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.

 

Q&A on FDA’s Requirements Related to Financial Disclosure by Clinical Investigators

What financial arrangements between clinical trial sponsors and clinical investigators must be disclosed in a drug, biologic or device marketing application? In a marketing application, FDA requires that four types of financial arrangements be disclosed: (1) any financial arrangement between the sponsor and the investigator whereby the value of the…

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What has contributed to the rising cost of Directors and Officers (D&O) Liability Insurance for new public companies?

Over the past year, the cost of obtaining D&O insurance for new public companies has increased substantially. Rates have increased from $50-60,000 per million dollars of coverage to over $150,000 per million dollars of coverage. Along with increased premiums, retention amounts have increased substantially (from $5 million to $10 million for…

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When does my patent expire?

To determine when your (or your competitor’s) patent expires, first identify the correct filing date of the patent application. A U.S. utility patent (filed on or after June 8, 1995) expires 20 years from the earliest filing date of the patent. If the patent claims priority to an earlier patent…

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I want to engage a consultant to provide services on behalf of the company, but that consultant is a professor at an academic institution. Can I still do so?

Yes. Many life sciences and biotech clients work with consultants that are associated with academic or research institutions. However, in considering whether to engage such a consultant, life sciences companies should be aware that the consultant will be subject to the intellectual property and conflict of interest policies of the…

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I want to license technology out of an academic or research institution. What kind of compensation will the institution typically look to receive?

Academic or research institutions are at the core of early-stage innovation in the life sciences and biopharmaceutical industries. In order to gain access to the intellectual property generated or owned by those institutions, institutions typically offer to grant a license to its owned intellectual property to companies. In exchange for…

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Key Takeaways from Goodwin + KPMG @ JPMorgan Symposium: Mergers and Acquisitions

On Wednesday, January 15, 2020, during the J.P. Morgan Healthcare conference, Goodwin and KPMG held their initial all-day Symposium at the St. Regis hotel in San Francisco.  The Symposium was composed of five separate “bursts” entitled (i) New Frontiers in Digital Diagnostics and MedTech, (ii) Europe Unleashed, (iii) Knowing the…

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Key Takeaways from Goodwin + KPMG @ JPMorgan Symposium: Knowing the Best IPO Strategy

On Wednesday, January 15, 2020, during the J.P. Morgan Healthcare conference, Goodwin and KPMG held their initial all-day Symposium at the St. Regis hotel in San Francisco.  The Symposium was composed of five separate “bursts” entitled (i) New Frontiers in Digital Diagnostics and MedTech, (ii) Europe Unleashed, (iii) Knowing the…

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