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Universities Pharmaceutical Industry

Hutchison PLLC

From Academia to the Marketplace: The Ins and Outs of University Spinout Licenses with Dan O’Korn

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In the latest episode of the Founder Shares podcast, I had the pleasure of diving into the dynamic universe of university licenses with Dan O'Korn, a seasoned life sciences attorney specializing in licensing and development...more

Goodwin

Leveraging Investigator-Initiated Trials in Rare Disease Drug Development

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Investigators interested in rare disease treatment development have the opportunity to approach drug and biologic developers to obtain investigational drug supply for trials in which the investigators, typically at academic...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

Hogan Lovells

Safeguarding drug development at academic institutions

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Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. ...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 9. In This Month's E-News: September 2020

Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more

Bass, Berry & Sims PLC

Significant Change to ClinicalTrials.gov Reporting Requirements: Ten Years' Worth of Back Data Owed

The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 7 In This Month's E-News: July 2020

Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more

Health Care Compliance Association (HCCA)

From Remote Oversight to Wind-Downs: Research Struggles in the Time of COVID-19

Report on Research Compliance 17, no. 4 (April 2020) - “In an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions and to preserve personal protective equipment for...more

Pullman & Comley, LLC

ALERT: Connecticut Colleges and Universities Should Develop Opioid Antagonist Policies Now So They Can Be Approved and In Place By...

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Colleges and universities in Connecticut must comply with a new law that requires them to implement a policy regarding the availability and use of opioid antagonists by their students and employees not later than January 1,...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - July 2019

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DHS Warns Businesses of Risk of Iranian-Backed Wiper Malware Attacks - The tension with Iran has generally increased, and it has been reported that the U.S. has launched a cyber-attack against Iran. In retaliation, the risk...more

Troutman Pepper

When Research Misconduct Violates the False Claims Act: Lessons from Duke's $112.5M Settlement

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On March 25, the U.S. Department of Justice (DOJ) announced that Duke University agreed to settle a False Claims Act qui tam action alleging widespread misconduct in federally funded research. ...more

Cozen O'Connor

The State AG Report Weekly Update

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AG Elections- Democrat Chris Mattei Announces Campaign for Connecticut Attorney General- Democrat Chris Mattei announced his candidacy for Connecticut AG in 2018, switching statewide races and forgoing a previously...more

Hogan Lovells

Not out of the woods yet: What the lifting of Sudan sanctions means for businesses and non-profits

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Yesterday, on October 12, 2017, the U.S. permanently revoked most sanctions against Sudan. This lifting represents the completion of a process that began in January 2017, and was extended in July 2017. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Patenting Necessary for Continued Innovation in Biotech/Pharma Industries, Academics Conclude

Most recent academic and some popular assessments of the effects of the Bayh-Dole Act have been critical. This has been due in part to political opposition to licensing university technology (and the purported soiling of the...more

McDonnell Boehnen Hulbert & Berghoff LLP

In Defense of Patenting

Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more

McDonnell Boehnen Hulbert & Berghoff LLP

The Futility of Petitioning Congress (After the Fix Is In): Stakeholders Tell Judiciary Committee What's Wrong with Goodlatte Bill...

What everybody doesn't seem to know is how to get Congress to listen to the needs of the innovation community when well-heeled sectors put their lobbying and financial support in favor of legislation purportedly aimed at...more

Morrison & Foerster LLP

Sharing an Umbrella

Big Pharma and academia cement big deals in the quest for bigger prizes - With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more

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