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. John C Lukas is a consulting scientist with Dynakin SL and based in France. He has been active in the pharmacokinetic/ pharmacodynamic modeling & simulation fields since 1997. He has had stints as a postdoctoral fellow in bioengineering at the University of Washington, as Marie Curie 40 fellow at the department of Pharmacy, University of Athens or a vsiting professor at the deparmtnet of Pharmacy of the University of Salamanca. He also taught at the Master’s in population pharmacokinetic methods at the University of the Basque Country while collaborating with industry. John joined Pharsight in 2005, as a Senior Scientist, until 2009 on clinical trial modeling & simulation acquiring considerable operational and managerial 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 also in metadata analysis. Dr. Lukas is the author or co-author of over 30 peer-reviewed publications.
Dr. Fatima-Zahra Agrad is Senior Assessor with Dynakin's Clinical Trial department. She has worked in the pharmaceutical industry in the preparation, management and execution of clinical trials in development. In the past year she has actively participated in the design of three clinical protocols and currently co-manages the trials in process where Dynakin is the CRO.
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.
Dr. Valvanera Vozmediano 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 an Assistant Scientist in the Modeling and Clinical Trial departments of Dynakin’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. She has actively participated in numerous modeling exercises. Itziar also has experience in clinical protocol and related SOP development and implementation and in BE analysis (Phoenix(R)).
Esther Encinas (B.Sc. Pharmacy) a doctoral candidate and visiting Junior Principal at Dynakin's strategic consulting group has participated in over 10 projects aimed to resolve complexities in bioequivalence and first in man trials with a strong clinical and regulatory aspect. She has accumulated experience in clinical trial design and protocol preparation.
Ana Abaigar (B.Sc. Pharmacy) a doctoral candidate and Associate Trainee at Dynakin's Clinical Trial department has participated pro actively in several clinical design projects and in the execution of a phase IV in oncology. She has practical expertise in the development of methods for SOP clinical trials.