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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

8:54

Top 5 Factors Determining AMC Funding

DarshanTalks Podcast ·

2025/09/09

Darshan Kulkarni and Edye Edens launch an exciting new episode, focusing on the unique challenges academic medical centers (AMCs) face in securing funding in an ever-changing political and regulatory environment. Unlike independent or commercial sites, AMCs operate at a different scale, often managing millions of dollars in government-funded research while navigating complex administrative structures, compliance layers, and internal politics. Edye, drawing from her 10 years inside a major AMC...

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9:44

New Series Drop: Exploring AMCs in Clinical Research

DarshanTalks Podcast ·

2025/09/06

Darshan Kulkarni and Edye Edens are kicking off a brand-new video series diving into the unique world of academic medical centers (AMCs) in clinical research. While KLF has long worked with sponsors, CROs, and independent sites, AMCs bring their own challenges: complex operations, unique funding models, layers of compliance, and requirements like investigator-initiated trials that don’t exist elsewhere. As Edye—drawing from 10 years inside a major AMC—explains, these environments operate at a...

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5:35

Why Choose a Licensed Attorney Over a Consultant?

DarshanTalks Podcast ·

2025/09/04

Edye Edens and Darshan Kulkarni share the origin story of KLF and explain what makes working with licensed attorneys different from hiring non-legal consultants. They highlight three key advantages: Privilege & Confidentiality: Legal privilege means attorneys must keep client information confidential indefinitely—offering stronger protections than standard NDAs. Broader Strategic Scope: Lawyers approach problems with a strategic lens, integrating legal, operational, and regulatory consid...

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3:45

Marketing Problems by Hims & Hers and Lilly

DarshanTalks Podcast ·

2025/09/02

Telehealth and pharma are facing some of their biggest compliance challenges yet—and the latest enforcement actions prove regulators aren’t slowing down. On one side, the FTC is investigating Hims & Hers, a popular telehealth company, over allegations of misleading advertising and unfair cancellation practices. This case highlights how patient-facing companies must tread carefully when making claims about access, outcomes, or subscription services. The FTC’s involvement signals that “grow...

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4:53

Should Sponsors Share Site Feedback?

DarshanTalks Podcast ·

2025/08/29

Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selected—or not—for a study. While it is technically possible for sponsors to share this information, they caution that doing so carries significant risks. These include liability concerns, potential miscommunication, and the practical challenge of managing feedback when dozens of sites may be competing for the same study. Darshan and Edye note that while most trials—such ...

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3:30

AI Marketing Playbook for Drug Companies

DarshanTalks Podcast ·

2025/08/26

AI is no longer a distant concept in pharma marketing—it’s here, transforming campaign design, review, and distribution. CEOs and CMOs face a critical question: Can I safely integrate AI into my marketing toolkit? AI offers speed, cost savings, precise targeting, and scalable personalization. Yet, it introduces significant risks, including data ownership, opaque algorithms, hallucinated content, and potential FDA violations. Accountability for AI-generated content remains a key concern—vendor...

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5:24

Should Sites Be Ready on Standby?

DarshanTalks Podcast ·

2025/08/23

Edye Edens and Darshan Kulkarni from KLF discuss the pros and cons for clinical trial sites considering becoming backup sites. Key points include: Sponsor Perspective: Signing up as a backup site can give first access to trials and increase the likelihood of being selected, especially since not all primary sites meet recruitment targets. Sponsors may expect some commitment, including potential startup or maintenance costs while waiting. Site Perspective: Some sites may worry about being seen...

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0:43

Eastern District of PA Targets Pharmacies

DarshanTalks Podcast ·

2025/08/21

The Eastern District of Pennsylvania has ramped up False Claims Act enforcement against pharmacies, with cases ranging from multi-million dollar settlements to outright bans on dispensing controlled substances. Coupled with the DOJ-HHS False Claims Act Working Group and a record-breaking national healthcare fraud takedown, the message is clear: enforcement is accelerating. Pharmacy owners must strengthen compliance programs, maintain accurate inventory records, and conduct early audits—before...

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3:32

DOJ and HHS Launch FCA Fraud Task Force

DarshanTalks Podcast ·

2025/08/18

The Office of Inspector General (OIG) recently issued an advisory opinion approving a telehealth business model where a management company leases clinicians and provides backend services—like scheduling, billing, and digital marketing—to a separate physician practice. While this setup might raise anti-kickback concerns, OIG says it’s compliant under the personal services and management contracts safe harbor. This matters for pharma, digital therapeutics, and connected device companies increas...

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6:20

DOJ and HHS Launch FCA Fraud Task Force

DarshanTalks Podcast ·

2025/08/15

In Fiscal Year 2024, whistleblower cases reached an all-time high of 979, signaling increased scrutiny of healthcare fraud. Just days after announcing a massive $14.6 billion healthcare fraud takedown involving 324 defendants, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) launched a False Claims Act (FCA) Working Group on July 2, 2025. This cross-agency task force is laser-focused on tightening enforcement and closing regulatory loopholes across the life sc...

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4:13

Should Sponsors Cover Malpractice Insurance?

DarshanTalks Podcast ·

2025/08/13

Darshan and Edye tackle a hot topic in clinical research budgeting: Should malpractice insurance be considered an overhead cost that sponsors cover? Edye explains both sides. Sponsors often argue that malpractice is simply a cost of being a physician, unrelated to research. Sites, however, may try to include it—at least partially—as part of trial-related overhead. But even then, justifying full coverage through a single trial is difficult. Darshan pushes back, suggesting that including ...

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4:44

Instagram Post that Sparked FDA Warning Letter

DarshanTalks Podcast ·

2025/08/11

In this episode, Darshan Kulkarni unpacks the May 29, 2025 FDA Warning Letter issued to Sprout Pharmaceuticals. The trigger? A promotional Instagram post from the company's CEO calling Addyi “the sex pill for women,” highlighting benefits but completely omitting the serious risks—like hypotension, syncope, alcohol interactions, and contraindications. To make matters worse, the post wasn’t submitted to the FDA via Form 2253 as required. This isn’t Sprout’s first offense; the FDA previously cit...

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4:26

Why Are So Many Doctors Getting Arrested?

DarshanTalks Podcast ·

2025/08/09

Why are headlines suddenly filled with stories of doctors, nurses, healthcare executives—and even accountants—being arrested for fraud? In this explosive episode of Daran Talks, we dive into what the Department of Justice is calling the largest healthcare fraud takedown in U.S. history. In July 2025, federal authorities charged 324 individuals in a sweeping investigation involving an alleged $14.6 billion in healthcare fraud. From fake telemedicine visits to unnecessary prescriptions and kick...

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7:54

How to Run Compliant Pharma Speaker Programs

DarshanTalks Podcast ·

2025/08/06

What really happens behind the scenes of pharmaceutical speaker programs—and why should smaller pharma companies care? In this episode of DarshanTalks, Darshan Kulkarni unpacks one of the most misunderstood but highly scrutinized parts of pharma marketing: speaker programs. These programs typically come in two forms—promotional (to raise product awareness and encourage prescribing) and educational (such as accredited CME events). While both are legal, they must be executed with extreme care. ...

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4:28

Are You Picking the Wrong KOLs?

DarshanTalks Podcast ·

2025/08/04

Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs can bring valuable expertise to a therapeutic area, simply labeling someone as a KOL—especially when they self-identify—can raise significant compliance concerns. They unpacks two major red flags: High Prescribers – Is the KOL being compensated for research or for prescribing power? Influencer Effect – Are they being used to sway other physicians...

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5:13

How KLF’s Client Base Evolved Over 20 Years

DarshanTalks Podcast ·

2025/08/02

Edye Edens interviews Darshan Kulkarni about the evolution of the Kulkarni Law Firm (KLF). Darshan reflects on how he originally envisioned working with large pharmaceutical and device companies, but over the past 15–20 years, the firm has expanded to support not only pharma, but also law firms, consulting companies, and research sites. They discuss how the clinical research landscape has shifted—from a focus on academic institutions and big players to a broader ecosystem that includes indepe...

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4:10

FDA Pushback on Accelerated Gene Therapy Approvals

DarshanTalks Podcast ·

2025/07/31

In this episode, Edye Edens dives into the FDA’s evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of Sarepta’s muscular dystrophy treatment, she explains how postmarket safety issues and incomplete confirmatory trials can put previously celebrated approvals under renewed FDA evaluation. Edye breaks down three common pitfalls sponsors face: Lagging confirmatory trials Outdated safety monitoring plans Poor communication across teams and with FDA ...

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6:04

Your DEI Program Could Trigger an FCA Case

DarshanTalks Podcast ·

2025/07/30

Darshan Kulkarni breaks down the Department of Justice’s new Civil Rights Fraud Initiative, launched on May 19, 2025, and why it should be on the radar of every pharmaceutical and medical device company. Under this initiative, the DOJ plans to use the False Claims Act (FCA) to pursue organizations that knowingly violate civil rights laws while receiving federal funds—including R&D grants, Medicare/Medicaid payments, or other government contracts. The discussion highlights how DEI programs...

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2:20

Teva’s Charity Partnership Scrutinized

DarshanTalks Podcast ·

2025/07/28

A recent $425 million settlement involving Teva Pharmaceuticals highlights the legal and ethical risks charities face when partnering with pharmaceutical companies. Teva was accused of using a charity to cover patient co-pays, a tactic intended to boost drug sales, leading to serious legal consequences. While pharma funding can provide essential resources for charities, it also raises concerns about indirect kickbacks and regulatory scrutiny. Charities must rethink their engagement strategies...

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12:50

Is There a “Right” Way to Calculate FMV?

DarshanTalks Podcast ·

2025/07/25

Darshan Kulkarni and Edye Edens take a deep dive into one of clinical research’s most persistent questions: how is fair market value (FMV) actually determined for clinical trial sites—and who gets to decide? Building on the previous discussion about whether all sites should be paid the same, this episode unpacks the complexity behind FMV calculations. Darshan shares an anecdote involving a DOJ official questioning the credibility of FMV data derived from industry benchmarks, asking: “How do w...

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298 results

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