Apr 222025

The Union of AI and Drug Discovery and Development Requires New Thinking for Structuring and Negotiating Strategic Transactions, and a Rigorous Analysis of Applicable Regulatory Considerations

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Adam Welland, Deeona R. Gaskin and Jon A. Olsen

The use of artificial intelligence and machine learning (AI/ML) in drug discovery and development is well established and here to stay. With AI tools developing the potential to impact virtually every stage of the life sciences product life cycle, the FDA continues to refine its framework for the use of AI to support regulatory decision-making. On April 7, the FDA ended its consultation period on two draft guidance documents, one containing recommendations on the use of AI to support FDA regulatory decision-making and another providing a “comprehensive approach” to the management of risk throughout the total product life cycle of AI-enabled devices. We also saw, in January of this year, the U.S. administration issue the Executive Order Removing Barriers to American Leadership in Artificial Intelligence. These developments, and potential developments, need to be carefully taken into account by life sciences companies that are considering transacting with an AI/ML tool provider.

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Apr 12025

“Refreshed” UK-wide Innovative Licensing and Access Pathway (ILAP) Applications Now Open

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Maria Isabel Manley and Victoria Kerr

Commercial and pre-commercial developers of potentially transformative medicines or drug-device combination products can now utilize a unique accelerated regulatory pathway in the UK. Article authored by Marie Manley and Victoria Kerr. (more…)

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Mar 262025

Unauthorized Drug Importation by Alternative Funding Programs: What Pharmaceutical Companies Need to Know and Options on How to Respond

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Benjamin B. Correa and Kathy P. Lee

Some entities known as Alternative Funding Programs (AFPs) are engaged in the unauthorized importation of specialty drugs into the United States and may pose a growing threat to the U.S. drug supply. Article authored by Benjamin B. Correa and Kathy P. Lee.

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Dec 182024

How Life Sciences Companies Can Respond To DOJ’s Focus on Clinical Trial Fraud

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David J. Ludlow and Julea Lipiz

For the past two years, clinical trial fraud has been a key enforcement area for the U.S. Department of Justice’s (DOJ) Consumer Protection Branch (CPB). David Ludlow and Julea Lipiz set out considerations for life sciences companies to help mitigate scrutiny of their trial results and related products. 

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Nov 82024

SEC Interest in FDA-Related Disclosures by Life Sciences Companies Highlighted

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Lara Mehraban

A recent SEC enforcement action against Cassava Sciences over misleading statements made to the FDA about clinical trial (CT) results highlights the importance of life sciences companies exercising care in how they disclose FDA-related information to investors. Lara Mehraban explains.

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Nov 52024

Risks and Benefits of Generative AI for Pharma Supply Chain Management

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Michele Tagliaferri, Eva von Mühlenen and Anna-Shari Melin

As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, and Anna-Shari Melin explain. (more…)

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Oct 292024

European Court of Justice Judgment Relating to Orphan Market Exclusivity

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Maria Isabel Manley, Dr. Chris Boyle and Alix Vermulst

In a recent judgment, the Court of Justice of the European Union (CJEU) has shed light on the scope of the ‘clinical superiority’ criteria providing for a derogation to orphan market exclusivity which is key to protect the orphan molecule from competition for the period of market exclusivity (10 or 12 years as the case may be). Marie Manley, Chris Boyle, and Alix Vermulst examine the impact of this judgment on pharmaceutical companies.

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Oct 222024

European Regulator Clarifies Guidance on the Use of AI in the Medicinal Product Lifecycle

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Josefine Sommer and Zina Chatzidimitriadou

The European Medicines Agency (EMA) has published a final reflection paper on the use of AI in the drug lifecycle, which provides important insights into the expectations from the EMA to clinical trial sponsors, as well as marketing authorization (MA) applicants and holders who use AI systems. Josefine Sommer and Zina Chatzidimitriadou explain.

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Sep 132024

As U.S. Biosecure Act Passes the House, Four Things Biotechs Can Do to Prepare

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Michael E. Borden, Andrew W. Shoyer and Ruchun Ji

The U.S. Senate may still reject the U.S. BIOSECURE Act , but the House of Representatives has now passed a version of the bill. Biotechs in both the P.R.C. and the U.S. therefore need to prepare for the new environment which it heralds. Michael Borden, Andrew Shoyer, and Ruchun Ji set out five steps to take now.

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Sep 92024

Are the revisions to the EU’s ‘Bolar’ system compatible with TRIPS?

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Maarten Meulenbelt, Dr. Chris Boyle, Lauren Shapiro, Maryanne W. Kamau and Alix Vermulst

The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau, and Alix Vermulst explain.

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