FountainBlue's Life Science Entrepreneurs' Forum August 16, 2010

FountainBlue's Life Science Entrepreneurs' Forum
Topic: Navigating the FDA Approval Process
Date & Time: Monday, August 16 from 5:30 - 7:30 p.m.
Location: UCSC Extension, 2505 Augustine, Santa Clara
Pre-register: $21 members, $32 partners, $42 general
Late and On-Site: $42 members, $52 non-members, $124 Ongoing membership and admission
Registration: Please pre-register by noon on 8/13 using the PayPal link at http://www.svlifescience.com.
Audience: Life Science entrepreneurs, intrapreneurs and investors, no service providers please

Navigating the FDA Approval Process
Navigating the FDA approval process has become increasingly more difficult for a number of reasons: 1) past litigations around approved products are making approvals more difficult to come by; 2) the changes in health care policies make approval standards a moving target for the reviewers; 3) many experienced FDA reviewers have left the organization, leaving new and less experienced staff to take their place; in addition, with the departure of specific reviewers, many applications in mid-approval were further delayed; 4) more risk-reducing measures are required of submitting organizations, which in turn requires more time and money from early stage entrepreneurs and fewer entrepreneurs are able to meet these new requirements; and 5) many entrepreneurs are seeking approval in other countries as a result of all of the above.
Yet some companies are able to successfully navigate these and other hurdles. This month’s panel will share their success stories and their advice to all.
Facilitator Susan Rowinski, Sue Rowinski Group
Panelist Madhuri Bhat, Vice-President, Clinical & Regulatory Affairs, Corventis
Panelist Brent Blackburn, President and CEO, Rpaidscan Pharma Solutions, Inc,
Panelist David Lustig, VP of Business Development, Optivia Biotechnology Inc.
Panelist Melanie Sit, Business Strategist, Optovue
Panelist Alice Varga, VP of Regulatory Affairs and Quality Systems, Geron

Information and Registration: NO SERVICE PROVIDERS PLEASE.
• Additional information about our life science entrepreneurs' forum and notes from our previous meetings are available at http://www.SVLifeScience.com.