Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs can bring valuable expertise to a therapeutic area, simply labeling someone as a KOL—especially when they self-identify—can raise significant compliance concerns.

They unpacks two major red flags:

1. High Prescribers – Is the KOL being compensated for research or for prescribing power?
   
   
2. Influencer Effect – Are they being used to sway other physicians’ prescribing behavior?
   
   

They also highlight issues with KOL selection based on outdated reputation or academic status rather than real-time operational capacity. Choosing the wrong KOL—one who can’t meet documentation or compliance standards—can derail your site’s performance.

Key takeaway:
 Don't focus on titles—focus on capability, compliance, and fit. Avoid the label "KOL" and instead qualify experts based on their patient databases, research experience, and operational readiness.

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Edye Edens interviews Darshan Kulkarni about the evolution of the Kulkarni Law Firm (KLF). Darshan reflects on how he originally envisioned working with large pharmaceutical and device companies, but over the past 15–20 years, the firm has expanded to support not only pharma, but also law firms, consulting companies, and research sites.

They discuss how the clinical research landscape has shifted—from a focus on academic institutions and big players to a broader ecosystem that includes independent and commercial sites. 

Importantly, Darshan shares how compliance, once an afterthought in the industry, has become central to legal and operational strategy. He recounts early pushback from stakeholders who dismissed compliance, and contrasts that with today’s environment, where regulatory awareness is essential and expected.

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In this episode, Edye Edens dives into the FDA’s evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of Sarepta’s muscular dystrophy treatment, she explains how postmarket safety issues and incomplete confirmatory trials can put previously celebrated approvals under renewed FDA evaluation.

Edye breaks down three common pitfalls sponsors face:

1. Lagging confirmatory trials
   
   
2. Outdated safety monitoring plans
   
   
3. Poor communication across teams and with FDA
   
   

She offers practical guidance to avoid regulatory setbacks:

• Build flexible governance frameworks
  
  
• Stay proactive with FDA engagement
  
  
• Plan for legal and regulatory risks in confirmatory trials
  
  
• Prepare for public, regulatory, and payer scrutiny post-approval

Accelerated approval is a major milestone—but it’s not the end. It's the beginning of the next regulatory chapter. Tune in to learn how to manage post-approval responsibilities and secure long-term success for your therapy.

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Darshan Kulkarni breaks down the Department of Justice’s new Civil Rights Fraud Initiative, launched on May 19, 2025, and why it should be on the radar of every pharmaceutical and medical device company. Under this initiative, the DOJ plans to use the False Claims Act (FCA) to pursue organizations that knowingly violate civil rights laws while receiving federal funds—including R&D grants, Medicare/Medicaid payments, or other government contracts.

The discussion highlights how DEI programs, supplier diversity efforts, and patient outreach initiatives—though often well-intentioned—can raise legal risks if they assign benefits or burdens based on protected traits like race or gender. Companies certifying compliance with civil rights obligations must ensure their practices truly align with federal requirements, or they risk triggering FCA liability. Darshan outlines concrete steps to update compliance programs: conducting audits, vetting DEI policies, documenting legal justifications, training internal teams, strengthening reporting systems, and preparing a response plan.

This episode is essential listening for in-house counsel, compliance officers, and executives navigating DEI and ESG obligations in a tightening regulatory landscape.

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A recent $425 million settlement involving Teva Pharmaceuticals highlights the legal and ethical risks charities face when partnering with pharmaceutical companies. Teva was accused of using a charity to cover patient co-pays, a tactic intended to boost drug sales, leading to serious legal consequences. While pharma funding can provide essential resources for charities, it also raises concerns about indirect kickbacks and regulatory scrutiny.

Charities must rethink their engagement strategies, ensuring transparency and compliance to avoid financial penalties and reputational harm. Conducting due diligence, seeking legal guidance, and structuring agreements carefully are essential steps to mitigate risks. Teva’s case serves as a warning—charities must be proactive in safeguarding their partnerships to maintain both their mission and legal standing.

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Darshan Kulkarni and Edye Edens take a deep dive into one of clinical research’s most persistent questions: how is fair market value (FMV) actually determined for clinical trial sites—and who gets to decide?

Building on the previous discussion about whether all sites should be paid the same, this episode unpacks the complexity behind FMV calculations. Darshan shares an anecdote involving a DOJ official questioning the credibility of FMV data derived from industry benchmarks, asking: “How do we know they’re not all overpaying?” That central question becomes the backdrop for a broader conversation about the opacity of FMV methodology.

Edye and Darshan explore the role of commercial pricing vs. Medicare/Medicaid benchmarks, the impact of patient compensation, and the often-overlooked categories of research-related costs like recruitment, reminders, and outreach. They suggest that standard FMV tools don’t always capture the true operational costs sites face—and that research-related services are fundamentally different from standard clinical care.

The conversation turns to the issue of transparency, revealing how internal silos at large pharmaceutical companies often prevent project managers or CROs from understanding, let alone justifying, the FMV numbers they're using in site negotiations. Meanwhile, sites—especially smaller or independent ones—have fewer layers and greater internal access to budget decisions, leaving them at a disadvantage when sponsors can't (or won’t) explain the rationale behind their numbers.

Ultimately, the episode questions whether a more transparent and stratified approach to FMV could lead to better negotiations, more equitable funding, and improved patient access. The hosts challenge the industry to consider how current power dynamics—and the lack of communication—may be shaping not just contracts, but clinical trial accessibility itself.

The episode closes by teasing a future conversation: Does the sponsor-site power imbalance impact patient care outcomes? Stay tuned.

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Can non-physicians own independent clinical trial sites? The answer isn’t as simple as it seems. In most states, including Texas, engaging in clinical research is considered the practice of medicine, which means that research sites must adhere to the same rules that apply to medical practices. This includes the corporate practice of medicine doctrine, which restricts ownership and control of medical practices to licensed physicians. As a result, non-physicians generally cannot own or manage research sites that involve clinical procedures requiring medical judgment, diagnosis, or treatment.

A common misconception is that clinical trials are separate from the practice of medicine, but the reality is that many of these trials do involve medical procedures that require compliance with state medical laws. For instance, when your principal investigator (PI) signs a Form 1572, they’re agreeing to comply with medical standards—this reinforces the idea that clinical research is governed by the same rules as medical practice.

Many research sites fail to audit their ownership structures for compliance with the corporate practice of medicine doctrine. While it’s easy to assume that “everyone else is doing it,” cutting corners can lead to disastrous consequences such as lawsuits, regulatory scrutiny, or even unwound deals. That’s why it’s important for sponsors, CROs, and investors to ensure that research sites are structured properly, that investigators are licensed in the trial state, and that sites have appropriate malpractice insurance.

At the Kulkarni Law Firm, we work with clients to ensure that their research operations are compliant, structured correctly, and protected from enforcement risks. Whether you're a sponsor, investor, or site operator, it’s critical to be proactive and audit your practices to avoid costly mistakes down the road.

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In this special episode, Senior Attorney Edye Edens sits down with Darshan Kulkarni, founder and principal of the Kulkarni Law Firm, for a personal and honest look at how the firm came to be. Darshan shares how the firm was born in the shadow of the 2008 financial crisis—at a time when job security was shaky and entrepreneurship felt more like a risk than an opportunity. What started as a leap of faith became a 15+ year journey rooted in intentionality, versatility, and a deep belief in building something better than the traditional legal mold.

Darshan recounts his unique path: working as both a pharmacist and a lawyer, taking client calls from the base of Machu Picchu, and embracing the uncertainty that comes with launching a firm from scratch. He and Edye reflect on the transitions between year one, year five, and year fifteen—how the vision has shifted, and how staying agile has helped the firm grow without losing its purpose. The conversation explores what it means to be different in a profession that often values conformity, and why both Darshan and Edye chose quality of life, real client value, and adaptability over rigid systems.

They also discuss big career moments, the influences that shaped their outlooks, and the challenges of being entrepreneurial in a space dominated by structure. Whether you’re a startup founder, a healthcare professional, or just curious about the story behind KLF, this episode offers an unfiltered glimpse into the passion and strategy behind one of the few boutique law firms dedicated to life sciences, clinical research, and regulatory innovation.

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We explore the growing wave of class action lawsuits hitting the telehealth industry—and why legal counsel, especially those advising telemedicine platforms or navigating pharma partnerships, must pay attention now.

Here’s the core issue: many ad tech stacks are leaking protected health information (PHI) through tracking pixels and cookies. These tools—common in e-commerce—are transmitting sensitive data to third parties like Meta, potentially without proper consent. That’s not a glitch; it’s a design feature—and it may violate HIPAA, the FTC Act, CCPA, and state consumer protection laws.

Key Legal Risks:

• Tracking pixels may result in unauthorized PHI disclosures.
  
  
• “Anonymized” data isn’t safe—reidentification is easier than ever.
  
  
• Partnering with pharma introduces a regulatory maze: HIPAA, FTC, FDA promotional rules, and anti-kickback statutes may all apply—and risks compound, they don’t cancel out.
  
  
• A simple ad campaign could result in kickback concerns, promotional violations, or privacy breaches.
  
  

What Legal Counsel Should Do:

1. Audit your tech stack—what tools are collecting what data, and where does it go?
   
   
2. Revisit consent practices—is the user aware of what’s being shared?
   
   
3. Separate clinical from commercial functions—these are legal firewalls.
   
   
4. Update your data sharing contracts—HIPAA, indemnification, audit rights, reuse clauses.
   
   
5. Retrain marketing teams—even one tag can trigger legal liability.
   
   

Real-World Consequences:

• OCR penalties, FTC consent decrees, and civil suits for emotional distress and privacy violations.
  
  
• Reputational damage, loss of investor confidence, and pharma partners pulling back.
  
  

At The Kulkarni Law Firm, we help telehealth platforms and FDA-regulated companies identify and mitigate these risks before they explode. From privacy reviews to marketing compliance and risk assessments, we’re here to help.

Ask yourself:

• Are you using ad pixels?
  
  
• Do your legal and marketing teams actually talk?
  
  
• Are you ready to explain, under subpoena, who got patient data—and why?
  
  

If this episode made you rethink your stack—or your strategy—share it with your team.

Get in touch with us if you have any questions. 

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In this episode of the KLF Deep Dive, Darshan Kulkarni and Edye Edens engage in a practical discussion around one of the most debated issues in clinical research: Should clinical trial sites be paid differently based on who they are, where they’re located, or what they bring to the table?

The conversation challenges the idea of flat-rate, standardized budgets for all sites and explores the concept of Fair Market Value (FMV) from both sponsor and site perspectives. Edye and Darshan break down how location, site type (academic vs. independent), operational capacity, and even patient population size can significantly affect the true cost of running a clinical trial. They also address common misconceptions—like whether having more patients always justifies higher pay—and emphasize the importance of effort tracking and cost documentation as tools for sites to advocate for reasonable compensation.

The two also examine the wide variability in how sites are funded, including differences driven by grants, institutional policies, and pass-through rules. They explore why attempts to equalize payments across the board—though well-intentioned—may backfire, creating unintended inequities that hurt both high-performing sites and trial timelines.

Darshan draws a parallel to J. Paul Getty’s famous quote, “Just a little bit more,” noting that many sites, regardless of how much they’re paid, still want more—while sponsors often feel they're already paying generously. This leads to a larger issue: the lack of transparency and shared understanding around how FMV is calculated. Sites are often expected to justify every line item with data, while sponsors rarely share the assumptions and benchmarks they use in return.

This episode explores key questions like:

• What does fair really look like in site budgeting?
  
  
• Should sponsors be more transparent about their FMV calculations?
  
  
• How do we balance standardization with the real-world variability in site operations?
  
  

The discussion sets the stage for a follow-up episode exploring whether sponsors should disclose their FMV methodologies—and how that could impact trust and negotiation dynamics across the clinical trial ecosystem.

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