Expediting Approval for Regenerative Drugs and Breakthrough Therapy Designation

FDA provides 4 programs for accelerated drug approval, each with a specific set of requirements and considerations. Drugs must be for serious conditions that fill an unmet medical need and can be approved based on a surrogate endpoint, or biomarker

A drug qualifies for BTD review if it is intended to treat a serious condition, and preliminary clinical evidence indicates it may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. BTD status affords the requestor more frequent meetings and written communications with FDA, rolling review, intensive guidance on efficient drug development and involvement of FDA senior managers to expedite the process.

Rolling Review enables a company to submit completed sections of its BLA or NDA for review by FDA. The eCTD format enables a company to account for all components, interdependencies, linkages and the lifecycle of a submission, facilitating the process.

Only 70% of all BTD requests are met with FDA approval. The standard for BTD is not the same as for drug approval, and preliminary clinical data are key. Specific study designs can aid in demonstrating substantial improvement. Early and effective communication with FDA are key to success.

Areas Covered in the Session :

  • Objectives
  • FDA’s Expedited Programs
  • Fast-Track Designation
  • Breakthrough Therapy Designation (BTD)
  • Accelerated Approval
  • Priority Review Designation
  • Expedited Program Highlights
  • BTD Details
  • BTD Process
  • Additional Considerations

Who Should Attend:
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the processes related to applying to FDA for a breakthrough therapy designation. Examples of who will benefit from this webinar include:

  • Regulatory Affairs Managers and Professionals
  • Compliance and Audit Managers
  • R&D Professionals
  • Clinical Data Management Professionals
  • Laboratory Professionals
  • Manufacturing Professionals
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.


Carolyn Troiano

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance