Executive Actions Impact Federally Funded Research: What Institutions Should Do Now – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 215: Bioactives for Human Health with Jan-Willem van Klinken of Brightseed
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
On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more
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
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
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act”...more
Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more
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
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
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) 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
Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more
Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more
Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more
Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more
For decades, antiviral drugs have been used to combat viral infections, including HIV/AIDS and influenza. Now they are a source of hope in the fight against the COVID-19 pandemic....more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more
Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more
The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more