Cristian Gradinaru, Ph.D.

Director, Applied Pharma Modeling & Statistics Ltd.
+44 (0) 7445 049387

Cristian Gradinaru

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Curriculum VITAE

Summary

Cristian held senior scientific roles at companies including Circassia Pharmaceuticals and F-star Biotechnology, as well as CRO’s including Physiomics Plc.. where he led and contributed to pre-clinical and clinical projects focused on PKPD modelling/pharmacometrics and statistics. He holds a Ph.D. from the Technical University of Copenhagen, Denmark in Stochastic Modelling of Biological Systems, an M.Sc. from Stanford University, USA in biophysics with a focus on biochemistry, and a B.A. from Cornell University, USA in chemistry.

He is currently using his skills in biostatistics and mathematical modelling, built on a strong background in chemistry and the life sciences, to help pharmaceutical and biotech companies with timely decision-making results that have a fundamental impact on drug development programs.

Past and Current Experience

Applied Pharma Modeling & Statistics Ltd. (Cambridge, UK): Director – Independent Consultant in PKPD Modeling & Statistics

Applied Pharma Modeling & Statistics Ltd. (ApPharMS) provides consultancy services in the areas of PKPD modelling and simulation, FIH trial design, RP2D selection; preclinical study and clinical trial design, statistical data analysis and powering; and other statistics and modeling services.

Physiomics Plc. (Oxford, UK)

Mathematical models to support the development of drug treatment regimens and personalised medicine solutions:

  • statistical analysis of preclinical and clinical oncology data
  • population PK and PKPD modelling in the oncology arena
  • assistance with FIH trial design and general input on study design and data analysis.

F-star Biotechnology Ltd. (Cambridge, UK)

Highly collaborative effort to support the development of F-star’s capabilities in modelling and statistics with application to the following areas: 

  • PKPD translational modelling of preclinical in vitro and in vivo data to enable first in-human dose selection and target therapeutic dose estimation:
    • led the population PKPD modeling efforts of preclinical (monkey, mouse) and clinical (phase I) data, allometric scaling to humans, and simulations of clinical PK for three different lead products (bispecific antibodies)
    • performed the data analysis and model building, fitting, and relevant simulations
    • prepared written technical reports, which became part of three successful IND applications for drugs currently tested in the clinic.
  • Preclinical (mouse) PK: lead/target selection; study design; and sample size calculations
    • provided expert support to project teams to design, execute and interpret quantitative pharmacology studies, by conducting statistical design of experiments including power studies, and implementing processes for statistical analysis of data
    • developed and implemented comprehensive methods in Stata for mixed effects model analysis of tumor-growth inhibition data in mice and sample size calculations using power studies, as well as for survival analysis using the log-rank test and Cox modeling
    • provided biostatistical leadership, training, and support to all areas of the R&D organization as needed

Circassia Pharmaceuticals Ltd. (Oxford, UK)

Collaborative effort to support the Circassia business by providing statistical analysis of product performance data to a level suitable for inclusion in regulatory submissions:

  • PK modeling of drug absorption via competing lung/stomach pathways using in vitro lung models
  • Developed novel statistical tools for and performed analysis of in vivo biochemical data to assess the immune response to allergy drug treatment
  • Performed statistical analysis of in vitro data for test vs. reference products (bioequivalence)
  • Internal statistical consultancy 

Upwork.com

Provided statistical/modeling consultancy and general science input to a range of clients and projects. Work performed included statistics and mathematical modeling, Matlab and Stata programming, science writing, and editing and proofreading of technical writing. Some examples are:

  • Developed the mathematical methodology and implemented a multi-exponential fit algorithm to extract underlying processes’ lifetimes from phosphorescence data
  • Performed log-rank testing and Cox-modeling for oncology survival data (Kaplan-Meier curves)
  • Developed a novel theoretical framework for complex linear combinational products (optimal buy/sell route in financial trading). Full Matlab implementation.
  • Several projects involving finding correlations between market indicators (independent variables) and financial performance, with the aim of constructing a model to predict near-future behavior.
  • Developed machine learning models to predict financial indicators (simple networks and SVM)

Education

Ph.D. Technical University of Denmark: Copenhagen, Denmark 

Thesis: “Stochastic models of cell motility”

M.Sc. Biophysics, Stanford University: Stanford, CA, USA • Concentration in biochemistry

Thesis: “Cargo Binding-Dependent Regulation of Myosin VI and Mechanistic Insights” 

B.A. Chemistry, Cornell University: Ithaca, NY, USA

Continuing Education/Training Courses:

  • Antibody PK/PD and ADAPT Workshop, University of Buffalo, NY Pharmacokinetic-Pharmacodynamic Modeling, University of Buffalo, NY
  • Pharmacokinetics and Pharmacodynamics of Protein Therapeutics, Merck
  • Machine Learning, Stanford University via Coursera.org
  • Data Science Processes: Exploration in data mining with SPSS
  • Oxford University Clinical Trials, Oxford University