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May 4, 2017

Effective Regulatory Strategies: Tapping into FDA Expedited Review Programs

Sponsored by:
wsgr

Charles Andres, JD, PhD, RAC
Patent & Innovation Strategies and FDA/Life Sciences Groups

Effective regulatory strategies are important success drivers for drug and medical device companies. They have several components and:

  • Sync seamlessly and synergistically with patent strategies;
  • Realize all available U.S. Food and Drug Administration (FDA) regulatory exclusivities;
  • Play a significant role in maximizing product life span (as part of lifecycle management);
  • Minimize costs, resources, and time devoted to clinical development; and
  • Shorten FDA review times and result in successful FDA clearance or allowance.

The talk will provide an introduction to four important FDA programs that are designed to help expedite drug and medical device development and market entry.  These programs should always be evaluated when designing effective regulatory strategies.

About Charles Andres

Charles Andres, Ph.D., RAC, is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati. He focuses on patent prosecution, strategic patent counseling, IP due diligence, drug and medical device FDA regulatory counseling, invalidity and non-infringement opinions, life-cycle management, Supreme Court and Federal Circuit amicus briefs, and related business matters.

Charlie has significant experience drafting patent applications, prosecuting patent applications in the U.S. and abroad, and evaluating the claims of issued patents. Patents Charlie has obtained have been listed in the Orange Book and asserted against a generic pharmaceutical manufacturer, and he has drafted and filed multiple applications for patent term extension.

Companies he has obtained patents for have been sold for a cumulative total of approximately $4 billion.

Charlie has also drafted and prosecuted patents covering three FDA approved drugs. He represented a client at a U.S. Senate HELP Committee full hearing on electronic health records and was part of a team that defended a generic pharmaceutical manufacturer in an Actavis reverse payment enquiry at the Federal Trade Commission.

Prior to becoming a patent and FDA professional, Charlie spent a decade as a medicinal chemist and early-phase project co-chair at Bristol-Myers Squibb Company, where he won a Presidential Award, among other accolades. He holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.

Upcoming Event

  • San Carlos Open House

    15:30-18:00
    11/01/2018
    Come to meet MBC BioLabs residents, tour our new space in San Carlos, and hear about our exciting plans for the future. There will be posters from our companies, a live band, and an opportunity to chat with our partners and staff. RSVP In just 4 years, we have helped 116 entrepreneurial teams create fast, focused and frugal biotech companies that have gone on to raise $2.4 billion and counting. With this new facility, we can empower more entrepreneurs with the space and resources they need to tackle world changing science. Come join us in celebrating our newest MBC Biolabs campus and welcome our residents and partners!

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953 Indiana St., San Francisco, CA 94107
Tel: (415)-347-8287
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