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AURP CEO Blog Post - 10.02.2020

Former Senators Birch Bayh and Bob Dole

The Economist Magazine, not known for idle puffery, called this ‘one of the most inspired pieces of legislation in the past half century’. The legislation? The Bayh-Dole Act. 
 
The 1980 Bayh-Dole Act helped to unlock the inventions in laboratories across the US that were made with taxpayer money. Before the Bayh-Dole Act was put into law, of the 28,000 patents owned by the US government, less than 5% were licensed to industry.  These technologies were lying on the shelf as the government negotiation process was complex, time-consuming and frustrating for industry. By giving incentives to universities and other entities to take title to patents funded by government research, the legislation created a whole new industry of technology intermediaries at universities and companies to help push the tech transfer process. 
 
Before the Bayh-Dole Act, few universities had tech commercialization offices, and fewer still had tech incubators, research parks or innovation districts to bring together public-private partnerships to fuel economic growth in the US.   The success of California's Silicon Valley and Massachusetts’ Kendall Square, but also places like North Carolina’s Research Triangle Park and the University of Arizona’s Tech Parks would have been inhibited, if not for robust university tech commercialization policies undergirded by Bayh-Dole. 
 
Unfortunately, some policymakers on both the left and right have seized on a provision in the Bayh-Dole Act in an attempt to control medical drug prices. March-in Rights under Bayh-Dole allows the federal government to take back patents if universities or companies have not made good faith efforts to commercialize the underlying technology. But this provision was never intended to be used as a price control mechanism for consumer drugs.  Previous administrations have rejected invoking march-in rights as a price control mechanism, and it would be especially detrimental to smaller biotech companies in our parks. Large pharmaceutical companies would survive but creating uncertainty for biotech patents owned by small companies would hurt bringing in needed capital to create new health therapies.
 
This year, as we celebrate the 40th Anniversary of the passage of this path breaking legislation, during the 2020 AURP International Conference (Nov 2-6), AURP is honored to have Joe Allen, one of the Act’s principal architects, leading a special panel looking at the history and policy emulation across the globe. www.aurp.net
 
Other changemaker keynoters include, entrepreneur and venture capitalist Steve Case, on Revolution and Rise of the Rest, along with BIO’s new CEO and President, Dr. Michelle McMurry-Heath.  Both the biotechnology industry and venture capital would look very different if the Bayh-Dole Act had not passed back in 1980, stimulating the growth of startup companies and new bio technologies in the US. 
 
Let’s celebrate the amazing success of the Bayh-Dole Act, and ensure it remains a force for innovation and new technologies for the next 40 years.

AURP CEO Blog Post - 08/11/2020

Two of the nation’s hottest COVID-19 topics is the need for the U.S. to ensure medical supply lines through domestic pharma and bio manufacturing plus maintaining our scientific expertise in bio innovations. Billions of dollars of funding for new vaccine production are being deployed across the country; medical device production is increasing; and new policies are being debated in Congress and The White House. Last week the Trump Administration issued a “Buy American” executive order with potential impact to drug manufacturers and patients. See below for details on the executive order from BIO.
On September 15, 2020 AURP will explore how your region, your park, innovation district or company can participate in the bio and pharma manufacturing renaissance. Connect with manufacturing executives, policy experts, developers and related industry leaders to examine how life science manufacturing is evolving to meet the challenges of COVID-19 to identify emerging tech clusters. Additionally, AURP will award the NIST-sponsored National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) its COVID-19 Excalibur Award for Response and Resiliency, located at the University of Delaware Research Park. Cost for the webinar is $75 for AURP members; $99 for non-members.
Register at https://www.aurp.net/bio-and-pharma-manufacturing-renaissance
This AURP forum on September 15th is a preview of the AURP International Conference taking place virtually November 2-6, 2020 – CHANGEMAKERS:
Leading Communities of Innovation in Uncertainty.

What you need to know about Trump’s “Buy American” order

Last week, President Trump issued another executive order with potential to impact drug manufacturers and patients. Here’s what you need to know.
Dubbed the “Buy American” order, the goal is to increase domestic manufacture of “essential medicines,” “medical countermeasures,” and “critical inputs,” and in turn, decrease America’s reliance on medicines manufactured in foreign countries.   
What it doesn’t do: The order does not require any manufacturer to physically move production of any particular medicines back to the United States. 
What it does do: It incentivizes production in the United States by directing federal agencies involved in contracting for these products to apply preferences aimed at increasing domestic procurement of them. However, agency heads can waive the preferences if sufficient supplies do not exist domestically, or if a number of other exceptions apply. 
The order specifically directs the Food and Drug Administration (FDA) to accelerate review and approval of domestically manufactured essential medicines. We anticipate FDA would need to issue some guidance on this in the future.
It might affect trade, too. The order directs the U.S. Trade Representative (USTR) to modify trade agreements to allow preferential procurement of domestically produced products and allow tariffs on imported medicines. And yes, this could trigger reciprocal action or even tariffs from trading partners. 
What’s next? We expect affected agencies (FDA, HHS, DoD, USTR) to engage in some kind of public dialogue about the implementation, so stay tuned. In the meantime, BIO will continue to work with our allies to mitigate the impacts on our sector and the patients we serve—and articulate why a resilient, diverse, dynamic supply chain is critical to ensuring access to medicines, in normal times and in emergencies.
From Good Day BIO, August 11, 2020