Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Updating the Research Compliance Handbook
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast - Discussing the Mission of Black Women's Health Imperative with CEO Linda Goler Blount
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
BLACK HISTORY MONTH | KATHERINE JOHNSON AND CHARLES DREW
Technology in Healthcare
The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more
The secondary cascade, although a normal physiological response, can contribute to ongoing neuroinflammation, oxidative stress and axonal injury, continuing in some cases years after the initial insult. There is no clearly...more
Recorded at SCbio’s 2025 annual conference, Matthew and Lauren welcome Kendalle O’Connell, President & CEO of MassBio, a powerhouse life sciences organization and the driving force behind Massachusetts’ thriving life sciences...more
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more
Recorded at SCbio’s 2025 annual conference, Heather and Lauren welcome Dr. Ray DuBois, a physician and researcher who has dedicated his life to cancer research and patient-centered care. Dr. DuBois, Director of MUSC’s...more
Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more
On April 7, 2025, New Mexico Governor Michelle Lujan Grisham signed into law SB-219, the Medical Psilocybin Act (the Act), making New Mexico the third state in the country to create a legal pathway for patients to access...more
In a remarkable federal human subject research policy development, it appears that the U.S. Department of Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) has been...more
Humans possess several well-established bodily systems, including the sympathetic nervous system, the central nervous system, and the endocrine system. A relatively recent discovery is the endocannabinoid system (ECS)....more
Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more
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
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more
Judge Angel Kelley of the U.S. District Court for the District of Massachusetts on March 12, 2025, issued a nationwide preliminary injunction halting the implementation, application or enforcement of the National Institutes...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
The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more
Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more
News Briefs - Proposed Budget Cuts Could Greatly Impact Healthcare Sector - House Republicans unveiled a budget resolution that asks the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880...more
On Friday, February 7, the National Institutes of Health (“NIH”) issued Policy Statement Supplemental Guidance affecting budgets both for active grants and for future grants, which was set to take effect on Monday, February...more
A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more
On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more
The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more
Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more
SUMMARY: On February 7, 2025, the Office of the Director for the National Institutes of Health (NIH) issued a Notice (Notice No. NOT-OD-25-068) imposing a cap of 15% on the indirect cost rates that can be charged to the...more
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more