News & Analysis as of

Research and Development Risk Management Life Sciences

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

Fenwick & West LLP on

As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 3 - International Clinical Trials Country Requirements-...

Woodruff Sawyer on

From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 2 - AI In Real Life (Science): Exploring Real World...

Woodruff Sawyer on

From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 1 - Navigating Risk from Lab to IPO: A Guide to...

Woodruff Sawyer on

From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Fenwick & West LLP

Navigating and Litigating 'Commercially Reasonable Efforts' Provisions: Considerations and Strategies for Tech & Life Sciences...

Fenwick & West LLP on

Commercially reasonable efforts (CRE) provisions are a common feature in technology and life sciences agreements, particularly in development collaborations, licensing deals, and milestone-based contracts. ...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

Husch Blackwell LLP on

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

Goodwin

Four Steps to Maximize AI Innovation in Medtech

Goodwin on

Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more

Fenwick & West LLP

Balancing AI-Powered Drug Discovery’s Risk and Reward

Fenwick & West LLP on

AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more

American Conference Institute (ACI)

[Complimentary Webinar] Mitigating Sanctions and Export Control Risks for Life Sciences, Research Institutes and Universities -...

Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more

Hogan Lovells

[Event] Privacy and Cybersecurity KnowledgeShare – September 19th, London, UK

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Join us on Thursday 19 September for the Hogan Lovells Privacy and Cybersecurity KnowledgeShare in London. We will share our latest thinking on the key privacy and cybersecurity issues faced by those with data protection...more

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