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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

2:32

Clinical Trial Principal Investigator Duties in...

DarshanTalks Podcast ·

2024/11/26

The FDA has stressed the critical importance of adequate supervision and monitoring in clinical trials to ensure they are conducted properly. A key figure responsible for this oversight is the Principal Investigator (PI), as outlined in 21 CFR 32.6. The PI must ensure the trial follows the protocol and all applicable regulations, and that the rights, safety, and welfare of the trial participants are protected, including obtaining informed consent.Consistently, the FDA has raised concerns abou...

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6:38

Supreme Court Redefined Pharma Marketing Rules

DarshanTalks Podcast ·

2024/11/23

The Supreme Court's ruling in Loper Bright Enterprises v. Raimondo significantly impacts off-label marketing for pharmaceutical and medical device companies by challenging the FDA's authority to restrict off-label speech. This decision is poised to reshape the regulatory landscape that has traditionally limited such communications.Key Legal Context:- Historically, the FDA has prohibited off-label promotion based on misbranding statutes, which require drug and device labeling to specify only F...

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6:16

AI concerns in M&A for Life Sciences

DarshanTalks Podcast ·

2024/11/20

Artificial intelligence (AI) is transforming the life sciences sector, offering groundbreaking advancements in areas like drug discovery, clinical trials, and personalized patient care. As AI-driven technologies become more integrated into these processes, the allure of acquiring AI-powered companies grows stronger. However, the complexities that come with AI introduce significant risks, especially when it comes to mergers and acquisitions (M&A). Life sciences attorneys must move beyond j...

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2:59

🔒 Trump Teams Potential Changes to Healthcare

DarshanTalks Podcast ·

2024/11/19

Subscriber-only episodeHealthcare and life sciences are on the brink of transformative change, fueled by a combination of technological innovation, ideological shifts, and evolving regulations. Visionaries like Elon Musk, Vivek Ramaswamy, and RFK Jr. are advocating for decentralization in healthcare, pushing for more personal control over patient data. While decentralization promises to reduce federal oversight, potentially lowering compliance costs and streamlining operations, it also raises...

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5:36

🔒 Can AI Rewrite the Rules of Clinical Trials?

DarshanTalks Podcast ·

2024/11/18

Subscriber-only episodeIn this episode, we're diving into the intersection of technology and healthcare, specifically the role of Artificial Intelligence (AI) in clinical trials. As a Food and Drug lawyer, Darshan has seen firsthand how AI is revolutionizing drug development and testing. The FDA is closely monitoring this shift, recognizing the potential of AI to enhance patient outcomes, improve trial efficiency, and reduce costs.However, it’s not all smooth sailing. AI can help identify the...

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14:52

Ad Promo Review in Pharma - How Far is Too Far?

DarshanTalks Podcast ·

2024/11/16

Katie Graham and I discuss various aspects of FDA and FTC regulations, including ad promo, the Chevron decision, and the evolving role of compliance in the pharmaceutical industry.Key topics include:What is Ad Promo?Chevron decision's influence on FDA/FTCShould administrative agencies cite letters? Can the FDA establish rules after someone challenges them?Uncertainty of Compliance White SpaceIs regulatory medical advice now just seen as a risk?Support the show

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1:51

Why Staff Training Problems are a liability for Your...

DarshanTalks Podcast ·

2024/11/14

Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staff, recent cases reveal significant lapses. PIs are responsible for certifying that all associates, colleagues, and employees involved in the research are adequately trained and informed. However, instances have emerged where this responsibility was neglected.In one notable case, PIs were prosecuted due to inadequate training and oversight of res...

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0:55

Neuralink: Breakthrough or Marketing Hype?

DarshanTalks Podcast ·

2024/11/12

Neuralink recently received the FDA's Breakthrough Device label for its neural implant aimed at restoring vision to the blind by interfacing with the brain. While this sounds like a monumental achievement, it's important to understand that the Breakthrough Device program merely expedites the review process for promising innovations without guaranteeing approval or effectiveness. Essentially, this label serves more as a marketing badge than a concrete breakthrough at this stage. While there's ...

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4:52

Telehealth Compliance Crisis: DOJ exposes $2.75B Fraud!

DarshanTalks Podcast ·

2024/11/09

DOJ filed criminal charges against 193 defendants, including 76 medical professionals for telemedicine violation. This alarming crackdown reveals the vulnerabilities within telemedicine, as illegal kickbacks and brief consultations have led to significant fraud, particularly in Medicare claims.Among the troubling cases highlighted, one psychiatrist was accused of billing for telehealth visits lasting only 10 to 30 seconds, falsely classified as legitimate patient consultations. The DOJ’s focu...

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10:43

Should You Go In-House or Outsource Your Advertising...

DarshanTalks Podcast ·

2024/11/06

In this episode, Heather McFalls discusses the pros and cons of in-house versus outsourced advertising compliance roles, along with tips for new regulatory professionals to embed themselves and add value. They also explore how the shift from FDA to FTC oversight may impact Ad Promo training and mentorship.We discuss,1. Role as a Director of Advertising & Promotion. 2. Is this job typically done in-house, or is it often outsourced? 3. What a...

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2:31

Research fraud tainting pharma per Nature Article

DarshanTalks Podcast ·

2024/11/04

Nature and Vox highlight the severe consequences of research fraud and its widespread impact on sectors like marketing, clinical research, medical affairs, regulatory compliance, and legal practices. Fraud can manifest in various ways, such as fabricating data or manipulating results, and its effects are far-reaching.The Nature article stresses that fraudulent research erodes public trust in science and endangers patient safety, especially in the pharmaceutical and medical device industries, ...

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7:25

Influencers are NOT KOLs. Know your Needs!

DarshanTalks Podcast ·

2024/10/31

Influencers are NOT KOLs. We discuss using key opinion leaders (KOLs) and influencers in pharmaceutical and medical device marketing. Key Takeaways:- Influencers vs. KOLs: Influencers have large social media followings and can engage younger demographics, while KOLs are respected experts whose endorsements are based on scientific evidence.- Benefits and Risks: Influencers can create relatable content but risk non-compliance, while KOLs offer credibility but may deliver more conservative ...

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9:43

🔒 AI and Clinical Trials: Faster Results, Bigger Risks?

DarshanTalks Podcast ·

2024/10/28

Subscriber-only episodeIn this episode, we’re diving into a crucial topic: the role of artificial intelligence in clinical research and the evolving landscape of data privacy laws that will impact every step of the process.In this episode, we’ll be unpacking insights from Dr. ElZarrad, the FDA’s Deputy Director for the Office of Medical Policy, on how AI is shaping clinical trial design and research. We’ll also explore how AI can speed up trials, enhance patient recruitment, and even predict ...

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2:01

Eli Lilly’s Unexpected Shift on Use of Mounjaro!

DarshanTalks Podcast ·

2024/10/25

Eli Lilly's changed its opinion on Off-Label uses! Eli Lilly, a company that makes a diabetes drug, is now urging people not to use it for weight loss, a common off-label use, despite not raising concerns about off-label uses in the past. Off-label use, where a drug is used for something other than its original purpose, is a normal part of healthcare, and the FDA acknowledges this practice. However, Lilly's sudden stance seems driven by a shortage of the drug, which they want to prioritize fo...

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10:53

Are CROs Losing Relevance in the Age of DCTs?

DarshanTalks Podcast ·

2024/10/23

In this episode, Isaac Rodriguez- Chavez and I discuss the impact of DCTs on sponsor relationships, CROs, and industry dynamics with the FDA. We discuss,1. How will DCTs impact sponsor relationships with CROs? 2. How do small CROs and sponsors adapt to emerging trends? 3. How do new trends impact industry relationships with the FDA?4. Does DCT allows the FDA to advise sponsors? 5. What is the role of technology in DCTs? 6. How do DCTs reduce the cost of bringing drugs...

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5:52

Managing Risks in Life Science Mergers and...

DarshanTalks Podcast ·

2024/10/19

In this episode, we discuss the importance of integrating insurance considerations into the due diligence process during M&A transactions with Kenneth White.Support the show

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3:16

Can a Pharmacist Override Your Doctor's Prescription?

DarshanTalks Podcast ·

2024/10/17

We'll briefly discuss when a pharmacist might choose not to dispense medication, even with a valid doctor's order.In a recent case, a doctor sued the Iowa Board of Pharmacy and the Iowa Board of Medicine when a pharmacy refused to fill a prescription for Ivermectin, a livestock drug sometimes used to treat parasites in people and allegedly COVID-19. This incident highlights a dilemma in the pharmacy world, especially post-pandemic. While pharmacists ensure the safety and appropriateness of me...

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3:33

FDA Concerns About AI’s impact on Good Clinical...

DarshanTalks Podcast ·

2024/10/15

Today we're delving into the evolving role of artificial intelligence (AI) in drug development and clinical trial design. We’ll explore the key concerns raised by the FDA and insights from Dr. ElZarrad on integrating AI into clinical research.AI has the potential to transform clinical trials by enhancing efficiency, accuracy, and outcomes. However, several challenges must be addressed to ensure its effective and ethical use. The FDA has highlighted six primary concerns:Bias: Variability in da...

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2:42

Patient Advocates Could Cost You Millions

DarshanTalks Podcast ·

2024/10/11

Patient Advocates play a crucial role in the pharmaceutical industry, especially in clinical research. They serve as the voice of patients, ensuring their needs and concerns are addressed throughout the drug development process. Here's a simple breakdown of their contributions and when their involvement might not be ideal.Why Are Patient Advocates Important?1. Improving Clinical Trial Design: Patient Advocates provide valuable insights into patient experiences and needs. Their feedback helps ...

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5:55

Managing Risks in Life Sciences Mergers and Acquisitions

DarshanTalks Podcast ·

2024/10/08

In this episode, we discuss key risks a life sciences company should consider during an acquisition with Kenneth White. We also explore the role of insurers in managing these risks. Support the show

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