Best DarshanTalks Podcasts (2025)

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$14M Fine Says This “Free” Offer Wasn’t Legal 3:40

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1d ago3:40

3:40

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 led to medically unnecessary tests billed to Medicare and Medicaid. This wasn’t just bad billing—it was a ma…

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Nonprofit Pharma Exists. Here is how it works 11:50

3d ago11:50

11:50

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 multip…

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FTC Rules for Pharma Companies 12:08

5d ago12:08

12:08

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, particula…

1
Whistleblowing in Clinical Trials: Is It Worth the Risk? 9:28

7d ago9:28

9:28

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…

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The Right Way to Do Medical Affairs on LinkedIn 14:58

10d ago14:58

14:58

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 receivi…

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Are We Paying Clinical Trial Patients Enough? 14:56

12d ago14:56

14:56

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. H…

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Pharma Ads Are Getting Canceled 4:46

15d ago4:46

4:46

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…

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Unpacking Screen Fail Payments in Research 11:42

19d ago11:42

11:42

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 pay…

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Post-Trump Antitrust Rules Are Crushing Pharma Deals 5:41

22d ago5:41

5:41

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 Sl…

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7 Must-Know Steps to transfer medical device ownership 2:03

26d ago2:03

2:03

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 obligatio…

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Responding to Site Findings 4:34

28d ago4:34

4:34

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 o…

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Is Your Medical Website Illegal? 3:32

1M ago3:32

3:32

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 Fact…

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Price Fixing in Clinical Research 4:03

1M ago4:03

4:03

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.…

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DOJ Cracks Down on Pharmacy Fraud 2:09

1M ago2:09

2:09

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…

1
Protect Your DTP Strategy 3:12

1M ago3:12

3:12

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 come…

1
AI Clinical Trial Negotiators 13:18

1M ago13:18

13:18

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 an…

1
SOPs: How Many is Too Many? 7:27

1M ago7:27

7:27

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 th…

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Is DTP Pharma’s Next Big Move? 13:04

1M ago13:04

13:04

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 esc…

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Hackers Are Stealing Your Personal Health Data 1:29

2M ago1:29

1:29

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 crea…

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How a “Medical Education” Program Became a $202M Fraud 3:01

2M ago3:01

3:01

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…

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Webinar Recap: What Sponsors Must Know About Fraud 4:06

2M ago4:06

4:06

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 launc…

1
AI-Powered Engagement is a Minefield 2:48

2M ago2:48

2:48

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 record…

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Webinar Update: Fraud Prevention Strategies Every Sponsor Needs 7:14

2M ago7:14

7:14

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 …

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Are Your Promotional Claims Putting Your Company at Risk? 1:38

2M ago1:38

1:38

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 stakehold…

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Privacy Dangers Lurking in Clinical Trial Mergers 5:45

2M ago5:45

5:45

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 saf…

1
The FDA's Crisis Is Now Your Problem 2:32

2M ago2:32

2:32

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 le…

1
Broken FDA, Big Consequences 0:35

2M ago0:35

0:35

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 potenti…

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You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations 14:52

2M ago14:52

14:52

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-provided insurance has been the backbone of the U.S. healthcare system, but evolving regulations, including the Af…

1
Essential Due Diligence Steps for Clinical Research M&A 3:45

2M ago3:45

3:45

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 considerations when acquiring or merging with clinical research entities, including sponsors, sites, and CROs. A …

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Is AI Telemarketing Strategy Illegal? 0:43

2M ago0:43

0:43

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 (CCPA & CIPA). Your telehealth campaign reflects your brand—don’t let privacy lawsuits define it. Contact th…

1
No Clinical Trial Waste 18:18

2M ago18:18

18:18

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 exist for research-related resources post-trial. Darshan is joined by: Lorri Warren, Program Director of the…

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The Real Meaning of Audit-Readiness in Clinical Research 2:34

2M ago2:34

2:34

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 real time, particularly those with safety or regulatory implications. Being audit-ready means having the infrast…

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Ordinary People Are Changing Medicine 3:47

3M ago3:47

3:47

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 complex medical problems themselves, leading to groundbreaking discoveries. This trend raises important questions…

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Investor Influence Can Trigger FCA Violations 2:19

3M ago2:19

2:19

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 of US XRL Martino Fleming vs. South Bay Mental Health Centers serves as a cautionary tale, highlighting how overs…

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Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons 2:38

3M ago2:38

2:38

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 because they provide structured negotiations around intellectual property (IP) rights, indirect costs, liability …

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Clinical Trial Site M&A: What Most Get Wrong 4:20

3M ago4:20

4:20

Most clinical trial site mergers focus on patient databases, sponsor contracts, and geographic expansion. While those are important, the real risks lie elsewhere—buried in compliance issues that can derail your deal before it even closes. Imagine acquiring a site that looks great on paper, only to face FDA or DOJ scrutiny months later due to undisc…

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Future-Proof Sites: SOS Insights Revealed 8:38

3M ago8:38

8:38

In this episode, Darshan Kulkarni sits down with Raymond Nomizu, founder and co-CEO of CRIO, to discuss key takeaways from the SOS conference and the evolving landscape of clinical research. Raymond shares his journey from running a clinical research site to founding CRIO, a platform designed to modernize site operations through eSource, CTMS, and …

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Why Food M&A Deals Collapse—And How to Prevent It 2:29

3M ago2:29

2:29

Darshan talks about a major blind spot in food M&A—hidden compliance risks that can destroy a deal overnight. While most focus on financials, market share, and synergies, they fail to account for regulatory pitfalls that can trigger investigations, recalls, or severe penalties. Imagine being deep in negotiations, only to discover unapproved ingredi…

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Non-Compliance Led to QOL Medical's $47M Settlement 2:00

3M ago2:00

2:00

The recent $47 million settlement involving QOL Medical and its CEO is a stark reminder of the consequences of crossing legal and ethical boundaries. Allegations of offering free Carbon 13 breath test kits as kickbacks to induce prescriptions for Sucraid, a treatment for congenital sucrose isomaltase deficiency (CSID), aren't just about non-complia…

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FDA Regulatory Submissions: Challenges, Trends, and Future Predictions 2:52

3M ago2:52

2:52

Edye Edens from KLF offers a brief yet in-depth overview of FDA regulatory submissions for clinical research in the U.S., reflecting on both current practices and predictions for 2025. She highlights how AI tools and evolving political dynamics are shaping the regulatory landscape, emphasizing that while efficiency improvements are necessary, caref…

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How to do a VR promo check - Carly Schaecter gives us her advice 14:42

3M ago14:42

14:42

Carly Schaechter discusses the potential of VR in drug promotion and the challenges of reviewing VR content for the PRC. Key points include the need for VR expertise to conceptualize interactive, engaging content. Choosing VR over AR depends on the objectives, with VR offering more controlled environments. Ensuring user control, addressing misinfor…

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Diversity Matters in Clinical Trials 5:42

3M ago5:42

5:42

In this insightful discussion, Shuja Naqvi, CEO of Biopharma Informatics, joins Darshan Kulkarni to explore the evolving landscape of clinical research. Shuja shares how his company has expanded across seven states, strategically choosing locations to promote diversity—not just in ethnicity, but also in socioeconomic and regional representation. He…

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EMA’s LLM Guidelines Impact Life Sciences 2:44

3M ago2:44

2:44

The EMA's new guiding principles on LLMs represent a transformative step in regulatory science, addressing both the immense potential and significant risks of these technologies. These principles emphasize the need to balance innovation with ethical considerations, tackling issues like data privacy, misinformation, and bias. LLMs, such as ChatGPT, …

1
How to Network Like a Pro at Conferences 17:08

3M ago17:08

17:08

In this episode, Darshan sits down with Brook White from CRIO to dive into the value of attending conferences and how to make the most of them. They met at a past conference and quickly realized how much we had to learn from each other, so I asked Brook to come on and share her insights. They start by discussing whether conferences are truly valuab…

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Getting Ready for SOS 2025: FDA 483s, SOPs, and Site Survival 10:35

3M ago10:35

10:35

In this conversation, Edye Edens and Darshan Kulkarni discuss the excitement and plans for the upcoming Save Our Sites (SOS) Second Annual Conference in Oklahoma City. They highlight the importance of connecting with key industry leaders and peers in person, including names like Dan Sfera, Brad Hightower, and others who have been instrumental voice…

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Maximizing Site Value 2:13

3M ago2:13

2:13

When selling a clinical trial site, many owners focus solely on the amount they’ll receive, but the real key is understanding the multiplier that determines your valuation. In M&A transactions, hitting the right EBITDA threshold—such as $3M, $10M, or $25M—can significantly increase your multiplier, turning a 6X valuation into 10X or more. While som…

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5 Key Areas to Review in Clinical Trial Agreements 3:33

4M ago3:33

3:33

Contract issues are more common than you think. Edye Edens shares the five critical areas you should always review before signing: Basic Details & Formatting – Ensure names, dates, and references are correct, pages are in order, and there are no typos or inconsistencies from previous templates. Appendices & Exhibits – Verify that referenced documen…

1
Discussing Stem Cell Research Opportunities with a Research Site Owner 7:43

4M ago7:43

7:43

At the Site Council meeting, Darshan Kulkarni had the opportunity to speak with Mohamed Hakim, a site owner who has consolidated six clinical research sites into three. Their conversation explored the evolving landscape of clinical research, particularly in stem cell studies, in light of the regulatory shifts happening under the Trump administratio…

1
Quality Management: A Must in Clinical Trial Contracts 6:23

4M ago6:23

6:23

In the second part of our discussion, Edye Edens speaks with subject matter expert Helen Maurer about integrating quality management into clinical trial contracts. While contracts often cover legal aspects like termination and jurisdiction, they frequently lack clear quality management plans. Helen emphasizes the importance of defining responsibili…

1
AI-Powered Chatbots in Pharma Sales and Education 5:29

4M ago5:29

5:29

ChatGPT's recent update introduced an AI engagement feature reminiscent of the movie Her, the conversation is highly relevant as AI becomes more integrated into daily business operations. While AI voice chat offers benefits like consistent messaging, 24/7 availability, and efficiency, it also brings significant risks—especially in the heavily regul…