DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
Episodes
237 episodes
Self-Reporting in Clinical Trials
In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some s...
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9:39
$14M Fine Says This “Free” Offer Wasn’t Legal
In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly...
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3:40
Nonprofit Pharma Exists. Here is how it works
In this episode, we talk to Martin Van Trieste about Civica Rx, nonprofit pharmaceutical company designed to address drug shortages in the U.S. The company focuses on sterile generics and biosimilars that have become economically unviable fo...
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11:50
FTC Rules for Pharma Companies
In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advi...
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12:08
Whistleblowing in Clinical Trials: Is It Worth the Risk?
In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to...
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9:28
The Right Way to Do Medical Affairs on LinkedIn
In this episode, Darshan Kulkarni sits down with Marie Ange Noue, Senior Director and Head of Scientific Communications at EMD Serono, to dive deep into the increasingly common practice of medical affairs teams creating dedicated LinkedIn ha...
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14:58
Are We Paying Clinical Trial Patients Enough?
In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? And if not, how can we ethically and compliantly pay them more?Key Takeaways:...
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14:56
Pharma Ads Are Getting Canceled
Google’s 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google blocked over 5.1 billion ads last year and restricted 9.1 billion more. Healthcare ads were ...
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4:46
Unpacking Screen Fail Payments in Research
In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topi...
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11:42
Post-Trump Antitrust Rules Are Crushing Pharma Deals
In this episode, we explore a crucial and timely issue: how the Trump administration’s approach to antitrust enforcement—combined with new state-level regulations—is creating a shifting legal environment for life sciences companies, especial...
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5:41
7 Must-Know Steps to transfer medical device ownership
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) clearance and thorough due diligence to avoid reg...
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2:03
Responding to Site Findings
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 it:Site Perspective:<...
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4:34
Is Your Medical Website Illegal?
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 challenges, particularly when these platforms ...
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3:32
Price Fixing in Clinical Research
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 site owner. While the intent was mutual s...
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4:03
DOJ Cracks Down on Pharmacy Fraud
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 medications that were never dispensed, target...
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2:09
Protect Your DTP Strategy
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, Lilly, and Novo Nordisk are leading the ...
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3:12
AI Clinical Trial Negotiators
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 Istvan Fekete from Huron Consulting, who s...
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13:18
SOPs: How Many is Too Many?
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 reality is more nuanced....
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7:27
Is DTP Pharma’s Next Big Move?
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 conversation explored how these changes are driv...
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13:04
Hackers Are Stealing Your Personal Health Data
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 mine for cybercriminals. Hackers use this ...
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1:29
How a “Medical Education” Program Became a $202M Fraud
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 straight.Here’s what happened: ...
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3:01
Webinar Recap: What Sponsors Must Know About Fraud
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-impact and incredibly timely conversatio...
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4:06
AI-Powered Engagement is a Minefield
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 voice tools in healt...
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2:48
Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/Registration Link- https://us02web.zoom...
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7:14
Are Your Promotional Claims Putting Your Company at Risk?
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 claims. This case is a wake-up call for drug a...
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1:38