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DarshanTalks Podcast
Darshan Kulkarni
288 episodes
1 day ago
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 ...
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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 ...
Show more...
Life Sciences
Education,
Society & Culture,
How To,
Science,
Documentary
Episodes (20/288)
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 ...
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1 day 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...
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3 days 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...
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4 days 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...
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1 week 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...
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1 week 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
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2 weeks 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...
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2 weeks 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...
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2 weeks 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...
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3 weeks 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...
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3 weeks 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
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3 weeks 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...
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4 weeks 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...
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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...
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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...
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1 month ago
2 minutes

DarshanTalks Podcast
What do PBMs do?
In this episode, Darshan Kulkarni talks with Thomas Siepka about the 340B program, rebates, and the crucial role of pharmacy benefit managers (PBMs) in today’s healthcare system. Siepka, a pharmacist and CEO of HCI Healthcare Consultants, shared his extensive experience working across health systems, community health centers, and tribal healthcare organizations. They break down the complex healthcare landscape, explaining the distinction between health insurance companies and PBMs. PBMs speci...
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1 month ago
12 minutes

DarshanTalks Podcast
How AMCs Build Stronger Compliance Cultures Together
In the episode of a new series on academic medical centers, Edye Edens of Kulkarni Law Firm sits down with Cortni Romaine of Florida Atlantic University (FAU) to explore how compliance offices in academia create programs that others aspire to emulate. Cortni explains FAU’s proactive approach to compliance, emphasizing the importance of partnerships both within the university and across the state. At FAU, new federal, state, or institutional requirements are reviewed collaboratively by c...
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1 month ago
10 minutes

DarshanTalks Podcast
How One DME Scheme Cost Medicare $61 Million
In one of the largest recent Medicare fraud cases, Peter Roussonicolos, a Florida durable medical equipment (DME) company owner, was sentenced to 12 years in federal prison for orchestrating a scheme that defrauded Medicare of more than $61 million. Here’s how the scheme worked: Hidden Ownership: Roussonicolos used straw owners to disguise his true role in several DME companies, evading disclosure requirements and regulatory oversight. Illegal Kickbacks: He arranged payments to marketers and...
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1 month ago
4 minutes

DarshanTalks Podcast
FDA to Step Up Enforcement on Pharma Advertising
The FDA has recently stepped up its enforcement of pharmaceutical advertising rules, issuing 100 cease-and-desist notices and thousands of letters. These notices were largely non-personalized and intended as general guidance, emphasizing that drug advertisements must not create misleading impressions. While such enforcement has always been possible, this renewed effort signals increased regulatory attention, particularly on direct-to-consumer marketing. Historically, FDA enforcement letters h...
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1 month ago
3 minutes

DarshanTalks Podcast
Top 5 Factors Determining AMC Funding
Darshan Kulkarni and Edye Edens launch an exciting new episode, focusing on the unique challenges academic medical centers (AMCs) face in securing funding in an ever-changing political and regulatory environment. Unlike independent or commercial sites, AMCs operate at a different scale, often managing millions of dollars in government-funded research while navigating complex administrative structures, compliance layers, and internal politics. Edye, drawing from her 10 years inside a major AMC...
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1 month ago
8 minutes

DarshanTalks Podcast
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 ...