Biosimilar World India 2015

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Conference Proceedings

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

CONTENTS The IMAPAC Difference

Section 1

Welcome About IMAPAC, Imagine Your Impact Speed Networking Media Partners Outside of Conference Hours

Conference Programme Day 1

Section 2

Conference Programme Day 2

Section 3

Conference Evaluation

Green Form

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

IMAPAC welcomes you to BIOSIMILAR WORLD INDIA 2015 WANG Ting Ting General Manager Tel: +65 6493 1880 Email: tingting.wang@imapac.com

Romilly SINCLAIR Creative Director Tel: +65 6493 2095 Email: romilly.sinclair@imapac.com

Natasha JIANDANI Project Director Tel: +65 6493 1881 Email: natasha.jiandani@imapac.com

Mathew ORIEL Creative Director Tel: +65 6493 1601 Email: mathew.oriel@imapac.com

Talha FAZAL Business Development Consultant Tel: +65 6493 1870 Email: tahal.fazal@imapac.com

Cecilia WONG Senior Marketing & Operations Manager Tel: +65 6493 2093 Email: cecilia.wong@imapac.com

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

About IMAPAC - Creating Conferences with A Cause IMAPAC is a social enterprise that is on an unrelenting mission to strive and make a difference to businesses of today. We believe businesses are not only meant to do well, but also to do good. We want you to find business opportunities at our conferences as well something good to aim for.

IMAPAC’s conferences are when you join other organizations such as governments, NGOs, businesses, academics and other stakeholders who standing up collectively to make a difference, to attest to the fact that businesses can and do make a positive impact to the world we are living in.

Just Imagine your Impact When you speak at an IMAPAC conference, not only does the industry hear you, the world does too – via IMAPAC TV broadcast FREE to everyone around the globe.

When participate at an IMAPAC conference, not only does your knowledge and contact book get extended, a child from a developing country gets to go to school for year.

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Speed Networking @ IMAPAC - Creating Conferences with A Cause We have an exciting networking activity planned for you during the conference.

Here’s how the IMAPAC speed networking session works: 1.

When you enter the networking area, make your way to any one of the bistro tables. Each table should be made up of a maximum of 8 - 10 people.

2.

You should have already picked up an envelope earlier during registration. Your envelope contains either a Blue or Green card. * Please request at the registration should you not receive it.

3.

At the sound of the bell, your networking time with others at your current table begins. You will have about 4-5 minutes.

4.

Then, at the sound of the second bell, and all subsequent bells, you should move to the next table* and begin your networking with the new group of people. * All delegates with blue cards move clockwise, and all delegates with green cards move anticlockwise. Directions will also be indicated on the tables.

5. The networking session will finish when you are back with your original group.

TIP: Use your envelope to collect business cards of your new acquaintances!

Wednesday

4 March

1.45 PM

 Masami Todokoro, Bioprocess Equipment Manager, JNC Corporation  Shigeyuki Aoyama, Cellufine Sales Manager, JNC Corporation

Chromatography Media: New Chromatography Systems for Downstream Processing

Thursday

5 March

1.30 PM

LUNCHTIME TECHNICAL WORKSHOP SCHEDULE

Culture and Immunology, Himedia Laboratories Pvt. Ltd., India

 Vishal G. Warke, Director R&D, Cell

High quality with low cost: Strategies for staying ahead in the Indian Biosimilars market

Lunchtime Technical Workshop Venue

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Media Partners

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Outside Conference Pune Hours

is the second city of the state of Maharashtra after Mumbai and the eighth largest city in India. It has an ancient tradition of grandeur and of warm hospitality and a majestic history of over 1200 years to tell. In the 18th century, Pune became the centre of Indian politics and then served as the "monsoon capital" of the Bombay Presidency until the independence of India. It is also the centre of traditional Marathi culture, in which education, arts and crafts, and theatre are given pride of place.

The narrow winding roads of the old Pune offer an interesting contrast to the open, spacious new city. The area is suffused with colorful sites, from ancient forts to expansive gardens, and the city is known for its high educational facilities and relative prosperity, which have allowed it to become a cosmopolitan city as well as an important commercial centre. However, Pune retains the old-world charm and its many quaint characteristics, including the omnipresent cyclists and rickshaws. Queen of the Deccan, Oxford of the East, Pune is a city with a future that promises to be as interesting as its history.

AGA KHAN PALACE Aga Khan Palace is a majestic building and is considered to be one of the greatest marvels of India. It was built in 1892 by Imam Sultan Muhammed Shah Aga Khan III as an act of charity to help the poor drastically hit by famine.

Following the launch of Quit India movement in 1942, Gandhi, his wife Kasturba and his secretary Mahadevbhai Desai were interned at the palace from August 1942 to May 1944, where Mahadevbhai and Kasturba passed away. The palace has developed into a national and international place of pilgrimage with over 100.000 visitors every year paying homage to their samadhis and ashes of Mahatma Gandhi.

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OSHO INTERNATIONAL MEDITATION RESORT The Osho International Meditation is the ashram of Osho, also known as Acharya Rajneesh, a mystic, guru, and spiritual teacher who garnered an international following.

The Osho resort is the world's largest meditation center and it is spread over 31 acres of flush green surroundings. It is a spiritual oasis made of marble pathways, elegant black buildings, and abundant foliage. Over 100 different meditation techniques are offered to visitors coming from over 60 countries to experience the spiritual journey.

RAJA DINKAR KELKAR MUSEUM The museum is housed in a Rajasthani styled building situated close to the hustle and bustle of the busy Bajirao Road of Pune. It holds the collection of Dr Dinkar G. Kelkar (1896–1990), dedicated to the memory of his only son, Raja, and includes some of the most fascinating Indian art crafts.

The exhibition consists of more than 2500 Indian decorative items from everyday life and other art objects, mostly from the 18th and 19th centuries.

SHREEMANT DAGDUSHETH HALWAI SARVAJANIK GANPATI Srimanth Dagaduseth Ganpati temple Pune is one of the most important and visited Ganesh temple in Maharashtra. It was built by Dagdusheth Halwai, a successful sweetmeat seller and a rich businessman in Pune, in 1893, to shun away his grief after the death of his son. The Ganesh idol is a sheer beauty: the 7.5 feet tall and 4 feet wide idol is adorned with nearly 8 kilos of gold and is enriched by the devotees’ offerings.

DARSHAN MUSEUM

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Darshan museum is dedicated to the noted Sindhi Saint and scholar, Sadhu T. L. Vaswani (1879-1966), an Indian educationist who started the Mira movement of education and set up the Sadhu Vaswani Mission (The organization is well known for its philanthropic work in the fields of education, healthcare, rural development, spiritual upliftment and feeding of the poor through its community kitchens). It offers an insight into Sadhu Vaswani’s life and teachings.

Darshan is not a conventional museum: the exhibition is done through 3D Holographics, Life-Like Statues, Realistic Sets, Hi-Def Audio, HD Video, Theatrical Lighting and much more. The visitor literally 'walks' into a scene which is played before his/her eyes.

PARVATI HILL The hillock of Parvati Hill rises up to 2,100 feet (640 m) above sea level. Atop the hillock is the Parvati Temples, which are one of the most scenic locations in Pune. The temple is the oldest heritage structure in Pune and was built in the Peshwa Dynasty rule (17th to 19th century). It is also used as an observation spot for visitors of the panorama of Pune since it is the second highest point in Pune premises after Vetal Hill. The hill has 103 steps, which is the way to the top of the hill where the temple is situated.

The main temple, Devdeveshwara, is made of Blackstone. It was completed under Nanasaheb Peshwa, in 1749.

Other temples are dedicated toVitthal and Rukmini, Vishnu, and Kartikeya.

Day 1 4 March 2015

CONFERENCE AGENDA Wednesday, March 04, 2015 Registration Commences

9:05 a.m.

IMAPAC's Welcome Remarks  Wang Ting Ting, General Manager, IMAPAC, Singapore

9:10 a.m.

Chairman’s Opening Remarks  Steven Lee, Global Head, Technical Operations & CEO Singapore Operations, Reddy’s Laboratories, India

9:15 a.m.

Exhibits Open

8:00 a.m.

Leadership Panel: Indian Biosimilars Success Strategy: Today and Tomorrow  Steven Lee, Global Head, Technical Operations and CEO Singapore Operations, Reddy’s Laboratories, India (Moderator)  Villoo Patell, Chairman & Managing Director, Avesthagen, India (Panelist)  Sanjay Singh, CEO, Gennova Biopharmaceuticals, India (Panelist)  M K Sahib, Director - Biotech & R&D, Quality, Wockhardt, India (Panelist)

10:00 a.m.

Case Study: India as Global Biosimilar Launch Pad  Amardeep Udesh, Head - Strategy & Market Assessment, Cipla, India

10:30 a.m.

Morning Refreshments & Speed Networking

11:00 a.m.

Understanding Regulatory Pathway in India from Manufacture to Market for Biosimilars  S. R. Rao, Advisor, DBT, Government of India, India

11:30 a.m.

Navigating the IP Minefield of Biosimilars  Murali Neelakantan, Former Global General Counsel, Cipla, India

12:00 p.m.

Cost by Design: Need for Global Harmonization for Development of Biosimilars: CMC Analytics & PAT for Biosimilars Manufacture  Himanshu Gadgil, Senior Vice President, R&D, Biologics, Intas Pharmaceuticals, India

12:30 p.m.

Tackling challenges in PAT for Development of MAb Biosimilars in comparison to Recombinant Protein based Biosimilars  Gopal Dasika, Senior Vice President, Head, Biologics, Hospira, India

1:00 p.m.

Lunch Networking Session + Lunch Technical Workshop by M R Sanghavi: Chromatography Media: New Chromatography Systems for Downstream Processing  Masami Todokoro, Bioprocess Equipment Manager, JNC Corporation , Japan  Shigeyuki Aoyama, Cellufine Sales Manager, JNC Corporation , Japan

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

2:10 p.m.

Formulation Aspects in Biosimilar Development  Dhananjay Patankar, Vice President, Pharma & Biopharma Development, Syngene International, Biocon, India

2:40 p.m.

Media Supplementation with Peptones and CD Supplements: Effects on Performance & Protein Quality  Matthias Brand, Market Development Manager, BD Advanced Bioprocessing, Singapore

3:10 p.m.

Optimization Platform Technologies for Faster Upstream Development of MAb Biosimilars  Ravishankar Kasturi, GM & Head - Biophamaceutical Process Development, Reliance Life Sciences, India

3:40 p.m.

Afternoon Refreshments

4:00 p.m.

Effectively Utilizing Post Translational Modification Analysis to Fast Track Process Development for Biosimilars  Sanjeev Gupta, Deputy General Manager, Biotech-R&D, IPCA Laboratories, India

4:30 p.m.

Continuous Processing & Process Intensification: Path Forward for Biosimilar Manufacturing  Arjun Raghuwanshi, Manager R&D, Senior Scientist, Gennova Biopharmaceuticals, India

5:00 p.m.

Panel Discussion: Single Use Technology for Biosimilar Manufacturing: Challenge Or Opportunity?  Sachin Joshi, Head - Bioprocess, GE Healthcare, India (Moderator)

5:45 p.m.

Chairman’s Closing Remarks  Steven Lee, Global Head, Technical Operations & CEO Singapore Operations, Reddy’s Laboratories, India

5:50 p.m.

End of Conference Day 1 & Welcome Cocktail

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Chairman’s Opening Remarks Steven Lee, Global Head, Technical Operations & CEO Singapore Operations, Reddy’s Laboratories, India

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Leadership Panel: Indian Biosimilars Success Strategy: Today and Tomorrow Steven Lee, Global Head, Technical Operations and CEO Singapore Operations, Reddy’s Laboratories, India (Moderator)

Villoo Patell, Chairman & Managing Director, Avesthagen, India (Panelist) Dr. Patell started her professional career at the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) at Hyderabad in 1978. She worked on projects on the biochemistry of nitrogen fixation in legumes, standardizing a screening technique for drought tolerance, and on Heat Shock Proteins in Millet and Sorghum, amongst other projects. Dr. Patell’s Ph.D. studies in plant molecular biology at University Louis Pasteur, Strasbourg, France, on Fundamental aspects of the plant mitochondrial genome, coming face to face with the role of each nucleotide and its importance in cis-, trans-, splicing and RNA editing, ignited a passion to learn and manage this information and develop new products. The Ph.D.was followed by 9 months as a post-doc at the Ghent University, Belgium, working with scientists from all around the world, that really sparked off her entrepreneurial spirit. She then returned to India with an idea rooted in her mind – to create a platform that would bridge Academia and Industry. Thus was the seed sown that would give birth, a few years later, to Avesthagen.

On her return to India, she established herself as an independent scientist and principal investigator working from the National Center for Biological Sciences (NCBS) with funding from the Rockefeller Foundation and subsequently at the University of Agricultural Sciences (UAS) in Bangalore with a grant from IFCPAR, the Indo-French Centre for the Promotion of Advanced Research.

Dr. Villoo Morawala-Patell experimented with different models on how best to create a sustainable innovation platform for the nation. In 1998, she registered

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Avesthagen as a public-private model as perhaps the best way to build an innovation model. The public–private model found few takers from Academia, Industry, and Financial Institutions. The need for speed in gearing for the 2005 opening up of India to WTO, was the trigger to go solo and to create a full private entity, Avestha Gengraine Technologies Pvt. Ltd in early 2000. A year later, ICICI Ventures, Global Trust Bank and Tata Industries invested 8 crores in the company, which had now settled in its new laboratories in the International Technology Park at Whitefield. This was only the beginning. Since then Villoo has ceaselessly worked to build the company and raised significant international funding, attracting foreign investors and partners who saw a potential in the young Indian biotech sector and particularly in this fast growing company with its promise of innovation in predictive, preventive, personalized healthcare and environment-adjusted crops and nutritionally-enhanced seeds for agriculture.

Avesthagen now has 650 employees. Foreign investment stands at 31% today.

Investors recognized that Avesthagen was unique.

Most Indian biotech companies survive by doing reverse engineering or contract work. Dr. Patell set out to give Avesthagen a strong focus in innovative R&D in diverse areas such as bioAgriculture, bioNutrition, bioPharmaceuticals. Today, the company has a portfolio of 350 patents filed, it continues to build and intensify its intellectual property through product commercialization. Dr. Patell has built a “Business of Science” and developed a new model of “Science of Business” to deliver products from ideas. Collaborating with several giants of global industry has also been one of Dr. Patell’s far-sighted endeavours.

Avesthagen has fruitful partnerships for co-development and research, with Cipla for bioPharma development and manufacture, a tie-up with France’s Groupe Limagrain (the largest seed company in Europe) to create new varieties of seeds, with bioMerieux for diagnostics and alliances with Groupe Danone, and Nestle Nutrition and Godrej Industries. Dr. Patell is a much sought after speaker at national and international events and conferences, and has given presentations at the Harvard University, at Stanford University and the The Kellogg Business School.

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Sanjay Singh, CEO, Gennova Biopharmaceuticals, India (Panelist) Dr. Sanjay Singh is the Chief Executive Officer of Gennova Biopharmaceuticals Ltd, Pune, India. Gennova is a leading biotechnology company dedicated to the research, development and commercialization of safe, efficacious and affordable bio-therapeutics to address the cardiovascular, renal care and oncology markets across the globe. After obtaining a PhD in Biochemistry from Central Drug Research Institute (CDRI), Lucknow, India, Dr. Singh worked on malaria vaccine development first at the International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India and then at the National Institute of Health (NIH), USA where he eventually headed the Antigen Research Section at the Malaria Vaccine Development Branch of National Institutes of Allergy and Infectious Diseases (NIAID), NIH, USA. During his tenure at the NIH, he was successful in taking four recombinant vaccine candidates from gene to human clinical trials.

In 2006, he joined as the CEO of Gennova Biopharmaceuticals Ltd., which was then a startup biotechnology company. At Gennova, Dr. Singh’s leadership has facilitated the launch of Elaxim™ (TNK-tPA); Vintor™ (erythropoietin); Emgrast™ (sargramostim); Exgrast™ (filgrastim); and PegEX™ (pegylated filgrastim) in the market. Under him Gennova was diversified into vaccine research specifically in the area of infectious diseases, in particular Malaria, HPV, Leishmaniasis and Tuberculosis in partnership with various national and global organizations.

Gennova's antibody engineering program includes five bio‐similar antibodies and one new biological entity(NBE) The NBE program at Gennova is funded by Council of Scientific and Industrial Research, Govt. of India.

Dr Singh is a member of the Steering Committee for the formulation of the Indian Biotechnology policies for Twelfth Five Year plan (Planning Commission Govt. of India). He also serves as a member of the Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India (DCGI), Ministry of Health, Govt. of India for development of the India Guidelines on Similar Biologics (Regulatory Requirements for Marketing Authorization). Additionally, he is part of the working group for Gene Therapy constituted jointly by the Department of Health Research (DHR) and Department of Biotechnology (DBT), Govt. of India.

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M K Sahib, Director - Biotech & R&D, Quality, Wockhardt, India (Panelist)

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Case Study: India as Global Biosimilar Launch Pad Amardeep Udesh, Head - Strategy & Market Assessment, Cipla, India

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Prioritizing the “right” biologics to establish competitive advantage on global counterparts and to respond to health challenges  

Importance of partnerships for a sustainable biosimilar industry Opportunities and challenges for pharmacovigilance (Phase IV) – entry into regulated markets through the Indian/ other semi-regulated biosimilar markets – India and Latin America

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Understanding Regulatory Pathway in India from Manufacture to Market for Biosimilars S. R. Rao, Advisor, DBT, Government of India, India S. R. Rao, Ph. D is Adviser, Department of Biotechnology (DBT), Ministry of Science & Technology; Government of India. He Served in various positions in department since 1989 and was associated with implementation of several national level programmes on R&D, technology development and commercialization of biotechnology. Currently, main responsibility is regulation of genetically engineering products as Scientific Member Secretary of statutory body namely "Review Committee on Genetic Manipulation" mandated with scientific risk assessment and management under Rules,1989 of Environmental Protection Act, 1986 of India. He is also serving Chairman of “Scientific Panel on GM Foods” of Food Safety Standards Authority of India (FSSAI) dealing with risk assessment of GM Foods and is also responsible for establishment of Biotechnology Regulatory Authority of India through enactment of legislation which replaces the existing regulatory framework. He also specializes in core and cross-sectoral policy issues of Biotechnology policy, development, regulation, safety, public private partnership, international relations and biotech R&D Innovation and Development, and public concerns and consensus building.

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Navigating the IP Minefield of Biosimilars Murali Neelakantan, Former Global General Counsel, Cipla, India Murali Neelakantan is a dual qualified (England & Wales and India) lawyer with over a decade's experience of working on cross border transactions at leading international law firms in London. He moved to global pharma major, Cipla Limited, as Global General Counsel and is part of the company’s core leadership team. He started his career at a leading firm in Mumbai in the mid 1990s where he worked on several significant transactions. Prior to returning to India in 2008, he was partner and head of the India Group at Ashurst LLP. He has been recommended for his expertise by Legal 500 which describes him as "He is said by clients to 'charm the other side into accepting our position as fair', is highly recommended as a 'sounding board for many business ideas' and for 'helping us decide a definitive course of action'."

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Cost by Design: Need for Global Harmonization for Development of Biosimilars: CMC Analytics & PAT for Biosimilars Manufacture Himanshu Gadgil, Senior Vice President, R&D, Biologics, Intas Pharmaceuticals, India

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Tackling challenges in PAT for Development of MAb Biosimilars in comparison to Recombinant Protein based Biosimilars Gopal Dasika, Senior Vice President, Head, Biologics, Hospira, India

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Lunch Technical Workshop by M R Sanghavi: Chromatography Media: New Chromatography Systems for Downstream Processing 1. Masami Todokoro PhD; Bioprocess equipment manager JNC Corporation, Japan 2. Shigeyuki Aoyama; Cellufine sales manager, JNC Corporation, Japan



JNC Corporation would like to present two topics below in the workshop.

1) Chromatography media “Cellufine” for vaccine manufacturing 2) Launched our new business; Column and equipments from pilot scale to commercialization for bio-pharmaceuticals production At first, we introduce chromatography media Cellufine. Cellufine is porous and spherical particle from cellulose which has chemical stability, mechanical strength and good bio-compatibility. All Cellufine products are manufactured in Japan and guaranteed by ISO. One of Cellufine products, Cellufine Sulfate is used for virus purification because of its unique ligand designed to mimetic heparin.

In this workshop, we show some applications of virus purification with the media. Second, we introduce our new business which contributes to accelerate commercial production of bio-pharmaceuticals. We offer new products launching, column, packing equipment and control system with competitive price. Columns are prepared in five different diameters (100, 140, 200. 300 and 450 mm) as usage and all equipments are designed easy to operate.

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Formulation Aspects in Biosimilar Development Dhananjay Patankar, Vice President, Pharma & Biopharma Development, Syngene International, Biocon, India Dr. Dhananjay Patankar is Vice President – Pharmaceutical and Biopharmaceutical Development at Syngene International in Bangalore.

Syngene is a leading contract service provider in India serving the pharma and biotech industry in drug discovery, development and manufacturing. At Syngene Dr. Patankar has overseen the manufacture of several products that have entered Phase 1 clinical trials worldwide.

Before joining Syngene Dr. Patankar was Chief Operating Officer of Intas Biopharmaceuticals and earlier worked at Wockhardt. In his 18 years in the biopharmaceutical industry, he has led the development and commercialization of several biosimilar products, and led the development of India’s first biosimilar product to receive marketing authorization in Europe (filgrastim, sold as Grastofil).

Dr. Patankar also serves as Chair of the USP Expert Committee for Medicines Compendium – Biologics, and previously served on the Mashelkar Task Force for regulatory pathway for biosimilars in India in 2004.

Dr. Patankar is a Chemical Engineer and obtained his bachelors’ degree from the Indian Institute of Technology, Bombay and his Masters’ and PhD from the University of Utah (US) which was followed by a postdoctoral fellowship at Rutgers University (US).

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Media Supplementation with Peptones and CD Supplements: Effects on Performance & Protein Quality Matthias Brand, Market Development Manager, BD Advanced Bioprocessing, Singapore Matthias has a BA in Business and after obtaining a PhD in Microbiology from the Albert-Ludwig University, Freiburg, Germany he did a Postdoc at UNSW, Sydney, Australia. For the last 16 years he worked in the Biotechnology/Biopharma field, initially with yeast and microbial expression systems later on cell line-, media- and process development with numerous mammalian expression systems. Since 2010 he is in his current role as Market Development Manager for the Asia Pacific region with BD Advanced Bioprocessing.

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Biopharmaceutical manufacturers have achieved significant cell culture performance and productivity improvements through cell culture process and medium optimization. Supplementation of basal media with protein hydrolysates or chemically defined supplements has greatly contributed to these improvements. Aside from performance and protein yield; achieving optimal protein quality is essential for the development of biosimilars. Here we address the use of hydrolysates and CD supplements on bioproduction and protein quality, multiple case studies from CHO based monoclonal antibody production systems will also be presented.

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Optimization Platform Technologies for Faster Upstream Development of MAb Biosimilars Ravishankar Kasturi, GM & Head - Biophamaceutical Process Development, Reliance Life Sciences, India Ravishankar Kasturi is General Manager and Head of Biopharmaceuticals Process Development at Reliance Life Sciences in Navi Mumbai, India. He is responsible for providing guidance and oversight to process development, technology transfer and technical support for all aspects of therapeutic protein manufacturing. The portfolio of products under development include proteins derived from microbial fermentation and mammalian cell culture covering cytokines, monoclonal antibodies, hormones and glyco proteins. His prior assignments were at Dr Reddy’s Biologics,. Hyderabad, and Uni-Sankyo ltd,.

Hyderabad. He received his M.Tech in Bio-Chemical Engineering from Andhra University , Vishakhapatnam and his Bachelors in Pharmacy from Gulbarga University , India.

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Effectively Utilizing Post Translational Modification Analysis to Fast Track Process Development for Biosimilars Sanjeev Gupta, Deputy General Manager, Biotech-R&D, IPCA Laboratories, India

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Continuous Processing & Process Intensification: Path Forward for Biosimilar Manufacturing Arjun Raghuwanshi, Manager R&D, Senior Scientist, Gennova Biopharmaceuticals, India Arjun is currently working as a lead scientist in the downstream processing group at Gennova Biopharmaceuticals Ltd., Pune.

Arjun holds a rich experience of 11 years in the field of downstream process development and manufacturing. He started his career in the area of downstream process at Wockhardt Ltd and worked on recombinant human insulin (2003). During his tenure with companies like Zenotech Labs and Intas Biopharmaceuticals, he worked on different biosimilar products e.g. GCSF, PEG GCSF, EPO and Rituximab. At Gennova he continued his efforts to develop novel purification strategies to support perfusion based production of EPO and TNKtPA. In last few years, Arjun’s team is also working on novel biologics especially vaccine candidates for leishmaniasis and malaria with global collaborations.

His research interest includes process intensification, continuous processing, and bioprocess design. His major focus areas are bioprocessing, drug development and technological innovations.

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As products, markets and needs in healthcare changes, there is an opportunity to also change manufacturing strategy. Over the last few years, the biopharma industry has seen a “gold rush” towards biosimilar products. Biopharmaceutical production is developing into a global industry; this is the high time to explore drivers and barriers for such development. In my talk I will try to answer few important questions: 1.What are the new technologies and approaches, industry in general has to adapt to meet the current needs and future direction, particularly in the areas of downstream operations?

2. Impact of process intensification on final manufacturing process, a case study.

3.Continuous processing: review of technology drivers and barriers for implementation.

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Panel Discussion: Single Use Technology for Biosimilar Manufacturing: Challenge Or Opportunity?

Sachin Joshi, Head - Bioprocess, GE Healthcare, India (Moderator)

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Chairman’s Closing Remarks Steven Lee, Global Head, Technical Operations & CEO Singapore Operations, Reddy’s Laboratories, India

Day 2 5 March 2015

CONFERENCE AGENDA Thursday, March 05, 2015 Registration Commences

9:05 a.m.

IMAPAC's Welcome Back Remarks  Wang Ting Ting, General Manager, IMAPAC, Singapore

9:10 a.m.

Chairman's Opening Remarks  S. R. Rao, Advisor, DBT, Government of India, India

9:15 a.m.

Global Clinical Trials Management for Global Biosimilars Development- A Reality?  Akhilesh Sharma, Chief Medical Officer , Senior Vice President, Global Head, Medical Affairs, Reddy’s Laboratories, India

9:45 a.m.

Case Study Panel: Biosimilars Clinical Research Study Designs for India vs Alternative Destinations  Akhilesh Sharma, Chief Medical Officer , Senior Vice President, Global Head, Medical Affairs, Reddy’s Laboratories, India (Moderator)  Kiran Mathak, Director - Head Global Clinical Development, Lambda Therapeutic Research, India (Panelist)  Jaideep Gogtay, Chief Medical Officer, Cipla, India (Panelist)  S. D. Sinha, Associate Vice President & Head, Global Operations, Clinical Development, Medical Affairs & Pharmacovigilance, Hetero Drugs, India (Panelist)

Exhibits Open

8:00 a.m.

10:30 a.m.

Morning Refreshment

11:00 a.m.

Biosimilar Quality: Biosimilarity and Bioequivalence Comparability StudiesBiosimilar Quality: Biosimilarity and Bioequivalence Comparability Studies  Subhash Pande, Senior Vice President, QA, Zydus Cadila, India

11:25 a.m.

Biosimilar Safety: Pharmacovigilance and Risk Management  Syed Numan, Associate Director, Regulatory Affairs, AbbVie, India

11:50 a.m.

Biosimilar Analytical Approaches, Extrapolation and Interchangeability for MAb Biosimilars  M K Sahib, Director - Biotech & R&D, Quality, Wockhardt, India

12:15 p.m.

Analytical Method Challenges in Biosimilars  Alok Sharma, Head, Analytical Department, Lupin, India

12:40 p.m.

Dilemma for a Relatively Late Biosimilar Entrant  Chae J. Lee, Vice-President, Global Strategy & Business Development , DongA ST, South Korea

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Lunch Networking Session + Lunch Technical Workshop by HiMedia: High quality with low cost: Strategies for staying ahead in the Indian Biosimilars market Vishal G. Warke, Director R&D, Cell Culture and Immunology, Himedia Laboratories Pvt. Ltd., India

2:05 p.m.

Panel Discussion: Getting Ahead in the Game: Biosimilars or Biobetters?  S. R. Rao, Advisor, DBT, Government of India, India (Moderator)  Umesh Shaligram, Director, R&D, Serum Institute of India, India (Panelist)  Steven Lee, Global Head, Technical Operations & CEO Singapore Operations, Reddy’s Laboratories, India (Panelist)  Chao-sheng Cheng, Plant Manager, Pharmaessentia, Taiwan (Panelist)

2:45 p.m.

Biobetters Through Novel Site-Specific PEGylation Platforms  Chao-sheng Cheng, Plant Manager, Pharmaessentia, Taiwan

3:10 p.m.

Monoclonal Antibodies & Biobetters - Innovations & Overcoming Challenges Development at Serum Institute  Umesh Shaligram, Director, R&D, Serum Institute of India, India

3:35 p.m.

4:00 p.m.

Exhibits Open

1:00 p.m.

Afternoon Refreshments Strategy for Future Manufacturing of Affordable Biologics  Steven Lee, Global Head, Technical Operations & CEO Singapore Operations, Reddy’s Laboratories, India

4:25 p.m.

Case study: Successful Biosimilar Development and Distribution Partnership Model  Chetak Buaria, Director, Partnerships & Alliances, Merck Serono, India

4:55 p.m.

Panel Discussion: The Right Partner, The Right Model, The Right Outcome  Gopal Dasika, Senior Vice President, Head, Biologics, Hospira, India (Moderator)  Chetak Buaria, Director, Partnerships and Alliances, Merck Serono, India (Panelist)  Amardeep Udesh, Head - Strategy & Market Assessment, Cipla, India (Panelist)  Chae J. Lee, Vice-President, Global Strategy & Business Development , DongA ST, South Korea (Panelist)

5:40 p.m.

Chairman's Closing Remarks  S. R. Rao, Advisor, DBT, Government of India, India

5:50 p.m.

End of Conference Day 2

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Chairman’s Opening Remarks S. R. Rao, Advisor, DBT, Government of India, India S. R. Rao, Ph. D is Adviser, Department of Biotechnology (DBT), Ministry of Science & Technology; Government of India. He Served in various positions in department since 1989 and was associated with implementation of several national level programmes on R&D, technology development and commercialization of biotechnology. Currently, main responsibility is regulation of genetically engineering products as Scientific Member Secretary of statutory body namely "Review Committee on Genetic Manipulation" mandated with scientific risk assessment and management under Rules,1989 of Environmental Protection Act, 1986 of India. He is also serving Chairman of “Scientific Panel on GM Foods” of Food Safety Standards Authority of India (FSSAI) dealing with risk assessment of GM Foods and is also responsible for establishment of Biotechnology Regulatory Authority of India through enactment of legislation which replaces the existing regulatory framework. He also specializes in core and cross-sectoral policy issues of Biotechnology policy, development, regulation, safety, public private partnership, international relations and biotech R&D Innovation and Development, and public concerns and consensus building.

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Global Clinical Trials Management for Global Biosimilars Development- A Reality?

Akhilesh Sharma, Chief Medical Officer , Senior Vice President, Global Head, Medical Affairs, Reddy’s Laboratories, India Dr Akhilesh Sharma is M.D., in Clinical Pharmacology with further training in Clinical Research and Global Pharmacovigilance at Berkley Extension, California State University, USA and Luton Medical Center, UK. He brings with him 22 years of significant experience in the areas of Clinical Research, Translation Medicine, Biomarkers, Clinical Pharmacology, Medical Affairs, global Pharmacovigilance, and across various multinational pharmaceutical companies in US as well as Asia-pacific.

He is currently working with Dr. Reddy’s as their Chief Medical Officer to bring speed to strategic scientific decision making, innovations in global Clinical Research & development, strategic medical Affairs, Global Pharmacovigilance & differentiated Medico-marketing activities.

He has been on the panel of Clinical Research and Drug Safety at various national and international forums. He has to his credit about 52 scientific & research publications, 47 patents and holds membership of International Pharmaceutical Society, American Academy of Dermatology, American Diabetes Association, European Society of Respiratory Medicine and Executive Founder Member of an NGO called, “Health Alert Organization of India”.

Dr Sharma is a passionate teacher and visiting speaker at various reputed institutions.

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BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Case Study Panel: Biosimilars Clinical Research Study Designs for India vs Alternative Destinations Akhilesh Sharma, Chief Medical Officer , Senior Vice President, Global Head, Medical Affairs, Reddy’s Laboratories, India (Moderator) Dr Akhilesh Sharma is M.D., in Clinical Pharmacology with further training in Clinical Research and Global Pharmacovigilance at Berkley Extension, California State University, USA and Luton Medical Center, UK. He brings with him 22 years of significant experience in the areas of Clinical Research, Translation Medicine, Biomarkers, Clinical Pharmacology, Medical Affairs, global Pharmacovigilance, and across various multinational pharmaceutical companies in US as well as Asia-pacific.

He is currently working with Dr. Reddy’s as their Chief Medical Officer to bring speed to strategic scientific decision making, innovations in global Clinical Research & development, strategic medical Affairs, Global Pharmacovigilance & differentiated Medico-marketing activities.

He has been on the panel of Clinical Research and Drug Safety at various national and international forums. He has to his credit about 52 scientific & research publications, 47 patents and holds membership of International Pharmaceutical Society, American Academy of Dermatology, American Diabetes Association, European Society of Respiratory Medicine and Executive Founder Member of an NGO called, “Health Alert Organization of India”.

Dr Sharma is a passionate teacher and visiting speaker at various reputed institutions.

Kiran Mathak, Director - Head Global Clinical Development, Lambda Therapeutic Research, India (Panelist)

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

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Jaideep Gogtay, Chief Medical Officer, Cipla, India (Panelist)

S. D. Sinha, Associate Vice President & Head, Global Operations, Clinical Development, Medical Affairs & Pharmacovigilance, Hetero Drugs, India (Panelist) 

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Currently Associate Vice-President & Head- global operations in clinical trials, pharmacovigilance & medical affairs at Hetero group of Pharmaceuticals.

MBBS (GS Medical college), MD (Medical pharmacology, TN Medical college) from Mumbai, has more than 15 years’ work experience in leading pharmaceutical organizations including Dr. Reddy’s Laboratories, Glenmark, Hetero Group of Pharmaceuticals, Vimta Laboratories, Organon and Accenture & clinical pharmacology deptts of leading academic institutions such as BYL Nair hospital, Mumbai.

Has developed and led teams of various sizes and faculties including clinical trials, global pharmacovigilance, medical writing, and global medico- regulatory support.

His experience in biologics including clinical development of monoclonal antibodies (primarily indicated in Non-Hodgkin’s lymphoma, metastatic colorectal cancer and rheumatoid arthritis), erythropoietin analogue, growth factors (G-CSF).

Has been a visiting faculty in pharmacology and clinical research in a few teaching institutions of repute including Jadavpur University, Kolkata & Mediciti institute of medical sciences, Hyderabad.

Has four publications in various reputed journals.

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Biosimilar Quality: Biosimilarity and Bioequivalence Comparability Studies Subhash Pande, Senior Vice President, QA, Zydus Cadila, India

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Biosimilar Safety: Pharmacovigilance and Risk Management Syed Numan, Associate Director, Regulatory Affairs, AbbVie, India 

Syed is a Clinical Physician by training and Education. Currently Syed is working as an Associate Director in the area of Regulatory Affairs at AbbVie

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He has over 12 years of healthcare experience across the biotechnology and pharmaceutical sectors in a career that has spanned Clinical Operations, Clinical Research, Clinical Development, Strategy consulting and Strategic intelligence roles.

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Before AbbVie, Syed was an Associate Director and strategy consultant at Prescient Lifesciences where his focus was on Brand Strategy, Competitive Intelligence and Regulatory intelligence

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Syed has also worked with Baxter Healthcare in the areas of Global Clinical development and Clinical Operations

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His core therapeutic areas of expertise and interest include Biosimilars, Immunology, Oncology, Hematology and Biosurgery

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Biosimilar Analytical Approaches, Extrapolation and Interchangeability for MAb Biosimilars M K Sahib, Director - Biotech & R&D, Quality, Wockhardt, India

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Analytical Method Challenges in Biosimilars Alok Sharma, Head, Analytical Department, Lupin, India Alok Sharma is Principal Scientist & Head at Analytical Development Lab, Biotech Division, Lupin Limited, India. Prior to Lupin he was Associate Director at Biologics Division of Hospira Healthcare in Chennai, India heading Bioanalytics and stability studies. He has also held positions at Panacea Biotec, Intas Biopharmaceticals, Virologik Gmbh. He has been part of teams that have developed Biosimilars and Vaccines from the concept to commercials.

He has more than 14 years of experience in development of analytical methodologies and also advanced structural characterization techniques. He supervised the analytical laboratories and implemented new sensitive methods for characterization and comparability exercises of proteins and mAbs. He holds a Ph.D in Molecular Microbiology from the GB Pant University of Pantnagar and was a postdoctoral researcher in the areas of protein structure biology at the Helmholtz Centre for Infection Research, Braunschweig, Germany. He has authored and co-authored 20+ international papers in this area and has published several review articles in these fields.

He is also serving as US Pharmacopoeia Expert Panel Member for therapeutic proteins (2011-2015).

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Dilemma for a Relatively Late Biosimilar Entrant Chae J. Lee, Vice-President, Global Strategy & Business Development , Dong-A ST, South Korea Mr. Chae J. Lee is currently the Vice-President of Global Strategy and Business Development with Dong-A ST, the leading pharmaceutical company in Korea. He is responsible for establishing Dong-A’s future growth engines by delivering global in/out-licensing partnerships and strategic alliances/JVs involving commercial, R&D, and/or manufacturing aspects.

For his professional career, Chae first joined A.T. Kearney, the global management consulting firm, in 1999 based out of their Chicago HQ in the Pharmaceutical & Healthcare/Consumer Products & Retail Practice. He then joined Samsung Electronics as a Director in Global Marketing Operations based out of their Seoul HQ. In 2008, Chae joined GlaxoSmithKline (GSK) in a dual role as the Senior Director of Asia-Pacific Business Development as well as GSK Korea Strategy and Business Development based out of Seoul. He also served in the CEO’s Office at GSK’s HQ just outside of London. He has been with Dong-A over two years in his latest role.

Chae received his Bachelor/Master of Applied Science degrees in Mechanical/Biomedical Engineering from the University of British Columbia in Vancouver, Canada. He completed the PhD candidacy requirements in Biomedical Engineering from Northwestern University in Chicago, USA while foregoing the dissertation thesis in order to co-found a biotech services start-up.

He also received an Executive MBA Certificate from the University of Michigan (Ross School of Business).

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There is a prevailing opinion among global biopharma experts are that a biosimilar products needs to be first 3 to4 to the market versus competition to have a shot at commercial success.

Given that Dong-A started 2-3 years later than the lead group of biosimilar manufacturers in terms of investing into a cGMP biologics plant, we had to adapt our partnering scenarios and consider mutiple strategic dimensions, e.g., geographic scope, production options, partner capability, product quality, investment/execution of clinical trials, commercial opportunity unpredictability and partnering landscape, among others.

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Considering these scenarios, in some instances up to 5 to 8 biosimilars could be viable to be launched inthe developed markets with a reasonable shot at commercial success.

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Lunch Technical Workshop by HiMedia: High quality with low cost: Strategies for staying ahead in the Indian Biosimilars market Vishal G. Warke, Director R&D, Cell Culture and Immunology, Himedia Laboratories Pvt. Ltd., India

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Panel Discussion: Getting Ahead in the Game: Biosimilars or Biobetters?

S. R. Rao, Advisor, DBT, Government of India, India (Moderator) S. R. Rao, Ph. D is Adviser, Department of Biotechnology (DBT), Ministry of Science & Technology; Government of India. He Served in various positions in department since 1989 and was associated with implementation of several national level programmes on R&D, technology development and commercialization of biotechnology. Currently, main responsibility is regulation of genetically engineering products as Scientific Member Secretary of statutory body namely "Review Committee on Genetic Manipulation" mandated with scientific risk assessment and management under Rules,1989 of Environmental Protection Act, 1986 of India. He is also serving Chairman of “Scientific Panel on GM Foods” of Food Safety Standards Authority of India (FSSAI) dealing with risk assessment of GM Foods and is also responsible for establishment of Biotechnology Regulatory Authority of India through enactment of legislation which replaces the existing regulatory framework. He also specializes in core and cross-sectoral policy issues of Biotechnology policy, development, regulation, safety, public private partnership, international relations and biotech R&D Innovation and Development, and public concerns and consensus building.

Umesh Shaligram, Director, R&D, Serum Institute of India, India (Panelist) Mr. Umesh Shaligram, Director – Research & Development leads the development and manufacturing of several recombinant products like HepatitisB vaccine, HPV vaccine, CRM197, Acellular pertussis component based vaccine, Erythropoietin, Polysialylated Erythropoietin, Polysialic acid, r-BCG vaccine, GCSF and Pegylation of recombinant products as well as development of liposomal delivery at Serum Institute of India. His professional and educational background is in the process development of recombinant products and has experience in genetic engineering and bio-physics DNA structure and oligoneuclotides manufacturing during his studies from the Indian Institute of Science and also University of Pune.

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Steven Lee, Global Head, Technical Operations & CEO Singapore Operations, Reddy’s Laboratories, India (Panelist)

Chao-sheng Cheng, Plant Manager, Pharmaessentia, Taiwan (Panelist)

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Biobetters Through Novel Site-Specific PEGylation Platforms Chao-sheng Cheng, Plant Manager, Pharmaessentia, Taiwan

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Monoclonal Antibodies & Biobetters - Innovations & Overcoming Challenges - Development at Serum Institute Umesh Shaligram, Director, R&D, Serum Institute of India, India Mr. Umesh Shaligram, Director – Research & Development leads the development and manufacturing of several recombinant products like HepatitisB vaccine, HPV vaccine, CRM197, Acellular pertussis component based vaccine, Erythropoietin, Polysialylated Erythropoietin, Polysialic acid, r-BCG vaccine, GCSF and Pegylation of recombinant products as well as development of liposomal delivery at Serum Institute of India. His professional and educational background is in the process development of recombinant products and has experience in genetic engineering and bio-physics DNA structure and oligoneuclotides manufacturing during his studies from the Indian Institute of Science and also University of Pune.

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Strategy for Future Manufacturing of Affordable Biologics Steven Lee, Global Head, Technical Operations & CEO Singapore Operations, Reddy’s Laboratories, India

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Case study: Successful Biosimilar Development and Distribution Partnership Model Chetak Buaria, Director, Partnerships & Alliances, Merck Serono, India Chetak has more than 15 years of experience in corporate development, business leadership, alliance management, strategic planning and international marketing in pharmaceutical industry. Chetak is based in Switzerland and is responsible for identifying, evaluating, partnering and managing alliances with partners for Merck's global biosimilar business.

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• What is the optimum business model for biosimilars?

• How to strategically build a global biosimilar portfolio while integrating regional considerations?

• Our experience and learnings

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Panel Discussion: The Right Partner, The Right Model, The Right Outcome Gopal Dasika, Senior Vice President, Head, Biologics, Hospira, India (Moderator)

Chetak Buaria, Director, Partnerships and Alliances, Merck Serono, India (Panelist) Chetak has more than 15 years of experience in corporate development, business leadership, alliance management, strategic planning and international marketing in pharmaceutical industry. Chetak is based in Switzerland and is responsible for identifying, evaluating, partnering and managing alliances with partners for Merck's global biosimilar business.

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Selecting the right model and the right partner Decision-making process behind the partner selection and contracting Our experience and learnings

Amardeep Udesh, Head - Strategy & Market Assessment, Cipla, India (Panelist)

Chae J. Lee, Vice-President, Global Strategy & Business Development , Dong-A ST, South Korea (Panelist)

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Mr. Chae J. Lee is currently the Vice-President of Global Strategy and Business Development with Dong-A ST, the leading pharmaceutical company in Korea. He is responsible for establishing Dong-A’s future growth engines by delivering global in/out-licensing partnerships and strategic alliances/JVs involving commercial, R&D, and/or manufacturing aspects.

For his professional career, Chae first joined A.T. Kearney, the global management consulting firm, in 1999 based out of their Chicago HQ in the Pharmaceutical & Healthcare/Consumer Products & Retail Practice. He then joined Samsung Electronics as a Director in Global Marketing Operations based out of their Seoul HQ. In 2008, Chae joined GlaxoSmithKline (GSK) in a dual role as the Senior Director of Asia-Pacific Business Development as well as GSK Korea Strategy and Business Development based out of Seoul. He also served in the CEO’s Office at GSK’s HQ just outside of London. He has been with Dong-A over two years in his latest role.

Chae received his Bachelor/Master of Applied Science degrees in Mechanical/Biomedical Engineering from the University of British Columbia in Vancouver, Canada. He completed the PhD candidacy requirements in Biomedical Engineering from Northwestern University in Chicago, USA while foregoing the dissertation thesis in order to co-found a biotech services start-up.

He also received an Executive MBA Certificate from the University of Michigan (Ross School of Business).

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

Chairman’s Closing Remarks S. R. Rao, Advisor, DBT, Government of India, India S. R. Rao, Ph. D is Adviser, Department of Biotechnology (DBT), Ministry of Science & Technology; Government of India. He Served in various positions in department since 1989 and was associated with implementation of several national level programmes on R&D, technology development and commercialization of biotechnology. Currently, main responsibility is regulation of genetically engineering products as Scientific Member Secretary of statutory body namely "Review Committee on Genetic Manipulation" mandated with scientific risk assessment and management under Rules,1989 of Environmental Protection Act, 1986 of India. He is also serving Chairman of “Scientific Panel on GM Foods” of Food Safety Standards Authority of India (FSSAI) dealing with risk assessment of GM Foods and is also responsible for establishment of Biotechnology Regulatory Authority of India through enactment of legislation which replaces the existing regulatory framework. He also specializes in core and cross-sectoral policy issues of Biotechnology policy, development, regulation, safety, public private partnership, international relations and biotech R&D Innovation and Development, and public concerns and consensus building.

THANKS TO OUR

Sponsors IMAPAC would like to thank the following sponsors for their support and contribution in making

BIOSIMILAR WORLD

INDIA 2015 a success. Hope to see you again in 2016.

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Pall Life Sciences products for the biopharmaceutical industry include:

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

• Single-use technologies with Pall Allegro™ systems incorporating biocontainers, sterile connectors and disconnectors, sterile and tangential flow filtration capsules, disposable depth filters, and chromatography capsules • Capsules, cartridges, and housings for prefiltration, sterile filtration, virus reduction, and mycoplasma reduction • Tangential flow filtration products and systems • Chromatography sorbents, membrane devices, columns and systems • Depth filter products in wide selection of formats • Integrity test instrumentation • Bioreactor systems • Quality control instrumentation • Consulting, training, validation, and instrumentation services For additional information: www.pall.com/biopharm | pallindiamarketing@pall.com

EX H I B I TOR S APPLIKON BIOTECHNOLOGY is a world leader in developing and supplying advanced bioreactor systems from laboratory scale to production scale.

We are the only company that can take a customer from the initial screening stage up to full-scale production using the same platform. This minimizes scale-up risks and guarantees the shortest time to market for our customers' new product development.

Applikon is known for bringing new technologies to the market. These new technologies offer advantages in process efficiency for research and development as well as pilot plant and production scale processes.

As a focused medium sized company we live by our motto "A Step Ahead" to differentiate ourselves from other suppliers. Our focus on developing bioreactor systems only, allows us to produce state-of-the-art equipment. This has resulted in a steady growth to the top position of the worldwide laboratory bioreactor market. The basis for our new product development lies in our strong cooperation with leading international universities and institutes. ………

HIMEDIA possesses world-class hi-tech knowhow for manufacturing a complete range of chromogenic and HiVeg™ media products. We have the broadest range of Vegetable Hydrolysate based microbiology culture media (HiVeg™), in the world. This is due to our vertically integrated manufacturing that produces a comprehensive range of Plant and Animal based hydrolysates. Advanced products in the fields of Animal Cell Culture, Plant Tissue Culture and Molecular Biology came next as demands grew. An excellent chemical testing facility equipped with the latest analytical instruments enables HiMedia to deliver consistent ultra-pure products. ………

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

KERRY 是全球蛋白質水解物,酵母抽出物及細胞營

養添加劑的主要供應廠商, 也是全球唯一同時擁有 酵母粉和蛋白腖生產線的傑出企業, 全集團以高品 質的產品服務全球細胞培養生物製藥發酵,疫苗,診 斷 及 傳 統 發 酵 行 業 已 近 70 年 . For more than 70 years, we have earned our reputation for reliability and excellence in serving the biotech, pharmaceutical and fermentation markets by delivering unsurpassed product value, enhanced opportunities for supply chain consolidation, and new technology innovation. ………

甘肃健顺生物科技有限公司致力于“无血清个 性化化学成份界定细胞培养基”及其工艺的研 究开发。产品主要应用于生物制药（治疗性重 组蛋白，包括单克隆抗体）、细胞治疗以及人/兽用疫苗的工艺开发与生产。公 司已通过 ISO9001 质量管理体系和 ISO14001 环境管理体系的认证。公司引进 国内外一流设备和高端人才，拥有年产细胞培养基 300 吨的工业化生产的产业 规模。细胞培养基是生物制药的关键原材料，公司将持续为海内外生物制药行 业提供世界一流的细胞培养基及工艺开发、技术支持与一站式配套服务。 JIANSHUN BIOSCIENCES CO., LTD. is committed to developing and manufacturing “customized serum-free, chemically-defined cell culture medium”, and focuses on development and research of bioprocess and technology. JS Bio’s cell culture media are mainly applied in biopharmaceutical manufacturing (therapeutic recombinant proteins, including monoclonal antibody), cell therapy, and human/animal vaccines’ manufacturing and bioprocess development. JS Bio has passed ISO9001 Quality Management System and ISO14001 Environmental Management System Certification.

JS Bio is equipped with world-class experts and facilities, with an annual output of 300 tons of cell culture media industry scale. Cell culture medium is the key raw material in biopharmaceutical manufacturing, JS Bio has the responsibility and confidence to work for the well-being of the world of human by producing the highest quality cell culture medium, process development and one-stop service for the biopharmaceutical industry.

Add: 甘肃省兰州市安宁区九州通西路 70 号（新城科技孵化大厦 B 塔） Tower B, Incubator Building, No70, Jiuzhoutong West Rd., Anning District, Lanzhou, GanSu, China Tel: +86-931-7711111 | Fax: +86-931-7706500 E-mail: sales@jianshunbio.com | Web: www.jianshunbio.com ………

KRISHGEN BIOSYSTEMS is a leading manufacturer & supplier of tools for Drug Discovery Research, Biopharmaceutical industry, plant & food sciences.

As pioneers for offering tools for the Biosimilar and Vaccine manufacturers, we have built expertise to offer a range of solutions for both upstream, downstream, in-process

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

and QC. We are also ISO 9001 2008 certified and D&B SMERA rated company.

We work with our parent company Krishgen BioSystems; USA and offer products that are exported to leading users based in USA, Europe & Asia. www.krishgen.com ………

LAMBDA THERAPEUTIC RESEARCH LIMITED is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad - India, with facilities and operations in Mumbai, Toronto (Canada), Warsaw (Poland), London (UK) and USA. Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry.

Lambda's core strengths Global presence with capabilities in Indian subcontinent, Europe and North America Global team comprising of professionals equipped with full lifecycle Clinical Trial Management expertise Huge investigator database Customised solutions for special population studies More than 1,50,000 active study participants in its global database More than 700 validated LC/MS - MS assays available globally Over 50 successful regulatory audits and inspections globally More than 40 LC-MS/MS systems CAP accredited Clinical, Molecular and Microbiological laboratory Conduct QT studies with replicate ECGs and ECG Core Laboratory Low temperature storage (2-8 °C, -20 °C and -80 °C) controlled storage facility to store over 3.5 million samples Adverse Event Safety Database State-of-the-art Medical Imaging Solutions EDC (paperless execution) of both BA-BE & clinical trials through means of a 21 CFR Part 11 compliant & indigenously developed validated software 'BizNet' ………

As a leading-edge company in the development of bio-agricultural technology, HEALTHGEN BIOTECHNOLOGY has innovated one of the most expressive bioreactors OryzHiExp, which can highly express proteins and small peptides in cereal crop endosperm. We had successfully developed comprehensive products, including rHSA(recombinant human serum albumin), rbFGF (recombinant human basic fibroblast growth factor), LF (recombinant lactoferrin), IGF-1 (recombinant Insulin-like Growth Factor-1) and rAAT (recombinant human a1 antitrypsin). All the recombinant components can optimize cell culture, stimulate growth and protein productivity and shorten downstream process development. Meanwhile we are experiencing

BIOSIMILAR WORLD INDIA 2015 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biosimilars-world-india-2015/

cooperation with other prospective biotechnology and pharmaceutical companies in expressing their ideal proteins or peptides. ………

SIGMA-ALDRICH is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. SigmaAldrich customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 37 countries and has more than 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through innovative products, customized solutions and unsurpassed service. Our mission is to enable science to improve the quality of life. ………

WEST works side-by-side with its healthcare partners from concept to the patient, designing and manufacturing packaging, diagnostic and delivery systems that promote the efficiency, reliability and safety of their drug products. West’s customers include the world’s leading pharmaceutical, biopharmaceutical and medical device companies.

Every day, West is leading the way with cutting-edge technologies and quality systems, a thorough understanding of global regulatory compliance, and an unmatched and growing knowledge base of relevant pharmaceutical product testing, development and packaging. Based in Exton, Pa., West supports its customers from sales, manufacturing, customer support and research and development locations in North and South America, Europe, Asia and Australia. Established in 1923, West's 2012 sales totaled $1.3 billion.

CONFERENCE EVALUATION CHAIRMAN / SPEAKER ASSESSMENT E = Excellent

VG = Very Good

G = Good

S = Satisfactory

Conference Day 1 Speaker

Presentation skills

P = Poor

4 March 2015 / Wednesday

Content of session

Speaker

Presentation skills

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Steven Lee –Chairperson

E VG G

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E

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Himanshu Gadgil

E VG G

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Steven Lee –Panel

E VG G

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Gopal Dasika

E VG G

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Villoo Patell –Panel

E VG G

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E

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Dhananjay Patankar

E VG G

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Sanjay Singh –Panel

E VG G

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Matthias Brand

E VG G

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M K Sahib –Panel

E VG G

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Ravishankar Kasturi

E VG G

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E

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Amardeep Udesh

E VG G

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Sanjeev Gupta

E VG G

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S. R. Rao

E VG G

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Arjun Raghuwanshi

E VG G

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Murali Neelakantan

E VG G

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Sachin Joshi –Panel

E VG G

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VG G

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Conference Day 2

5 March 2015 / Thursday

Content of session

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Presentation skills

Content of session

Speaker

Presentation skills

S. R. Rao –Chairperson

E VG G

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E

VG G

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U. Shaligram –Panel

E VG G

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VG G

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Akhilesh Sharma

E VG G

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VG G

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Steven Lee –Panel

E VG G

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Akhilesh S. –Panel

E VG G

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C.S Cheng –Panel

E VG G

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Kiran Mathak –Panel

E VG G

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Chao-Sheng Cheng

E VG G

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Jaideep G. –Panel

E VG G

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Umesh Shaligram

E VG G

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S.D Sinha –Panel

E VG G

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Steven Lee

E VG G

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Subhash Pande

E VG G

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Chetak Buaria

E VG G

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Syed Numan

E VG G

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E VG G

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M K Sahib

E VG G

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VG G

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E VG G

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VG G

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Alok Sharma

E VG G

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E VG G

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VG G

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Chae. J. Lee

E VG G

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E

VG G

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E VG G

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E

VG G

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S. R. Rao –Panel

E VG G

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E

VG G

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Gopal Dasika –Panel Chetak B. –Panel Amardeep U. –Panel Chae J. Lee –Panel

Name

Job Title

Company

Comments on conference programme:

Which speaker(s) / topic(s) did you particularly come to hear?

What objective do you like to achieve by attending the conference?

What can IMAPAC do in the future to improve your conference experience?

CONFERENCE 1.

Did you benefit from attending this conference? Is your objective met?

If no, why?

YES / NO

2.

Was the conference up to your expectations?

YES / NO

Comments on the Conference as a whole (may we use your quote as a testimonial for our future events?)

3.

How would you rate this conference overall?

E VG G

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P

4.

How would you rate IMAPAC’s customer service? a) Pre-Conference

E VG G

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b) Conference Day

E VG G

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CONFERENCE VENUE / FACILITIES

Conference Room

E VG G

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Catering

E VG G

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Audio visual equipment

E VG G

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Service (by venue)

E VG G

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Cocktail

E VG G

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THANK YOU FOR TAKING THE TIME TO COMPLETE THIS QUESTIONAIRE.

Vaccine World CIS & CEE Summit (7 – 8 November 2013)

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