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Research and Development

Faegre Drinker Biddle & Reath LLP

New Investment Opportunity in China’s Health Care Sector Following Recent Legal Reforms

Policy Announcements - On September 6, 2024, the People’s Republic of China’s (PRC) National Development and Reform Commission and the PRC Ministry of Commerce issued the “Special Administrative Measures for Foreign...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

Goldberg Segalla

National Science and Technology Council’s PFAS R&D Strategy Plan Highlights Substantial Deficiencies

Goldberg Segalla on

Recently, as part of the Joint Subcommittee on Environment, Innovation, and Public Health, the PFAS Strategy Team of the National Science and Technology Council released a report titled the “Per- and Polyfluoroalkyl...more

Foley & Lardner LLP

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

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Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.  The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more

Integral Consulting Inc.

The U.S. Releases a Moonshot Research and Development Strategy for PFAS

The enormity and complexity of the scientific and engineering challenges posed by per- and polyfluoroalkyl substances (PFAS) cannot be overstated. More than 10,000 chemicals meet the varied definitions of PFAS. Their...more

Health Care Compliance Association (HCCA)

Missing COI Program, Fabricated Outreach, Job, Health Records: The Many Types of Falsehoods

Report on Research Compliance 21, no. 9 (September, 2024) - How many types of falsehoods might sully applications for research funds and the studies they support? Unfortunately, the most recent semiannual report to...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

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 12th, 8:00 am - 5:00 pm CT

Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more

Bergeson & Campbell, P.C.

NASEM Will Hold Virtual Town Hall on September 5 as Part of Its Quadrennial Review of the NNI

As part of its quadrennial review of the National Nanotechnology Initiative (NNI), the National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a virtual town hall on September 5, 2024, for stakeholders to...more

Hogan Lovells

Nouveaux modèles de convention unique pour la recherche clinique: plus de standardisation, moins de simplification

Hogan Lovells on

De nouveaux modèles de convention unique pour la recherche clinique ont été publiés le 5 aout 2024. Ceux-ci mettent à jour les précédents modèles en prenant en compte les nouvelles tendances de la pratique en matière de...more

IPRally

How AI is Transforming Patent Intelligence

IPRally on

2023 was a breakthrough year for AI technology, marked by the rise of generative AI with a multitude of new GPT models and advanced diffusion models....more

Foley & Lardner LLP

Using Global Patent Trends in Smart Manufacturing to Develop an Informed and Effective IP Strategy 

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In today’s global economy, product research and development (R&D) has historically been concentrated in the U.S. and China. However, these efforts are beginning to decentralize and spread into new regions, such as Japan and...more

K&L Gates LLP

Taiwan's National Science And Technology Council Has Published The Draft Bill Of The Basic Act On Artificial Intelligence For...

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The rapid development and spread of advanced artificial intelligence (AI) has led to legislative responses around the world to find suitable and adaptable governance measures. On 15 July 2024, the National Science and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Health Care Compliance Association (HCCA)

‘No Evidence’: Judges Toss KU Researcher’s Conviction; Reinstatement Battle Is Next

“I am writing with good news!!! Yesterday, the 10th Circuit overturned Franklin’s only remaining conviction and ordered the trial judge to enter a verdict of NOT GUILTY!!! After five long and difficult years, Franklin has...more

Mintz - Energy & Sustainability Viewpoints

Energy & Sustainability Washington Update – August 2024

New Bipartisan Energy Permitting Reform Legislation - US Senators Joe Manchin (I-WV) and John Barrasso (R-WY), Chairman and Ranking Member of the Senate Energy and Natural Resources Committee, have unveiled the Energy...more

Hogan Lovells

Research security program guidelines: more work for federally-funded research institutions -Universities and academic research...

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The White House Office of Science and Technology Policy (OSTP) has issued long-awaited Guidelines for Research Security Programs at Covered Institutions (“Guidelines”), which outline how federal research agencies must require...more

McDermott Will & Emery

Preliminary Injunction Upheld in Cancer Relapse Detection Case

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction (PI) in the biopharmaceutical space, concluding that the plaintiff satisfied the requirements for injunctive relief, including...more

Womble Bond Dickinson

Certification and AI in eVTOLs and eCTOLs: Industry Leaders Avoid Autopilot in Bringing Electric Aircraft to Market

Womble Bond Dickinson on

This client alert was originally published in Monitor Daily. The march toward electric vertical takeoff and landing aircraft (eVTOL) certification is progressing, though some predict a delay in eVTOLs’ market entry....more

Holland & Knight LLP

New Requirements for Research Security Programs Raise the Stakes for Compliance

Holland & Knight LLP on

The National Security Presidential Memorandum-33 (NSPM-33), issued in January 2021, directed federal agencies that fund research and development (R&D) projects to require certain "Covered Institutions" to certify that the...more

Akin Gump Strauss Hauer & Feld LLP

Research Security Program Guidelines Have (Finally) Arrived

On July 9, 2024, the White House Office of Science and Technology Policy (OSTP) released the long-awaited “Guidelines for Research Security Programs at Covered Institutions” (the Guidelines). The Guidelines are intended to...more

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

This Summer in Artificial Intelligence: Newly Released USPTO Guidance and Exemplary Worldwide Inventorship Updates

The United States Patent and Trademark Office (USPTO) recently published new guidance on subject-matter eligibility as related to Artificial Intelligence (AI), opening a written comment window to respond with a deadline of...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

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

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The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

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