In this conversation, Edye Edens and Darshan Kulkarni discuss the excitement and plans for the upcoming Save Our Sites (SOS) Second Annual Conference in Oklahoma City. They highlight the importance of connecting with key industry leaders and peers in person, including names like Dan Sfera, Brad Hightower, and others who have been instrumental voices in the clinical research space.

Darshan shares that Kulkarni Law Firm (KLF) will be participating and is excited to engage with attendees, talk about their offerings, and provide exclusive giveaways related to compliance and FDA inspections. Darshan emphasizes that KLF will focus on how to prevent and respond to FDA 483s, covering topics like audit readiness, proper handling of inspections, and how to de-escalate findings before they escalate into warning letters. He also underscores the importance of understanding the inspection process, including the fact that "it's a negotiation until the report is issued," and the role of policies, procedures, and professional conduct during audits.

Edye highlights her session on SOPs (Standard Operating Procedures), where she will speak alongside Jen Pages, Scott Wit, and Brad Hightower (moderator). Their panel will cover critical topics like:

• How to start SOPs if you don’t have any
• Scaling SOPs as your site grows
• Using SOPs strategically to protect and defend sites in audits and inspections
• Addressing sponsor expectations regarding site processes

They aim to address real-life issues sites face, including how to tailor or adapt SOP templates and how to leverage them to prevent issues with sponsors and regulators. A surprise giveaway will also be available for those who attend the session.

Both Edye and Darshan emphasize that SOS is about community supporting community, not just traditional presentations. The goal is to share actionable, free value, foster real conversations about clinical site challenges, and help each other grow in the clinical research space. They also playfully joke about friendly competition on session attendance, adding a light-hearted tone to the conversation.

In summary, attendees can expect:

• Deep dives on 483 prevention and response
• Practical SOP guidance for sites
• Meaningful networking and community building
• Unique giveaways and actionable takeaways

Stay tuned for more updates. 

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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 determines your valuation. In M&A transactions, hitting the right EBITDA threshold—such as $3M, $10M, or $25M—can significantly increase your multiplier, turning a 6X valuation into 10X or more. While some claim multipliers as high as 26X, the reality is more complex.

Beyond valuation, choosing the right private equity partner is just as critical. Do they want a standalone site, or will you be part of a network? Will you need to align with new processes or teams? Is your payout immediate, or will some be deferred? Many sellers are caught off guard when the check they expected never arrives as planned.

If you're considering an M&A transaction, don't just focus on the final price—understand the full process. We help clinical research sites navigate these deals strategically. Call, click, or email to learn more!

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Contract issues are more common than you think. Edye Edens shares the five critical areas you should always review before signing:

1. Basic Details & Formatting – Ensure names, dates, and references are correct, pages are in order, and there are no typos or inconsistencies from previous templates.
2. Appendices & Exhibits – Verify that referenced documents, such as addendums, exhibits, and budgets, are included and properly linked to the contract.
3. Budget & Payment Terms – Clarify payment schedules, invoice requirements, dispute procedures, and financial obligations to avoid misunderstandings.
4. Choice of Law & Jurisdiction – Understand which state or country governs the contract and whether arbitration or legal obligations align with your interests.
5. Termination Clauses – Review conditions for ending the contract, including payment responsibilities, study impacts (for clinical trials), and notice periods.

A thorough review of these areas can prevent costly mistakes. Need expert guidance? Call us. 

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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 administration. Mohamed highlighted the increasing number of clinical trials and the expansion of pharmaceutical research into Europe, creating new opportunities for site owners like himself.

One of the most exciting developments he shared was his team’s work in stem cell research. They have been conducting investigator-initiated trials, including a recent study on concussions using stem cells. The study involved 20 participants—military personnel, football players, and soccer players, both male and female—who received IV injections of stem cells. The preliminary results were highly promising, demonstrating significant potential for using stem cells in neurological recovery.

They also discussed the complex regulatory framework surrounding stem cell research. Stem cell therapies exist in a regulatory gray area, straddling the line between medical practice and drug development. The FDA has historically scrutinized stem cell treatments, particularly when manipulation is involved—such as freezing and thawing cells, which can push the therapy into the category of a drug requiring extensive clinical trials. Mohamed explained that his team is carefully navigating these challenges by ensuring compliance with FDA regulations. In California, they operate under strict guidelines, treating patients with same-day stem cell procedures to avoid regulatory pitfalls associated with long-term storage or modification.

A key aspect of their approach is leveraging the “Right to Try” law, which allows patients who have exhausted other treatment options to access investigational therapies. Mohamed noted that this has been particularly relevant in their work on conditions like concussions and Alzheimer’s. While they are not aiming to reverse Alzheimer’s, their research focuses on delaying its progression.

The discussion also touched on the commercialization of stem cell therapies. Some clinics, particularly in states like Texas, have bypassed the traditional FDA approval process by charging patients directly for experimental treatments. However, Mohamed and his team are committed to following proper research protocols and avoiding legal risks. They briefly operated a sub-site dedicated to stem cell treatments but shut it down after seeing the FDA crack down on similar operations in New York. Now, they are taking a cautious approach, waiting for regulatory clarity before expanding further.

Mohamed’s journey into stem cell research was driven by his partnership with an orthopedic surgeon and a sports medicine doctor—who was also the team doctor for the Chargers. Their initial goal was to find effective treatments to help athletes recover faster. From there, they expanded their research into broader medical applications, including orthopedic and cardiovascular conditions.

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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 responsibilities, risk levels, and monitoring expectations upfront to avoid confusion and compliance issues later.

Key takeaways:

• Contracts should outline quality expectations beyond general regulatory compliance.
• A quality management plan should be a living document, adaptable as the trial progresses.
• Budgets must align with quality requirements to ensure proper execution.
• Negotiations often meet resistance when defining specifics, but clear planning prevents future disputes.

By embedding quality management into contracts and budgets, research teams can set clear expectations, improve compliance, and avoid costly surprises down the line.

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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 regulated pharmaceutical and medical device sectors.

The episode explores key challenges, starting with privacy and security concerns. AI-enabled systems handle large amounts of sensitive patient data, often governed by regulations like HIPAA in the U.S. and GDPR in Europe. Companies must ensure they have proper consent and compliance mechanisms in place to avoid major privacy breaches. Darshan also highlights risks related to the accuracy and reliability of AI responses. AI algorithms can misinterpret queries or provide outdated information, which could lead to serious legal and financial consequences.

Compliance with regulatory standards is another major topic. AI systems must adhere to strict FDA, CMS, OIG, and DOJ guidelines, just like human representatives. Improper training or significant deviations by AI can be considered violations, leading to fines or even jail time. The ethical dimension is also discussed, emphasizing that while AI can mimic empathy, it lacks the emotional intelligence of human interactions, which could result in dissatisfaction or ethical concerns.

We talk about the importance of managing these risks with well-established policies, robust training, regular auditing of AI systems, and a balance between AI and human interactions. He underscores the need for expert legal guidance in ensuring that AI systems are both compliant and secure.

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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 own tariffs. This could disrupt global supply chains, making due diligence even more critical for buyers evaluating international pharmaceutical and biotech companies. Traditionally, M&A analysis focuses on vendor agreements, but in light of these tariffs, companies must now assess the entire supply chain—including alternative sourcing options, regulatory approvals for suppliers, and potential delays in manufacturing. Some predict this will drive more companies to acquire U.S.-based API manufacturers to reduce dependency on foreign supply chains, especially if domestic tax incentives, such as potential Trump-era tax cuts, make U.S.-based production more attractive. If these factors align, the industry could see a shift toward reshoring pharmaceutical manufacturing and a surge in domestic M&A transactions as companies adapt to a changing trade landscape.

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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 centers—to understand whether their privacy regulations fall under state or federal jurisdiction. They explore hypothetical scenarios where federal agencies or other entities might request access to clinical trial data, questioning the potential motivations behind such requests, including public health initiatives or policy changes. Edye and Helen stress the importance of ensuring that participant data remains protected, that any data-sharing aligns with consent agreements, and that institutions are prepared to navigate these complex regulatory challenges. Given the rapidly shifting legal landscape, they highlight the need for vigilance and proactive compliance strategies to safeguard sensitive healthcare data.

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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 FDA diversity initiatives, and potential scrutiny of diversity efforts in private companies.

A major focus is the changing environment of off-label marketing, where reliance on FDA guidances is being replaced by stricter adherence to statutory regulations due to court rulings like Coronia and Loper Bright. This shift creates uncertainty for regulated industries, as enforcement becomes less predictable.

Key Topics Discussed:

Off-Label Promotion & Enforcement:

• Off-label use is legal, but off-label promotion remains a complex issue.
• Enforcement is increasingly driven by the False Claims Act, with oversight from multiple agencies (FDA, FTC, DOJ, OIG, CMS).
• The blurring of lines between medical and sales functions is a growing concern, especially with AI chatbots playing a role in medical communications.

Compounding & the GLP-1 Market:

• The discussion explores drug compounding, particularly regarding GLP-1 weight loss medications.
• Regulatory challenges stem from drug shortages, compounding rules, and market competition, with potential Lanham Act violations and unfair competition claims.
• The Inflation Reduction Act and its implications for drug shortages and penalties are also considered.

Key Compliance Considerations:

• Maintaining clear separation between sales and medical functions.
• Ensuring compliance with FDA promotional material regulations.
• Managing risks related to AI chatbots and speaker programs.
• Implementing robust compliance programs in line with DOJ, OIG, and FDA guidelines.
• Understanding the growing role of state attorneys general and competitor-driven enforcement actions.

The overall sentiment reflects industry uncertainty as pharmaceutical companies navigate regulatory and legal shifts in this new landscape.

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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 medical degrees, completing training, and gaining clinical experience for 5 to 10 years before transitioning into leadership.

Lee also discusses the financial pitfalls physician leaders often face, particularly not recognizing their own value. He explains how clinical expertise can reduce waste and inefficiencies in healthcare organizations, bringing significant value beyond patient care. He also emphasizes the importance of collaboration between clinicians and non-clinical peers, advocating for mutual understanding and respect to strengthen healthcare teams.

Additionally, Lee talks about his podcast "Fire Chief," which addresses disaster management and crisis leadership for CMOs. He shares his experiences in high-pressure situations like the COVID-19 pandemic and offers advice on managing stress, urging future leaders to stay proactive in maintaining their well-being. Lee concludes by encouraging aspiring leaders to focus on developing their leadership skills and find mentors to guide them in their career journey.

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