DarshanTalks Podcast
af Darshan Kulkarni
Seneste episode
AI Drug Discovery: Who Owns the IP Rights?
AI Drug Discovery: Who Owns the IP Rights?
Om denne podcast
Welcome to DarshanTalks! 152254
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.
152254
Episoder
De nyeste 50 af 358 episoder
- AI Drug Discovery: Who Owns the IP Rights? · 18 min.Send us Fan Mail Episode Summary When an AI model designs a novel therapeutic molecule or predicts an enzyme structure, who legally owns the resulting intellectual property? In…
- Multi-State Non-Competes: The Site Network Template Trap · 6 min.Send us Fan Mail Episode Summary: Can a clinical trial site network legally enforce a standardized, templated employment agreement containing restrictive covenants against a…
- 100% HIPAA Compliant"? Why Your Badges Are Legal Debt · 14 min.Send us Fan Mail Episode Summary: "We are 100% HIPAA compliant." If this claim sits on your clinical trial site, digital health app, or pharma landing page, you may be quietly…
- Decoding 340B: History, Legislative Styles, and Healthcare Policy with Deborah Williams · 14 min.Send us Fan Mail Episode Overview: In this episode of KLF Deep Dive, host Darshan Kulkarni sits down with Deborah Williams, Founder of Health Policy Insights, LLC, to explore…
- Contrast Therapy: The Hidden Legal & Water Risks · 15 min.Send us Fan Mail The wellness industry is undergoing a massive boom, but modern contrast therapy, thermal bathing, and sauna facilities are stepping directly into an unseen legal…
- BPC-157: The FDA Blacklist, PCAC Vote & Legal Exposure · 5 min.Send us Fan Mail When podcast hosts and biohacking influencers promote "The Wolverine Stack"—coupling BPC-157 and TB-500 for rapid tissue and gut repair—it generates millions of…
- FDA Under Pressure: Enforcement, DOGE & Global Supply Chains · 18 min.Send us Fan Mail What is happening inside the FDA, and how are regulatory shifts impacting pharmaceutical, medical device, and food companies? In this episode of the KLF Deep…
- Health Tech Startups: From Garage to FDA · 15 min.Send us Fan Mail Thinking about launching a health tech startup, digital health app, or wearable device? Moving fast and breaking things might work in software, but in…
- Is Your Clinical Trial IP Already Leaked? · 14 min.Send us Fan Mail The wellness industry is undergoing a massive boom, but modern contrast therapy, thermal bathing, and sauna facilities are stepping directly into an unseen legal…
- Decoding Australia's TGA Regulations · 18 min.Send us Fan Mail Thinking about launching a health product, dietary supplement, or digital health solution in the Australian market? You might want to hit pause before assuming…
- AI "Going Rogue": The Legality of Healthcare Chatbots · 15 min.Send us Fan Mail What happens when an artificial intelligence chatbot moves past answering basic questions and starts actively pretending to be a licensed psychiatrist? In this…
- Pharmacy's Critical Role in Clinical Trial Compliance · 15 min.Send us Fan Mail Think clinical trial compliance is just a part-time job or a paperwork exercise that can be passed off to a medical assistant? Think again. In this episode of…
- The Wild Lizard Venom Origins of Ozempic · 5 min.Send us Fan Mail How a "Failed" 4-Minute Molecule Created a Trillion-Dollar Cultural Eclipse Imagine pitching a drug to a room of venture capitalists that is biologically…
- Unlicensed Medical Advice & The Legal Battle Over Character.AI · 15 min.Send us Fan Mail What happens when an artificial intelligence chatbot generates a fake medical license number and starts giving psychiatric advice? In this episode of the KF Deep…
- Sponsoring Cannabis Research · 5 min.Send us Fan Mail NOT LEGAL ADVICE For decades, cannabis research in the U.S. was stifled by Schedule I restrictions, requiring high-security vaults, mountains of paperwork, and…
- The New Era of Personal Consent Decrees · 8 min.Send us Fan Mail Is your career protected from your company’s mistakes? For decades, a Federal Consent Decree was a corporate headache. Today, it’s a personal professional death…
- Why Private Membership Associations Fail FDA Scrutiny · 7 min.Send us Fan Mail In this episode of the KLF Deep Dive, Darshan Kulkarni deconstructs a persistent and dangerous myth circulating in life sciences and investment circles: the…
- The Hidden Reason Sites are Firing Recruiters · 8 min.Send us Fan Mail What would happen if your clinical trial sites were suddenly banned from using you? In this episode, Darshan Kulkarni uncovers a hidden regulatory shift: state…
- Don’t Let Your PI Walk Away With Your Study · 1 min.Send us Fan Mail In this tactical masterclass, Darshan Kulkarni breaks down the critical legal architecture required to protect clinical trial sites during rapid expansion. As…
- Safe or Just "Not Dirty"? The Regulatory Gamble of Compounded Drugs · 2 min.Send us Fan Mail In this episode, Darshan Kulkarni breaks down the staggering legal difference between the branded drugs you know (like Mounjaro) and the compounded versions…
- "Basically Employees" Isn't a Legal Category (And the OIG Knows It) · 4 min.Send us Fan Mail Stop playing compliance theater. In this episode, Darshan Kulkarni pulls back the curtain on a dangerous trend in the life sciences: the over-reliance on…
- The Hidden Legal Risks of AI Sponsor Protocols · 1 min.Send us Fan Mail Is AI the savior of clinical research costs, or a ticking time bomb for data integrity? In this episode, Darshan Kulkarni dives into the murky waters of…
- The $100M Mistake: Why AI-Generated Drugs May Not Be Patentable · 3 min.Send us Fan Mail "The model said so" is not a defense. In the rush to integrate AI into drug discovery, life science companies are sprinting toward a compliance cliff. In this…
- Is AI replacing your Doctor? · 13 min.Send us Fan Mail In this episode of DarshanTalks, host and attorney-pharmacist Darshan Kulkarni explores the unsettling transition from "Googling your symptoms" to "Chatting with…
- Why the OIG Just Revolutionized Pharma Marketing (And What It Costs You) · 1 min.Send us Fan Mail On January 27, 2026, the HHS Office of Inspector General (OIG) changed the game for pharmaceutical manufacturers. In a landmark Special Advisory Bulletin, the…
- 6 Categories of "Bulk Data" That Could Land You in Federal Court. · 1 min.Send us Fan Mail The DOJ just changed the rules of the game for the Life Sciences industry. As of January 2025, transferring "Bulk Sensitive Personal Data" to countries of…
- The Utah Experiment: The Dangerous New Frontier of AI Prescribing · 2 min.Send us Fan Mail Is your state "sandbox" a playground or a legal minefield? In this episode, Darshan Kulkarni—pharmacist and attorney—dissects the quiet movement of states like…
- Is Your DTC Program a Kickback Trap? · 3 min.Send us Fan Mail The OIG has officially shifted the goalposts for Direct-to-Consumer (DTC) and Direct-to-Patient (DTP) programs. For years, federal healthcare discounts were a…
- The Hidden Death Sentence for Trial Sites · 1 min.Send us Fan Mail In this episode of KLF Deep Dive, Darshan Kulkarni uncovers the catastrophic risks clinical trial sites face when they fail to vet their staff against federal…
- FDA "Screams": The Real Reason Your Snack Is At Risk · 10 min.Send us Fan Mail Undeclared allergens remain the #1 cause of food recalls in the U.S., yet many brands still treat labeling as a "marketing" task rather than a "legal" one. In…
- 2 Laws More Dangerous Than HIPAA for Patient Engagement · 3 min.Send us Fan Mail Think HIPAA is your biggest hurdle in pharma marketing? Think again. In this episode of KLF Deep Dive, Darshan Kulkarni reveals why focusing solely on HIPAA…
- "Invite-Only" Compliance Is Over: Is Your Cosmetic Company Ready? · 3 min.Send us Fan Mail The "handshake" era of cosmetic compliance is officially over. Under new authorities in Sections 605, 610, and 704, the FDA has moved from simple observation to…
- Audit-Proof Your Site: The Training Gap Killing Your Contracts · 1 min.Send us Fan Mail In clinical research, if it isn't documented, it never happened. Many site owners mistake a competent team for a compliant one—a mistake that leads to disastrous…
- 15 Years in Prison for Marketing Fraud · 3 min.Send us Fan Mail Is your marketing team building a brand or a federal case? In this episode, we deconstruct the $1.2 billion collapse of Boom Care. What looked like a runaway…
- Is your "Clinical Decision Support" tool actually an unregulated medical device? · 4 min.Send us Fan Mail In January 2026, the FDA sharpened the line between helpful software and regulated medical devices. If your AI sits inside an EHR, providing "black box"…
- The FDA’s New Political Enforcement Strategy · 5 min.Send us Fan Mail In this episode, Darshan Kulkarni exposes a massive legal shift that is quietly dismantling the "Practice of Medicine" defense. We track the whiplash from the…
- Why Your "Physician-Only" Ads Aren't Safe from Regulators · 23 min.Send us Fan Mail In this episode of the KLF Deep Dive, Darshan Kulkarni sits down with Phyllis Marcus, Vice President of the National Advertising Division (NAD) and former FTC…
- The Messy Reality of AI Prescriptions · 2 min.Send us Fan Mail State governments are racing to innovate by allowing AI to renew and improve prescriptions—but are they walking into a federal trap? In this episode of KLF Deep…
- Why Your Consultant’s Report Is a Legal Liability · 2 min.Send us Fan Mail In the high-stakes world of Life Science M&A, hiring expert consultants for GXP, IT, and data privacy is standard operating procedure. But there is a hidden…
- Stop Reporting Results? The NIH’s "Get Out of Jail Free" Card · 6 min.Send us Fan Mail The NIH just dropped a regulatory bombshell: Notice NOT-OD-26-032. Effectively immediately, Basic Experimental Studies in Humans (BESH) are no longer classified…
- Final LGBTQ Individuals in clinical research · 2 min.Send us Fan Mail Support the show www.kulkarnilawfirm.com
- When the FDA Plays Politics · 3 min.Send us Fan Mail In this episode of KLF Deep Dive, we examine a chilling shift in regulatory enforcement: the weaponization of "Intended Use." If the science hasn't changed and…
- Your Site’s Background Check is Illegally Incomplete - Here is why · 1 min.Send us Fan Mail In this episode, Darshan Kulkarni dives into the terrifying reality of compliance failures at clinical trial sites. While most directors worry about standard…
- Is Your Off-Label Use Now a Federal Crime? · 6 min.Send us Fan Mail For decades, a "clean mental line" existed: Doctors prescribe, and companies don't promote off-label. That line just got a lot messier. In this episode, Darshan…
- 10,000 Specialists: A Futurist’s Vision for AI Healthcare · 14 min.Send us Fan Mail In this episode, we sit down with world-renowned futurist Bruce McCabe to cut through the hype of large language models like ChatGPT and explore the "stunningly…
- The Battle Over Weight Loss and Compounded Drugs · 15 min.Send us Fan Mail In this episode of DarshanTalks, host and attorney-pharmacist Darshan Kulkarni deconstructs the legal "scorched-earth" offensive currently reshaping the weight…
- Why Cosmetic Ingredient Names Matter and What MOCRA Really Means - Interview with Heather Bustos · 18 min.Send us Fan Mail In this episode, I sit down with FDA compliance attorney Heather Butos to unpack two topics most cosmetic pros ignore until it’s too late: INCI (ingredient)…
- Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk · 26 min. · Sæson 1 Episode 2Send us Fan Mail Life sciences M&A is picking up again, but today’s deals look nothing like they did two years ago. In this episode, Darshan Kulkarni sits down with Stephanie…
- Cosmetic ingredients the FDA doesn’t want you to use · 2 min.Send us Fan Mail A brief discussion on the various cosmetic ingredients used by cosmetic manufacturers and the concerns FDA has recently found as a result of their own study into…
- Why Federal Agencies Are Targeting Executives · 8 min.Send us Fan Mail Federal enforcement is changing. Regulators aren’t just going after companies anymore. They’re naming CEOs, CMOs, heads of clinical, quality, and operations in…
