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Faculty: Carolyn Troiano

  • Date: 6/21/2022 01:00 PM - 6/21/2022 02:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


One of the most impact incentives from the FDA is the Breakthrough Therapy Designation (BTD). It helps in getting the product/drug to market much faster than any other expedited approval pathway. The application processes for Breakthrough Therapy Designation need to request for special meetings with FDA to discuss the development steps, and become eligible for priority review. However, getting a BTD status is not simple. As per recent statistics there is about 70% rejection rate for applicants of BTD. The important factors that the FDA considers would include seriousness of the disease targeted and the product being developed. BTD request also requires significant resources from the applicant. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced and drug development is fast tracked.

Why You Should Attend:

This webinar is being presented by a leading regulatory affairs expert with successful BTD applications. She will discusses FDA expectations from BTD requests, the best practices to write a BTD request, and pros and cons of applying for a BTD. The session will also shine light on key regulatory requirements, the dos and don’ts as well as common areas of concern. We will discuss how to trouble-shoot BTD requests using case studies and examples from the presenter’s vast experience helping both small and large companies while applying for a BTD. The format and rules governing BTD request will be discussed along with success and challenge factors. The training is designed to provide a well-rounded training to all stakeholders in all aspects of the BTD application process.

Areas Covered in the Session :

  • Assessing the eligibility of a product for BTD
  • Best practices for format, style and organization of the BTD application
  • Best time in the development timeline to apply for the BTD
  • Pros and cons of applying for the BTD
  • What to do when the BTD is rejected: process to re-apply and appeal
  • Managing public information related to the BTD
  • Common errors and potential solutions

Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Departments
  • Research and Development Departments
  • Clinical Personnel
  • Manufacturing Departments
  • Auditors
  • Clinical Research Associates (Monitors)
  • Legal Personnel