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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

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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1:52

What Really Starts Pharmacy Investigations?

DarshanTalks Podcast ·

2024/09/07

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 organizations can confidentially report wrongdoing, potentially leading to legal action under the False Claims Act.4. Patient Complaints: Concerned pa...

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4:52

🔒 Is your clinical trial AI racist?

DarshanTalks Podcast ·

2024/08/20

Subscriber-only episodeWe 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 Study:The Yale study found that ChatGPT demonstrates racial bias in its responses, raising concerns about the use of AI in clinical research. Biased AI...

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3:04

Another Pharmacy owner Jailed in Fraud Case

DarshanTalks Podcast ·

2024/08/17

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, the Department of Justice sentenced Richard Hall, a 53-year-old pharmacy owner from Fort Worth, to several years in prison. The charges? Hall paid...

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3:25

Navigating FDA's clinical trial expectations after...

DarshanTalks Podcast ·

2024/08/13

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-world setting. PMCs, while not legally mandated, are additional studies agreed upon by the drug developer, providing valuable insights.Both PMR...

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0:59

Legal Minute: Do dietary supplements interact with...

DarshanTalks Podcast ·

2024/08/09

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, which often interact with drugs. Dietary supplements, like any food or drug, can cause interactions. Have you experienced a drug interaction from usin...

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1:26

How Expert Pharma Marketers Navigate Privacy

DarshanTalks Podcast ·

2024/08/07

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. Seeking user consent without relying on cookies is crucial.2. Context-Based Information: Emphasize direct data collection from customers, in line with ...

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1:51

3 Hidden Dangers of Telehealth Marketing

DarshanTalks Podcast ·

2024/07/29

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 developed relationships. This has drawn scrutiny from Congress, FDA, and FTC, raising concerns about potential non-compliance.2. Inappropriat...

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0:52

Legal Minute: Why are there chemo drug shortages?

DarshanTalks Podcast ·

2024/07/24

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 prices further reduces profit margins, disincentivizing investment in production quality. Consequently, manufacturers prioritize newer, more expensi...

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30:10

Are Pharma Giants Ignoring Clinical Trial Site Issues?

DarshanTalks Podcast ·

2024/07/22

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 for patient-centric practices, and underscores the roles of telehealth and AI in research, promoting transparency and ethical standards in clinical ...

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3:53

Who are patient advocates?

DarshanTalks Podcast ·

2024/07/16

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 the patient voice in clinical trials. By advocating for patient-centric endpoints and highlighting symptoms that matter most to patients, they help e...

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1:43

Why Drug Accountability Matters in Clinical Trials

DarshanTalks Podcast ·

2024/07/11

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 of improper disposal or false certifications have been identified, highlighting the importance of vigilance in maintaining accurate drug records.&nb...

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0:47

Legal Minute: What do I do if my med is on shortage?

DarshanTalks Podcast ·

2024/07/09

We discuss how to address drug shortages. First things first, it's important to stay calm. Just because there's a shortage doesn't mean you'll lose access to your medication entirely. Here are some action steps you can take: 1. Schedule an appointment with your doctor to discuss alternative medications that might be effective for you. It's crucial to also talk about potential side effects and weigh the options together.2. Pharmacies can be a great resource. They may have information on w...

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299 results

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