הפודקאסטים הטובים ביותר ב-DarshanTalks (2024)

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

1d 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

3d 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

7d 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…

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

10d ago9:43

9:43

Subscriber-only episode 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, o…

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

13d 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…

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

15d 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

19d 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 showעל ידי Darshan Kulkarni

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

21d 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…

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

23d 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…

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Patient Advocates Could Cost You Millions 2:42

27d 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…

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Managing Risks in Life Sciences Mergers and Acquisitions 5:55

1M 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 showעל ידי Darshan Kulkarni

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

1M 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 …

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AI Data Ownership in Pharma 4:59

1M 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…

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

1M 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…

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Why are medicine names so complicated? 2:09

2M 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…

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Fixing Congruency Reviews in 8 Minutes 8:36

2M 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…

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The Dark Side of Med Device Kickbacks 4:45

2M 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…

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

2M 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

2M 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…

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What Really Starts Pharmacy Investigations? 1:52

2M 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 …

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🔒 Is your clinical trial AI racist? 4:52

3M 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

3M 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…

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

3M 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…

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

3M 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…

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How Expert Pharma Marketers Navigate Privacy 1:26

3M 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…

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Hiring New Employees in PharmaTech Companies 22:05

3M 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…

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3 Hidden Dangers of Telehealth Marketing 1:51

3M 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…

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

3M 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…

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

4M 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…

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

4M 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…

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Why Adverse Events Go Unreported in Clinical Trials 1:51

4M 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…

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Who are patient advocates? 3:53

4M 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…

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Why Drug Accountability Matters in Clinical Trials 1:43

4M 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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Legal Minute: What do I do if my med is on shortage? 0:47

4M ago0:47

0:47

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 …

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5 reasons not to use AI in creating pharma marketing content 1:26

4M ago1:26

1:26

We discuss the risks associated with using AI in your pharma marketing plans: 1. Data Privacy and Security: Ensuring the security and privacy of data, whether it pertains to patients or non-patients, is paramount. 2. Bias: Questions arise regarding the sources of information, control over data, and addressing privacy concerns to prevent biases and …

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8 essential elements of a valid prescription 1:03

4M ago1:03

1:03

In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse: Verify the prescriber's identity. Know the prescriber's DEA number. Know your patient thoroughly. Verify prescription dates for validity; ensure prescriptions are current. Communicate directly with prescribers if any concerns arise. Request identi…

1
No more lawyers in PRC? 12:16

4M ago12:16

12:16

In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape in the pharmaceutical industry. Dive into the conversation as we explore the impact of regulatory bodies like the FDA, FTC, and NAD, and the importance …

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Legal Minute: 4 Ways to Get Unapproved Drugs Legally! 0:53

4M ago0:53

0:53

Today, we discuss four legal pathways to acquire unapproved drugs. First, over-the-counter drugs offer a route as some bypass FDA approvals, relying instead on a nomograph. Second, compounded drugs crafted by pharmacists provide an alternative despite lacking FDA approval. Third, the FDA's new policy allows for state-imported drugs, provided certai…

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The 4 Building Blocks of Using AI in any Pharma Marketing Strategy 0:53

4M ago0:53

0:53

We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use: 1. Define Clear Goals: Establishing clear objectives is crucial for developing a comprehensive compliance plan for AI use. Without clear goals, executing a successful strategy becomes challenging. 2. Establish Policies and Procedures: Clearly defined pol…

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Legal Minute: Why Clinical Trials Are Right for You! 0:58

4M ago0:58

0:58

In this short, we explore four key reasons to get involved in clinical research. First, it offers potential access to cutting-edge therapies, though it's important to note you might only receive the standard of care. Second, participation ensures closer monitoring by healthcare professionals. Third, it provides an opportunity to contribute to medic…

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Why Clinical Researchers Are Flocking to MedSpas 32:13

5M ago32:13

32:13

In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee . Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-…

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Legal Minute: Why You Should Never Trust a Celebrity with Your Health 0:51

5M ago0:51

0:51

Darshan explains why you shouldn’t Trust Celebrities When Choosing Your Drugs! Hidden Agendas: They're paid to promote, not give unbiased advice. Not Medical Experts: Trust your doctor's knowledge, not a celebrity's opinion. Oversimplified Info: 30-second ads can't tell the whole story. Not Personalized: Your doctor can give you the right advice fo…

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Essential tips for pharmacy shutdowns 2:09

5M ago2:09

2:09

Recent pharmacy walkouts and closures at major chains highlight a critical issue: staffing shortages. Independent pharmacies are also at risk. Here are 5 tips for pharmacy owners and managers to prepare for potential temporary closures: Cross-Train Staff: Train front-end staff on basic pharmacy procedures (depending on state regulations) so they ca…

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Legal Minute: 5 Surprising Benefits of Ozempic! 0:45

5M ago0:45

0:45

We dive deep into 5 uses of Ozempic, a drug known for managing diabetes, but with surprising potential beyond! Here are 5 intriguing uses you might not have heard of: Liver Support: Early research suggests Ozempic could benefit liver health, but more studies are needed. Weight Loss Weapon: Ozempic has a weight-loss version, offering a powerful tool…

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Who Owns AI Generated Content in Pharma? 7:00

5M ago7:00

7:00

In today's episode, we discuss AI-generated content in the pharmaceutical industry. AI has revolutionized content creation, but it's not without its legal and ethical dilemmas. Take, for instance, the New York Times' lawsuit against OpenAI, highlighting the contentious issue of data ownership. As pharma companies increasingly rely on AI for content…

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Legal Minute: Why does my drug cost so much? 0:48

5M ago0:48

0:48

In today’s short, Darshan discusses why drugs cost so much. It takes around 10 to 15 years and roughly $2.3 billion to bring a drug to market. That means a drug company spends between $420,000 and $630,000 daily during this process. Imagine going to a casino every day, betting that much money without knowing the outcome, for 10 to 15 years. What ki…

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AI for Promotions in FDA-Regulated Industries 0:57

5M ago0:57

0:57

Join Darshan Kulkarni, a Food and Drug attorney, as he explores the dynamic intersection of artificial intelligence, drug and device promotion, and the law. In this podcast series, we'll dive deep into AI's role in promotional and non-promotional communications within the pharmaceutical and medical device industries. From regulatory compliance and …

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Legal Minute: Billion-Dollar Speaker Scheme! 0:44

5M ago0:44

0:44

Speaker programs are events sponsored by drug and device companies where a physician or other healthcare professional (HCP) delivers a speech or presentation to fellow HCPs regarding a specific drug, device product, or disease state on behalf of the sponsoring company. Typically, the company compensates the speaker with an honorarium and may also p…

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Off-Label Risks: Compliance Matters Now More Than Ever 24:35

5M ago24:35

24:35

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry. We discuss the following: What does off-label mean from a reimbursement standpoint? Lessons from the US v. Eli Lilly 2009 case How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau How ar…

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