Best Darshan Kulkarni Podcasts (2024)

1
The 4 Building Blocks of Using AI in any Pharma Marketing Strategy 0:53

16h 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…

1
Legal Minute: Why Clinical Trials Are Right for You! 0:58

1d 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…

1
Why Clinical Researchers Are Flocking to MedSpas 32:13

4d 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-…

1
Legal Minute: Why You Should Never Trust a Celebrity with Your Health 0:51

10d 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…

1
Essential tips for pharmacy shutdowns 2:09

12d 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…

1
Legal Minute: 5 Surprising Benefits of Ozempic! 0:45

17d 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…

1
Who Owns AI Generated Content in Pharma? 7:00

20d 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…

1
Legal Minute: Why does my drug cost so much? 0:48

21d 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…

1
AI for Promotions in FDA-Regulated Industries 0:57

22d 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 …

1
Legal Minute: Billion-Dollar Speaker Scheme! 0:44

23d 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…

1
Off-Label Risks: Compliance Matters Now More Than Ever 24:35

25d 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…

1
6 Must-Knows Before Buying a Drug or Device Company 1:31

29d ago1:31

1:31

Buying a Drug or Device Company? 6 Compliance Must-Knows Thinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown: The DOJ offers a 6-month "safe harbor" for confessing past compliance issues. Use it! The DOJ demands strong compliance programs with thorough risk assessme…

1
Legal Minute: Are there chemo drug shortages? 0:50

1M ago0:50

0:50

We discuss how recent shortages of chemotherapy drugs like cisplatin and carboplatin have caused delays and changes in treatment plans for some cancer patients. While the situation is improving, shortages still exist for some drugs. Staying informed is crucial, and the FDA is actively tracking drug shortages to mitigate them. It's important to comm…

1
Legal Minute: Don’t Ignore State Registrations 0:35

1M ago0:35

0:35

We discuss how failure to register with the appropriate state boards of Pharmacy as a drug or device manufacturer can lead to severe consequences. These consequences include 1. Hefty fines, revoked licenses, and even legal charges, potentially ruining your business. 2. Additionally, non-compliance can result in reputational damage, eroding public t…

1
Legal Minute: 6 Crucial Mistakes in Informed Consent 0:59

1M ago0:59

0:59

We discuss six critical errors in the informed consent process: 1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed consent process. 2. Lack of Detailed Discussion: Staff members did not take the time to thoroughly discuss the study's potential benefits and risks with prospective subjects. 3. Inadequate Training: Co…

1
Legal Minute: What is informed consent in clinical trials? 0:46

2M ago0:46

0:46

Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full disclosure of information, allowing subjects to ask questions and address concerns with a knowledgeable medical professional. For minors, parental inv…

1
Stop Risky Ads: Class Actions Could Cost You 22:53

2M ago22:53

22:53

In this podcast, we discuss the following: Recent updates from the courts in class action lawsuits. Difference between equity and law. Demerging or diverging equity and law. Dictionaries used by courts to interpret contracts. Update on Johnson and Johnson baby powder case (Suing plaintiff’s witnesses for defamation and false advertising) Experts ne…

1
Legal Minute: How do drugs work? 0:14

2M ago0:14

0:14

Darshan explains that drugs work by either enhancing or inhibiting processes that already occur in the body. Put simply, they amplify or reduce the body's natural functions. This fundamental principle underscores how drugs interact with our biology. Support the Show.By Darshan Kulkarni

1
5 Surprising Causes of Life Science Deal Failures 2:08

2M ago2:08

2:08

We discuss the five common reasons behind the failure of mergers, acquisitions and licensing deals in the life sciences industry. Inadequate understanding of capability, where focusing solely on financials without comprehending the target company's regulatory and compliance processes leads to failure. The side project dilemma, illustrated by Philip…

1
Legal Minute: Is pharma bribing your doctor? 0:48

2M ago0:48

0:48

In this short, Darshan sheds light on the relationship between doctors and pharmaceutical companies. He explains how pharmaceutical companies often pay doctors to ensure they understand their drugs and promote their products. However, patients can now access information on what doctors are being paid by pharmaceutical companies through the CMS webs…

1
Legal Minute: Drug Registrations that can’t be ignored 0:56

2M ago0:56

0:56

When acquiring a drug or device company, regulatory attorneys play a crucial role in ensuring compliance during the due diligence process. It's vital to recognize that registration with state and local authorities is often overlooked by these companies, who may mistakenly believe that FDA registration suffices. However, failure to register appropri…

1
Legal Minute: Why do pharmacies take so long to fill prescriptions? 0:57

2M ago0:57

0:57

Have you ever wondered why your prescription takes what feels like an eternity to fill at the pharmacy? Darshan will shed some light on the process. When you drop off your prescription, the pharmacist isn't just mindlessly grabbing bottles from shelves. They're meticulously reviewing your medication to ensure it's the right fit for your condition, …

1
Legal Minute: 3 Steps to Avoid Food Recalls 0:39

3M ago0:39

0:39

We cover three steps for preventing food recalls: Identify all potential hazards. Focus on known and foreseeable risks. Develop preventive controls for specific hazards. Ensure every bite is safe! Need help? Call Darshan at 302.252.6959. Support the Show.By Darshan Kulkarni

1
Legal Minute: Are dietary supplements as good as drugs? 0:44

3M ago0:44

0:44

In this video, Darshan distinguishes between dietary supplements and drugs. The primary difference lies in the claims they can make. Dietary supplements are treated as foods and can only make limited claims, such as improving health or well-being. In contrast, drugs undergo rigorous FDA approvals and trials to make claims of curing, treating, preve…

1
Legal Minute: Clinical Trial Record Retention Disasters 0:51

3M ago0:51

0:51

Here are 5 clinical trial record retention problems. 1. Fabricating Data and Documentation, 2. Forging the Principal Investigator's signatures, 3. Data Manipulation, 4. Misappropriating Samples and 5. Forging Subject Dairies Join us as we delve into the complexities of record retention and data integrity in clinical trials. Learn why compliance is …

1
Legal Minute: Why is your medicine so expensive? 0:47

3M ago0:47

0:47

Bringing a drug to market is a costly and intricate process, averaging $2.3 billion. This expense encompasses multiple levels of testing, ranging from small animals to extensive human trials. The drug company, whether partnering with a university or a private investor, foots the bill for each phase of testing, ensuring safety and efficacy before re…

1
McKinsey’s 2030 vision: A challenge for medical affairs 2:34

3M ago2:34

2:34

McKinsey’s vision for Medical Affairs in 2030 envisions profound integration of digital tools, analytical innovation, evidence generation, and leadership transformation. However, this vision faces a critical challenge as recent lawsuit losses against the FDA have shifted the landscape. Previously, Medical Affairs held the exclusive right to share o…

1
Legal Minute: 3 must-do takeaways for collecting diversity data in clinical trials 0:58

3M ago0:58

0:58

In an ideal world, every patient in clinical trials would feel truly represented. In this video, Darshan Kulkarni outlines three crucial takeaways for collecting diversity data in clinical trials, following guidelines from the FDA. The guidance emphasizes that one size does not fit all when it comes to race and ethnicity, encouraging detailed categ…

1
Legal Minute: Are Brand and Generic Drugs Truly Different? 0:54

3M ago0:54

0:54

We explore the chemical similarities and key differences between brand-name and generic drugs. Learn about: Equivalence in active ingredients, as approved by the FDA. Exceptions: Narrow Therapeutic Index drugs and inactive ingredients. When to consult a doctor before switching brands. Listen to find out if you can save money without sacrificing qua…

1
Legal Minute: Who's REALLY Responsible for a Clinical Trial Congruency review? 0:56

3M ago0:56

0:56

In this short, we discuss who is responsible for a congruency review in clinical trials. Our guest Istvan Fekete emphasizes that both pharmaceutical companies and research sites share the responsibility for ensuring congruency between the budget, contract, informed consent form (ICF), and coverage analysis. Istvan mentions that a lack of congruency…

1
This Drug Ad is FULL of Red Flags (We Expose Them All!) 2:53

4M ago2:53

2:53

Today, we analyze a fictional drug advertisement, identifying and highlighting the nine key unethical and non-compliant elements. - Misleading Information: The claim "The End of High Blood Pressure" suggests that the drug can completely cure high blood pressure, which is likely exaggerated and misleading. 2- Absolute Efficacy Claims: Stating "Prove…

1
7 ways to challenge FDA’s regulation of LDTs 2:57

4M ago2:57

2:57

The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among developers, anticipating significant financial implications. We provide a comprehensive overview of seven strategic approaches for LDT developers to challenge the FDA's regulatory proposal. Firstly, lever…

1
Legal Minute: eBay’s $59 Million Drug-Making Problem 0:40

4M ago0:40

0:40

eBay found itself as an unexpected marketplace for pill-making equipment, resulting in the company paying a hefty $59 million for facilitating the sale of such equipment. In our video, Darshan delves into this crackdown, shedding light on the hidden underbelly of online retail. The incident highlights the ease with which tools for potentially illeg…

1
Ep 17 - Brahman vesh mein arjun ka vivah 9:29

4M ago9:29

9:29

A significant event unfolds in the Mahabharata history as Draupadi, the daughter of Drupad, is handed over to a mysterious stranger chosen by her father. Despite the efforts of Duryodhan and his brothers to claim her, their attempts are futile, leaving everyone puzzled about Draupadi's mysterious husband. As tensions rise, Draupadi announces her de…

1
Legal Minute: Neuralink is a Game-Changer: 3 Lessons You Can't Afford to Miss 0:59

4M ago0:59

0:59

In a recent announcement, Elon Musk's company Neuralink revealed the successful implantation of a brain device in a human, pushing the boundaries of neurotechnology. In our latest short, we discuss key considerations for those venturing into such groundbreaking work. We emphasize the importance of having a clear investigational plan that outlines s…

1
Legal Minute: Off-label marketing not ok again? 0:46

4M ago0:46

0:46

In the US v. Facteau case, a recent development adds complexity to the FDA's ongoing struggle with off-label communications, particularly in light of the SIUU guidance and the CFL guidance. The First Circuit ruled against Facteau, emphasizing the distinction from the Caronia case. Unlike Coronia, where the focus was on broader free speech and off-l…

1
Ep 16 - Draupadi ka swayamvar 9:29

4M ago9:29

9:29

Ashwatthama senses the heat of vengeance from his childhood. He witnessed King Drupad's insult towards his father and was prepared for retaliation for years. Finally, the time came for Drupad's revenge, as he prepared his children, Dhrishtdyumn and Draupadi, to seek vengeance. Ashwatthama, unaware of Drupad's plans, participated in the contest. At …

1
Don't Become the Next Fraud Headline: Lawyer Reveals Compliance Traps 1:15

4M ago1:15

1:15

We discuss biotech fraud and the pivotal role of a comprehensive legal strategy, especially one that integrates FDA regulatory lawyers. A biotech CEO's admission to securities fraud, misleading investors about a crucial test, underscores the need for stringent legal oversight. At the Kulkarni Law Firm: We’re on the lookout for major red flags, We e…

1
Ep 15 - Bheem ki Hidimba 9:19

4M ago9:19

9:19

Ashwatthama's internal struggle amidst the chaos of the Varnawat episode. With uncertainty looming over the fate of the Pandavas, Ashwatthama grapples with conflicting emotions and moral dilemmas. As news of the Pandavas' supposed demise spreads, Ashwatthama is torn between duty and friendship. His loyalty to Duryodhana clashes with his conscience,…

1
Legal Minute: 3 Insider Secrets for a Successful Medical Device Recall 0:59

4M ago0:59

0:59

In December 2023, two US senators raised concerns, urging the government to scrutinize the FDA's oversight of medical device recalls, notably amidst the ongoing Phillips Respironics recall. Join us today as we delve into the world of medical device recalls. Facing a recall is every manufacturer's nightmare, but handling it right is paramount. It sa…

1
Key elements of a successful congruency review for clinical trial agreements 3:06

5M ago3:06

3:06

In a congruency review, the primary objective is to ensure alignment across various elements in clinical research. The initial crucial step involves accurately analyzing Medicare coverage, determining designations based on National and Local Coverage Determinations. This forms the foundation for what is billed to the study sponsor and insurance. An…

1
Ep 14 - Laksha bhavan ki agni 9:55

5M ago9:55

9:55

Ashwatthama had heard of Varnavat but had never seen it. His father never discussed it. When the Pandavas were to visit Varnavat, Ashwatthama was curious. King Dhritrashtra entrusted him with seeing the Pandavas and their mother off, but Ashwatthama didn't inquire about their purpose. Upon returning, he asked his father, who explained that Varnavat…

1
Why Private Equity firms are betting big on clinical research sites 0:58

5M ago0:58

0:58

We delve into the growing allure of clinical research sites and organizations for private equity firms. Backed by BPOC, these investments signify more than just single business deals; they are a testament to the increasing interest in fueling healthcare innovation and services. As this trend gains momentum, thorough due diligence becomes crucial in…

1
5 Ways to Legally Share Off-Label Information 1:51

5M ago1:51

1:51

In this episode, the focus is on navigating the complex landscape of off-label information sharing, exploring legal aspects in the context of the life sciences industry. Sponsored by the Kulkarni Law Firm, the episode highlights key points: 1. Scientific discussions: Courts are generally cautious about FDA scrutiny in scientific discussions, such a…

1
Ep 13 - Arjun ka Agni baan 9:51

5M ago9:51

9:51

Ashwatthama's story is marked by significant changes in his thoughts. Initially, he opposed seeking revenge against King Drupad but later felt empathy towards his father when Drupad gave birth to two children in response. He wanted to convey that life doesn't change through revenge but through compromise, which his teacher, Dronacharya, understood.…

1
DOJ's "Get Out of Jail Free" card for pharma and device mergers? 8:04

5M ago8:04

8:04

Darshan discussed crucial updates to the Department of Justice's (DOJ) corporate enforcement policies, particularly impacting FDA-regulated industries like pharmaceuticals and medical devices. The DOJ's focus on mergers and acquisitions (M&A) emphasizes the importance of compliance professionals throughout the entire process. Key Highlights: 1. Cor…

1
Legal Minute: 5 factors to get your digital speaker program approved 0:41

5M ago0:41

0:41

In this podcast, we discuss the legal and regulatory factors for securing approval for your digital speaker program. Key points include prioritizing audience privacy, adhering to FTC disclosure regulations, explicit audience definition, distinguishing between educational and promotional content, and navigating health versus product claims. Link to …

1
Legal Minute: Decoding the FDA's prescription drug use related software guidance 0:59

5M ago0:59

0:59

FDA Issues Crucial Guidance on Prescription Drug Software! Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related software. The discussion revolves around three key considerations: 1. software functions, 2. end-user output, and 3. regulatory guidelines. Notably, the FDA emphasizes distinguishing between functions relyin…

1
Ep 12 - Drupad ko bandi banane ki Gurudakshina 9:57

5M ago9:57

9:57

Ashwatthama reflects on his rebellious nature and questions his father's adherence to Dronacharya's strategies. Despite his father's loyalty, Ashwatthama's inclination toward dissent surfaces. When Dronacharya sends Pandavas and Kauravas to make King Drupad a captive, Ashwatthama's refusal to follow suit becomes evident. He grapples with the unders…

Podcasts Worth a Listen

Darshan Kulkarni Podcasts

Podcasts Worth a Listen

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