Top Talks
Vinay Prasad FDA CBER · 主任
Source ↗

Prasad cautions that ADCs with potent nonspecific payloads like MMAE may work through the payload alone, so extra evidence is needed to credit the novel targeting component.

If you make a new drug but tether it to MMAE or a powerful radioisotope, note that the payload can be cleaved after killing one cell, or before, and the payload can do cancer killing all by itself. A high enough dose of an ADC with active payload will work in other places besides the target. Microtubule inhibitors work in a lot of cancer. It takes extra to persuade me that the novel ADC is critical to that.

All statements by Vinay Prasad ›

Other recent statements by Vinay Prasad

Source ↗

Prasad argues AI tools and private markets, not government, will best solve access to medical advice, with information quality exceeding most doctors.

The solution here is likely to be private markets and AI driven. These tools dramatically lower the barrier to ask medical questions, and the quality of the information surpasses most doctors. Technology and not government is best poised to address this.
Source ↗

Prasad says many new drugs and devices don't work or do more harm than good, and the ACA worsened this by letting lobbyists add unproven products to public spending.

Many novel drugs, devices and procedures debuted don’t work/ have harms exceeding benefits. The ACA has only exacerbated this problem by allowing lobbyists to add more and more unproven remedies, tactics, strategies and products to the public tab.
Source ↗

Prasad doubts government cost control will be value-driven, predicting indiscriminate cuts that discourage both transformative and marginal products.

I have little confidence it will be value driven. In other words, I doubt that government will reduce spending on marginal goods and service and incentivize innovation and valuable services. Instead, very likely it will be done haphazardly and indiscriminately resulting in disincentives to make transformative products and marginal products alike.
Source ↗

Prasad warns that cost control will rely on tiers and arbitrary delays, frustrating American consumers' access to new therapies.

Again, because we are unable to differentiate good vs marginal products, cost control will rely on tiered structures, arbitrary delays, etc. This will likely result in further frustration from the American consumer.
Source ↗

Prasad argues overall survival is the only meaningful endpoint in smoldering myeloma trials because early treatment adds toxicity and cost without proven benefit.

With smoldering myeloma, the only endpoint that matters is overall survival. After all, if you treat a pre-cancer with a temporizing regimen, you add toxicity and cost, by definition. Your tumor will still eventually grow, and it will still eventually kill you.