MalariaRACV ImagingMDD/GAD/BipolarKidney TransplantProstate CancerColorectal Cancer
 Project ManagerAlana St. ClairTrisha Simpson/Mikenlette Avent (Fellow)Amy PalmerAmy PalmerLaura ButteJohn Owen

John Owen, Rene Dahlheimer

Clinical TA Expert(s) 
  1. Lelsey Workman
  2. Karen Barnes
  3. Elizabeth Allen
Benjamin Hsu

Roslyn B. Mannon
  1. Liz Zhou
  2. Jason Martin
  1. Barbara Leutgeb
  2. Marie-Laurence Harle-Yge
  3. Stefan Sherer
  4. Federico Nasroulah
  5. Dianne Reeves
FDA Division Representative(s)
  1. Shukal Bala
  2. Elizabeth O'Shaughnessy
  1. Yongman Kim
  2. Gregory Levin
  3. David Petullo
  4. Sarah Yim
  5. Nikolay Nikolov
  6. Janet Maynard


Marc Cavaille-CollFatima Frye
  1. Fatima Frye
  2. Boris Brodsky
Metadata Developers
  1. Bess LeRoy
  2. Jon Neville
  1. Christine Fleeman
  2. Kathryn Engstrom

  1. Bess LeRoy
  2. Emili
  3. Emily
  4. Amy
  5. Lauren
  6. Mike
  1. Jon Neville
  2. Bess LeRoy
  1. Archana Bhaskaran
  2. Anita Umesh
  3. Michelle Nusser-Meany
  4. Regina Norelli
  5. Anh Nguyen
  1. Dany Guerendo (Lead, Fellow)
  2. Cliff Reinhardt (Fellow)
  3. Anh Nguyen
  4. Iska Gans
  5. Anita Umesh  
  6. Catherine Mulvaney (Review Only)
Statistician/Statistical Programmer
  1. Xin Wang (biostatistician)
  2. Thomas Kumke (biostatistician)
  3. Bridget Cory
  4. Alex Cuza
  5. Cliff Aspinall


Richard Croy
  1. Carl Dmuchowski
  2. Paul Slagle
  3. Matt Dudley
  4. Baoqing Li
  5. Susan Li
  6. Deepthi Jayawardene
  1. Barbara Mueller
  2. Tara Erb
  3. Qin Qin
  4. Liao Qiming
SDTM Representative
  1. Bess LeRoy
  2. Jon Neville
  1. Kristin Kelly
  2. Jerry Salyers (and CDASH)


Jon Neville Rene DahlheimerTBD
CDASH Representative
  1. Kit Howard
  2. Alec Vardy
  3. Gary Walker
  4. Maura Kush
  5. Shannon Labout
  6. Matthew Dame
  7. Grace Kao
  1. Nikki Flores
  2. Karen Dhami
  3. Kumar Chidam
  4. Lan Huynh


TBDElizabeth Langevin
  1. Elizabeth Langevin (Lead)
  2. Alec Vardy
  3. Melanie Migliore
ADaM RepresentativeTBD
  1. Tatiana Sotingco
  2. Beth Seremula

  1. Mike
  2. Shelley
  3. Scott
  4. Pat
TBD
  1. Susan Kenny
  2. Susan Zhao
  1. Susan Kenny
  2. Nate Freimark
Terminology/
QS Representative

Erin Muhlbradt

Erin Muhlbradt

Rene Dahlheimer
  1. Dana Booth
  2. Jim Kramer

Jim Kramer

Medical Writer
Marissa Bernstein

Jason SchwartzBarbara SowinskiBarbara Sowinski
Others

Diane Wold

Rhonda Facile

  1. Julie Chason - SHARE
  2. Gloria Jones - CDASH/SHARE/Metadata
  3. Emily Pirc - Concept mapping
  1. Steve Kopko
  2. Christine Fleeman
  3. Rebecca Wilgus
  4. Chris Price
  5. Maria Isler


  1. Ina Assfalg (Fellow)
  2. Sharon Powell (Fellow)
  3. Rene Dahlheimer
  4. Sara Ramaker

5 Additional

Clinical Experts


  1. Julie Chason - SHARE Project manager
  2. Gloria Jones - BC Developer
  3. Kapilar Patel - BC Developer (Fellow)
  4. Melanie Paules - Onco SDS Representative
EbolaTCMNutritionVaccines
  1. Shannon Labout – CDISC
  2. Maura Kush – PharmaStat
  3. Gary Walker – Quintiles
  4. Carolyn Famatiga-Fay – CDISC Fellow
  5. Dany Guerenda – CDISC Fellow
  6. Kristin Kelly – Accenture
  7. Sarah McLaughlin – Independent
  8. Yves Claeys – ISARIC
  9. Laura Merson – OUCRU
  10. Lac Huynh Van Nhat – OUCRU
  11. Tien Nguyen Thanh – OUCRU
  12. Jon Neville – C-Path
  13. Joyce Hernandez – Independent
  14. Kim Truett – KCT Data
  15. Theresa Ockerhausen – Clinical RM
  16. Steve Wilson – FDA
  17. Marian Strazzeri – FDA
  18. Robert Lindblad – Emmes
  1. Junchao  Chen – 1 *
  2. Xiankun Chen – 2 *
  3. Meng  Cui –  3 *    
  4. Geng Li  – 2 *
  5. Jinghua  Li –  3 *
  6. Joy  Li – 4 *
  7. Xiaoyan  Li – 2 *
  8. Fang  Lu – 4 *
  9. Xiaoying Lyu – 5 *
  10. Ruiling Peng – Beijing Improve-quality Tech. Ltd.Co.


  1. Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine
  2. Key Unit of Methodology in Clinical Research (KUMCR), Guangdong Provincial Hospital of Chinese Medicine
  3. Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences(CACMS)
  4. Institution of  Clinical Pharmacology, Xiyuan Hospital, CACMS
  5. Clinical Evaluation Center of CACMS
  1. Simon Lebeau – Ividata/Danone Research
  2. Hanneke Lankheet – Danone Nutricia Research
  3. Emilie Ba – Nestlé
  4. Elsbeth Verdonk – Danone Nutricia Research
  5. Johan Schilt – Unilever
  6. Stephane Auger – Danone Research
  7. Fabien Foltzer – Nestlé
  8. Geraldine Baggs – Abbott Nutrition
  9. Sue Zhang – Abbott Nutrition
  10. LuAnn Hitzemann – Abbott Nutrition
  11. Crystal Stollings – Abbott Nutrition
  12. Anna Lyra – DuPont Nutrition & Health
  13. Anne Salonen – University of Helsinki
  1. Frances M. Acton (Merck&Co)
  2. Brenda Baldwin (FDA CBER)
  3. Anne-Sophie Bekx (BDLS)
  4. Karin Botilde (GSK)
  5. Dorina Bratfalean (CDISC)
  6. Xavier Cornen (SanofiPasteur-MSD)
  7. Cedric Davister (GSK)
  8. Pamela Freese (Pfizer)
  9. Audrey Hagenbach (Sanofi-Pasteur)
  10. Christian Hoppe (Charite)
  11. Paul Houston (CDISC)
  12. Ragini Khedoe (GSK)
  13. Veronique Long (Sanofi-Pasteur)
  14. Dave O’Riordan (GSK)
  15. John Owen (CDISC)
  16. John Perez (Pfizer)
  17. Kirk Prutzman (FDA CBER)
  18. Barbara Rath MD PhD (Charite)
  19. Magali Savoy (Sanofi-Pasteur)
  20. Ramana Setty (Sanofi-Pasteur)
  21. Olive Yuan (Johnson & Johnson)
  22. Elodie Zaworski (Sanofi-Pasteur)
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