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Biotechnology: The Future for Biosimilars

2007 saw the 25th anniversary of the first genetically engineered drug approved by the FDA- Humulin, recombinant insulin. Patents of many of the biotechnology industry's best-selling drugs have already expired or are set to expire in the next few years. While the EU has already approved the first follow-on-biologics, the U.S. has yet to define a pathway for regulatory approval. Panelists will address the competitive dynamics in the follow-on-biologics landscape from the perspective of innovator biotech companies and follow-on companies. This panel will also discuss the main areas of concern from a legislative, policy, regulatory, scientific, and economic perspective.

Confirmed Panelists:

Moderator & Panelist Bios

Laura Furstenthal Ph.D., Associate Principal, McKinsey & Company
Laura Furstenthal is an Associate Principal in McKinsey & Company's Silicon Valley Office and a leader within the West Coast Healthcare Practice. She serves health care clients in the pharmaceutical, biotechnology, and medical device sectors across the U.S., Europe, and Japan. Examples of her experience include:

  • Competitive strategy: Developing strategies to optimally compete in markets for biopharmaceutical and medical device products, where she is one of McKinsey's Firm experts in war gaming.
  • Mergers & Acquisitions and Post-Merger Management: Leading major efforts with global biopharmaceutical and medical device manufacturers to plan and execute deals valued from ~$50 million - $10+ billion, and to execute post-merger integration.
  • Supply chain operations: Optimizing global supply chains for biopharmaceutical and medical device manufacturers through creative partnerships and development of new supply chain models that have saved >$1 billion in cumulative value.
  • R&D Strategy: Working with multiple pharmaceutical and biotech players to transform R&D performance through changes in portfolio, TA strategy, governance processes, and operational improvement.
  • Technology strategy and commercialization: Working with multiple leading platform technology companies to develop commercialization strategies for new products and new applications of cutting-edge technology to healthcare industry.
  • Non-profit strategy: Working with non-profit organizations, governments, and Nobel Laureates on a wide variety of topics from business models for children's organizations, to global vaccination strategies for under-served populations, to development of leading research institutions at the interface between academia and industry.
  • Personal Counseling: Active in personal counseling of CEOs and Executive Management on strategic, operational and organization issues.
    • Dr. Furstenthal has an A.B. in Biology from Harvard University and worked as a laboratory researcher studying osteoarthritis at Massachusetts General Hospital. She received a Ph.D. in Cancer Biology from Stanford University, where she studied cell cycle control and taught a course on the underlying mechanisms of carcinogenesis.

William F. Bennett, Ph.D., Sr. Director of Regulatory Science and Policy Assessment, Genentech
Bill Bennett is Sr. Director of Regulatory Science and Policy Assessment at Genentech, and leads the Genentech Biosimilars working group. He has been at Genentech for 18 years altogether, having held high-level positions in Research, Process Development, and Regulatory Affairs. Scientifically, his work on human growth hormone and tissue-type plasminogen activator has resulted in over 50 publications and 19 US patents. He led the research and development of Activase & TNKase, (first and second generation thrombolytic treatments for Acute Myocardial Infarction and Stroke). During a period away from Genentech, as CSO at Sensus Corporation, he led the research & development of Somavert (a treatment for acromegaly) and was the VP of Research at Cor Therapeutics, and the Sr VP of R&D at Nuvelo. He returned to Genentech in 2003. Bill has a Ph.D. in Biochemistry from the University of Texas Southwestern Medical School.

David Essayan, MD, Executive Vice President, ONCORD Inc.
David M. Essayan, MD, FACP is Executive Vice President for ONCORD, Inc., a clinical and regulatory consulting firm based in southern California. Prior to joining ONCORD, David was Executive Director of Regulatory Affairs at Amgen, Inc., where he held global responsibility for both pipeline and marketed products in the inflammation and general medicine therapeutic areas. Prior to Amgen, David was a Supervisory Medical Officer in the Office of Therapeutics Research and Review, CBER/FDA and a Principle Investigator in the Laboratory of Tumor Molecular Biology, CBER/FDA.

David received his BS in Chemistry from Yale University and his MD from the University of Pennsylvania. He completed his Residency in Internal Medicine at Temple University Hospital and his Fellowship in Allergy and Clinical Immunology at the Johns Hopkins University School of Medicine, where he held a faculty appointment for 12 years. David is Board Certified in both Internal Medicine and Allergy and Clinical Immunology.

Deborah Wong, Director of Operations Strategy, Amgen
Deborah Wong is Director of Operations Strategy at Amgen. She joined Amgen in 2006 and is responsible for providing operations-focused strategic analyses and recommendations to Amgen's executive/senior leaders. She has led several cross-functional projects advancing Amgen's corporate and operational strategies including: Biosimilars, pipeline development, platform technologies and product fulfillment. She is an active participant of Amgen's Global Taskforce on Biosimilars and CMC Strategy Council. Previously, Ms. Wong was an associate in the Health Practice at Booz Allen Hamilton, a management strategy consulting firm. There she served a number of clients in pharmaceutical industry and health regulatory agencies including the Bayer (now Bayer Schering Pharma), Food & Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS). She was also scientific researcher in the Molecular Oncology Research group at Genentech, Inc where she focused on the cell biology and protein engineering of second-generation Herceptin molecules.

Ms. Wong attended the University of Michigan where she earned a BS in Molecular Biology and attended the F.W. Olin Graduate School of Business at Babson College where she earned a MBA.

Harald Summer, Technical Project Manager - Biopharmaceutical Operations, Novartis
Dr. Harald Summer, PMP, is Technical Project Manager within Biopharmaceutical Operations at Novartis, Vacaville, CA since the beginning of 2008. He received his Ph.D. in Chemistry and worked several years as synthetic organic chemist within Sandoz in Austria. In 1999 he became International Project Manager for the development of generic chemical drugs.

In 2005 Novartis and Sandoz combined their biopharmaceutical development and production activities in the Biopharmaceutical Operations unit (BPO). BPO is located at several facilities in Switzerland, France, Austria, US and Slovenia. Harald joined this unit in 2005 as Technical Project Manager. He managed the transfers of cell culture products from Novartis to BPO and the subsequent production of Drug Substance for clinical studies and he was also responsible for the technical development of several biosimilar products.

Richard Lieblich, Pharmacy Director of Contracting, Blue Shieldof California
Richard Lieblich is Director of Pharmaceutical and Pharmacy Network Contracting for Blue Shield of California. In this role he oversees Pharmaceutical Contracting, Pharmacy Network Contracting, Therapeutic Strategies, Data and Trend Analysis, and Quality Assurance.

Prior to joining Blue Shield, Richard was with Kaiser Permanente for fifteen years serving in various roles; Assistant Director of Pharmacy Materiel Services, Clinical Operations Manager and Drug Education Coordinator. Previous to Kaiser Permanente, Richard held various management positions in community and hospitals pharmacies in California and Massachusetts.

Richard holds B.S. in Pharmacy from the Massachusetts College of Pharmacy and has served as a clinical instructor for the Massachusetts College of Pharmacy and Northeastern University. He is an active member of a number of national pharmaceutical organizations.