experience in the biopharma industry. New recruits are chosen from the best technical schools and trained by Biopharmax training department, based on programmes developed relying on experience derived from hundreds of projects successes. While performing the design tasks, the latest design tools are utilised and highest engineering standards are maintained. Biopharmax is committed to comply with cGMP as required by the various regulatory authorities, both local and FDA / EMEA.

Plants and systems Biopharmax core competency is to design, build and validate cutting-edge, cost- effective biopharmaceutical manufacturing facilities. The company's experience and solution range includes manufacturing facilities for biotechnology, API and formulation. In the last four decades, the company has created and improved manufacturing technologies and tailor-made solutions to cover manufacturing facilities entire requirements and to comply with the industry standards evolution. The company caters to its

Biotechnology is a highly specialised segment within the biopharma space. In recent years, biotechnology has evolved which has lead the industry manufacture medicines as biosimilar to become more accessible for patients globally. The challenge of modifying the manufacturing processes, optimising and scaling them up, and finally implementing into commercial scale manufacturing – requires years of experience and in-depth specialised know how. Biopharmax accumulated unmatched experience and high level of expertise since many years. It has pioneered in cost effective manufacturing facilities design and implementation. Biopharmax experience includes biotechnology facilities, which manufactures therapeutics products, with all common manufacturing technologies – fermentation, mammalian, bacterial, blood fractionation, plant cells and others. By utilising Biopharmax generic experience, the company has been able to design, even in the most complex biotechnology projects, compact design with linear process flow to enable operational excellence and competitive advantage. Products include mammalian and bacterial proteins, monoclonal antibodies, blood derivatives, transgenic and other administered as parenteral, enteral or topical.

Biopuremax: The next generation of pharma pretreatment water system Biopuremax is the ultimate pure water system solution. It is an environmental friendly, clean, simple, reliable and effective way of supplying chemical free hardness reduced water for use as RO feed water without the need of any additional treatment. The Electrolytic Scale Reduction (ESR) process is an elegant solution that replaces both ion exchange softeners and antiscalant chemicals. An electric field generates a high pH near the cathode which deposits scale in the reaction chamber and releases CO2. The system has no moving parts, no regeneration requirement and no media that may incubate biogrowth. Furthermore, municipal feed water is commonly treated with a sanitisation agent that damages delicate RO membranes or CEDI resin. This oxidizer is removed by the high-powered ultraviolet lamp – the BioPuremax HOD unit. The HOD unit is an electromagnetic radiation device that uses no additional substance. As with the EHR unit, the HOD unit has no moving parts, no regeneration requirement and its SS 316L smooth clean pipe construction has no media that may trap incoming contamination and incubate biogrowth. Continuous, complete hot water sanitisation capability gives Biopuremax system a unique advantage: the removal of all biofilm and viable organisms through an 80°-90°C hot water cycle. As part of its all-in-one standard comprehensive service, Biopuremax surveys the customer’s requirements, performs dimensioning and fabrication, provides FAT, on-site installation, SAT and IQ-OQ validation and documentation.

PHARMA ALLY CASE STUDY

QSpace powers Archimedisâ&#x20AC;&#x2122;global expansion strategy Archimedis is an aspiring pharmaceutical manufacturing firm with a promising product pipeline. To succeed with its global strategy, Archimedis developed a cost-effective and user-friendly software solution (QSpace) to manage all the GxP validation requirements across facilities, utility systems, manufacturing equipment, lab instruments and computerised systems. Realising the value QSpace can deliver to life sciences organisations, Archimedis has recently commercialised QSpace software. An insight by Duraisamy Rajan Palani, MD, Archimedis Healthcare

ARCHIMEDIS IS an aspiring pharmaceutical manufacturing firm. Having succeeded with domestic business in India and backed by promising product pipeline, Archimedis laid out a business strategy to enter the UK market. As a pre-requisite to entering the UK market, Archimedis was required to obtain MHRA accreditation (MHRA stands for Medicines and Healthcare products Regulatory Agency which is UKâ&#x20AC;&#x2122;s regulatory authority for healthcare products).

Strategy To realise its global vision, Archimedis had to make a major overhaul across people, process and technology. With its young and aspiring leadership, Archimedis was able to attract talents who had worked in highly regulated pharma markets. Once the MHRA ace team was formed, people followed people. A stellar quality leadership is key in transforming an organisation to a higher level of quality and regulatory maturity. Archimedis was fortunate to

have one. Archimedis quality leadership worked tirelessly in establishing a quality management system and ensured that people adhered to the same at all times. In parallel, factory modernisation effort was triggered, which included installation of new water purification system, renewal of air handling unit (AHU), procurement of manufacturing equipment and lab instruments. To ensure that the systems operated consistently, Archimedis also introduced digital practices for key business processes.

Challenges As the regulatory requirements would insist every system had to be validated in accordance with applicable regulatory requirements before they were made

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

September 1-15, 2017

PHARMA ALLY operational. For instance, if a new lab instrument was installed, it had to be validated with objective evidence that the system would operate as intended and designed for (a process widely known as GxP validation). As a rule of thumb, any system that would impact patient safety, product quality or data integrity would be termed a GxP system and they would be subjected to GxP validation process. So, on one hand, Archimedis was upgrading the facility with utility systems, manufacturing equipment, lab instruments, software and other computerised systems. On the other hand, GxP validation had to be planned for each new system and any existing system that historically lacked objective evidence. If manual (paper-based) validation approach was adopted, Archimedis would not be able to scale rapidly. Also, such an approach would expose more compliance risks (such as data integrity concerns) than they addressed. It became clear that a software system would be mandatory to control and manage the diverse GxP validation needs.

Inspired by ‘Quality by Design’ principle, QSpace was built with three functional components – Process Governance Center, Project Space and Executive Insight Center But, Archimedis realised the available GxP validation software were either insufficient or required additional effort to make them regulatory compliant.

Solution and implementation Archimedis designed and built a software system called ‘QSpace’ to address this challenge. Inspired by ‘Quality by Design’ principle, QSpace was built with three functional components – Process Governance Center, Project Space and Executive Insight Center. Validation process packages can be designed in the process governance centre. Each system would get a project space created from a process template. Within a project space, systems would manage their user requirements specification, functional specification,

validation protocols, test cases, execution results, evidences and defects. Systems would also can create releases to allow for incremental evolution of systems. Executive insight centre gives ‘bird’s eye view’ visibility into systems quality and compliance health at the organisational level. Due to its inclusive design, traceability is automatically built and maintained between entities. Regulatory reports can be generated in single click. With electronic signature and CFR Part 11 compliance, QSpace allows users to collaborate remotely through a configurable review and approval workflow. In QSpace, an Intelligent Compliance Engine (ICE) actively manages compliance needs, while the end-users can apply all their focus on system quality.

Outcomes: Accomplishments, changes, lessons learned QSpace is very user-friendly and hence users could get on board quickly and operate with high efficiency with a very short learning curve. Powered by advanced data visualisation techniques, minimalistic dashboard views reflect system quality and compliance at first glance. Key value delivered by QSpace are: ◗ End-to-end GxP validation process automation (process design and adoption) ◗ In-process compliance to regulatory requirements ◗ Assured audit-readiness all the time ◗ Minimal dashboard that reflects system quality at the first glance ◗ High productivity and pleasant user experience

At Archimedis, QSpace became the central repository of all GxP validation assets.

Way forward: Future steps Life sciences organisations thrive on scientific discovery and product quality. In taking a scientific innovation from lab to scale, computerised systems play a vital role. They infuse and catalyse process efficiency and advance products to the market. But, for the computerised systems to be deployed and to remain in operation, they should consistently meet the regulatory requirements, a practice collectively known as Computerized Systems Validation (CSV). CSV is a cumbersome yet mandatory process in the life sciences industry. And it should be done for hundreds of regulated (GxP) systems that automate critical business processes like drug discovery, device design, formulation, laboratory, clinical, manufacturing, supply chain and post marketing surveillance. It is imperative to maintain quality and compliance at the speed of business. This is exactly why Archimedis has commercialised QSpace for other aspiring life sciences organisations around the world.

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India. Board line: 0120-6651500. Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com

CHENNAI Mathen Mathew The Indian Express (P) Ltd. Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 9840826366 Fax: 044- 28543035 Email id: mathen.mathew@expressindia.com

BANGALORE Mathen Mathew The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Mobile: +91 9840826366 Fax: 080- 22231925 Email id: mathen.mathew@expressindia.com

HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936, Fax: 040 23418675 Email Id: e.mujahid@expressindia.com

KOLKATA Ajanta Sengupta The Indian Express (P) Ltd. Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati, Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com

AHMEDABAD Nirav Mistry The Indian Express (P) Ltd. 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015, Mobile: +91 9586424033 Email Id: nirav.mistry@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

46 EXPRESS PHARMA September 1-15, 2017

BUSINESS AVENUES

EXPRESS PHARMA

September 1-15, 2017

BUSINESS AVENUES

EXPRESS PHARMA

Stainless Steel Cleanroom Tools

OSMOMETER 3250

Replacing carbon steel tools with Steritoolsâ&#x201E;¢ eliminates risk and should be considered a standard operation procedure for any modern facility.

4Bench Press 4Cabinet Key 4Chain Wrench 4Chisels 4Clamps 4Hand Files 4Feeler Gauge Sets & Gauge Stick

4Hemostat Forceps & Tweezers 4Ball Pein Hammer & Hamallet 4Hex Keys (Allen Keys) 4Ice Pick, O-ring Tool, Pointer 4Knives 4Nut Drivers 4Pliers Many More....

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

September 1-15, 2017

June Enterprises Pvt. Ltd | +91 9323021231 info@june4gmp.com | www.june4gmp.com

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

September 1-15, 2017

BUSINESS AVENUES

September 1-15, 2017

EXPRESS PHARMA

BUSINESS AVENUES

Wiper Type Sight Glass

EXPRESS PHARMA LABORATORY EQUIPMENTS

DIN 100 Light Glass LED

Swastik Associates Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com Lab Stirrers

Our other product details u

SS Fittings

SS Valves Manual & Pneumatic

SS Filters

SS Pumps: Centrifugal, Self Priming & Shear Pump

SS Powder Blender

SS Steam & Water Mixing Station

Drain Trap

Manhole Round Dia 450

Sight Glass Flange with LED

LED Bush

Hot Plate Magnetic Stirrers

Walk-in chamber

Refrigerated Centrifuge 4W / 15W / 20W / 24W

Manhole Pressure Type

Deep freezer

Laboratory Centrifuge

Manhole Elliptical

Single Door Refrigerator

Cyclomixer

Mini Rotary Shakers

Incubator Shaker

REMI SALES & ENGINEERING LTD. Remi House, 3rd Floor, 11 Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai - 400 063. India Tel: +91 22 4058 9888 / 2685 1998 Fax: +91 22 4058 9890 E-mail: sales@remilabworld.com l Website: ww.remilabword.com

EXPRESS PHARMA

September 1-15, 2017

BUSINESS AVENUES

September 1-15, 2017

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

To Advertise in

Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Mathen Mathew 09840826366 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

www.kesarcontrol.com

Humidity Chamber

Cold Chamber

Service Network all over INDIA Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727

Mobile : 09427613646 Email : service@kesarcontrol.com

EXPRESS PHARMA

September 1-15, 2017

BUSINESS AVENUES

September 1-15, 2017

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

Experiment With The Truth Certified ISO 9001: 2008

A BENCHMARK FOR

QUALITY SOLUTIONS

STABILITY CHAMBER

WALK-IN STABILITY CHAMBER

AUTOCLAVE-WINGNUT

PRODUCT RANGE l l l l l l

Autoclave BOD Incubator Bacteriological Incubator Cooling Incubator Deep Freezer Hot Air Oven

l l l l l l

Muffle Furnace Photo Stability Chamber Pharma Refrigerator Stability Chamber Vacuum Oven Walk-in Stability Chamber

Osworld Scientific Equipments Pvt. Ltd.

B.O.D INCUBATOR

B-44, New Empire Industrial Premises, Kondivita, J. B. Nagar, Andheri (East), Mumbai - 400 059. India Tel.: +91-22-28320880 / 28390487 E-mail: info@osworldindia.com

EXPRESS PHARMA

www. a. ldindi oswor com

September 1-15, 2017

PHARMA LIFE APPOINTMENTS

Kiran Mazumdar-Shaw joins Keck Graduate Institute's Board of Trustees KGI’s Board of Trustees consists of 26 leaders who are pioneers across bioscience, healthcare, and education industries

iran Mazumdar-Shaw, Chairperson and MD of Biocon and Chief Mentor of Biocon Academy, has been appointed to the ‘Board of Trustees’ of Keck Graduate Institute (KGI), Claremont, California, a leader in applied life sciences and pharmacy education. KGI’s Board of Trustees consists of 26 leaders who are

pioneers across bioscience, healthcare, and education industries. Reportedly, Biocon Academy, a CSR initiative of Biocon in collaboration with KGI has been instrumental in shaping the careers of more than 300 aspiring bio – scientists by imparting the requisite experiential learning that serves to

bridge the existing industry – academia gap through its 18 weeks flagship programme Biocon KGI Certificate Programme in Biosciences. Commenting on her new role, Kiran Mazumdar-Shaw, said, “As a member of the Board of Trustees at KGI, I am excited to play a meaningful role in shaping future leaders

Dr Angelo Secci joins Vyome Biosciences as CMO He will be responsible for leading Vyome’s clinical development, including the clinical programme of lead molecule, VB 1953, for the treatment of moderate to severe acne VYOME BIOSCIENCES has appointed Dr Angelo Secci, MD as chief medical officer (CMO), bringing with him more than 20 years of senior executive level experience in the pharma and medical device industries. Dr Secci will be responsible for leading Vyome’s clinical development, including the clinical programme of lead molecule, VB 1953, for the treatment of moderate to severe acne. “Dr Secci brings tremendous experience and a proven track record of clinical development through all drug development stages from INDenabling studies through regulatory approval and has deep knowledge of the dermatology space. He has developed and launched multiple best-in-class products, expe-

56 EXPRESS PHARMA September 1-15, 2017

rience that will prove invaluable as we further develop our dermatology pipeline,” said Venkateswarlu Nelabhotla (N Venkat), Co-Founder and CEO, Vyome Biosciences. Most recently, Dr Secci served as the Senior Medical Director at GlaxoSmithKline where he led clinical development programmes in dermatology. Dr Secci also served as Senior Director of Global Clinical Development at Otsuka Pharmac Development and Commercialisation, where he was responsible for overseeing product development across multiple therapeutic areas. Previously he served as the Vice President of Clinical Development and Operations at Eurand Pharma. “I’m excited to join Vyome

and lead the development of VB 1953, which possesses the characteristics to be a potential best-in-class drug for the treatment of moderate to severe acne,” said Dr Secci. He added, “I was also drawn to Vyome’s research pipeline and its proprietary DART platform, which has great potential to develop therapeutic options for patients facing skin diseases caused by opportunistic pathogens of the skin.” Dr Secci received his medical degree from the Sapienza University of Rome and was on staff at the vascular surgery department of IDI-IRCCS. In addition, Dr Secci also served as a visiting professor of vascular surgery at UCLA Medical Centre. He is board certified in Italy for medicine and surgery.

in the Biotech sector. Our partnership for Biocon Academy has successfully developed high-end, industry-ready talent in India by equipping bio-scientists with skills that enhance their employability both for domestic and international markets.” EP News Bureau

Manju Deshbandhu Gupta is Lupin's new Chairman This non-executive role will be for a period of two years THE BOARD of Directors, Lupin announced the unanimous appointment of Manju Deshbandhu Gupta as Chairman. Gupta has been a member of the board for over 40 years. The board felt that this is a deserving recognition for one of the co-founders and first investor of the company and is an important step in ensuring continuity. This non-executive role will be for a period of two years. Commenting on the appointment, Gupta said, “I am honoured with the confidence that the board has placed in me and I look forward to working with the board to take Lupin to greater heights. I am also very pleased that Dr Kamal Sharma will continue to guide the management team for another year. I look upon my role as helping to take Dr Deshbandhu Gupta’s legacy forward and transitioning over the next two years to Vinita and Nilesh.” EP News Bureau

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18, PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001