Key Regulatory and Compliance Considerations for Early-Stage Life Sciences Companies and Their Investors

Early-stage life sciences companies and the investors that back them are laser-focused on evidenced-based development and approval hurdles. However, even at early stages, failure to adequately prioritize more nuanced regulatory and compliance issues can have a significant impact on exit value and create potential liability for investors and acquirers. Geoffrey Levin, Torrey Cope, Marie Manley, Donielle McCutcheon, Andrew Shoyer, Michele Tagliaferri, and Julea Lipiz highlight eight key areas for focus.

Beyond Technology: Embracing Blockchain for a Paradigm Shift in Life Sciences

Blockchain is not only the preserve of the fintech industry, but may have multiple uses for life sciences companies, including providing a consent structure for clinical trials to give enhanced patients more control over their own data. Sidley’s Eva von Mühlenen and Daniel Fritz, executive director of the PharmaLedger Association, explain.

HHS-OIG Rejects Calls for New Safe Harbors for Financial Support to Patients Enrolled in Clinical Trials

Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) declined to establish new safe harbors that would protect arrangements under which clinical trial sponsors provide financial support to participants. Catherine Starks, Deeona Gaskin, Meenakshi Datta, and Taylor Andelman report.

FDA Offers New Clinical Trial Guidance for Oncology Accelerated Approval

FDA details its view of the “limitations” of single-arm trials in oncology drug development and invites comment on its favored approach going forward.  Becky Wood, Emily Marden, and Julea Lipiz explain. 

Navigating Decentralized Clinical Trials In the EU and the UK

Decentralized clinical trials are on the rise in the EU and the UK. This month, new EU level guidance on how to conduct them has supplemented existing guidance on the topic. Zina Chatzidimitriadou, Lauren Cuyvers and Bronwyn Tonelli give seven considerations for decentralized trial sponsors in the region.

Five Global Bellwether Trends for Clinical Trials

Scott Bass explains why taking a multi-disciplinary, multi-continent approach to the planning of clinical trials will help you anticipate regulatory changes and ward off investigations.

Scott Bass

New York, Washington, D.C.

sbass@sidley.com

Are China-only Clinical Trials Enough for U.S. Approvals?

Torrey Cope looks at the recent FDA emphasis on the challenges of a China-only trial strategy. He explores the FDA concern that a China-only clinical trial will be unable to prove that a drug is suitable for the U.S. population, and considers the regulatory requirements for U.S. approvals based on ex-U.S. trial data.

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Might the Remote Monitoring of Clinical Trials in Europe Continue after Covid-19 Despite Data Privacy Concerns?

Olivier Goarnisson in Geneva and Francesca Blythe in London look at the benefits that were seen when some European countries temporarily permitted remote monitoring during the pandemic, and consider whether remote monitoring might have a long-term future if data privacy concerns are addressed.

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