Examining the Roadmap to Therapeutically Equivalent Biologics: Are Therapeutically Equivalent Biologics Feasible and Desirable? 3/5/2003
From: Jean Campbell of the National Organization for Rare Disorders, 203-744-0100 News Advisory: BACKGROUND: As controversy regarding the skyrocketing costs of key drugs and biologicals continues to escalate, this invitation-only conference, hosted by the National Organization for Rare Disorders, will address the question: Can equivalent biologics be produced safely and economically to increase access and reduce costs for biologics treatments for people afflicted with rare "orphan" diseases? Speakers will address that question by exploring the scientific, legal, regulatory, and economic issues surrounding this increasingly important healthcare issue. Attendance is complimentary but registration is required to reserve your seat. Please contact Jean Campbell at (203) 744-0100 When: Wednesday, March 19, 2003 Where: Capital Hilton, 16th & K Streets NW, Washington, DC 20036, Congressional/Senate Rooms Time: 9 a.m. to 4 p.m. Agenda: Continental Breakfast and Registration will be held from 7:00 a.m. to 8:45 a.m. in the Congressional Room at the Capital Hilton Hotel. 9:00 a.m. -- Introduction -- Abbey Meyers, President, National Organization for Rare Disorders (NORD) 9:15-10:15 a.m. -- Genomic Therapeutics, -- Dr. Alan Guttmacher, Deputy Director National Human Genome Research Institute (15 min. Q&A) 10:15-11:00 a.m. -- An Update on the CBER/CDER Consolidation Initiative -- Dr. Mac Lumpkin, Principal Associate Commissioner Food & Drug Administration (FDA) (15 min. Q&A) 11:00-11:15 a.m. -- Coffee Break 11:15-12:15 p.m. -- Developing and Marketing Therapeutically Equivalent Biologics in Europe -- Mrs. Zdravka Knezevic, Director of Development -- Mr. Nediljko Pavlovic, Deputy Director of Biotechnology PLIVA, Inc. (10 min. Q&A) 12:15-1:00 p.m. -- Lunch, South American AB Room 1:00-1:45 p.m. -- USP Approach to Considering Science Factors -- Dr. Roger Williams, Executive Vice President, U.S. Pharmacopoeia (10 min. Q&A) 1:45-2:30 p.m. -- Legal and Regulatory Issues -- Frank Sasinowski, Hyman, Phelps & McNamara, P.C. (15 min. Q&A) 2:30-3:00 p.m. -- Economic Factors: Current Marketing Dynamics for Generics -- Dr. Ernst Berndt, Professor of Economics, Massachusetts Institute of Technology (MIT) 3:00-4:00 p.m. -- Economic Factors Affecting Therapeutically Equivalent Biologics -- Panel Discussion moderated by Dr. Berndt -- Dr. Stephen Schondelmeyer, Professor of Pharmaceutical Economic, University of Minnesota -- Dr. James Green, Vice President Pre-clinical and Clinical Development Sciences, Biogen, Inc. -- Marvin Samson, President & CEO, Sicor, Inc. -- Dr. Anthony A. Barrueta, Senior Counsel Government Relations, Kaiser Foundation Health Plans 3:40-4:00 p.m. -- Questions to Panelists 4:00 p.m. -- Closing Remarks -- Abbey Meyers |