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
224 episodes
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
Privacy Dangers Lurking in Clinical Trial Mergers
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 correctly. The key is understanding wheth...
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5:45
The FDA's Crisis Is Now Your Problem
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 attention—now.
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2:32
Broken FDA, Big Consequences
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 flags, with one likening the situation to...
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0:35
You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations
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 healthcare costs. Traditionally, employer-provi...
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14:52
Essential Due Diligence Steps for Clinical Research M&A
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 explore the key legal and operational cons...
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3:45
Is AI Telemarketing Strategy Illegal?
Today’s episode is a wake-up call for pharma marketers launching telehealth campaigns. If you're using AI voice assistants or call automation tools in your outreach, you could be stepping into a legal minefield under California’s privacy law...
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0:43
No Clinical Trial Waste
In this episode, Darshan Kulkarni explores an important yet often overlooked question—what happens after a clinical trial ends? While much focus is placed on clinical trials as a care option, the conversation shifts to the opportunities that...
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18:18
The Real Meaning of Audit-Readiness in Clinical Research
Edye Edens discusses what it truly means to be site audit ready and dispels the misconception that it requires 100% compliance. No auditor expects perfection—what matters is having strong processes in place to catch and address issues in rea...
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2:34
Ordinary People Are Changing Medicine
Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medicine falls short. Driven by necessity, love, and a desire for survival, many have solved comp...
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3:47
Investor Influence Can Trigger FCA Violations
Mergers and Acquisitions (M&A) in the healthcare sector can be highly profitable, but they carry significant legal risks, particularly for private equity investors and board members who hold excessive influence over operations. The case ...
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2:19
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons
Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research organizations and academic medical centers often prefer sponsor-to-organization agreements beca...
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2:38