x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

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

6:05

Why Telehealth Platforms Are Getting Sued

DarshanTalks Podcast ·

2025/07/17

We explore the growing wave of class action lawsuits hitting the telehealth industry—and why legal counsel, especially those advising telemedicine platforms or navigating pharma partnerships, must pay attention now. Here’s the core issue: many ad tech stacks are leaking protected health information (PHI) through tracking pixels and cookies. These tools—common in e-commerce—are transmitting sensitive data to third parties like Meta, potentially without proper consent. That’s not a glitch; it’s...

en-us

12:21

Should Clinical Trial Sites Be Paid Differently?

DarshanTalks Podcast ·

2025/07/15

In this episode of the KLF Deep Dive, Darshan Kulkarni and Edye Edens engage in a practical discussion around one of the most debated issues in clinical research: Should clinical trial sites be paid differently based on who they are, where they’re located, or what they bring to the table? The conversation challenges the idea of flat-rate, standardized budgets for all sites and explores the concept of Fair Market Value (FMV) from both sponsor and site perspectives. Edye and Darshan break down ...

en-us

5:46

How to Build an AI Compliance Program

DarshanTalks Podcast ·

2025/07/14

In this episode of KLF Deep Dive, Darshan Kulkarni explores the growing urgency for in-house counsel to develop AI compliance programs as artificial intelligence becomes embedded in drug discovery, clinical decision-making, patient engagement, and beyond. Darshan emphasizes that AI can create significant legal risk—even without breaking the law—if companies fail to address issues of transparency, validation, privacy, and governance. As regulators like the FDA and FTC tighten their expectation...

en-us

5:06

What the Big Beautiful Bill Means for Trial Sites

DarshanTalks Podcast ·

2025/07/11

Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed “Big Beautiful Bill”—a sweeping piece of legislation tied to the Trump administration’s political agenda. While the bill itself does not directly reference clinical research, Darshan and Edye highlight how its provisions—particularly the reduction in Medicare and Medicaid funding—could have serious downstream effects on clinical trial access and site viability. Edye raises concerns that the legislation m...

en-us

1:51

Co-Pay Mistakes Can Trigger DOJ Action

DarshanTalks Podcast ·

2025/07/09

In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding the government by: Routinely waiving co-pays without documenting financial hardship, Shipping unrequested supplies, Allegedly paying kickbacks to boost business. While most claims were dismissed—not because they weren’t serious, but due to insufficient specifics—the upcoding charges remained. Wh...

en-us

6:12

NIH Grant Denials Ruled Discriminatory?

DarshanTalks Podcast ·

2025/07/08

Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIH’s decision to halt grant funding for projects focused on LGBTQ+ populations and DEI-related research. The judge ruled that cutting off funding solely on a discriminatory basis—such as the subject matter being DEI or LGBTQ+ related—may itself be unconstitutional. While this has sparked optimism among affected researchers, Edye and Darshan caution that this is just one step in a longer legal process...

en-us

1:31

Are Speaker programs supposed to be salesy?

DarshanTalks Podcast ·

2025/07/04

Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, but many companies blur the lines—leading to billion-dollar fines. Government bodies like the OIG consider these programs “inherently suspect” unless strict criteria are met. To stay compliant, speakers must have relevant expertise (not just high prescription rates), and every presentation is vetted by a Medical-Legal-Regulatory (MLR) team. Desp...

en-us

2:52

DTP Compliance Just Got Tricky

DarshanTalks Podcast ·

2025/06/28

The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickback Statute (AKS) compliance. In this case, Sorenson’s company paid marketers to generate patient interest in orthopedic braces reimbursed by Medicare. These marketers gathered patient details and sent unsigned prescriptions to physicians. While most leads went nowhere, the court ruled this did no...

en-us

12:39

Should You Use AI to Draft Informed Consent?

DarshanTalks Podcast ·

2025/06/26

Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they explore how AI could save time, whether it fits institutional IRB requirements, and the real-world value (or lack thereof) for different types of organizations. Key Takeaways: Drafting vs. Final Use: AI can be useful as a first-draft tool, especially for high-volume sponsors. But using it for final ...

en-us

2:41

Could You Survive a Surprise Pharmacy Audit?

DarshanTalks Podcast ·

2025/06/23

Imagine you're filling a script when a State Board of Pharmacy inspector walks in—no warning, just a clipboard and serious consequences. Most community pharmacists assume, "That won’t happen to me," but audits are no longer rare—they're the norm. Controlled substances are under intense scrutiny. Inspectors now expect airtight records, ongoing (not one-time) training, and SOPs that reflect current laws—not ones from 2019. If you’re relying on outdated policies, verbal explanations, or friendly...

en-us

9:39

Self-Reporting in Clinical Trials

DarshanTalks Podcast ·

2025/06/20

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 situations legally require reporting, while in others, organizations might have room to implement corrective actions without immediate reporting—but they must carefully understand applicable regulations and enforcement trends. Darshan highlights the distinc...

en-us

3:40

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

DarshanTalks Podcast ·

2025/06/18

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 marketing strategy gone wrong. The DOJ saw it as a kickback scheme, and the case highlights how well-meaning “value-add” services can turn into legal...

en-us

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...

en-us

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...

en-us

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 ...

en-us

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...

en-us

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...

en-us

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...

en-us

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...

en-us

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...

en-us

296 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter