Archives: Speakers

Nick is the Director of Operations at Leapcure. Leapcure’s mission is to enable equitable clinical trials, aligning the needs of sponsors, sites, and patients. Nick oversees dozens of patient-centric study projects and partnerships, leading the Leapcure team to thousands of impactful, live patient conversations every month, keeping study enrollments on or ahead of schedule. Nick has particular experience synchronizing the interests of patients, sites, and sponsors with rare diseases.

Renee C. St.Clair, Esq. is In-House Counsel for Valis Biosciences Inc, where she also serves at the Regulatory Affairs, Operations, and Compliance Lead.  Ms. St.Clair has over 25 years of legal and regulatory experience advising California employers, is the co-founder of a woman owned law firm based in San Diego, California, and is a specialist in appellate research and writing, including a successful appeal to the U.S. Supreme Court.

Ms. St.Clair pivoted to the life sciences industry hoping to apply her legal skillset to advance science, medicine, and patient outcomes; particularly for patients and veterans struggling with mental health issues.  She has a unique perspective, having been on various sides of the clinical trial process.  Ms. St.Clair provided regulatory guidance at one of the first clinical trial sites in the world to administer psilocybin to participants with depression, has worked with R&D scientists as they developed clinical trial protocols for ketamine, co-drafted IND applications, transitioned a biopharma lab from R&D to GMP-readiness, positioned a biopharma company to obtain state authorization to conduct nonhuman research of Schedule I compounds (DMT, LSD, psilocin, THC, MDMA, 5-MEO-DMT), and currently applies her regulatory background to facilitate Valis Biosciences Inc.’s science based and technology driven clinical trial tools and solutions—often in challenging populations (children) or difficult to measure conditions (mental health and CNS).

As a seasoned global leader, I’ve delivered concrete business outcomes and enhanced productivity. My unwavering dedication to customer satisfaction and team growth has been instrumental in propelling organizational success. Proficient in navigating intricate transformations, I’ve elevated staff engagement and strategically harnessed existing technologies for a competitive edge. Aligning operational strategies with company goals, I’ve successfully executed significant projects across diverse contexts. My strength lies in fostering collaboration, establishing partnerships at all organizational levels, and implementing practical business solutions across cultural landscapes. My unwavering commitment to operational excellence has streamlined manufacturing and logistics facilities, enhancing efficiency. Throughout my career, I’ve contributed to a prominent organization known for exceptional manufacturing and engineering capabilities in the life sciences sector

Experienced outsourcing professional with passion for clinical technology and clinical research in the oncology field.