Every Cure reposted this
Physician-Scientist @ UPenn | National Bestselling Author, Chasing My Cure | Co-Founder @ Every Cure & CDCN
When a drug receives FDA approval, its research and development (R&D) often shifts away from further exploration into areas such as new indications or formulation improvements. It's a common misconception that approval marks the peak of a drug's journey. In reality, it’s the opposite. When the drug eventually turns generic, it becomes more affordable and accessible than ever. Yet paradoxically, this is when R&D typically comes to a standstill. As someone whose life was saved by an old, generic drug, I am deeply invested in this topic. We should be maximizing these opportunities, not diminishing them. At Every Cure we are on a mission to shift the narrative and focus on how we can leverage these accessible drugs to their fullest potential. What are your thoughts on how we can reinvigorate R&D for generic drugs to enhance their impact and accessibility? #drugdevelopment #drugdiscovery #pharma #drugdelivery #repurposing
I’ve always believed that getting a new FDA regulatory marketing exclusivity to explore a new indication would go a long way to help. Invest in a new clinical trial and expand your exclusivity lifespan
Thanks so much for sharing. As a Penn Medicine patient, I have been fortunate to have a great healthcare team who have used various medications to manage my Lupus and hypertension. As a result of COVID-19 vaccine, I have experienced a phenomenal complete change. 20 years of chronic hypertension has changed! The past two years have been incredible. Hypertension is gone! along with constant Lupus flares. Sometimes medications prescribed for specific diagnosis used interchangeably can realize unbelievable results. Thanks for thinking outside the box.
The days of high throughput screening on lab equipment and then in animal models are long behind us. People often think of AI for writing or other helpful tasks. However when we use it to weed through hundreds of thousands of potential targets it is lifechanging. There are incredible advancements ahead of us
David Fajgenbaum, MD, MBA, MSc - Yiou are spot on with your analysis except there are number crunchers and investors that want 3-5x return on their capital and want patent protected drugs with no competition for 15 years. Once the competition comes in and margins are diminished, there is no appetite to continue in the space. There are new generics and biosimilars companies with lower overheads that are seeing this as an opportunity and doing what you are saying - which is finding new cures for existing drugs with a known track record of side effects.
So very true, and the new FDA PDUS guidance now allows a route to enhance drug efficacy through software applied to the drug, a new world for precision medicine.
I'm confident that leveraging AI to identify new uses for generic drugs will be a game-changer, unlocking vast potential in existing treatments. It's inspiring to see Every Cure driving this initiative, and I believe this approach could truly reshape drug development by maximizing the impact of what's already available.
Linkedin Top Voice| Life Science Lawyer | Emily Whitehead Foundation Board Member | Entrepreneur | Drexel Univ. Adjunct Prof. | DarshanTalks podcast host | Author, and Speaker
2moI think its worth pointing out that this may be true under the 505(b)(1) pathway, but there is incentivized innovation under the 505(b)(2) pathway in these scenarios.