Dr. John C Lukas is a Senior Scientist with Dynakin SL and interim Director of Drug Modeling & Consulting (DMC). Dr. Lukas earned his PhD in Astrophysics and has had stints as a postdoctoral fellow at the University of Washington and as Marie Curie 40 fellow. He was a professor of the Master’s in population pharmacokinetic methods at the University of the Basque Country several years while collaborating with industry. John joined Pharsight in 2005 where he worked until 2009 on clinical trial modeling & simulation acquiring considerable operational experience in the pharmaceutical industry as a CRO. Apart from population PK/PD M&S, he has particular expertise in drug efficacy biomarker and disease modeling in several TA’s and metadata analysis. He is the driving force behind our MBDD techniques, applications and R&D and a key partner in most of our public competitively funded initiatives. Dr. Lukas is the author or co-author of many peer-reviewed publications.
Dr. Monica Rodriguez is a Senior Scientist at Dynakin SL, Drug Modeling & Consulting (DMC) group and one of the co-founders. She currently also serves as interim VP of Sales for Dynakin. Dr. Rodriguez earned her PhD in Pharmacology applying population M&S in an industry sponsored project. She has extensive experience in pre-clinical to FTIM and Model Based Drug Development (MBDD) (Modeling & Simulation) methods in regulatory submissions. She has acted as liaison for several companies in MBDD related matters in submissions to the EMEA, BfArm and DKMA. She is the driving force behind our adaptive trial design and pediatric and special population protocol designs for the industry. Dr Rodriguez has authored several peer-reviewed articles.
Dr. Nerea Leal is a Senior Associate at Dynakin SL’s Drug Modeling & Consulting (DMC) group and one of the co-founders. She also serves as VP of Operations and Research Services at Dynakin SL. She is our European pharmaceutical industry contract research account manager. Dr. Leal completed her PhD in pharmacy using population PK methods for an industry sponsored anesthesia project. She has extensive experience in biostatistical methods, population PK and Modeling & Simulation applications in industry having supervised or participated in over 10 industry or industry / public sector sponsored projects. Dr. Leal is responsible for the successful fulfillment of all our contract research activities and is the driving force behind our R&D efforts.
Valvanera Vozmediano (B.Sc. pharmacy) is a Junior Scientist with Dynakin SL’s Drug Modeling & Consulting group. She is also director of the GLP Bioanalysis Quality Assurance unit. Valvanera is our allometric scaling expert using population PK/PD methods. She is successfully completed 3 industry projects in that domain as a CRO. She also has experience in modeling & simulation and population PK methods.
Dr. Itziar Oteo is a Junior Associate with Dynakin SL’s Drug Modeling & Consulting group. Itziar completed her PhD using population PK methods in immunosuppression. She has experience in population PK (NONMEM) and the use of data analysis tools for biostatistical methods.