Welcome to the Goodwin’s Life Sciences Perspectives Blog, a resource specifically aimed at addressing your most frequent and pressing issues and providing insights on current developments.

The challenges across the life sciences industry are as abundant as the opportunities. From tightening federal regulations and market forces to revolutionary innovations, the headwinds are stiff and shifting but they are navigable. We will be tracking emerging issues and developments on private and public company matters, licensing deals and collaborations, patent and IP matters, FDA and healthcare regulatory compliance, and European and Asian developments for life sciences companies. Sign up to receive postings from Goodwin’s Life Sciences Perspectives blog by clicking here.

 

Conducting Internal Investigations – In-House Counsel’s Guide

Whether you are a director, or a member of an in-house legal, human resources, or internal audit team, there are sensitive scenarios that occur daily in life sciences companies that trigger the need for an internal investigation. Goodwin has crafted an “In-House Counsel’s Guide” that sets forth a framework of…

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Disrupt + Innovate + Transform: Key Regulatory Issues for Digital Health Companies Webinar

Goodwin Life Sciences and Healthcare partner Roger Cohen and associate Anne Brendel along with Life Sciences and FDA associate Steven Tjoe kicked off Goodwin’s multi-part webinar series “Disrupt + Innovate + Transform: A Healthcare Webinar Series” with “Key Regulatory Issues for Digital Health Companies” discussing the key regulatory issues affecting…

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A Joint Research Pitfall - Soon to be Resolved?

Innovators in life sciences at companies and universities often collaborate and conduct research under a joint research agreement (JRA). The Cooperative Research and Technology Enhancement Act of 2004 (the “CREATE Act”) was enacted to promote collaboration and cooperative research between different entities. The United States Patent and Trademark Office (“USPTO”)…

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The Rise of SPACs in Biotech

The use of special purpose acquisition companies, or SPACs, as an alternative to the traditional IPO process has gained significant traction over the past few years and in 2020 in particular. While these transactions have historically focused more on the tech space, with top-tier biotech investors such as Perceptive Advisors,…

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EDPB Clarifies Scientific Research GDPR Compliance; Key Questions for US Sponsors Remain

Last month, the European Data Protection Board (“EDPB”) issued additional guidance on the application of the General Data Protection Regulation (“GDPR”) in the area of scientific health research. You can read our summary of the key takeaways here. While the EDPB’s responses offer some clarifications, many obstacles and complications remain…

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Five Tips for Life Sciences Companies to Protect Their AI Technologies

Given that artificial intelligence (AI) – historically the domain of software companies – is a new frontier for many life sciences companies, we have assembled five helpful tips to consider for protecting AI technologies: Tip 1:  Make sure you have permission to use the data Familiarize yourself with the data…

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2020 Year in Review: Securities Litigation Against Life Sciences and Healthcare Companies

Despite the turmoil and disruption of 2020, plaintiffs’ lawyers and courts appear to have adapted readily to our “new normal.” Although at lower rates than previous years, plaintiffs’ firms continued to file securities class actions against publicly traded pharmaceutical, biotechnology, medical device and healthcare product and services companies in 2020,…

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Goodwin's Clinical Trials Service Offering

    Given the breadth of clinical-stage companies that the Goodwin FDA and Healthcare teams advise, our regulatory attorneys together with our commercial contracting, products liability and insurance attorneys play an integral role in counseling clinical-stage companies on matters related to the conduct of clinical trials. Learn more about our…

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