Businesses thrive by knowing customer insights, because today’s insights are tomorrow's facts. At iResearch we live and breathe insights. And despite searching high and low, we were unable to find a customer insights podcast that answers one of the most important questions in business: why do customers do what they do? So we launched one.
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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 ...
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Energy channels, updates and meditations for helping navigate challenging times.
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Extend with Darshan Shah, MD is a podcast dedicated to cutting-edge science, research, tools, and protocols designed to help you extend your healthspan. Starting my medical journey at 16 and becoming one of the youngest doctors in the country, studying and training at the Mayo Clinic, Harvard Business School, Singularity University and other prestigious institutions, becoming a board certified surgeon and accumulating over two decades of practice, I have discovered that a mere 20% of health ...
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Everyone matters :)
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Dear Friends I shall be presenting poems &Songs of famous writers of Hindi in this series.
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Sharing my life stories, experiences, and motivational teachings and wisdom. Early in my life I survived a life threatning illness where I was given no chance to live more the 6 months. That was 26 years ago....... Cover art photo provided by Oleg Laptev on Unsplash: https://unsplash.com/@snowshade
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Get all the practical solutions to all your problems in spiritual ways through Akram Vignan.
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DarShea's Place is a place where you go and sit on the couch, have tea or wine. And just tap into your inner self. The place where you can get inspiration and hear/read the truth. Also, a place that offers your systems/ways/formulas to overcome trauma and pain in life.
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SWAMINARAYAN SAMPRADAY SAHITYA DARSHAN SANATAN DHARM PRAVARTAK SARVOPARI SHRI SWAMINARAYAN BHAGWAN NA DIVYA LILA CHARITRA SABHAR SAHITYA. OUR SPIRITUAL HISTORY OUR ANCIENT ART OUR CULTURE OUR HUMAN ENTITY
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Sri Birendra Chandra Chakraborty, His Excellency was well known to the general mass as Param Pita Janmasiddyha Thakur Sri Sri Balak Brahmachari Maharaj. Sri Sri Thakur's disciples, devotees, followers and impassioned counts to 25 Crores in India itself. During his tenure, many great men of different name and fame from various castes, creeds and sects of the society had the opportunity to seek His blessings.The Great Hymn “RAM NARAYAN RAM” was given by Sri Sri Thakur which is the revamp of “H ...
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[Greatest Hits] Data-Driven Content with Becky Lawlor, Chief Research and Content Officer at Redpoint
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In this Greatest Hits episode of Getting to Aha!, Darshan Mehta revisits his discussion with Becky Lawlor, Founder and Chief Research and Content Officer at Redpoint. Together, they explore the power of niche research in content marketing, the critical role of research in crafting high-quality content, the transformative impact of AI, and the value…
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5 Common Clinical Trial Site Failures
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Darshan discusses the five most common clinical trial site issues: 1. Failure to Follow Investigational Plan: Treating clinical trials like routine medical practice instead of strictly following the protocol can lead to serious issues. 2. Inadequate and Inaccurate Records: The FDA emphasizes that if it’s not documented, it didn’t happen. Inaccurate…
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19. The Supplement Myths You Need to Stop Believing
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Have you ever felt overwhelmed by the endless options in the supplement aisle? In this episode of Extend, I take a closer look at why so many people struggle to make sense of supplementation—and what you can do to make smarter, science-backed decisions. From the declining nutrient density in modern diets to the role of supplements in addressing def…
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The FDA’s Center for Devices and Radiological Health (CDRH) has launched a groundbreaking initiative aimed at improving the efficiency and speed of recall communications for medical devices. Here are the five key strategies from the FDA's new medical device recall initiative: Faster Alerts for High-Risk Devices: The FDA aims to reduce the time betw…
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18. Dr. Dale Bredesen: This Hidden Risk is Damaging Your Brain, Can Alzheimer’s Be Reversed + The New Breakthroughs Everyone Needs to Know
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Have you ever wondered if memory loss or cognitive decline is inevitable as we age? What if I told you it’s not—and that, with the right strategies, you can even reverse early signs of neurodegeneration? In this episode of Extend with Dr. Darshan Shah, I sit down with my friend and esteemed colleague, Dr. Dale Bredesen, a pioneer in brain health an…
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IRB Challenges and Updates for 2024
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In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involvement. They also cover the impact of new guidance, the Trump administration, and the FDA's relationship with IRBs. We discuss: 1. The FDA’s Finalized G…
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The polio vaccine, credited with eradicating a crippling disease in the U.S., faces renewed scrutiny after attorney Aaron Siri, linked to Robert F. Kennedy Jr., petitioned the FDA to revoke its approval. Kennedy, nominated as Health and Human Services Secretary, has distanced himself from the "anti-vaccine" label but calls for further vaccine studi…
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FDA blue print to discuss off label topics
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FDA has changed its mind about off label marketing. Today, we're diving into how drug and device companies can effectively engage with payers and providers, exploring recent updates and guidelines. Let’s start with the basics: FDA Regulations and the First Amendment. The FDA’s ability to impose restrictions on speakers and content is limited by the…
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[Greatest Hits] Unlocking Cultural Insights in Branding with Kalil Vicioso, Principal Consultant at Tiny Hat Consulting
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In this Greatest Hits episode of Getting to Aha!, Darshan Mehta welcomes Kalil Vicioso, Principal Consultant at Tiny Hat Consulting, a firm dedicated to empowering brands through cultural and consumer insights. Kalil also serves as a Board Member for Insights in Color. Together, they explore Kalil's Aha! journey, his dynamic career, and his work on…
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17. Why Your Diet Isn’t Working (And What Actually Does)
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Are you trapped in the cycle of endless dieting and calorie counting? For years, we've been told that weight loss is as simple as “calories in, calories out,” but if that’s true, why do so many of us still struggle? What if the problem isn’t just the numbers, but how we think about them? In this episode of theExtend podcast, I take a closer look at…
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🔒 Opportunities AI provides in Clinical Research
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Subscriber-only episode Today, we're discussing the FDA's use of artificial intelligence (AI) to transform clinical trials. AI is emerging as a cornerstone in clinical research, with the FDA recognizing its potential in several key areas. First, predictive modeling allows AI to optimize pharmacokinetic profiles, streamlining dosing regimens and enh…
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16. JJ Virgin: The Real Reason You’re Not Building Muscle (+ What to Do Instead)
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Ever find yourself putting in the time at the gym, only to feel like you’re barely moving the needle? Or notice that staying in shape seems to get tougher every year? Here’s the thing: muscle health is the backbone of your metabolism, strength, and long-term vitality, but it’s often the missing link in most people’s routines. In this episode, I’m t…
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Telehealth and Biohacking: A Risky Combination
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The rise of biohacking has transitioned from a niche interest to a mainstream trend, particularly in the context of drugs like Ozempic and ketamine. While biohacking aims to enhance human performance and health, it raises significant questions about the risks and benefits, especially concerning telehealth services. Individuals are increasingly seek…
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Is the FDA’s Response to AI Falling Behind?
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The FDA’s current approach to AI in healthcare highlights significant gaps in regulatory preparedness. Although the FDA has approved thousands of AI-enabled tools, it still lacks the resources, clear guidelines, and enforcement power necessary to address the rapid advancements and risks of AI effectively. The agency has issued frameworks and adopte…
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Healthcare Is in Crisis: How do we fix it?
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In this episode, guest host Kate Woods and Darshan Kulkarni delve into current healthcare issues, including the unsettling news of the CEO of United Healthcare being shot. They discuss the broader implications of this event, questioning how it reflects the state of the healthcare system and whether CEOs in troubled companies are becoming targets. T…
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Unlocking the Power of Social Insights with Maz Nadjm
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In this episode of Getting to Aha!, host Darshan Mehta is joined by Maz Nadjm, a leading figure in the world of social media and generative AI. Maz shares his journey from programming to becoming a global leader in AI marketing at Tata Consultancy Services, detailing his path through roles at Ogilvy, Wipro, and Sky. The conversation explores the ev…
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Robert F. Kennedy Jr. has announced plans for a presidential mandate to restore federal agencies, including the FDA, to the "gold standard" of scientific review. This bold proposal has significant implications for the life sciences industry, affecting drug advertisers, clinical researchers, and M&A attorneys. Key Takeaways by Sector For Drug Advert…
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15. How to Reverse Metabolic Syndrome
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Are you part of the 88% of people who are metabolically unhealthy—and don’t even know it? Do you know what metabolic health really means? Or why is it the root cause of nearly every chronic disease? In this episode of Extend, I’m diving deep into the critical world of metabolic health—how it works, why it matters, and what you can do today to optim…
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Florida medical clinic owner and staff were charged with falsifying clinical trial data. According to the indictment, from September 2015 to March 2018, the defendants at AMB Research Center in Miami fabricated clinical trial data for profit. They knowingly enrolled subjects who did not meet eligibility criteria, falsified lab data and medical reco…
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14. Darin Olien: The Deceptive Nature of Ultra-Processed Foods, Toxins in our Products, Top Tips on Nutrition, Daily Stress Busters + More
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What if simple lifestyle changes could transform your health in ways you never imagined? In this episode of Extend with Darshan Shah, MD with my guest, Darin Olien, we dig into the basics—nutrition, exercise, and stress management—that lay the foundation for a healthier life. Darin also explains why cutting out ultra-processed foods in favor of fre…
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Darshan Fixes Big Pharma Misconceptions
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In this reaction video, Darshan responds to claims about the effectiveness of prescribed medications. While patients often expect their drugs to work, a statement suggesting that only 20% of people benefit from these medications is misleading. Darshan emphasizes that the FDA focuses on ensuring drugs are not harmful and assesses efficacy based on t…
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How Trump’s Tariffs will Disrupt Clinical Trials and Drug Marketing?
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In today's podcast, we dive into President Trump's proposed tariffs on Canada, Mexico, and China and what these moves could mean for the life sciences industry. Tariffs, essentially taxes on imported goods, are designed to protect domestic industries by making foreign goods more expensive. While the Trump administration believes tariffs will boost …
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Compassion, Critical Thinking, and Change with Hawah Kasat
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In this episode of Getting to Aha! Host Darshan Mehta engages Hawah Kasat, a global humanitarian and co-founder of One Common Unity, in an inspiring discussion about the transformative power of moments. Hawah shares his journey, shaped by his early travels, passion for peacebuilding, and commitment to fostering connection through education and the …
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13. Are You Fueling or Failing Your Body?
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Are you overwhelmed by all the conflicting diet advice out there? In this episode of Extend, I simplify it all with a framework that works: the good, the bad, and the ugly of food. We’ll dive deep into how to structure your meals around nutrient-dense choices that nourish your body, help you maintain energy, and support long-term health. I’ll walk …
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Why China is Targeting Top Scientists!
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The Wall Street Journal recently reported that China is aggressively targeting tech talent with lucrative job offers, offering triple the pay for positions in the chip-making industry, sparking concerns in the West. This trend isn't unique to tech; similar tactics have been used in the life sciences. For instance, a Harvard law professor was charge…
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12. Kayla Barnes-Lentz: Female-Specific Health Approach, Reducing Toxins from Daily Products, Aligning Routines with Menstrual Cycles, Understanding Your Genetics + More!
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What if you could get the full potential of your health by tailoring it to your unique genetic blueprint? Ever wondered how personalized wellness could transform your approach to health and well-being? In this episode of Extend with Dr. Shah, we dive into this fascinating concept with biohacking expert Kayla Barnes Lentz, a pioneer in personalized …
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Trump’s Bold Picks Shake Up Life Sciences
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The Trump administration’s new appointees, including Elon Musk, Dr. Marty Makary, Dr. Jay Bhattacharya, and Robert F. Kennedy Jr., promise a significant shift for the life sciences industry. Each brings a disruptive approach to their respective agencies, signaling potential changes in clinical research, drug advertising, and regulatory oversight. K…
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3 Regulatory Opportunities in Clinical Trials!
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We explore the rapidly evolving role of artificial intelligence (AI) in clinical trial research design. He discusses how AI is reshaping the pharmaceutical landscape and highlights key areas identified by the FDA where AI is expected to make a significant impact. Darshan delves into the transformative power of digital health technologies, which ena…
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From English Major to EdTech Leader: John Jorgenson’s Transformative Journey
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35:09
In this episode of Getting to Aha! Host Darshan Mehta interviews John Jorgenson, CMO of Cambium Learning Group, to explore the interplay of education, marketing, and technology. John reflects on his career transition from English major to EdTech marketing leader, emphasizing the importance of aligning marketing strategies with educators' and studen…
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11. Can The Damage of Ultra-Processed Foods Be Stopped?
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We’ve all been there—grabbing a quick snack or packaged meal, trusting it to be “not that bad.” But what if I told you these ultra-processed foods are quietly undermining your health? Engineered for taste and convenience, they’re doing far more harm than you realize, contributing to fatigue, metabolic issues, and even chronic disease. If you’re ser…
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Don't Take Non-Prescription Ozempic or other Weight Loss Drugs
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We explore the emerging trend of patients bypassing traditional healthcare to obtain weight loss medications like Ozempic through unofficial channels and telehealth platforms. This underground movement raises serious ethical and legal concerns, as individuals manipulate systems to access these drugs without proper prescriptions, risking their healt…
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Clinical Trial Principal Investigator Duties in Clinical Trials
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The FDA has stressed the critical importance of adequate supervision and monitoring in clinical trials to ensure they are conducted properly. A key figure responsible for this oversight is the Principal Investigator (PI), as outlined in 21 CFR 32.6. The PI must ensure the trial follows the protocol and all applicable regulations, and that the right…
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10. Dr. Andy Galpin: Debunking One-Size-Fits-All Approach with Fitness and Health, Importance of Muscle Building + Personalized Approach to Wellness
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What if you could customize your health like a pro athlete? Imagine having a health and fitness routine tailored to your unique needs, just like a world-class athlete?! In this episode of Extend with Dr. Shah, we sit down with Dr. Andy Galpin, a leading expert in health and fitness technology, to explore the game-changing innovations that are trans…
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Supreme Court Redefined Pharma Marketing Rules
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6:38
The Supreme Court's ruling in Loper Bright Enterprises v. Raimondo significantly impacts off-label marketing for pharmaceutical and medical device companies by challenging the FDA's authority to restrict off-label speech. This decision is poised to reshape the regulatory landscape that has traditionally limited such communications. Key Legal Contex…
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[Greatest Hits] A Guide to Great Customer Service with Robert Spector, Author of The Nordstrom Way
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45:59
In this greatest hits episode of Getting to Aha!, Darshan Mehta is joined by Robert Spector, Author of Nordstrom Way. They discuss Robert's aha! moments, how to use customer service to improve businesses, the benefits of efficient customer service, and approaches to delivering more value to customers. Robert Spector speaks to salesmen about the imp…
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9. What’s Wrong with Our Food System? The Lies You’ve Been Told + Believe
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Why does a slice of bread today barely resemble the one your grandmother baked? Our food system has transformed dramatically over the decades, turning simple ingredients into what some call "Frankenstein foods." On this week’s solo episode of the Extend podcast, I dive deep into how we got here, exposing the missteps and misinformation that have sh…
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AI concerns in M&A for Life Sciences
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6:16
Artificial intelligence (AI) is transforming the life sciences sector, offering groundbreaking advancements in areas like drug discovery, clinical trials, and personalized patient care. As AI-driven technologies become more integrated into these processes, the allure of acquiring AI-powered companies grows stronger. However, the complexities that c…
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Trump Teams Potential Changes to Healthcare
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2:59
Healthcare and life sciences are on the brink of transformative change, fueled by a combination of technological innovation, ideological shifts, and evolving regulations. Visionaries like Elon Musk, Vivek Ramaswamy, and RFK Jr. are advocating for decentralization in healthcare, pushing for more personal control over patient data. While decentraliza…
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8. Dr. Casey Means: Impact of Metabolic Dysfunction, Actionable Tips to Optimize Metabolic Health, Key Metabolic Biomarkers and More
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Is your metabolic health the key to unlocking overall wellness? In our latest episode, we sit down with Dr. Casey Means, a leading voice in metabolic health, to talk about how your metabolism affects everything from obesity to Alzheimer's. Dr. Casey also dive into how our industrialized world is disrupting cellular biology and fueling chronic disea…
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Can AI Rewrite the Rules of Clinical Trials?
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In this episode, we're diving into the intersection of technology and healthcare, specifically the role of Artificial Intelligence (AI) in clinical trials. As a Food and Drug lawyer, Darshan has seen firsthand how AI is revolutionizing drug development and testing. The FDA is closely monitoring this shift, recognizing the potential of AI to enhance…
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Ad Promo Review in Pharma - How Far is Too Far?
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Katie Graham and I discuss various aspects of FDA and FTC regulations, including ad promo, the Chevron decision, and the evolving role of compliance in the pharmaceutical industry. Key topics include: What is Ad Promo? Chevron decision's influence on FDA/FTC Should administrative agencies cite letters? Can the FDA establish rules after someone chal…
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Simple Insights, Big Impact: Unlocking Customer Insights with Renee Brown
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36:13
In this episode of Getting to Aha!, host Darshan Mehta and guest Renee Brown dive deep into the world of customer insights and marketing strategies. Renee, a seasoned leader in financial services, shares her expertise on using ethnographic research to uncover customer pain points, and how simple, often overlooked insights can lead to transformative…
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Why Staff Training Problems are a liability for Your Clinical Trial site
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Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staff, recent cases reveal significant lapses. PIs are responsible for certifying that all associates, colleagues, and employees involved in the research are adequately trained and informed. However, inst…
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7. How Traditional, Functional, and Longevity Medicine Create a Healthier Future
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14:17
Is your health just something you react to when problems arise, or is it something you actively shape every day? For many, the journey to wellness only begins when they’re already facing a health crisis. I’m Dr. Darshan Shah, and I know this personally—I went from being overweight and on multiple medications to achieving a level of health I never t…
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Neuralink: Breakthrough or Marketing Hype?
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0:55
Neuralink recently received the FDA's Breakthrough Device label for its neural implant aimed at restoring vision to the blind by interfacing with the brain. While this sounds like a monumental achievement, it's important to understand that the Breakthrough Device program merely expedites the review process for promising innovations without guarante…
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6. Jay Shetty: Top 3 Mistakes People Make with Mental Health, Expert Tips to Balance Stress + more
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Are you struggling to find balance in your mental and spiritual well-being? Do you want to feel more grounded, less stressed, and truly connected to your roots? In this episode of Extend with Dr. Shah, my guest, Jay Shetty shares his journey from monastic life to becoming a global digital creator. We dive deep into the world of meditation, mindset,…
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Telehealth Compliance Crisis: DOJ exposes $2.75B Fraud!
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DOJ filed criminal charges against 193 defendants, including 76 medical professionals for telemedicine violation. This alarming crackdown reveals the vulnerabilities within telemedicine, as illegal kickbacks and brief consultations have led to significant fraud, particularly in Medicare claims. Among the troubling cases highlighted, one psychiatris…
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[Greatest Hits] Tension & Conflict: The Key to Brand Storytelling with Joe Lazer, Head of Marketing at A.Team
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38:34
In this Greatest Hits episode of Getting to Aha!, host Darshan Mehta talks with Joe Lazer, Head of Marketing at A.Team. Joe shares his pivotal "aha!" moment and highlights the critical role of storytelling in marketing. He emphasizes the need to connect with audiences genuinely, especially as attention spans shorten. Joe leads marketing at A.Team, …
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5. How This Underrated Thing Can Transform Your Health
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What if the secret to transforming your health isn’t about discipline but understanding how your brain is wired? In this episode of Extend with Dr. Shah, I dive into the fascinating science of habit formation and uncover why routines like regular exercise and structured eating are the real keys to long-term health and longevity. As a physician, I b…
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Should You Go In-House or Outsource Your Advertising Compliance?
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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…
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