Choosing the Right Drug Approval Pathway
Speedier Approvals with Less Risk

Wednesday, Feb. 21, 2018 · 1:30 p.m. - 3:00 p.m. EST

The 21st Century Cures Act has ushered in a new era of business friendliness. Helped along by a pro-business White House and Congress, the FDA wants to help get your new drugs to market.

This is the moment to discover how, with guidance from a top Washington lawyer.

Mark your calendar for 90 minutes in the company of Julie Tibbets Esq. and Alexander Varond, attorneys in the FDA regulatory practice of Goodwin Procter. They'll help you figure out your own fast-track strategies, with specifics including:

  • 21st Century Cures Act implementation update, including FDA guidance-development activities
  • The latest FDA maze jargon: Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review — and what they mean to you
  • Strategic planning: Aligning R&D with regulatory approval pathways
  • Case studies
  • And much more!

Golden opportunities don’t come along every day. For new-drug developers, this is such a moment. Gain the tools to fast-track your innovative therapies ... ahead of the competition. Sign up today.

Who Will Benefit

This presentation is right for clinical-stage drug and biologics developers innovating new therapies, especially for unmet needs and rare diseases. Specific job responsibilities include but are not limited to:

  • Executive suite
  • Regulatory/compliance
  • Clinical operations
  • Planning and development
  • Marketing and sales
  • Public affairs
  • Investor relations
  • Legal counsel

Webinar plus Audio Recording/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus Audio Recording/Transcript
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$487

add to cart

24/7 Encore Presentation
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$287

add to cart

Audio Recording/Transcript
Learn more

$287

add to cart

 

 

 

Meet Your Presenters

Julie Tibbets Esq.

FDA Partner in the Technology & Life Sciences group
Goodwin Procter LLP

Julie Tibbets Esq., a FDA partner in the Technology & Life Sciences group at Goodwin Procter LLP, works closely with clinical-stage companies on product development and approval strategies, and communicating to investors regarding those pathways.

Alexander Varond

Senior Associate
Goodwin Procter LLP

Alexander Varond is a senior associate at Goodwin where he works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity issues.

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