Peter Kolchinsky

Heartening to see such insight here on Twitter. Thank you David standing up for the people who do so much good yet who are among the most hated in America. It’s a paradox that needs resolving. The problems can be fixed; let’s not lose sight of the net good… ie this!

Anyone interested in getting more into biotech policy will benefit from following NPLB. They post about every new policy and every new action in response to that policy.

Often I do too, but you won’t miss anything if you follow @NPLB_org.

Next few years are likely to get really intense. Trump has offered his own personal chaos, but what Democrats have long pushed for has been coordinated, deliberate, and legislative (not ephemeral executive orders). Pill penalty came from Dem party leadership, not fringe left. That leadership is largely intact. No signs yet that they have changed their minds on the wisdom of price controls as a way of making novel medicines affordable. No signs yet that they recognize that 9y is too short. Meanwhile, we do have evidence that they wish to extend 9-13 to commercial insurance. Lots of companies are going to feel that.

We’ll go from not funding early-stage R&D into NDA-path drugs for non-orphan diseases of aging to not funding NDA-path drugs for non-orphan diseases for anyone. And if some who favor 9-9 or 5-5 get their way, we won’t fund any R&D, NDA or BLA, for non-orphan diseases. And if they waive the orphan exemption, then no R&D of any kind except aesthetics (cash pay).

Only a naive person would think this couldn’t happen after seeing how unstoppable the pill penalty was once it was proposed. Surely no executives are naive as to how policy might upend their work. As long as Americans remain angry at our industry and misunderstand both the risk/costs of R&D and the role of insurance in making medicines affordable and driving innovation (which is complex), there will be politicians happy to offer price controls as a vote getter.

So any biotech executive that doesn’t already have a degree in policy is going to be getting one. Think of NPLB like a cheat code to keep you in the know about the details of how a policy will play out. Don’t let the touchy feely name fool you. NPLB is all about the policy details, as every biotech leader needs to be.

nopatientleftbehind.org

Talk of China competing with US biotech has sparked interest in protectionism (coins), which, like mistaking a boomerang for a stick, rarely works out the way you think.

It’s cool to see many here speak passionately about preserving US biopharma like it’s the most important thing ever.

But the greatest threat to US biopharma is our own government and America’s misunderstanding and hatred of pharma, not China. It’s the calls for price controls and patent waivers from Congress. The pill penalty (also impacts oligos) causes harm. MFN causes harm (now companies give up on factoring ex-US sales into their plans, reducing value of success and incentives for trying).

That we have as much R&D still going on is testament to how much of the pro-innovation policy framework remains intact (for now, pill penalty only applies to non-orphan diseases of aging) and how modestly revenues from other countries contributed to investment calculus before. But that shouldn’t make anyone think US biopharma is safe from flawed policy. More price controls and continued MFN will deter investment, coins or no coins.

So I hope Americans are proud and protective of their biopharma sector (most aren’t actually unless it’s versus China). If you are curious about what set of policies would bolster biotech and pharma and solve the affordability challenges Americans are demanding Congress solve, follow the work of No Patient Left Behind, the advocacy organization my peers and I started to actually fix what needs fixing. Details in next comments.

@NPLB_org

Having waded through 163 pages of the draft COINS rule published by Treasury, my team and I can now respond with a simple graphic.

It will blind US companies and undermine our biopharma capabilities and national security, exactly opposite to what the policy is aiming to achieve. It does nothing to actually block a Chinese biotech from commercializing a drug in the US, with a European partner, European investors, or on its own. We value medicines highly and will now be paying others for them. Why would we do this to ourselves? We shouldn’t.

But you can’t submit a comic to Treasury so we wrote out a detailed comment that both lays out how the draft rule would backfire on American biotech and what revisions would allow Treasury to better achieve their stated national security objectives.

Have a look. Biotech investors and executives are welcome to sign onto our comment but the main purpose of publishing it now is to drive discussion that helps everyone sharpen their thinking and informs their own comment to Treasury, due Dec 7th. Anyone is welcome to crib from this. No need to ask.

We wrote it after considerable input from legal experts and peers. Since coins draft rule is itself unclear on many points, reasonable people can disagree as to its intent and meaning, so some of our comments address broader points meant to encompass a range of possibilities.

If you read what Treasury wrote, you might get the sense that they know this will backfire on America and are looking for support to revise their language to avert harm. So give this thought and submit your own analysis. We provide links in the article to the submission page.

And thanks to all who have already signed on.

@NPLB_org

racap.com/rapport/commen…

“Please stop putting stuff in my urethra” should have been the title of this article my colleagues and I wrote about a cool drug (oral selective FGFR3 Inhibitor) being developed by our portfolio company Tyra for bladder cancer and a few other diseases.

Writing this made me squirm. 1% of people will need this drug at some point in their lives. If you do, you’ll be super glad it exists.

This is part of our series of articles that gets into the societal value of the medicines our companies are working on. You can’t talk about price without value, so we do using GCEA. Any company developing a medicine should use GCEA to present the societal value of their invention before someday NICE and ICER undervalue it. @NPLB_org has more on this methodology & just hired a health economist to help companies do this work.

racap.com/rapport/tyras-…