False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Wiley's 10 Key Trade Developments: The CHIPS Act and Inflation Reduction Act (IRA)
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely Teasdel, Deputy Secretary of SC Department of Commerce
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 180: SCBIO and the Life Sciences Industry in South Carolina with James Chappell, SCBIO CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim Dall, Healthcare Economist
Stoel Rives | Deeply Rooted Podcast S3E3: AgTech Innovation and Robotics with Burro CEO Charlie Andersen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 166 — Christine Vannais, COO of Fujifilm Diosynth Biotechnologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Delivering Successful Research Projects: What Legal Marketers Need to Know - Passle's CMO Series Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 154: Andy Schwartzkopf, General Counsel and Chief Administration Officer, Signature Medical Group
Business Better Podcast Episode: Accelerating Life Sciences: How Accelerators and Education Are Joining Forces to Catapult the Life Sciences Industry
The 'Secrets' of Trade Secrets in Government Contracting
R&D Tax Credit: What Healthcare Professionals Should Know
No Fear: Lessons from Lebanon to Life Sciences with Dr. Moise Khayrallah
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
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
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
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
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
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
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
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
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
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
YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
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
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
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Research into psychedelic-assisted therapy receives funding in the National Defense Authorization Act for Fiscal Year 2024. In an epoch marked by rapid innovation in mental health treatments, a paradigm shift is on the...more
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...more
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more
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
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
Editor’s Note: In our recent white paper, Achieving Clinical Trial Diversity: Expanding Hospital Capacity to Offer Trials in the Community, Manatt Health discusses the important role of community hospitals and health systems...more
Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more