NJ CDISC Users Group Meeting Feb 27, 2017 Novartis Pharmaceuticals Corporation East Hanover, NJ

Welcome Suggestions for future topics can be sent to any of the program committee members (see slide 3) Next meeting planned for Jun, 2017 We need a volunteer company to host the meeting If your company is interested in hosting a meeting, please contact a program committee member

Welcome 2017 program committee members Ram Govindaraju, ram.govindaraju@wcct.com (Lead) Max Kanevsky, mkanevsky@pinnacle21.net Terry Katz, terry.katz@merck.com Pat Majcher, patricia.majcher@novartis.com Parag Shiralkar, pshiralkar@eliassen.com Sergiy Sirichenko, sergiy@opencdisc.org Gina Wood, Georgina.wood@navitas.net Tai Xie, tomx@brightech-intl.com Saravanan Kandasamy: saravanank@navitas.net Kumari Sai: kumari.sai@novartis.com Venkat Lajapathirajan Venkateshwaran.Lajapathirajan@ppdi.com

Agenda for Today Presentations What’s new in SDTM 1.5 – Mike DiGiantomasso (Pinancle) Demo on creating ARM using P21E - Max Kanevsky (Pinnacle) Networking opportunity, refreshments courtesy of Novartis Practical considerations for data validation - Sergiy Sirichenko (Pinnacle) Standards driven Oncology Studies (Response Criteria, CDISC) – Kevin Lee (Clindata Insight) Closing

Presentations To Be Posted in CDISC Portal Presentations will be posted Go to www.cdisc.org Click on CDISC Portal at the top of the screen Click on CDISC User Groups, toward top left of the screen Click on North America under Sites in the left hand panel Click on Atlantic(Tri-State: CT, NJ, NY) under Sites in the left hand panel Click on Presentations in the left hand panel Click on folder 2017_02_meeting

Next meeting planned: Jun, 2017 -- location TBD Closing Thank you To our presenters To our hosts at Novartis To everyone attending Next meeting planned: Jun, 2017 -- location TBD