Leadership

Vijay Ivaturi holds the positions of Co-Founder and CEO at Pumas-AI, Inc., as well as the Endowed Chair and Professor at the Centre for Pharmacometrics at Manipal University, India. Before assuming his current roles, he was a member of the faculty at the University of Maryland, Baltimore’s Center for Translational Medicine for a decade, subsequently transitioning to an Adjunct Faculty position.

With a steadfast commitment to the advancement of pharmacometrics, Vijay has been an active participant in the pharmacometrics community since the founding of the American Conference on Pharmacometrics (ACoP) in 2008. He has undertaken various responsibilities within the International Society of Pharmacometrics (ISoP) since 2014 and played a pivotal role as the chair of the education committee for several years before being appointed to the ISoP Board in 2020. He will serve as the President of ISoP for a 2 year term starting January 2024.

Trained as a clinical pharmacologist and pharmacometrician, Vijay has been instrumental in leading Project Pumas from its inception, passionately developing it into a revolutionary modeling and simulation platform since 2017. His research primarily focuses on the creation of innovative tools and methodologies to enhance drug development and clinical therapeutics.

Vijay completed his doctoral studies in Experimental and Clinical Pharmacology at the University of Minnesota, followed by a post-doctoral fellowship in Pharmacometrics at Uppsala University, Sweden. With over 15 years of experience in drug development, he has also contributed to key policy crafting projects as an ORISE research scholar at the US Food and Drug Administration (FDA).

Kevin Dykstra is Vice President, Clinical Pharmacology, Modeling and Simulation with Akebia Therapeutics. Before his current role, he spent over 20 years as a pharmacometric consultant. Most recently, he was VP of Consulting Services with Cognigen/Simulations Plus. He cofounded and led qPharmetra for over eight years as its CEO and President. Before that, he spent 10 years with Pharsight/Certara, starting as a Sr. Scientist and rising to Sr. Vice President of Strategic Consulting. He works with drug development teams to identify strategic questions in drug development and formulates quantitative modeling approaches to answer those questions. Particular interests include clinical utility, clinical trial simulation, and assessing probability of regulatory and market success in a variety of therapeutic areas. He received his PhD in Biochemical Engineering from the University of Michigan, and completed post-doctoral training in Bioengineering at the National Institutes of Health. His undergraduate training is in Chemical Engineering and German at the University of Colorado. He was elected to the ISoP Board of Trustees in 2020, serving as Treasurer 2022-2023, and continues as President Elect since January of 2024. He is a Fellow in Clinical Pharmacology with the American College of Clinical Pharmacology.

Dr. Cynthia J. (C.J.) Musante is Vice President of Scientific Research and Global Head of Pharmacometrics and Systems Pharmacology (PSP) within Translational Clinical Sciences at Pfizer. She received her Ph.D. in Applied Mathematics from North Carolina State University and has over twenty years of experience in model informed drug discovery and development (MIDD). At Pfizer, her group is responsible for developing and applying MIDD approaches across the portfolio to enhance the robustness and quality of decision-making at the program- and therapeutic strategy-level. CJ is an advocate for MIDD, both internally and externally. She is a frequent organizer and invited speaker at national and international conferences and is the Immediate Past President of the International Society of Pharmacometrics (ISoP). C.J. also served as the inaugural Chair of ISoP's first Special Interest Group (SIG), the Quantitative Systems Pharmacology (QSP) SIG, and as the Conference Chair for the 9th American Conference on Pharmacometrics (ACoP).

Dr. So Miyoshi is Head of Clinical Pharmacology and Bioanalytics at Pfizer R&D Japan. He has more than 20 years of experience in the application of quantitative clinical pharmacology and pharmacometrics for clinical development and new drug application work not only for Japan but also for the US, Europe, China, and Korea as a Global Clinical Pharmacology Lead and Pharmacometrician. Dr. Miyoshi received his PhD in Pharmaceutical Science from Kyushu University in 2008 after training at Pfizer UK and Uppsala University in pharmacometrics.

Dr. Miyoshi has organized sessions and been invited as a speaker at many regional and intranational conferences including the Population Approach Group in Japan, the Japanese Society of Clinical Pharmacology and Therapeutics, and Drug Information Association (DIA). He is Community Lead of Clinical Pharmacology, which was established in December 2021, in DIA Japan. Dr. Miyoshi served as Leader of Clinical Pharmacology Task Force in the Japan Pharmaceutical Manufacturers Association (JPMA) in 2015-2020. During the period, he collaborated with regulatory authorities and academia, making efforts to establish Japanese pharmacometrics guidelines. He is Topic Leader of ICH Expert WG for Drug-Drug Interaction (M12) as JPMA representative.

Dr. Miyoshi has been serving on the Board of Directors of the International Society of Pharmacometrics as an Asia representative since 2021 and will serve as Secretary for two years starting in 2024.

Dr. Hao Zhu is the director of the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center of Drug Evaluation and Research, U.S. Food and Drug Administration. Dr. Zhu received his Ph.D. in pharmaceutical sciences and Master in statistics from the University of Florida. He started his career in modeling and simulation teams in Johnson & Johnson and Bristol-Myers-Squibb. He joined FDA as a pharmacometrics reviewer more than 16 years ago. Dr. Zhu has been a clinical pharmacology team leader for more than 6 years and a QT-IRT scientific lead for 2 years. Then he became the deputy director at the Division of Pharmacometrics. His division reviews the pharmacometrics related submissions and supports pharmacometrics-related policy development. 

Amparo de la Peña is the VP of Pharmacometrics at Simulations Plus (SLP), Clinical Pharmacology and Pharmacometrics Business Unit. She earned her Bachelor of Chemistry and Pharmaceutical Chemist degrees from the University of the Republic, Uruguay, and a  Ph.D. in Pharmaceutics from the University of Florida, under Dr. Hartmut Derendorf.

Over the following 21 years, she accrued experience in the pharmaceutical industry at Eli Lilly and Company, both as a PK/PD scientist and as an Asset Manager. Amparo also has more than 10 years of consulting experience, starting at Chorus (Lilly) and now at SLP. Through those years, she led cross-functional teams in diverse therapeutic areas (e.g. diabetes, neuroscience, oncology, rare diseases, and COVID-19) to design, optimize, and implement integrated development plans. As a scientist, she has guided strategic pharmacometrics approaches to support global drug development from the early stages to regulatory approval and post-marketing.

During her career, she has been a member of scientific organizations such as ISOP, ACCP, ASCPT, and AAPS, and has volunteered for them as an abstract reviewer (AAPS), coordinating student awards (AAPS), by volunteering in committees, providing ideas for highlighting members and developing presentations to educate about the organization (ACCP), by submitting abstracts (PAGE) and organizing workshop proposals, teaching a workshop (ACoP) or chairing a symposium (ACoP, AAPS), and by reviewing manuscripts for peer-reviewed journals. She has also held memberships and given scientific presentations for therapeutic area organizations (e.g. ADA, EASD, ICAAC, ECCMID, and ISSX). 

She has published extensively in peer-reviewed journals in several languages, and presented at scientific conferences worldwide. One of her passions is to mentor and develop diverse people, and to foster inclusion. Besides work, her time is shared between my family and her involvement in scientific and community organizations as a volunteer, peer reviewer, or Board member.

Jeff (Jeffrey R.) Sachs, PhD is a Distinguished Scientist (Executive Director) in the Quantitative Pharmacology and Pharmacometrics Department (“QP2”) in Merck Research Laboratories, where he is responsible for modeling and simulation supporting vaccine program decisions from early discovery through late-stage clinical development.  His publication areas include methods for and applications of pharmacometrics, biotechnology, signal processing, and AI/ML.

Dr. Sachs received his Sc.B. and Sc.M in Applied Math from Brown University and his Ph.D. in Math at MIT where he worked with Alan Grodzinsky on the electromechanochemistry of articular cartilage, supporting design of a minimally-invasive arthroscopic diagnostic device. After postdoctoral appointments in Applied Physics (Tokyo Univ.), Biomedical Engineering (Northwestern Univ.), and Biotechnology (N.I.S.T.), he developed two successful biotechnology consulting businesses. He came to Merck in 1999 and initially worked on developing gene expression analysis, data mining, and SAR integration platforms.  He was lead inventor of Merck's proteomics and metabolomics technology platforms. He was then in charge of the therapeutic area-aligned modeling and simulation group, and led the design, implementation, and global deployment of a web-based tool providing a user-friendly, non-technical, modeling interface for internal and external decision makers. That tool, used in many therapeutic areas, helped gain recommendations for products in >40 countries. He was the department’s first lead for infectious diseases, oncology, and digital health/adherence strategy. He is QP2 Therapeutic Area Lead for vaccines.  He is on the Board of Directors for the International Society of Pharmacometrics (ISoP), active in editorial boards and committees for the Society for Industrial and Applied Mathematics (SIAM), and is a mentor for the Association for Women in Mathematics (AWM) and for the ISoP.