How to Apply for a Breakthrough Therapy Designation and Win It

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

Course Director: 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.