DarshanTalks Podcast
Episodes
Investor Influence Can Trigger FCA Violations
02 Apr 2025
Contributed by Lukas
Mergers and Acquisitions (M&A) in the healthcare sector can be highly profitable, but they carry significant legal risks, particularly for private...
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons
31 Mar 2025
Contributed by Lukas
Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research orga...
Clinical Trial Site M&A: What Most Get Wrong
29 Mar 2025
Contributed by Lukas
Most clinical trial site mergers focus on patient databases, sponsor contracts, and geographic expansion. While those are important, the real risks li...
Future-Proof Sites: SOS Insights Revealed
27 Mar 2025
Contributed by Lukas
In this episode, Darshan Kulkarni sits down with Raymond Nomizu, founder and co-CEO of CRIO, to discuss key takeaways from the SOS conference and the ...
Why Food M&A Deals Collapse—And How to Prevent It
25 Mar 2025
Contributed by Lukas
Darshan talks about a major blind spot in food M&A—hidden compliance risks that can destroy a deal overnight. While most focus on financials, ma...
Non-Compliance Led to QOL Medical's $47M Settlement
23 Mar 2025
Contributed by Lukas
The recent $47 million settlement involving QOL Medical and its CEO is a stark reminder of the consequences of crossing legal and ethical boundaries. ...
FDA Regulatory Submissions: Challenges, Trends, and Future Predictions
21 Mar 2025
Contributed by Lukas
Edye Edens from KLF offers a brief yet in-depth overview of FDA regulatory submissions for clinical research in the U.S., reflecting on both current p...
How to do a VR promo check - Carly Schaecter gives us her advice
19 Mar 2025
Contributed by Lukas
Carly Schaechter discusses the potential of VR in drug promotion and the challenges of reviewing VR content for the PRC. Key points include the need...
Diversity Matters in Clinical Trials
18 Mar 2025
Contributed by Lukas
In this insightful discussion, Shuja Naqvi, CEO of Biopharma Informatics, joins Darshan Kulkarni to explore the evolving landscape of clinical researc...
EMA’s LLM Guidelines Impact Life Sciences
16 Mar 2025
Contributed by Lukas
The EMA's new guiding principles on LLMs represent a transformative step in regulatory science, addressing both the immense potential and signifi...
How to Network Like a Pro at Conferences
12 Mar 2025
Contributed by Lukas
In this episode, Darshan sits down with Brook White from CRIO to dive into the value of attending conferences and how to make the most of them. They m...
Getting Ready for SOS 2025: FDA 483s, SOPs, and Site Survival
10 Mar 2025
Contributed by Lukas
In this conversation, Edye Edens and Darshan Kulkarni discuss the excitement and plans for the upcoming Save Our Sites (SOS) Second Annual Conference ...
Maximizing Site Value
07 Mar 2025
Contributed by Lukas
When selling a clinical trial site, many owners focus solely on the amount they’ll receive, but the real key is understanding the multiplier that de...
5 Key Areas to Review in Clinical Trial Agreements
05 Mar 2025
Contributed by Lukas
Contract issues are more common than you think. Edye Edens shares the five critical areas you should always review before signing:Basic Details & ...
Discussing Stem Cell Research Opportunities with a Research Site Owner
03 Mar 2025
Contributed by Lukas
At the Site Council meeting, Darshan Kulkarni had the opportunity to speak with Mohamed Hakim, a site owner who has consolidated six clinical research...
Quality Management: A Must in Clinical Trial Contracts
01 Mar 2025
Contributed by Lukas
In the second part of our discussion, Edye Edens speaks with subject matter expert Helen Maurer about integrating quality management into clinical tri...
AI-Powered Chatbots in Pharma Sales and Education
27 Feb 2025
Contributed by Lukas
ChatGPT's recent update introduced an AI engagement feature reminiscent of the movie Her, the conversation is highly relevant as AI becomes more ...
Will New Tariffs Disrupt Your Next Pharma Deal?
26 Feb 2025
Contributed by Lukas
The proposed 25% tariff on pharmaceutical APIs from China could have far-reaching effects on M&A transactions within the life sciences and healthc...
Protecting Patient Data in a Changing Regulatory Landscape
25 Feb 2025
Contributed by Lukas
In this discussion, Edye Edens and Helen Maurer dive into the critical topic of data privacy and security in clinical research, particularly in light ...
Off-Label Promotion Changes in 2025
24 Feb 2025
Contributed by Lukas
Stephanie Trunk and Darshan Kulkarni discuss the evolving landscape of the pharmaceutical industry under the Trump Administration in 2025. They highli...
Turning Physicians into Leaders
21 Feb 2025
Contributed by Lukas
Kate Woods interviews Lee Scheinbart, who shares valuable advice for physicians aspiring to become Chief Medical Officers (CMOs) or take on leadership...
Key Regulatory Agencies in Pharma M&A
20 Feb 2025
Contributed by Lukas
When conducting an M&A transaction in the pharmaceutical or medical device industry, compliance must be a top priority. Regulatory agencies like t...
Does E6 (R3) Blur the Line Between GCP and Privacy Laws?
19 Feb 2025
Contributed by Lukas
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 evolvi...
RFK Jr. Confirmed as HHS Secretary: What It Means for Healthcare Policy
18 Feb 2025
Contributed by Lukas
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 ...
America’s Research Future in Jeopardy
15 Feb 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens break down the significant impact of the Trump administration’s decision to cut NIH funding and reduce agency workfo...
Trump Administration’s NIH cuts: Will they cripple US medical research?
14 Feb 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens discuss the recent controversy surrounding the Trump administration’s decision to cap NIH overhead funding (also kno...
DEI Under Trump: What It Means for Clinical Trials
13 Feb 2025
Contributed by Lukas
The Trump administration’s early actions have significantly impacted federally funded programs, particularly in the clinical trial space, by rolling...
CAPA & RCA: A Must for Pharma M&A
12 Feb 2025
Contributed by Lukas
When acquiring a pharmaceutical company, evaluating its quality and compliance programs is crucial. A strong program starts with well-documented polic...
Trump Targets Indirect Costs in NIH Funding
11 Feb 2025
Contributed by Lukas
On Friday, the Trump administration announced a 15% cap on NIH indirect costs, raising important questions about its impact on research funding. Edye ...
The USAID Halt and Its Consequences for Clinical Research
10 Feb 2025
Contributed by Lukas
The Trump administration’s actions have effectively halted USAID-funded clinical research worldwide, creating an unprecedented situation with signif...
Ebola Vaccine Trial in Record Time!
08 Feb 2025
Contributed by Lukas
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 effic...
Your Clinical Trial Site M&A Agreement is Exposing You to Risk
07 Feb 2025
Contributed by Lukas
When working on an M&A transaction involving a clinical trial site, it's crucial to thoroughly review vendor agreements. It's not just a...
What Does ICH E6 R3 Say About Returning Data to Participants?
05 Feb 2025
Contributed by Lukas
The most recent ICH E6(R3) final guidance introduces critical updates to Good Clinical Practice (GCP), particularly around informed consent and partic...
Navigating the Ongoing HHS Communication Freeze
04 Feb 2025
Contributed by Lukas
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 w...
Ordinary People Are Changing Medicine
03 Feb 2025
Contributed by Lukas
Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medici...
Trump’s First 10 Days: The Impact on Clinical Trials
31 Jan 2025
Contributed by Lukas
Edye Edens discusses how the first nine to ten days under the new administration have brought notable shifts for both healthcare and clinical research...
Selling a Business with Issues
31 Jan 2025
Contributed by Lukas
When selling a company, certain issues may arise that could concern potential buyers. Here's a breakdown of how to approach them:Price Adjustment...
Breaking Down GCP E6(R3)
28 Jan 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens discuss the latest update to Good Clinical Practice (GCP) guidelines, E6 R3, was explored. GCP, developed by the Inter...
AdvaMed 7 rules for Essential AI Innovation
25 Jan 2025
Contributed by Lukas
Artificial intelligence (AI) is rapidly reshaping healthcare, with over 950 FDA-authorized AI devices transforming diagnosis, treatment, and administr...
Teva’s Case Should Shape Your Pharma Strategy
22 Jan 2025
Contributed by Lukas
Teva Pharmaceutical's $450 million settlement highlights the challenges of compliance in the pharmaceutical industry. The Department of Justice a...
AI’s Impact on Healthcare: Liability, Ethics, and Responsibility
21 Jan 2025
Contributed by Lukas
Today, we explore a pressing issue in the healthcare landscape: the liability associated with artificial intelligence (AI). As AI technologies transfo...
Four Types of Research related Grant Fraud
18 Jan 2025
Contributed by Lukas
Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals.1. Foreign Influence and Funding:Fail...
Defining Scope in Due Diligence Transactions
17 Jan 2025
Contributed by Lukas
When conducting due diligence for a life sciences company, it's essential to align the scope with the transaction's objectives. Key consider...
Clinical Trial Checklist
16 Jan 2025
Contributed by Lukas
Darshan Kulkarni and Edye Edens discuss the essential steps for launching a clinical trial site, emphasizing the importance of navigating both state-s...
Presidential Changes and Impact on Drug Related Misinformation
14 Jan 2025
Contributed by Lukas
Misinformation around vaccines and treatments isn’t new, but with figures like Robert F. Kennedy Jr. in the spotlight, how should regulatory agencie...
Prep for Selling Your Company!
12 Jan 2025
Contributed by Lukas
When preparing to sell your pharmaceutical company, particularly with a Phase 1 product, it’s essential to assess potential buyers and ensure readin...
Top Tips for Starting a Clinical Trial Site
10 Jan 2025
Contributed by Lukas
Launching a clinical trial site is an exciting opportunity, but it comes with important legal, regulatory, and operational challenges.Darshan Kulkarni...
When Drug Reps Visit: Darshan Reacts
09 Jan 2025
Contributed by Lukas
Darshan reacts to a fake interaction between a drug sales representative and a doctor. He shares insights on pharmaceutical marketing tactics, highlig...
Is Pfizer competing with your pharmacy?
08 Jan 2025
Contributed by Lukas
Pharmaceutical companies, like Pfizer, are venturing into digital healthcare platforms, raising questions about competition with traditional pharmacie...
Talking to a Functional Medicine Doctor
07 Jan 2025
Contributed by Lukas
In this episode, guest host Kate Woods interviews Jessica Miller, who shares her journey with functional medicine, highlighting its focus on addressin...
Four Types of Research related Grant Fraud
05 Jan 2025
Contributed by Lukas
Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals:Foreign Influence and Funding:Failing...
Leveraging AI and RWD to Reshape Drug Trials!
03 Jan 2025
Contributed by Lukas
In this episode, Darshan explores how artificial intelligence (AI) is transforming clinical trial design, with a focus on using real-world data (RWD)....
DCTs in Oncology: Can They Work?
01 Jan 2025
Contributed by Lukas
The FDA’s 2024 guidance on decentralized clinical trials (DCTs) has the potential to transform clinical research, particularly in oncology. While ma...
Marketing Due Diligence in Stem cell M&A Transactions
31 Dec 2024
Contributed by Lukas
The stem cell industry is growing rapidly but faces heightened regulatory scrutiny, particularly regarding marketing practices. Recent events highligh...
Why Are PBMs Blocking Your Meds? - Darshan reacts
30 Dec 2024
Contributed by Lukas
In this episode, Darshan reacts to how at the start of each year, pharmacists often face the challenge of informing patients that their medications ar...
Misleading Ads: Ad laws and Consumer Protection for Marketers
28 Dec 2024
Contributed by Lukas
Rebecca Tushnet discusses the potential explores the implications of misleading advertisements, particularly concerning pregnancy clinics. Even true s...
5 Common Clinical Trial Site Failures
26 Dec 2024
Contributed by Lukas
Darshan discusses the five most common clinical trial site issues:1. Failure to Follow Investigational Plan: Treating clinical trials like routine med...
Faster FDA Recalls
24 Dec 2024
Contributed by Lukas
The FDA’s Center for Devices and Radiological Health (CDRH) has launched a groundbreaking initiative aimed at improving the efficiency and speed of ...
IRB Challenges and Updates for 2024
23 Dec 2024
Contributed by Lukas
In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHR...
Is the Polio Vaccine Safe?
22 Dec 2024
Contributed by Lukas
The polio vaccine, credited with eradicating a crippling disease in the U.S., faces renewed scrutiny after attorney Aaron Siri, linked to Robert F. Ke...
FDA blue print to discuss off label topics
20 Dec 2024
Contributed by Lukas
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...
Opportunities AI provides in Clinical Research
18 Dec 2024
Contributed by Lukas
Today, we're discussing the FDA's use of artificial intelligence (AI) to transform clinical trials.AI is emerging as a cornerstone in clinic...
Telehealth and Biohacking: A Risky Combination
16 Dec 2024
Contributed by Lukas
The rise of biohacking has transitioned from a niche interest to a mainstream trend, particularly in the context of drugs like Ozempic and ketamine. W...
Is the FDA’s Response to AI Falling Behind?
14 Dec 2024
Contributed by Lukas
The FDA’s current approach to AI in healthcare highlights significant gaps in regulatory preparedness. Although the FDA has approved thousands of AI...
Healthcare Is in Crisis: How do we fix it?
13 Dec 2024
Contributed by Lukas
In this episode, guest host Kate Woods and Darshan Kulkarni delve into current healthcare issues, including the unsettling news of the CEO of United H...
Will RFK Break Pharma?
12 Dec 2024
Contributed by Lukas
Robert F. Kennedy Jr. has announced plans for a presidential mandate to restore federal agencies, including the FDA, to the "gold standard" ...
Fake data in Clinical Trials
10 Dec 2024
Contributed by Lukas
Florida medical clinic owner and staff were charged with falsifying clinical trial data. According to the indictment, from September 2015 to March 201...
Darshan Fixes Big Pharma Misconceptions
08 Dec 2024
Contributed by Lukas
In this reaction video, Darshan responds to claims about the effectiveness of prescribed medications. While patients often expect their drugs to work,...
How Trump’s Tariffs will Disrupt Clinical Trials and Drug Marketing?
06 Dec 2024
Contributed by Lukas
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 lif...
Why China is Targeting Top Scientists!
04 Dec 2024
Contributed by Lukas
The Wall Street Journal recently reported that China is aggressively targeting tech talent with lucrative job offers, offering triple the pay for posi...
Trump’s Bold Picks Shake Up Life Sciences
02 Dec 2024
Contributed by Lukas
The Trump administration’s new appointees, including Elon Musk, Dr. Marty Makary, Dr. Jay Bhattacharya, and Robert F. Kennedy Jr., promise a signifi...
3 Regulatory Opportunities in Clinical Trials!
30 Nov 2024
Contributed by Lukas
We explore the rapidly evolving role of artificial intelligence (AI) in clinical trial research design. He discusses how AI is reshaping the pharmaceu...
Don't Take Non-Prescription Ozempic or other Weight Loss Drugs
28 Nov 2024
Contributed by Lukas
We explore the emerging trend of patients bypassing traditional healthcare to obtain weight loss medications like Ozempic through unofficial channels ...
Clinical Trial Principal Investigator Duties in Clinical Trials
26 Nov 2024
Contributed by Lukas
The FDA has stressed the critical importance of adequate supervision and monitoring in clinical trials to ensure they are conducted properly. A key fi...
Supreme Court Redefined Pharma Marketing Rules
23 Nov 2024
Contributed by Lukas
The Supreme Court's ruling in Loper Bright Enterprises v. Raimondo significantly impacts off-label marketing for pharmaceutical and medical devic...
AI concerns in M&A for Life Sciences
20 Nov 2024
Contributed by Lukas
Artificial intelligence (AI) is transforming the life sciences sector, offering groundbreaking advancements in areas like drug discovery, clinical tri...
Trump Teams Potential Changes to Healthcare
19 Nov 2024
Contributed by Lukas
Healthcare and life sciences are on the brink of transformative change, fueled by a combination of technological innovation, ideological shifts, and e...
Can AI Rewrite the Rules of Clinical Trials?
18 Nov 2024
Contributed by Lukas
In this episode, we're diving into the intersection of technology and healthcare, specifically the role of Artificial Intelligence (AI) in clinic...
Ad Promo Review in Pharma - How Far is Too Far?
16 Nov 2024
Contributed by Lukas
Katie Graham and I discuss various aspects of FDA and FTC regulations, including ad promo, the Chevron decision, and the evolving role of compliance i...
Why Staff Training Problems are a liability for Your Clinical Trial site
14 Nov 2024
Contributed by Lukas
Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staf...
Neuralink: Breakthrough or Marketing Hype?
12 Nov 2024
Contributed by Lukas
Neuralink recently received the FDA's Breakthrough Device label for its neural implant aimed at restoring vision to the blind by interfacing with...
Telehealth Compliance Crisis: DOJ exposes $2.75B Fraud!
09 Nov 2024
Contributed by Lukas
DOJ filed criminal charges against 193 defendants, including 76 medical professionals for telemedicine violation. This alarming crackdown reveals the ...
Should You Go In-House or Outsource Your Advertising Compliance?
06 Nov 2024
Contributed by Lukas
In this episode, Heather McFalls discusses the pros and cons of in-house versus outsourced advertising compliance roles, along with tips for new regul...
Research fraud tainting pharma per Nature Article
04 Nov 2024
Contributed by Lukas
Nature and Vox highlight the severe consequences of research fraud and its widespread impact on sectors like marketing, clinical research, medical aff...
Influencers are NOT KOLs. Know your Needs!
31 Oct 2024
Contributed by Lukas
Influencers are NOT KOLs. We discuss using key opinion leaders (KOLs) and influencers in pharmaceutical and medical device marketing. Key Takeaways:-...
AI and Clinical Trials: Faster Results, Bigger Risks?
28 Oct 2024
Contributed by Lukas
In this episode, we’re diving into a crucial topic: the role of artificial intelligence in clinical research and the evolving landscape of data priv...
Eli Lilly’s Unexpected Shift on Use of Mounjaro!
25 Oct 2024
Contributed by Lukas
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...
Are CROs Losing Relevance in the Age of DCTs?
23 Oct 2024
Contributed by Lukas
In this episode, Isaac Rodriguez- Chavez and I discuss the impact of DCTs on sponsor relationships, CROs, and industry dynamics with the FDA. We disc...
Managing Risks in Life Science Mergers and Acquisitions with Strategic Insurance
19 Oct 2024
Contributed by Lukas
In this episode, we discuss the importance of integrating insurance considerations into the due diligence process during M&A transactions with Ken...
Can a Pharmacist Override Your Doctor's Prescription?
17 Oct 2024
Contributed by Lukas
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...
FDA Concerns About AI’s impact on Good Clinical Practices
15 Oct 2024
Contributed by Lukas
Today we're delving into the evolving role of artificial intelligence (AI) in drug development and clinical trial design. We’ll explore the key...
Patient Advocates Could Cost You Millions
11 Oct 2024
Contributed by Lukas
Patient Advocates play a crucial role in the pharmaceutical industry, especially in clinical research. They serve as the voice of patients, ensuring t...
Managing Risks in Life Sciences Mergers and Acquisitions
08 Oct 2024
Contributed by Lukas
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 in...
How do pharmacists’ read doctors’ cursive letters?
06 Oct 2024
Contributed by Lukas
Pharmacists often use a process of elimination to decipher doctors' handwritten prescriptions. Pharmacists rely on clues like drug names and dose...
AI Data Ownership in Pharma
03 Oct 2024
Contributed by Lukas
We explore how AI is transforming content generation in the pharmaceutical industry, particularly in marketing, sales, and medical engagements. While ...
Role of Tech Transfer in Clinical trial agreements
30 Sep 2024
Contributed by Lukas
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 o...
Why are medicine names so complicated?
22 Sep 2024
Contributed by Lukas
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 distinc...
Fixing Congruency Reviews in 8 Minutes
21 Sep 2024
Contributed by Lukas
In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounte...
The Dark Side of Med Device Kickbacks
17 Sep 2024
Contributed by Lukas
Today, we're discussing a critical issue for pharmaceutical and medical device marketers – promotional compliance.Overview of the Innovasis Set...
Which Hair Loss Treatment Is Right for You?
14 Sep 2024
Contributed by Lukas
Darshan addresses common questions about potential treatments for hair loss. He provides insights based on his expertise as both a pharmacist and an F...