PharmaPro Consulting stands apart from other consultancy companies through our capacity to engage our seasoned Expert Consultants on all assignments, no matter how large or small. We can partner with you, bringing a full repertoire of functional expertise as you take your product from discovery to market.
The PharmaPro Consulting team consists of well-tenured professionals with long-term experience in clinical pharmacology, pharmacometrics, and pharmacokinetics as well as clinical trial design, interpretation, publications, and more. We bring this wealth of experience from big and small Pharma and Biotech to bear to empower our clients to meet their aggressive timelines, make informed decisions, and save their valuable resources of time and money.
Dr. Dontabhaktuni is the Founder and CEO of PharmaPRO Consulting. She has 25 years’ experience in Pharma industry including corporate and academic research in the United States, U.K. and India. She has served as DSMB Scientific Board Member. Prior to this she was a Director at Lilly and headed the PK, Pharmacometrics department there.
In her career, Dr. Dontabhaktuni has supported 60+ assets in various therapeutic areas, authoring/reviewing various eCTDs modules; 2.7.1 and 2.7.2, Biologics License Applications (BLA), New Drug Applications (NDA), Investigational New Drug (IND) applications, Breakthrough Therapy Designations applications,and briefing books.
Dr. Dontabhaktuni has shown unrivaled expertise as a research scientist in many pharmacological areas, including many of the most cutting-edge advances of modern Clinical Pharmacology, including population pharmacokinetics. She has authored 45+ peer-reviewed publications. She has been invited to numerous national and international conferences as a Keynote Speaker and Plenary speaker. In 2019 she received “The Pharma Ratna Award” as Youngest Female Scientist for Extraordinary Scientific Achievement by Rab Di Meher, an international organization.
Dr. Dontabhaktuni obtained BS Pharmacy from Karnataka Pharmacy Collage, Gulbarga University India and PhD, in pharmaceutical sciences specializing in Pharmacokinetics from Long Island University, Arnold & Marie Schwartz College of Pharmacy, New York.
Michael R. Stevens, PharmD is accomplished results-oriented, science-based professional with a well-diversified career in the pharmaceutical/biotechnology industry over more than thirty years.
Michael has served in a number of positions in “Big Pharma” and “Small Biotech” ranging from entry level to executive in the areas of Market Research, Oncology Marketing, Medical Nutritionals Marketing, Drug Discovery, New Product Development, Phase 1 through 4 Clinical Trials in HIV/AIDS and Clinical Nutrition, Medical Market Development in the hepatitis B market, and Medical Affairs. He served as the Vice President, Medical Affairs Virology for the Bristol-Myers Squibb HIV franchise.
Dr. Stevens has served as the Bristol-Myers Squibb representative to both the NIH’s AIDS Clinical Trial Group (ACTG) and the Forum for Collaborative HIV research, gaining valuable experience in working with colleagues in academia and other pharmaceutical companies to write, field, analyze, and publish clinical trials involving products from multiple manufacturers. He has also worked to write, field, analyze, and publish clinical trials dealing with a therapeutic vaccine for HIV.
With extensive experience in both Big Pharma and Small Biotech, Michael has consulted with companies across the full range of clinical trials from pre-clinical to Phase 4. He has authored/co-authored over 50 posters and peer-reviewed publications and has presented the data at national and international conferences. His background in both Marketing and Medical gives him a unique insight into positioning study results to provide robust labeling.
• Regulatory Strategies
• CMC
• Manufacturing
• Biologics
• Parenteral Formulations
• Down Steam Processing
Mr. Goldstein has over 30 years of experience in biologics development including down stream development, parenteral formulation development and analytical development. Mr. Goldstein’s experience includes leadership roles for the approval of Eli Lilly’s cetuximab (ERBITUX®), ramucirumab (CYRAMZA®), necitumumab (PORTRAZZA™) and Olaratumab (LARTRUVO™).
Ms. Goldstein was formerly Vice President, Formulation Development, Lilly, NJ (formerly ImClone Systems Incorporated).
Dr Guzy has 30 years’ experience in the Pharma industry including corporate and academic research in the United States and Israel. In the past 13 years, he has consulted for many Pharmaceutical and Biotech companies providing Pharmacometrics and Biostatistics. Serge provides consulting in Biostatistics, Mathematical modeling, Statistical modeling, Simulation of clinical trials, Pharmacokinetics, Pharmacodynamics, Compartment Analysis, Design of Experiments, Optimization Algorithms development. Training in Population Pharmacokinetics and Pharmacodynamics, modeling and simulations. Working with clients like XOMA, TEVA Israel, Obecure, Neuroderm, Roche, Abott, Omrix, Pharmapolaris, Jerusalem University (Yissum), Indiana University, USA, Azienda University, Italy, Genentech, Optimata, Regulus, Pharsight, Modigenetech, TEVA, America, Medigen, Medistat, Bioforum, Yissum, immunopharma, medigen, Sunovion.
Dr. Guzy is the co-developer of the MC-PEM algorithm for Mixed Effect Modeling which utilizes the expectation maximization algorithm combined with importance sampling and Maximum a posteriori estimation. This new algorithm has been implanted within the gold standard softwares for Population Pharmacokinetic analysis which uses Mixed effect modeling approach and has been proved to be unbiased, precise, stable, and robust. Dr. Guzy has authored/co-authored 48+ peer-reviewed publications. Presented or led over 30 workshops in many international conferences. He holds a PhD at the Technion in Biomedical Engineering (Haifa, Israel), a master’s degree at the Weizmann Institute in biomathematics and Chemistry and a BSc degree in Chemical Engineering from the University of Brussels. Serge brings vast professional experience. He serves as Head of Pharmacometrics as he is World class expert in PK/PD and Statistical Modeling. He is Affiliate Professor at the University of Maryland, Adjunct Professor at the University of Minnesota, Visiting Professor at the Medical School of Jerusalem, Courtesy Professor at the College of Pharmacy, Florida and Adjunct Professor at the University of Denver.
Dr. Gonzalez Sales has more than 10 years’ experience in the pharmaceutical industry; helping make better and faster decisions about drugs by using modeling and simulation. He has also worked as a pharmacometrics reviewer at the FDA, where he was awarded for his excellent team collaboration, and for using innovative quantitative approaches to answer challenging regulatory questions. Moreover, he is (co) author of several high impact papers in the field of pharmacokinetics and pharmacodynamics. He holds a PharmD, MSc, MStat, and a PhD in Pharmacometrics.
Dr. Collins has 20 years’ Clinical Pharmacology leadership expertise in a broad range of experiences including working as principal investigator and medical director at clinical research sites, CROs, and academia. She is experienced at applying problem solving and critical thinking skills to complex drug development issues including leveraging model-informed approaches.
Most recently Dr. Collins was a Senior Clinical Pharmacologist at Medpace where she provided strategic input and review for clinical pharmacology sections of pre-IND briefing documents, modules 2 and 5 of eCTDs and investigator’s brochures. Represented Clinical Pharmacology in FDA teleconferences including breakthrough therapy and End-of-Phase 2b meetings. Designed clinical trials including first in human, single and multiple ascending doses, bioequivalence, food effect, drug-drug interactions, and population pharmacokinetic studies. She has provided educational training to project team members on new innovative/impactful clinical and translational pharmacology approaches to drug development. She has collaborated with project managers, medical writers and sponsors to advance overall drug development strategy.
Dr. Collins has authored/co-authored 35+ peer-reviewed publications. She obtained her MD and MS Physiology, Urology Residency, and Surgery Residency from the Ohio State University and the Teaching Scholar from University of Washington.
Rubi Mahato, BS, MBA, PhD. is a pharmaceutical scientist with over 6 years of teaching experience. She has broad experience in drug discovery ranging from formulations to preclinical and Drug Discovery to development. For the past 6 years she has worked as Assistant professor of Pharmaceutical Sciences and taught fourth- and fifth-year PhamD students in Fairleigh Dickson University and now in Binghamton University.
Dr. Mahato has authored/co-authored more than 19 publications, text book chapters, posters, and abstracts. She obtained her PhD in Pharmaceutical Sciences from University of Missouri-Kansas City (UMKC), Kansas City, MO, MBA from Fairleigh Dickinson University, Madison, NJ and her BS Pharmacy from Rajiv Gandhi University of Health Sciences, Manipal, India.
Mr. Naidu is a pharmaceutical scientist with over 6 years of experience working for clinical CROs where he was responsible for review of clinical trial study protocols, review of clinical trial results, data preparation, and conducting hands-on data analysis using SAS and R. Research literature on proposed therapeutic moieties to unresolved scientific questions. He also has hands-on experience in bio analytical method development, method validation and bioanalysis of samples for BA/BE studies. He also has knowledge of conducting/managing clinical trials. Mr. Naidu obtained his M.Pharmacy (Pharmaceutical Technology) from Andhra University, India.
Manish Kumar Sharma, MS. Pharm (PhD) has 4 years of pharmaceutical industry and academia experience. As a regulatory officer at Mac-Chem products he gained scientific expertise in regulatory affairs responding to query submitted dossiers as per global regulatory requirement (5 US and 5 CEP filing). He has conducted hands-on data analysis, developed and applied PK, PBPK and PKPD models using WinNolin (Phoenix), NLME, Gastro-plus and Monolix software. He has also conducted in-vitro and in-vivo metabolism, pharmacokinetics and tissue distribution studies in support of small molecule drug discovery development, Bioanalytical method development and preclinical DMPK studies.
Mr. Sharma has authored/co-authored 17 publications, posters, and abstracts. He is working on defending his PhD thesis from National Institute of Pharmaceutical Education Research (NIPER), Gandhinagar. He got his M.S Pharmaceutical Analysis from Institute of pharmacy, Nirma University-Ahmedabad, and Bachelor of Pharmacy from Rajasthan University of Health Science Jaipur, Rajasthan, India.
Ramya Mahadevan, PharmD is a pharmaceutical scientist with a passion to learn drug development and apply mathematical learning tools to Clinical Pharmacology. She is proficient with multiple PK PKPD tools with Phoenix Winnonlin, PK SIM, Pharmaceutical Modeling and Simulation (PUMAS). Data packages like R. She has received certification from Uppsala monitoring center for “Signal detection and causality assessment” and “Statistical reasoning and algorithms in Pharmacovigilance”. Dr. Mahadevan has authored 6 posters, and abstracts. She received her PharmD from PSG College of Pharmacy, Coimbatore, India.
30+ Years Experience
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