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
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
As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more
Deal volume across the healthcare industry generally appears to have steadied despite headwinds. The general sentiment is that buyers have adapted to the current interest rates and are gritting their teeth and pressing...more
On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more
The United States occupies a leadership position in clinical advancements, in terms of pharmaceuticals, medical devices, innovative care processes and interventional techniques. At the nexus of these advances are clinical...more
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...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
Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When...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
EXECUTIVE SUMMARY - Clinical trials are a lifesaving option for many cancer patients. But too many patients face barriers preventing access to this critical treatment. Everyone suffers when patients cannot access...more
Recorded at NC Life Sciences Organization’s 2023 annual meeting, hosts Heather and Matthew welcome Christine Harhaj, the Senior Director for Pharmaceutical Research and Manufacturers of America (PhRMA). They have an...more
President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more
Editor’s Note: In the autumn issue of the Clinical Research as a Care Option (CRAACO) newsletter, an interview with Manatt Health’s Donna O’Brien gives pharma readers insight into how hospitals view trials, some of the...more
The concept of artificial intelligence (AI) in drug discovery and manufacturing has been in progress for more than 10 years; however, with the current advancements in technology, medicine, and research, AI is closer than ever...more
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA...more
Wellness claims are everywhere. Do they work? Ah, wellness! Such a positive word! Such a noble aspiration for all of us! And such an opportunity for hucksters, hokum and high jinks in the eternal battle to separate...more
In October of 2022, the Biden Administration started an official cannabis policy review process, which began with granting pardons to all people convicted of simple cannabis possession under federal law. At the time, this was...more
On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more
Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more
On Aug. 15, the Food and Drug Administration (FDA) issued new guidance aimed at assisting institutional review boards (IRBs), clinical investigators and sponsors in complying with the FDA’s informed consent requirements for...more