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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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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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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In this episode, we discuss how drug and device manufacturers may seem to collaborate with telemedicine companies to market products and ensure patient needs are met conveniently. However, there are three major concerns: 1. Ignoring Pharma Laws: Telehealth companies might not adhere to pharma marketing laws and could act as agents for pharma due to…
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Why a food lawyer would stop your restaurant’s marketing?
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Today, we're tackling a critical issue for restaurants and food marketers: promotional compliance and the risks of misbranding, as highlighted by a recent case in Biloxi. Mary Mahoney's Old French House Restaurant and its co-owner, Anthony Charles Savanovich, recently pled guilty to conspiracy and misbranding seafood. Over six years, they sold over…
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Following Your Passion: Greg Segal's Journey from Lawyer to Filmmaker
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In this episode of @Getting to Aha!, Darshan Mehta is joined by Greg Segal, a writer/director and producer. Join them as they discuss Greg's journey from lawyer to filmmaker, the value of contemplating life choices, and his involvement in producing vertical movies for platforms like TikTok. Greg Segal is a writer/director and producer based in New …
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Legal Minute: Why are there chemo drug shortages?
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We discuss how the shortage of chemotherapy drugs stems from economic challenges faced by generic drug manufacturers. Many cannot afford to produce these drugs due to low profitability. Factors include factory shutdowns for quality issues, a complex global supply chain, and older generic drugs being unprofitable to produce. Government pressure on p…
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Are Pharma Giants Ignoring Clinical Trial Site Issues?
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In this episode, Daniel Fox discusses the key challenges faced by research sites, including trust issues, payment delays, and operational setbacks. He emphasizes initiatives like the "Open Mic" policy for anonymous feedback and the grassroots movement Save Our Sites (SOS). Dr. Fox also explores issues with decentralized clinical trials, advocates f…
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[Greatest Hits] Turning a Hobby into a Career with Jim Turner and Steve Sidelnyk
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In this ‘Greatest Hits’ episode of Getting to Aha!, host Darshan Mehta is joined by Steve Sidelnyk, highly accomplished session drummer and music programmer, and Jim Turner, an experienced entertainment industry professional. Join them as they discuss the importance of standing out in a competitive industry, the importance of curiosity and learning…
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Why Adverse Events Go Unreported in Clinical Trials
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In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disru…
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In this episode, we delved into the pivotal role of patient advocates within the pharmaceutical industry. Patient advocates are champions who ensure that patients' voices are not only heard but also central to decisions affecting their health. They play a crucial role in various aspects: Firstly, patient advocates are instrumental in representing t…
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The Importance of Empathy in Sales Management: Insights from Alan Versteeg, Global Chief Revenue Officer at Growth Matters
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In this episode of Getting to Aha!, Darshan Mehta is joined by Alan Versteeg, Global Chief Revenue Officer at Growth Matters. Join them as they discuss conveying customer value, the use of generative AI, and the role of empathy in sales. Alan also touches on the future of sales, and the role of sales managers. Alan Versteeg is an engineer turned sa…
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Why Drug Accountability Matters in Clinical Trials
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Drug accountability is a critical aspect monitored by the FDA at clinical trial sites. Principal investigators must maintain and document control over investigational products, ensuring they are only administered under direct supervision. Clinical research organizations also conduct routine audits to verify drug accountability. However, instances o…
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Legal Minute: What do I do if my med is on shortage?
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We discuss how to address drug shortages. First things first, it's important to stay calm. Just because there's a shortage doesn't mean you'll lose access to your medication entirely. Here are some action steps you can take: 1. Schedule an appointment with your doctor to discuss alternative medications that might be effective for you. It's crucial …
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5 reasons not to use AI in creating pharma marketing content
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We discuss the risks associated with using AI in your pharma marketing plans: 1. Data Privacy and Security: Ensuring the security and privacy of data, whether it pertains to patients or non-patients, is paramount. 2. Bias: Questions arise regarding the sources of information, control over data, and addressing privacy concerns to prevent biases and …
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8 essential elements of a valid prescription
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In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse: Verify the prescriber's identity. Know the prescriber's DEA number. Know your patient thoroughly. Verify prescription dates for validity; ensure prescriptions are current. Communicate directly with prescribers if any concerns arise. Request identi…
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[Greatest Hits] How Twitter Changed the Branding Game with Brandon Rhoten, CMO at GroundTruth
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In this ‘Greatest Hits’ episode of Getting to Aha!, host Darshan Mehta is joined by Brandon Rhoten, Chief Marketing Officer at GroundTruth. Join them as they discuss the impact of social media in humanizing brands, why digital marketing channels should be seen as tools to solve specific brand problems, and leveraging customer insights beyond surfac…
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In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape in the pharmaceutical industry. Dive into the conversation as we explore the impact of regulatory bodies like the FDA, FTC, and NAD, and the importance …
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Legal Minute: 4 Ways to Get Unapproved Drugs Legally!
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Today, we discuss four legal pathways to acquire unapproved drugs. First, over-the-counter drugs offer a route as some bypass FDA approvals, relying instead on a nomograph. Second, compounded drugs crafted by pharmacists provide an alternative despite lacking FDA approval. Third, the FDA's new policy allows for state-imported drugs, provided certai…
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Disruptive Innovation in the Restaurant Industry: Insights from Steve Bigari, EVP, AI for Restaurants at Soundhound
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In this episode of Getting to Aha!, Darshan Mehta is joined by Steve Bigari, the EVP, AI for Restaurants at Soundhound. Join them as they discuss how technology, particularly AI, can enhance the restaurant experience, the mindset needed to be a disruptor in the industry, and the importance of removing friction from the customer's life. Steve also s…
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The 4 Building Blocks of Using AI in any Pharma Marketing Strategy
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We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use: 1. Define Clear Goals: Establishing clear objectives is crucial for developing a comprehensive compliance plan for AI use. Without clear goals, executing a successful strategy becomes challenging. 2. Establish Policies and Procedures: Clearly defined pol…
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Legal Minute: Why Clinical Trials Are Right for You!
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In this short, we explore four key reasons to get involved in clinical research. First, it offers potential access to cutting-edge therapies, though it's important to note you might only receive the standard of care. Second, participation ensures closer monitoring by healthcare professionals. Third, it provides an opportunity to contribute to medic…
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Why Clinical Researchers Are Flocking to MedSpas
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In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee . Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-…
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[Greatest Hits] Exploring the Power of the Subconscious with Shalini Josh Yamdagni of EFT Thailand
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In this ‘Greatest Hits’ episode of Getting to Aha!, host Darshan Mehta is joined by Shalini Joshi Yamdagni, Chronic Pain Relief Expert at EFT Thailand. Join them as they explore helping people with chronic pain find relief through alternative approaches, the power of emotions in influencing physical wellbeing, and the use of Emotional Freedom Techn…
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Legal Minute: Why You Should Never Trust a Celebrity with Your Health
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Darshan explains why you shouldn’t Trust Celebrities When Choosing Your Drugs! Hidden Agendas: They're paid to promote, not give unbiased advice. Not Medical Experts: Trust your doctor's knowledge, not a celebrity's opinion. Oversimplified Info: 30-second ads can't tell the whole story. Not Personalized: Your doctor can give you the right advice fo…
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Recent pharmacy walkouts and closures at major chains highlight a critical issue: staffing shortages. Independent pharmacies are also at risk. Here are 5 tips for pharmacy owners and managers to prepare for potential temporary closures: Cross-Train Staff: Train front-end staff on basic pharmacy procedures (depending on state regulations) so they ca…
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Exploring the World: A Journey of Aha! Moments with Heath Tredell of Bablake House Limited
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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…
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Legal Minute: 5 Surprising Benefits of Ozempic!
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We dive deep into 5 uses of Ozempic, a drug known for managing diabetes, but with surprising potential beyond! Here are 5 intriguing uses you might not have heard of: Liver Support: Early research suggests Ozempic could benefit liver health, but more studies are needed. Weight Loss Weapon: Ozempic has a weight-loss version, offering a powerful tool…
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In today's episode, we discuss AI-generated content in the pharmaceutical industry. AI has revolutionized content creation, but it's not without its legal and ethical dilemmas. Take, for instance, the New York Times' lawsuit against OpenAI, highlighting the contentious issue of data ownership. As pharma companies increasingly rely on AI for content…
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Legal Minute: Why does my drug cost so much?
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In today’s short, Darshan discusses why drugs cost so much. It takes around 10 to 15 years and roughly $2.3 billion to bring a drug to market. That means a drug company spends between $420,000 and $630,000 daily during this process. Imagine going to a casino every day, betting that much money without knowing the outcome, for 10 to 15 years. What ki…
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[Greatest Hits] Mastering Influencer Marketing for Business Growth with Prateek Panda, VP of Marketing at Phyllo
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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…
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AI for Promotions in FDA-Regulated Industries
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Join Darshan Kulkarni, a Food and Drug attorney, as he explores the dynamic intersection of artificial intelligence, drug and device promotion, and the law. In this podcast series, we'll dive deep into AI's role in promotional and non-promotional communications within the pharmaceutical and medical device industries. From regulatory compliance and …
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Legal Minute: Billion-Dollar Speaker Scheme!
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Speaker programs are events sponsored by drug and device companies where a physician or other healthcare professional (HCP) delivers a speech or presentation to fellow HCPs regarding a specific drug, device product, or disease state on behalf of the sponsoring company. Typically, the company compensates the speaker with an honorarium and may also p…
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Off-Label Risks: Compliance Matters Now More Than Ever
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We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry. We discuss the following: What does off-label mean from a reimbursement standpoint? Lessons from the US v. Eli Lilly 2009 case How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau How ar…
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Misconceptions and Realities: Exploring Performance Enhancement with Dustin Elliott of the Vitamin Shoppe
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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 …
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6 Must-Knows Before Buying a Drug or Device Company
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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…
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Legal Minute: Are there chemo drug shortages?
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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…
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Legal Minute: Don’t Ignore State Registrations
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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…
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[Greatest Hits] Experiences Beyond the Product with Experiential Designer, Xuan Xu
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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…
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Legal Minute: 6 Crucial Mistakes in Informed Consent
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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…
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Building Brands through Creative Storytelling: Lessons from Matt Swieca of The Martin Agency
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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…
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Legal Minute: What is informed consent in clinical trials?
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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…
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Stop Risky Ads: Class Actions Could Cost You
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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…
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[Greatest Hits] The Philosophy of Unleadership with Steve Krull, CEO and Co-Founder of Be Found Online
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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…
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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
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5 Surprising Causes of Life Science Deal Failures
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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…
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Insights and Empathy: Building Meaningful Customer Relationships with Alex Genov, Head of Customer Research and Marketing Insights at Zappos
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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…
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Legal Minute: Is pharma bribing your doctor?
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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…
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[Greatest Hits] Handling Challenging Interactions with Haider Aabidi, Chief Marketing Officer at Country Chicken Co.
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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…
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Legal Minute: Drug Registrations that can’t be ignored
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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…
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Debunking Nutrition Myths: Taking a Balanced Approach with Ross Franklin, Founder of Pure Green
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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?
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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, …
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