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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

11:42

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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2:48

AI-Powered Engagement is a Minefield

DarshanTalks Podcast ·

2025/04/29

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 healthcare marketing, especially under California’s strict privacy laws. A federal court ruling in Ambrose v. Google suggests that recording conversations without explicit real-time consent may be illegal. This could impact pharma companies using AI voice assistants, Alexa skills, vo...

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7:14

Webinar Update: Fraud Prevention Strategies Every...

DarshanTalks Podcast ·

2025/04/24

Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/ Registration Link- https://us02web.zoom.us/meeting/register/KhsVL6C6Tg6KKNDRHYTEKA In this kickoff conversation, Darshan Kulkarni and Edye Edens introduce a candid new series exploring how legal and compliance professionals approach clinical research differently—but with a shared mission. The idea was born at the Save Our Sites event, where they realized they often take distinct, yet ...

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1:38

Are Your Promotional Claims Putting Your Company at...

DarshanTalks Podcast ·

2025/04/23

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 and device companies navigating complex FDA and FTC regulations. False advertising not only misleads stakeholders but also exposes companies to significant financial losses and regulatory scrutiny. Compliance officers and marketers must work together to ens...

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5:45

Privacy Dangers Lurking in Clinical Trial Mergers

DarshanTalks Podcast ·

2025/04/21

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 whether privacy laws like HIPAA apply, ensuring the site is already handling data compliance well, and putting safeguards in place to mitigate risks. Investors should conduct thorough due diligence to assess the site's current privacy practices before the merge...

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2:32

The FDA's Crisis Is Now Your Problem

DarshanTalks Podcast ·

2025/04/18

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. With mass layoffs, frozen guidances, and a reorganization shaking CDER and CBER to their core, trial timelines, IRB reliance, and even legal interpretations are in flux. Marketing teams are flying blind with the FDA’s communications division gutted and post-Loper Bright challenges lo...

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0:35

Broken FDA, Big Consequences

DarshanTalks Podcast ·

2025/04/16

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 "flat earthers taking over NASA." With vaccine data access becoming politicized, stem cell oversight potentially weakening, and the user fee system in jeopardy, startups and pharma companies must treat this not as a minor policy shift but as a major compl...

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298 results

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