Several panelists voted "yes" for approval not because of a compelling risk/benefit profile, but because they believe physicians and patients should have the "option" to choose the therapy. This reveals a philosophy where regulatory approval is seen as a gateway to choice, deferring the final, nuanced risk-benefit decision to the clinic.

The medical community is slow to adopt advanced preventative tools like genomic sequencing. Change will not come from the top down. Instead, educated and savvy patients demanding these tests from their doctors will be the primary drivers of the necessary revolution in personalized healthcare.

The NIH's cancellation of mRNA research is a profound strategic error. The technology's key advantage is speed, which is critical not only for future pandemics but also for personalized cancer treatments. These therapies must be developed for individual patients quickly, making mRNA the most promising platform.

An ideologically driven and inconsistent FDA is eroding investor confidence, turning the U.S. into a difficult environment for investment in complex biologics like gene therapies and vaccines, potentially pushing innovation to other countries.

The 'FDA for AI' analogy is flawed because the FDA's rigid, one-drug-one-disease model is ill-suited for a general-purpose technology. This structure struggles with modern personalized medicine, and a similar top-down regime for AI could embed faulty assumptions, stifling innovation and adaptability for a rapidly evolving field.

When a highly effective therapy like EV Pembro was approved for 'cisplatin ineligible' patients, the definition of 'ineligible' became very elastic in practice. This demonstrates that when a new treatment is seen as transformative, clinicians find ways to qualify patients, putting pressure on established guidelines.

The future of medicine isn't about finding a single 'best' modality like CAR-T or gene therapy. Instead, it's about strategic convergence, choosing the right tool—be it a bispecific, ADC, or another biologic—based on the patient's specific disease stage and urgency of treatment.

As AI allows any patient to generate well-reasoned, personalized treatment plans, the medical system will face pressure to evolve beyond rigid standards. This will necessitate reforms around liability, data access, and a patient's "right to try" non-standard treatments that are demonstrably well-researched via AI.

The FDA is predicted to approve new PARP inhibitors from trials like AMPLITUDE only for BRCA-mutated patients, restricting use to where data is strongest. This contrasts with the EMA's potential for broader approvals or denials. This highlights the diverging regulatory philosophies that create different drug access landscapes in the US and Europe.