Strategic guidance from
proven professionals

Teodora (Dora) Pene Dumitrescu, Ph.D.

Senior Consultant, Pharmacometrics

Dr. Pene Dumitrescu has 8 years of experience as a clinical pharmacology and pharmacometrics lead on cross-functional clinical development teams resulting in successful regulatory approvals. She has extensive regulatory experience, including development of clinical pharmacology modules of INDs and CTDs, authoring PIPs, PSPs, briefing documents, and participating in regulatory interactions such as pre-IND, end-of-phase 1/2, pre-submission meetings with FDA, EMEA, Health Canada, or ANVISA. In her role, Dr. Pene Dumitrescu was instrumental in the design, analysis, and interpretation of clinical pharmacology studies including ADME, DDI, BE/FE, SAD/MAD, TQT, as well as Phase 2 & 3 studies. Her broad experience also extends to population PK/PD modeling, clinical trial simulation and design, probabilistic risk assessment, pediatric extrapolation, and applying quantitative pharmacology principles for decision making in multiple therapeutic areas including dermatology, respiratory, infectious diseases, oncology, and antiviral.

Education

  • Doctorate of Philosophy, Pharmacology,
    • University of Pittsburgh, Pittsburgh, PA
  • Master of Science, Pharmacology
    • University of Ottawa, Ontario, Canada