Policy, Biotech, Science Chris Morrison Policy, Biotech, Science Chris Morrison

Proposals for Modernizing IND Processes, Clinical Trial Development, and Good Clinical Practice Standards

In an effort to encourage continued discussion between and within our biopharmaceutical community and the regulatory bodies we collaborate with, RA Capital Management has submitted several recommendations to the US Department of Health and Human Services and the Food and Drug Administration to help the agencies as they continue to modernize their processes to benefit the American public.

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Biotech, Policy, Culture Chris Morrison Biotech, Policy, Culture Chris Morrison

Resolving the Massachusetts Paradox

In Washington, senators and representatives usually fight for their states’ economic interests. Why then, when it comes to the biopharmaceutical industry that is so important to Massachusetts, are we such an outlier? This article examines the origins of this Massachusetts Paradox, what kinds of biopharma-related policies the state’s voters and politicians should logically support, and proposes a new approach to rallying our neighbors to support those policies. This campaign is rooted in a kind of engaging storytelling that all of us in the biopharma ecosystem, from startup to pharma and from investor to banker, can and should contribute to.

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Biotech, Science, Policy Chris Morrison Biotech, Science, Policy Chris Morrison

A Cautious FDA Also Threw Out the Baby: In restricting the label for COVID-19 vaccines, the FDA is being too conservative

We believe the FDA’s new COVID vaccine guidelines are too narrow, leaving young children vulnerable. If it were up to us and we were deciding on how to best use boosters, we would have approved and recommended them for healthy children under 5 years of age and to pregnant women (which protects infants under 6 months who are ineligible for vaccination due to their immature immune systems).

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Policy, Biotech Chris Morrison Policy, Biotech Chris Morrison

No More Freeriding on the Great American Drug Deal

President Trump’s recent “most-favored nation” proposal seeks to compel companies to charge the same prices in the US as they do elsewhere. But the price controls sought by MFN override market negotiation and threaten to backfire by drastically reducing spending on R&D that drives tomorrow’s treatments and cures. That would undermine the return on investment America has been getting – financially and in terms of better health. Instead of price-controlling in the US, we must convince other countries to pay their fair share for novel medicines. This is an intractable trade puzzle that the US should begin trying to solve. And to end other countries’ freeriding, first we need to examine the extent of it.

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Finance, Biotech, Policy Thomas Culman Finance, Biotech, Policy Thomas Culman

NPLB’s GCEA Calculator

To truly appreciate the advances offered by GCEA, there's nothing as illustrative as getting in there and running the numbers yourself. However, building a de-novo cost-effectiveness model can be a daunting task. 

Well, not to worry! Just in time for the ISPOR Annual Meeting 2025, we've released an easy-to-use GCEA calculator that allows you to explore and appreciate the societal value of innovative medicines, and underpin the key value drivers without building a full-on model. The GCEA calculator offers an interactive user interface that lets you customize your own GCEA. 

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Science, Policy, Biotech Thomas Culman Science, Policy, Biotech Thomas Culman

Managing pain without opioids is on the horizon – if we decide it’s worth it

Thanks to the relentless efforts of scientists at Vertex Pharmaceuticals, there will likely soon be a novel non-opioid pain medicine. How insurance plans, including Medicare, decide to cover this drug will make a world of difference to whether we get even better non-opioid options down the road — and whether this progress makes a dent in the ongoing opioid misuse crisis.

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Policy, Finance Chris Morrison Policy, Finance Chris Morrison

Discount rates and drug value: A Q&A with Josh Cohen

All else being equal, people care more about outcomes that happen in the near future than about outcomes that happen later. The discount rate represents how much timing matters. We sit down with Josh Cohen, Deputy Director of the Center for the Evaluation of Value and Risk in Health (CEVR) at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, and Research Professor of Medicine at Tufts University School of Medicine, to learn about how changes to the discount rate can alter how we value medicines.

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Policy, Science, Planetary Health Thomas Culman Policy, Science, Planetary Health Thomas Culman

Now boarding: Net-zero aviation

Whether you enjoy air travel or not, it’s increasingly common and persistently bad for the environment. Almost three million passengers fly in and out of US airports each day and global demand for air travel is expected to double by 2050. In addition to emitting pollutants that lower air quality, aviation is recognized as a hard-to-decarbonize sector and accounts for ~3% of global CO2 emissions. Airlines have recently announced commitments to switch to "green" fuels, but as of today 95% of jet fuel is produced from fossil fuels. Why is that? 

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Biotech, Policy, Culture Peter Kolchinsky Biotech, Policy, Culture Peter Kolchinsky

Eroding tolerance: A wonder drug shows us the drug industry’s fundamental failure to communicate

Many people who dedicate their lives to discovering, developing, and making new, lifesaving drugs don’t understand the extent to which the drug industry has failed to communicate its value proposition to society and to inspire its customers to pay for that value. That is to say, when the public and even legislators representing our biotech innovation hubs focus on the price of a breakthrough drug without a sense of its value or how it came into being and insist that innovators should not only invent medicines but pay for them, too, that’s a self-inflicted wound. Vertex’s Trikafta, one of our industry’s greatest success stories, provides an example.

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