Podcast Episodes
Back to SearchThe KLF Story You Haven’t Heard
In this special episode, Senior Attorney Edye Edens sits down with Darshan Kulkarni, founder and principal of the Kulkarni Law Firm, for a personal and honest look at how the firm came to be. Darshan…
Published on 1 month, 2 weeks ago
Why Telehealth Platforms Are Getting Sued
We explore the growing wave of class action lawsuits hitting the telehealth industry—and why legal counsel, especially those advising telemedicine platforms or navigating pharma partnerships, must pa…
Published on 1 month, 3 weeks ago
Should Clinical Trial Sites Be Paid Differently?
In this episode of the KLF Deep Dive, Darshan Kulkarni and Edye Edens engage in a practical discussion around one of the most debated issues in clinical research: Should clinical trial sites be paid …
Published on 1 month, 3 weeks ago
How to Build an AI Compliance Program
In this episode of KLF Deep Dive, Darshan Kulkarni explores the growing urgency for in-house counsel to develop AI compliance programs as artificial intelligence becomes embedded in drug discovery, c…
Published on 1 month, 3 weeks ago
What the Big Beautiful Bill Means for Trial Sites
Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed “Big Beautiful Bill”—a sweeping piece of legislation tied to the Trump administration’s political agenda. Whi…
Published on 1 month, 4 weeks ago
Co-Pay Mistakes Can Trigger DOJ Action
In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding t…
Published on 1 month, 4 weeks ago
NIH Grant Denials Ruled Discriminatory?
Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIH’s decision to halt grant funding for projects focused on LGBTQ+ populations and DEI-related research. …
Published on 2 months ago
Are Speaker programs supposed to be salesy?
Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, but many companies blur the lines—leading to bill…
Published on 2 months ago
DTP Compliance Just Got Tricky
The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickb…
Published on 2 months, 1 week ago
Should You Use AI to Draft Informed Consent?
Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they ex…
Published on 2 months, 1 week ago