सर्वश्रेष्ठ DarshanTalks पॉडकास्टस (2025)

1
Discussing Stem Cell Research Opportunities with a Research Site Owner 7:43

23h ago7:43

7:43

At the Site Council meeting, Darshan Kulkarni had the opportunity to speak with Mohamed Hakim, a site owner who has consolidated six clinical research sites into three. Their conversation explored the evolving landscape of clinical research, particularly in stem cell studies, in light of the regulatory shifts happening under the Trump administratio…

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Quality Management: A Must in Clinical Trial Contracts 6:23

3d ago6:23

6:23

In the second part of our discussion, Edye Edens speaks with subject matter expert Helen Maurer about integrating quality management into clinical trial contracts. While contracts often cover legal aspects like termination and jurisdiction, they frequently lack clear quality management plans. Helen emphasizes the importance of defining responsibili…

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AI-Powered Chatbots in Pharma Sales and Education 5:29

5d ago5:29

5:29

ChatGPT's recent update introduced an AI engagement feature reminiscent of the movie Her, the conversation is highly relevant as AI becomes more integrated into daily business operations. While AI voice chat offers benefits like consistent messaging, 24/7 availability, and efficiency, it also brings significant risks—especially in the heavily regul…

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Will New Tariffs Disrupt Your Next Pharma Deal? 1:21

6d ago1:21

1:21

The proposed 25% tariff on pharmaceutical APIs from China could have far-reaching effects on M&A transactions within the life sciences and healthcare industries. Since a significant portion of pharmaceutical raw materials originate in China, companies may face increased costs not only in sourcing but also in sales, as Canada considers imposing its …

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Protecting Patient Data in a Changing Regulatory Landscape 5:10

7d ago5:10

5:10

In this discussion, Edye Edens and Helen Maurer dive into the critical topic of data privacy and security in clinical research, particularly in light of potential federal oversight. Helen, an expert in compliance and quality assurance within oncology research, emphasizes the need for clinical trial sites—especially those at major academic medical c…

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Off-Label Promotion Changes in 2025 31:17

8d ago31:17

31:17

Stephanie Trunk and Darshan Kulkarni discuss the evolving landscape of the pharmaceutical industry under the Trump Administration in 2025. They highlight the uncertainty surrounding regulatory changes, particularly with new leadership at the FDA, CMS, and HHS (with RFK confirmed). There is concern over shifting prosecutorial priorities, overturned …

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Turning Physicians into Leaders 16:23

11d ago16:23

16:23

Kate Woods interviews Lee Scheinbart, who shares valuable advice for physicians aspiring to become Chief Medical Officers (CMOs) or take on leadership roles in healthcare. Lee stresses the importance of being intentional in career decisions and encourages young physician leaders to first focus on becoming competent clinicians. He advises earning me…

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Key Regulatory Agencies in Pharma M&A 1:18

12d ago1:18

1:18

When conducting an M&A transaction in the pharmaceutical or medical device industry, compliance must be a top priority. Regulatory agencies like the DOJ, FDA, OIG, and OCR have strengthened oversight, emphasizing successor liability and the need for strong compliance programs. Beyond FDA regulations, companies must consider fraud prevention, HIPAA,…

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Does E6 (R3) Blur the Line Between GCP and Privacy Laws? 1:37

13d ago1:37

1:37

In this video, Edye Edens discusses the recent transition of ICH GCP E6 from R2 to R3, highlighting an interesting question she received: Is R3 evolving into a privacy doctrine? Given its increased focus on data protection, system validation, and privacy responsibilities, some wonder if it overlaps with regulatory frameworks like HIPAA, especially …

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RFK Jr. Confirmed as HHS Secretary: What It Means for Healthcare Policy 8:01

14d ago8:01

8:01

Edye Edens and Darshan Kulkarni dive into the confirmation of RFK Jr. as Secretary of Health and Human Services and the immediate impact of President Trump’s latest executive order. The order mandates a comprehensive national health assessment, addressing issues like obesity, diabetes, and pediatric disorders, and aims to reshape the country’s appr…

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America’s Research Future in Jeopardy 7:44

17d ago7:44

7:44

Darshan Kulkarni and Edye Edens break down the significant impact of the Trump administration’s decision to cut NIH funding and reduce agency workforces, including the FDA, OHRP, and other key regulatory bodies. They discuss how these cuts could lead to serious disruptions in research funding, approval timelines, and the overall pace of medical inn…

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Trump Administration’s NIH cuts: Will they cripple US medical research? 7:48

18d ago7:48

7:48

Darshan Kulkarni and Edye Edens discuss the recent controversy surrounding the Trump administration’s decision to cap NIH overhead funding (also known as indirect costs or F&A) at 15%. This sweeping change has already sparked significant backlash, with academic medical centers, particularly in Democratic states, filing lawsuits to challenge the pol…

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DEI Under Trump: What It Means for Clinical Trials 7:47

19d ago7:47

7:47

The Trump administration’s early actions have significantly impacted federally funded programs, particularly in the clinical trial space, by rolling back diversity, equity, and inclusion (DEI) initiatives. This shift raises serious concerns for scientific research, as diversity in clinical trials ensures that drugs and devices are effective across …

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CAPA & RCA: A Must for Pharma M&A 1:39

20d ago1:39

1:39

When acquiring a pharmaceutical company, evaluating its quality and compliance programs is crucial. A strong program starts with well-documented policies and procedures, followed by comprehensive training to ensure employees understand and follow them. However, having policies in place isn’t enough—regulatory bodies like the FDA and DOJ stress that…

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Trump Targets Indirect Costs in NIH Funding 1:21

21d ago1:21

1:21

On Friday, the Trump administration announced a 15% cap on NIH indirect costs, raising important questions about its impact on research funding. Edye Edens breaks down what this means, clarifying that while direct costs like salaries and equipment remain unchanged, the cap affects crucial behind-the-scenes expenses such as lab maintenance, IT infra…

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The USAID Halt and Its Consequences for Clinical Research 2:29

22d ago2:29

2:29

The Trump administration’s actions have effectively halted USAID-funded clinical research worldwide, creating an unprecedented situation with significant ethical, legal, and medical implications. Clinical trials that relied on USAID funding have stopped, leaving ongoing research in limbo and raising serious concerns about what happens to trial part…

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Ebola Vaccine Trial in Record Time! 2:29

24d ago2:29

2:29

On January 30, 2025, Uganda confirmed an outbreak of the Ebola Sudan virus, and in an unprecedented global first, a clinical trial to assess the efficacy of a vaccine against the virus was launched within just four days. This rapid response was made possible by proactive planning following a 2022 outbreak, during which the Ugandan Ministry of Healt…

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Your Clinical Trial Site M&A Agreement is Exposing You to Risk 0:50

25d ago0:50

0:50

When working on an M&A transaction involving a clinical trial site, it's crucial to thoroughly review vendor agreements. It's not just about what is included, but what is missing. For example, do you have the right quality and privacy agreements in place, or are you unknowingly exposing yourself to liability? If there’s a lack of necessary agreemen…

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What Does ICH E6 R3 Say About Returning Data to Participants? 1:01

27d ago1:01

1:01

The most recent ICH E6(R3) final guidance introduces critical updates to Good Clinical Practice (GCP), particularly around informed consent and participant data access. The guidance emphasizes greater flexibility and the use of technology-driven innovations to enhance how patients understand what they are consenting to. A significant update appears…

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Navigating the Ongoing HHS Communication Freeze 2:28

28d ago2:28

2:28

Now that we’ve passed February 1st, a key date for the potential easing of the freeze on all HHS communications, we find ourselves at February 3rd with no significant updates or changes. Despite expectations that restrictions might begin to lift, there has been no broad release of communications across federal agencies involved in clinical trials a…

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Ordinary People Are Changing Medicine 3:47

29d ago3:47

3:47

Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medicine falls short. Driven by necessity, love, and a desire for survival, many have solved complex medical problems themselves, leading to groundbreaking discoveries. This trend raises important questions…

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Trump’s First 10 Days: The Impact on Clinical Trials 2:29

1M ago2:29

2:29

Edye Edens discusses how the first nine to ten days under the new administration have brought notable shifts for both healthcare and clinical research, particularly in regulatory compliance and funding. While remaining politically neutral, the focus is on understanding how these changes impact clinical trials and research oversight. A key update is…

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Selling a Business with Issues 0:58

1M ago0:58

0:58

When selling a company, certain issues may arise that could concern potential buyers. Here's a breakdown of how to approach them: Price Adjustments: Some issues can be acknowledged, and the buyer may adjust the price accordingly, allowing the sale to proceed with minimal adjustments. Successor Liability: Issues like DOJ concerns or successor liabil…

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Breaking Down GCP E6(R3) 11:44

1M ago11:44

11:44

Darshan Kulkarni and Edye Edens discuss the latest update to Good Clinical Practice (GCP) guidelines, E6 R3, was explored. GCP, developed by the International Council for Harmonisation (ICH), provides globally accepted ethical and operational standards for conducting clinical trials. The 2025 update represents a significant revision since its last …

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AdvaMed 7 rules for Essential AI Innovation 5:54

1M ago5:54

5:54

Artificial intelligence (AI) is rapidly reshaping healthcare, with over 950 FDA-authorized AI devices transforming diagnosis, treatment, and administrative workflows. AdvaMed's new position paper emphasizes seven foundational principles to guide AI in medical technology development and regulation. Key Highlights: A Robust Regulatory Framework: Adva…

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Teva’s Case Should Shape Your Pharma Strategy 1:21

1M ago1:21

1:21

Teva Pharmaceutical's $450 million settlement highlights the challenges of compliance in the pharmaceutical industry. The Department of Justice accused Teva of violating the anti-kickback statute and the False Claims Act by using co-payment assistance programs to steer Medicare payments for its drug Copaxone while raising prices. Additionally, Teva…

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🔒 AI’s Impact on Healthcare: Liability, Ethics, and Responsibility 8:10

1M ago8:10

8:10

Subscriber-only episode Today, we explore a pressing issue in the healthcare landscape: the liability associated with artificial intelligence (AI). As AI technologies transform healthcare—from diagnostic tools to treatment recommendations—it's crucial to understand the legal and ethical implications surrounding their use, particularly regarding acc…

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Four Types of Research related Grant Fraud 4:56

2M ago4:56

4:56

Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals. 1. Foreign Influence and Funding: Failing to disclose foreign government support, as seen in Ohio State University's $875,000 settlement (November 2022). Similar allegations against U Ming Qing Xiao in the Southern District of Illinois …

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Defining Scope in Due Diligence Transactions 0:53

2M ago0:53

0:53

When conducting due diligence for a life sciences company, it's essential to align the scope with the transaction's objectives. Key considerations include: Transaction Purpose: Determine if the goal is asset divestiture, strategic acquisition, or another objective. Regulatory Compliance: Assess adherence to industry regulations, including FDA guide…

1
Clinical Trial Checklist 7:33

2M ago7:33

7:33

Darshan Kulkarni and Edye Edens discuss the essential steps for launching a clinical trial site, emphasizing the importance of navigating both state-specific regulations and the logistics involved. They begin by highlighting the critical role of informed consent and legal authority, which vary across states. In particular, states like Texas and Cal…

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Presidential Changes and Impact on Drug Related Misinformation 11:28

2M ago11:28

11:28

Misinformation around vaccines and treatments isn’t new, but with figures like Robert F. Kennedy Jr. in the spotlight, how should regulatory agencies respond? There will be potential changes coming to the FDA and public health regulations with the new administration. Historical transitions, such as the one from the Obama administration to the Trump…

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Prep for Selling Your Company! 4:10

2M ago4:10

4:10

When preparing to sell your pharmaceutical company, particularly with a Phase 1 product, it’s essential to assess potential buyers and ensure readiness. Darshan’s Insights: When preparing to sell your pharmaceutical company, it’s crucial to evaluate potential buyers and readiness. Key factors include: 1. Compliance Programs: Ensure adherence to OIG…

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Top Tips for Starting a Clinical Trial Site 6:00

2M ago6:00

6:00

Launching a clinical trial site is an exciting opportunity, but it comes with important legal, regulatory, and operational challenges. Darshan Kulkarni Says: Starting a clinical trial site is an exciting step, but it requires careful planning to address key legal and regulatory considerations. Privacy compliance is a major factor—going beyond HIPAA…

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When Drug Reps Visit: Darshan Reacts 4:27

2M ago4:27

4:27

Darshan reacts to a fake interaction between a drug sales representative and a doctor. He shares insights on pharmaceutical marketing tactics, highlighting that while doctors often find sales reps personable, they may not trust them as much as medical science liaisons (MSLs) due to limitations on what reps can legally discuss about drugs. Darshan e…

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Is Pfizer competing with your pharmacy? 2:29

2M ago2:29

2:29

Pharmaceutical companies, like Pfizer, are venturing into digital healthcare platforms, raising questions about competition with traditional pharmacies. Pfizer recently announced its initiative, "Pfizer for All," a digital platform that offers services such as vaccine scheduling and potential savings on medications, possibly bypassing pharmacy bene…

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Talking to a Functional Medicine Doctor 23:54

2M ago23:54

23:54

In this episode, guest host Kate Woods interviews Jessica Miller, who shares her journey with functional medicine, highlighting its focus on addressing root causes of illness through personalized, lifestyle-based approaches. They discuss its challenges, benefits, and empowering patients to take charge of their health. Functional medicine focuses on…

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🔒 Leveraging AI and RWD to Reshape Drug Trials! 5:17

2M ago5:17

5:17

Subscriber-only episode In this episode, Darshan explores how artificial intelligence (AI) is transforming clinical trial design, with a focus on using real-world data (RWD). The episode dives into the FDA’s recognition of AI’s potential to enhance clinical trials by using data from electronic health records (EHRs), medical claims, and disease regi…

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DCTs in Oncology: Can They Work? 12:04

2M ago12:04

12:04

The FDA’s 2024 guidance on decentralized clinical trials (DCTs) has the potential to transform clinical research, particularly in oncology. While many still view DCTs as either fully virtual or fully in-person, the guidance promotes a hybrid approach, blending traditional and decentralized elements. This flexibility may help smaller sites participa…

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Marketing Due Diligence in Stem cell M&A Transactions 6:35

2M ago6:35

6:35

The stem cell industry is growing rapidly but faces heightened regulatory scrutiny, particularly regarding marketing practices. Recent events highlight this issue: Rebecca Tushnet's blog on state "Little FTC Acts" emphasizes their enforcement power against deceptive marketing, and the guilty plea of a stem cell product manufacturer’s CEO for fraud …

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Why Are PBMs Blocking Your Meds? - Darshan reacts 4:10

2M ago4:10

4:10

In this episode, Darshan reacts to how at the start of each year, pharmacists often face the challenge of informing patients that their medications are no longer covered due to formulary changes managed by Pharmacy Benefit Managers (PBMs). PBMs, who work for insurance companies, negotiate drug prices and determine which medications are covered, oft…

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Misleading Ads: Ad laws and Consumer Protection for Marketers 14:10

2M ago14:10

14:10

Rebecca Tushnet discusses the potential explores the implications of misleading advertisements, particularly concerning pregnancy clinics. Even true statements can be disparaging if they mislead consumers. Cases like the California lawsuit questioning the use of "Dr." titles. Tushnet examines when products like milk can be labeled as such and scrut…

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5 Common Clinical Trial Site Failures 1:07

2M ago1:07

1:07

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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Faster FDA Recalls 4:06

2M ago4:06

4:06

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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IRB Challenges and Updates for 2024 15:07

2M ago15:07

15:07

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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Is the Polio Vaccine Safe? 5:45

2M ago5:45

5:45

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 8:40

2M ago8:40

8:40

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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Opportunities AI provides in Clinical Research 3:50

3M ago3:50

3:50

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 enhancing trial efficiency.…

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Telehealth and Biohacking: A Risky Combination 3:06

3M ago3:06

3:06

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? 2:05

3M ago2:05

2:05

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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