Clinical Research Coach

What does it take to bring cutting-edge research to new populations—and new continents?In this episode of The Clinical Research Coach, Leanne sits down with Julio Martinez-Clark, CEO of bioaccess®, to talk about why Latin America—especially Colombia—is becoming a prime destination for clinical trials. Julio shares insights into navigating regulatory pathways, building trusted networks, and designing trials that are both scientifically rigorous and locally relevant.Whether you're exploring new geographies or simply curious about how patient-centric research is evolving globally, this conversation will broaden your perspective.To Learn More:Julio Martinez Clark:https://www.linkedin.com/in/juliomartinezclark/bioaccesshttps://www.bioaccessla.com/

In this episode of The Clinical Research Coach, host Leanne Woehlke sits down with trailblazer Nasha Fitter—tech entrepreneur, rare disease advocate, and co-founder of both the FOXG1 Research Foundation and Citizen Health.After Nasha’s daughter was diagnosed with FOXG1 syndrome, an ultra-rare neurological disorder, her world shifted. Instead of accepting the limitations of the current research landscape, she took action- building a foundation, galvanizing the scientific community, and redefining what’s possible for families facing rare disease.What began as a grassroots foundation now drives innovative drug development, redefines data collection, and challenges the status quo in drug development.In this conversation, Nasha shares:How a small, determined parent community raised $10M and launched a gene therapy programWhy traditional research models fail rare disease patients—and how to fix themThe power of patient-owned data and how platforms like Citizen Health are transforming access and insightsHow to build empathy for families navigating special needsWhat pharma gets wrong (and right) in working with advocacy groupsHer vision for a precision medicine future—starting with ultra-rareThis is a story about courage, creativity, and a more inclusive, patient-driven future of medicine. Nasha’s bold vision and action oriented approach will leave you inspired and hopeful.To Find Out More:Nasha Fitterhttps://www.linkedin.com/in/nashafitter/FOXG1 Research Foundation: https://www.foxg1research.org/Citizen Health:https://www.citizen.health/

In this heartfelt episode, we sit down with Katie Diaz, Managing Partner of the Dan Diaz Biotech Breakfast Club. Katie shares the deeply personal story of her father, Dan Diaz, whose ALS diagnosis changed the course of her life- and inspired her to continue the work he started. Together we explore the importance of empathy, the emotional layers of navigating a rare disease and how Katie transformed grief into advocacy, mission and action. Enjoy!To Learn More:Katherine (Diaz) Harakel The Dan Diaz Biotech Breakfast Club:https://thedandiazbiotechbreakfastclub.godaddysites.com/

In this powerful episode of The Clinical Research Coach, we sit down with Kay Kays — a 30-year pancreatic cancer survivor and passionate patient advocate. Kay’s story is nothing short of extraordinary. Diagnosed with one of the most challenging cancers to treat, she not only defied the odds but has spent the last three decades using her voice to push for better patient access to clinical trials.With her signature honesty and infectious energy, Kay shares why she believes clinical trials should be the appetizer — not the dessert — in the treatment journey. We talk survivorship, advocacy, and the urgent need to change how patients are introduced to research as a care option. Whether you’re in clinical research, oncology, or simply need a dose of inspiration, this conversation is not to be missed.To learn more about Kay Kays:https://www.linkedin.com/in/kay-kays-2a993649/

In this episode of The Clinical Research Coach, host Leanne Woehlke sits down with Robert Goldman, Head of Clinical Operations at Contraline, a company pioneering innovation in reproductive health. Robert is a true industry disruptor, challenging traditional clinical trial models by integrating AI, decentralized trial frameworks, and real-time data analytics to accelerate timelines and improve patient outcomes.Robert shares his journey into clinical research, the challenges he’s faced while introducing disruptive models, and his vision for the future of clinical operations. He also offers practical advice for clinical leaders looking to embrace innovation and transform the patient experience.If you’re ready to explore how technology and human-centered design are shaping the future of clinical trials, this is an episode you don’t want to miss!To learn more:Robert Goldman is the Head of Clinical Trail Operations at Contraline as well as the Founder of ALCOA Consulting. https://www.linkedin.com/in/robert-s-goldman-358b0868/

In this episode of The Clinical Research Coach, host Leanne Woehlke sits down with Stacy Martin, who shares her journey of entering a clinical trial. Stacy talks about her mother’s stage 4 uterine cancer diagnosis, which led to genetic testing that revealed a hereditary mutation called CDH1. This mutation increased the likelihood of cancer in Stacy and her siblings. Stacy describes the moment she discovered she was CDH1 positive, the challenges she faced afterward, and the lessons she learned through the clinical trial process. No longer having a stomach, Stacy has to eat more frequently to keep her energy up. Becoming a "professional snacker" led her to turn her newfound snacking habit into a business and Seahorse Snacks was born. Seahorse Snacks makes healthy delicious roasted nuts with unique and unusual flavors.To Connect with Stacy:Stacy MartinStacy@seahorsesnacks.comLinked In:https://www.linkedin.com/in/stacy-martin-461b33a/Seahorse Snacks:https://seahorsesnacks.com/Instagram: @seahorse_snacksTikTok: @seahorse_snacks

In this episode of The Clinical Research Coach, Leanne Woehlke sits down with Wessam Sonbol, CEO of Delve Health, to explore the evolving world of clinical trials. Wessam shares his personal experience as a clinical trial participant and offers insights on helping people navigate the process—especially those with limited access to technology. They discuss the power of decentralized trials, wearables, strategies for engaging underrepresented populations, concierge services and why truly understanding patients is key to making research more accessible and effective.Enjoy!To learn more:Wessam Sonbolhttps://www.linkedin.com/in/wsonbol/Delve Health:https://www.linkedin.com/company/delve-health/https://delvehealth.com/

In this episode ofThe Clinical Research Coach, recorded live at SCOPE, hostLeanne Woehlke sits down withOr Shaked, MD-MPH, Medical Research Lead at Briya, to explore the transformative role ofreal-world data (RWD) and real-world evidence (RWE) in clinical trials. They discuss how RWD is reshaping trial design, improving patient recruitment, and enhancing the overall efficiency of research. Or shares insights on the latest advancements, the challenges of integrating real-world evidence, and what the future holds for decentralized trials.This episode offers valuable perspectives on the evolving landscape of clinical trials. Tune in for an insightful conversation on how data-driven innovation is driving better outcomes in research and patient care!To connect with Or Shaked, MD-MPH:https://www.linkedin.com/in/orshakedd/To learn more about Briya:https://briya.com/

In this special live episode recorded atSCOPE, hostLeanne Woehlke sits down withKate Shaw, CEO ofInnovative Trials, to explore the evolving landscape of patient recruitment and retention in clinical research. We discuss some of the age old issues in the industry and share insights on the biggest challenges sites and sponsors face today.Whether you're a clinical research professional, a site leader, or simply passionate about advancing patient-centric trials, this episode is packed with expert insights and actionable takeaways.🎧Tune in now to hear the latest from the frontlines of clinical trial innovation—recorded live at SCOPE!To connect with Kate Shaw, CEO of Innovative Trials:https://www.linkedin.com/in/kate-shaw-250a8a6/?originalSubdomain=ukhttps://innovativetrials.com/

In this episode of The Clinical Research Coach Podcast, recorded live at SCOPE 2025, we welcome Jeff James, CEO of Wilmington Health and CEO and Co-Founder of Innovo Research. Jeff is a nationally recognized leader in healthcare transformation. With a wealth of experience in physician leadership, accountable care, and clinical research integration, Jeff shares insights on how healthcare organizations can align incentives, improve patient outcomes, and drive innovation in clinical trials. As the leader of Physician Healthcare Collaborative (PHC)—one of the top-performing Medicare ACOs—Jeff has firsthand experience navigating the complexities of value-based care and integrating research into clinical practice. In this episode we discuss: ✅ The role of clinical research in modern healthcare✅ How value-based care is reshaping patient outcomes✅ Strategies for aligning providers, payers, and researchers✅ The future of healthcare innovation and leadership Enjoy! To learn more: Jeff James: Linked In: https://www.linkedin.com/in/jeff-james-9a0b9b3/ Innovo Research: https://www.innovoresearch.com/ Wilmington Health: https://www.wilmingtonhealth.com/

In this deeply personal episode, Michelle courageously shares her experience participating in a clinical trial to determine if she carries the genetic marker for Alzheimer’s disease. With raw honesty, she walks us through the emotional rollercoaster of making the decision, the testing process, and the weight of knowing—or not knowing—what her future may hold. Through her story, we explore the power of clinical research, the fears and hopes that come with genetic testing, and the importance of advocacy in Alzheimer’s awareness. Whether you're considering participating in a trial, have a loved one affected by Alzheimer’s, or simply want to hear an inspiring story of resilience, this episode is for you. Tune in as Michelle opens up about her journey, reminding us that vulnerability is strength—and knowledge is power. To protect Michelle's privacy, we are not sharing her full name or identifying details.

In this episode, I chat with Rob Freishtat, Co-Founder and President of Uncommon Cures and former emergency physician. Rob shares his journey into the world of rare disease clinical research and his mission to transform the clinical trial landscape. We discuss the unique challenges of diagnosing and treating rare diseases and the critical role of clinical trials in advancing treatments. Rob shares howUncommon Cures, works to remove the unnecessary "barnacles" that have accumulated over decades to reduce delays and inefficiencies. With home-based visits, after hours appointments and family involvement, Rob outlines his approaches to reduce friction and improve the patient experience make clinical trials more accessible. We also explore the impact of AI in rare disease, strategies to enhance patient recruitment, and the importance of advocating for better regulatory pathways. Whether you're a patient, a healthcare professional, or simply curious about rare disease advancements, this episode offers valuable insights into the future of clinical research. Dr. Robert J. Freishtat is a highly regarded physician-executive renowned for his transformative impact on biotechnology ventures, clinical medicine, and international healthcare initiatives. With a storied professional history spanning over two decades, Dr. Freishtat has consistently demonstrated his ability to lead high-stakes organizational transformations, drive clinical solutions to the marketplace, and forge strategic global partnerships. As the President and Co-Founder of Uncommon Cures, Dr. Freishtat has transformed clinical trials for rare diseases by implementing a unique trial model that eliminated inefficiencies and accelerated drug approval processes. Under his leadership, the company has expanded rapidly and secured key contracts to establish strategic partnerships with leading pharmaceutical companies. Previously, Dr. Freishtat served as the Co-Founder and Chief Scientific Officer of Adipomics, where he commercialized groundbreaking obesity-related diagnostics and empowered innovation – securing critical funding for entrepreneurial milestones. You can connect with Dr Freishtat at: https://uncommoncures.com/contact-us/ Or on Linked In: https://www.linkedin.com/in/rob-freishtat/

Colleen Melchiorre is a dynamic strategic leadership executive and a devoted mother. In this compelling episode, Colleen shares an extraordinary story of courage and resilience as she advocates for her son, Paul, diagnosed prenatally with Hypoplastic Left Heart Syndrome. Fueled by her unwavering maternal instincts, Colleen embraced the role of "Medical Mom," fearlessly navigating the intricate and often overwhelming medical system. With a perfect blend of wit, wisdom, and practical insight, she recounts her journey, offering invaluable advice on managing complex medical information, building effective relationships with care teams, and creating a sense of home even within the hospital walls. Colleen’s tenacity and compassion make her the ultimate advocate—exactly the ally anyone would want in their corner. Her candid reflections also serve as a powerful lesson for the healthcare industry, providing critical insights into how to engage meaningfully with patients and families. This episode is a masterclass in advocacy, resilience, and the profound strength of a mother’s love About Colleen: Colleen Coffey Melchiorre, Ed.D. is a seasoned executive consultant, speaker, and strategist with over 23 years of experience specializing in organizational development and team dynamics. Her expertise spans corporate, non-profit, and higher education sectors, where she has consistently driven business growth and improved team performance for organizations ranging from small non-profits to Fortune 500 companies. A published researcher and thought leader, Dr. Melchiorre holds degrees from Belmont University (B.S.W.), Eastern Illinois University (M.S.), and Trevecca Nazarene University (Ed.D.). She advocates for organ donation, neurodiversity, and emotional wellness, serving as a parent partner at a leading children's hospital. Beyond her professional work, she is an adaptive cheer coach, certified Pilates and barre instructor, and dedicated yogi. Active in her church community, Dr. Melchiorre resides near Nashville, TN with her family. From the boardroom to the sidelines, to the mat-her authentic, holistic approach inspires teams, athletes, and organizations alike.

Join host Leanne Woehlke and clinical research professional, Suzanne Kincaid, for a compelling conversation about the unseen demands of family caregiving. With candor and humor, Suzanne shares her journey managing the healthcare of multiple elderly family members, discussing the hurdles of medication management, doctor visits, and technology support. This episode dives deep into the practical and emotional sides of caregiving, exploring why self-care is essential yet often overlooked, and how systemic changes could ease the load on caregivers everywhere. For anyone supporting a loved one through aging or illness, this conversation offers insights, resources, and a reminder that you’re not alone. Suzanne Kincaid, CCRA, ACRP-PM, FACRP Owner and Independent Consultant, Responsibility Research Suzanne has over 25 years of clinical research experience. She has conducted clinical trials from every aspect, from study coordinator to global project manager. She was the Study Delivery Program Leader of AstraZeneca’s Oncology Phase I Team, Director of Operations for Sarah Cannon’s Phase I Drug Development Unit, and Chief Operating Officer of Aperio Clinical Outcomes.   Suzanne’s clinical research passions include process improvement, project management, training clinical research professionals, cultivating high performing teams, and Risk Based Quality Management.   Suzanne is actively involved in the Association of Clinical Research Professionals (ACRP), serving on the board of the Greater Nashville Chapter since 2011, and is currently Chair of the ACRP Fellows Advisory Panel.  In 2020, Suzanne was honored as one of the PharmaVoice 100 Most Inspiring People in Life Sciences. To connect with Suzanne on Linked In: https://www.linkedin.com/in/responsibilityresearch/

With a focus on Patient Focused Drug Development (PFDD), many pharma companies have begun incorporating patient insights into protocols, recruitment strategies, and brand messaging, yet many efforts miss the mark. In this episode, I chat with with Kirsten York, an industry expert with over 25 years of experience. Kirsten is passionate about helping teams identify and overcome entrenched beliefs that can get in the way of creating trust and building authentic connections. Kirsten shares the importance of creating meaningful patient journeys and shares how the standard "cookie-cutter" approach does not work. We discuss what it really takes to build a “patient odyssey”—an approach that goes far beyond the typical patient journey methodology. Kirsten shares how she gathers insights straight from patients’ voices on social media, discussion groups, and advocacy platforms to create journeys that actually resonate. She also explains why these journeys need to evolve over time and should be used to inform every aspect of drug development- from molecule to market. If you’re curious about how pharma can lead with empathy and build more authentic connections with patients, this episode is for you! Kirsten's Bio: Kirsten York is the Executive Vice President of Human Experience Strategy at ENTRADA. As a Patient Experience Organization, or PXO, ENTRADA is driven to reimagine the way patients interact with pharmaceutical companies throughout their treatment journey.   With over 30 years of experience in pharmaceutical, biotech, and device brand strategy and communication, Kirsten has developed deep expertise for impacting the human experience across the life sciences industry, with particular emphasis in oncology and rare disease.   Kirsten possesses a deep passion for brokering the intersection between patients/caregivers and pharma and is committed to helping people feel more in control of their health journey than ever before. Whether a product is in early development or has been on the market for years, Kirsten is able to identify opportunities for intervention and innovation that can transform the way people experience their health odyssey.   Kirsten specializes in Patient-Focused Strategy, Patient Positioning, meaningful Advocacy Partnerships, Lexicon & Data Visualization, and uncovering powerful patient insights than result in brand transformation. You can connect with Kirsten via email at: Kirsten@thinkentrada.com Or on LinkedIn at: https://www.linkedin.com/in/kirstenyork/ To find out more about Entrada: https://thinkentrada.com/

In this episode Heidi Hawkins shares her story of personal discovery and healing through psychedelics. Heidi shares her experience of finding connection and integration through her journey with plant medicine.

In this episode, I sat down with Paresh Shah, the Founder and CEO of CliniLink. Paresh shared views on the importance of DE&I and accessibility in clinical trials, as well as social determinants of health and impact in clinical trial recruitment. CliniLink Health stands out in revolutionizing patient engagement in clinical trials, through their AI enabled data platform. To connect with Paresh, and find out more: https://www.linkedin.com/in/pareshkshah/

In this episode, Joe Dustin, a long time industry leader, shares stories and wisdom gleaned from decades of experience. Joes's passion for the industry and the patients he serves is palpable. From his driving curiosity to excitement about the latest tech advancement, Joe's desire to connect and impact others is clearly a superpower. His advice to remember the people that matter in one's personal life serves as a poignant reminder to find balance. Enjoy this episode! To learn more about Joe, and connect with him on LinkedIn: https://www.linkedin.com/in/eclinical/

Scott Schliebner is an industry executive with deep knowledge of clinical research coupled with a commitment to patients and a growth mindset. He is a true industry disruptor, not afraid to step out of his comfort zone. Scott has a passion for building teams and nurturing others towards their goals. In this episode we discuss adopting a patient focused approach throughout drug development. We talk about the implications when we as an industry fail to take into account what patients really want. Scott shares about differences in the Rare Disease community and how to address some of the challenges and then apply those learnings to other areas. Scott shares tips for empowering patients and how to assess patient burden and ensure ROI. Enjoy this episode! Scott Schlieber takes people, teams, and organizations further than they would otherwise go. A strategic, innovative, and commercially-oriented clinical drug development executive with 30 years experience across the biopharma, CRO, and non-profit sectors. Scott creates, builds, transforms, and accelerates growth for clinical research organizations. He drives commercial success through relationship-building, strategic partnerships, creativity, transparency, and integrity. Scott is passionate about patient-centric research and developing innovative approaches to accelerate clinical drug development.

In this episode, Alex Wykoff, vulnerably shares her patient journey through Lupus. We discuss the lengthy period searching for answers and being dismissed by the medical community. Alex shares how she was able to advocate for herself and navigate the clinical trial landscape. She outlines the challenges with getting doctors to talk to one another and ensuring one's care team has all pertinent information. Alex shares about getting a doctor to think she was "worth their time" and building a partnership to address her health. Alex tells about the emotional and physical toll of her journey and the power of resiliency. She shares how she was able to find momentum and develop a positive identity. She shares practical tips for how to document and effectively communicate symptoms to aid with diagnosis. She talks about how to find accurate information and engage with support groups. Ales's journey is one of resiliency and personal growth. About Alex, in her own words: As a native of Fairfield, Connecticut, a graduate of Gettysburg College, and a 6 year resident of New York City – it’s safe to say that I should probably get out more. In 2016 I was formally diagnosed with Lupus CLE/SLE – a chronic and complex autoimmune disease. Thanks to the support of my amazing family, friends, colleagues, and my exceptional “Dream Team” of physicians and specialists, I am grateful for the strength and resilience that living with lupus has taught me. I firmly believe that care is contingent on communication, and through my own personal journey I’ve found a passion for patient advocacy, clinical research, and health literacy. By furthering the dialogue and contributing to clinical research, we can collectively contribute to the creation of the next life changing or lifesaving treatments globally.