Adaptive Clinical Trials Experts

Dr. Reinhard Eisebitt

Dr. Reinhard Eisebitt oversees a team of US and EU based adaptive design experts, who work closely with clients to design and conduct adaptive trials, and with industry partners to develop new and innovative methods in drug development. Prior to joining ICON, he was managing director of ClinResearch GmbH, a full service CRO specialising in the planning, execution and reporting of adaptive clinical trials. He is also co-founder of ADDPLAN GmbH, the first commercial software package for the design, simulation, and analysis of adaptive trials.

Dr. Sergei Leonov, Ph.D.

Dr. Sergei Leonov championed the development of innovative statistical methodology based on the theory of optimal model-based experimental design, coordinating its application in over 20 drug development projects that included dose ranging studies, adaptive designs of early phase trials, and optimization of sampling schemes for pharmacokinetic/pharmacodynamic studies. 

Dr. Tobias Mielke, Ph.D.

Dr. Tobias Mielke helped to develop ADDPLAN DF, a fully validated design, simulation and analysis software for adaptive Dose-Finding designs. He has been responsible for the development of innovative trial design methodology and the resulting implementation into the software. Dr. Mielke trains statisticians in various companies on the implementation of ADDPLAN’s innovative statistical methodology in early phase clinical development.  In addition, Dr. Mielke consults sponsor companies on the use of Dose-Finding and adaptive confirmatory study designs in various indications. 

Dr. Parvin Fardipour, Ph.D.

Dr. Parvin Fardipour is an innovative professional with 27 years of clinical research experience in the pharmaceutical and contract research organization (CRO) industry. The past 10 years, Dr. Fardipour has been working in the adaptive design space to bring innovative approaches to clinical drug development and facilitate better and earlier decision making. She is recognised as an expert in designing, implementing and executing adaptive designs, enabling real-time learning and applying innovative designs across different therapeutic areas in both drugs and devices development.

Dr. Valerii Fedorov, Ph.D.

Dr. Valerii Fedorov is an author of more than 200 publications including several books in various areas of statistics and biostatistics, such as design of clinical trials, bioequivalence, random effects models, regression analysis, numerical methods in design of experiments, econometrics, theory of optimal design of experiments, model oriented adaptive design of experiments, and Bayesian methods in experimental design.  His monograph on Theory of Optimal Experiments, Academic Press, is the most cited book in optimal experimental design area. 

Dr. Silke Jorgens, Ph.D.

Dr. Silke Jorgens has more than 15 years of experience in statistical consultancy both in academia and industry. Dr. Jorgens provides adaptive consultancy and has aggregated experience over a vast range of indications, from orphan to widespread diseases.