Gloved hand grabs beaker with rolled currency.

Rethinking Funding for Scientific Innovation

By Matthew Bauer

Academic science laboratories typically survive by applying for private- and government-funded grants. This model of funding scientific innovation is being flipped on its head with the creation of the Arc Institute in Palo Alto.

Research labs no longer need to apply for highly competitive processes for grants. Instead, the Arc Institute aims to put science first, by funding its scientific investigators’ salaries and research costs for 8 years.

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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

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Mushrooms containing psilocybin grow in the forest.

Washington Psilocybin Bill Would Legalize Supported Adult Use

By Mason Marks

On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.

Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.

I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.

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Gloved hand grabs beaker with rolled currency.

Leverage COVID-19 Frameworks to Prepare for the Next Pandemic

By Matthew Bauer

How should scientists, policy makers, and governments balance efforts to address the current pandemic with initiatives to prevent the next one?

We have seen this play out before during the 2003 SARS crisis. A burst of research funding and resources were thrown at tackling the health emergency that spread to 29 different countries. Ultimately, enormous efforts across the globe were able to halt the crisis, but as scientific research continued post-outbreak, it became difficult to sustain funding.

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Photo of person with gloved hand holding flask at lab bench.

In Academia, Innovators Receive Unfair Compensation for Their Discoveries

By Matt Bauer

In academia, many of the scientists who are recognized as inventors on patents see little economic gain from these agreements.

Instead, royalties are primarily assigned toward their home institutions.

The scientists who drive discoveries within the walls of academia are not receiving an equitable share of the benefits of their innovations. Despite being the source of these discoveries, students and postdoctoral researchers don’t see the financial upside of the commercialization of their inventions.

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close up of an open book

Monthly Round-Up of What to Read on Pharma Law and Policy 

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of September. The selections feature topics ranging from an analysis of the regulatory outcomes of cancer drugs that received accelerated approval and had negative post-approval trials, to an evaluation of how federal public funding contributed to the development of Pregabalin (Lyrica), to a systematic literature review of the criticisms against the use of the quality-adjusted life-year (QALY) in health technology assessments. A full posting of abstracts/summaries of these articles may be found on our website.

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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

The NIH Has the Opportunity to Address Research Funding Disparities

By Leah Pierson

The Biden administration plans to greatly increase funding for the National Institutes of Health (NIH) in 2022, presenting the agency with new opportunities to better align research funding with public health needs.

The NIH has long been criticized for disproportionately devoting its research dollars to the study of conditions that affect a small and advantaged portion of the global population.

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Pile of colorful pills in blister packs

The Age of Orphans

Join the author today for the 2021 CeBIL Symposium. Register here!

By Sarah Rickwood

The 2020s are the age of orphan medicines.

Orphan medicines are available for a larger number of diseases and patients than ever before, a testament to the success of legislation established decades ago encouraging the development of these medicines in both the U.S. and European Union.

Orphan medicines were the majority of European Medicines Agency (EMA) approvals for the first time ever in 2016 (59%) and the majority of U.S. Food and Drug Administration (FDA) approvals for the first time ever in 2018 (58%).

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person cuts salami sausage on a wooden cutting board.

Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives

Join the author on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Sven Bostyn

The development of orphan drugs, so named for the rare diseases they treat, has been incentivized through regulation in the European Union. The primary reward is 10 years’ market protection (or exclusivity).

But are these incentive mechanisms working as they should? To date, only 131 orphan drugs have been brought to market. Findings from the European Commission’s long-awaited evaluation of the orphan drug system in Europe, 20 years after its inception, suggest there may be cause for concern.

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