We are pleased to announce our Keynote Presentations.
by Todd Case, Statistical Programming Director, Vertex Pharmaceuticals
The theme of the 2019 PharmaSUG China conference is “Preparing for New Policy, Technology and Opportunity”. This presentation will provide examples of the most cutting edge advancements in clinical trials and their impact on data. It will also feature how these changes will impact statistical programming, discuss the myths and realities about how emerging technologies can solve issues facing programmers, and conclude by offering suggestions for the future.
Todd Case is currently leading the Data Standards, Strategic Outsourcing and Quality Assurance Biometrics teams at Vertex Pharmaceuticals. He has previously led and managed Statistical Programming teams to many successful regulatory filings, led a Biometrics Inspection Readiness effort which resulted in successful audits by the MHRA and FDA and initiated, led and hosted PhUSE Single Day Events, Cross-Company Meetings, Team and Departmental Meetings as well as participated in PhUSE and other Industry Working Groups. He is a requested presenter and panelist as well as author of numerous papers and presentations at meetings and conferences in the US and internationally, including: JSM (Joint Statistical Meetings), NESUG (Northeastern SAS Users Group), PharmaSUG, PharmaSUG China, PharmaSUG Single Day Event (SDE), PhUSE, PhUSE SDE, SAS Global Forum, and the Women's Innovation Network. He received a MS degree in Epidemiology from Columbia University in the City of New York. In his spare time he enjoys travelling, reading and volunteering.
by Travis Collopy, Implementation Manager and Director of Support, Pinnacle 21
Pinnacle 21 Community, previously known as OpenCDISC, is an open-source project created by a few people in their free time to help all users with implementation of CDISC standards. Ten years later, Pinnacle 21 would like to share their experience working with industry and regulatory agencies on adaption and utilization of data standards. These and other important questions will be addressed from the users' perspective. What makes a successful standard? How standards change lives? What can we expect in the future?
Travis Collopy worked for 18 years at Merck Pharmaceuticals (MSD) managing Clinical Data Systems including EDC systems, clinical data repositories, and statistical computing support. There he met and worked with Max Kanevsky who went on to create Pinnacle 21. Travis joined Pinnacle 21 in 2014 where he helped develop the define.xml module. Now he works as a Project Manager for CDER and CBER at the FDA on the DataFit project, and he helps customers implement Pinnacle 21 products and services.