Kelly Austin, PhD, PPM and her team are regulatory strategists specializing in Orphan Drug Designations (ODD)
Use an experienced partner known for strong guidance, an understanding of the unwritten rules for ODD, and the most solid arguments possible for
successful submissions in the rare disease space.
A consultation during in vitro or pre-clinical stages will help you get the most out of your animal studies.
We understand how to get the special designations that attract investors and how to communicate with the FDA to keep your development plan on track.
We focus on the details of your development program to ensure a smooth path to ODD, Fast Track, RMAT, and Breakthrough designations.
Almost 90% of our contracts are return clients or referrals. The KLA team is honored to have earned the trust of so many pharma and biologic companies in the very competitive environment of drug development.
The Pediatric Rare Disease Voucher Program was just reinstated by an act of Congress. This gives us until September 2024 to gain Pediatric Rare Disease Designation (PRD). While this program is not as important to large drug development companies, who can simply purchase a voucher if they think it will improve their balance sheet, it is mission critical for smaller companies in the rare disease space.
Why is the term ‘orphan subsetting‘ important for you to understand, and how does it affect your Orphan Drug Designation (ODD) application? This important consideration can make the difference in whether your ODD is approved. Let’s break it down.
The FDA Office of Orphan Products Development (OOPD), the EMA Committee for Orphan Medicinal Products (COMP), and your FDA review division are unique entities with individual characteristics. Care should be taken to ensure any submissions are written with your particular audience in mind.
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