Clinical Research Coach Leanne Woehlke

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.

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!