Clinical Trial Tech Platforms: Next Wave with 5 Experts

Rosa Coppolecchia is a board-certified physician of internal medicine with training in preventive medicine with over 18 years of work at Bayer in both the Pharma and Consumer Care divisions. Dr Coppolecchia has a wide range of experience in medical affairs and clinical development and is a leader in the field of cardiology and preventive medicine with expertise in anti-platelets specifically the use of aspirin (ASA) in both primary and secondary cardiovascular event prevention and has co-authored several peer review journal articles.In her current role, Dr Coppolecchia is a Global Clinical Lead in clinical development for thrombosis and vascular diseases. She is one of the lead strategists for Phase II and Phase III studies to support new indications, approvals, and product launches in the cardiovascular therapeutic area. She oversees traditional large, randomized controlled trials and is leading a Decentralized Trial in the anti-thrombosis category. Dr Coppolecchia is a strong advocate for increasing awareness of cardiovascular disease in women, as well as increasing diversity and inclusion in clinical trials.Dr Coppolecchia received her Doctor of Osteopathy degree from the University of Medicine and Dentistry School of Osteopathic Medicine in Stratford, NJ and a Master of Public Health from UMDNJ-Robert Wood Johnson School of Medicine and Rutgers The State University in Piscataway, NJ. She is a Fellow in the American College of Physicians and Fellow in the American College of Preventive Medicine.Prior to her career at Bayer, Dr Coppolecchia worked at Schering Plough Corporation (currently Merck & Co.,Inc.) as the Assistant Corporate Medical Director in the Employee Health Department.

Stuart Cotter is the Vice President of Product Strategy and Innovation at Advarra. In this role, he collaborates with current customers and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Cotter also leads the Advarra Site-Sponsor Consortium, helping to seamlessly connect site and sponsor technology by addressing key data and process inefficiencies across the clinical research ecosystem. Prior to joining Advarra's strategic team, Cotter worked as a Product Manager for Advarra eRegulatory Management System, and as Product Support Specialist on Allegro CTMS, where he worked alongside dozens of small- to mid-sized research sites to help them overcome their operational hurdles.

Darcy Forman is the Chief Delivery Officer for Science 37, where she has responsibility and oversight for clinical operations service delivery, including patient engagement, clinical operations, data management, and nursing solutions.Ms Forman has more than 20 years of experience bridging clinical operational expertise and strategic corporate development initiatives with a passion for innovative and decentralized clinical trial execution. Most recently, she served as the vice president of corporate development at Firma Clinical Research, where she had oversight and leadership responsibility for the identification, development, and execution of corporate development opportunities, including the evaluation of Firma corporate strategies and strategic planning. Ms Forman started her career at Pfizer Pharmaceuticals as a bench scientist before transitioning into a role in Pfizer’s clinical research division. She continued her career with ascending clinical operations and project management positions at various CROs spanning large, mid-size, and niche including i3 Research (now Syneos Health), Health Decisions, Clinipace, and Firma Clinical. During her career, she has fostered her passion for innovation and intelligent operational strategy by bringing metric-driven decision making to each role and organization. Ms Forma holds a BA in chemistry from Lake Forest College.

Katherine (Kathy) Taylor is Head of Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role she leads the implementation, delivery, and all aspects of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) continuous improvement initiative to further the organization’s risk-based quality management (RBQM) through advanced analytics.As the head of REAIM, Ms Taylor champions cross-functional engagement and alignment on the AIM strategy and execution of AIM activities in clinical trials. This includes development of central monitoring plans (CMPs) and clinical data specifications aligned with critical data, process, and risk assessments. She ensures execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis and Central Statistical Analytics to support identification of important study issues that require monitoring, management, and adaptation of study plans.Ms Taylor has 25 years of experience managing the quality of clinical trial conduct and execution, strategic implementation of quality-by-design principles, building high-performing teams, database management expertise and leading all aspects of GCP health authority inspections. She is a sought-out industry speaker for optimizing inspection readiness and the exacting risk-based quality management methodologies.Ms Taylor is committed to creating a more diverse and inclusive work environment. She is a member of the inaugural GCTO Diversity & Inclusion Council as well as Merck’s League of Employees of African Descent (LEAD), serving on the Group Mentoring Project Team

Jaydev Thakkar, Chief Operating Officer of Biofourmis currently leads global operations across various business functions, including Customer Success, Sales and Marketing Operations, Clinical Research Operations and Supply Chain. Mr Thakkar has over 25 years of experience in leadership roles at organizations that include fortune 100 companies and rapidly growing start-ups. Prior to Biofourmis, Mr Thakkar was instrumental in founding a Digital Health and Innovation group at world’s leading biotech, Amgen, where he served for 14 years. During this time, Mr Thakkar led its “beyond the therapy” digital innovation strategy to maximize product value and clinical outcomes across the patient journey—from clinical development through product launch and post-marketing. At Amgen, Mr Thakkar also led information technology operations for the company’s large portfolio of global clinical trials—including some of the largest ever in the industry, with more than 27,000 participants across 50 countries and more than 1,000 sites. Before Amgen, Mr Thakkar was a telecommunications, technology and finance consultant who co-founded a technology startup and also managed his family’s manufacturing business in India.