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PODCAST

DarshanTalks Podcast

Darshan Kulkarni

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

science life sciences

All Episodes

11:50

Nonprofit Pharma Exists. Here is how it works

DarshanTalks Podcast ·

2025/06/16

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 for other manufacturers. Initially operating as a broker, Civica transitioned into manufacturing, filing multiple ANDAs monthly and building a plant in West Virginia capable of producing 200 million doses annually. Civica's mission-driven approach includes t...

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12:08

FTC Rules for Pharma Companies

DarshanTalks Podcast ·

2025/06/14

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 advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particularly around unfair competition and antitrust concerns. Joe explains how his firm helps private equity clients during the investment process by condu...

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9:28

Whistleblowing in Clinical Trials: Is It Worth the Risk?

DarshanTalks Podcast ·

2025/06/12

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 report, especially given the financial and relational ties between sites and sponsors. They discuss examples, like overpayments or data integrity violations, which might compel a whistleblower to act. However, they highlight the gray areas where judgment ...

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14:58

The Right Way to Do Medical Affairs on LinkedIn

DarshanTalks Podcast ·

2025/06/09

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 handles. Marie explains that this trend is driven by healthcare professionals’ evolving preferences for receiving medical information—today, over 70% prefer digital formats, and more than 50% use LinkedIn to connect, exchange ideas, and consume scientific co...

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14:56

Are We Paying Clinical Trial Patients Enough?

DarshanTalks Podcast ·

2025/06/07

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: The Coercion Concern Compensation for trial participation is often scrutinized by IRBs due to concerns around coercion. Historically, this concern stems from extreme abuses (e.g., experiments in Holocaust camps) and evolved to include more nuanced forms, such as...

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4:46

Pharma Ads Are Getting Canceled

DarshanTalks Podcast ·

2025/06/04

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 hit especially hard, with over 106 million healthcare and medicine ads being blocked. If you’re still relying on old review systems or outdated playbooks, you’re in trouble—Google’s new AI can spot violations at lightning speed, often before you even see i...

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11:42

Unpacking Screen Fail Payments in Research

DarshanTalks Podcast ·

2025/05/31

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 topic. From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that paying for every screen fail, without oversight, opens the door to unlimited financial exposure—and more dangerously, potential kickback violations. T...

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5:41

Post-Trump Antitrust Rules Are Crushing Pharma Deals

DarshanTalks Podcast ·

2025/05/28

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, especially those involved in mergers and acquisitions (M&A). At the federal level, Assistant Attorney General Gail Slater, in her first major antitrust address, emphasized a renewed focus on strict legal enforcement. Rather than relying on expansive regulatory...

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2:03

7 Must-Know Steps to transfer medical device ownership

DarshanTalks Podcast ·

2025/05/24

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 regulatory delays. Next, companies must assess ongoing clinical trial responsibilities and contractual obligations tied to the device. Compliance programs should align with both the 2024 DOJ and OIG guidelines to demonstrate regulatory commitment. Conducting ...

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4:34

Responding to Site Findings

DarshanTalks Podcast ·

2025/05/22

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: Sites know the boots-on-the-ground reality. When a finding is made—especially during an external inspection like the FDA—they’re often the ones best positioned to analyze what went wrong. The site team (usually led by QA or compliance professionals) needs to: Conduct a r...

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3:32

Is Your Medical Website Illegal?

DarshanTalks Podcast ·

2025/05/20

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 are accessed by broader audiences, including non-scientists. Key risks include: Off-Label Promotion: The Facteau case highlights how communications implying off-label use can lead to violations under the Food, Drug, and Cosmetic Act, even for FDA-cleared d...

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4:03

Price Fixing in Clinical Research

DarshanTalks Podcast ·

2025/05/17

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 support, concerns quickly arose when some attendees began advocating for standardized pricing across sites (e.g., "$200 for an X-ray")—a move that borders on illegal price fixing. Darshan raised red flags, emphasizing that while site collaboration is valuab...

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2:09

DOJ Cracks Down on Pharmacy Fraud

DarshanTalks Podcast ·

2025/05/15

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, targeting Medicare, Medicaid, and private insurance. This pattern of fraud is not new, as the Department of Justice (DOJ) recently charged nearly 200 individuals in similar cases amounting to $2.75 billion in fraud claims. Pharmacies, both large and small, are i...

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3:12

Protect Your DTP Strategy

DarshanTalks Podcast ·

2025/05/13

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 way, cutting out intermediaries like pharmacists, PBMs, and even traditional physicians. But convenience comes at a cost. By removing these safeguards, companies take on massive compliance liabilities. Telehealth prescribing raises serious questions around...

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13:18

AI Clinical Trial Negotiators

DarshanTalks Podcast ·

2025/05/10

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 share their experiences and thoughts on using AI for contract and budget negotiations. They discuss the potential and limits of AI, highlighting concerns over copyright, data ownership, and "black box" decision-making. While AI can streamline contract revie...

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7:27

SOPs: How Many is Too Many?

DarshanTalks Podcast ·

2025/05/09

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. From a site perspective, having extensive SOPs can feel overwhelming, but they are essential for compliance and audits. SOPs are the first thing requested during inspections by the FDA or sponsors. However, sites must strike a balance—too few SOPs indicate a lack of structure, ...

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13:04

Is DTP Pharma’s Next Big Move?

DarshanTalks Podcast ·

2025/05/07

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 driven by the pressure to reduce drug and device costs, especially in light of new tariffs that could further escalate prices. Darshan emphasized the need for pharmaceutical companies to rethink their operational models, including cutting out intermediaries to...

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1:29

Hackers Are Stealing Your Personal Health Data

DarshanTalks Podcast ·

2025/05/05

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 data to steal identities, open credit cards, and even file fake tax returns. The scariest part? They can create fake identities for illegal activities, such as drug purchases or money laundering. Why does this happen? Healthcare organizations often rely on...

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3:01

How a “Medical Education” Program Became a $202M Fraud

DarshanTalks Podcast ·

2025/05/03

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: The DOJ alleged that Gilead turned 17,000 speaker programs into a covert marketing machine to boost HIV drug prescriptions. We’re not talking about the occasional misstep — we’re talking wine-paired steak dinners at the James Beard House, prescribers being paid over $3...

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4:06

Webinar Recap: What Sponsors Must Know About Fraud

DarshanTalks Podcast ·

2025/05/01

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 conversation. Nirpal (the newest face on the team, leading business development) shared how exciting it was to finally launch a series we’ve been planning for months — tackling hot-button issues like regulatory scrutiny from DOJ, ORI, OIG, and the political narrative...

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264 results

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