DarshanTalks Podcast

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 “Free” Offer Wasn’t 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

Google’s 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 administration’s approach to antitrust enforcement—combined 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 simple—but 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 challenges—budgets,...

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 world—offering 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 Pharma’s 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 “Medical Education” Program Became a $202M Fraud

03 May 2025

Contributed by Lukas

We unpack the $202 million storm surrounding Gilead’s so-called “educational” speaker programs — 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 ‘Protecting Sponsors, Fraud & Compliance in Research,’ 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 Health’s 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 turmoil—staff 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

Today’s 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 question—what 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...

Investor Influence Can Trigger FCA Violations

02 Apr 2025

Contributed by Lukas

Mergers and Acquisitions (M&A) in the healthcare sector can be highly profitable, but they carry significant legal risks, particularly for private...

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

31 Mar 2025

Contributed by Lukas

Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research orga...

Clinical Trial Site M&A: What Most Get Wrong

29 Mar 2025

Contributed by Lukas

Most clinical trial site mergers focus on patient databases, sponsor contracts, and geographic expansion. While those are important, the real risks li...

Future-Proof Sites: SOS Insights Revealed

27 Mar 2025

Contributed by Lukas

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 ...

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

25 Mar 2025

Contributed by Lukas

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, ma...

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

23 Mar 2025

Contributed by Lukas

The recent $47 million settlement involving QOL Medical and its CEO is a stark reminder of the consequences of crossing legal and ethical boundaries. ...

FDA Regulatory Submissions: Challenges, Trends, and Future Predictions

21 Mar 2025

Contributed by Lukas

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 p...

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

19 Mar 2025

Contributed by Lukas

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...

Diversity Matters in Clinical Trials

18 Mar 2025

Contributed by Lukas

In this insightful discussion, Shuja Naqvi, CEO of Biopharma Informatics, joins Darshan Kulkarni to explore the evolving landscape of clinical researc...

EMA’s LLM Guidelines Impact Life Sciences

16 Mar 2025

Contributed by Lukas

The EMA's new guiding principles on LLMs represent a transformative step in regulatory science, addressing both the immense potential and signifi...

How to Network Like a Pro at Conferences

12 Mar 2025

Contributed by Lukas

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 m...

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

10 Mar 2025

Contributed by Lukas

In this conversation, Edye Edens and Darshan Kulkarni discuss the excitement and plans for the upcoming Save Our Sites (SOS) Second Annual Conference ...

Maximizing Site Value

07 Mar 2025

Contributed by Lukas

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 de...

5 Key Areas to Review in Clinical Trial Agreements

05 Mar 2025

Contributed by Lukas

Contract issues are more common than you think. Edye Edens shares the five critical areas you should always review before signing:Basic Details & ...

Discussing Stem Cell Research Opportunities with a Research Site Owner

03 Mar 2025

Contributed by Lukas

At the Site Council meeting, Darshan Kulkarni had the opportunity to speak with Mohamed Hakim, a site owner who has consolidated six clinical research...

Quality Management: A Must in Clinical Trial Contracts

01 Mar 2025

Contributed by Lukas

In the second part of our discussion, Edye Edens speaks with subject matter expert Helen Maurer about integrating quality management into clinical tri...

AI-Powered Chatbots in Pharma Sales and Education

27 Feb 2025

Contributed by Lukas

ChatGPT's recent update introduced an AI engagement feature reminiscent of the movie Her, the conversation is highly relevant as AI becomes more ...

Will New Tariffs Disrupt Your Next Pharma Deal?

26 Feb 2025

Contributed by Lukas

The proposed 25% tariff on pharmaceutical APIs from China could have far-reaching effects on M&A transactions within the life sciences and healthc...

Protecting Patient Data in a Changing Regulatory Landscape

25 Feb 2025

Contributed by Lukas

In this discussion, Edye Edens and Helen Maurer dive into the critical topic of data privacy and security in clinical research, particularly in light ...

Off-Label Promotion Changes in 2025

24 Feb 2025

Contributed by Lukas

Stephanie Trunk and Darshan Kulkarni discuss the evolving landscape of the pharmaceutical industry under the Trump Administration in 2025. They highli...

Turning Physicians into Leaders

21 Feb 2025

Contributed by Lukas

Kate Woods interviews Lee Scheinbart, who shares valuable advice for physicians aspiring to become Chief Medical Officers (CMOs) or take on leadership...

Key Regulatory Agencies in Pharma M&A

20 Feb 2025

Contributed by Lukas

When conducting an M&A transaction in the pharmaceutical or medical device industry, compliance must be a top priority. Regulatory agencies like t...

Does E6 (R3) Blur the Line Between GCP and Privacy Laws?

19 Feb 2025

Contributed by Lukas

In this video, Edye Edens discusses the recent transition of ICH GCP E6 from R2 to R3, highlighting an interesting question she received: Is R3 evolvi...

RFK Jr. Confirmed as HHS Secretary: What It Means for Healthcare Policy

18 Feb 2025

Contributed by Lukas

Edye Edens and Darshan Kulkarni dive into the confirmation of RFK Jr. as Secretary of Health and Human Services and the immediate impact of President ...

America’s Research Future in Jeopardy

15 Feb 2025

Contributed by Lukas

Darshan Kulkarni and Edye Edens break down the significant impact of the Trump administration’s decision to cut NIH funding and reduce agency workfo...

Trump Administration’s NIH cuts: Will they cripple US medical research?

14 Feb 2025

Contributed by Lukas

Darshan Kulkarni and Edye Edens discuss the recent controversy surrounding the Trump administration’s decision to cap NIH overhead funding (also kno...

DEI Under Trump: What It Means for Clinical Trials

13 Feb 2025

Contributed by Lukas

The Trump administration’s early actions have significantly impacted federally funded programs, particularly in the clinical trial space, by rolling...

CAPA & RCA: A Must for Pharma M&A

12 Feb 2025

Contributed by Lukas

When acquiring a pharmaceutical company, evaluating its quality and compliance programs is crucial. A strong program starts with well-documented polic...

Trump Targets Indirect Costs in NIH Funding

11 Feb 2025

Contributed by Lukas

On Friday, the Trump administration announced a 15% cap on NIH indirect costs, raising important questions about its impact on research funding. Edye ...

The USAID Halt and Its Consequences for Clinical Research

10 Feb 2025

Contributed by Lukas

The Trump administration’s actions have effectively halted USAID-funded clinical research worldwide, creating an unprecedented situation with signif...

Ebola Vaccine Trial in Record Time!

08 Feb 2025

Contributed by Lukas

On January 30, 2025, Uganda confirmed an outbreak of the Ebola Sudan virus, and in an unprecedented global first, a clinical trial to assess the effic...

Your Clinical Trial Site M&A Agreement is Exposing You to Risk

07 Feb 2025

Contributed by Lukas

When working on an M&A transaction involving a clinical trial site, it's crucial to thoroughly review vendor agreements. It's not just a...

What Does ICH E6 R3 Say About Returning Data to Participants?

05 Feb 2025

Contributed by Lukas

The most recent ICH E6(R3) final guidance introduces critical updates to Good Clinical Practice (GCP), particularly around informed consent and partic...

Navigating the Ongoing HHS Communication Freeze

04 Feb 2025

Contributed by Lukas

Now that we’ve passed February 1st, a key date for the potential easing of the freeze on all HHS communications, we find ourselves at February 3rd w...

Ordinary People Are Changing Medicine

03 Feb 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...

Trump’s First 10 Days: The Impact on Clinical Trials

31 Jan 2025

Contributed by Lukas

Edye Edens discusses how the first nine to ten days under the new administration have brought notable shifts for both healthcare and clinical research...

Selling a Business with Issues

31 Jan 2025

Contributed by Lukas

When selling a company, certain issues may arise that could concern potential buyers. Here's a breakdown of how to approach them:Price Adjustment...

Breaking Down GCP E6(R3)

28 Jan 2025

Contributed by Lukas

Darshan Kulkarni and Edye Edens discuss the latest update to Good Clinical Practice (GCP) guidelines, E6 R3, was explored. GCP, developed by the Inter...

AdvaMed 7 rules for Essential AI Innovation

25 Jan 2025

Contributed by Lukas

Artificial intelligence (AI) is rapidly reshaping healthcare, with over 950 FDA-authorized AI devices transforming diagnosis, treatment, and administr...

Teva’s Case Should Shape Your Pharma Strategy

22 Jan 2025

Contributed by Lukas

Teva Pharmaceutical's $450 million settlement highlights the challenges of compliance in the pharmaceutical industry. The Department of Justice a...

AI’s Impact on Healthcare: Liability, Ethics, and Responsibility

21 Jan 2025

Contributed by Lukas

Today, we explore a pressing issue in the healthcare landscape: the liability associated with artificial intelligence (AI). As AI technologies transfo...

Four Types of Research related Grant Fraud

18 Jan 2025

Contributed by Lukas

Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals.1. Foreign Influence and Funding:Fail...

Defining Scope in Due Diligence Transactions

17 Jan 2025

Contributed by Lukas

When conducting due diligence for a life sciences company, it's essential to align the scope with the transaction's objectives. Key consider...

Clinical Trial Checklist

16 Jan 2025

Contributed by Lukas

Darshan Kulkarni and Edye Edens discuss the essential steps for launching a clinical trial site, emphasizing the importance of navigating both state-s...

Presidential Changes and Impact on Drug Related Misinformation

14 Jan 2025

Contributed by Lukas

Misinformation around vaccines and treatments isn’t new, but with figures like Robert F. Kennedy Jr. in the spotlight, how should regulatory agencie...

Prep for Selling Your Company!

12 Jan 2025

Contributed by Lukas

When preparing to sell your pharmaceutical company, particularly with a Phase 1 product, it’s essential to assess potential buyers and ensure readin...

Top Tips for Starting a Clinical Trial Site

10 Jan 2025

Contributed by Lukas

Launching a clinical trial site is an exciting opportunity, but it comes with important legal, regulatory, and operational challenges.Darshan Kulkarni...

When Drug Reps Visit: Darshan Reacts

09 Jan 2025

Contributed by Lukas

Darshan reacts to a fake interaction between a drug sales representative and a doctor. He shares insights on pharmaceutical marketing tactics, highlig...

Is Pfizer competing with your pharmacy?

08 Jan 2025

Contributed by Lukas

Pharmaceutical companies, like Pfizer, are venturing into digital healthcare platforms, raising questions about competition with traditional pharmacie...

Talking to a Functional Medicine Doctor

07 Jan 2025

Contributed by Lukas

In this episode, guest host Kate Woods interviews Jessica Miller, who shares her journey with functional medicine, highlighting its focus on addressin...

Four Types of Research related Grant Fraud

05 Jan 2025

Contributed by Lukas

Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals:Foreign Influence and Funding:Failing...

Leveraging AI and RWD to Reshape Drug Trials!

03 Jan 2025

Contributed by Lukas

In this episode, Darshan explores how artificial intelligence (AI) is transforming clinical trial design, with a focus on using real-world data (RWD)....

DCTs in Oncology: Can They Work?

01 Jan 2025

Contributed by Lukas

The FDA’s 2024 guidance on decentralized clinical trials (DCTs) has the potential to transform clinical research, particularly in oncology. While ma...

Marketing Due Diligence in Stem cell M&A Transactions

31 Dec 2024

Contributed by Lukas

The stem cell industry is growing rapidly but faces heightened regulatory scrutiny, particularly regarding marketing practices. Recent events highligh...

Why Are PBMs Blocking Your Meds? - Darshan reacts

30 Dec 2024

Contributed by Lukas

In this episode, Darshan reacts to how at the start of each year, pharmacists often face the challenge of informing patients that their medications ar...

Misleading Ads: Ad laws and Consumer Protection for Marketers

28 Dec 2024

Contributed by Lukas

Rebecca Tushnet discusses the potential explores the implications of misleading advertisements, particularly concerning pregnancy clinics. Even true s...

5 Common Clinical Trial Site Failures

26 Dec 2024

Contributed by Lukas

Darshan discusses the five most common clinical trial site issues:1. Failure to Follow Investigational Plan: Treating clinical trials like routine med...

Faster FDA Recalls

24 Dec 2024

Contributed by Lukas

The FDA’s Center for Devices and Radiological Health (CDRH) has launched a groundbreaking initiative aimed at improving the efficiency and speed of ...

IRB Challenges and Updates for 2024

23 Dec 2024

Contributed by Lukas

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHR...

Is the Polio Vaccine Safe?

22 Dec 2024

Contributed by Lukas

The polio vaccine, credited with eradicating a crippling disease in the U.S., faces renewed scrutiny after attorney Aaron Siri, linked to Robert F. Ke...

FDA blue print to discuss off label topics

20 Dec 2024

Contributed by Lukas

FDA has changed its mind about off label marketing. Today, we're diving into how drug and device companies can effectively engage with payers and...

Opportunities AI provides in Clinical Research

18 Dec 2024

Contributed by Lukas

Today, we're discussing the FDA's use of artificial intelligence (AI) to transform clinical trials.AI is emerging as a cornerstone in clinic...

Telehealth and Biohacking: A Risky Combination

16 Dec 2024

Contributed by Lukas

The rise of biohacking has transitioned from a niche interest to a mainstream trend, particularly in the context of drugs like Ozempic and ketamine. W...

Is the FDA’s Response to AI Falling Behind?

14 Dec 2024

Contributed by Lukas

The FDA’s current approach to AI in healthcare highlights significant gaps in regulatory preparedness. Although the FDA has approved thousands of AI...

Healthcare Is in Crisis: How do we fix it?

13 Dec 2024

Contributed by Lukas

In this episode, guest host Kate Woods and Darshan Kulkarni delve into current healthcare issues, including the unsettling news of the CEO of United H...

Will RFK Break Pharma?

12 Dec 2024

Contributed by Lukas

Robert F. Kennedy Jr. has announced plans for a presidential mandate to restore federal agencies, including the FDA, to the "gold standard" ...