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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Forthcoming HHS Regulatory Actions and Opportunities Relevant for Pharmaceutical Manufacturers for the Rest of this Year and Next
Pharmaceutical manufacturers need to note some key forthcoming regulatory actions and opportunities which the Department of Health and Human Services (“HHS”) has recently published. Meena Datta and Catherine Starks give a bird’s eye view of the key points, the key dates and the stage which each new rule has reached.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Meenakshi Datta
Chicago
mdatta@sidley.com
Catherine Y. Starks
Chicago
cstarks@sidley.com
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Catherine Y. Starks
Chicago
cstarks@sidley.com
Deeona R. Gaskin
Washington D.C.
dgaskin@sidley.com
Meenakshi Datta
Chicago
mdatta@sidley.com
Taylor Andelman
Washington, D.C.
tandelman@sidley.com
China’s Generative AI Measures Could Affect Life Sciences Companies That Make Apps
Those medtech companies which embed AI into an app allowing healthcare professionals or patients to ask questions and to receive a response will probably need to comply with China’s new Interim Measures for the Management of Generative Artificial Intelligence Services (the “Measures”). Lianying Wang explains.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Lianying Wang
Beijing
lianying.wang@sidley.com
New EU Subsidies Rules Likely to Catch Global Life Sciences Companies
Given their extensive involvement in public procurement contracting, life sciences companies are likely to be heavily impacted by the EU’s Foreign Subsidies Regulation (the “FSR”), which has the potential to hold up tender awards over competition concerns. Michele Tagliaferri and Alessandra Moroni explain.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Michele Tagliaferri
Brussels
mtagliaferri@sidley.com
Alessandra Moroni
Brussels
amoroni@sidley.com
AI-Powered Drug Discovery Efforts Could Lead to New Treatments
Stephen Abreu, Sidley partner, talks to Colin Hill, CEO and Co-Founder of AI-powered drug discovery company Aitia, about how the use of AI is revolutionizing the biotech space.
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This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Stephen Abreu
San Francisco
sabreu@sidley.com
Europe’s Regulatory Approach to Continuous Learning AI
The regulation of continuous learning models involves the challenge of navigating the future. The EU is striving to stay ahead of the game with its forthcoming AI Act and harmonised standards. Eva von Mühlenen, Oliver Haase of Validate, and Leon Doorn of Aidance discuss.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Innovation, Collaboration, and Access to Capital: Key Takeaways from the Sidley Healthcare Investment Conference
At Sidley’s Healthcare Investment Conference on 12 September, speakers analysed the flow of capital across the global life sciences and healthcare ecosystem in panels discussing collaborative deals, sources of funding, the regulatory scrutiny of deals, and women’s health.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
GLS Blog Contributor
sidleyglsblog@sidley.com
Five Governance Steps To Consider When Using Generative AI Within A Pharma Company
Pharma companies are looking to better understand how Generative AI (GAI) can facilitate innovation. Early adopters can gain distinct advantages while properly managing the top-of-mind potential risks discussed below. Francesca Blythe and Steve McInerney explain the corporate governance principles that should be considered.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Francesca Blythe
London
fblythe@sidley.com
Stephen W. McInerney
Chicago
smcinerney@sidley.com
Start Thinking About Human Rights and Environmental Impact of Subsidiaries and Value Chains
The impending EU Corporate Sustainability Due Diligence Directive (“CS3D”) means most EU and some non-EU life sciences companies should begin to assess their wider human rights and environmental impacts and rethink compliance programmes. Michele Tagliaferri explains.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Michele Tagliaferri
Brussels
mtagliaferri@sidley.com
Four Tips for Successful Development of Cell and Gene Therapies
Developing a cell or gene therapy (CGT) involves a range of regulatory considerations and challenges. Emily Marden and Jaclyn Fonteyne point to some key factors that are currently the focus of FDA attention and may merit consideration by sponsors early in the development process.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Emily Marden
San Francisco
emarden@sidley.com
Jaclyn G. Fonteyne
Washington, D.C.
jaclyn.fonteyne@sidley.com