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Making Clarity a Priority
BVGH testifies before the FDA on how to make the PRV program a success.
It has been exactly three years since the first Priority Review Voucher (PRV) legislation was passed, more than one year since the first PRV was awarded, and just a month since the most recent amendments to the program were proposed in the Senate with the Creating Hope Act of 2010.  So where do we stand with the PRV as an incentive for investment in the development of new drugs and vaccines for neglected tropical diseases?  And as an advocate for this critical financial incentive since the beginning, what do we think are the key things that need to be done to strengthen the program? Last week, BIO Ventures for Global Health (BVGH) testified before the U.S. Food and Drug Administration (FDA) outlining the current issues with the PRV program and our recommendations for the program moving forward. 
 
The success of the program depends on the participation of the biopharmaceutical industry.  So our recommendations to the FDA were: 1) to eliminate limits on the transferability of PRVs, 2) to improve the transparency and clarify the regulations of the PRV program, and 3) to develop a rule-making process to ensure that the list of PRV-eligible diseases is complete and comprehensive.
 
The value of the PRV to a company is defined in one of two ways: 1) the revenue generated by introducing a drug that would normally undergo standard review to the market earlier (i.e., first mover advantage), and 2) the revenue generated by the sale or transfer of the PRV to another company.  As the program currently stands, the PRV can only be sold or transferred once.  Limiting the sale or transfer of the PRV limits the value of the PRV to companies, since part of the program's appeal to investor groups and companies is the idea of a secondary market for PRVs.
 
Another issue is the need for greater clarity and transparency around the FDA's policies and guidelines for using the voucher.   This sentiment is oft repeated by company representatives to BVGH, including at last week's FDA hearing.  It is also feedback generated through BVGH's PRV Working Group, a multi-stakeholder group that includes representatives from the Bill & Melinda Gates Foundation, product development partnerships focused on neglected tropical diseases, economists, investors, and biopharmaceutical companies.  This point is especially critical.  Without a clear understanding of the guidelines, companies may not be as interested in seeking out the PRV.
 
In addition to clarity around use of the PRV, there needs to be clarity around the rule-making process to ensure that the list of PRV-eligible diseases is complete and comprehensive. BVGH advocates for an evidence-based process for adding additional diseases. For example, Chagas disease is not on the list, even though it should be eligible per the WHO Neglected Tropical Disease list.  This was an oversight in the original legislation that we recommend be remedied.
 
We at BVGH support the PRV program and are working to ensure that it is implemented as it was intended. We encourage companies to take advantage of this incentive, and hope the FDA will continue to support implementation of rapid regulatory review so that the PRV may demonstrate the power of market-based incentives to drive the development of desperately-needed innovative products for the neglected tropical diseases affecting people all over the world.
 
Read more about BVGH's thoughts on the proposed PRV fixes in the recently introduced Creating Hope Act of 2010 here.
Innovative AID
BVGH talks with Wendy Taylor, founder of BVGH and Senior Advisor to the Obama Administration.
Wendy Taylor, founder of BIO Ventures for Global Health (BVGH), was recently named Senior Advisor, Innovative Finance and Public Private Partnership at the United States Agency for International Development (USAID).  We spoke with Wendy about this exciting development and what the new innovative financing arm of USAID may mean for bringing biopharmaceutical innovation to global health research and development.

Q: Congratulations on your new position at USAID.  You managed to accomplish quite a lot during your time at Malaria No More, so we're excited about the momentum you are bringing to the Obama Administration. Can you tell us about your position and what you hope to accomplish?

 
This summer I was brought on board at USAID to help launch the President's $63 billion Global Health Initiative, with a specific focus on bringing the benefits of innovative financing, public private partnerships, and innovation to global health programs, government-wide. It's an exciting time to join both the Administration and USAID.  Just this last week at the UN General Assembly in New York, the President emphasized that, while we have made real progress against many of the Millennium Development Goals, we ultimately will not succeed unless we start to tackle these problems in new ways.  A key part of that vision, underlined by USAID Administrator Rajiv Shah, is a greater emphasis on innovation, and that includes investment in game-changing technologies.  To spur that innovation, part of our task going forward will be to coordinate strategically with the many players that bring a diverse set of tools to the table. We also need to make sure that innovations can get out of the lab and benefit the world's poor by using our tremendous purchasing power to create incentives for producers and by pursuing strategies that improve regulatory systems and smooth the path for product uptake in the developing world.  
 
Q: Your title includes innovative financing.  There are a lot of initiatives and proposals out there that are aimed at spurring innovation for global health.  Are there particular initiatives or types of financing structures that you think will have a greater impact?
 
This is such an important area of focus and one that will benefit from continued creative thinking from multiple sectors -- including the companies, academics, and NGOs with whom you regularly interact. What's clear is that there is no one-size-fits-all solution.  What works for big pharma may not work for mid- or small-sized biotechs.  And what works for vaccines may not work for drugs or diagnostics.  There are some good tools now, including an Advance Market Commitment and priority review vouchers, and there are some intriguing ideas that have been put forth over the last few years.  We encourage continued thinking on how best to develop the mechanisms that can help tap the tremendous resources that biotechs and pharma companies have to offer global health. 

 
Q: You were integral to the work that BVGH initially did in advocating for the FDA Priority Review Voucher (PRV) program. Given that you were involved with this idea from the beginning, how do you see the proposed bill to amend the PRV legislation affecting the program?
 
I can't comment on the bill specifically, but I can emphasize that this is one of the truly novel incentives to emerge in recent years.  It will be important to ensure that the program has a chance to fully mature and operate in the marketplace.  BVGH is playing an important role in helping make that happen.  There are also intriguing ideas under consideration that build on the PRV concept.  The USPTO just issued a notice seeking comment on a proposal to offer patent holders who make their technology available for humanitarian purposes a voucher entitling them to an accelerated re-examination of a patent.  Like PRVs, this voucher could be traded in the marketplace. 
 
Q: As the founder of BIO Ventures for Global Health, you obviously support the idea that we need to engage more biotech companies in the effort against neglected tropical diseases.  Generally speaking, how has your thinking on how best to engage companies evolved over time?

The global health R&D landscape has changed dramatically over the last decade -- spurred in large part by robust philanthropic and public sector support, entrepreneurial product development partnerships, and forward thinking leaders and scientists within industry.  There are now many more companies at the table who are leading the charge in the pursuit of new vaccines, drugs, and diagnostics that meet the needs of the developing world.  Their reasons for engaging have also changed.  While corporate social responsibility may have dominated decision making not that long ago, companies are now finding ways to make engaging in global health product development in their business interest.  This has been, and continues to be, a critical ingredient for meaningful industry engagement.  We still have a ways to go, and we need to continue to encourage others to come to the table, but the tremendous movement in the field is exciting.  The possibilities for progress in the field over the next decade are truly remarkable. 
Biotech Briefs
News of interest in global health, biotechnology, policy, academia, and finance.
USPTO Looking for Ways to Incentivize Humanitarian Technologies
The U.S. Patent and Trade Organization announced that it is seeking public comment on a new initiative modeled after the FDA priority review voucher.  The initiative is aimed at incentivizing the creation and wider distribution of technologies to address humanitarian needs.  The USPTO is accepting comment through November 19.
Patent Docs 22 September 2010


New TV Show "BioCentury This Week" Debuted September 17
"BioCentury This Week," a new television program developed by BioCentury Publications in partnership with W*USA, the CBS affiliate serving the Washington, D.C. market premiered this month.  The program will stream online each week and focus on topics ranging from healthcare to nutrition and energy.  BVGH CEO Melinda Moree will be featured in an upcoming episode.
BioCenturyTV.com 17 September 2010

 
Researchers Uncover Tuberculosis' Genomic Signature
Researchers at Baylor Institute for Immunology Research in Dallas have discovered a molecular signature in the blood of patients with tuberculosis (TB) that could explain why some patients develop active TB.  The discovery could lead to new and more effective diagnostics and vaccines.
PR Newswire 23 September 2010

 
Carlos Slim Finds Global Health Success is Harder Than Business
Carlos Slim, the Mexican entrepreneur who topped this year's Forbes list of the richest people in the world, is following in the steps of Bill Gates, focusing on improving health care for people in need. Slim has pledged a total of $6 billion dollars through his three foundations, which also focus on education and economic development. 
The Seattle Times 23 September 2010
 

Melinda Gates Addresses the UN
Melinda Gates addressed both the United Nations General Assembly and gave a TedxChange talk about progress on the Millennium Development Goals last week.
MyNorthwest.com 23 September 2010


September 2010

BIO Ventures for Global Health is a non-profit organization whose mission is to save lives by accelerating the development of novel biotechnology-based drugs, vaccines, and diagnostics to address the unmet medical needs of the developing world.

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Board of Directors

Carl B. Feldbaum, Chairman
President Emeritus, BIO

G. Steven Burrill
CEO, Burrill & Co.

Robert Chess
Chairman, Nektar Therapeutics

James A. Geraghty
Senior Vice President and Officer
Genzyme Corporation

James C. Greenwood
President, Biotechnology Industry Organization

Donald R. Joseph
COO, BVGH

Vaughn M. Kailian
General Partner, MPM Capital

Melinda Moree
CEO, BVGH

J. Leighton Read
Partner, Alloy Ventures
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