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PODCAST

DarshanTalks Podcast

Darshan Kulkarni

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

science life sciences

All Episodes

7:43

Discussing Stem Cell Research Opportunities with a...

DarshanTalks Podcast ·

2025/03/03

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, particularly in stem cell studies, in light of the regulatory shifts happening under the Trump administration. Mohamed highlighted the increasing number of clinical trials and the expansion of pharmaceutical research into Europe, creating new opportunitie...

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6:23

Quality Management: A Must in Clinical Trial Contracts

DarshanTalks Podcast ·

2025/03/01

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, they frequently lack clear quality management plans. Helen emphasizes the importance of defining responsibilities, risk levels, and monitoring expectations upfront to avoid confusion and compliance issues later. Key takeaways: Contracts should outline qual...

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5:29

AI-Powered Chatbots in Pharma Sales and Education

DarshanTalks Podcast ·

2025/02/27

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 messaging, 24/7 availability, and efficiency, it also brings significant risks—especially in the heavily regulated pharmaceutical and medical device sectors. The episode explores key challenges, starting with privacy and security concerns. AI-enabled system...

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1:21

Will New Tariffs Disrupt Your Next Pharma Deal?

DarshanTalks Podcast ·

2025/02/26

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 China, companies may face increased costs not only in sourcing but also in sales, as Canada considers imposing its own tariffs. This could disrupt global supply chains, making due diligence even more critical for buyers evaluating international pharmaceutica...

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5:10

Protecting Patient Data in a Changing Regulatory...

DarshanTalks Podcast ·

2025/02/25

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 oncology research, emphasizes the need for clinical trial sites—especially those at major academic medical centers—to understand whether their privacy regulations fall under state or federal jurisdiction. They explore hypothetical scenarios where federal ...

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31:17

Off-Label Promotion Changes in 2025

DarshanTalks Podcast ·

2025/02/24

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 FDA, CMS, and HHS (with RFK confirmed). There is concern over shifting prosecutorial priorities, overturned FDA diversity initiatives, and potential scrutiny of diversity efforts in private companies. A major focus is the changing environment of off-label...

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16:23

Turning Physicians into Leaders

DarshanTalks Podcast ·

2025/02/21

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 and encourages young physician leaders to first focus on becoming competent clinicians. He advises earning medical degrees, completing training, and gaining clinical experience for 5 to 10 years before transitioning into leadership. Lee also discusses the ...

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1:18

Key Regulatory Agencies in Pharma M&A

DarshanTalks Podcast ·

2025/02/20

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 the need for strong compliance programs. Beyond FDA regulations, companies must consider fraud prevention, HIPAA, and evolving privacy laws at both federal and state levels. Ignoring these factors can lead to serious legal and financial consequences. Stay ...

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1:37

Does E6 (R3) Blur the Line Between GCP and Privacy Laws?

DarshanTalks Podcast ·

2025/02/19

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, and privacy responsibilities, some wonder if it overlaps with regulatory frameworks like HIPAA, especially as OCR proposes significant updates to the Security Rule. However, Edens notes that while R3 contains more references to privacy, it does not expli...

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8:01

RFK Jr. Confirmed as HHS Secretary: What It Means for...

DarshanTalks Podcast ·

2025/02/18

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 assessment, addressing issues like obesity, diabetes, and pediatric disorders, and aims to reshape the country’s approach to preventive care. While the focus on public health challenges is timely, the broad and vague nature of the directive raises questions about ...

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7:44

America’s Research Future in Jeopardy

DarshanTalks Podcast ·

2025/02/15

Darshan Kulkarni and Edye Edens break down the significant impact of the Trump administration’s decision to cut NIH funding and reduce agency workforces, including the FDA, OHRP, and other key regulatory bodies. They discuss how these cuts could lead to serious disruptions in research funding, approval timelines, and the overall pace of medical innovation in the U.S. While some argue that such reductions could improve efficiency and reduce waste, others fear the immediate and long-term conseq...

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7:48

Trump Administration’s NIH cuts: Will they cripple US...

DarshanTalks Podcast ·

2025/02/14

Darshan Kulkarni and Edye Edens discuss the recent controversy surrounding the Trump administration’s decision to cap NIH overhead funding (also known as indirect costs or F&A) at 15%. This sweeping change has already sparked significant backlash, with academic medical centers, particularly in Democratic states, filing lawsuits to challenge the policy. The cap threatens to disrupt funding structures that support essential research, potentially undermining the United States’ role as a glob...

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7:47

DEI Under Trump: What It Means for Clinical Trials

DarshanTalks Podcast ·

2025/02/13

The Trump administration’s early actions have significantly impacted federally funded programs, particularly in the clinical trial space, by rolling back diversity, equity, and inclusion (DEI) initiatives. This shift raises serious concerns for scientific research, as diversity in clinical trials ensures that drugs and devices are effective across different populations. Historically, most approved treatments have been tested primarily on white males, creating gaps in data for other demographi...

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1:39

CAPA & RCA: A Must for Pharma M&A

DarshanTalks Podcast ·

2025/02/12

When acquiring a pharmaceutical company, evaluating its quality and compliance programs is crucial. A strong program starts with well-documented policies and procedures, followed by comprehensive training to ensure employees understand and follow them. However, having policies in place isn’t enough—regulatory bodies like the FDA and DOJ stress that enforcement and documentation are essential. If an issue isn’t written down, it effectively never happened. No regulator expects perfection, but t...

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1:21

Trump Targets Indirect Costs in NIH Funding

DarshanTalks Podcast ·

2025/02/11

On Friday, the Trump administration announced a 15% cap on NIH indirect costs, raising important questions about its impact on research funding. Edye Edens breaks down what this means, clarifying that while direct costs like salaries and equipment remain unchanged, the cap affects crucial behind-the-scenes expenses such as lab maintenance, IT infrastructure, cybersecurity, and compliance. Understanding these distinctions is key as institutions adapt—watch as Edye unpacks the details. Support ...

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2:29

The USAID Halt and Its Consequences for Clinical...

DarshanTalks Podcast ·

2025/02/10

The Trump administration’s actions have effectively halted USAID-funded clinical research worldwide, creating an unprecedented situation with significant ethical, legal, and medical implications. Clinical trials that relied on USAID funding have stopped, leaving ongoing research in limbo and raising serious concerns about what happens to trial participants and who bears responsibility for any resulting harm. Key Legal and Ethical Questions: 1. Who is the sponsor? If the U.S. government was ...

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2:29

Ebola Vaccine Trial in Record Time!

DarshanTalks Podcast ·

2025/02/08

On January 30, 2025, Uganda confirmed an outbreak of the Ebola Sudan virus, and in an unprecedented global first, a clinical trial to assess the efficacy of a vaccine against the virus was launched within just four days. This rapid response was made possible by proactive planning following a 2022 outbreak, during which the Ugandan Ministry of Health, Makerere University, and the Uganda Virus Research Institute implemented a strategy to fast-track future trial activations. By pre-selecting inv...

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0:50

Your Clinical Trial Site M&A Agreement is Exposing...

DarshanTalks Podcast ·

2025/02/07

When working on an M&A transaction involving a clinical trial site, it's crucial to thoroughly review vendor agreements. It's not just about what is included, but what is missing. For example, do you have the right quality and privacy agreements in place, or are you unknowingly exposing yourself to liability? If there’s a lack of necessary agreements, it’s important to assess whether it’s due to ignorance or an oversight that could lead to future legal risks. If you're unsure, reach out t...

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1:01

What Does ICH E6 R3 Say About Returning Data to...

DarshanTalks Podcast ·

2025/02/05

The most recent ICH E6(R3) final guidance introduces critical updates to Good Clinical Practice (GCP), particularly around informed consent and participant data access. The guidance emphasizes greater flexibility and the use of technology-driven innovations to enhance how patients understand what they are consenting to. A significant update appears in section 2.8 (Investigator Responsibilities), which now requires a clear plan for returning trial-related data to participants when appropriate....

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2:28

Navigating the Ongoing HHS Communication Freeze

DarshanTalks Podcast ·

2025/02/04

Now that we’ve passed February 1st, a key date for the potential easing of the freeze on all HHS communications, we find ourselves at February 3rd with no significant updates or changes. Despite expectations that restrictions might begin to lift, there has been no broad release of communications across federal agencies involved in clinical trials and regulatory oversight. While this does not provide definitive insight into the administration’s plans, it does confirm that, for now, the freeze ...

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298 results

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