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Expert Speaker:
Dr. Simon Sellers, CEO, Bioavailability Systems LLC (USA)
Dr. Sellers has managed pharmaceutical chemical supply-chain businesses for Great Lakes, Sumitomo Chemical, Catalytica Pharmaceuticals and BTP. He has a PhD in chemistry and spent fifteen years working as a process development chemist before moving into management. He is currently CEO of Bioavailability Systems, LLC- an emerging biopharmaceutical company developing combination drugs with enhanced oral bioavailability. He also consults for the chemical and pharmaceutical industries.
Change in the Pharma Industry- What it Means for the Supply Chain
Abstract:Shrinking pipelines, poor return on R&D investment, loss of patent protection on key products, regulatory, political and investor pressures are all leading to a major shift in the business management of large pharmaceutical companies. Implications for the global supply-chain will be examined.
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| Dr. Simon Sellers, CEO, Bioavailability Systems LLC (USA) |
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Expert Speaker:
Dr. Jay Reddy, Vice President, Sai Advantium Pharma Limited
Dr. Jay Reddy is a Vice President at Sai Advantium Pharma Ltd managing the Process and Analytical R&D functions. Jay received his BSc from University of Madras (India), his PhD from The University of Kansas and was a post-doctoral fellow at Indiana University. Over the 14 years he has been in the industry, his career has been spent at Bristol-Myers Squibb, AMRI, Neurocrine Biosciences and Takeda where he managed several projects in development and in various stages of manufacturing. Also, Jay helped start a company called American Advanced Organics, a CRO that merged with AMRI and became the Syracuse Research Center in 2000.
Contracting with Indian and Chinese CROs-Challenges and Opportunities
Abstract:Challenges faced by a biopharma or pharma client in dealing with typical CROs in India and China will be discussed. With a critical look at relationships between clients and contractors, opportunities for improvement will be presented. |
| Dr. Jay Reddy, Vice President, Sai Advantium Pharma Limited |
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Expert Speaker:
Dr. Kerry Spear, Executive Director, Sepracor Corporation (USA)
Dr. Spear is Executive Director of Medicinal Chemistry at Sepracor, a pharmaceutical company headquartered in Marlborough, MA, USA. He is currently in charge of all medicinal chemistry efforts within Sepracor’s Discovery Research Department. Trained in natural products synthesis, he has over 25 years of experience as a medicinal chemist in both the pharmaceutical (e.g., G.D. Searle) and the biotechnology (e.g., Chiron) industries. He has participated in or led programs that cover a broad range of drug discovery research and which have resulted in the acceptance by the FDA of 7 IND applications. Dr. Spear completed a postdoctoral fellowship at the University of California, Berkeley. He received a Ph.D. degree in organic chemistry from the University of Wisconsin, Madison and a B.S. degree in chemistry from Juniata College.
The Role of China in Drug Discovery in the 21st Century: A View From the Starting Gate
Abstract:In less than a decade, outsourcing of some aspects of pharmaceutical research to Asia has emerged as an integral part of Pharma’s drug discovery strategy. While these efforts initially focused on compound synthesis, recently CROs in China have begun adding in vitro and in vivo biology proficiencies to compliment their core strengths in chemistry. Additionally, by building a deeper leadership pool, these CROs are now poised to contribute drug discovery expertise and knowledge as well as fundamental chemistry and biology skills. These additional capabilities offer new and broader opportunities for partnering with Chinese CROs in order to accelerate drug discovery efforts and control costs. Efforts to integrate chemistry and biology resources within Chinese CROs with ongoing drug discovery efforts at Sepracor will be discussed.
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Dr. Kerry Spear, Executive Director, Sepracor Corporation (USA)
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Expert Speaker:
Dr. Lee Kang, Director, Perrigo Company (USA)
Dr. Kang is Director Asia/Pacific Quality Operations at Perrigo Company, the Over-The-Counter, generic drugs and nutritionals manufacturers for North America and Europe. As the head of Quality Operations for the region, he is responsible for partnering between the suppliers and manufacturers in the region and the Perrigo global operations to assure uninterrupted supply of quality materials. Dr. Kang has more than 17 years of industry experience in pharmaceutical development (both API and finished products), quality control and regulatory affairs. He held positions of increasing responsibility in various pharmaceutical companies Bristol-Myers Squibb, Wyeth, and Sanofi-Aventis Pharmaceutical Companies. Dr. Kang holds a Ph.D. degree in Analytical Chemistry from the Virginia Tech, Blacksburg, Virginia; and a M.B.A. degree from the State University of New York at Buffalo.
Generic Drug Development-Life Cycle and Patent Game
Abstract:
Developing and marketing generic drugs are getting sophisticated and competitive as the development cycle time is shorter and patent fight with innovators is costly. As low hanging fruits are all picked up by big generic companies, Teva, Sandoz, to name a few, knowing the rule, having a game plan and finding niche product is a winning recipe. |
Dr. Lee Kang, Director, Perrigo Company (USA) |
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