DarshanTalks Podcast
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 medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
Is DTP Pharma’s Next Big Move?
In a recent interview between Nirpal Virdee and Darshan Kulkarni, they discussed the ongoing shifts in the pharmaceutical industry, particularly the rise of Direct-to-Patient (DTP) models. The conversation explored how these changes are driven by the pressure to reduce drug and device costs, especially in light of new tariffs that could further escalate prices. Darshan emphasized the need for pharmaceutical companies to rethink their operational models, including cutting out intermediaries to bring down costs while still optimizing patient engagement.
The role of AI was also debated. While AI is seen as a potential tool...
Hackers Are Stealing Your Personal Health Data
Health records are one of the top targets for hackers. These records contain a wealth of personal information like Social Security numbers, insurance details, and medical history, making them a gold mine for cybercriminals. Hackers use this data to steal identities, open credit cards, and even file fake tax returns. The scariest part? They can create fake identities for illegal activities, such as drug purchases or money laundering.
Why does this happen? Healthcare organizations often rely on outdated technology, making them vulnerable to attacks. Hackers exploit these weaknesses, and because the stakes are high...
How a “Medical Education” Program Became a $202M Fraud
We unpack the $202 million storm surrounding Gilead’s so-called “educational” speaker programs — and why it should make every medical affairs, legal, marketing, and compliance professional sit up straight.
Here’s what happened: The DOJ alleged that Gilead turned 17,000 speaker programs into a covert marketing machine to boost HIV drug prescriptions. We’re not talking about the occasional misstep — we’re talking wine-paired steak dinners at the James Beard House, prescribers being paid over $300,000 in honoraria, and attendees showing up to the same slide deck as many as 75 times.
The DOJ didn’t just scru...
Webinar Recap: What Sponsors Must Know About Fraud
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 launch a series we’ve been planning for months — tackling hot-button issues like regulatory scrutiny from DOJ, ORI, OIG, and the political narratives surrounding clinical research.Edye emphasized the strong audience engagement — not just around prevention of fraud but real, practical...AI-Powered Engagement is a Minefield
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 recording conversations without explicit real-time consent may be illegal. This could impact pharma companies using AI voice assistants, Alexa skills, voice bots, and patient support apps. If your tech processes speech wi...
Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
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 research differently—but with a shared mission. The idea was born at the Save Our Sites event, where they realized they often take distinct, yet complementary, paths to solve the same problems.
Edye dr...
Are Your Promotional Claims Putting Your Company at Risk?
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 stakeholders but also exposes companies to significant financial losses and regulatory scrutiny.
Compliance officers and marketers must work together to ensure promotional materials are accurate, legally sound, and fully substantiated. Your PRC team should include both regulatory experts and legal professionals to verify claims, su...
Privacy Dangers Lurking in Clinical Trial Mergers
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 safeguards in place to mitigate risks. Investors should conduct thorough due diligence to assess the site's current privacy practices before the merger or acquisition.
One major misconception is that HIPAA always applies to clinical trial data. In reality, properly an...
The FDA's Crisis Is Now Your Problem
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 legal interpretations are in flux. Marketing teams are flying blind with the FDA’s communications division gutted and post-Loper Bright challenges looming large.
Darshan outlines urgent next steps:
✔️ Rethink your submission timelines
✔️ R...
Broken FDA, Big Consequences
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 potentially weakening, and the user fee system in jeopardy, startups and pharma companies must treat this not as a minor policy shift but as a major compliance crisis. If you're not already reassessing your regulatory strategy, you're falling behind.
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You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations
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 Affordable Care Act (ACA), have made individual plans more accessible. This shift has given employees greater flexibility but also placed the burden of navigating complex insurance options on them, often without sufficient guidance.
One key development in this transition is the rise of Individual Coverage Health Reimbursement Arrangements...
Essential Due Diligence Steps for Clinical Research M&A
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 major focus of the conversation is understanding the risks associated with clinical trial sites. Many private equity investors are actively looking to acquire research sites, but without proper planning, these deals can present significant challenges. One of the biggest concerns is the departure of key...
Is AI Telemarketing Strategy Illegal?
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 the Kulkarni Law Firm for a legal review of your telehealth tools to ensure compliance and protect your reputation.
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No Clinical Trial Waste
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 MedSurplus Alliance at the Task Force for Global Health, which focuses on improving healthcare systems and managing medical product donations.Donna Libretti Cooke, a consultant for Kits4Life, who formerly worked at Ba...The Real Meaning of Audit-Readiness in Clinical Research
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 infrastructure to identify whether mistakes are isolated incidents or part of a larger trend requiring corrective action. Just like building credit requires a history of responsible transactions, regulatory credibility comes from demonstrating the ability to detect and resolve compliance issues effectively.
...Ordinary People Are Changing Medicine
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 about safety, ethics, and the future of healthcare, with both promise and complexity.
One of the most well-known examples is Lorenzo’s Oil, where Michaela and Augusto Odone developed a treatment for their son Lorenzo, who was diagnosed with a rare and fatal genetic disorder. Their re...
Investor Influence Can Trigger FCA Violations
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 overstepping operational boundaries can lead to False Claims Act (FCA) violations. Investors, eager to enhance efficiency and profitability, may inadvertently trigger scrutiny by imposing aggressive performance targets or controlling daily operations, which could cross the line into operational control. In this...
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons
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 protections, and compliance oversight. These agreements also ensure that investigators have access to institutional resources and support.
On the other hand, direct investigator agreements may offer a faster turnaround, but they come with greater risks. Investigators negotiating independently might agree to terms that organizations would typically reject, potentially exposing themselves to legal and financial liabilities.<...
Clinical Trial Site M&A: What Most Get Wrong
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 undisclosed 483s, protocol deviations, or even kickback violations. Instead of scaling operations, you're dealing with regulatory investigations and potential fraud issues.
These risks are avoidable—if you know where to look. Before merging clinical trial sites, conduct thorough due...
Future-Proof Sites: SOS Insights Revealed
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 real-time data solutions. They explore major industry trends, including the rise of site networks, increasing sponsor demand for real-time data access, and the shifting role of decentralized clinical trials (DCTs).
They also discuss whether DCTs are...
Why Food M&A Deals Collapse—And How to Prevent It
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 ingredients, misleading health claims, or an undisclosed FDA warning letter buried in company files. Some executives make the mistake of pushing forward, thinking they’ll fix it later—but regulators like the FDA, USDA, and FTC won’t wait.
Many assume their in...
Non-Compliance Led to QOL Medical's $47M Settlement
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-compliance—they’re about patient safety. The breath tests could not specifically diagnose CSID but were marketed as such, leading to inappropriate prescriptions and fraudulent claims submitted to federal healthcare programs. This not only wasted resources but also put vulnerable patients at risk.
For those in t...
FDA Regulatory Submissions: Challenges, Trends, and Future Predictions
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, careful and strategic approaches are critical to maintain the FDA’s global reputation and safety standards.
Edye discusses the complexity of submissions like Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, noting the significant preclinical work, detailed documentation, and thorough FDA review pr...
How to do a VR promo check - Carly Schaecter gives us her advice
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 misinformation, and learning from past mistakes are crucial for successful VR implementation. Gamification and user experience evaluation are critical elements of the review process.
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Diversity Matters in Clinical Trials
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 highlights the importance of gathering data from various populations to improve the effectiveness and inclusivity of clinical trials.
They delve into the growing role of research as a care option, particularly for uninsured patients who, through clinical trial participation, gain access to free medical care, me...
EMA’s LLM Guidelines Impact Life Sciences
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, hold promise for automating workflows like medical translations, pharmacovigilance reporting, and coding support. However, the EMA stresses continuous education, ethical governance, and collaboration among stakeholders to ensure responsible use.
Key recommendations include adopting strategies like prompt engineering to optimize AI outputs and fostering collaboration through initiatives...
How to Network Like a Pro at Conferences
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 valuable—considering the costs, time investment, and potential for networking. While online learning can be beneficial, conferences offer unique opportunities for interaction and relationship-building, which can lead to new clients, pa...
Getting Ready for SOS 2025: FDA 483s, SOPs, and Site Survival
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 voices in the clinical research space.
Darshan shares that Kulkarni Law Firm (KLF) will be participating and is excited to engage with attendees, talk about their offerings, and provide exclusive giveaways related to compliance and FDA inspections. Darshan emphasizes that KLF...
Maximizing Site Value
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 some claim multipliers as high as 26X, the reality is more complex.
Beyond valuation, choosing the right private equity partner is just as critical. Do they want a standalone site, or will you be part of a networ...
5 Key Areas to Review in Clinical Trial Agreements
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 documents, such as addendums, exhibits, and budgets, are included and properly linked to the contract.Budget & Payment Terms – Clarify payment schedules, invoice requirements, dispute procedures, and financial obligations to avoid misunderstandings.Choice of Law & Jurisdiction – Understand which state or country...Discussing Stem Cell Research Opportunities with a Research Site Owner
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 administration. Mohamed highlighted the increasing number of clinical trials and the expansion of pharmaceutical research into Europe, creating new opportunities for site owners like himself.
One of the most exciting developments he shared was his team’s work in stem cell research. They ha...
Quality Management: A Must in Clinical Trial Contracts
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 responsibilities, risk levels, and monitoring expectations upfront to avoid confusion and compliance issues later.
Key takeaways:
Contracts should outline quality expectations beyond general regulatory compliance.A quality management plan should be a living document, adaptable as the trial progresses.Budgets...AI-Powered Chatbots in Pharma Sales and Education
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 regulated pharmaceutical and medical device sectors.
The episode explores key challenges, starting with privacy and security concerns. AI-enabled systems handle large amounts of sensitive patient data, often governed by regulations like HIPAA in the U.S. and GDPR in Europe. Companies must ensure they have proper co...
Will New Tariffs Disrupt Your Next Pharma Deal?
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 own tariffs. This could disrupt global supply chains, making due diligence even more critical for buyers evaluating international pharmaceutical and biotech companies. Traditionally, M&A analysis focuses on vendor agreements, but in light of these tariffs, companies must now assess the entire supply chain—including alternative so...
Protecting Patient Data in a Changing Regulatory Landscape
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 centers—to understand whether their privacy regulations fall under state or federal jurisdiction. They explore hypothetical scenarios where federal agencies or other entities might request access to clinical trial data, questioning the potential motivations behind such requests, including public health initiatives or policy changes. Edye and Hele...
Off-Label Promotion Changes in 2025
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 FDA diversity initiatives, and potential scrutiny of diversity efforts in private companies.
A major focus is the changing environment of off-label marketing, where reliance on FDA guidances is being replaced by stricter adherence to statutory regulations due to court rulings like Coronia and <...
Turning Physicians into Leaders
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 medical degrees, completing training, and gaining clinical experience for 5 to 10 years before transitioning into leadership.
Lee also discusses the financial pitfalls physician leaders often face, particularly not recognizing their own value. He explains how clinical expertise can reduce waste and inefficiencies in healthcare organizations...
Key Regulatory Agencies in Pharma M&A
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, and evolving privacy laws at both federal and state levels. Ignoring these factors can lead to serious legal and financial consequences. Stay informed—compliance isn’t optional.
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Does E6 (R3) Blur the Line Between GCP and Privacy Laws?
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 as OCR proposes significant updates to the Security Rule. However, Edens notes that while R3 contains more references to privacy, it does not explicitly mention cybersecurity, which is a major focus of OCR’s changes. She argues that R3 is not attempting to replace or overshadow ex...
RFK Jr. Confirmed as HHS Secretary: What It Means for Healthcare Policy
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 approach to preventive care. While the focus on public health challenges is timely, the broad and vague nature of the directive raises questions about its execution and potential consequences.
A key concern is how the administration will interpret health data—whether it wil...
