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?