A(z) DarshanTalks csatorna legjobb podcastjai (2025)

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Four Types of Research related Grant Fraud 4:56

16h ago4:56

4:56

Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals: 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 (Ap…

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

3d 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

5d 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

6d 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

7d 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

9d 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

11d 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

13d 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

14d 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

15d 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

17d 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

19d ago3:50

3:50

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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Telehealth and Biohacking: A Risky Combination 3:06

21d 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

23d 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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Healthcare Is in Crisis: How do we fix it? 17:54

23d ago17:54

17:54

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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Will RFK Break Pharma? 2:46

25d ago2:46

2:46

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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Fake data in Clinical Trials 1:58

27d ago1:58

1:58

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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Darshan Fixes Big Pharma Misconceptions 3:00

29d ago3:00

3:00

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? 6:50

1M ago6:50

6:50

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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Why China is Targeting Top Scientists! 3:22

1M ago3:22

3:22

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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Trump’s Bold Picks Shake Up Life Sciences 4:52

1M ago4:52

4:52

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! 5:27

1M ago5:27

5:27

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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Don't Take Non-Prescription Ozempic or other Weight Loss Drugs 3:15

1M ago3:15

3:15

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 2:32

1M ago2:32

2:32

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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Supreme Court Redefined Pharma Marketing Rules 6:38

1M ago6:38

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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AI concerns in M&A for Life Sciences 6:16

2M ago6:16

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 2:59

2M ago2:59

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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Can AI Rewrite the Rules of Clinical Trials? 5:36

2M ago5:36

5:36

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? 14:52

2M ago14:52

14:52

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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Why Staff Training Problems are a liability for Your Clinical Trial site 1:51

2M ago1:51

1:51

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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Neuralink: Breakthrough or Marketing Hype? 0:55

2M ago0:55

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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Telehealth Compliance Crisis: DOJ exposes $2.75B Fraud! 4:52

2M ago4:52

4:52

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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Should You Go In-House or Outsource Your Advertising Compliance? 10:43

2M ago10:43

10:43

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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Research fraud tainting pharma per Nature Article 2:31

2M ago2:31

2:31

Nature and Vox highlight the severe consequences of research fraud and its widespread impact on sectors like marketing, clinical research, medical affairs, regulatory compliance, and legal practices. Fraud can manifest in various ways, such as fabricating data or manipulating results, and its effects are far-reaching. The Nature article stresses th…

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Influencers are NOT KOLs. Know your Needs! 7:25

2M ago7:25

7:25

Influencers are NOT KOLs. We discuss using key opinion leaders (KOLs) and influencers in pharmaceutical and medical device marketing. Key Takeaways: - Influencers vs. KOLs: Influencers have large social media followings and can engage younger demographics, while KOLs are respected experts whose endorsements are based on scientific evidence. - Benef…

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AI and Clinical Trials: Faster Results, Bigger Risks? 9:43

2M ago9:43

9:43

In this episode, we’re diving into a crucial topic: the role of artificial intelligence in clinical research and the evolving landscape of data privacy laws that will impact every step of the process. In this episode, we’ll be unpacking insights from Dr. ElZarrad, the FDA’s Deputy Director for the Office of Medical Policy, on how AI is shaping clin…

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Eli Lilly’s Unexpected Shift on Use of Mounjaro! 2:01

2M ago2:01

2:01

Eli Lilly's changed its opinion on Off-Label uses! Eli Lilly, a company that makes a diabetes drug, is now urging people not to use it for weight loss, a common off-label use, despite not raising concerns about off-label uses in the past. Off-label use, where a drug is used for something other than its original purpose, is a normal part of healthca…

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Are CROs Losing Relevance in the Age of DCTs? 10:53

2M ago10:53

10:53

In this episode, Isaac Rodriguez- Chavez and I discuss the impact of DCTs on sponsor relationships, CROs, and industry dynamics with the FDA. We discuss, 1. How will DCTs impact sponsor relationships with CROs? 2. How do small CROs and sponsors adapt to emerging trends? 3. How do new trends impact industry relationships with the FDA? 4. Does DCT al…

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Managing Risks in Life Science Mergers and Acquisitions with Strategic Insurance 5:52

3M ago5:52

5:52

In this episode, we discuss the importance of integrating insurance considerations into the due diligence process during M&A transactions with Kenneth White. Support the showDarshan Kulkarni által

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Can a Pharmacist Override Your Doctor's Prescription? 3:16

3M ago3:16

3:16

We'll briefly discuss when a pharmacist might choose not to dispense medication, even with a valid doctor's order. In a recent case, a doctor sued the Iowa Board of Pharmacy and the Iowa Board of Medicine when a pharmacy refused to fill a prescription for Ivermectin, a livestock drug sometimes used to treat parasites in people and allegedly COVID-1…

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FDA Concerns About AI’s impact on Good Clinical Practices 3:33

3M ago3:33

3:33

Today we're delving into the evolving role of artificial intelligence (AI) in drug development and clinical trial design. We’ll explore the key concerns raised by the FDA and insights from Dr. ElZarrad on integrating AI into clinical research. AI has the potential to transform clinical trials by enhancing efficiency, accuracy, and outcomes. However…

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Patient Advocates Could Cost You Millions 2:42

3M ago2:42

2:42

Patient Advocates play a crucial role in the pharmaceutical industry, especially in clinical research. They serve as the voice of patients, ensuring their needs and concerns are addressed throughout the drug development process. Here's a simple breakdown of their contributions and when their involvement might not be ideal. Why Are Patient Advocates…

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Managing Risks in Life Sciences Mergers and Acquisitions 5:55

3M ago5:55

5:55

In this episode, we discuss key risks a life sciences company should consider during an acquisition with Kenneth White. We also explore the role of insurers in managing these risks. Support the showDarshan Kulkarni által

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How do pharmacists’ read doctors’ cursive letters? 1:30

3M ago1:30

1:30

Pharmacists often use a process of elimination to decipher doctors' handwritten prescriptions. Pharmacists rely on clues like drug names and doses, this method isn’t foolproof. If the handwriting is unclear, identifying the correct medication can be challenging, leading to potential errors. The shift to electronic prescribing has improved accuracy …

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AI Data Ownership in Pharma 4:59

3M ago4:59

4:59

We explore how AI is transforming content generation in the pharmaceutical industry, particularly in marketing, sales, and medical engagements. While AI presents groundbreaking opportunities, it also raises critical challenges, notably concerning data ownership and compliance. A significant issue is the lack of clarity around ownership of input and…

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Role of Tech Transfer in Clinical trial agreements 7:30

3M ago7:30

7:30

In this episode, we are joined by Istvan Fekete to have a discussion over tech transfer offices, IP, and more. The video explains what tech transfer offices are, their significance in the research ecosystem, and why they might be the best place to negotiate equity stakes in intellectual property (IP) created by investigators, especially when funded…

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Why are medicine names so complicated? 2:09

4M ago2:09

2:09

Darshan was asked to explain why drug names can be so complicated, and the answer lies in the fact that each drug typically has at least three distinct names. First, there’s the chemical name, which is a technical identifier describing the drug’s molecular structure—these names are often long and complex, like “acetylsalicylic acid,” and are more f…

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Fixing Congruency Reviews in 8 Minutes 8:36

4M ago8:36

8:36

In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Additionally, we will delve into the processes that can be implemented to mitigate risks associated with congruency r…

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The Dark Side of Med Device Kickbacks 4:45

4M ago4:45

4:45

Today, we're discussing a critical issue for pharmaceutical and medical device marketers – promotional compliance. Overview of the Innovasis Settlement: Innovasis Inc. recently settled a $12 million case for alleged kickback schemes to doctors. This highlights the importance of promotional compliance. Allegations Against Innovasis: From Jan. 1, 201…

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Which Hair Loss Treatment Is Right for You? 2:29

4M ago2:29

2:29

Darshan addresses common questions about potential treatments for hair loss. He provides insights based on his expertise as both a pharmacist and an FDA regulatory lawyer. Darshan explains that FDA-approved treatments for hair loss include minoxidil and finasteride. Minoxidil, originally a blood pressure medication, can lower blood pressure and has…

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