最高の DarshanTalks ポッドキャスト (2024)

1
Will RFK Break Pharma? 2:46

7h ago2:46

2:46

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 Sector For Drug Advert…

1
Fake data in Clinical Trials 1:58

2d ago1:58

1:58

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 reco…

1
Darshan Fixes Big Pharma Misconceptions 3:00

4d ago3:00

3:00

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 t…

1
🔒 How Trump’s Tariffs will Disrupt Clinical Trials and Drug Marketing? 6:50

6d ago6:50

6:50

Subscriber-only episode In 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 beli…

1
Why China is Targeting Top Scientists! 3:22

8d ago3:22

3:22

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 charge…

1
Trump’s Bold Picks Shake Up Life Sciences 4:52

10d ago4:52

4:52

The 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. K…

1
🔒 3 Regulatory Opportunities in Clinical Trials! 5:27

12d ago5:27

5:27

Subscriber-only episode We 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…

1
Don't Take Non-Prescription Ozempic or other Weight Loss Drugs 3:15

14d ago3:15

3:15

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 healt…

1
Clinical Trial Principal Investigator Duties in Clinical Trials 2:32

16d ago2:32

2:32

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 right…

1
Supreme Court Redefined Pharma Marketing Rules 6:38

19d ago6:38

6:38

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 Contex…

1
AI concerns in M&A for Life Sciences 6:16

22d ago6:16

6:16

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 c…

1
Trump Teams Potential Changes to Healthcare 2:59

23d ago2:59

2:59

Healthcare 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 decentraliza…

1
🔒 Can AI Rewrite the Rules of Clinical Trials? 5:36

24d ago5:36

5:36

Subscriber-only episode In 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 po…

1
Ad Promo Review in Pharma - How Far is Too Far? 14:52

26d ago14:52

14:52

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/FTC Should administrative agencies cite letters? Can the FDA establish rules after someone chal…

1
Why Staff Training Problems are a liability for Your Clinical Trial site 1:51

28d ago1:51

1:51

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, inst…

1
Neuralink: Breakthrough or Marketing Hype? 0:55

1M ago0:55

0:55

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 guarante…

1
Telehealth Compliance Crisis: DOJ exposes $2.75B Fraud! 4:52

1M ago4:52

4:52

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 psychiatris…

1
Should You Go In-House or Outsource Your Advertising Compliance? 10:43

1M ago10:43

10:43

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 Adver…

1
Research fraud tainting pharma per Nature Article 2:31

1M ago2:31

2:31

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 th…

1
Influencers are NOT KOLs. Know your Needs! 7:25

1M ago7:25

7:25

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. - Benef…

1
AI and Clinical Trials: Faster Results, Bigger Risks? 9:43

2M ago9:43

9:43

In 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 clin…

1
Eli Lilly’s Unexpected Shift on Use of Mounjaro! 2:01

2M ago2:01

2:01

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 healthca…

1
Are CROs Losing Relevance in the Age of DCTs? 10:53

2M ago10:53

10:53

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 al…

1
Managing Risks in Life Science Mergers and Acquisitions with Strategic Insurance 5:52

2M ago5:52

5:52

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 showDarshan Kulkarni による

1
Can a Pharmacist Override Your Doctor's Prescription? 3:16

2M ago3:16

3:16

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-1…

1
FDA Concerns About AI’s impact on Good Clinical Practices 3:33

2M ago3:33

3:33

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…

1
Patient Advocates Could Cost You Millions 2:42

2M ago2:42

2:42

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…

1
Managing Risks in Life Sciences Mergers and Acquisitions 5:55

2M ago5:55

5:55

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 showDarshan Kulkarni による

1
How do pharmacists’ read doctors’ cursive letters? 1:30

2M ago1:30

1:30

Pharmacists often use a process of elimination to decipher doctors' handwritten prescriptions. Pharmacists rely on clues like drug names and doses, this method isn’t foolproof. If the handwriting is unclear, identifying the correct medication can be challenging, leading to potential errors. The shift to electronic prescribing has improved accuracy …

1
AI Data Ownership in Pharma 4:59

2M ago4:59

4:59

We explore how AI is transforming content generation in the pharmaceutical industry, particularly in marketing, sales, and medical engagements. While AI presents groundbreaking opportunities, it also raises critical challenges, notably concerning data ownership and compliance. A significant issue is the lack of clarity around ownership of input and…

1
🔒 Role of Tech Transfer in Clinical trial agreements 7:30

2M ago7:30

7:30

Subscriber-only episode In this episode, we are joined by Istvan Fekete to have a discussion over tech transfer offices, IP, and more. The video explains what tech transfer offices are, their significance in the research ecosystem, and why they might be the best place to negotiate equity stakes in intellectual property (IP) created by investigators…

1
Why are medicine names so complicated? 2:09

3M ago2:09

2:09

Darshan was asked to explain why drug names can be so complicated, and the answer lies in the fact that each drug typically has at least three distinct names. First, there’s the chemical name, which is a technical identifier describing the drug’s molecular structure—these names are often long and complex, like “acetylsalicylic acid,” and are more f…

1
Fixing Congruency Reviews in 8 Minutes 8:36

3M ago8:36

8:36

In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Additionally, we will delve into the processes that can be implemented to mitigate risks associated with congruency r…

1
The Dark Side of Med Device Kickbacks 4:45

3M ago4:45

4:45

Today, we're discussing a critical issue for pharmaceutical and medical device marketers – promotional compliance. Overview of the Innovasis Settlement: Innovasis Inc. recently settled a $12 million case for alleged kickback schemes to doctors. This highlights the importance of promotional compliance. Allegations Against Innovasis: From Jan. 1, 201…

1
Which Hair Loss Treatment Is Right for You? 2:29

3M ago2:29

2:29

Darshan addresses common questions about potential treatments for hair loss. He provides insights based on his expertise as both a pharmacist and an FDA regulatory lawyer. Darshan explains that FDA-approved treatments for hair loss include minoxidil and finasteride. Minoxidil, originally a blood pressure medication, can lower blood pressure and has…

1
Analyzing the Publication Rights Clause in CTAs 1:49

3M ago1:49

1:49

Today's discussion revolves around the legal clauses found in clinical trials, with a focus on Article 8, the Publication Rights Clause. The following points are discussed: Unrestricted Rights: The clause prov ides the Site with unrestricted rights to publish all trial data. This is excessive and could jeopardize the Sponsor's control over the inte…

1
What Really Starts Pharmacy Investigations? 1:52

3M ago1:52

1:52

We discuss the seven ways pharmacy investigations can begin: 1. Data Analysis: Agencies like the DEA and DOJ monitor prescription data for unusual patterns, such as excessive dispensing of certain drugs. 2. Tips: Anonymous reports from the public or industry insiders alert authorities to suspicious activities. 3. Whistleblowers: Individuals within …

1
🔒 Is your clinical trial AI racist? 4:52

4M ago4:52

4:52

Subscriber-only episode We dive into the critical issue of racial bias in AI, highlighted by a recent Yale study focusing on ChatGPT. This has significant implications for clinical research sponsors, sites, and principal investigators. We also explore the FDA's perspective on AI in clinical trials, presented by Dr. Elzarrad. Overview of the Yale St…

1
Another Pharmacy owner Jailed in Fraud Case 3:04

4M ago3:04

3:04

Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickbacks and engaging in a money laundering conspiracy. This case has significant implications for promotional compliance within the pharmacy industry, and we're here to explore them in detail. In a landmark case…

1
Navigating FDA's clinical trial expectations after approval 3:25

4M ago3:25

3:25

Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs). PMRs are mandatory studies required by the FDA after a drug's approval, focusing on real-world data for long-term safety and effectiveness. Think of them as an extension of the initial research phase, but in a real-w…

1
Legal Minute: Do dietary supplements interact with drugs? 0:59

4M ago0:59

0:59

Do dietary supplements interact with drugs? Many people think only prescription drugs can cause interactions, but dietary supplements can too. From an FDA perspective, a drug is defined by its claims and indications. Some supplements make drug-like claims and can interact with medications. Common examples include grapefruit juice and vitamin K, whi…

1
How Expert Pharma Marketers Navigate Privacy 1:26

4M ago1:26

1:26

In today's consumer landscape, privacy concerns reign supreme. Pharmaceutical and medical device manufacturers must prioritize meeting the expectations of this privacy-conscious generation. This begins with three key measures: 1. Consent Management: Clear communication about data usage is essential, aligning with regulations like CCPA and GDPR. See…

1
Hiring New Employees in PharmaTech Companies 22:05

4M ago22:05

22:05

Edye Edens, a consultant and attorney with a background in regulatory affairs, shared insights into her unexpected yet exciting role at Weave, a rapidly growing startup specializing in AI-driven solutions for regulatory content creation. Edye discussed her journey from freelance consultancy to joining Weave, highlighting the unique challenges and o…

1
3 Hidden Dangers of Telehealth Marketing 1:51

5M ago1:51

1:51

In this episode, we discuss how drug and device manufacturers may seem to collaborate with telemedicine companies to market products and ensure patient needs are met conveniently. However, there are three major concerns: 1. Ignoring Pharma Laws: Telehealth companies might not adhere to pharma marketing laws and could act as agents for pharma due to…

1
Why a food lawyer would stop your restaurant’s marketing? 1:38

5M ago1:38

1:38

Today, we're tackling a critical issue for restaurants and food marketers: promotional compliance and the risks of misbranding, as highlighted by a recent case in Biloxi. Mary Mahoney's Old French House Restaurant and its co-owner, Anthony Charles Savanovich, recently pled guilty to conspiracy and misbranding seafood. Over six years, they sold over…

1
Legal Minute: Why are there chemo drug shortages? 0:52

5M ago0:52

0:52

We discuss how the shortage of chemotherapy drugs stems from economic challenges faced by generic drug manufacturers. Many cannot afford to produce these drugs due to low profitability. Factors include factory shutdowns for quality issues, a complex global supply chain, and older generic drugs being unprofitable to produce. Government pressure on p…

1
Are Pharma Giants Ignoring Clinical Trial Site Issues? 30:10

5M ago30:10

30:10

In this episode, Daniel Fox discusses the key challenges faced by research sites, including trust issues, payment delays, and operational setbacks. He emphasizes initiatives like the "Open Mic" policy for anonymous feedback and the grassroots movement Save Our Sites (SOS). Dr. Fox also explores issues with decentralized clinical trials, advocates f…

1
Why Adverse Events Go Unreported in Clinical Trials 1:51

5M ago1:51

1:51

In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disru…

1
Who are patient advocates? 3:53

5M ago3:53

3:53

In this episode, we delved into the pivotal role of patient advocates within the pharmaceutical industry. Patient advocates are champions who ensure that patients' voices are not only heard but also central to decisions affecting their health. They play a crucial role in various aspects: Firstly, patient advocates are instrumental in representing t…

1
Why Drug Accountability Matters in Clinical Trials 1:43

5M ago1:43

1:43

Drug accountability is a critical aspect monitored by the FDA at clinical trial sites. Principal investigators must maintain and document control over investigational products, ensuring they are only administered under direct supervision. Clinical research organizations also conduct routine audits to verify drug accountability. However, instances o…

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