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Artificial Intelligence Life Sciences Risk Management

Fenwick & West LLP

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

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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-...

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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...

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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...

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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

Hogan Lovells

AI Summit panelists weigh emerging data & privacy risks for novel technology

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Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more

MoFo Life Sciences

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

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AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must...more

Venable LLP

Addressing Insider Threats to Intellectual Property

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Want to learn more about drafting, negotiating, and understanding intellectual property and technology contracts and have 10 minutes to spare? Grab your morning coffee or afternoon tea and dig into our Tech Contract Quick...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Butler Snow LLP

Junk Science: What Courts are Seeing and How It Affects Us: A Judge’s Eye View

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Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more

MoFo Life Sciences

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

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Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more

Mintz - Intellectual Property Viewpoints

Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

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In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

DLA Piper

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

Hogan Lovells

FDA unveils long-awaited guidance on AI use to support drug and biologic development

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Faegre Drinker Biddle & Reath LLP

FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models

On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more

MoFo Life Sciences

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Orrick, Herrington & Sutcliffe LLP

FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions

The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more

Venable LLP

AI On the Prize: Decoding FDA's Latest Guidance

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Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Fenwick & West LLP

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more

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