Navigation Links
Medical Community Reacts to Obama and Congressional Plans to Approve Generic Forms of Biologic Medicines
Date:4/16/2009

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


'/>"/>
SOURCE Jefferson School of Population Health
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Several Minnesota Medical Groups Improve Care for Patients Served by Minnesota Health Care Programs, but Disparities Gap Remains
2. 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-Injector
3. Varian Medical Systems to Exhibit the Latest X-Ray Image Detectors, and X-Ray Tubes at the CMEF Show in Shenzhen, China
4. California Certifying Board for Medical Assistants Signs Exclusive Contract with Pearson VUE
5. ATS Medical Announces Regulatory Approval of the ATS Open Pivot AP360 Mechanical Heart Valve in Japan
6. MedicAlert Brings History of Saving Lives to Chicago for Inaugural Thrive Allergy & Gluten-free Expo
7. 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 Discovery
8. Medical Mutual of Ohio Names Dugan Chief Legal Counsel
9. Frost & Sullivan Recognizes Zecotek Photonics Medical Imaging Achievement, Development of Next-Generation Scintillation Crystals and Photo Detector Technology
10. Bruce R. Korf, MD, PhD is Named President of the American College of Medical Genetics
11. Delta Employees Blanket Salt Lake City Medical Center With Warm Gifts
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... Scottsdale, AZ (PRWEB) , ... January 24, 2017 , ... ... than 30 lives in the last month. Yellow fever is primarily spread through contact ... the health community’s focus on how to prevent its spread. , According to multiple ...
(Date:1/24/2017)... ... January 24, 2017 , ... “Spiritual ... improve the connection with God. “Spiritual Vitamins: A Spiritual Energy Booster” is the ... Christian Faith Publishing, Mathai Yohannan’s new book engages the mind and spirit in ...
(Date:1/24/2017)... ... January 23, 2017 , ... CLICKco LLC, a ... drink, announced its CLICK® Coffee Protein Drink is now available for purchase on ... has become popular among health-conscious consumers who love coffee but are looking to ...
(Date:1/24/2017)... ... 23, 2017 , ... Texas Home Health, an AccentCare, Inc. ... care service companies: Padre Home Health in Corpus Christi, Texas, and Royalty Personal ... regarded in their respective markets, these two agencies align with Texas Home Health’s ...
(Date:1/23/2017)... ... January 23, 2017 , ... A Northwestern Pennsylvania addiction treatment ... Alpine Springs Rehabilitation & Recovery Center’s new website can be found at ... its redesigned and retooled website. The treatment center has also revamped its social ...
Breaking Medicine News(10 mins):
(Date:1/24/2017)... NEW YORK , Jan. 23, 2017 /PRNewswire/ ... a long way from conventional syringes with vials ... free systems. These modern devices have become preferred ... demand for prefilled syringes has been rising strongly ... of healthcare facilities are now adopting this format ...
(Date:1/24/2017)... , January 23, 2017 ... Growth A majority of medicines ... formulating Active Pharmaceutical Ingredients (API), and such processes require ... glycol. Production of pharmaceutical solvents continues to ... excluding Japan (APEJ) region as ...
(Date:1/23/2017)... Endo International plc (NASDAQ / TSX: ENDP) ... a joint motion in the U.S. District Court for ... seeking the entry of a ten-year Stipulated Order for ... the FTC and Endo relating to the patent infringement ... ER and Lidoderm® products.  It also resolves the FTC,s ...
Breaking Medicine Technology: