พอดคาสท์ Darshan ชั้นนำ (2024)

1
Exploring the World: A Journey of Aha! Moments with Heath Tredell of Bablake House Limited 39:57

2d ago39:57

39:57

In this episode of Getting to Aha!, Darshan Mehta is joined by Heath Tredell, the Managing Director of Bablake House Limited. Join them as they discuss formative Aha! moments, retiring early, and prioritizing experiences over possessions. Heath Tredell is the Managing Director of Bablake House Limited, a family-owned residential home that offers ho…

1
Why Clinical Researchers Are Flocking to MedSpas 32:13

2d 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-p…

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

5d 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

8d 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

9d 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
[Greatest Hits] Mastering Influencer Marketing for Business Growth with Prateek Panda, VP of Marketing at Phyllo 44:39

9d ago44:39

44:39

In this ‘Greatest Hits’ episode of Getting to Aha!, host Darshan Mehta is joined by Prateek Panda, VP of Marketing at Phyllo. join them as they explore the importance of customer insights, the importance of authenticity, and the future of the industry. Prateek also shares valuable insights and advice for businesses looking to leverage influencers f…

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

10d 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

11d 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

13d 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
Misconceptions and Realities: Exploring Performance Enhancement with Dustin Elliott of the Vitamin Shoppe 43:00

16d ago43:00

43:00

In this episode of Getting to Aha!, Darshan Mehta is joined by Dustin Elliott, the Senior Brand Manager at The Vitamin Shoppe. Join them as they explore misconceptions about performance enhancement, the impact of gut health on overall wellbeing, emerging trends in the supplements industry, and the future of nutrition and healthcare. Dustin Elliott …

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

17d 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

19d 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

23d 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
[Greatest Hits] Experiences Beyond the Product with Experiential Designer, Xuan Xu 52:06

23d ago52:06

52:06

In this ‘Greatest Hits’ episode of Getting to Aha!, Darshan Mehta was joined by Xuan Xu, Managing Director of Xuan Xu Experiences. Together they explore why the accessibility of commodities and the rise of digitalization means consumers seek unique and memorable experiences, as well as the challenges faced by experiential designers. Xuan also discu…

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

27d 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
Building Brands through Creative Storytelling: Lessons from Matt Swieca of The Martin Agency 30:36

1M ago30:36

30:36

In this episode of Getting to Aha!, Darshan Mehta is joined by Matt Swieca, Executive Producer/Program Director at The Martin Agency. Join them as they discuss the importance of customer insights, storytelling, and adapting to the evolving landscape of digital marketing and advertising. Matt shares valuable insights into the industry and the strate…

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

1M 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

1M 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
[Greatest Hits] The Philosophy of Unleadership with Steve Krull, CEO and Co-Founder of Be Found Online 43:33

1M ago43:33

43:33

In this ‘Greatest Hits’ episode of Getting to Aha!, host Darshan Mehta is joined by Steve Krull, CEO and co-founder of Be Found Online, a strategy-driven, people-focused digital marketing agency that connects brands and humans in innovative ways. Join them as they explore Steve’s journey to starting Be Found Online, why hiring should be based on cu…

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

1M 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.โดย Darshan Kulkarni

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

1M 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
Insights and Empathy: Building Meaningful Customer Relationships with Alex Genov, Head of Customer Research and Marketing Insights at Zappos 38:06

1M ago38:06

38:06

In this episode of Getting to Aha!, Darshan Mehta is joined by Alex Genov, the Head of Customer Research and Marketing Insights at Zappos. Join them as they discuss the importance of customer insights and empathy in creating remarkable products and services, and explore misconceptions about data reliance, channel optimization, and hospitality. Alex…

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
[Greatest Hits] Handling Challenging Interactions with Haider Aabidi, Chief Marketing Officer at Country Chicken Co. 30:02

2M ago30:02

30:02

In this Greatest Hits episode of Getting to Aha!, Darshan Mehta is joined by Haider Aabidi, Chief Marketing Officer and Head of D2C at Country Chicken Co. Together, we delve into why you should always surround yourself with people who are smarter than you; what it means to take a calculated risk in entrepreneurship; and why you need to respect your…

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

2M 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…

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

2M 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.โดย Darshan Kulkarni

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

2M 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
[Greatest Hits] Switching Mindsets: Engineering to Marketing with Pavangopal A, Chief Marketing Officer at Nandu’s 33:13

2M 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

2M 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

2M 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

2M 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
[Greatest Hits] Find Simplicity to Find Your Aha! With Monish Debnath, CMO of WickedGüd 33:36

3M 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

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

3M 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…

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

3M 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…

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

3M 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

3M 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
The Significance of Customer Insights for Business Success with Arnold Lee of CFO Growth Advisors 50:09

3M 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 …

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

3M 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
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
[Greatest Hits] Seeing the Future with the Help of Consumer Insights with Danielle Blugrind, Senior Consumer Manager at Roku 34:12

4M 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…

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

4M 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…

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…

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