Therapeutics
References 1Vincent, Grayson K and Velkoff, Victoria A. The Next Four Decades, The Older Population in the United States: 2010 to 2050. U.S. Census Bureau. May 2010.
www.census.gov.
http://www.census.gov/prod/20 10pubs/p25-1138.pdf. Accessed 14 Mar. 2011. 2 Mason, Chris. The strong financial case for regenerative medicine and the regen industry. Regen Med (2008) 3 (3), 351-363. 3 Forecasting the Future of Cardiovascular Disease in the United States: A Policy Statement from the American Heart Association. Journal of the American Heart Association. Circulation. 2011; 123. 4 Forecasting the Future of Cardiovascular Disease in the United States: A Policy Statement from the American Heart Association. Journal of the American Heart Association. Circulation. 2011; 123. 5 Buckler, Lee. Cell Therapy Industry Overview: Products And Applications. Cell Manufacturing 2010 Symposium, October 13, 2010. 6 Forecasting the Future of Cardiovascular Disease in the United States: A Policy Statement from the American Heart Association. Journal of the American Heart Association. Circulation. 2011; 123. 7 Mason, C, Manzotti, E. Regenerative Medicine cell therapies: numbers of units manufactured and patents treated between 1998 and 2010. Regen. Med.(2010) 5(3), 307-13. 8 Stem Cell – Analysis and Market Forecasts. RRY Publications, LLC. February 2011. 9 Advanced BioHealing files for IPO of $200 mln. Reuters. February 25, 2011. 10 Duff, Wilson. Patent Woes Threaten Drug Firms. NY Times. March 6, 2011.
Cross-agency co-ordination
Increased co-ordination between the FDA and NIH on regenerative medicine related issues is crit- ical to identifying and rolling out new methods to facilitate translation of scientific discoveries into products for patients and to support regulatory sci- ence research. The FDA-NIH Leadership Council could address these issues. The Council was creat- ed in 2010 to facilitate research and product devel- opment through agency co-operation. The Alliance has recommended the creation of a sub-committee to focus on regenerative medicine with the active participation of representatives from the regenera- tive medicine community. At the least, the Council should create an advisory board for the sub-com- mittee comprised of representatives from industry, patient advocacy groups, research organisations and universities that has ongoing interaction with the subcommittee and Council. Creating an insti- tutionalised mechanism for input will ensure that information is shared across sectors and that poli- cies developed by the agencies are guided by the experience and expertise of people working in the relevant fields.
Regulatory science
The agency needs increased funding to perform regulatory research, so that FDA can become bet- ter equipped with scientific expertise needed to reg- ulate new products in regenerative medicine and to define regulatory pathways. This research should be performed not only at FDA but also through public-private partnerships, such as consortia of industry, academia and others. The regenerative medicine community – industry, patient advocacy groups, non-profit research organisations and uni- versities and researchers – should participate in the setting of regulatory research priorities. NIH should participate as well and help fund this research. Since regenerative medicine research is occurring throughout the world, efforts should also be made to ensure co-ordination among vari- ous government regulatory bodies.
All of these issues are being addressed by the Alliance through meetings and discussions between agency decision-makers and leaders from industry and other stakeholders. Additionally, Congress has entered the debate through the introduction last year of the Regenerative Medicine Promotion Act (HR 6173). The legislation contained provisions designed to develop a regulatory system that would enable speedy approval of safe and effective regen- erative medicine products. Specifically, the legisla- tion called for an assessment of current federal
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actions and policies on regenerative medicine; cre- ated a new national Regenerative Medicine Co- ordinating Council to include senior officials from all federal agencies that fund or regulate regenera- tive medicine research or products to co-ordinate federal funding and regulatory policies; and autho- rised funding for the FDA to conduct regulatory research in regenerative medicine.
The Alliance is working with a bi-partisan group of Congressmen and Senators in 2011 to reintro- duce the bill this year.
DDW
Michael Werner is a Partner at Holland and Knight LLP and the co-founder and Executive Director of the Alliance for Regenerative Medicine. Mr Werner has more than 25 years of healthcare law, lobbying, policy development and regulatory experience in Washington. He focuses on issues affecting biotechnology and pharmaceutical com- panies, researchers and research institutions, healthcare investors, physicians and patients with particular expertise in regenerative medicine.
Morrie Ruffin has 17 years of experience in the biotech and healthcare industries. In addition to forming the Alliance for Regenerative Medicine and serving as its Managing Director, he is also the Managing Director at Adjuvant Global Advisors (AGA), a strategic consultant and business devel- opment company. Mr Ruffin received his MA in International Studies & Economics from the Johns Hopkins School for Advanced International Studies (SAIS) and his BA from the University of Virginia.
Elizabeth West is the Director of Programs at the Alliance for Regenerative Medicine. Prior to this position, Elizabeth worked at numerous organisa- tions focusing on science policy issues in a research capacity. Ms West received her MA in International Science and Technology Policy from the Elliott School for International Affairs at George Washington University and her BA from the University of Hawaii.
Drug Discovery World Spring 2011
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