Bayh-Dole Compliance: 2020 Wrap-up

by Nora Gildea, Senior Contributor

What a year it has been. Universities, large and small, have grappled with fiscal constraints, revenue shortfalls and research sidelined or shuttered for months at a time. Tech transfer operations have felt the impact yet persevered in their mission. Effective remote work plans have been established and researchers continue to innovate albeit with many initiatives shifted toward the demands of the pandemic.


Transition to NIST Ongoing

As NIST picks up on the transition of iEdison from NIH, the redesign of the system is well underway. Early in the year, NIST reached out for public feedback about what works well in the current system and what does not. Now the redevelopment of the iEdison core business functions is well underway. For ongoing updates from NIST on this initiative check in here: https://www.nist.gov/tpo/bayh-dole/iedison-rebuild. The important thing to remember is that until the new iEdison launches (currently scheduled for Spring 2022), continue to report under the current system and keep a healthy sense of humor!


Compliance and Operations Training

2020 was the first year that AUTM combined the Compliance and TOOLs courses and for the first time the entire meeting was deployed remotely. A twelve-person committee of compliance and tech transfer operations professionals met regularly over a period of six months to design a virtual course that would offer as much valuable material as possible in a shorter time frame. More than 100 people attended and although the session was remote, participants had the opportunity to meet in small groups in breakout rooms to meet colleagues and exchange information. A highlight was the presentation offered by introductory speaker Bethany Loftin from NIST. She provided an update on the phases of development for the new iEdison database.


Bayh-Dole Policy Update

The movement to use the provisions of Bayh-Dole as leverage on pharmaceutical companies to reduce pricing is nothing new. However, this year saw increased pressure motivated by the accelerated development of COVID-19 vaccines and treatments. Every day of the year, there are three academic inventions turned into new products and three new startup companies formed because of Bayh-Dole. Industry, universities and federal laboratories are able to collaborate, knowing that the rules for owning and managing inventions are well established and dependable. Joe Allen, who worked on the passage of Bayh-Dole in concert with the senators, has written well-reasoned rebuttals to Bayh-Dole critics and we are confident that wiser heads will prevail. Nevertheless, the cacophony of criticism continues.


Hopefully one year from now we will be looking at an optimistic post-COVID landscape. For Bayh-Dole administrators this leaves plenty of time to clean up the data and wrestle down any compliance issues related to existing disclosures before we look forward to the implementation of the new reporting system.


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