News & Analysis as of

Research and Development Life Sciences Clinical Trials

A&O Shearman

A new European strategy to foster life sciences innovation and market access

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On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Gardner Law

The Importance of a Clinical Trial Strategy

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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...

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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...

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

Foley & Lardner LLP

Rethinking University Research: Innovating the Innovation Ecosystem to Support Life Sciences and Personalized Medicine

Foley & Lardner LLP on

Personalized medicine—tailoring treatments to individual patients based on their genetic makeup, lifestyle, and environment—is transforming healthcare. But this revolution didn’t begin in the private sector. It was sparked...more

Morgan Lewis - As Prescribed

New Measures to Encourage Clinical Trials in the United Kingdom

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...more

Latham & Watkins LLP

FDA and NIH Announce Initiatives to Reduce Animal Testing and Encourage Alternative Methodologies

Latham & Watkins LLP on

The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

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Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

Foley & Lardner LLP

Unlocking the Future of Medicine: The Role of AI in Drug Discovery

Foley & Lardner LLP on

Since 1995, Nature Medicine has been chronicling advances in medical technology and health care. To mark the journal’s 30th anniversary, each month an issue of critical importance for the future of medicine will be...more

DLA Piper

HHS Implements Communication Freeze: Top points

DLA Piper on

Last week, Acting Secretary of the US Department of Health and Human Services (HHS) Dorothy Fink instructed federal health agencies within the HHS to freeze all external communications, including health advisories, weekly...more

Faegre Drinker Biddle & Reath LLP

Recap of the FDA and CTTI Public Workshop on AI in Drug Development

On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

McDermott Will & Emery

Key Takeaways | Clinical Research Technology (ClinTech)

McDermott Will & Emery on

During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more

Hogan Lovells

The use of IVDs as CDx in pharmaceutical clinical trials - Pathways for legacy companion diagnostic IVDs, IVD performance studies,...

Hogan Lovells on

The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for pharmaceutical companies....more

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

TransPerfect Legal on

Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development,...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Matthew welcome Shirley Paddock, Senior Vice President of Clinical Development for Syneos Health. She shares exciting insights on the...more

Woodruff Sawyer

How to Manage Exposures When Commercializing a Life Sciences Product

Woodruff Sawyer on

The road to commercializing a life sciences product is a long one, spanning years to perform research, develop the product, conduct clinical trials and testing, and receive approval from the Food and Drug Administration...more

Woodruff Sawyer

What Are Key Exposures of Pre-Human Clinical Trial-Stage Companies?

Woodruff Sawyer on

Life sciences companies face unique exposures. Even within the various stages of research and development, the risks companies face change depending on their stage of development. With more than 500 clients in the life...more

Amundsen Davis LLC

FDA Issues First Ever Guidance for Research of Psychedelics

Amundsen Davis LLC on

Earlier this summer, the Food & Drug Administration (FDA) issued draft guidance for those researching the use of psychedelics to treat certain serious medical conditions including major depressive disorder, PTSD, and...more

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