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PODCAST

DarshanTalks Podcast

Darshan Kulkarni

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 involving

science life sciences

All Episodes

0:53

Defining Scope in Due Diligence Transactions

DarshanTalks Podcast ·

2025/01/17

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 guidelines and privacy laws.Operational Areas: Evaluate critical functions such as sales, marketing, and manufacturing processes.Risk Assessment: Identify...

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7:33

Clinical Trial Checklist

DarshanTalks Podcast ·

2025/01/16

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 California have stringent regulations that can impact how clinical research organizations are structured, especially regarding ownership and the corpo...

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11:28

Presidential Changes and Impact on Drug Related...

DarshanTalks Podcast ·

2025/01/14

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 administration, will shape policy going forward, particularly in terms of regulatory priorities. The government will need to combat misinforma...

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4:10

Prep for Selling Your Company!

DarshanTalks Podcast ·

2025/01/12

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 rules and updated compliance elements.DOJ expectations require established compliance programs, privacy policies, and Sunshine Act adheren...

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6:00

Top Tips for Starting a Clinical Trial Site

DarshanTalks Podcast ·

2025/01/10

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 to account for email and text marketing laws, state-specific business registrations, and corporate structures like MSOs to manage ownership ru...

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4:27

When Drug Reps Visit: Darshan Reacts

DarshanTalks Podcast ·

2025/01/09

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 explains industry regulations, such as the Pharma Code and the Sunshine Act, which restrict certain gifts to avoid conflicts of interest. He also cr...

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2:29

Is Pfizer competing with your pharmacy?

DarshanTalks Podcast ·

2025/01/08

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 benefit managers (PBMs). This platform supports patients with private and government insurance, but there are concerns about how it addresses those wit...

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23:54

Talking to a Functional Medicine Doctor

DarshanTalks Podcast ·

2025/01/07

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 addressing the root causes of illness and disease rather than simply treating symptoms, which is often the approach in traditional Western medicine...

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4:56

Four Types of Research related Grant Fraud

DarshanTalks Podcast ·

2025/01/05

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 (April 2022).Misrepresenting Data for Funding:Using falsified or fabricated data to secure grants undermines the integrity of funding decisions.The DOJ a...

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5:17

🔒 Leveraging AI and RWD to Reshape Drug Trials!

DarshanTalks Podcast ·

2025/01/03

Subscriber-only episodeIn 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 registries. AI’s ability to analyze large data sets enables identification of patterns that can predict chronic disease progression, leading to more per...

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12:04

DCTs in Oncology: Can They Work?

DarshanTalks Podcast ·

2025/01/01

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 participate alongside large academic medical centers, making trials more accessible to rural and underserved areas.However, challenges remain, including reg...

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6:35

Marketing Due Diligence in Stem cell M&A Transactions

DarshanTalks Podcast ·

2024/12/31

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 underscores the stakes involved. Key Considerations for M&A Buyers:1. Legal Landscape: Understanding state and federal regulations is cruc...

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4:10

Why Are PBMs Blocking Your Meds? - Darshan reacts

DarshanTalks Podcast ·

2024/12/30

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, often based on profitability. Surprisingly, PBMs may prioritize brand-name drugs over generics because of the rebates they receive, which can lead to ...

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14:10

Misleading Ads: Ad laws and Consumer Protection for...

DarshanTalks Podcast ·

2024/12/28

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 scrutinizes claims like "clinically proven" by SlimFast. She also addresses dark patterns, deceptive tactics affecting user behaviour, and the FTC's enf...

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1:07

5 Common Clinical Trial Site Failures

DarshanTalks Podcast ·

2024/12/26

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 records can lead to compliance problems.3. Inadequate Drug Accountability: Not knowing where your investigational product has gone is a major issue....

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4:06

Faster FDA Recalls

DarshanTalks Podcast ·

2024/12/24

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 between discovering a recall-worthy issue and notifying the public, especially for high-risk devices in areas like cardiovascular, gastroente...

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15:07

IRB Challenges and Updates for 2024

DarshanTalks Podcast ·

2024/12/23

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 Guidance on Decentralized Clinical Trials (DCTs): The recent FDA guidance formalizing decentralized elements in clinical trials raises crit...

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5:45

Is the Polio Vaccine Safe?

DarshanTalks Podcast ·

2024/12/22

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 studies. Public health officials, including Senator Mitch McConnell, stress the vaccine’s proven safety and life-saving impact.While President-elect Tru...

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8:40

FDA blue print to discuss off label topics

DarshanTalks Podcast ·

2024/12/20

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 First Amendment, which protects commercial speech. While the FDA can regulate marketing to prevent false or misleading claims, it must balanc...

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3:50

🔒 Opportunities AI provides in Clinical Research

DarshanTalks Podcast ·

2024/12/18

Subscriber-only episodeToday, 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. Additionally, AI can create counterfactual simulations, enabling researchers to predict outcomes without putting real patien...

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270 results

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