Kelly Austin, PhD, PPM and her team are regulatory strategists specializing in Orphan Drug Designations (ODD) and Pediatric Rare Disease Vouchers (PRD)
Use an experienced partner known for strong guidance, an understanding of
the unwritten rules at the Office of Orphan Products Development (OOPD),
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.
Knowledge
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.
Dedication
We focus on the details of your development program to ensure a smooth path to ODD, Fast Track, RMAT, and Breakthrough designations.
Service
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.
Latest Blog Post
What NOT to Do in an FDA Meeting
Many Sponsors come out of a positive-response FDA meeting thinking they have gotten everything they wanted. Unfortunately, the FDA is not obligated to tell you what you missed. Did you get permission to conduct a trial, or did you get confirmation your drug discovery program is on track to receive marketing approval? I’ve seen topContinue reading “What NOT to Do in an FDA Meeting”
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Pediatric Rare Disease Vouchers Sell for an Average of $100M. Can You Qualify?
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.
Getting the ODD: The Art of Orphan Subsetting
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.
Fundamental Concept: Know Your Audience!
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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