Why Are PBMs Blocking Your Meds? - Darshan reacts

DarshanTalks Podcast

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Kandungan disediakan oleh Darshan Kulkarni. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Darshan Kulkarni atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.

This Is Woman's Work with Nicole Kalil

1
How To Pitch Yourself (And Get A Yes) | 300 27:52

13 days ago27:52

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Senarai

Suka

Disukai

27:52

We made it— 300 episodes of This Is Woman’s Work ! And we’re marking this milestone by giving you something that could seriously change the game in your business or career: the skill of pitching yourself effectively. Whether you’re dreaming of being a podcast guest, landing a speaking gig, signing a client, or just asking for what you want with confidence—you’re already pitching yourself, every day. But are you doing it well? In this milestone episode, Nicole breaks down exactly how to pitch yourself to be a podcast guest … and actually hear “yes.” With hundreds of pitches landing in her inbox each month, she shares what makes a guest stand out (or get deleted), the biggest mistakes people make, and why podcast guesting is still one of the most powerful ways to grow your reach, authority, and influence. In This Episode, We Cover: ✅ Why we all need to pitch ourselves—and how to do it without feeling gross ✅ The step-by-step process for landing guest spots on podcasts (and more) ✅ A breakdown of the 3 podcast levels: Practice, Peer, and A-List—and how to approach each ✅ The must-haves of a successful podcast pitch (including real examples) ✅ How to craft a pitch that gets read, gets remembered, and gets results Whether you’re new to pitching or want to level up your game, this episode gives you the exact strategy Nicole and her team use to land guest spots on dozens of podcasts every year. Because your voice deserves to be heard. And the world needs what only you can bring. 🎁 Get the FREE Podcast Pitch Checklist + Additional Information on your Practice Group, Peer Group, and A-List Group Strategies: https://nicolekalil.com/podcast 📥 Download The Podcast Pitch Checklist Here Related Podcast Episodes: Shameless and Strategic: How to Brag About Yourself with Tiffany Houser | 298 How To Write & Publish A Book with Michelle Savage | 279 How To Land Your TED Talk and Skyrocket Your Personal Brand with Ashley Stahl | 250 Share the Love: If you found this episode insightful, please share it with a friend, tag us on social media, and leave a review on your favorite podcast platform! 🔗 Subscribe & Review: Apple Podcasts | Spotify | Amazon Music…

about a year ago 4:10

MP3•Laman utama episod

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 sudden changes in coverage.

While PBMs claim to help reduce drug costs, they are currently under scrutiny, with the Federal Trade Commission and several state attorneys general investigating their pricing practices and potential anti-competitive behaviors. On the other side, pharmaceutical companies and PBMs often shift blame onto each other, sparking debates about who’s responsible for rising drug prices. Ultimately, clearer communication with doctors about medication costs could improve patient care, though the current system's complexity makes this challenging for both doctors and pharmacists.

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#Science #Society #Biology #Documentaries #Podcasting Education #DarshanTalks #Pharma #Medical Device #FDA #Law #Regulations #Guidance #Clinical Research #Advertising #Mergers #Acquisitions #M #Pharmacy

Why Are PBMs Blocking Your Meds? - Darshan reacts

DarshanTalks Podcast

published about a year ago

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214 episod

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1
Webinar Update: Fraud Prevention Strategies Every Sponsor Needs 7:14

4 days ago7:14

7:14

Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/ Registration Link- https://us02web.zoom.us/meeting/register/KhsVL6C6Tg6KKNDRHYTEKA In this kickoff conversation, Darshan Kulkarni and Edye Edens introduce a candid new series exploring how legal and compliance professionals approach clinical research differently—but with a shared mission. The idea was born at the Save Our Sites event, where they realized they often take distinct, yet complementary, paths to solve the same problems. Edye draws from her deep operational and academic background, including experience with the ORI and FDA, and focuses on making complex issues relatable and engaging. Darshan brings a broader regulatory lens—from sponsor, CRO, and site perspectives—and specializes in enforcement expectations from DOJ, OIG, OCR, and FDA. Together, they balance legal precision with practical implementation. They tease their upcoming live webinar on April 28th, which will focus on how sponsors can detect and prevent fraud in clinical trials. Expect real-world insights, early intervention strategies, and conversations that go beyond theory—because preventing fraud starts long before the red flags. This isn’t your typical compliance chat. It’s a thoughtful, back-and-forth series that reflects how diverse perspectives can create stronger, smarter research environments. Support the show…

1
Are Your Promotional Claims Putting Your Company at Risk? 1:38

5 days ago1:38

1:38

Guardant Health’s recent $292 million victory against Natera in a false advertising lawsuit sets a critical precedent for the biotech industry, highlighting the severe consequences of misleading claims. This case is a wake-up call for drug and device companies navigating complex FDA and FTC regulations. False advertising not only misleads stakeholders but also exposes companies to significant financial losses and regulatory scrutiny. Compliance officers and marketers must work together to ensure promotional materials are accurate, legally sound, and fully substantiated. Your PRC team should include both regulatory experts and legal professionals to verify claims, substantiate benefits, and avoid exaggerations. The cost of non-compliance can far exceed the effort required to get it right. At Kulkarni Law Firm, we help companies mitigate advertising risks and stay compliant. Subscribe to our podcast for practical insights, and contact us to safeguard your organization’s reputation and bottom line. What steps has your company taken to audit its advertising practices? Share your thoughts with us! Support the show…

1
Privacy Dangers Lurking in Clinical Trial Mergers 5:45

7 days ago5:45

5:45

Darshan Kulkarni and Edye Edens discuss the critical role of data privacy in clinical trial site acquisitions. While privacy concerns can seem daunting, they don’t have to be a dealbreaker if managed correctly. The key is understanding whether privacy laws like HIPAA apply, ensuring the site is already handling data compliance well, and putting safeguards in place to mitigate risks. Investors should conduct thorough due diligence to assess the site's current privacy practices before the merger or acquisition. One major misconception is that HIPAA always applies to clinical trial data. In reality, properly anonymized trial data often falls outside its scope, though certain patient records may still be regulated. Beyond HIPAA, state-specific laws such as the California Consumer Privacy Act (CCPA) and disease-specific privacy regulations (e.g., HIV, weight loss treatments) add layers of complexity. Additionally, compliance risks arise when acquiring companies use AI-driven tools, as AI itself is facing lawsuits over privacy violations. A smart approach to privacy in M&A involves firewalling sensitive data whenever possible—if an acquiring company doesn’t need direct access to regulated data, it should avoid handling it altogether. Investors should also consider risks tied to telemedicine regulations, patient communications (TCPA, CAN-SPAM), and wiretapping laws in certain states. The goal is to minimize exposure while maintaining operational efficiency. Ultimately, data privacy in clinical trial acquisitions is about proactive risk management. Understanding the regulatory landscape, setting clear boundaries around data access, and ensuring compliance with both federal and state laws can help investors navigate these challenges. If you’re considering acquiring a clinical trial site and want to safeguard your investment, reach out to us to discuss your privacy strategy. Support the show…

1
The FDA's Crisis Is Now Your Problem 2:32

10 days ago2:32

2:32

The FDA you designed your protocol around may no longer exist. In this episode, Darshan Kulkarni breaks down why clinical researchers, regulatory attorneys, and promotional review teams need to pay attention— now . With mass layoffs, frozen guidances, and a reorganization shaking CDER and CBER to their core, trial timelines, IRB reliance, and even legal interpretations are in flux. Marketing teams are flying blind with the FDA’s communications division gutted and post-Loper Bright challenges looming large. Darshan outlines urgent next steps: ✔️ Rethink your submission timelines ✔️ Reassess your SOPs for oversight and reporting ✔️ Update your promotional risk strategy—especially in digital If you're in life sciences and relying on yesterday’s FDA to approve tomorrow’s innovation, it’s time to rethink. Reach out to the Kulkarni Law Firm—we specialize in compliance during regulatory chaos. Support the show…

1
Broken FDA, Big Consequences 0:35

12 days ago0:35

0:35

The FDA is facing unprecedented turmoil—staff cuts, a sweeping reorganization, and political interference are undermining its ability to safeguard public health. Former agency leaders are raising red flags, with one likening the situation to "flat earthers taking over NASA." With vaccine data access becoming politicized, stem cell oversight potentially weakening, and the user fee system in jeopardy, startups and pharma companies must treat this not as a minor policy shift but as a major compliance crisis. If you're not already reassessing your regulatory strategy, you're falling behind. Support the show…

1
You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations 14:52

14 days ago14:52

14:52

In this episode, Kate Woods and Darshan Kulkarni discussed the shift from employer-sponsored health insurance to individual responsibility, a transition accelerated by policy changes and rising healthcare costs. Traditionally, employer-provided insurance has been the backbone of the U.S. healthcare system, but evolving regulations, including the Affordable Care Act (ACA), have made individual plans more accessible. This shift has given employees greater flexibility but also placed the burden of navigating complex insurance options on them, often without sufficient guidance. One key development in this transition is the rise of Individual Coverage Health Reimbursement Arrangements (ICHRA), which allow employers to fund employees' insurance plans rather than providing direct coverage. While this model expands consumer choice, it also raises concerns about decision fatigue and potential financial risks, especially for younger employees who may prioritize lower premiums over comprehensive coverage. As the workforce becomes more mobile and remote work grows, the demand for personalized, portable health coverage is likely to increase. The discussion also explored the role of AI and digital tools in simplifying healthcare decision-making. AI-powered platforms can assess consumer needs, predict potential risks, and recommend tailored insurance plans. However, while these tools offer convenience and efficiency, they also introduce risks related to bias, transparency, and over-reliance on automated decision-making. Without proper safeguards, employees may make uninformed choices based on incomplete or misleading AI-generated recommendations. Both Kate and Darshan emphasized the importance of balancing technology with human expertise in healthcare decisions. While AI can streamline processes, it cannot fully replace the nuanced understanding of a skilled advisor. As the healthcare landscape continues to evolve, education, transparency, and regulatory oversight will be critical to ensuring that individuals can make informed choices without unintended consequences. Support the show…

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Essential Due Diligence Steps for Clinical Research M&A 3:45

16 days ago3:45

3:45

When mergers and acquisitions intersect with clinical trials, due diligence becomes a crucial step in ensuring a successful transition. In this insightful discussion, Darshan Kulkarni and Edye Edens explore the key legal and operational considerations when acquiring or merging with clinical research entities, including sponsors, sites, and CROs. A major focus of the conversation is understanding the risks associated with clinical trial sites. Many private equity investors are actively looking to acquire research sites, but without proper planning, these deals can present significant challenges. One of the biggest concerns is the departure of key personnel—often the very individuals who understand how the site operates. If a site owner exits without a succession plan, the entire operation could be at risk. Investors must assess whether there are trained personnel in place to sustain operations. Ownership structure is another critical factor. The MSO (Management Services Organization) model is commonly used in healthcare acquisitions, but not all clinical research sites are structured this way. Some investors may assume that site acquisitions function like medical practice acquisitions, which can lead to compliance and operational gaps. Additionally, many site owners have handshake agreements with principal investigators (PIs) rather than formal contracts, posing risks when it comes to continuity and regulatory compliance. From an operational standpoint, investors and sponsors need to evaluate where a site stands in its progression—its infrastructure, ability to handle feasibility audits, and experience in running trials. Conducting a thorough review of contracts, policies, and procedures is crucial. Beyond the high-level strategic risks, a deeper, on-the-ground audit of compliance and operational readiness is necessary to avoid unforeseen liabilities. This discussion highlights the complexity of due diligence in clinical trial acquisitions. While this conversation only scratches the surface, it underscores the importance of a comprehensive review process. Investors, sponsors, and site owners must collaborate with legal and compliance experts to navigate these challenges effectively. For a deeper dive into these issues, watch the full discussion or reach out to Kulkarni Law Firm for guidance. Support the show…

1
Is AI Telemarketing Strategy Illegal? 0:43

18 days ago0:43

0:43

Today’s episode is a wake-up call for pharma marketers launching telehealth campaigns. If you're using AI voice assistants or call automation tools in your outreach, you could be stepping into a legal minefield under California’s privacy law (CCPA & CIPA). Your telehealth campaign reflects your brand—don’t let privacy lawsuits define it. Contact the Kulkarni Law Firm for a legal review of your telehealth tools to ensure compliance and protect your reputation. Support the show…

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No Clinical Trial Waste 18:18

20 days ago18:18

18:18

In this episode, Darshan Kulkarni explores an important yet often overlooked question—what happens after a clinical trial ends? While much focus is placed on clinical trials as a care option, the conversation shifts to the opportunities that exist for research-related resources post-trial. Darshan is joined by: Lorri Warren, Program Director of the MedSurplus Alliance at the Task Force for Global Health, which focuses on improving healthcare systems and managing medical product donations. Donna Libretti Cooke, a consultant for Kits4Life , who formerly worked at Bayer and helped implement the Kits4Life initiative. Greg Folks, Chair of the Kits4Life Advisory Council, who has over 30 years of experience in clinical research, particularly from the site perspective. The discussion highlights how clinical trial sites often accumulate surplus medical supplies and equipment, which are typically destroyed due to logistical and liability concerns. The Kits4Life initiative, built within the MedSurplus Alliance, aims to redirect these valuable resources to humanitarian efforts rather than letting them go to waste. Greg shares how the idea stemmed from the realization that research sites were discarding perfectly usable, medical-grade supplies. Donna discusses the legal and compliance challenges faced by pharmaceutical companies in supporting such donations, emphasizing how structured donation agreements and liability protections help overcome these concerns. Lorri provides insights into how the MedSurplus Alliance facilitates these large-scale donations through vetted organizations to ensure compliance and proper distribution. The episode underscores the importance of structured donation systems that allow surplus clinical trial supplies to benefit underserved healthcare communities, turning research into an ongoing care option even after a trial has concluded. Support the show…

1
The Real Meaning of Audit-Readiness in Clinical Research 2:34

22 days ago2:34

2:34

Edye Edens discusses what it truly means to be site audit ready and dispels the misconception that it requires 100% compliance. No auditor expects perfection—what matters is having strong processes in place to catch and address issues in real time, particularly those with safety or regulatory implications. Being audit-ready means having the infrastructure to identify whether mistakes are isolated incidents or part of a larger trend requiring corrective action. Just like building credit requires a history of responsible transactions, regulatory credibility comes from demonstrating the ability to detect and resolve compliance issues effectively. Rather than aiming for unattainable perfection, sites should focus on maintaining a proactive compliance system that ensures high-risk issues are caught early and addressed. If you need guidance on achieving true audit readiness, KLF is here to help. Support the show…

1
Ordinary People Are Changing Medicine 3:47

24 days ago3:47

3:47

Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medicine falls short. Driven by necessity, love, and a desire for survival, many have solved complex medical problems themselves, leading to groundbreaking discoveries. This trend raises important questions about safety, ethics, and the future of healthcare, with both promise and complexity. One of the most well-known examples is Lorenzo’s Oil, where Michaela and Augusto Odone developed a treatment for their son Lorenzo, who was diagnosed with a rare and fatal genetic disorder. Their research and persistence led to a groundbreaking treatment that helped slow the disease's progression. Another inspiring story is that of Dr. David Fajgenbaum, who, after being diagnosed with Castleman’s disease, repurposed existing drugs to stabilize his condition, saving his life and offering hope to others. These remarkable examples demonstrate how determination and innovation can lead to life-saving breakthroughs. However, citizen biohacking raises crucial concerns, such as safety and ethics. Operating outside the traditional medical system, it challenges regulatory bodies to reconsider how innovation is validated and tested. Despite these challenges, citizen biohacking is changing the landscape of medicine, pushing the medical community to think differently, adapt more quickly, and collaborate with unconventional innovators. If you’re interested in exploring these stories and the legal implications of this trend, tune in to our Darshan Talks podcast or reach out to Kulkarni Law Firm for expert guidance. Support the show…

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Investor Influence Can Trigger FCA Violations 2:19

26 days ago2:19

2:19

Mergers and Acquisitions (M&A) in the healthcare sector can be highly profitable, but they carry significant legal risks, particularly for private equity investors and board members who hold excessive influence over operations. The case of US XRL Martino Fleming vs. South Bay Mental Health Centers serves as a cautionary tale, highlighting how overstepping operational boundaries can lead to False Claims Act (FCA) violations. Investors, eager to enhance efficiency and profitability, may inadvertently trigger scrutiny by imposing aggressive performance targets or controlling daily operations, which could cross the line into operational control. In this case, allegations of fraudulent billing practices arose due to the investor’s involvement in clinical and administrative operations. Such claims can result in severe financial penalties and irreparable damage to reputation, affecting future investment opportunities. The key takeaway here is that undue influence by investors can unintentionally create compliance liabilities. It is crucial for private equity firms to maintain a balance between oversight and operational independence. As part of M&A due diligence, integrating compliance reviews is essential. The Department of Justice (DOJ) issued updated guidance in 2023 and 2024, emphasizing the need for these reviews to focus on federal healthcare program regulations. This includes everything from Medicare billing practices to compliance with the Stark Law and Anti-Kickback Statute. Investors must conduct operational audits, understand the limits of control in regulated industries, and set up post-acquisition compliance frameworks to avoid liability. Ultimately, proactive compliance strategies are crucial to safeguarding against FCA violations and ensuring M&A transactions remain successful. Reach out to the Kulkarni Law Firm for tailored legal guidance and subscribe to the DarshanTalks Podcast for more insights into healthcare M&A best practices. Support the show…

1
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons 2:38

28 days ago2:38

2:38

Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research organizations and academic medical centers often prefer sponsor-to-organization agreements because they provide structured negotiations around intellectual property (IP) rights, indirect costs, liability protections, and compliance oversight. These agreements also ensure that investigators have access to institutional resources and support. On the other hand, direct investigator agreements may offer a faster turnaround, but they come with greater risks. Investigators negotiating independently might agree to terms that organizations would typically reject, potentially exposing themselves to legal and financial liabilities. Understanding these distinctions is crucial for managing risk. While direct agreements may have their place, it’s essential to carefully evaluate the terms and ensure adequate protections. If you're unsure about the best approach for your situation, consult legal experts before signing. Need guidance? Get in touch with KLF. Support the show…

1
Clinical Trial Site M&A: What Most Get Wrong 4:20

4 weeks ago4:20

4:20

Most clinical trial site mergers focus on patient databases, sponsor contracts, and geographic expansion. While those are important, the real risks lie elsewhere—buried in compliance issues that can derail your deal before it even closes. Imagine acquiring a site that looks great on paper, only to face FDA or DOJ scrutiny months later due to undisclosed 483s, protocol deviations, or even kickback violations. Instead of scaling operations, you're dealing with regulatory investigations and potential fraud issues. These risks are avoidable—if you know where to look. Before merging clinical trial sites, conduct thorough due diligence: 1. IRB Approvals and Regulatory Compliance History – Review IRB approvals and study regulatory compliance history. 2. 483s and FDA warning letters- Review past 483s, and FDA warning letters. 3. IRB approvals- Ensure that all ongoing studies have IRB approvals. 4. Ensure Past Deviations & Adverse Events Are Resolved – Review all protocol deviations and adverse event reports to confirm they have been properly addressed. Compliance violations don’t disappear after a merger—they become your responsibility. 5. Site Contracts & Investigator Agreements – Ensure contracts transfer post-merger and aren’t tied to individual physicians. 6. Verify Financial Disclosure Reporting – Ensure all financial disclosures are accurate and complete to avoid undisclosed conflicts of interest post-merger. 7. Clinical Staff & Oversight – Verify investigator credentials, GCP training, and past compliance violations. 8. Verify PI Credentials – Confirm that the Principal Investigator’s credentials, licenses, and certifications are valid and up to date. 9. Confirm GCP Training Compliance – Ensure all investigators have completed the required Good Clinical Practice (GCP) training. 10. Review Investigator-Specific Protocol Violations – Identify any past protocol violations linked to individual investigators. 11. Assess Payment Structures & Financial Arrangements – Review whether payments are percentage-based or fee-for-service, and check for any financial perks like free rent. 12. Data Integrity & Patient Safety – Look for missing consent forms, protocol adherence issues, and any history of data fabrication. 13. Verify Informed Consent Documentation – Ensure all informed consent forms are properly documented and complete. 14. Review Protocol Adherence Records – Verify that the site consistently follows approved protocols. Hidden compliance risks don’t disappear after a merger—they become your problem. The Kulkarni Law Firm helps clinical research sites, CROs, and investors identify and mitigate these risks before closing a deal. Contact us to safeguard your next clinical trial site merger. Support the show…

1
Future-Proof Sites: SOS Insights Revealed 8:38

5 weeks ago8:38

8:38

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 evolving landscape of clinical research. Raymond shares his journey from running a clinical research site to founding CRIO, a platform designed to modernize site operations through eSource, CTMS, and real-time data solutions. They explore major industry trends, including the rise of site networks, increasing sponsor demand for real-time data access, and the shifting role of decentralized clinical trials (DCTs). They also discuss whether DCTs are truly revolutionizing research or simply becoming part of standard clinical operations. Raymond emphasizes that while centralization can improve efficiency in areas like finance, data management, and regulatory processes, the investigator-patient relationship must remain localized for research to be effective. The SOS conference highlighted these ongoing shifts, and the conversation dives into how sites can stay competitive by adapting to sponsor expectations, leveraging technology, and optimizing operations. Support the show…

DarshanTalks Podcast

1
Off-Label Promotion Changes in 2025 31:17

9 weeks ago31:17

31:17

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. Support the show…

DarshanTalks Podcast

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Turning Physicians into Leaders 16:23

9 weeks ago16:23

16:23

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. Support the show…

DarshanTalks Podcast

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Key Regulatory Agencies in Pharma M&A 1:18

10 weeks ago1:18

1:18

When conducting an M&A transaction in the pharmaceutical or medical device industry, compliance must be a top priority. Regulatory agencies like the DOJ, FDA, OIG, and OCR have strengthened oversight, emphasizing successor liability and the need for strong compliance programs. Beyond FDA regulations, companies must consider fraud prevention, HIPAA, and evolving privacy laws at both federal and state levels. Ignoring these factors can lead to serious legal and financial consequences. Stay informed—compliance isn’t optional. Support the show…

DarshanTalks Podcast

1
Does E6 (R3) Blur the Line Between GCP and Privacy Laws? 1:37

10 weeks ago1:37

1:37

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 evolving into a privacy doctrine? Given its increased focus on data protection, system validation, and privacy responsibilities, some wonder if it overlaps with regulatory frameworks like HIPAA, especially as OCR proposes significant updates to the Security Rule. However, Edens notes that while R3 contains more references to privacy, it does not explicitly mention cybersecurity, which is a major focus of OCR’s changes. She argues that R3 is not attempting to replace or overshadow existing privacy regulations but rather aligns with their broader goals of data confidentiality and integrity. She invites discussion on whether others see any regulatory overlap. Support the show…

DarshanTalks Podcast

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RFK Jr. Confirmed as HHS Secretary: What It Means for Healthcare Policy 8:01

10 weeks ago8:01

8:01

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 Trump’s latest executive order. The order mandates a comprehensive national health assessment, addressing issues like obesity, diabetes, and pediatric disorders, and aims to reshape the country’s approach to preventive care. While the focus on public health challenges is timely, the broad and vague nature of the directive raises questions about its execution and potential consequences. A key concern is how the administration will interpret health data—whether it will rely on scientific evidence or lean into controversial theories, particularly regarding vaccines and chronic illnesses. RFK Jr.’s alignment with the "food as medicine" movement could bring renewed attention to nutrition and prevention, but there is also the risk of oversimplifying complex health issues. Will this shift in policy lead to meaningful improvements in healthcare access and disease prevention, or will it fuel misguided initiatives based on correlation rather than causation? Darshan and Edye explore the broader implications, including the potential for changes in clinical trial funding, regulatory oversight, and access to medications. They emphasize the need for a balanced approach that values scientific rigor while addressing public health challenges. With major policy shifts on the horizon, this is a developing issue that will demand close scrutiny in the weeks to come. Stay tuned as they continue to break down the impact of these decisions on healthcare, research, and patient outcomes. Support the show…

DarshanTalks Podcast

1
America’s Research Future in Jeopardy 7:44

10 weeks ago7:44

7:44

Darshan Kulkarni and Edye Edens break down the significant impact of the Trump administration’s decision to cut NIH funding and reduce agency workforces, including the FDA, OHRP, and other key regulatory bodies. They discuss how these cuts could lead to serious disruptions in research funding, approval timelines, and the overall pace of medical innovation in the U.S. While some argue that such reductions could improve efficiency and reduce waste, others fear the immediate and long-term consequences—particularly for investigator-initiated trials, rare disease research, and the ability of institutions to remain globally competitive. The conversation highlights the potential ripple effects, including workforce layoffs, the shuttering of critical trials, and delays in drug approvals. With the FDA considered the gold standard in regulatory oversight, a drastic reduction in its capacity could have global repercussions, potentially undermining trust in the U.S. approval process. Moreover, the lack of transition planning and abrupt implementation raises concerns about whether the administration has fully considered the real-world impact of these cuts. Edye and Darshan also examine the broader economic and geopolitical implications, questioning whether these cuts align with the administration’s “America First” philosophy. They discuss how China and other countries are rapidly advancing in drug innovation, in part due to U.S.-led research. If domestic funding dries up, there is a risk that pharmaceutical and biotech breakthroughs could shift overseas, weakening America’s leadership in life sciences. Ultimately, they stress the need for informed decision-making, transparency, and better representation of key stakeholders in these high-stakes policy shifts. Without a strategic approach, the short-term cost-cutting measures could create long-term challenges, not only for researchers and institutions but also for patients who depend on groundbreaking medical advancements. Support the show…

DarshanTalks Podcast

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Trump Administration’s NIH cuts: Will they cripple US medical research? 7:48

10 weeks ago7:48

7:48

Darshan Kulkarni and Edye Edens discuss the recent controversy surrounding the Trump administration’s decision to cap NIH overhead funding (also known as indirect costs or F&A) at 15%. This sweeping change has already sparked significant backlash, with academic medical centers, particularly in Democratic states, filing lawsuits to challenge the policy. The cap threatens to disrupt funding structures that support essential research, potentially undermining the United States’ role as a global leader in medical innovation. They break down the impact of this decision, highlighting how research costs vary significantly based on location—conducting studies in Boston versus Oklahoma City, for example, involves vastly different expenses. A one-size-fits-all cap could have unintended consequences, particularly in an era where supply chain disruptions and rising costs are already straining research budgets. A major concern is how this will affect investigator-initiated and subsidized trials, which often operate at a loss but are crucial for rare diseases and specialized treatments. These trials provide hope to patients who might otherwise have no viable treatment options, and without adequate funding, such research could dwindle. The discussion also covers the broader legal and political landscape. The Association of American Medical Colleges (AAMC) has now filed a federal lawsuit seeking a nationwide temporary restraining order on enforcing the cap, marking a significant escalation in the legal battle. With past instances of the Trump administration disregarding court orders, Darshan and Edye explore the potential for a constitutional crisis if the executive branch ignores judicial rulings. Further, they examine the possible influence of private corporations on this policy shift. Many corporations that fund research typically limit their overhead contributions to around 15%, and some members of the administration have ties to these corporations. The hosts speculate that the policy may have been designed to align federal funding with corporate standards—potentially at the expense of public research institutions. Ultimately, they question whether these cuts truly support the administration’s “America First” philosophy. If the goal is to maintain U.S. dominance in scientific research, slashing funding without strategic adjustments could have the opposite effect, weakening the country’s ability to innovate and compete globally. With legal challenges underway and research institutions scrambling to adjust, this conversation is just the beginning of what promises to be a rapidly evolving and highly contentious issue. Support the show…

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1
DEI Under Trump: What It Means for Clinical Trials 7:47

11 weeks ago7:47

7:47

The Trump administration’s early actions have significantly impacted federally funded programs, particularly in the clinical trial space, by rolling back diversity, equity, and inclusion (DEI) initiatives. This shift raises serious concerns for scientific research, as diversity in clinical trials ensures that drugs and devices are effective across different populations. Historically, most approved treatments have been tested primarily on white males, creating gaps in data for other demographic groups. Despite the removal of DEI-related FDA guidance, clinical trial sponsors, sites, and institutions must consider broader legal and financial risks. The Department of Justice (DOJ) and other agencies are scrutinizing compliance, and organizations receiving federal funding could face funding cuts or legal action for perceived discrimination. Companies must carefully assess the regulatory landscape and determine their risk tolerance while ensuring their trials remain scientifically sound. Darshan Kulkarni and Edye Edens discuss the rapidly evolving situation, the potential risks for the clinical research industry, and what companies should do to navigate these shifting regulations. Support the show…

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1
CAPA & RCA: A Must for Pharma M&A 1:39

11 weeks ago1:39

1:39

When acquiring a pharmaceutical company, evaluating its quality and compliance programs is crucial. A strong program starts with well-documented policies and procedures, followed by comprehensive training to ensure employees understand and follow them. However, having policies in place isn’t enough—regulatory bodies like the FDA and DOJ stress that enforcement and documentation are essential. If an issue isn’t written down, it effectively never happened. No regulator expects perfection, but they do expect companies to investigate mistakes, determine their root causes, and take corrective and preventive actions (CAPAs) to ensure compliance issues don’t recur. A well-structured CAPA process demonstrates a company’s commitment to regulatory standards and operational excellence. Corrective actions address immediate issues, while preventive actions ensure systemic improvements. When evaluating a potential acquisition, look beyond vendor agreements and examine the entire supply chain. A company with a proactive compliance culture is less likely to face regulatory penalties and will provide greater long-term value. Support the show…

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1
Trump Targets Indirect Costs in NIH Funding 1:21

11 weeks ago1:21

1:21

On Friday, the Trump administration announced a 15% cap on NIH indirect costs, raising important questions about its impact on research funding. Edye Edens breaks down what this means, clarifying that while direct costs like salaries and equipment remain unchanged, the cap affects crucial behind-the-scenes expenses such as lab maintenance, IT infrastructure, cybersecurity, and compliance. Understanding these distinctions is key as institutions adapt—watch as Edye unpacks the details. Support the show…

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1
The USAID Halt and Its Consequences for Clinical Research 2:29

11 weeks ago2:29

2:29

The Trump administration’s actions have effectively halted USAID-funded clinical research worldwide, creating an unprecedented situation with significant ethical, legal, and medical implications. Clinical trials that relied on USAID funding have stopped, leaving ongoing research in limbo and raising serious concerns about what happens to trial participants and who bears responsibility for any resulting harm. Key Legal and Ethical Questions: 1. Who is the sponsor? If the U.S. government was the official sponsor of a trial, sovereign immunity could come into play. This legal doctrine generally protects governments from being sued unless they explicitly waive immunity. Whether the U.S. government would assert sovereign immunity in this situation remains unclear. 2. Can individuals be held responsible? Legal action against government officials, including former President Trump and members of his administration, would depend on whether they were acting in their official capacities. If they were, they may be shielded from personal liability. 3. What about pharmaceutical companies? If a trial was co-funded by multiple entities—such as the NIH, USAID, and a private pharmaceutical company—the company might still bear responsibility. The extent of its liability would depend on contractual agreements, funding structures, and trial oversight mechanisms. This situation is virtually without precedent, making it difficult to predict outcomes. However, if trial participants suffer harm due to halted research, legal action is almost certain. The coming months may bring lawsuits, debates over liability, and broader discussions about the role of government funding in global clinical research. Support the show…

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1
Ebola Vaccine Trial in Record Time! 2:29

11 weeks ago2:29

2:29

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 efficacy of a vaccine against the virus was launched within just four days. This rapid response was made possible by proactive planning following a 2022 outbreak, during which the Ugandan Ministry of Health, Makerere University, and the Uganda Virus Research Institute implemented a strategy to fast-track future trial activations. By pre-selecting investigators, securing protocol approvals, and ensuring regulatory readiness, they positioned themselves to immediately initiate the trial once a new outbreak emerged. With WHO’s support, this initiative represents a groundbreaking moment in clinical research—offering real-time data collection during an active outbreak while potentially saving countless lives. The WHO’s press release details the extensive collaboration and meticulous groundwork that made this possible, reinforcing the importance of preparedness in global health crises. Support the show…

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1
Your Clinical Trial Site M&A Agreement is Exposing You to Risk 0:50

11 weeks ago0:50

0:50

When working on an M&A transaction involving a clinical trial site, it's crucial to thoroughly review vendor agreements. It's not just about what is included, but what is missing. For example, do you have the right quality and privacy agreements in place, or are you unknowingly exposing yourself to liability? If there’s a lack of necessary agreements, it’s important to assess whether it’s due to ignorance or an oversight that could lead to future legal risks. If you're unsure, reach out to ensure you're on the right track and avoid unnecessary liabilities. Support the show…

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1
What Does ICH E6 R3 Say About Returning Data to Participants? 1:01

12 weeks ago1:01

1:01

The most recent ICH E6(R3) final guidance introduces critical updates to Good Clinical Practice (GCP), particularly around informed consent and participant data access. The guidance emphasizes greater flexibility and the use of technology-driven innovations to enhance how patients understand what they are consenting to. A significant update appears in section 2.8 (Investigator Responsibilities), which now requires a clear plan for returning trial-related data to participants when appropriate. This shift acknowledges the growing importance of transparency and participant rights in clinical trials. However, the guidance does not explicitly assign this responsibility to sponsors, despite them often being the ones who restrict access to participant data. While this change is a major step forward in ethical research practices, its practical enforcement remains uncertain without direct sponsor obligations. These updates reflect a broader shift toward patient-centric clinical trials, but questions remain about how effectively they will be implemented. Support the show…

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1
Navigating the Ongoing HHS Communication Freeze 2:28

12 weeks ago2:28

2:28

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 with no significant updates or changes. Despite expectations that restrictions might begin to lift, there has been no broad release of communications across federal agencies involved in clinical trials and regulatory oversight. While this does not provide definitive insight into the administration’s plans, it does confirm that, for now, the freeze remains in place. A critical concern emerging from this situation is the growing tendency of certain federal agencies to offer guidance on behalf of others. While this may be well-intentioned, it presents a risk for those in regulatory and research compliance. Some professionals are now uncertain about whether to report specific matters to Agency A, B, or C, given that the usual communication channels remain restricted. In some cases, agencies that are not the primary governing bodies for certain regulatory matters are advising stakeholders on reporting requirements, creating potential compliance pitfalls. It is essential to recognize that no directive has been issued allowing agencies to speak on behalf of one another. If an agency suggests a course of action based on its assumptions about another agency’s stance, this does not guarantee compliance. Any decision based on such unofficial guidance could lead to regulatory missteps. In light of this uncertainty, professionals should exercise extreme caution. For any matters related to patient safety or immediate harm, necessary clinical actions should be taken without hesitation, with follow-up reporting to the appropriate governing body as soon as possible. However, for proactive regulatory filings or compliance-related decisions that do not require urgent action, it may be prudent to wait for official guidance once communication channels reopen. As the situation develops, we encourage industry professionals to stay informed and connected. Continue monitoring updates from KLF for the latest insights and recommendations on navigating regulatory challenges during this period of restricted federal communication. If you have specific concerns, feel free to reach out for further guidance. Support the show…

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1
Why Food M&A Deals Collapse—And How to Prevent It 2:29

5 weeks ago2:29

2:29

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, market share, and synergies, they fail to account for regulatory pitfalls that can trigger investigations, recalls, or severe penalties. Imagine being deep in negotiations, only to discover unapproved ingredients, misleading health claims, or an undisclosed FDA warning letter buried in company files. Some executives make the mistake of pushing forward, thinking they’ll fix it later—but regulators like the FDA, USDA, and FTC won’t wait. Many assume their internal legal teams can handle compliance due diligence, but food regulations are complex, spanning labeling, safety, advertising, and state consumer protection laws. The Kulkarni Law Firm specializes in identifying and resolving these risks before they become deal-breakers. We help buyers conduct regulatory due diligence, engage with federal and state regulators, assess liability risks in labeling and advertising, and structure compliance-driven transactions. If you're involved in food M&A, don’t let compliance issues turn your investment into a liability. Reach out to the Kulkarni Law Firm to protect your deal and ensure regulatory success. Support the show…

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1
Non-Compliance Led to QOL Medical's $47M Settlement 2:00

5 weeks ago2:00

2:00

The recent $47 million settlement involving QOL Medical and its CEO is a stark reminder of the consequences of crossing legal and ethical boundaries. Allegations of offering free Carbon 13 breath test kits as kickbacks to induce prescriptions for Sucraid, a treatment for congenital sucrose isomaltase deficiency (CSID), aren't just about non-compliance—they’re about patient safety. The breath tests could not specifically diagnose CSID but were marketed as such, leading to inappropriate prescriptions and fraudulent claims submitted to federal healthcare programs. This not only wasted resources but also put vulnerable patients at risk. For those in the rare disease treatment space, this case highlights the need for transparency and truth in marketing. Ask yourself: Are your promotional strategies truthful? Are you offering incentives that could be misconstrued as kickbacks? In a field with limited data and high stakes, misleading marketing can erode trust, tarnish reputations, and invite legal scrutiny. Compliance is not just a checkbox—it’s a commitment to ethical practices that prioritize patient well-being. As you navigate these challenges, ensure your marketing practices are compliant while effectively educating healthcare providers about rare disease treatments. QOL Medical’s costly misstep should serve as a warning. For guidance on staying compliant, reach out to the Kulkarni Law Firm and learn how we can help. Support the show…

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1
FDA Regulatory Submissions: Challenges, Trends, and Future Predictions 2:52

5 weeks ago2:52

2:52

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 practices and predictions for 2025. She highlights how AI tools and evolving political dynamics are shaping the regulatory landscape, emphasizing that while efficiency improvements are necessary, careful and strategic approaches are critical to maintain the FDA’s global reputation and safety standards. Edye discusses the complexity of submissions like Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, noting the significant preclinical work, detailed documentation, and thorough FDA review process involved. She also underscores the global weight of FDA approvals, as many international regulatory bodies rely on FDA assessments as a benchmark. Finally, Edye poses key questions to her audience: How familiar are you with regulatory submissions? Are you considering outsourcing this complicated process? Where do you see opportunities for efficiency—through AI, technology, or administrative changes? If you’ve been a reviewer, how do you balance efficiency with safety? Reach out for more info! Support the show…

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1
How to do a VR promo check - Carly Schaecter gives us her advice 14:42

6 weeks ago14:42

14:42

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 for VR expertise to conceptualize interactive, engaging content. Choosing VR over AR depends on the objectives, with VR offering more controlled environments. Ensuring user control, addressing misinformation, and learning from past mistakes are crucial for successful VR implementation. Gamification and user experience evaluation are critical elements of the review process. Support the show…

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1
Diversity Matters in Clinical Trials 5:42

6 weeks ago5:42

5:42

In this insightful discussion, Shuja Naqvi, CEO of Biopharma Informatics, joins Darshan Kulkarni to explore the evolving landscape of clinical research. Shuja shares how his company has expanded across seven states, strategically choosing locations to promote diversity—not just in ethnicity, but also in socioeconomic and regional representation. He highlights the importance of gathering data from various populations to improve the effectiveness and inclusivity of clinical trials. They delve into the growing role of research as a care option, particularly for uninsured patients who, through clinical trial participation, gain access to free medical care, medications, and life-saving screenings. While this model presents clear benefits, it also raises ethical concerns, such as the potential for undue influence when patients rely on trials for necessary healthcare. Shuja emphasizes the role of informed consent and IRB oversight in ensuring that participation remains voluntary and ethical. The conversation also addresses compensation for trial participants. Shuja argues that current payments are insufficient, considering the risks involved in testing non-FDA-approved treatments. He stresses that researchers should ask themselves: “Would I enroll my own family in this trial?” If not, it’s a sign that ethical standards and participant compensation need to be reconsidered. Support the show…

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1
EMA’s LLM Guidelines Impact Life Sciences 2:44

6 weeks ago2:44

2:44

The EMA's new guiding principles on LLMs represent a transformative step in regulatory science, addressing both the immense potential and significant risks of these technologies. These principles emphasize the need to balance innovation with ethical considerations, tackling issues like data privacy, misinformation, and bias. LLMs, such as ChatGPT, hold promise for automating workflows like medical translations, pharmacovigilance reporting, and coding support. However, the EMA stresses continuous education, ethical governance, and collaboration among stakeholders to ensure responsible use. Key recommendations include adopting strategies like prompt engineering to optimize AI outputs and fostering collaboration through initiatives like the European Specialized Expert Community (ESEC) for AI knowledge sharing. Bite-sized, accessible training programs can also help demystify LLMs for teams. As the life sciences sector embraces these tools, organizations must align with these principles to ensure compliant and impactful AI integrations. The Kulkarni Law Firm offers expert advice for ethical AI deployment—don’t wait to make your AI strategy future-ready! Support the show…

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1
How to Network Like a Pro at Conferences 17:08

7 weeks ago17:08

17:08

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 met at a past conference and quickly realized how much we had to learn from each other, so I asked Brook to come on and share her insights. They start by discussing whether conferences are truly valuable—considering the costs, time investment, and potential for networking. While online learning can be beneficial, conferences offer unique opportunities for interaction and relationship-building, which can lead to new clients, partnerships, and ideas. Brooke emphasizes the importance of setting clear goals before attending a conference, whether it's for lead generation, education, or brand awareness. They also talk about market segmentation and how CRIO approaches conferences with a targeted strategy, dividing attendees into categories like existing clients, partners, and prospective future clients. This helps the team prioritize and engage with the right people, even before the conference begins. Brooke shares her process of reaching out to these groups and how CRIO maximizes their time at events. Finally, they touch on the importance of building relationships at conferences—whether you're engaging with potential partners, clients, or learning from industry leaders. And while swag might seem trivial, Brooke explains that it's more about creating brand recognition and offering an opportunity to engage with attendees. If you're heading into conference season, this conversation is packed with valuable tips to help you navigate the event landscape more effectively. #SOSconference2025 #SaveOurSites2025 #clinicaltrials #clinicalresearch #clinicaltrialcompliance #clinicaltrialmanagement #FDACompliance #darshantalks #dt #kulkarnilawfirm #klf Support the show…

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1
Getting Ready for SOS 2025: FDA 483s, SOPs, and Site Survival 10:35

7 weeks ago10:35

10:35

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. Support the show…

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Maximizing Site Value 2:13

7 weeks ago2:13

2:13

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! Support the show…

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1
5 Key Areas to Review in Clinical Trial Agreements 3:33

8 weeks ago3:33

3:33

Contract issues are more common than you think. Edye Edens shares the five critical areas you should always review before signing: Basic Details & Formatting – Ensure names, dates, and references are correct, pages are in order, and there are no typos or inconsistencies from previous templates. Appendices & Exhibits – Verify that referenced documents, such as addendums, exhibits, and budgets, are included and properly linked to the contract. Budget & Payment Terms – Clarify payment schedules, invoice requirements, dispute procedures, and financial obligations to avoid misunderstandings. Choice of Law & Jurisdiction – Understand which state or country governs the contract and whether arbitration or legal obligations align with your interests. 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. Support the show…

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Discussing Stem Cell Research Opportunities with a Research Site Owner 7:43

8 weeks ago7:43

7:43

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. Support the show…

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Quality Management: A Must in Clinical Trial Contracts 6:23

8 weeks ago6:23

6:23

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. Support the show…

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1
AI-Powered Chatbots in Pharma Sales and Education 5:29

9 weeks ago5:29

5:29

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. Support the show…

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Will New Tariffs Disrupt Your Next Pharma Deal? 1:21

9 weeks ago1:21

1:21

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. Support the show…

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Protecting Patient Data in a Changing Regulatory Landscape 5:10

9 weeks ago5:10

5:10

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. Support the show…

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