An Open Forum on Scientific and Regulatory Issues — March 2–4, 2008 — Boston Marriott Copley Place Hotel
The Barnett Institute of Chemical and Biological Analysis at Northeastern University is proud to announce its role as host of BIOGENERICS 2008: An Open Forum on the Scientific and Regulatory Issues, held from March 2–4, 2008. By the year 2010, $20 billion worth of protein pharmaceuticals will be off patent and in a market open to generic manufacturers. The Institute will act as a catalyst to assemble influential industry leaders on the global level for a comprehensive and open discussion about the questions and issues surrounding this development. The unique conference will showcase the latest scientific advances, specific case histories and distinguished panels.
The Barnett Institute at Northeastern is a leader in bioanalytical research. This conference underscores this leadership role in analytical and scientific aspects of protein analysis by bringing all constituencies together to address unmet scientific needs of regulators.
“The decisions addressing the biogeneric industry will have far reaching impacts in the futures of the pharmaceutical, healthcare and biotechnology industries worldwide,” said Barry L. Karger, Director of the Barnett Institute and James L. Waters Chair at Northeastern. “BIOGENERICS 2008 will bring the highest levels of industry and regulatory leadership into an open and detailed discussion, focusing on the scientific methodology needed by the FDA to determine that biogenerics are appropriately safe and effective.”
The decisions on biogenerics will be of crucial importance to other areas as well, including research, academia, insurance, advocacy, venture capital and the media. For the first time ever, this three-day conference will bring together a distinguished group of academics, industrial leaders, regulators, lawyers and legislators from all of these areas to discuss important concerns facing the biogenerics (biosimilars) industry.
A welcome address via video is scheduled to be given by Senator Edward Kennedy, Chairman of the U.S. Senate Committee on Health, Education, Labor and Pensions on Sunday, March 2nd.
The following two days of events will include plenary lectures followed by presentations and panel discussions:
Monday, March 3rd
o Plenary Lecture by Dr. Randall Lutter, Deputy Commissioner for Policy, U.S. Food and Drug Administration (FDA)
o Bioanalytical – Presentations and panel discussion by Barry L. Karger, Director of the Barnett Institute and James L. Waters Chair, Northeastern University (Panel Chair); Charles DiLiberti, Vice President of Scientific Affairs, Barr Laboratories, Inc.; Reed Harris, Director of Analytical Development, Genentech, Inc.; Ram Sasisekharan, Professor of Biological Engineering, MIT; Emily Shacter, Chief, Lab. Of Biochem., Div. of Therapeutic Proteins, CDER, FDA; and Huub Schellekens, Professor, Director of the Central Lab Animal Institute, Utrecht University.
o Immunogenicity – Presentations and panel discussion by James D. Green, Sr. Vice President of Preclinical and Clinical Development Sciences, Biogen Idec, Inc. (Panel Chair); Takeo Hayakawa, Senior Advisor, Pharmaceutical and Medical Devices Agency, Japan; Amy Rosenberg, Director, Division of Theraspeutic Proteins, FDA; Meena Subramanyam, Sr. Director, Clinical Science & Technology, Biogen Idec, Inc.; and Steve Swanson, Director of Clinical Immunology, Amgen, Inc.
Tuesday, March 4th
o Plenary Lecture by Dr. Jean-Hugues Trouvin, Chair of Biologics Working Party, European Medicines Agency (EMEA).
o Biomanufacturing – Presentations and panel discussion by Toni Lubiniecki, Vice President of Technology Transfer & Project Planning, Centocor, Inc. (Panel Chair); Stuart Builder, Consultant, Strategic Biodevelopment; William S. Hancock, Professor of Chemistry and Bradstreet Chair, Barnett Institute, Northeastern University; and Ganesh Venkataraman, Sr. Vice President, Momenta Pharmaceuticals.
o Regulatory – Presentations and panel discussion by Stephen G. Dilly, CEO, APT Pharmaceuticals, Inc. (Panel Chair); Robert Garnick, Sr. Vice President of Regulatory, Quality and Complience, Genentech, Inc.; Mathias Hukkelhoven, Sr. Vice President, Global Head of Drug Regulatory Affairs, Novartis; Peter Hutt, Sr. Counsel, Covington & Burling, LLP; and Alison Lawton, Sr. Vice President, Regulatory Affairs and Quality Systems, Genzyme Corp.
Regulatory agencies have been responding to the general public’s need for inexpensive products. This conference will focus on products that are far more complicated than small molecule generic drugs, and will explore what type of equipment is needed to test similarity, in addition to the types of science needed for effective regulation of products.
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in interdisciplinary research, urban engagement, and the integration of classroom learning with real-world experience. The university’s distinctive cooperative education program, where students alternate semesters of full-time study with semesters of paid work in fields relevant to their professional interests and major, is one of the largest and most innovative in the world. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in six undergraduate colleges, eight graduate schools, and two part-time divisions. For more information, please visit www.northeastern.edu.
About The Barnett Institute
The Barnett Institute at Northeastern University is recognized internationally as one of the premier centers for cutting-edge research and advanced training in analytical chemistry for biomedical applications. Established in 1973, the Institute’s close ties to the medical community and industry in Boston and beyond, along with its active program of licensing technology, provides for many “real life” applications of research advances which have led to innumerable published papers and 70 patents.Bioanalytical research is at the interface of biology, medicine, informatics and chemistry. Students and staff in the Institute are trained to think analytically and to understand the complexity of biological samples. The Institute’s entrepreneurial approach and commitment to excellence has trained over 300 students to become leaders in industry and academia worldwide.