최고 Darsh 팟캐스트 (2024)

1
Legal Minute: Don’t Ignore State Registrations 0:56

23h ago0:56

0:56

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
Debunking Nutrition Myths: Taking a Balanced Approach with Ross Franklin, Founder of Pure Green 33:04

4d ago33:04

33:04

In this episode of Getting to Aha!, Darshan Mehta is joined by Ross Franklin, the founder of Pure Green and CEO of Pure Green Franchise. Join them as they discuss challenges in the fitness industry, the misconceptions surrounding nutrition, and Ross’ creation of Pure Green, a juice bar franchise focused on high-performance superfoods. Ross also dis…

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

4d 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

8d 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.저자 Darshan Kulkarni

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

11d 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…

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[Greatest Hits] Switching Mindsets: Engineering to Marketing with Pavangopal A, Chief Marketing Officer at Nandu’s 33:13

11d ago33:13

33:13

In this Greatest Hits episode of Getting to Aha!, Darshan Mehta is joined by Pavangopal A, CMO at Nandu’s, to discuss how engineers and marketers could learn from each other; why marketing is really all about objectivity; and why you should focus on yourself, not just on the competitors! Pavangopal is the Chief Marketing Officer at Nandu’s, one of …

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

15d 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
Constant Innovation, Fearlessness, and Humor: Lessons from Mary Crafts, the founder of Utah’s Largest Off-Site Caterer 43:10

18d ago43:10

43:10

In this episode of Getting to Aha!, Darshan Mehta is joined by Mary Crafts, CEO of Mary Crafts, Inc, and founder of Culinary Crafts. Join them as they explore Mary’s experience of starting a multimillion-dollar catering company, overcoming the fear of failure, and the importance of vulnerability when connecting with others. Mary also talks about th…

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

19d 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

23d 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

25d 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…

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[Greatest Hits] Find Simplicity to Find Your Aha! With Monish Debnath, CMO of WickedGüd 33:36

25d ago33:36

33:36

In this Greatest Hits episode of Getting to Aha!, Darshan Mehta is joined by Monish Debnath, CMO and Founding Team Member of WickedGüd, to discuss the fascinating world of consumer insights. They delve into how culture impacts consumer behavior; why simple moments are the biggest aha moments; and why taste is the number one consideration for brands…

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

1M 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…

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The Power of Customer Insights: Uncovering Why Customers Do What They Do with Vashte Johnson of Slidedesignr 54:46

1M ago54:46

54:46

In this episode of Getting to Aha!, Darshan Mehta is joined by Vashte Johnson, the Founder of Slidedesignr. Join them as they discuss the importance of customer insights, Vashte’s insights accelerator model for creating powerful deliverables, as well as the importance of storytelling, clarity, and emotional engagement in visualizations. Vashte John…

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

1M 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…

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[Greatest Hits] Is Passion Enough to Succeed in Business? With Karthikeyan Selvaraj, Founder & CEO of Dunkel Kitchen 30:29

1M ago30:29

30:29

In this Greatest Hits episode of Getting to Aha!, Darshan Mehta is joined by Karthikeyan Selvaraj, Founder & CEO of Dunkel Kitchen, a successful cloud kitchen chain! They delve into why passion and business are two different but essential things in your entrepreneurial journey and why you should always find different ways to succeed, as well as out…

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

1M 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

2M 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…

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The Significance of Customer Insights for Business Success with Arnold Lee of CFO Growth Advisors 50:09

2M ago50:09

50:09

In this episode of Getting to Aha!, Darshan Mehta is joined by Arnold Lee, CFO and Managing Director of CFO Growth Advisors. Join them as they explore the need for companies to understand why customers behave the way they do, the challenges faced by startups, and the formula of finance, strategy, and customer insights as the key to success. Arnold …

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

2M 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…

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

2M 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…

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[Greatest Hits] Seeing the Future with the Help of Consumer Insights with Danielle Blugrind, Senior Consumer Manager at Roku 34:12

2M ago34:12

34:12

In this Greatest Hits episode of Getting to Aha!, Darshan Mehta is joined by Danielle Blugrind, Senior Consumer Manager at Roku. They discuss Danielle’s aha! journey; why you shouldn’t try to reinvent the wheel with your product; how insights can help you see into the future and figure out who your customers are; the importance of keeping your prod…

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

2M 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…

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

2M 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…

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From Lawyer to Creative Director: Journeying into Insights and Storytelling with Kory Grushka 47:16

2M ago47:16

47:16

In this episode of Getting to Aha!, Darshan Mehta is joined by Kory Grushka, Founder and Creative Director of Stories Bureau. Together, they delve into the interaction of Kory’s creative and legal career paths; explore the founding of Stories Bureau; and examine the impact of AI on storytelling. Kory Grushka is an entrepreneur and creative director…

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

2M 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…

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[Greatest Hits] All Insights Are About Building a Connection with Lynn Adelmund, Senior VP of Market Research at Trifecta Research 25:43

2M ago25:43

25:43

In this Greatest Hits episode of Getting to Aha!, Darshan Mehta is joined by Lynn Adelmund, Senior VP of Market Research at Trifecta Research, a leading research and advisory firm serving Fortune 1000 companies and agencies. They discuss some of Lynn’s Aha! moments; how technology has impacted the world of consumer insights; how insight professiona…

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

2M 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…

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

2M 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…

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Differentiation and Authenticity in Marketing with Alex Montas of BENlabs 29:54

2M ago29:54

29:54

In this episode of Getting to Aha!, Darshan Mehta is joined by Alex Montas, Head of Marketing at BENlabs. They discuss Alex’s background and entrepreneurial mindset, the importance of differentiation, the need to maintain humanity and connection in the digital landscape, the evolution of AI in marketing, and the importance of taking risks and learn…

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

3M 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…

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

3M 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…

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[Greatest Hits] How AI Helps You Better Understand Your Consumer with Alex Charlton 32:44

3M ago32:44

32:44

In this Greatest Hits episode of Getting to Aha!, Darshan Mehta is joined by Alex Charlton as they unveil the importance of harnessing the power of customer insights to drive business success and the potential of AI in improving research processes and running effective marketing strategies. They also touch on the balance between human intelligence …

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

3M 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 …

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

3M 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…

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Congruency Review: The Game Changer 2:53

3M ago2:53

2:53

Insider Exposes crucial missing step in Clinical Trial Agreements activation - Congruency Review Details Revealed! In the clinical trial agreement activation pathway, the journey involves several critical steps. It begins with the signing of the Confidentiality Disclosure Agreement (CDA), followed by the study team's review of the protocol and feas…

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Data-Driven Content with Becky Lawlor, Chief Research and Content Officer at Redpoint 33:31

3M ago33:31

33:31

In this episode of Getting to Aha!, Darshan Mehta is joined by Becky Lawlor, Founder and Chief Research and Content Officer at Redpoint. They discuss the importance of niche research in the world of content marketing, the role of research in creating quality content, AI’s impact on research, and the importance of offering affordable excellence. Bec…

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Legal Minute: 5 hacks to fast-track your speaker program reviews 0:27

3M ago0:27

0:27

Accelerate your digital speaker program review with these 5 game-changing strategies: Policy Creation & Training Pre-reviews AI-based Reviews Modular Reviews Applying Quality Learnings Across the Program Dive deeper into each strategy on our podcast! Watch the full podcast- https://www.youtube.com/watch?v=Ud8jn4c3cCM…

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Selecting your ideal subject recruitment partner 2:08

3M ago2:08

2:08

Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company's experience and expertise in a specific disease state or area, its reach (national, international, or local), and the associated costs. He warns against the trend of traditional marketing companies enteri…

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[Greatest Hits] Why Customers Act the Way They Do with Rebecca Brooks, CEO & Founder of Alter Agents 49:20

3M ago49:20

49:20

In this episode of Getting to Aha!, Darshan Mehta is joined by Rebecca Brooks, CEO & Founder of Alter Agents. They discuss Rebecca’s aha! moments, how to improve customer experience by making it more powerful and emotional for them, the revelation of customer truths, the future of brand loyalty, the emotional side of customer experience, product in…

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Your digital sales team’s success depends on these 5 compliance rules 5:00

3M ago5:00

5:00

We discuss five key legal and regulatory considerations for a digital sales force: Starting with updates to the Physician Payment Sunshine Act, emphasizing the need for training, robust internal controls, and monitoring. It also touches on guidance for interactions with healthcare professionals, emphasizing transparency and ethical practices. The S…

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Legal Minute: 3 FTC rules for winning comparative claims 0:25

3M ago0:25

0:25

We explore the crucial aspects outlined by the FTC regarding comparative claims in drug and device advertising. the paramount importance of transparency in promotional efforts, the pitfalls associated with broad generalizations, and the need for readiness in the face of scrutiny from both the FDA and the FTC. Providing a valuable intersection of ph…

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The risks and rewards of Clinical Research as a Care Option 2:23

3M ago2:23

2:23

In this podcast, we explore a groundbreaking shift where clinical research is emerging as a viable care option, known as Clinical Research as a Care Option (CRACO). While the concept seems promising, particularly for patients with conditions like rare diseases or cancer, it introduces a host of concerns. The alignment of Institutional Review Board …

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Influencer Marketing vs Celebrity Endorsements with Gil Eyal, Head of Marketing and Innovation at Silverstein Properties 37:01

3M ago37:01

37:01

In this episode of Getting to Aha!, Darshan Mehta is joined by Gil Eyal, Head of Marketing and Innovation at Silverstein Properties. They discuss Gil’s aha! moments, influencer marketing vs. celebrity endorsements, avoiding celebrity endorsement pitfalls, the importance of storytelling, diversification in digital marketing, the importance of conver…

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3 game changing ways the FDA says AI will transform drug development 1:48

3M ago1:48

1:48

In this podcast, we discuss artificial intelligence (AI) and machine learning, exploring their pivotal roles in drug development. AI, a fusion of computer science, statistics, and engineering, employs algorithms to perform tasks like learning, decision-making, and prediction. Within the context of drug development, we unravel three significant appl…

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Legal Minute: Comparative claim review by NAD 0:59

3M ago0:59

0:59

The National Advertising Division (NAD) recently examined a TV ad by Bravecto, comparing its flea and tick prevention product with NexGard's. The ad suggested Bravecto's greater effectiveness, disputed by NexGard. NAD sided with NexGard, emphasizing the need for clear and conspicuous disclosures in comparative advertising. In a separate case, Googl…

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5 foolproof ways to get your digital speaker program approved 2:52

4M ago2:52

2:52

In this podcast, five crucial considerations for obtaining approval for a digital speaker program are discussed: 1. Privacy Compliance: - Consider where audience data will be stored and ensure compliance with privacy laws (TCPA, CCPA, GDPR, etc.). - Prioritize secure handling of sensitive information and always obtain audience consent. 2. Transpare…

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Our Best Aha! Moments: Our Top 5 Insights From Recent Episodes (2nd Edition) 13:44

4M ago13:44

13:44

Last year, we unveiled our Special Compilation Episode - Aha! Moments from Our First 20th Episode, and the response was so heartwarming that we did it twice! Now, we're delighted to present our third special: the top 5 best episodes from our recent 20. We've had the privilege of hosting extraordinary guests from diverse fields, generously sharing t…

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Legal Minute: Prepare your Cosmetics Company for 2024 0:48

4M ago0:48

0:48

he recently issued FDA guidance mandates manufacturers, packers, and distributors to adhere to new standards, emphasizing mandatory product and facility registrations, creation of safety substantiation information, and implementation of adverse event reporting. Daron breaks down key definitions, clarifies information submission processes, and discu…

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[Greatest Hits] Balancing the Digital Scales: Ethics, Inclusivity, and Accountability with Katrina German 42:50

4M ago42:50

42:50

In this Greatest Hits episode of Getting to Aha!, Darshan Mehta is joined by Katrina German as they delve deep into the realms of digital marketing, underscoring the crucial roles of inclusivity, ethics, and accountability. Katrina sheds light on the dual-edged sword that is social media: its unprecedented power in connecting individuals and champi…

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