DarshanTalks Podcast
Episodes
What Happens When a Sponsor Walks Away Early?
23 Dec 2025
Contributed by Lukas
 Early termination by a sponsor can leave a clinical research site holding the bill for prep work, fees, and staffing. In this episode, Darshan expla...
Cosmetic Claims the FDA Hates
22 Dec 2025
Contributed by Lukas
Your skincare product may look like a cosmetic, but one wrong claim can legally turn it into an unapproved drug.In this episode of KLF Deep Dive, we b...
Biggest Legal Mistakes in Influencer Marketing
18 Dec 2025
Contributed by Lukas
Influencers can boost visibility fast, but they also create real regulatory exposure if they go off script. The FTC requires influencers to clearly di...
Your Mood, Energy, and Sleep Claims Might Be Regulated
11 Dec 2025
Contributed by Lukas
 A lot of brands start with harmless wellness promises like better mood, more energy, or improved sleep. As the business grows, though, marketing oft...
Device Fail: The Legal Anatomy of a Faulty Implant Scandal
10 Dec 2025
Contributed by Lukas
 A knee implant meant to restore mobility. A surgeon secretly collecting international trips and consulting checks. A device company accused of selli...
5 Documents the FDA Will Demand on Site â Are You Ready?
09 Dec 2025
Contributed by Lukas
In this episode of DarshanTalks, you dive into what U.S. Food and Drug Administration (FDA) inspectors will demand when they show up on-site. You walk...
Cosmetic Marketing Mistakes That Trigger Regulators
04 Dec 2025
Contributed by Lukas
 Beauty brands hit trouble when they forget theyâre dealing with two regulators, not one. The FDA controls how cosmetics are labeled and when a cla...
Why Your Clinical Trial Contract Is Leaving Cash on the Table
02 Dec 2025
Contributed by Lukas
Clinical research sites lose money when sponsor contracts skip the real costs of running a study. In this episode, Darshan breaks down how to protect ...
Why Testimonials Can Get Your Brand Sued
29 Nov 2025
Contributed by Lukas
Before-and-after photos and glowing testimonials can sell products fast, but theyâre also some of the most heavily scrutinized tools in advertising....
How to Get Sponsors to Pay Faster than Net 90
27 Nov 2025
Contributed by Lukas
 Can I negotiate faster payment terms so I don't run out of cash flow? Many sponsor contracts set 90 to 120 day payment timelines. This, however...
Pharma merger killers
14 Nov 2025
Contributed by Lukas
Darshan Kulkarni explores why compliance isnât just a side issueâitâs often the ultimate dealbreaker in pharma and biotech transactions.When buy...
Balance FDA Rules with FTC Advertising Requirements
12 Nov 2025
Contributed by Lukas
Brands often struggle to balance FDA cosmetic rules with FTC advertising standards. The FDA oversees labeling and determines whether a product is a co...
Key Clauses in PI Contracts to Review
10 Nov 2025
Contributed by Lukas
Many clinical trial site leaders overlook critical risks hidden in physician employment agreements. These contracts often contain clauses that can exp...
Compliance guru talks practical Insights on Speaker Programs
07 Nov 2025
Contributed by Lukas
In this episode, host Darshan Kulkarni speaks with Joseph Keeney about speaker programs in the life sciences industry, exploring practical differences...
Trends in Small Life Sciences Transactions
05 Nov 2025
Contributed by Lukas
Darshan Kulkarni in conversation with Nella Bloom, for an in-depth discussion on the current state of small business transactions, private equity tren...
Protect Your Site If a Sponsor Terminates Early
03 Nov 2025
Contributed by Lukas
When sponsors terminate a clinical trial early, research sites may face financial losses for preparatory or ongoing work. To mitigate this risk, contr...
Are Pharma Chatbots Putting You at Regulatory Risk?
01 Nov 2025
Contributed by Lukas
Pharmaceutical chatbots are increasingly used to answer patient drug questions, but they carry significant regulatory and compliance risks. While the ...
Are Your Cosmetic Company Records Ready for FDA Audits?
30 Oct 2025
Contributed by Lukas
Companies must maintain thorough records to meet FDA inspection requirements, including safety substantiation files, labeling proofs, ingredient docum...
When Medical Affairs Becomes Commercial in Disguise
24 Oct 2025
Contributed by Lukas
Darshan explores a critical question for life sciences companies: is your medical affairs team truly independent from commercialâor are you just pre...
Serious Adverse Event Reporting Under MoCRA
22 Oct 2025
Contributed by Lukas
Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serio...
Key SOPs for Clinical Trials
20 Oct 2025
Contributed by Lukas
Darshan Kulkarni highlights that to stay compliant with the FDA, companies donât need an exhaustive set of SOPsâjust the essential ones. Inspector...
Payer Presentations Can Trigger Enforcement
18 Oct 2025
Contributed by Lukas
The boundary between scientific exchange and marketing in payer presentations is increasingly blurred, creating significant compliance and enforcement...
Pharmacies v manufacturers
16 Oct 2025
Contributed by Lukas
In this episode, Darshan Kulkarni speaks with Dae Lee about the growing conflict between pharmaceutical manufacturers and pharmacy benefit managers (P...
Is Clinical Research Ready for the new FDA?
13 Oct 2025
Contributed by Lukas
The FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compl...
Is your cosmetics company FDA-registered?
11 Oct 2025
Contributed by Lukas
Cosmetics companies must now register both their facilities and products with the FDA under the new MoCRArequirements, a shift from the previous volun...
Will AI Replace Doctors in clinical research?
09 Oct 2025
Contributed by Lukas
Darshan discusses the potential role of AI in medicine. He believes fears of AI replacing doctors for diagnosis are currently overblown, as trust in p...
Risks in Direct-to-Patient Engagement
07 Oct 2025
Contributed by Lukas
Direct-to-Patient (DTP) models are transforming how medications reach patients, moving beyond clinical research into commercial distribution. Original...
Inside 340B: Challenges, Controversies, and Opportunities
01 Oct 2025
Contributed by Lukas
Darshan Kulkarni speaks with Thomas Siepka, CEO of HCI Healthcare Consultants, to take a deep dive into the often-misunderstood world of the 340B drug...
IRBs in 2025: Whatâs Really Changing?
27 Sep 2025
Contributed by Lukas
In this conversation, Edye Edens with Nyssa Towsley from UNLV, examine how todayâs shifting funding landscape is reshaping IRB operations. Historica...
3 Red Flags in Telemedicine Partnerships
25 Sep 2025
Contributed by Lukas
In this video, Darshan discusses recent enforcement trends show three weak spots to watch:Encounter Quality â If prescribers are just checking boxes...
What do PBMs do?
21 Sep 2025
Contributed by Lukas
In this episode, Darshan Kulkarni talks with Thomas Siepka about the 340B program, rebates, and the crucial role of pharmacy benefit managers (PBMs) i...
How AMCs Build Stronger Compliance Cultures Together
19 Sep 2025
Contributed by Lukas
 In the episode of a new series on academic medical centers, Edye Edens of Kulkarni Law Firm sits down with Cortni Romaine of Florida Atlantic Univer...
How One DME Scheme Cost Medicare $61 Million
15 Sep 2025
Contributed by Lukas
In one of the largest recent Medicare fraud cases, Peter Roussonicolos, a Florida durable medical equipment (DME) company owner, was sentenced to 12 y...
FDA to Step Up Enforcement on Pharma Advertising
12 Sep 2025
Contributed by Lukas
The FDA has recently stepped up its enforcement of pharmaceutical advertising rules, issuing 100 cease-and-desist notices and thousands of letters. Th...
Top 5 Factors Determining AMC Funding
09 Sep 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens launch an exciting new episode, focusing on the unique challenges academic medical centers (AMCs) face in securing fun...
New Series Drop: Exploring AMCs in Clinical Research
06 Sep 2025
Contributed by Lukas
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 r...
Why Choose a Licensed Attorney Over a Consultant?
04 Sep 2025
Contributed by Lukas
Edye Edens and Darshan Kulkarni share the origin story of KLF and explain what makes working with licensed attorneys different from hiring non-legal c...
Marketing Problems by Hims & Hers and Lilly
02 Sep 2025
Contributed by Lukas
Telehealth and pharma are facing some of their biggest compliance challenges yetâand the latest enforcement actions prove regulators arenât slowin...
Should Sponsors Share Site Feedback?
29 Aug 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selectedâor notâfor a st...
AI Marketing Playbook for Drug Companies
26 Aug 2025
Contributed by Lukas
AI is no longer a distant concept in pharma marketingâitâs here, transforming campaign design, review, and distribution. CEOs and CMOs face a crit...
Should Sites Be Ready on Standby?
23 Aug 2025
Contributed by Lukas
Edye Edens and Darshan Kulkarni from KLF discuss the pros and cons for clinical trial sites considering becoming backup sites. Key points include:Spon...
Eastern District of PA Targets Pharmacies
21 Aug 2025
Contributed by Lukas
The Eastern District of Pennsylvania has ramped up False Claims Act enforcement against pharmacies, with cases ranging from multi-million dollar settl...
Telehealth Done Right
18 Aug 2025
Contributed by Lukas
The Office of Inspector General (OIG) recently issued an advisory opinion approving a telehealth business model where a management company leases clin...
DOJ and HHS Launch FCA Fraud Task Force
15 Aug 2025
Contributed by Lukas
In Fiscal Year 2024, whistleblower cases reached an all-time high of 979, signaling increased scrutiny of healthcare fraud. Just days after announcing...
Should Sponsors Cover Malpractice Insurance?
13 Aug 2025
Contributed by Lukas
Darshan and Edye tackle a hot topic in clinical research budgeting:Â Should malpractice insurance be considered an overhead cost that sponsors cover?E...
Instagram Post that Sparked FDA Warning Letter
11 Aug 2025
Contributed by Lukas
In this episode, Darshan Kulkarni unpacks the May 29, 2025 FDA Warning Letter issued to Sprout Pharmaceuticals. The trigger? A promotional Instagram p...
Why Are So Many Doctors Getting Arrested?
09 Aug 2025
Contributed by Lukas
Why are headlines suddenly filled with stories of doctors, nurses, healthcare executivesâand even accountantsâbeing arrested for fraud? In this ex...
How to Run Compliant Pharma Speaker Programs
06 Aug 2025
Contributed by Lukas
What really happens behind the scenes of pharmaceutical speaker programsâand why should smaller pharma companies care? In this episode of DarshanTal...
ââAre You Picking the Wrong KOLs?
04 Aug 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs ca...
How KLFâs Client Base Evolved Over 20 Years
02 Aug 2025
Contributed by Lukas
Edye Edens interviews Darshan Kulkarni about the evolution of the Kulkarni Law Firm (KLF). Darshan reflects on how he originally envisioned working wi...
FDA Pushback on Accelerated Gene Therapy Approvals
31 Jul 2025
Contributed by Lukas
In this episode, Edye Edens dives into the FDAâs evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of ...
Your DEI Program Could Trigger an FCA Case
30 Jul 2025
Contributed by Lukas
Darshan Kulkarni breaks down the Department of Justiceâs new Civil Rights Fraud Initiative, launched on May 19, 2025, and why it should be on the ra...
Tevaâs Charity Partnership Scrutinized
28 Jul 2025
Contributed by Lukas
A recent $425 million settlement involving Teva Pharmaceuticals highlights the legal and ethical risks charities face when partnering with pharmaceuti...
Is There a âRightâ Way to Calculate FMV?
25 Jul 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens take a deep dive into one of clinical researchâs most persistent questions: how is fair market value (FMV) actually ...
Can Non-Physicians Own Clinical Trial Sites?
23 Jul 2025
Contributed by Lukas
Can non-physicians own independent clinical trial sites? The answer isnât as simple as it seems. In most states, including Texas, engaging in clinic...
The KLF Story You Havenât Heard
20 Jul 2025
Contributed by Lukas
In this special episode, Senior Attorney Edye Edens sits down with Darshan Kulkarni, founder and principal of the Kulkarni Law Firm, for a personal an...
Why Telehealth Platforms Are Getting Sued
17 Jul 2025
Contributed by Lukas
We explore the growing wave of class action lawsuits hitting the telehealth industryâand why legal counsel, especially those advising telemedicine p...
Should Clinical Trial Sites Be Paid Differently?
15 Jul 2025
Contributed by Lukas
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 clinic...
How to Build an AI Compliance Program
14 Jul 2025
Contributed by Lukas
In this episode of KLF Deep Dive, Darshan Kulkarni explores the growing urgency for in-house counsel to develop AI compliance programs as artificial i...
What the Big Beautiful Bill Means for Trial Sites
11 Jul 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed âBig Beautiful Billââa sweeping piece of legislation t...
Co-Pay Mistakes Can Trigger DOJ Action
09 Jul 2025
Contributed by Lukas
In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns....
NIH Grant Denials Ruled Discriminatory?
08 Jul 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIHâs decision to halt grant funding for projects focus...
Are Speaker programs supposed to be salesy?
04 Jul 2025
Contributed by Lukas
Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, ...
DTP Compliance Just Got Tricky
28 Jun 2025
Contributed by Lukas
The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about d...
Should You Use AI to Draft Informed Consent?
26 Jun 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AIâlike ChatGPTâto draft informed consent documents in clinical resear...
Could You Survive a Surprise Pharmacy Audit?
23 Jun 2025
Contributed by Lukas
Imagine you're filling a script when a State Board of Pharmacy inspector walks inâno warning, just a clipboard and serious consequences. Most c...
Self-Reporting in Clinical Trials
20 Jun 2025
Contributed by Lukas
In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses ...
$14M Fine Says This âFreeâ Offer Wasnât Legal
18 Jun 2025
Contributed by Lukas
In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys...
Nonprofit Pharma Exists. Here is how it works
16 Jun 2025
Contributed by Lukas
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 co...
FTC Rules for Pharma Companies
14 Jun 2025
Contributed by Lukas
In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the phar...
Whistleblowing in Clinical Trials: Is It Worth the Risk?
12 Jun 2025
Contributed by Lukas
In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that...
The Right Way to Do Medical Affairs on LinkedIn
09 Jun 2025
Contributed by Lukas
In this episode, Darshan Kulkarni sits down with Marie Ange Noue, Senior Director and Head of Scientific Communications at EMD Serono, to dive deep in...
Are We Paying Clinical Trial Patients Enough?
07 Jun 2025
Contributed by Lukas
In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? ...
Pharma Ads Are Getting Canceled
04 Jun 2025
Contributed by Lukas
Googleâs 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google...
Unpacking Screen Fail Payments in Research
31 May 2025
Contributed by Lukas
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 ...
Post-Trump Antitrust Rules Are Crushing Pharma Deals
28 May 2025
Contributed by Lukas
In this episode, we explore a crucial and timely issue: how the Trump administrationâs approach to antitrust enforcementâcombined with new state-l...
7 Must-Know Steps to transfer medical device ownership
24 May 2025
Contributed by Lukas
Transferring medical device ownership during a company sale requires careful planning to ensure compliance and operational continuity. The process beg...
Responding to Site Findings
22 May 2025
Contributed by Lukas
At first glance, responding to site-level findings seems simpleâbut when Edye and Darshan dug into the details, it became clear that the lines of re...
Is Your Medical Website Illegal?
20 May 2025
Contributed by Lukas
Medical communications teams must exercise caution when using websites dedicated to medical affairs, as legal risks go beyond overt sales promotion. D...
Price Fixing in Clinical Research
17 May 2025
Contributed by Lukas
At the Save Our Sites (SOS) conference, many site owners expressed excitement over finally having a space to openly discuss real challengesâbudgets,...
DOJ Cracks Down on Pharmacy Fraud
15 May 2025
Contributed by Lukas
The recent conviction of a Michigan pharmacist and his brother in a $15 million healthcare fraud scheme highlights the growing crackdown on pharmacy-r...
Protect Your DTP Strategy
13 May 2025
Contributed by Lukas
Pharma is finally catching up to the on-demand worldâoffering direct-to-patient (DTP) services that promise convenience, faster delivery, and a more...
AI Clinical Trial Negotiators
10 May 2025
Contributed by Lukas
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 ...
SOPs: How Many is Too Many?
09 May 2025
Contributed by Lukas
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? Wh...
Is DTP Pharmaâs Next Big Move?
07 May 2025
Contributed by Lukas
In a recent interview between Nirpal Virdee and Darshan Kulkarni, they discussed the ongoing shifts in the pharmaceutical industry, particularly the r...
Hackers Are Stealing Your Personal Health Data
05 May 2025
Contributed by Lukas
Health records are one of the top targets for hackers. These records contain a wealth of personal information like Social Security numbers, insurance ...
How a âMedical Educationâ Program Became a $202M Fraud
03 May 2025
Contributed by Lukas
We unpack the $202 million storm surrounding Gileadâs so-called âeducationalâ speaker programs â and why it should make every medical affairs,...
Webinar Recap: What Sponsors Must Know About Fraud
01 May 2025
Contributed by Lukas
After our first-ever deep dive webinar on âProtecting Sponsors, Fraud & Compliance in Research,â Darshan Kulkarni, Edye Edens, and Nirpal Vird...
AI-Powered Engagement is a Minefield
29 Apr 2025
Contributed by Lukas
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 i...
Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
24 Apr 2025
Contributed by Lukas
Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/Registration Link- https://us02web.zoom.us/...
Are Your Promotional Claims Putting Your Company at Risk?
23 Apr 2025
Contributed by Lukas
Guardant Healthâs recent $292 million victory against Natera in a false advertising lawsuit sets a critical precedent for the biotech industry, high...
Privacy Dangers Lurking in Clinical Trial Mergers
21 Apr 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens discuss the critical role of data privacy in clinical trial site acquisitions. While privacy concerns can seem dauntin...
The FDA's Crisis Is Now Your Problem
18 Apr 2025
Contributed by Lukas
The FDA you designed your protocol around may no longer exist. In this episode, Darshan Kulkarni breaks down why clinical researchers, regulatory atto...
Broken FDA, Big Consequences
16 Apr 2025
Contributed by Lukas
The FDA is facing unprecedented turmoilâstaff cuts, a sweeping reorganization, and political interference are undermining its ability to safeguard p...
You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations
14 Apr 2025
Contributed by Lukas
In this episode, Kate Woods and Darshan Kulkarni discussed the shift from employer-sponsored health insurance to individual responsibility, a transiti...
Essential Due Diligence Steps for Clinical Research M&A
12 Apr 2025
Contributed by Lukas
When mergers and acquisitions intersect with clinical trials, due diligence becomes a crucial step in ensuring a successful transition. In this insigh...
Is AI Telemarketing Strategy Illegal?
10 Apr 2025
Contributed by Lukas
Todayâs episode is a wake-up call for pharma marketers launching telehealth campaigns. If you're using AI voice assistants or call automation t...
No Clinical Trial Waste
08 Apr 2025
Contributed by Lukas
In this episode, Darshan Kulkarni explores an important yet often overlooked questionâwhat happens after a clinical trial ends? While much focus is ...
The Real Meaning of Audit-Readiness in Clinical Research
06 Apr 2025
Contributed by Lukas
Edye Edens discusses what it truly means to be site audit ready and dispels the misconception that it requires 100% compliance. No auditor expects per...
Ordinary People Are Changing Medicine
04 Apr 2025
Contributed by Lukas
Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medici...