The Drug Modeling & Consulting (DMC) group consultants have decade long success track record of proven experience in pre-clinical and clinical development responding to a wide range of needs in all therapeutic areas with over 140 projects in all therapeutic areas and a 85% repeat client rate (from a source of > 60 clients from around the world, start-ups to big-pharma). The DMC team has extensive regulatory expertise and also in protocol and report preparation as well PIP development. DMC has prepared, consulted and chaperoned several major drug applications to the EMEA, the FDA, the BfArM, the ANVISA, among others, including the first PIP (with an adaptive trial design) to be presented and approved by the EMA.
John C Lukas (BSc, MSc, PhD) is a Senior Associate DMC and simultaneously acting Director of DMC. 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 departrment of Pharmacy & Technology, 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, working on clinical trial modeling & simulation. 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. John is based in France.
Monica Rodriguez (BSc, PhD) is a Senior Scientist and our strategic consultant at Dynakin, Drug Modeling & Consulting (DMC) group. She is one of the co-founders of Dynakin. She has guided and lead teams successfully addressing industrial development challenges through the projects, that include full NCE development and bioequivalence hurdles. She also has extensive experience in pre-clinical to FTIM and translational application of population PK/PD and Modeling & Simulation methods also for regulatory submissions. She has acted as liaison for several companies in MBDD related matters in submissions or scientific advice meetings at the FDA, EMA, BfArm, MHRA and DKMA among others. She is the driving force behind our strategic development and regulatory assistance to customers, pediatric and special population protocol designs for the industry as well as for novel methods for bioequivalence testing. Dr Rodriguez has authored several peer-reviewed articles.
Nerea Leal (BSc, PhD) is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group and one of the company’s 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 several industry or industry / public sector sponsored projects. Dr. Leal is also responsible for the successful fulfillment of all our contract research activities and is the driving force behind our R&D efforts.
Paula Muniz (MSc, PhD) is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. She is a doctor in Pharmacy by the U of Navarra with a PhD in cardiovascular pharmacology. She is also a MSc in Clinical Research by the U of Cardiff and MBA by the Barcelona School of Managment from de U Pompeu Fabra. Paula has more than 15 years of experience within pharmaceutical industry in an international setting where she has worked on regulatory strategy, clinical study design and result evaluation in several indications for a NCE and a fixed dose combination for EMA and FDA submissions. Focusing on comparative bioavailability, in vivo in vitro relationships/correlations and pragmatic application of regulatory requirements, she has participated in the development of numerous complex immediate and modified release pharmaceutical alternatives for oral, inhalation and intramuscular routes. She has also set up and participated in scientific meetings with EMA, national authorities and the FDA. Since her initial involvement with Dynakin she has built experience in the regulatory application of modeling & simulation and population PK/PD methods for the evaluation of interactions, pediatric product development and bridging between populations.
Valvanera Vozmediano (BSc, PhD) is a Junior Consultant with Dynakin’s Drug Modeling & Consulting group. She is also director of the R&D Department. Valvanera has expertise in allometric scaling and preclinical MBDD expert applying population PK/PD methods. She also gathers experience in translation across populations, mainly in the pediatric field. Valva has successfully completed several projects in that domain as a consultant in FTIM questions, PIPs, and bridging studies. She also has experience in modeling & simulation and population PK methods in several therapeutic areas, including support to successful filings for new drug applications and is the author of peer-reviewed research also as Marie Curie fellow. Valva is based in Florida, USA.
Flavia De Toni Uchoa (BSc, MSc, PhD) is a Principal Scientics at DMC. She has been working with pre-clinical pharmacokinetics and bioanalysis in 2006, during her PhD and joined Dynakin in 2011 as a Study Director in the Laboratory, moving to the DMC Department (Consulting Services) in 2013. She combines expertise in new compound pharmacokinetics and bioanalytical methods with modeling approaches and meta- analysis. Dr. De Toni is the author or co-author of over 15 peer-reviewed publications. Flavia is based in Texas, USA.
Esther Encinas (BSc, PhD) is a Consulting Associate with Dynakin’s DMC department having participated in projects to resolve pre- and post-submission concerns, especially on bioequivalence, with a strong clinical and regulatory component. Esther also has experience in clinical trial design and protocol preparation and provides regulatory and modeling support to the CT and R&D departments. She is one of our pediatric ontogenic MBDD based scaling and design experts having authored significant research on that field. She completed her doctorate on pediatric modeling within Dynakin. Esther is based in Bilbao.
Borja Ruiz (BSc, PhD) is Associate Advisor at DMC. He joined Dynakin in 2013 as Medical Advisor in the Clinical department, moving to DMC in 2015. Borja completed his PhD in the field of pharmacovigilance, drug metabolism and pharmacogenetics. During his PhD he worked at the Pharmacovigilance Unit of the Basque Country as study monitor and investigator. He has been lecturer at the Faculty of Medicine of the University of Basque Country between 2010 and 2013, where he has taught basic pharmacology and clinical pharmacology. Borja is the author or co-author of over 10 peer-reviewed publications.
Seeking consultation for drug development