DarshanTalks Podcast

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DarshanTalks Podcast

Darshan Kulkarni

293 episodes

5 days ago

Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions. When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival. Darshan explains how regulators—...

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Society & Culture,

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Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions. When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival. Darshan explains how regulators—...

Show more...

Society & Culture,

Episodes (20/293)

DarshanTalks Podcast

Pharma merger killers

Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions. When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival. Darshan explains how regulators—...

5 days ago

6 minutes

DarshanTalks Podcast

Balance FDA Rules with FTC Advertising Requirements

Brands often struggle to balance FDA cosmetic rules with FTC advertising standards. The FDA oversees labeling and determines whether a product is a cosmetic, drug, or soap, while the FTC enforces truth in advertising across all marketing. Claims like “clinically proven” require solid scientific evidence, and overreaching claims can trigger scrutiny from both agencies. For growing brands—especially those investing in digital marketing—regulatory compliance is essential. Aligning marketing clai...

1 week ago

1 minute

DarshanTalks Podcast

Key Clauses in PI Contracts to Review

Many clinical trial site leaders overlook critical risks hidden in physician employment agreements. These contracts often contain clauses that can expose sites to financial, legal, and operational danger if not carefully reviewed. Key Risks to Watch Out For: Compensation Structures: Incentives tied to patient enrollment can raise anti-kickback and fraud concerns. Payments should reflect fair market value for time and expertise, not results. Data Ownership: If not explicit, investigators may ...

1 week ago

6 minutes

DarshanTalks Podcast

Compliance guru talks practical Insights on Speaker Programs

In this episode, host Darshan Kulkarni speaks with Joseph Keeney about speaker programs in the life sciences industry, exploring practical differences between small and large companies. They highlight that while fundamentals like compliance, pragmatism, and sound business principles apply across organizations, strong mitigating controls and adherence to legal and industry codes are critical. Joseph explains the importance of engaging with various business units to understand real plans, align...

1 week ago

13 minutes

DarshanTalks Podcast

Trends in Small Life Sciences Transactions

Darshan Kulkarni in conversation with Nella Bloom, for an in-depth discussion on the current state of small business transactions, private equity trends, and the challenges of advising clients in an unpredictable market. Nella, an experienced attorney specializing in mergers and acquisitions and fractional general counsel services, explains how today’s business climate feels increasingly unstable. Rapid regulatory changes, unpredictable government responses, and evolving funding structures ha...

2 weeks ago

12 minutes

DarshanTalks Podcast

Protect Your Site If a Sponsor Terminates Early

When sponsors terminate a clinical trial early, research sites may face financial losses for preparatory or ongoing work. To mitigate this risk, contracts should explicitly guarantee payment for all work performed up to the termination date, as well as reimbursement for non-cancellable expenses such as IRB fees, recruitment advertising, and staff training. Including a wind-down clause ensures compensation for necessary closeout activities—such as patient chart reviews, final visits, and data ...

2 weeks ago

DarshanTalks Podcast

Are Pharma Chatbots Putting You at Regulatory Risk?

Pharmaceutical chatbots are increasingly used to answer patient drug questions, but they carry significant regulatory and compliance risks. While the FDA has issued guidance on AI in drug development and medical devices, it does not yet provide a framework for patient-facing drug Q&A. That means chatbots that discuss side effects, dosing, or interactions exist in a gray zone, and any missteps could trigger FDA enforcement. The FTC enforces truth in advertising and consumer protection. Mis...

2 weeks ago

5 minutes

DarshanTalks Podcast

Are Your Cosmetic Company Records Ready for FDA Audits?

Companies must maintain thorough records to meet FDA inspection requirements, including safety substantiation files, labeling proofs, ingredient documentation, and adverse event logs. Adverse event logs must be retained for six years (three for small businesses), while registration and product listing records require annual updates. Organized, accessible, and up-to-date records are essential not only for compliance but also for growth, due diligence, and investor confidence. Compliance is a s...

2 weeks ago

1 minute

DarshanTalks Podcast

When Medical Affairs Becomes Commercial in Disguise

Darshan explores a critical question for life sciences companies: is your medical affairs team truly independent from commercial—or are you just pretending? In this episode of KLF Deep Dive, Darshan highlights why organizational charts alone are not enough to satisfy regulators. He explains that regulators focus on conduct, process, and intent, not PowerPoint slides. Using the 2013 GlaxoSmithKline settlement as a cautionary example, he demonstrates how blurred lines between medical and commer...

3 weeks ago

6 minutes

DarshanTalks Podcast

Serious Adverse Event Reporting Under MoCRA

Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serious incidents—such as hospitalizations, infections, disfigurement, or medically treated allergic reactions—within 15 business days. They must also maintain records of all adverse events for six years (or three years for small businesses). Practically, this requires setting up a system to capture and assess customer complaints, determine seriousne...

4 weeks ago

1 minute

DarshanTalks Podcast

Key SOPs for Clinical Trials

Darshan Kulkarni highlights that to stay compliant with the FDA, companies don’t need an exhaustive set of SOPs—just the essential ones. Inspectors primarily focus on SOPs covering informed consent, adverse event reporting, drug/device accountability, source documentation, PI oversight, protocol deviations, and record retention. He emphasizes keeping SOPs concise, practical, and enforceable, training staff consistently, and expanding them only as operational needs grow. Support the show

1 month ago

DarshanTalks Podcast

Payer Presentations Can Trigger Enforcement

The boundary between scientific exchange and marketing in payer presentations is increasingly blurred, creating significant compliance and enforcement risks. While payers demand real-world evidence, comparative studies, and economic models beyond FDA-approved labeling, manufacturers must ensure all shared information is truthful, non-misleading, properly contextualized, and backed by competent and reliable scientific evidence. Key pitfalls include: Cherry-picking data without balanced limitat...

1 month ago

6 minutes

DarshanTalks Podcast

Pharmacies v manufacturers

In this episode, Darshan Kulkarni speaks with Dae Lee about the growing conflict between pharmaceutical manufacturers and pharmacy benefit managers (PBMs) — and how it’s reshaping the U.S. drug supply chain. They unpack the recent dispute involving AstraZeneca, which alleges discrepancies between the number of branded claims submitted by pharmacies through PBMs and the rebates invoiced by those PBMs. The issue shines a spotlight on how PBMs control formulary access and drug distribution, ofte...

1 month ago

11 minutes

DarshanTalks Podcast

Is Clinical Research Ready for the new FDA?

The FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compliance letters. This raises the question: if similar scrutiny applied to clinical research, what would stand out first? Likely areas include proper informed consent, accurate recordkeeping, and potential upticks in physician enforcement. While this use of AI in research compliance hasn’t fully emerged yet, AI is already being applied in promotion...

1 month ago

DarshanTalks Podcast

Is your cosmetics company FDA-registered?

Cosmetics companies must now register both their facilities and products with the FDA under the new MoCRArequirements, a shift from the previous voluntary system. Each facility must register, and product listings — including categories, ingredients, and manufacturing sites — must be submitted and updated annually. Growing companies face challenges in tracking reformulations, rebrandings, or acquisitions, as missing updates can trigger FDA enforcement or product removal. To scale safely, compa...

1 month ago

1 minute

DarshanTalks Podcast

Will AI Replace Doctors in clinical research?

Darshan discusses the potential role of AI in medicine. He believes fears of AI replacing doctors for diagnosis are currently overblown, as trust in physicians remains crucial. However, he suggests AI could assist with preliminary research tasks, such as reviewing inclusion/exclusion criteria and conducting initial screening. Have you seen AI being used in this manner? Support the show

1 month ago

DarshanTalks Podcast

Risks in Direct-to-Patient Engagement

Direct-to-Patient (DTP) models are transforming how medications reach patients, moving beyond clinical research into commercial distribution. Originally developed to help rare disease trial participants avoid long travel to research sites, DTP has become a standard solution for improving patient access and convenience. Today, patients can receive small molecules, complex biologics, and even medical devices directly at home, making what was once exceptional now routine. Despite the benefits, D...

1 month ago

2 minutes

DarshanTalks Podcast

Inside 340B: Challenges, Controversies, and Opportunities

Darshan Kulkarni speaks with Thomas Siepka, CEO of HCI Healthcare Consultants, to take a deep dive into the often-misunderstood world of the 340B drug pricing program. Drawing on Siepka’s extensive experience as a pharmacist and healthcare leader, they explore how the 340B program was designed to support covered entities—such as disproportionate share hospitals and federally qualified health centers—by requiring manufacturers to provide steep discounts. These savings allow organizations servi...

1 month ago

14 minutes

DarshanTalks Podcast

IRBs in 2025: What’s Really Changing?

In this conversation, Edye Edens with Nyssa Towsley from UNLV, examine how today’s shifting funding landscape is reshaping IRB operations. Historically, IRBs were built around the assumption that most research would be government-funded. That assumption is being challenged, with changes in funding priorities and availability beginning to influence the volume and nature of submissions. At UNLV, for example, faculty research submissions show a slight dip in volume and a change in character. Wit...

1 month ago

5 minutes

DarshanTalks Podcast

3 Red Flags in Telemedicine Partnerships

In this video, Darshan discusses recent enforcement trends show three weak spots to watch: Encounter Quality – If prescribers are just checking boxes without real patient relationships, it’s not care—it’s exposure. Demand documented standards, ID proofing, intake, decision support, and supervision. Don’t take claims at face value—audit them. Cash Flow Logic – Murky subscription fees, misuse of facility fees, or volume-driven compensation are red flags. Require transparent fee schedules, fair...

1 month ago

2 minutes