WASHINGTON, DC – (May 9, 2012) – The U.S. regulatory environment strongly impacts innovation and the development of new drugs and biologics. With this in mind, the Achieving Regulatory Approval and Compliance educational track at the 2012 BIO International Convention will tackle the most pressing regulatory issues facing the industry, specifically the reauthorization of the Prescription Drug User Fee Act (PDUFA V), implementation of the new biosimilars pathway, and efforts to modernize and expedite drug development. Hosted by the Biotechnology Industry Organization(BIO), this year’s global event for biotechnology will take place June 18-21, 2012 at the Boston Convention and Exhibition Center in Boston, MA.
“Attendees can expect to hear from a distinguished group of speakers from the Food and Drug Administration (FDA), as well as major biotechnology and pharmaceutical companies,” said BIO CEO and President Jim Greenwood. “Sessions will address the steps involved in research and development of healthcare products and how to successfully bring these products to market, all while maintaining rigorous standards for safety, effectiveness, and compliance.”
Session highlights include:
FDA Town Hall
In this session, senior U.S. Food and Drug Administration leaders will discuss current hot topics in each of the centers for review of drugs and biologics, CDER and CBER, including PDUFA V and the process for human drug review; efforts to advance innovation and expedite patient access to novel therapies for serious and life-threatening conditions; regulatory science and approaches to integrating new scientific tools into FDA regulatory practices; appropriate FDA access to external medical and scientific expertise; FDA funding and scientific infrastructure; transparency initiatives; and biosimilars implementation. Time is planned for interactive discussion with attendees.
Tuesday, June 19, 2:00 p.m. – 3:30 p.m.
Speakers: Karen Midthun, MD, Director, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA) and Janet Woodcock, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)
PDUFA V: Impact on Innovation, Patients, and Modern Medicines– Super Session
Industry leaders will discuss the reauthorization of the Prescription Drug User Fee Act (PDUFA V) and efforts to modernize the FDA regulatory environment, as well as the implications for patients, providers, and the industry.
Sponsored by MedImmune.
Wednesday, June 20, 3:45 p.m. - 5:15 p.m.
Moderator: Steve Usdin, Washington Editor, BioCentury, Co-host, BioCentury This Week
Speakers: Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council, Peter Greenleaf, President, MedImmune, and Margaret Hamburg, M.D., Commissioner of Food and Drug Administration (FDA)
Analysis and Impact of PDUFA V: What Regulatory Affairs Professionals Need to Know
The pharmaceutical industry and FDA concluded Prescription Drug User Fee Act (PDUFA V) discussions in May of 2011. Prior to its enactment in October 2012, regulatory affairs professionals will need to understand the terms of the new PDUFA agreement, the rationale behind it, and the practical impact it will have on interactions with the FDA. One of the most significant changes is a new review model for new molecular entity (NME) applications that will enhance FDA-Sponsor communication. These new interactions represent a paradigm-shift in how FDA conducts an NME review. The panel will educate attendees on the significance of these changes for biopharmaceutical companies and will highlight other PDUFA V initiatives.
Tuesday, June 19, 8:30 a.m. - 9:45 a.m.
Moderator: Janet Jenkins-Showalter, Senior Regulatory Group Director, Genzyme, A Member of the Roche Group
Speakers: Andrew Emmett, Managing Director, Science and Regulatory Affairs, Biotechnology Industry Organization, Kay Holcombe, Senior Policy Advisor, Genzyme, a Sanofi Company, and Patrick Frey, Director, Office of Planning and Analysis, Center for Drug Evaluation and Research (CDER), Food and Drug Administration
Interchangeable Biosimilars: Distinguishing between Aspiration and Achievement
In recent months, FDA has issued draft guidances that detail how the Agency will implement the new regulatory pathway for the review and approval of biosimilars. As part of the ongoing implementation process, FDA is expected to evaluate the interchangeability of biosimilar products—whether a patient can be switched from one product to the other without involving a prescriber. Panelists will discuss the scientific and administrative challenges of interchangeability; how it affects manufacturers, health care providers, patients and payers; and what public policy issues it raises.
Thursday, June 21, 8:30 a.m. – 9:45 a.m.
Moderator: Ramsey Baghdadi, Senior Editor, The RPM Report
Speakers: Erika Lietzan, Special Counsel, Covington & Burling LLP,Joseph Miletich, Senior Vice President, Research and Development, Amgen, Gregory Schimizzi, Co-Founder, Carolina Arthritis, Coalition of State Rheumatology Organizations and Jan Wyatt, Patient Advocate, Arthritis Foundation
Biological Product Pediatric Development in the US: Implementation of PREA and BPCIA
With the passage of the EU Pediatric Legislation of 2007 and the required Pediatric Investigational Plan after Phase 1 and more recently the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) companies are now challenged to craft pediatric development plans for four pieces of legislation, two health authorities and one highly vulnerable pediatric population to be able to achieve regulatory compliance and business incentives for biological drug products in the pipeline. Attendees will learn about their R&D obligations under these policies—as well as the available opportunities and incentives—for developing biological products.
Monday, June 18, 3:45 p.m. – 5:00 p.m.
Moderator: Chin Koerner, Executive Director, Novartis Pharmaceuticals
Speakers: Barbara Buch, MD, Supervisory Medical Officer, Center for Biologics and Evaluation Research, Food and Drug Administration (FDA), Sharon Olmstead, Vice President, Novartis Pharmaceuticals and Karen Weiss, Vice President, Janssen Research and Development
The BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world. Speakers at the sessions will share breakthroughs in medicine, diagnostics, the environment, energy production, business operations, financing, partnerships, policy issues and food and agriculture. Visit http://convention.bio.org/program/ for the most up-to-date program and speaker information.
The Convention also features the BIO Business Forum, a unique platform for biotechnology and pharmaceutical companies, academic research institutions, and investors from around the world to gather and discuss strategic opportunities. For registration, conference agenda and exhibitor information, visit2012 BIO International Convention.
Upcoming BIO Events
May 15-16, 2012
June 18 – 21, 2012
September 12 – 13, 2012
September 19 – 21, 2012
Kansas City, MO
October 9-10, 2012
San Francisco, CA
October 24 – 25, 2012