Archives: Speakers

Judy Skroback

Judy Skroback is the former Director of Clinical Research at SynCardia Systems, LLC, where she spent 10 years overseeing medical device trials and continues as a Consultant. She is a Certified IRB Professional, a Certified Clinical Research Contract Professional and an Affiliated IRB Member at Advarra. She previously served for 16 years in the Human Subjects Protection Program of a major research university

Kathryn Wine

Vice President of Clinical Operations: Reporting to the COO and 4th employee of the company, built a clinical operations team and led re-design, enrollment and completion of the pivotal (IDE) trial of the Jada System for abnormal postpartum uterine bleeding and hemorrhage. Strategic leadership for all U.S. and O.U.S. clinical operations. In this role Kathryn has;
• Led 15-center US pre-market pivotal IDE study, enrolling the maximum of 107 subjects in a challenging recruitment setting. Developed site relationships, negotiated favorable study contracts and budgets with each site, led training program that certified over 700 site team members as investigators and research staff, drove enrollment programs that approached >16,000 patients and secured informed consent from >7,000 in under 15 months.
• Built clinical study team from 0 to maximum of 6 team members including the roles of Director, Prof Ed Manager, In-house, Field-based and Contract CRAs and Clinical Coordinator. Recruited key talent to executive and adjacent teams.
• Designed and executed “Continued Access” program to ensure extended data collection after close of pivotal study, including successful FDA approval of IDE.
• Presented Clinical Operations updates to quarterly BOD Meetings and investor presentations.
• Developed relationships and key interactions with OB/GYN and Maternal Fetal Medicine specialist KOLs for understanding and advancement of the Jada System.

Vij Senthilnathan

Vij Senthilnathan is currently working at PTC Therapeutics, a US pharmaceutical company as Associate Director. She is a PTC leader in clinical operations working on the small molecule therapy PTC743 (vatiquinone), now in a Phase 3 global clinical trial for patients with mitochondrial disease and associated refractory epilepsy. Her involvement in rare diseases has been since 2014 starting with her role in clinical operations at BioElectron Technology Corporation (previously known as Edison Pharmaceuticals) where her responsibilities included running global clinical trials for Leigh Syndrome, Pearson Syndrome, Friedreich Ataxia, Amyotrophic lateral sclerosis (ALS), Parkinson Disease and Rett Syndrome. As a global lead and point of contact for clinical operations and strategy, she ensures effective execution of the clinical studies, strategies and mitigation plan for key regulatory submissions keeping patients first. She has been a strong advocate for patient’s voice and believes that patient advocates are an integral part of drug development process from start to finish. She works closely with different patient advocacy groups to understand their perspective for a clinical trial and ensures that the patients get asked the question they wish others would ask.

She holds a master’s degree in Molecular Medicine from University of Sheffield, UK and Bachelor’s of Technology in Biotechnology from India. She currently lives in San Francisco Bay Area, California. Her work: https://www.ptcbio.com/2021/02/08/working-to-treat-mitochondrial-epilepsy-one-seizure-at-a-time/