OPPORTUNITY

Change is a given. Few people want to plan for change, but it’s inevitable that things are constantly changing whether we recognize it or not.

Change opens doors for opportunity. One opportunity that our Biopharma Global team was lucky enough to be presented with recently was to aid in the FDA Orphan Drug Designation (ODD) approval process for a new treatment for ALS being developed by Cerion Pharmaceuticals.

 ALS, also known as Lou Gehrig's disease, is a disease that causes the death of neurons controlling voluntary muscles. While the ALS Association’s 2014 ice bucket challenge garnered significant social media attention, the condition is classified as a rare disease, meaning less than 200,000 people in the US are affected. In fact, research shows that less than 20,000 cases of ALS exist at any given time, and approximately 5000 people are being diagnosed annually in the US.

This project came to the BPG office by way of introduction through our collaboration with the University of Connecticut School of Pharmacy regulatory affairs intern rotation program. James LaFlamme, CEO of BioPharma Global brought the project in pro bono from another UConn School of Pharmacy Advisory Board Member’s referral. Our 2019 Uconn intern, Hasan Merza, Pharm D. 2020  participated start to finish on this project with direct supervision by our regulatory writing and leadership team. Within just a few months of submission, the ODD application was swiftly approved and hopefully will have impact on hundreds, if not thousands, of ALS patients.

 Many thanks to our entire, hardworking BioPharma Global team who put great collaborative effort into every project we participate on. This was a collective effort with the whole team but Antony Kaprelian (RAPS CERTIFIED) , Dr. Abby Ho and Chief Science Officer Dr. Sandi Heibel all directly had a major impact on this project. 

 Pls share this article - and if you or someone you know is looking for a Pharm D to join the team- reach out to Hasan Merza with the link above - He is a dynamic person currently seeking a full time career opportunity.