|
|
 |
Expert Speaker
Dr. James J. Chen, President, Agno Pharma (USA)
Dr. Chen is currently President of Agno Pharma, an international pharmaceutical contract research and manufacturing company engaged in providing cGMP product development and API manufacturing services to both branded and generic pharmaceutical companies mainly in North America. In addition, Agno Pharma represents many reliable Chinese API manufacturers in registering and selling their products in North America. Dr. Chen has 15 years of pharmaceutical development & commercialization experience with both API and finished pharmaceutical products. His current responsibilities include setting corporative directives and strategies as well as developing strategic business partnership and alliance with clients and partnering suppliers. Dr. Chen has given numerous lectures in the area of “GMPs for APIs”, “CMC Regulatory Submissions and Requirements” and “Outsourcing APIs to China” in major US and Canadian cities. Prior to founding Agno Pharma, Dr. Chen was employed by the DuPont Merck Pharmaceuticals Company (now Bristol-Myers Squibb) and Schering-Plough Corporation. Dr. Chen published more than 20 research publications, including review articles and book chapters, and has given numerous podium presentations at national scientific, compliance and outsourcing meetings. Dr. Chen holds a Ph.D. in Chemistry from University of Pittsburgh, an DuPont Merck sponsored MBA from University of Delaware and a B.Sc. from State University of New York at Stony Brook.
Outsourcing of Clinical APIs: Is China Ready?
Abstract:India and China have been the major beneficiaries of outsourced pharmaceutical intermediates and generic APIs by North American clients. Due to competitive pressure, many North American clients have started to outsource clinical APIs and generic dosage forms, particularly to Indian CROs & CMOs. Clinical APIs involves more stringent intellectual property protection and higher degree of client services as compared to generic APIs. Is China ready to capitalize this high value-added business from North American clients? This presentation will provide unbiased perspectives on this topic. |
| Dr. James J. Chen, President & Founder, Agno Pharma (USA) |
 |
Expert Speaker:
Mr. Aviv Laor, Director, Azad Fine Chemicals (Switzerland)
Aviv Laor has been involved in the heart of the generic business for the past 15 years. He has studied, selected, managed the development of, and marketed many APIs in North America, Europe, and the Middle East. Mr. Laor has gathered experience in marketing simple molecules to highly complex Paragraph IV challenges. In addition to APIs, Aviv is also involved in the marketing of Finished Dosage and value added generics.
Mr. Laor is a graduate of Concordia University and lives in Montreal Canada with his family.
Introducing generic APIs to the Highly Competitive North American Market
Abstract:Planning to introduce Generic APIs to the North American market involves many considerations. This presentation will go over key deliberations such as understanding where the market is headed, where your clients are going, and how you are perceived. In addition, we will look at positioning your line of products, patent considerations, revenue timing, and customer relations. By the end of the presentation the audience will get a better sense of what it takes to plan for the North American future.
|
| Mr. Aviv Laor, Director, Azad Fine Chemicals (Switzerland) |
 |
Expert Speaker:
Mr. Max Zive, President, Zipharm International Inc (Canada)
A pharmacist by profession, Max Zive resides in Toronto, Canada and has extensive pharmaceutical experience in North America and internationally.
He presently serves as President, of Zipharm International Inc, a company he founded in 1998 specializing in:
Regulatory Affairs
Business Consulting Services
R&D Projects
Marketing of Pharmaceuticals, Medical Devices
Pharmaceutical Formulation and Product development
Registration of pharmaceuticals, medical devices and herbal medicines
Organizing and providing educational “certification courses” e.g. Regulatory Affairs; Manufacturing Operations; Quality Control (Laboratory); Quality Assurance etc.
Arranging Clinical and Biostudies for Medicines and Medical devices
International distribution network.
Early in his career, Mr. Zive was instrumental is establishing, Genpharm Inc, a company that was to become one of Canada’s leading generic drug manufacturers and distributors generating sales over $450,000,000 per annum before merging with E.Merck of Germany in the 1990’s. As one of the company’s first Presidents, he established “state of the art” pharmaceutical manufacturing facilities, analytical laboratories and an R&D centre. He also oversaw clinical and bio studies for newly developed drugs.
Canadian Client Expectations in Sourcing Generic API’s
Abstract:China represents an enormous opportunity, not just as a source of competitively priced APIs, but also the sale of pharmaceutical products in China forecast to grow between 15 and 17% per annum between 2006 to 2008. China and India combined are now the major exporters of Active Pharmaceutical Ingredients (APIs) in the world.
China represents a low cost R&D environment is a major driver in this off-shore trend. In China chemists and researchers are in the order of 60-70% lower than the costs of similarly experienced staff in the West. To API manufacturers in particular, export markets are vital, and for the indigenous drug manufacturing sector, alliances with Western pharmaceutical companies are just as important.
Some very real problems had slowed the pace of both these developments, namely lack of GMP compliance, and the somewhat shaky stance on the protection of intellectual property (IP) in China. Still today the majority of API and pharmaceutical manufacturers do not meet GMP standard Q7A in China.
The State is legislating heavily in the area of compliance, but implementation is slow, and has instituted rigorous GMP regulations to ensure that Chinese pharmaceutical companies can hold their heads up on the world stage, and can compete with as well as ally themselves with established Western manufacturers. WTO membership has forced China to tackle compliance and IP issues head-on, but unfortunately lacking the expertise to assist the companies to reach the Q7A compliance standards as well as the GMP standards of EU and North America, will take a long time until they reach their goals, but eventually this will inevitably result in the creation of more and more business opportunities for Western pharmaceutical enterprises looking to set up independent or joint-venture Chinese-based companies, or to source high quality APIs.
Our presentation provides “The Outsourcing Expectation from a Canadian Client perspective”. The lessons learned from the Canadian perspective can also relate to other Western countries due to similarity of our GMP regulations. |
Mr. Max Zive, President, Zipharm International Inc (Canada) |
|
 |
Expert Speaker:
Dr. James J. Zhu, Partner, Perkins Coie LLP (USA)
Dr. James Zhu is currently a partner in Perkins Coie's Los Angeles Office, and the managing partner of Perkins Coie's Beijing Office. James' practice includes patent procurement, patent opinion, patent analysis & strategy, intellectual property litigation, technology licensing, primarily focusing on life science, material science, medical devices, etc. Prior to his advancement in law, James was President and CEO of China United On-line, a company of over 400 employees and 18 subsidiaries in China. James was a co-founder and General Counsel of GanTech International, a Silicon Valley start-up where he helped to raise capital commitment of $17 million from a venture capital firm, the Sprout Group, and spearheaded legal and business development activities. In early 90s, James worked at the pharmaceutical giant Merck & Co. as a research scientist.
James is a frequent author and speaker for various intellectual property related subjects. A registered patent attorney at the US Patent & Trademark Office, James is a member of the State Bar of California, American Intellectual Property Law Association, and the License Executive Society. James has been actively involved with the BIO organization where he serves as a delegation committee member and promotes the presence of the Chinese delegation and pavilion in BIO. James is a mentor in the Southern California BioMedical Council where he advises a number of start-ups in Los Angeles areas. James also sits in the Boards of BayHelix Group and Chinese Biological Investigator Society (Wu-Ray Society).
James graduated from Fudan University. With a total of seven academic years, James obtained a Ph.D. degree in Molecular and Cellular Biology from the California Institute of Technology and J.D. & MBA dual degrees from Columbia University.
Intellectual Property Issues in Outsourcing - Measures to Lower IP Risks But Increase Business Opportunities.
Abstract:Pharmaceutical outsourcing is closely associated with intellectual property (IP) protection and risks. In the rapidly evolving IP system in China, how to protect you IP in outsourcing, how to lower your IP risks, how to become IP-savvy outsourcing companies, how to attract more IP-heavy outsourcing work of higher profit margin, and how to create business entry barrier using IP shield are issues to be discussed during the presentation. |
Dr. James J. Zhu, Partner, Perkins Coie LLP (USA) |
|
 |
Expert Panelist:Dr. Wayne Li, Project Manager, Morningside Techologies (HK)
Dr. Wayne Li has over 18 years of experiences in pharmaceutical and biotech research and development. He joined Morningside Technologies in 2007, which focused heavily on biopharmaceutical and health care investments at early and middle stages. Prior to joining Morningside Technologies, Dr. Wayne Li was the Director of the Drug Metabolism and Pharmacokinetic Department at Genelabs. Before taking this position, he served as the Manager of Preclinical Pharmacology Department at Rigel. He had also served as a Project Manager in Pharmaceutical Chemistry Department of Covance Laboratories Inc. Dr. Li got his Master of Science Degree from Research Center for Eco-environmental Sciences, Chinese Academy of Sciences and Ph.D. from Brigham Young University. He did his post-doctor research at Haskell Laboratory for Toxicology and Industrial Medicine of DuPont Company and worked thereafter as a research chemist for more than 5 years. Through his career, Dr. Li has more than 30 peer-reviewed papers published in leading scientific journals and more than 34 presentations on international or national conferences. His research interests and expertise ranged from separate science, drug metabolism and pharmacokinetics, various in vitro and in vivo preclinical studies for drug discovery and development, pharmaceutical chemistry, to research and developmental project licensing-in or licensing-out deals.
Status of CRO/CMO in China: A US Returnee Perspective
|
Dr. Wayne Li, Project Manager, Morningside Techologies (HK) |
|
|
|
|
