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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

3:50

🔒 Opportunities AI provides in Clinical Research

DarshanTalks Podcast ·

2024/12/18

Subscriber-only episodeToday, we're discussing the FDA's use of artificial intelligence (AI) to transform clinical trials.AI is emerging as a cornerstone in clinical research, with the FDA recognizing its potential in several key areas. First, predictive modeling allows AI to optimize pharmacokinetic profiles, streamlining dosing regimens and enhancing trial efficiency. Additionally, AI can create counterfactual simulations, enabling researchers to predict outcomes without putting real patien...

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3:06

Telehealth and Biohacking: A Risky Combination

DarshanTalks Podcast ·

2024/12/16

The rise of biohacking has transitioned from a niche interest to a mainstream trend, particularly in the context of drugs like Ozempic and ketamine. While biohacking aims to enhance human performance and health, it raises significant questions about the risks and benefits, especially concerning telehealth services. Individuals are increasingly seeking prescriptions for medications traditionally used for specific medical conditions, such as diabetes, and utilizing them off-label for weight los...

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2:05

Is the FDA’s Response to AI Falling Behind?

DarshanTalks Podcast ·

2024/12/14

The FDA’s current approach to AI in healthcare highlights significant gaps in regulatory preparedness. Although the FDA has approved thousands of AI-enabled tools, it still lacks the resources, clear guidelines, and enforcement power necessary to address the rapid advancements and risks of AI effectively. The agency has issued frameworks and adopted some risk-based approaches, but these efforts fall short, leaving companies in limbo and patient safety at risk. AI in healthcare demands consist...

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17:54

Healthcare Is in Crisis: How do we fix it?

DarshanTalks Podcast ·

2024/12/13

In this episode, guest host Kate Woods and Darshan Kulkarni delve into current healthcare issues, including the unsettling news of the CEO of United Healthcare being shot. They discuss the broader implications of this event, questioning how it reflects the state of the healthcare system and whether CEOs in troubled companies are becoming targets. The conversation shifts to potential solutions for the healthcare crisis, considering options like Medicare for All and the inefficiencies in drug p...

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2:46

Will RFK Break Pharma?

DarshanTalks Podcast ·

2024/12/12

Robert F. Kennedy Jr. has announced plans for a presidential mandate to restore federal agencies, including the FDA, to the "gold standard" of scientific review. This bold proposal has significant implications for the life sciences industry, affecting drug advertisers, clinical researchers, and M&A attorneys.Key Takeaways by SectorFor Drug AdvertisersExpect stricter scrutiny on advertising claims, requiring robust, data-driven evidence.Collaborations between marketing, regulatory, and leg...

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1:58

Fake data in Clinical Trials

DarshanTalks Podcast ·

2024/12/10

Florida medical clinic owner and staff were charged with falsifying clinical trial data. According to the indictment, from September 2015 to March 2018, the defendants at AMB Research Center in Miami fabricated clinical trial data for profit. They knowingly enrolled subjects who did not meet eligibility criteria, falsified lab data and medical records, and falsely represented that subjects were taking the studied drug when they were not.Co-owners Montalvo and Garmendia, were charged, along wi...

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3:00

Darshan Fixes Big Pharma Misconceptions

DarshanTalks Podcast ·

2024/12/08

In this reaction video, Darshan responds to claims about the effectiveness of prescribed medications. While patients often expect their drugs to work, a statement suggesting that only 20% of people benefit from these medications is misleading. Darshan emphasizes that the FDA focuses on ensuring drugs are not harmful and assesses efficacy based on their effectiveness for a sufficient number of individuals, rather than a simplistic percentage. He discusses the growing field of personalized medi...

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6:50

🔒 How Trump’s Tariffs will Disrupt Clinical Trials...

DarshanTalks Podcast ·

2024/12/06

Subscriber-only episodeIn today's podcast, we dive into President Trump's proposed tariffs on Canada, Mexico, and China and what these moves could mean for the life sciences industry. Tariffs, essentially taxes on imported goods, are designed to protect domestic industries by making foreign goods more expensive. While the Trump administration believes tariffs will boost domestic manufacturing and reduce trade deficits, there are potential long-term disadvantages, particularly in clinical rese...

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3:22

Why China is Targeting Top Scientists!

DarshanTalks Podcast ·

2024/12/04

The Wall Street Journal recently reported that China is aggressively targeting tech talent with lucrative job offers, offering triple the pay for positions in the chip-making industry, sparking concerns in the West. This trend isn't unique to tech; similar tactics have been used in the life sciences. For instance, a Harvard law professor was charged in 2020 for funneling information to China, while in 2019, the Department of Justice settled with two researchers over undisclosed Chinese grants...

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4:52

🔒 Trump’s Bold Picks Shake Up Life Sciences

DarshanTalks Podcast ·

2024/12/02

Subscriber-only episodeThe Trump administration’s new appointees, including Elon Musk, Dr. Marty Makary, Dr. Jay Bhattacharya, and Robert F. Kennedy Jr., promise a significant shift for the life sciences industry. Each brings a disruptive approach to their respective agencies, signaling potential changes in clinical research, drug advertising, and regulatory oversight.Key highlights:Elon Musk will lead the Department of Government Efficiency, introducing innovation-focused reforms that could ...

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5:27

🔒 3 Regulatory Opportunities in Clinical Trials!

DarshanTalks Podcast ·

2024/11/30

Subscriber-only episodeWe explore the rapidly evolving role of artificial intelligence (AI) in clinical trial research design. He discusses how AI is reshaping the pharmaceutical landscape and highlights key areas identified by the FDA where AI is expected to make a significant impact.Darshan delves into the transformative power of digital health technologies, which enable real-time patient monitoring and enhance adherence to treatment protocols. These technologies not only improve patient sa...

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3:15

Don't Take Non-Prescription Ozempic or other Weight...

DarshanTalks Podcast ·

2024/11/28

We explore the emerging trend of patients bypassing traditional healthcare to obtain weight loss medications like Ozempic through unofficial channels and telehealth platforms. This underground movement raises serious ethical and legal concerns, as individuals manipulate systems to access these drugs without proper prescriptions, risking their health and undermining physicians' reputations.Recent reports from The Atlantic and ABC News highlight the rise of "OZIC hackers" and Eli Lilly's decisi...

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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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271 results

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