DarshanTalks Podcast

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, …

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…

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:

1. …

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 ar…

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 achiev…

DOJ filed criminal charges against 193 defendants, including 76 medical professionals for telemedicine violation. This alarming crackdown reveals the vulnerabilities within telemedicine, as illegal k…

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 v…

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.…

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 soci…

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…

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 con…

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 …

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

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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 Medi…

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. ElZarr…

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 …

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. 

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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 …

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…

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 ec…