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. |
|

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
|
|
|