Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 240: Independent Practice In Dermatology with Dr. Darragh and Dr. Shuler of Carolina Dermatology
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 237: Tackling Cancer with Cellular Immunotherapy with Dr. Leonardo Ferreira of Torpedo Bio
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
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
Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP
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 use of diffusion tensor imaging (“DTI”) to assess mild Traumatic Brain Injury (mTBI) has been discussed in several prior posts. Also as discussed in prior posts, DTI evidence has been challenged in dozens of cases (the...more
Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
In this powerful episode, hosts Heather and Matthew are joined by Sydney Severance, a young woman and former competitive athlete whose life changed dramatically when she unexpectedly became wheelchair-bound. After a...more
Great thinkers have sought for centuries to convey a crucial truth about humanity’s interconnection. As the poet John Donne wrote: “No man is an island, entire of itself; every man is a piece of the continent, a part of the...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
The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more
In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...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
In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical trial approaches, including trials that implement decentralized elements, trials that allow...more
On September 10, the Food and Drug Administration (FDA) Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....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
On February 21, 2024, the Advanced Research Projects Agency for Health (ARPA-H) announced a $100 million commitment to research and development in women’s health through Sprint for Women’s Health, a first-of-its-kind effort....more
Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each phase of clinical trials that are needed...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
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
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
With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more
With the health care industry under pressure to improve patient outcomes while controlling costs, artificial intelligence (AI) and machine learning (ML) are quickly becoming indispensable tools. These technologies show...more
Denver jury acquits DaVita, former CEO, of all charges in antitrust trial - After two days of deliberations, a Denver jury found DaVita and former CEO Kent Thiry not guilty of all charges relating to charges they...more