DarshanTalks Podcast

Transferring medical device ownership during a company sale requires careful planning to ensure compliance and operational continuity. The process begins with accurate documentation of 510(k) clearan…

At first glance, responding to site-level findings seems simple—but when Edye and Darshan dug into the details, it became clear that the lines of responsibility blur fast. Here's how each side sees i…

Medical communications teams must exercise caution when using websites dedicated to medical affairs, as legal risks go beyond overt sales promotion. Drug and device manufacturers face compliance chal…

At the Save Our Sites (SOS) conference, many site owners expressed excitement over finally having a space to openly discuss real challenges—budgets, pricing, contracting, and the isolation of being a…

The recent conviction of a Michigan pharmacist and his brother in a $15 million healthcare fraud scheme highlights the growing crackdown on pharmacy-related fraud. The scheme involved billing for med…

Pharma is finally catching up to the on-demand world—offering direct-to-patient (DTP) services that promise convenience, faster delivery, and a more personalized experience. Major players like Pfizer…

Today, we're diving into a hot topic in clinical trials: should you use AI to negotiate your next clinical trial agreement? Darshan is joined by Elizabeth  from the University of Cincinnati and Istva…

In this discussion, Edye Edens and Darshan Kulkarni tackle one of the most common questions in clinical research: How many SOPs should a site have? While many assume a fixed number like 12, the reali…

In a recent interview between Nirpal Virdee and Darshan Kulkarni, they discussed the ongoing shifts in the pharmaceutical industry, particularly the rise of Direct-to-Patient (DTP) models. The conver…

Health records are one of the top targets for hackers. These records contain a wealth of personal information like Social Security numbers, insurance details, and medical history, making them a gold …

We unpack the $202 million storm surrounding Gilead’s so-called “educational” speaker programs — and why it should make every medical affairs, legal, marketing, and compliance professional sit up str…

After our first-ever deep dive webinar on ‘Protecting Sponsors, Fraud & Compliance in Research,’ Darshan Kulkarni, Edye Edens, and Nirpal Virdee sat down to reflect on what turned out to be a high-im…

AI voice tech might be the next big privacy risk for pharma marketers, and lawsuits are already in motion. In this episode of Darshan Talks, we dive into the legal challenges surrounding AI-powered v…

Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/

Registration Link- https://us02web.zoom.us/meeting/register/KhsVL6C6Tg6KKNDRHYTEKA

In this ki…

Guardant Health’s recent $292 million victory against Natera in a false advertising lawsuit sets a critical precedent for the biotech industry, highlighting the severe consequences of misleading clai…

Darshan Kulkarni and Edye Edens discuss the critical role of data privacy in clinical trial site acquisitions. While privacy concerns can seem daunting, they don’t have to be a dealbreaker if managed…

The FDA you designed your protocol around may no longer exist. In this episode, Darshan Kulkarni breaks down why clinical researchers, regulatory attorneys, and promotional review teams need to pay a…

The FDA is facing unprecedented turmoil—staff cuts, a sweeping reorganization, and political interference are undermining its ability to safeguard public health. Former agency leaders are raising red…

In this episode, Kate Woods and Darshan Kulkarni discussed the shift from employer-sponsored health insurance to individual responsibility, a transition accelerated by policy changes and rising healt…

When mergers and acquisitions intersect with clinical trials, due diligence becomes a crucial step in ensuring a successful transition. In this insightful discussion, Darshan Kulkarni and Edye Edens …