Clinical Research Coach

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.

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: Alex Wykoff works in the life sciences industry helping clients improve global communication. She is also a patient dealing with a Lupus diagnosis. Alex was a competitive athlete, and often calls on the skills she learned as an athlete to help her navigate her patient journey.

Rebecca Little is the Executive Vice President Clinical Strategy and Development at Objective Health. In this episode, we discuss changes in the industry. We address the need to integrate research into the flow of patient care and forge collaborative relationships through education and communication. We explore patient education about clinical trials and the need for communication and education of patients and the impact on retention in clinical trials. We discuss the role of advocacy groups in engaging communities and using real data for site feasibility. We chat about integrating technology into the workflow and tips for ensuring compliance. We touch on turn-over at both the site and CRA level and and the role of education and communication. We explore campaigns and strategies to meaningfully move the needle for patients. Have a listen and let us know what most resonates. Rebecca Little is an Executive Vice President, Clinical Strategy and Development at ObjectiveHealth. Prior to joining ObjectiveHealth, Rebecca led the global commercial team for ICON's clinical research site network, where Rebecca specialized in developing and growing partnerships with both large pharma and biotechs, specifically in the therapeutic areas of Immuno-Inflammation (GI and Derm), Respiratory, CNS, Vaccines, Women's Health and CVM. Rebecca has worked in the clinical research industry for the last 16 years, both in the research site networks and full service CRO spaces. Rebecca graduated from Clemson University with a BS in Health Science.

In this candid conversation about workplace stress and mental health, Jess Thompson, shares her experience with ketamine assisted psychotherapy. Jess recounts how ketamine based psychotherapy allowed her to revisit past traumatic experiences and allow her to move forward with a new sense of emotional freedom. Through treatment, Jess was able to release trauma in the body, leaving her feeling as if, "things are just a little brighter." She recounts, it was like I "got through years of therapy in so little time." Jess has wanted to, "heal out loud, so others don't suffer in silence." She felt her position at work was compromised because of her mental health, her job threatened. After experiencing passive suicidal ideations, Jess took time off from work to deal with her mental health. However after sharing about her struggles on social media, a company representative informed she was, "shedding a bad light on the organization." Laid off from her project management position after returning from mental health leave, Jess was compelled to create the Association of Clinical Research Project Managers, where she sees "people as whole individuals, not productivity engines." Following her course of 6 ketamine sessions, Jess is busy implementing new healthy habits and developing new neuropathways. She says it feels like a dark cloud has been lifted and the, "sun seems to shine brighter." You can catch up with Jess and find out more about the Association of Clinical Research Project Managers here: https://acrpm.org/.

In this episode, I connect with industry Zane Courbay, CEO of Baja Clinical Trials. Zane shares this insights and perspectives of 30+ years of rich industry experiences. We discuss nuances of running clinical trials in Mexico, including language and cultural differences, as well as pricing and budgets. We talk about managing multiple vendors and communicating effectively with patients. We dive into the impact psychedelics are having on the market and the challenges some of the newer psychedelic companies are having. Zane shares his perspectives on medical tourism and the importance of inclusive clinical trials. Enjoy this episode. Zane Courbay is the COO of Baja Clinical Trials and Founder of Zane Consulting. Connect with Zane on LinkedIn https://www.linkedin.com/in/zane-courbay-a05221a/ To find out more about Baja Clinical Trials: Baja Clinical Trials https://www.bajaclinicaltrials.xyz/

In this episode I sat down with Virginia Nido, the global head of Industry Collaborations for Roche and Genentech. Virginia shares her ideas on what constitutes a great collaboration and the need to embed clinical trials into primary care. We discuss the importance of EMRs that are "research ready" and the need to make trials better for patients. Virginia elaborates on the power of collaboration in the industry and how to approach the top 3 industry challenges. We discuss the progress that has been made in diverse patient recruitment and companion diagnostic. Virginia challenges, "If you are not comfortable with your mom participating in a clinical trials, we are doing something wrong." Virginia shares a personal story about her Mom's cancer journey and how at the time, there were no available clinical trials. This serves as a poignant reminder of gratitude for all who participate in clinical trials to make new treatments available. Enjoy this episode! Virginia Nido is the global head of Industry Collaborations for Roche and Genentech. She is the co-founder and past board chair of the Clinical Research Data Sharing Alliance. Virginia serves on leadership teams for the Clinical Trials Transformation Initiative, the Society for Clinical Research Sites, the Association for Clinical Research Sites, and the Tufts Center for the Study of Drug Development, and she is a former member of the TransCelerate Integrated Leadership Team. She holds an undergraduate degree from Barnard College, a Master degree in education from the University of Pennsylvania, and professional certificates in Bioethics from Columbia University and Precision Medicine from the Harvard Business School. Virginia is passionate about the power of industry collaborations to improve the efficiency and quality of clinical research.

In this episode, I sat down with Jimmy Bechtel, the Vice President of Site Engagement at Society for Clinical Research Sites (SCRS). We had a candid, open conversation about the challenges sites face, including: Vulnerable/ honest conversations between sites and sponsors DCTs E-Devices Tech burden at the site level Costs of using technology Training and turnover Site payments In order for sites to be able to successfully conduct clinical trials, these issues must be addressed. Sites are the backbone of the industry and the primary connection to the patients. It's time their voices are heard and they are treated as the valuable partners. Organizations such as SCRS serve to support and empower sites. Enjoy!

Frank Rivera, is the Founder of Stronger Than Sarcoidosis and Sarcoidosis of Long Island. He is also a patient living with Sarcoidosis, a rare disease. Frank's story is one of determination, resiliency and a true desire to be of service to others. In this episode he shares the importance of mindset in dealing with chronic conditions and the hurdles patients experience when finding trials. Frank relays the heartbreaking feelings of rejection patients feel when not qualifying. He vulnerably shares about the emotional toll of a rare disease and challenges that occur when one's identity is taken away, and the importance of reinventing one's self and finding purpose. Frank tells the patient's perspective using clinicaltrials.gov and the need for trials to be listed in "patient-speak." Sites, such as Power, are making strides in relaying information about trials in a manner that is easy for patients to search and understand. Patients want to be involved in trials from beginning to end, not just recruitment. When the number of trials listed on clinicaltrials.gov dropped from 226 to 70, Frank phoned pharmaceutical companies to inquire what happened. After learning the reason was lack of enrollment, Frank's natural inquisitiveness and solution-oriented mindset led him to look to partner with other rare disease organizations and optimize successful strategies. In this episode, Frank outlines the characteristics of a fantastic care team and the steps he took to partner with government advocates. Grab a notepad, you'll want to take notes, and prepare to be inspired. To find out more about Frank Rivera and his organizations, check out: Sarcoidosis of Long Island: https://www.sarcoidosisofli.org/ IG: StrongerThanSarcoidosis https://www.instagram.com/strongerthansarcoidosis/ LinkedIn: https://www.linkedin.com/in/sarcoidosisofli/ Also mentioned in this episode: Power https://www.withpower.com/

In this mini episode, with Kelsey Brown, Director of Medical Writing at TransPerfect, she shares the importance of health literacy to build relationships, trust and understanding with patients. You'll come away from this episode with practical tips to ensure you can connect with your intended audience in meaningful ways. Enjoy!

Heather Leverington Dotterer is an organ donor advocate, mom and former co-head coach for indoor and outdoor track and field at Lockhaven Univeristy. Heather is an elite athlete, 5 time national champion in shotput, and previous olympic hopeful. In this episode, Heather shares her story of going from athlete, to being in a wheelchair on oxygen as she waited for a lung transplant. Heather recounts her story with vulnerability and honesty as she shares about the waiting for donor lungs and the decision to enter a clinical trial with lungs that underwent an ex viva lung profusion. Heather reminds us of the power of relationships, and the gift of second chances. Her story is one of resiliency, mental toughness and a willingness to find solutions to break through and persevere.

In this episode, Craig Serra, shares how he found his path in clinical research by cultivating a healthy sense of curiosity. He explains the importance of tenacity and follow through to bring solutions forward and the necessity of cultivating a thick skin. Craig offers sage advice for those wanting to get into the industry and how rejection can build character. We talk about lessons learned during covid and how to carry those forward to advance the industry. We address the issues of workload at clinical research sites and discuss how to alleviate some of the challenges of the most over burdened people in the industry. Craig's message of empathy and understanding will inspire and encourage you to look at things through a different lens. Enjoy!

Dr Daniel Fox is an advocate for clinical research sites. Living out his purpose driven mission of restoring basic business rights for sites. Dr Fox and I discuss the challenges of underfunded studies, why 70% of physicians who try clinical research never take on another study and the importance of efficiencies and trust in order to elevate the playing field and optimize clinical research. Dr Fox speaks of a collaborative network with unity in the industry and open communication. Truly a visionary, Dr Fox shares about his Good Clinical Business Practices (GCBP) training program and increasing access to clinical research through healthcare integration. Dr Daniel Fox is a translational researcher with almost 2 decades of experience in science, quality, and research. He has worked at small biotechs, global pharma, academic institutions, military bases, and clinical research sites. Dr. Fox dedicates his life to ensuring patients receive new and innovative therapies as quickly, efficiently, and safely as possible. Currently, he focuses on site rights and advocacy to help patients, physicians, and sites access research opportunities as an integrated healthcare solution. To find out more about Dr Fox: Check out: https://www.crpaynet.com/ LinkedIn: https://www.linkedin.com/in/daniel-fox-mph-phd-3955b222/

In this episode, Kelsey Brown, Director of Medical Writing at TransPerfect, shares about the importance of plain language and health literacy. Health literacy is the degree in which someone understands text and can take action. Data suggests the lower one's health literacy, the poorer their health outcomes. It's critical that information be provided in a way in which patients can understand and take action. Kelsey shares tips for drafting plain language documents and tools to measure readability. We also discuss EU/CTR, the new regulations going into effect in January 2023, and what sponsor companies must do to be compliant. For further questions and information, you can reach Kelsey at: medicalwriting@transperfect.com To find out more about TransPerfect's Medical Writing: https://lifesciences.transperfect.com/medical-writing To read Kelsey's recent white paper: CLINICAL DATA TRANSPARENCY & PUBLIC DISCLOSURES: OVERCOMING CHALLENGES WITH PROSPECTIVE WRITING https://marketing.transperfect.com/acton/fs/blocks/showLandingPage/a/687/p/p-00d0/t/page/fm/0

Danieska Sandino's experience from CRC to Director of Clinical Operations at a sponsor, gives her the ability to appreciate industry challenges from a broad perspective. In this far reaching episode we discuss how to handle turnover, managing expectations and the need for transparency and collaboration in the industry. Danieska shares practical tips and systems for onboarding staff, negotiating budgets and patient recruitment. We talk about bringing a protocol to life and how to support your team with mission driven goals.

In this episode, we chat with, Lucy Coassin, Current Health's Senior Director of Pharma Partnerships. Lucy explains how Best Buy's entry into the healthcare sector with Current Health empowers patients and provides greater flexibility utilizing remote patient monitoring technology. We discuss the changing landscape of clinical trials and the need for greater collaboration, commitment and interoperability as we usher in this new age of healthcare. Lucy shares advice for those who wanting to get into the industry, as well as suggestions for getting industry to accept and adopt innovative technology. Lucy Coassin is the Senior Director of Pharma Partnerships at Current Health. Previously at Science 37, she is well versed in bringing revolutionary technology to the market. Lucy is a trailblazer, boldly brining transformational technology to the pharma industry. Lucy has an MBA from Stanford and a BS in Chemistry from Duke.

Daniel A. Perez is a rebel in clinical research and passionate advocate for diversity and equity in healthcare. With a servant's heart and desire to lead, he elevates those around him while challenging the industry status quo. In this episode we chat about the state of the industry and what may transform the relationships with investigators and what is necessary to create a successful ecosystem at the site level. We talk about the importance of resources, education and financial compensation, layered in with empathy. A Los Angeles native, Daniel's passion for clinical research materialized over a decade ago, when a new diagnosis forced him to face critical treatment options evolving only as fast as clinical trials allowed. It was during this experience when he recognized his fortune in benefitting from clinical research-fueled medical breakthroughs, as well as the unnecessary dysfunction and inefficiency that existed within this same space. With a newfound desire to make an impact on the traditional clinical trial paradigm, Daniel entered the neurosciences department at Cedars-Sinai Medical Center, where his talent and motivation led to several quick promotions within academia. It was in his expansive role as Clinical Research Manager at Children's Hospital Los Angeles (CHLA) where Daniel fine-tuned his talents across all regulatory, managerial and operational aspects of clinical research. After recognizing the amplified impact possible outside of traditional medical institutions, and experiencing MACRO as a clinical operations consultant, he made the leap and joined MACRO full time. At MACRO, Daniel combined his meticulous operational acumen with his comprehensive research and regulatory expertise to help bring their vision into a tangible reality. Daniel leads by constantly questioning how things have always been done, and continuously evaluating the clinical research process through the lens of the human subjects on which they are based. Daniel cofounded the Coalition for Advancing Research Equity (CARE) and also serves as a founding board member for Clinical Trials in Color, a 501(c)(3) non-profit foundation with a mission to improve health outcomes in communities of color by increasing diversity and access to clinical trials. Daniel is currently the Global Head, Patient Experience, Diversity & Inclusion at Worldwide Clinical Trials.

In this episode, Steve Wimmer, recounts his experience as a patient in clinical trials. Steve is no newcomer to the clinical trials industry, but in this episode, he shares through the lens of participant, not industry expert. His experience reminds us of the need for clear communication with participants, beginning with the informed consent process, all the way through to sharing study results. We discuss the need to consider the patient journey, and how to consider the safety of a trial. Have you ever participated in a clinical trial? Would you consider participating? Reach out, we'd love to hear your experience. When Steve Wimmer isn't participating in clinical trials, you can likely find him out in the real world wearing a Hawaiian shirt. Steve is the Director of Partnerships at 1nHealth, where he helps speed up clinical trials by finding more patients to enroll.

When Jessica Landsdown's son, Will, was diagnosed with Niemann Pick Type C, she was willing to go anywhere in order to give her son access to a potentially life saving treatment. In this episode, Jessica shares a mother's story of enrolling her son into two expanded access programs for investigational new drugs. Jessica relays her fears of the possibility of losing access to the only possible treatment and the impact that could have on her son. As you listen to this vulnerable conversation, consider how sponsor companies, investigational sites and the entire drug development industry can better serve vulnerable populations.

Einstein said doing the same thing over and over and expecting a different result is the definition of insanity. Are there blind spots you are missing?