Pharmaceutical Challenges and Opportunities in Asia

Speakers

Joshua Berlin Executive Editor & Director of Business Development

Elsevier Business Intelligence

Joshua Berlin is Executive Editor & Director of Business Development for Elsevier Business Intelligence (EBI), a global publisher that provides analysis and insight on the biopharma and medical device industries. At EBI, Mr. Berlin is responsible for generating business and editorial opportunities for a suite of industry-leading publications, including “The Pink Sheet”; IN VIVO; and PharmAsia News. He also spearheads emerging markets strategy, including the development and launch of PharmAsia News, a daily online publication that provides regulatory and business intelligence to life sciences executives doing business in China, India and other Asian markets, and the PharmAsia Summit, an annual strategic conference.

Jeff Shacket Practice Area Leader

Gerson Lehrman Group

Jeff Shacket is the Practice Area Leader for Healthcare in the Americas. Mr. Shacket joined the Gerson Lehrman Group in December 2009 after ten years with Thomson Reuters. At Thomson, he directed industry analysts who delivered stock market intelligence and investor relations support to senior executives at leading healthcare and biotech firms. Jeff earned his undergraduate degree from Cornell and a graduate degree from Harvard.

Katherine Wang Counsel

Sidley Austin LLP

Katherine Wang is a Counsel for Sidley Austin LLP’s Global Life Sciences Practice in Beijing/Shanghai. She advises pharmaceutical, biotechnology, and medical device companies on a wide range of corporate, commercial, and regulatory matters, including product registration, pricing, reimbursement, clinical studies, sales and marketing practices, licensing, and corporate structure. Prior to joining Sidley Austin, Ms. Wang was the head of AstraZeneca’s legal departments in the Asia Pacific and China. She advised on critical strategic and operational initiatives to ensure statutory compliance and realization of business objectives. She was also responsible for cross-functional intellectual property enforcement and anti-counterfeiting efforts. She was selected as one of the top 25 in-house counsels in the Asia Pacific by Asia Legal Business. 

Dr. James Zhu Partner

Jun He Law Offices

Dr. James Zhu is a partner at Jun He Law Offices responsible for co-building the firm’s IP practice as well as its Silicon Valley office. Dr. James Zhu’s practice includes intellectual property (IP) counseling, strategies, analysis, opinion, procurement, litigation and technology licensing in a wide range of technology fields including life sciences, biopharmaceutical, energy, material sciences, medical devices, and electronics. James represents international companies to protect and enforce their IP rights and expand their research capacity and collaboration in the rapidly evolving but challenging Chinese environment.  As a conduit between China and the rest of the world, James provides IP advice and strategies for international companies’ entry into China as well as Chinese companies’ inroad into the global market. A registered patent attorney at the US Patent & Trademark Office and a licensed attorney in California, James is a member of the State Bar of California and American Intellectual Property Law Association.

Nathan A. Evans Associate

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Nathan Evans practices complex patent litigation with a specialty in chemical and pharmaceutical technologies. His experience extends from litigation preparation to discovery, trial, and appellate work. He also has experience with due diligence matters, opinion work, as well as client counseling in the fields of litigation and patent prosecution for both domestic and international companies, including start-up companies. Active in leadership roles at American Bar Association, co-chairing subcommittees regarding compulsory licensing issues and changes to India’s patent law regime. He is also the coauthor for several successful publications.

Dean Edwards

IMS Health

Dean Edwards is VP Sales, Asia Pacific, and heads up a team of over 60 sales professional, who are responsible for business development and client relationships for the IMS Health portfolio, across the Asia Pacific region. Previously he was Practice Leader, Performance Management in Asia-Pacific. This Practice Area was focused around the Primary Market Research offerings of IMS Health. With his team of market research experts he managed a wide variety of qualitative and quantitative market research surveys and provided strategic consulting services. These supported decisions on product launch strategies, product positioning, sales force optimization and customer satisfaction. The projects spanned different therapeutic areas from Cardiovascular, Hepatitis B, Respiratory to Musculoskeletal, Pain and Oncology.

Wenseng Pan, JD, PhD Associate

Morgan Lewis & Bockius

Wenseng "Wendy" Pan is a member of the life sciences practice group of Morgan Lewis & Bockius. Ms. Pan advises multinational pharmaceutical companies, biotech startups, specialty pharmas, and medical device companies in structuring and negotiating all phases of complex commercial transactions. Her practice covers early stage research collaboration, product and technology licensing, and global alliance formation for product development and commercialization, as well as asset acquisition and divesture, manufacturing, and supply agreements. As a former scientist and a registered U.S. patent attorney, Ms. Pan provides unique knowledge in resolving business and patent issues in commercial transactions relating to small molecular drugs, biologics, medical devices, protein and antibody-related platform technologies, and drug-delivery technologies. Ms. Pan also has significant experience in mergers and acquisitions (M&A) and the aggregate value of the M&A transactions she has advised is above $10 billion.

Alberto Grignolo, PhD Corporate Vice President

PAREXEL Consulting

Alberto Grignolo, Ph.D. is a Corporate Vice President at PAREXEL Consulting. An 18-year veteran of the firm who led and developed the Drug Development Consulting Practice to be recognized among the best in the world, he is now responsible for the firm’s Global Strategy and Services for bio/pharmaceutical and medical device client companies, with a particular focus on Asia Pacific, Latin America and other emerging markets. He advises clients in the areas of drug development strategy, regulatory negotiation and best regulatory and clinical practices. Dr. Grignolo is a Member of the Executive Committee of the Clinical Trials Transformation Initiative (CTTI), a Public Private Partnership between the FDA and Duke University aiming to increase the quality and efficiency of clinical trials. He was the winner of the 2008 Lifetime Achievement Award from the GCP Journal and was recognized as one of the 100 Most Inspiring People in the Life-Sciences Industry in 2008 by the readers of PharmaVOICE.

Robert A. Rhoades Senior Director & Practice Leader, Quality Systems

Quintiles

Within his thirty-two year career, Robert A. Rhoades has been a preferred advisor to senior pharmaceutical and medical device executives regarding compliance and its impact on corporate direction and strategy. A skilled practitioner of both the Quality System Regulation (QSR) and the pharmaceutical cGMPs, he has designed and implemented compliance improvement initiatives for major manufacturers in the US, Europe, China and India.

Mr. Rhoades is often engaged to provide post-Warning-Letter guidance and remediation project management to re-establish client credibility with the FDA, as well as assisting manufacturers in proactively designing quality systems to assure successful inspections. Mr. Rhoades has also worked in concert with client counsel on a wide variety of legal cases. He was selected by client counsel to advise in the contaminated heparin crisis that reached world-wide proportions in 2008. He is currently managing third-party oversight for a landmark FDA enforcement action of a major global pharmaceutical producer.

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