National Press Club Event to Highlight Patient Safety and Discuss Policy Recommendations for Moving Forward
WASHINGTON, April 16 /PRNewswire-USNewswire/ -- The Obama administration's goal of expanding the availability of generic forms of biologic drugs - and a variety of congressional efforts to fulfill the administration's goal - will be discussed on April 21st at the National Press Club in Washington, DC when the Jefferson School of Population Health hosts a forum on the quality and safety issues surrounding the creation of a regulatory pathway for follow-on biologic drugs. Attendees will also offer recommendations and key take-away messages for policy makers on Capitol Hill and in the administration.
The outcome of this debate is likely to have far-reaching implications with regard to access, cost, safety, and therapeutic impact for thousands of patients with serious, life-threatening, and chronic diseases. For this reason, it is critical that decision makers hear from all key stakeholders who have information and insights on the various touch points of this important health care issue before reaching a conclusion.
Many important factors must be taken into consideration when developing an appropriate process to review, assess, approve, and regulate the use of follow-on biologics and other related complex molecules:
- How to protect patient safety;
- What level of evidence should be required for consideration of use of a follow-on product;
- What factors should be considered when creating guidelines around interchangeability;
- How will post-marketing surveillance be conducted for these new products to monitor for adverse events;
- How will we determine efficacy; and
- What are the ethical considerations when conducting a cost-benefit analysis?
The April 21st event will be held at the National Press Club, Holeman Lounge, 529 14th Street, N.W., Washington, DC. The featured speakers at the event will be:
- David B. Nash, MD, MBA, Dean, Jefferson School of Population Health
- Geno Merli, MD, Professor of Medicine, Jefferson Medical College, Senior Vice President and Chief Medical Officer, Thomas Jefferson University Hospital
- Michael McCaughan, Editor-in-Chief, The Pink Sheet, FDC/Windhover Biopharma Group
- Ann Witt, JD, Health Counsel to U.S. Congressman Henry Waxman
Also speaking will be:
- Brian Harvey, MD, PhD, Vice President Regulatory Policy, sanofi-aventis
- R. Terry Hisey, Vice Chairman, U.S. Life Sciences Leader, Deloitte LLP
- Judith Jones, MD, PhD, President & CEO, Degge Group, Ltd.
- Laurence Kotlikoff, PhD, Professor of Economics, Boston University
- Gundu H. R. Rao, PhD, Professor, Laboratory Medicine and Pathology, Lillehei Heart Institute, Institute for Engineering Medicine, University of Minnesota
- Randy Vogenberg, RPh, PhD, Chief Strategic Officer, EPS LLC, Executive Director, Biologic Finance and Access Council
For more information on the forum, please visit: http://guest.cvent.com/EVENTS/Info/Invitation.aspx?i=73fb184e-40d2-4b90-8817-7601a080b179
A live webcast of this event is available. To register for the webcast please visit: http://www.visualwebcaster.com/event.asp?id=57562
Related medicine news :1
|SOURCE Jefferson School of Population Health|
Copyright©2009 PR Newswire.
All rights reserved
. Several Minnesota Medical Groups Improve Care for Patients Served by Minnesota Health Care Programs, but Disparities Gap Remains2
. Medical International Technology Inc. "MIT" announces a minimum of 6 million dollars exclusive agreement for a period of 5 years with a Malaysian Distributor for its Med-Jet(R) Needle-Free Jet-Injector3
. Varian Medical Systems to Exhibit the Latest X-Ray Image Detectors, and X-Ray Tubes at the CMEF Show in Shenzhen, China4
. California Certifying Board for Medical Assistants Signs Exclusive Contract with Pearson VUE5
. ATS Medical Announces Regulatory Approval of the ATS Open Pivot AP360 Mechanical Heart Valve in Japan6
. MedicAlert Brings History of Saving Lives to Chicago for Inaugural Thrive Allergy & Gluten-free Expo7
. Chicagos Top Minds Join National Business and Health Leaders in Addressing Medical Innovation, Highlighting Policies Needed to Maintain U.S. Competitiveness in Medical Science and Discovery8
. Medical Mutual of Ohio Names Dugan Chief Legal Counsel9
. Frost & Sullivan Recognizes Zecotek Photonics Medical Imaging Achievement, Development of Next-Generation Scintillation Crystals and Photo Detector Technology10
. Bruce R. Korf, MD, PhD is Named President of the American College of Medical Genetics11
. Delta Employees Blanket Salt Lake City Medical Center With Warm Gifts