About Jessica:

Jessica Jackson currently holds the position of Head of Clinical Operations at Galderma Laboratories. Her pharmaceutical career spanning over 27 years has included being a Study Coordinator, Clinical Research Associate, Project Management, Program Management and Operational management roles with increasing responsibilities leading multidisciplinary-matrix project teams, driving portfolio development plans, and supporting resource strategies across a  multitude of indications.

Jessica is driven to accelerate the clinical development process by designing and implementing innovative, adaptive, and platform trials across all therapeutics areas. Jessica’s experience includes clinical trial design experience; clinical trial management with a focus on innovating the clinical operations process, protocol development, CRO selection and management, forming and maintaining strategic collaborations; identifying programmatic challenges and opportunities and developing result-driven operational strategies.

About Richard:

A veteran of 25-years in life sciences, Richard is Vice President, Strategy, Vault CDMS. Richard is responsible for defining strategy and direction for Vault CDMS, especially with respect to clinical data management.  Richard brings Veeva customers both keen executive vision and proven operational experience in data management, eClinical Solutions, and advanced clinical strategies (e.g. adaptive trials, risk based monitoring, strategic technology reviews).

Richard has overseen the transition from concept to delivery of initially EDC, and now CDMS, and assists customers and partners in their strategic future setting.

About Craig:

Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors.  Craig is Co-Chair for the Decentralized Trials & Research Alliance, Vice Chair of the MedStar Health Research Institute, and Vice President of the Foundation for Sarcoidosis.  He is Adjunct Assistant Professor in Health Informatics at Rutgers University.

Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

About Mayank:

Mayank is presently working as Vice President and Global Head for GSK. His department includes Data Management, Centralized Monitoring, Data Acquisition, Medical Coding, Data Analytics, Clinical Platform and SDTM/Data standards. His present teams are spread across US, Canada, UK, Lat America, Europe, Australia, Japan, China and India.

He has held various leadership roles across Industry. In past he has been part of organizations like: BMS, Syneos Health, TCS, Cognizant and Accenture.

By education, he has a Masters in Biotechnology, Graduate in Biotechnology and Honors in Genetic engineering. He is presently pursuing his doctorate in AI/ML.

He is Chairperson for Global SCDM (Society for clinical data management) Board of trustees. Keynote and guest speaker for many global forums and conferences.

His belief in “We” Vs “I” is foundation for his leadership style.

About Marion:

Marion’s Bio: Marion Wolfs is a senior leader within the Integrated Data Analytics and Reporting (IDAR) organization from Janssen Pharmaceutical Companies of JnJ. In this role she is responsible for the oversight, execution, and management of the Analytical Risk-Based Monitoring (ARBM) processes including beyond trial level risk analysis at Janssen. She has been an RBM workstream co-lead for TransCelerate from 2016 till 2019 and is currently co-leading the RBM working group at PHUSE. Marion joined the pharmaceutical industry in 2007 and worked in various clinical operations roles until joining the Risk Management-Central Monitoring Group in October 2014. Marion holds a Master of Science degree in Biomedical Sciences from the Maastricht University and an International Certificate in Enterprise Risk Management from IRM.

About Jonathan:

Jonathan Rowe has more than 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Principal, Head of R&D Quality, Operations and Risk Management at ZS. In this role he partners across the industry to design and implement advanced approaches to identifying and mitigating clinical development risk, and improving end-to-end process, study, site and vendor quality.  From 2014-2019 Jonathan was the Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities included monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for both Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

About Joe:

Joe Dustin is the Vice President of Product Strategy for eCOA  at Medable where his priority is to accelerate how decentralized clinical trials are defined, executed and adopted within life sciences companies and change the face of how research is conducted to improve the human condition.  Joe has spent 20 years as a voice and thought leader in the Life Sciences industry specifically in eClinical Technology across all categories of EDC / eSource, eCOA, IRT, CTMS, RBQM, Medical Imaging and the rise of decentralized clinical trials.

Joe has worked with top Pharmaceutical companies Biotechs and CRO’s in clinical innovation, change management, implementation, IT, product development, solution consulting and business development roles. He is focused on making the drug development process faster and providing a better experience for all stakeholders through the eyes of great technology, service, and partnership.

Joe is a graduate of Roger Williams University Gabelli School of Business with a degree in Computer Information Systems and Political Science. Previously, he has worked at eClinical technology companies such as CRF Health (now Signant Health), etrials (now IBM Clinical Development) and Medidata (now part of Dassault Systemes).  Most recently, Joe was the Head of Clinical Innovation and Change Management at Bristol Myers Squibb. Originally from the Boston area and a current New Jersey resident, Joe is passionate about technology, an avid guitar player and dreams of one day going to space.

About Linda:

Ms Sullivan is Senior Advisor, Metrics & Performance Management at WCG where she serves as a subject matter expert to the WCG Clinical Service Organization, WCG-Avoca Quality Consortium work groups, regulatory authorities, and industry groups. She hosts the Clinical Trial Optimization Podcast show that explores current topics such as Quality-by-Design, risk-based quality management, vendor oversight, and data analytics. She founded and served as Executive Director of the Metrics Champion Consortium, an industry consortium dedicated to bringing clinical research sponsors, vendors and investigative sites together to collaboratively develop standardized performance metrics that help organizations oversee and manage studies, identify areas in need of improvement and assess process improvement activities. The consortium was acquired by WCG and merged with the WCG Avoca Quality Consortium in 2021.

She has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations optimize processes to improve financial and quality outcomes. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings, published articles in leading journals and served on industry advisory boards such as the NIH-NCATS Methods and Process Domain Task Force.

Ms Sullivan received a B.S. in Biology from Trinity College and a M.B.A. from Dartmouth College where she was named a Tuck Scholar.

About Peter:

Wide experience in drug development in Europe and the US, in Regulatory Affairs, Project Management and Clinical Development, at Organon, Schering-Plough, MSD and Bayer. Leadership roles in Clinical Data Management since 2003.

Joined Bayer in 2017 as Business Lead for the clinical data reporting and review environment, focusing on the development and implementation of indicator dashboards on compliance, performance, data quality, risks, and tolerance limits. These dashboards – using classical statistical approaches as well as advanced analytics methods – support Risk-Based Quality Management across clinical development.

Peter has been serving the Clinical Data Management community in leadership roles via the DIA, INCDMA and the SCDM. Currently member of the SCDM Board of Trustees and chair of the SCDM EMEA Steering Committee. He is chair of a local geological society and an amateur beekeeper.