SAN FRANCISCO, Jan. 13 /PRNewswire/ -- In the wake of a decision last month to move more than $600 million from the nation's Project BioShield Special Reserve Fund to other government agencies, representatives of BARDA (Biomedical Advanced Research and Development Authority), NIH (National Institutes of Health), NIAID (National Institute for Allergies and Infectious Diseases) and DTRA (Defense Threat Reduction Agency), 15 CEO's from some of the country's leading biodefense and infectious diseases companies and a leading biodefense investment banking firm met yesterday during the JP Morgan Healthcare Conference here to discuss how best to facilitate the development and approval of products in this critical sector. (All participants are listed below.)
Organized by FreeMind Group (www.freemindconsultants.com) , specialists in helping companies and academic institutions in life sciences raise money from government agencies through grants and contracts, the wide-ranging discussion covered what federal agencies are doing to create greater transparency for their funding initiatives, communicate their individual projects to each other and encourage investment from the venture capital community.
Steve Brozak, president of WBB Securities LLC, a research and investment firm focusing on biotechnology, medical devices and specialty pharmaceuticals, launched the discussion, noting that "there must be more transparency in terms of what the government expects from the companies it will fund" — regarding milestones, results, and areas of prioritization (such as what threats are in focus), both for prospective grantees and to give the venture capital community the security to invest in these companies.
Public sector participants agreed — and see the need. The number of applications for NIH's SBIR funding alone has doubled since private sector money has withdrawn from early stage companies, many "in danger of going out of business" — and there was speculation that the success rate for these applications could plummet from its current 25 percent to below ten percent. There is also pressure within the granting agencies to allow venture capital-funded companies to compete for available dollars, and it is possible a small percentage may be permitted. Funding for BARDA, which is dedicated to the development and purchase of necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies and manages Project BioShield, has increased from $100 million in 2007 and 2008 to $305 million for this year.
The awareness has led to shorter applications for some grants and contracts, and in some cases, larger awards — notably in NIH's RO1 programs — particularly where there is an academic/industry partnership. Much information on the status of potential grants is now published on the individual agencies' Web sites. And a very new development is the creation of the Integrated National Biodefense Portfolio, a collaborative effort among BARDA, DTRA, NIH, NIAID and the Department of Defense to minimize duplication of projects and to monitor progress of all candidates in the portfolio.
"Government and industry are much closer collaborators in the biodefense sector than ever before," said Ram May-Ron, Vice President of FreeMind. "The efforts cited above and the sheer volume of information now being exchanged signals much more clarity of communication and bodes well for better and more targeted grants and contracts for important emerging science."
Among other topics covered in the two-hour discussion:
- intellectual property issues, particularly in the case of reagents
- investigation of licensed drugs for off-label uses in response to bio-terror threats, to mitigate response time
- using the NIAID's 11 Centers of Excellence as incubators, rather than strictly as academic research sites.
The discussion will be posted on the FreeMind Web site, www.freemindconsultants.com, in the next few weeks.
In addition to Ram May-Ron and FreeMind's chief analyst, Dr. Merav Geva, the roundtable included:
From the public sector: Clare K. Schmitt, Ph.D., Deputy Director--Office of Biodefense Research Affairs, DMID/NIAID, NIH; Michael R. Schaefer, PhD, Regional Centers of Excellence Program Officer--Office of Biodefense Research Affairs, DMID-NIAID, NIH; Brian Reinhardt, CIV, Chemical and Biological Defense Directorate--DTRA; Gary L. Disbrow Ph.D., Deputy Director, Division of CBRN Countermeasures--BARDA, Assistant Secretary for Preparedness and Response ASPR--Department of Health and Human Services and Gregory Milman, Ph. D. , Director, Office for Innovation and Special Programs, Division of Extramural Activities--NIAID, NIH, DHHS.
From the private sector: Michael Eichberg, Director, Business Development--Achaogen; Patrick Flavin, Esq., JD--Advanced Life Sciences; Eric J. Patzer, Founder & President--Aridis Pharma; James L. Knighton, President & CEO--AvidBiotics; Michael Fonstein, PhD, CEO--Cleveland Biolabs; Lynn Stevenson, CEO--DesignMedix; Steven Dong, PhD, Director of Drug Discovery and Development--Epiphany Biosciences; Richard Haiduck, Chief Business Officer—Implicit Biosciences; Steve Parkinson, President & CEO--Lakewood-Amedex; Jeff Meshulam, COO-- Profectus BioSciences; Christopher J. Schaber, President & CEO--Soligenix; Joyce Sutcliffe, SVP, Biology—TetraPhase Pharmaceuticals; David Fanning, CEO--Theraclone Sciences and Steve Brozak, President--WBB Securities, LLC.
About FreeMind: Established in 1999, FreeMind is the largest consultancy in the world that specializes in raising funds from U.S. government agencies and other non-dilutive sources such as the Bill and Melinda Gates Foundation and the Susan G. Komen Breast Cancer Foundation. At our offices in Boston, MA, Princeton, NJ and Jerusalem, Israel, our team of 25 analysts and writers fully support the grant process--providing everything from a strategic assessment of a client's research objectives to writing the funding application. Our client portfolio includes more than 400 organizations—from small, mid-size and large pharmaceutical companies to universities and research institutions. Since it was founded, FreeMind has assisted its clients in winning over $1 billion, and in 2008 alone, won over $300 million from NIH and DOD. We aim to maximize our client's grant-winning potential through our extensive experience, and by utilizing a carefully crafted, systematic process. For further information, please visit our website, www.freemindconsultants.com.