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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

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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1:30

How do pharmacists’ read doctors’ cursive letters?

DarshanTalks Podcast ·

2024/10/06

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 and reduced confusion. For more insights on this topic, check out my video linked below. Support the show

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4:59

🔒 AI Data Ownership in Pharma

DarshanTalks Podcast ·

2024/10/03

Subscriber-only episodewe 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 output data, illustrated by legal disputes like The New York Times suing OpenAI. For pharma companies, the stakes are high d...

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7:30

🔒 Role of Tech Transfer in Clinical trial agreements

DarshanTalks Podcast ·

2024/09/30

Subscriber-only episodeIn 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, especially when funded by charitable organisations. We discuss the pros and cons of sponsors seeking a return on investment (ROI). Additionally, t...

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2:09

Why are medicine names so complicated?

DarshanTalks Podcast ·

2024/09/22

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 for scientific use. Next, there’s the generic name, which is what most people are familiar with, such as “penicillin” or “aspirin.” These names are ...

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8:36

Fixing Congruency Reviews in 8 Minutes

DarshanTalks Podcast ·

2024/09/21

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 reviews. The discussion will also cover the potential benefits of involving third-party to ensure the accuracy and integrity of the review process.P...

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4:45

The Dark Side of Med Device Kickbacks

DarshanTalks Podcast ·

2024/09/17

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, 2014, to Dec. 31, 2022, Innovasis allegedly provided improper remuneration to surgeons, inducing them to use their products. These remunerations included ...

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2:29

Which Hair Loss Treatment Is Right for You?

DarshanTalks Podcast ·

2024/09/14

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 other side effects. Finasteride, used for benign prostatic hypertrophy, is also FDA-approved for hair loss but has limitations and potential side e...

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1:49

Analyzing the Publication Rights Clause in CTAs

DarshanTalks Podcast ·

2024/09/09

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 provides the Site with unrestricted rights to publish all trial data. This is excessive and could jeopardize the Sponsor's control over the integrity and proper use of the data.No Sponsor Review: There's no requirement for the Sponsor to review or approve publications, which can lead to i...

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271 results

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