1 / 5

Vaccines Project Snapshot

Vaccines Project Snapshot. Status Main project = stepwise work by topic On current topic: reactogenicity SDTM model Next steps: finalise SDTM + terms, CDASH, ADaM Next topics: lab data (Immunogenicity, safety) – not started yet. Project Mission

barronl
Download Presentation

Vaccines Project Snapshot

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Vaccines Project Snapshot Status • Main project = stepwise work by topic • On current topic: reactogenicity SDTM model • Next steps: finalise SDTM + terms, CDASH, ADaM • Next topics: lab data (Immunogenicity, safety) – not started yet Project Mission Ensure a consistent use and development of the CDISC standards for use in vaccines studies, intended to support regulatory submissions, across all diseases/Vaccines preventable diseases areas in all age groups. • Project Scope • Vaccines User Guide, • CDASH, SDTM, ADaM standards and Controlled Terminology • Iterative work by topic: piecewise development of guides • Current topic is reactogenicity (SDTM + terminology) for v1.0 • Define requirements. • Develop guidelines. • Elaborate and submit proposals for extension/update of these standards to the related CDISC teams (Terminology, SDTM Gov. Committee, CDASH, ADaM). • Interact with and providefeedback to other teams. Full Team Members – AE subteam Frances M. Acton (Merck&Co) Brenda Baldwin (FDA CBER) Anne-Sophie Bekx (BDLS) Karin Botilde (GSK) Dorina Bratfalean (CDISC) Xavier Cornen (SanofiPasteur-MSD) Cedric Davister (GSK) Pamela Freese (Pfizer) Audrey Hagenbach (Sanofi-Pasteur) Christian Hoppe (Charite) Paul Houston (CDISC) Ragini Khedoe (GSK) Veronique Long (Sanofi-Pasteur) Dave O’Riordan (GSK) John Owen (CDISC) John Perez (Pfizer) Kirk Prutzman (FDA CBER) Barbara Rath MD PhD (Charite) Magali Savoy (Sanofi-Pasteur) RamanaSetty (Sanofi-Pasteur) Olive Yuan (Johnson&Johnson) ElodieZaworski (Sanofi-Pasteur)

  2. Traditional Chinese Medicine-Acupuncture Project Snapshot Status Stage 0 – Focus on understanding acupuncture concepts and prepare proposal Project Mission Develop a v1.0 CDISC Acupuncture Therapeutic Area User Guide (TAUG) using the most common acupuncture concepts. Project Launched in Q2 2015 Project Scope • Core acupuncture concepts • CDASH and SDTM • Terminology • Analysis guidelines Team Members • Wen Zehuai • Xiaoyan Li – Key Unit of Methodology in Clinical Research (KUMCR) Guangdong • Geng Li –KUMCR Guangdong • Zibao Zhang – PPDI • Jordan Li – NCI-EVS • Erin Muhlbradt – NCI-EVS • Rebecca Kush – CDISC • Rhonda Facile – CDISC • Alana St. Clair – CDISC • Sheila Leaman – CDISC • Anthony Chow – CDISC

  3. Nutrition Project Snapshot Status Stage 0 – Focus on Charter, TA Survey, building concept list Project Mission Ensure the consistent use of existing CDISC standards for clinical research in nutrition, and to facilitate alignment and development of new standards for research in all areas and for all life-stages in nutrition. Project Launched in Q1 2015 Project Scope • Core nutrition concepts • SDTM • CDASH • Terminology • CDISC TAUG Team Members • Simon Lebeau – Ividata/Danone Research • Hanneke Lankheet – Danone Nutricia Research • Emilie Ba – Nestlé • Elsbeth Verdonk – Danone Nutricia Research • Johan Schilt – Unilever • Stephane Auger – Danone Research • Fabien Foltzer – Nestlé • Geraldine Baggs – Abbott Nutrition • Sue Zhang – Abbott Nutrition • LuAnn Hitzemann – Abbott Nutrition • Anna Lyra – DuPont Nutrition & Health

  4. Malaria Project Snapshot Status Stage 2 Project Mission Ensure the consistent use of existing CDISC standards for clinical research in malaria, and to facilitate alignment and development of new standards to ensure a standard method of recording, storing and reporting of clinical malaria data. Project Launched in Q1 2015 Project Scope • Core malaria diagnosis and treatment concepts • SDTM • CDASH • Terminology • CDISC TAUG Team Members • Lesley Workman – WWARN • Philippe Guerin – WWARN • Diane Wold – CDISC • Carolyn Famatiga-Fay – CDISC Fellow • Christine Fleeman – UCB, CDISC Fellow • Linda Kililani – UCB • Trisha Simpson – UCB • Kamal Hamed – Novartis • Justin green – GSK • Stephan Chalon – MNV • Valerie Lameyre – Sanofi • Andrea Bosman – WHO

  5. Ebola Project Snapshot Status Stage 0 – Focus on Charter, TA Survey, building on concept list developed by WHO and ISARIC EVD researchers Project Mission Ensure the consistent use of existing CDISC standards for clinical research in Ebolavirus Disease (EVD) research, and to facilitate alignment and development of new standards for research in all areas and for all life-stages in EVD. Project Launched in Q1 2015 Project Scope Not yet finalized, but will include at least: • EVD research concepts • CDASH • SDTM • Terminology • CDISC TAUG Team Members • Shannon Labout – CDISC • Maura Kush – PharmaStat • Jon Neville – C-Path • Laura Merson – OUCRU • Lac Huynh Van Nhat – OUCRU • Tien Nguyen Thanh – OUCRU • Yves Claeys – ISARIC • Laura Butte – C-path • Carolyn Famatiga-Fay - CDISC Fellow • Sarah McLaughlin – Biogen Gail Carson – Nuffield Department of Medicine Gary Walker – Quintiles Kristin Kelly – Accenture Vicki Tifft – Clinical RM Douglas Mayers – USAMRIID Kim Truett – KCT Data Theresa Ockershausen – Clinical RM Steve Wilson – FDA

More Related