How to Apply for a Breakthrough Therapy Designation and Win It

Duration: 90 Minutes
This webinar, presented by a leading regulatory affairs expert with successful BTDs, 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 highlight key regulatory requirements, dos and don'ts, common areas of concern, and trouble-shooting BTD requests using case studies and examples from the presenter's vast experience helping companies big and small in successfully 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.
Applying for a Breakthrough Therapy
Instructor: Carolyn Troiano
Product ID: 504525
Objectives of the Presentation
After attending this webinar, you will understand:
  • How to identify the characteristics for eligibility of a BTD product and determine whether your organization has such new drug products in their portfolio
  • The proper format, content and structure of the BTD application to ensure you will meet all of the requirements and provide FDA with an easy-to-review document that is very well written
  • The BTD process and when it is the best time and opportunity to submit your application; doing this too early or late will create issues that can be easily avoided
  • The significance of getting your product on a track for BTD designation, especially in terms of the pros and cons, costs, benefits, and compliance issues
  • The process for resubmission, should your BTD application be denied/rejected to make the appeal go more smoothly
  • How, as an organization, you should communicate your BTD status to the public in order to maximize the benefit to your bottom line and reputation
  • What the best practices are and potential pitfalls and how to avoid them in order to make your submission have the highest chance of approval while keeping down cost and ensuring compliance
Why Should you Attend
The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the development steps, and become eligible for priority review. However, getting a BTD is not easy; there is about 70% rejection rate for applicants of BTD; the success of BTD award depends a lot on the disease targeted and the product being developed and BTD request requires significant resources from the applicant.

Areas Covered
  • 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 will Benefit
  • Regulatory Affairs Personnel
  • Quality Personnel
  • Research Personnel
  • Clinical Personnel
  • Manufacturing Personnel
  • Auditors
  • Clinical Research Associates (Monitors)
  • Legal Personnel
Topic Background
The Breakthrough Therapy Designation (BTD) process implemented by the US FDA facilitates expedited regulatory review of a drug candidate intended to treat a serious or life-threatening condition. To be designated BTD, the sponsor must share preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The program has been largely popular with the pharmaceutical/biotech industry since its introduction in July 2012 with the Food and Drug Administration Safety and Innovation Act (FDASIA) approval. By the end of March 31, 2016, the Center for Drug Evaluation and Research (CDER) had received 342 BTD requests (BTDR) of which 111 were designated BTD. Getting a BTD designation is hugely beneficial to the sponsor and according to some estimates can result in approximately 3.5 years less development time than a drug not granted any of the other expedited statuses by the FDA.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
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