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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

5:42

Diversity Matters in Clinical Trials

DarshanTalks Podcast ·

2025/03/18

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 locations to promote diversity—not just in ethnicity, but also in socioeconomic and regional representation. He highlights the importance of gathering data from various populations to improve the effectiveness and inclusivity of clinical trials. They delve i...

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2:44

EMA’s LLM Guidelines Impact Life Sciences

DarshanTalks Podcast ·

2025/03/16

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 ethical considerations, tackling issues like data privacy, misinformation, and bias. LLMs, such as ChatGPT, hold promise for automating workflows like medical translations, pharmacovigilance reporting, and coding support. However, the EMA stresses continu...

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17:08

How to Network Like a Pro at Conferences

DarshanTalks Podcast ·

2025/03/12

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 asked Brook to come on and share her insights. They start by discussing whether conferences are truly valuable—considering the costs, time investment, and potential for networking. While online learning can be beneficial, conferences offer unique opportun...

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10:35

Getting Ready for SOS 2025: FDA 483s, SOPs, and Site...

DarshanTalks Podcast ·

2025/03/10

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 peers in person, including names like Dan Sfera, Brad Hightower, and others who have been instrumental voices in the clinical research space. Darshan shares that Kulkarni Law Firm (KLF) will be participating and is excited to engage with attendees, talk a...

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2:13

Maximizing Site Value

DarshanTalks Podcast ·

2025/03/07

When selling a clinical trial site, many owners focus solely on the amount they’ll receive, but the real key is understanding the multiplier that determines your valuation. In M&A transactions, hitting the right EBITDA threshold—such as $3M, $10M, or $25M—can significantly increase your multiplier, turning a 6X valuation into 10X or more. While some claim multipliers as high as 26X, the reality is more complex. Beyond valuation, choosing the right private equity partner is just as critica...

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3:33

5 Key Areas to Review in Clinical Trial Agreements

DarshanTalks Podcast ·

2025/03/05

Contract issues are more common than you think. Edye Edens shares the five critical areas you should always review before signing: Basic Details & Formatting – Ensure names, dates, and references are correct, pages are in order, and there are no typos or inconsistencies from previous templates.Appendices & Exhibits – Verify that referenced documents, such as addendums, exhibits, and budgets, are included and properly linked to the contract.Budget & Payment Terms – Clarify payment ...

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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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264 results

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