News & Analysis as of

Life Sciences Research and Development

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)

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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

McDermott Will & Emery

Key Takeaways | Pharma and MedTech Services Market Overview With McKinsey & Company

McDermott Will & Emery on

During this session, McDermott Partner Kristian Werling and Jeff Smith, a senior partner at McKinsey & Company, shared insights across the pharma and MedTech services industries, including key trends and opportunities shaping...more

Fenwick & West LLP

Balancing AI-Powered Drug Discovery’s Risk and Reward

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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

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences...

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For this week’s episode, Heather and Lauren welcome David Stefanich, the CEO and co-founder of Rymedi, an award-winning tech company helping labs modernize the clinical diagnostic experience. David shares his thoughts on...more

Hogan Lovells

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

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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

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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

Latham & Watkins LLP

Healthcare and Life Sciences Trends and Developments Across MENA

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The healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification. The United Arab Emirates (UAE) and Kingdom of Saudi Arabia (KSA) are...more

Manatt, Phelps & Phillips, LLP

Biden Administration Doubles Down on Investment in Women’s Health

On March 18, the Biden Administration announced that it is doubling down on its commitment—previously announced during President Biden’s State of the Union address—to transform women’s health research and improve the lives of...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Maynard Nexsen

Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist

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Recorded at SCbio’s 2024 annual conference, hosts Heather and Matthew welcome Sarah Glaven, a research biologist and the Assistant Director of Biotechnology and Biomanufacturing for The White House Office of Science and...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

Health Care Compliance Association (HCCA)

In This Month’s E-News: April 2024

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more

Maynard Nexsen

Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine

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Recorded at the 2024 SCbio annual conference, hosts Heather and Lauren welcome Adam Bruns, the Editor-in-Chief of Site Selection Magazine, which covers corporate real estate and economic development. Join us as we discuss...more

Manatt, Phelps & Phillips, LLP

February 29, 2024: The “Rarest Day of the Year”

Rare Disease Day took place on February 29, 2024. Created in 2008, Rare Disease Day is observed on the “rarest day of the year”—February 29 in leap years (February 28 in non-leap years)—as a way to galvanize the global rare...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely...

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Recorded at SCbio’s 2024 annual conference, hosts Heather and Matthew welcome Ashely Teasdel, Deputy Secretary for the South Carolina Department of Commerce. Ashely is a key player in South Carolina’s economic development and...more

Mintz - Energy & Sustainability Viewpoints

A $1 Billion, 10-year Climate Tech Investment Effort to Come in Massachusetts

As part of the Healey–Driscoll administration’s continued efforts to ensure Massachusetts remains a state where people want to live, work, and raise families — and businesses want to start and operate companies — the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 180: SCBIO and the Life Sciences Industry in South...

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Recorded at SCBIO’s 2024 annual conference, hosts Heather and Matthew welcome back James Chappell, the President and CEO of SCBIO. With a distinguished career in the biosciences industry, James is recognized for his...more

Perkins Coie

BARDA BioMaP-Consortium Up and Running

Perkins Coie on

In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim...

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Recorded at SCBIO’s 2024 annual meeting, hosts Heather and Lauren welcome healthcare economist and GlobalData Director Tim Dall, who has studied the economic burden of chronic disease for over 25 years. The group discusses...more

Robinson+Cole Data Privacy + Security Insider

HHS Addresses the Growing Influence of Artificial Intelligence in Health Care

Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform­ its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions,...more

McDermott Will & Emery

Transaction Trends in Life Sciences

In November, we were delighted to once again host our annual European Health & Life Sciences Symposium in Paris. The event attracted a large number of healthcare professionals, investors and dealmakers to the Shangri-La Hotel...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

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