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
215 episodes
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 healt...
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2:48
Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/Registration Link- https://us02web.zoom...
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7:14
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 a...
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1:38
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 wheth...
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5:45
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.
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2:32
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...
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0:35
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-provi...
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14:52
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 cons...
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3:45
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...
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0:43
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...
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18:18
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 rea...
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2:34
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 comp...
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3:47
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