Best Darshan Kulkarni Podcasts (2025)

1
Webinar Recap: What Sponsors Must Know About Fraud 4:06

20h 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

3d 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…

1
Webinar Update: Fraud Prevention Strategies Every Sponsor Needs 7:14

8d 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 …

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

9d 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…

1
Privacy Dangers Lurking in Clinical Trial Mergers 5:45

11d 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

14d 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

16d 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…

1
You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations 14:52

18d 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

20d 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 …

1
Is AI Telemarketing Strategy Illegal? 0:43

22d 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

24d 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…

1
The Real Meaning of Audit-Readiness in Clinical Research 2:34

26d 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…

1
Ordinary People Are Changing Medicine 3:47

28d 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…

1
Investor Influence Can Trigger FCA Violations 2:19

1M 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…

1
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons 2:38

1M 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 …

1
Clinical Trial Site M&A: What Most Get Wrong 4:20

1M 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…

1
Future-Proof Sites: SOS Insights Revealed 8:38

1M 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 …

1
Why Food M&A Deals Collapse—And How to Prevent It 2:29

1M 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…

1
Non-Compliance Led to QOL Medical's $47M Settlement 2:00

1M 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…

1
FDA Regulatory Submissions: Challenges, Trends, and Future Predictions 2:52

1M 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…

1
How to do a VR promo check - Carly Schaecter gives us her advice 14:42

1M 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…

1
Diversity Matters in Clinical Trials 5:42

2M 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…

1
EMA’s LLM Guidelines Impact Life Sciences 2:44

2M 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

2M 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…

1
Getting Ready for SOS 2025: FDA 483s, SOPs, and Site Survival 10:35

2M 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…

1
Maximizing Site Value 2:13

2M 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…

1
5 Key Areas to Review in Clinical Trial Agreements 3:33

2M 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

2M 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

2M 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

2M 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…

1
Will New Tariffs Disrupt Your Next Pharma Deal? 1:21

2M ago1:21

1:21

The proposed 25% tariff on pharmaceutical APIs from China could have far-reaching effects on M&A transactions within the life sciences and healthcare industries. Since a significant portion of pharmaceutical raw materials originate in China, companies may face increased costs not only in sourcing but also in sales, as Canada considers imposing its …

1
Protecting Patient Data in a Changing Regulatory Landscape 5:10

2M ago5:10

5:10

In this discussion, Edye Edens and Helen Maurer dive into the critical topic of data privacy and security in clinical research, particularly in light of potential federal oversight. Helen, an expert in compliance and quality assurance within oncology research, emphasizes the need for clinical trial sites—especially those at major academic medical c…

1
Off-Label Promotion Changes in 2025 31:17

2M ago31:17

31:17

Stephanie Trunk and Darshan Kulkarni discuss the evolving landscape of the pharmaceutical industry under the Trump Administration in 2025. They highlight the uncertainty surrounding regulatory changes, particularly with new leadership at the FDA, CMS, and HHS (with RFK confirmed). There is concern over shifting prosecutorial priorities, overturned …

1
Turning Physicians into Leaders 16:23

2M ago16:23

16:23

Kate Woods interviews Lee Scheinbart, who shares valuable advice for physicians aspiring to become Chief Medical Officers (CMOs) or take on leadership roles in healthcare. Lee stresses the importance of being intentional in career decisions and encourages young physician leaders to first focus on becoming competent clinicians. He advises earning me…

1
Key Regulatory Agencies in Pharma M&A 1:18

2M ago1:18

1:18

When conducting an M&A transaction in the pharmaceutical or medical device industry, compliance must be a top priority. Regulatory agencies like the DOJ, FDA, OIG, and OCR have strengthened oversight, emphasizing successor liability and the need for strong compliance programs. Beyond FDA regulations, companies must consider fraud prevention, HIPAA,…

1
Does E6 (R3) Blur the Line Between GCP and Privacy Laws? 1:37

2M ago1:37

1:37

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 evolving into a privacy doctrine? Given its increased focus on data protection, system validation, and privacy responsibilities, some wonder if it overlaps with regulatory frameworks like HIPAA, especially …

1
RFK Jr. Confirmed as HHS Secretary: What It Means for Healthcare Policy 8:01

2M ago8:01

8:01

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 Trump’s latest executive order. The order mandates a comprehensive national health assessment, addressing issues like obesity, diabetes, and pediatric disorders, and aims to reshape the country’s appr…

1
America’s Research Future in Jeopardy 7:44

3M ago7:44

7:44

Darshan Kulkarni and Edye Edens break down the significant impact of the Trump administration’s decision to cut NIH funding and reduce agency workforces, including the FDA, OHRP, and other key regulatory bodies. They discuss how these cuts could lead to serious disruptions in research funding, approval timelines, and the overall pace of medical inn…

1
Trump Administration’s NIH cuts: Will they cripple US medical research? 7:48

3M ago7:48

7:48

Darshan Kulkarni and Edye Edens discuss the recent controversy surrounding the Trump administration’s decision to cap NIH overhead funding (also known as indirect costs or F&A) at 15%. This sweeping change has already sparked significant backlash, with academic medical centers, particularly in Democratic states, filing lawsuits to challenge the pol…

1
DEI Under Trump: What It Means for Clinical Trials 7:47

3M ago7:47

7:47

The Trump administration’s early actions have significantly impacted federally funded programs, particularly in the clinical trial space, by rolling back diversity, equity, and inclusion (DEI) initiatives. This shift raises serious concerns for scientific research, as diversity in clinical trials ensures that drugs and devices are effective across …

1
CAPA & RCA: A Must for Pharma M&A 1:39

3M ago1:39

1:39

When acquiring a pharmaceutical company, evaluating its quality and compliance programs is crucial. A strong program starts with well-documented policies and procedures, followed by comprehensive training to ensure employees understand and follow them. However, having policies in place isn’t enough—regulatory bodies like the FDA and DOJ stress that…

1
Trump Targets Indirect Costs in NIH Funding 1:21

3M ago1:21

1:21

On Friday, the Trump administration announced a 15% cap on NIH indirect costs, raising important questions about its impact on research funding. Edye Edens breaks down what this means, clarifying that while direct costs like salaries and equipment remain unchanged, the cap affects crucial behind-the-scenes expenses such as lab maintenance, IT infra…

1
The USAID Halt and Its Consequences for Clinical Research 2:29

3M ago2:29

2:29

The Trump administration’s actions have effectively halted USAID-funded clinical research worldwide, creating an unprecedented situation with significant ethical, legal, and medical implications. Clinical trials that relied on USAID funding have stopped, leaving ongoing research in limbo and raising serious concerns about what happens to trial part…

1
Ebola Vaccine Trial in Record Time! 2:29

3M ago2:29

2:29

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 efficacy of a vaccine against the virus was launched within just four days. This rapid response was made possible by proactive planning following a 2022 outbreak, during which the Ugandan Ministry of Healt…

1
Your Clinical Trial Site M&A Agreement is Exposing You to Risk 0:50

3M ago0:50

0:50

When working on an M&A transaction involving a clinical trial site, it's crucial to thoroughly review vendor agreements. It's not just about what is included, but what is missing. For example, do you have the right quality and privacy agreements in place, or are you unknowingly exposing yourself to liability? If there’s a lack of necessary agreemen…

1
What Does ICH E6 R3 Say About Returning Data to Participants? 1:01

3M ago1:01

1:01

The most recent ICH E6(R3) final guidance introduces critical updates to Good Clinical Practice (GCP), particularly around informed consent and participant data access. The guidance emphasizes greater flexibility and the use of technology-driven innovations to enhance how patients understand what they are consenting to. A significant update appears…

1
Navigating the Ongoing HHS Communication Freeze 2:28

3M ago2:28

2:28

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 with no significant updates or changes. Despite expectations that restrictions might begin to lift, there has been no broad release of communications across federal agencies involved in clinical trials a…

1
Trump’s First 10 Days: The Impact on Clinical Trials 2:29

3M ago2:29

2:29

Edye Edens discusses how the first nine to ten days under the new administration have brought notable shifts for both healthcare and clinical research, particularly in regulatory compliance and funding. While remaining politically neutral, the focus is on understanding how these changes impact clinical trials and research oversight. A key update is…

1
Selling a Business with Issues 0:58

3M ago0:58

0:58

When selling a company, certain issues may arise that could concern potential buyers. Here's a breakdown of how to approach them: Price Adjustments: Some issues can be acknowledged, and the buyer may adjust the price accordingly, allowing the sale to proceed with minimal adjustments. Successor Liability: Issues like DOJ concerns or successor liabil…

Podcasts Worth a Listen

Darshan Kulkarni Podcasts

Podcasts Worth a Listen