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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

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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3:47

Ordinary People Are Changing Medicine

DarshanTalks Podcast ·

2025/02/03

Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medicine falls short. Driven by necessity, love, and a desire for survival, many have solved complex medical problems themselves, leading to groundbreaking discoveries. This trend raises important questions about safety, ethics, and the future of healthcare, with both promise and complexity. One of the most well-known examples is Lorenzo’s Oil, where ...

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2:29

Trump’s First 10 Days: The Impact on Clinical Trials

DarshanTalks Podcast ·

2025/01/31

Edye Edens discusses how the first nine to ten days under the new administration have brought notable shifts for both healthcare and clinical research, particularly in regulatory compliance and funding. While remaining politically neutral, the focus is on understanding how these changes impact clinical trials and research oversight. A key update is that the federal communication freeze across health agencies is expected to ease by February 1, which should provide more clarity on the administr...

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0:58

Selling a Business with Issues

DarshanTalks Podcast ·

2025/01/31

When selling a company, certain issues may arise that could concern potential buyers. Here's a breakdown of how to approach them:Price Adjustments: Some issues can be acknowledged, and the buyer may adjust the price accordingly, allowing the sale to proceed with minimal adjustments.Successor Liability: Issues like DOJ concerns or successor liability might require more attention, especially in asset-based transactions.Risk-Based Analysis: For less critical matters, such as design defects, you ...

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11:44

Breaking Down GCP E6(R3)

DarshanTalks Podcast ·

2025/01/28

Darshan Kulkarni and Edye Edens discuss the latest update to Good Clinical Practice (GCP) guidelines, E6 R3, was explored. GCP, developed by the International Council for Harmonisation (ICH), provides globally accepted ethical and operational standards for conducting clinical trials. The 2025 update represents a significant revision since its last update in 2016, emphasizing technology, data integrity, and structural changes to accommodate rapid innovation in clinical research.Key Highlights ...

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5:54

AdvaMed 7 rules for Essential AI Innovation

DarshanTalks Podcast ·

2025/01/25

Artificial intelligence (AI) is rapidly reshaping healthcare, with over 950 FDA-authorized AI devices transforming diagnosis, treatment, and administrative workflows. AdvaMed's new position paper emphasizes seven foundational principles to guide AI in medical technology development and regulation.Key Highlights:A Robust Regulatory Framework: AdvaMed urges alignment with international standards for AI-driven innovations while maintaining patient safety.Privacy and Data Transparency: Transparen...

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1:21

Teva’s Case Should Shape Your Pharma Strategy

DarshanTalks Podcast ·

2025/01/22

Teva Pharmaceutical's $450 million settlement highlights the challenges of compliance in the pharmaceutical industry. The Department of Justice accused Teva of violating the anti-kickback statute and the False Claims Act by using co-payment assistance programs to steer Medicare payments for its drug Copaxone while raising prices. Additionally, Teva admitted to price-fixing schemes for generic drugs like pravastatin. This case serves as a stark reminder that compliance isn't just about avoidin...

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8:10

🔒 AI’s Impact on Healthcare: Liability, Ethics, and...

DarshanTalks Podcast ·

2025/01/21

Subscriber-only episodeToday, we explore a pressing issue in the healthcare landscape: the liability associated with artificial intelligence (AI). As AI technologies transform healthcare—from diagnostic tools to treatment recommendations—it's crucial to understand the legal and ethical implications surrounding their use, particularly regarding accountability.AI systems can analyze vast amounts of data, providing insights that aid in diagnosing diseases and personalizing treatment plans. Howev...

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4:56

Four Types of Research related Grant Fraud

DarshanTalks Podcast ·

2025/01/18

Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals.1. Foreign Influence and Funding:Failing to disclose foreign government support, as seen in Ohio State University's $875,000 settlement (November 2022).Similar allegations against U Ming Qing Xiao in the Southern District of Illinois (April 2022).2. Misrepresenting Data for Funding:Using falsified or fabricated data to secure grants undermines the integrity of funding decisions.The...

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0:53

Defining Scope in Due Diligence Transactions

DarshanTalks Podcast ·

2025/01/17

When conducting due diligence for a life sciences company, it's essential to align the scope with the transaction's objectives. Key considerations include:Transaction Purpose: Determine if the goal is asset divestiture, strategic acquisition, or another objective.Regulatory Compliance: Assess adherence to industry regulations, including FDA guidelines and privacy laws.Operational Areas: Evaluate critical functions such as sales, marketing, and manufacturing processes.Risk Assessment: Identify...

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7:33

Clinical Trial Checklist

DarshanTalks Podcast ·

2025/01/16

Darshan Kulkarni and Edye Edens discuss the essential steps for launching a clinical trial site, emphasizing the importance of navigating both state-specific regulations and the logistics involved. They begin by highlighting the critical role of informed consent and legal authority, which vary across states. In particular, states like Texas and California have stringent regulations that can impact how clinical research organizations are structured, especially regarding ownership and the corpo...

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11:28

Presidential Changes and Impact on Drug Related...

DarshanTalks Podcast ·

2025/01/14

Misinformation around vaccines and treatments isn’t new, but with figures like Robert F. Kennedy Jr. in the spotlight, how should regulatory agencies respond?There will be potential changes coming to the FDA and public health regulations with the new administration. Historical transitions, such as the one from the Obama administration to the Trump administration, will shape policy going forward, particularly in terms of regulatory priorities. The government will need to combat misinforma...

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4:10

Prep for Selling Your Company!

DarshanTalks Podcast ·

2025/01/12

When preparing to sell your pharmaceutical company, particularly with a Phase 1 product, it’s essential to assess potential buyers and ensure readiness. Darshan’s Insights: When preparing to sell your pharmaceutical company, it’s crucial to evaluate potential buyers and readiness. Key factors include:1. Compliance Programs:Ensure adherence to OIG rules and updated compliance elements.DOJ expectations require established compliance programs, privacy policies, and Sunshine Act adheren...

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6:00

Top Tips for Starting a Clinical Trial Site

DarshanTalks Podcast ·

2025/01/10

Launching a clinical trial site is an exciting opportunity, but it comes with important legal, regulatory, and operational challenges.Darshan Kulkarni Says: Starting a clinical trial site is an exciting step, but it requires careful planning to address key legal and regulatory considerations. Privacy compliance is a major factor—going beyond HIPAA to account for email and text marketing laws, state-specific business registrations, and corporate structures like MSOs to manage ownership ru...

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4:27

When Drug Reps Visit: Darshan Reacts

DarshanTalks Podcast ·

2025/01/09

Darshan reacts to a fake interaction between a drug sales representative and a doctor. He shares insights on pharmaceutical marketing tactics, highlighting that while doctors often find sales reps personable, they may not trust them as much as medical science liaisons (MSLs) due to limitations on what reps can legally discuss about drugs. Darshan explains industry regulations, such as the Pharma Code and the Sunshine Act, which restrict certain gifts to avoid conflicts of interest. He also cr...

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264 results

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