Breakthrough Therapy Designation (BTD)

BTD increases investor interest and accelerates the pathway to FDA approval.

Navigating the Breakthrough Therapy Designation Process can be Challenging.

Key hurdles developers run into include:

Demonstrating Unmet Medical Need:

Clearly articulating the significant unmet medical need and how your drug candidate addresses it.

Convincing investors and FDA of the Drug's Potential:

Effectively communicating the drug's potential to provide substantial improvement for patients with serious conditions.

Gathering Strong Preliminary Data:

Collecting and analyzing robust data that highlights how your product is important to FDA, physicians, and patients.

If your product prevents, diagnoses, mitigates, or treats a serious or life-threatening condition, partner with experienced experts to take advantage of all that BTD has to offer.

Have Questions? Let’s Talk

At Facet, we’ve helped many small companies secure BTD.

Our experienced team knows how to optimize the BTD application to improve your probability of a BTD grant. If you have questions, our team has answers.

BTD grant is only the beginning!

Our team has successfully helped companies with breakthrough designation complete development, hold productive meetings with FDA, and speed their marketing application to approval to expedite the product to patients in need.

Benefits of Working with Facet

Reduce Time-to-Market:

Our integrated approach minimizes delays and gets your BTD product to patients faster.

Increase Success Rate:

Benefit from our deep understanding of FDA regulations and proven track record of expediting programs with breakthrough designation.

Mitigate Risks:

Proactive risk management strategies ensure you don’t fall into potholes during development.

Access Expertise:

Gain access to a team of seasoned regulatory professionals with recent success with BTD programs.

Optimize Resources:

Streamline your internal processes and free up valuable resources by outsourcing your BTD needs to our experienced clinical, nonclinical, and CMC regulatory team.

Think you could benefit from a conversation with one of our experts?

Let’s Talk