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  1. CDER Center for Clinical Trial Innovation (C3TI)

Facilitating Collaboration Across CDER

CDER Center for Clinical Trial Innovation (C3TI) in Action

C3TI facilitates collaboration across CDER through multi-channel engagement and a network of champions.

C3TI Champions

C3TI Champions are CDER staff who partner with C3TI to help promote and nurture a culture of innovation in clinical trials. They serve as liaisons for their respective CDER offices, convene regularly to exchange insights and lessons learned, provide subject matter expertise to C3TI programs, and represent C3TI at external events.

  • Eugenio Andraca-Carrera, PhD, Master Mathematical Statistician; Division of Biometrics VII; Office of Biostatistics; Office of Translational Sciences
  • Mammah Borbor-Lebbie, MBA, MS, Regulatory Health Project Manager; Office of Surveillance and Epidemiology
  • Andrew Clerman, MD, PhD, Clinical Team Lead; Division of Pulmonology, Allergy, and Critical Care; Office of Immunology and Inflammation; Office of New Drugs
  • Cheryl Grandinetti, PharmD, Associate Director for Clinical Policy; Division of Clinical Compliance Evaluation; Office of Scientific Investigations; Office of Compliance
  • Xiling Jiang, PhD, Associate Director for Therapeutic Review (Acting); Division of Cancer Pharmacology I; Office of Clinical Pharmacology; Office of Translational Sciences
  • Ami Mankodi, MD, Lead Physician; Division of Neurology II; Office of Neuroscience; Office of New Drugs
  • Valentina Mantua, MD, PhD, Associate Director for Regulatory Science; Office of Neuroscience; Office of New Drugs
  • Atasi Poddar, PhD, Health Science Policy Analyst; Office of Medical Policy Initiatives; Office of Medical Policy
  • Mitchell Psotka, MD, PhD, Senior Physician; Division of Cardiology and Nephrology; Office of Cardiology, Hematology, Endocrinology, and Nephrology; Office of New Drugs
  • Yunzhao Ren, MD, PhD, Master Pharmacokineticist; Office of Clinical Pharmacology; Office of Translational Sciences
  • Nisha Shah, JD, MSc, Senior Regulatory Counsel; Division of Regulatory Policy I; Office of Regulatory Policy
  • Heather Stone, MPH, Health Science Policy Analyst; Office of Medical Policy
  • James Travis, PhD, Master Mathematical Statistician; Division of Biometrics II; Office of Biostatistics; Office of Translational Sciences

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