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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

6:35

Marketing Due Diligence in Stem cell M&A Transactions

DarshanTalks Podcast ·

2024/12/31

The stem cell industry is growing rapidly but faces heightened regulatory scrutiny, particularly regarding marketing practices. Recent events highlight this issue: Rebecca Tushnet's blog on state "Little FTC Acts" emphasizes their enforcement power against deceptive marketing, and the guilty plea of a stem cell product manufacturer’s CEO for fraud underscores the stakes involved. Key Considerations for M&A Buyers:1. Legal Landscape: Understanding state and federal regulations is cruc...

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4:10

Why Are PBMs Blocking Your Meds? - Darshan reacts

DarshanTalks Podcast ·

2024/12/30

In this episode, Darshan reacts to how at the start of each year, pharmacists often face the challenge of informing patients that their medications are no longer covered due to formulary changes managed by Pharmacy Benefit Managers (PBMs). PBMs, who work for insurance companies, negotiate drug prices and determine which medications are covered, often based on profitability. Surprisingly, PBMs may prioritize brand-name drugs over generics because of the rebates they receive, which can lead to ...

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14:10

Misleading Ads: Ad laws and Consumer Protection for...

DarshanTalks Podcast ·

2024/12/28

Rebecca Tushnet discusses the potential explores the implications of misleading advertisements, particularly concerning pregnancy clinics. Even true statements can be disparaging if they mislead consumers. Cases like the California lawsuit questioning the use of "Dr." titles. Tushnet examines when products like milk can be labeled as such and scrutinizes claims like "clinically proven" by SlimFast. She also addresses dark patterns, deceptive tactics affecting user behaviour, and the FTC's enf...

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1:07

5 Common Clinical Trial Site Failures

DarshanTalks Podcast ·

2024/12/26

Darshan discusses the five most common clinical trial site issues:1. Failure to Follow Investigational Plan: Treating clinical trials like routine medical practice instead of strictly following the protocol can lead to serious issues.2. Inadequate and Inaccurate Records: The FDA emphasizes that if it’s not documented, it didn’t happen. Inaccurate records can lead to compliance problems.3. Inadequate Drug Accountability: Not knowing where your investigational product has gone is a major issue....

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4:06

Faster FDA Recalls

DarshanTalks Podcast ·

2024/12/24

The FDA’s Center for Devices and Radiological Health (CDRH) has launched a groundbreaking initiative aimed at improving the efficiency and speed of recall communications for medical devices. Here are the five key strategies from the FDA's new medical device recall initiative: Faster Alerts for High-Risk Devices: The FDA aims to reduce the time between discovering a recall-worthy issue and notifying the public, especially for high-risk devices in areas like cardiovascular, gastroente...

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15:07

IRB Challenges and Updates for 2024

DarshanTalks Podcast ·

2024/12/23

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involvement. They also cover the impact of new guidance, the Trump administration, and the FDA's relationship with IRBs.We discuss: 1. The FDA’s Finalized Guidance on Decentralized Clinical Trials (DCTs): The recent FDA guidance formalizing decentralized elements in clinical trials raises crit...

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5:45

Is the Polio Vaccine Safe?

DarshanTalks Podcast ·

2024/12/22

The polio vaccine, credited with eradicating a crippling disease in the U.S., faces renewed scrutiny after attorney Aaron Siri, linked to Robert F. Kennedy Jr., petitioned the FDA to revoke its approval. Kennedy, nominated as Health and Human Services Secretary, has distanced himself from the "anti-vaccine" label but calls for further vaccine studies. Public health officials, including Senator Mitch McConnell, stress the vaccine’s proven safety and life-saving impact.While President-elect Tru...

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8:40

FDA blue print to discuss off label topics

DarshanTalks Podcast ·

2024/12/20

FDA has changed its mind about off label marketing. Today, we're diving into how drug and device companies can effectively engage with payers and providers, exploring recent updates and guidelines. Let’s start with the basics: FDA Regulations and the First Amendment. The FDA’s ability to impose restrictions on speakers and content is limited by the First Amendment, which protects commercial speech. While the FDA can regulate marketing to prevent false or misleading claims, it must balanc...

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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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299 results

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