Thought Leadership Series:
Leveraging FDA expedited review programs

Now Available On-Demand:

Originally Recorded:  August 25, 2021 

Speaker:      Elaine B. Taylor, Vice President,            
                     Regulatory Strategy and Policy at Certara, Inc.

Moderator:  Meagan Parrish, Senior Editor, Pharma Manufacturing

Speaker from:
Certara-CMYK-01

 

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The U.S. FDA offers four distinct programs to speed the development and availability of drugs that address an unmet medical need in the treatment of a serious or life-threatening conditions: Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Additionally, other programs, such as the Regenerative Medicine Advanced Therapy Designation, Infectious Disease Product Designation, Orphan Drug Designation, and Real-time Oncology Review, are available to assist sponsors with development and to decrease time to market. Each program has its own caveats, eligibility requirements, and benefits, and navigating the process can be challenging.

This webinar will help clarify the process of choosing which track best suits each product in order to create a more effective regulatory strategy and speed products to patients who need them.

Key Takeaways:

  • When and how do you file for these programs?
  • What products are eligible?
  • What are the differences among the programs and how do I know which ones are most suitable for my product?
  • What are the key elements to best position my product to gain access to these programs?

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Meet the presenter

Elaine Taylor_CertaraElaine B. Taylor
Vice President
Regulatory Strategy and Policy at Certara, Inc.

Ms. Taylor has more than 30 years of experience in the pharmaceutical industry and has extensive experience in developing and providing strategic guidance and regulatory advice at all stages of product development. Ms. Taylor provides regulatory strategy, consulting, and submissions support to our customers. She began her career in nonclinical (pharmacology, toxicology) research and then moved to clinical research and regulatory affairs.

Ms. Taylor’s specialties include creating innovative and efficient regulatory strategies for drug development, including 505(b)(2) programs, regulatory agency meetings, responses to regulatory agencies, INDs, and marketing applications. Her work has covered many complex therapeutic areas, including endocrine, dermatology, cardiovascular and renal, reproductive, analgesia, arthritis, oncology, gastrointestinal, CNS, and musculoskeletal.

Prior to joining Certara, Ms. Taylor was the Global Head of the Regulatory Consulting group at Syneos Health. She also worked at a specialty 505(b)(2) consulting company and worked for more than 20 years in research and pharmaceutical drug development at Procter and Gamble.

 

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