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.
Episodes
203 episodes
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 ...
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2:19
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 beca...
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2:38
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. Im...
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4:20
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 runni...
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8:38
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 inve...
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2:29
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 prescription...
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2:00
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 dynam...
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2:52
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 d...
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14:42
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 lo...
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5:42
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...
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2:44
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...
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17:08
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...
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10:35
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 ...
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2:13
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 ...
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3:33
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,...
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7:43
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, ...
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6:23
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 m...
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5:29
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 Ch...
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1:21
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...
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5:10
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...
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31:17
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 ...
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16:23
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 ...
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1:18
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, a...
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1:37
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 assessme...
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8:01