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Novartis, AbbVie, and GSK Discuss Expedited Drug Development Tracks

The Innovative Regulatory Pathways Summit is taking place January 29–30, 2018 in Arlington, VA! This intimate summit will bring together leading regulatory experts and senior-level executives to discuss breakthrough therapy designations and other regulatory strategies to expedite patient drug development in the U.S., EU, and Japan. Download the brochure here to review the sessions and speakers featured at this event.

Join our professional speaking faculty, which includes representatives from:

  • Amicus Therapeutics
  • Alexion Pharmaceuticals
  • Sanofi Pasteur
  • Sanaria Inc.
  • Novartis
  • Eiasi
  • AbbVie
  • Otsuka
  • GlaxoSmithKline
  • Sandoz Inc.

Our chairperson, Alejandro D. Ricart, M.D., Executive Medical Director, Oncology, Early Development Strategy and Innovation at Novartis, will be discussing breakthrough therapy designations in Oncology. Here is what you can expect from Dr. Ricart’s session:

  • Provide safe and effective novel oncology drugs to market quickly for life-threatening diseases and unmet needs
  • Identify the importance of clinical trial design and clinical setting: Pivotal study vs. confirmatory study for BTD
  • Discuss surrogate endpoints, well-established surrogate endpoints, and endpoints that reflect patient benefit
  • Understand concern over the timely conduct of postmarketing-study commitment

Download the brochure here for the full lineup of sessions and speakers.

Register here!

ExL’s Innovative Regulatory Pathways Summit will bring together leading regulatory experts and thought leaders to discuss breakthrough therapy designations, accelerated approvals, and global regulatory strategies to expedite review/approval of drugs that have promise in treating serious or life–threatening conditions.

Top Five Reasons to Attend

  1. Navigate the expedited drug development options provided by the FDA
  2. Discuss clinical requirements for breakthrough therapy designation and the impact of receiving designation on trail design/CMC plans
  3. Utilize patient–focused drug development to build clinical trial frameworks for breakthrough therapy applications
  4. Discuss regulatory strategies to expedite oncology and rare disease product development timelines
  5. Compare Sakigake, PRIME, and Breakthrough Therapy Designation to expedited tracks in non-ICH countries

Get Involved!

Want to learn more about sponsorship and exhibition opportunities? Contact David Finkel, Business
Development Manager, at 917-242-3898 or dfinkel@exlevents.com.

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