Leadership

Meet our leadership team

ISoP is a 501©3 non-profit organization led by a volunteer Board of Trustees and managed by a professional staff. Meet our leadership and staff below. 

Board of Trustees

Vijay Ivaturi

President, 2024 - 2025

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

President-Elect

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.

C.J. Musante

Immediate Past President

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).

So Miyoshi

Secretary

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.

Wei Gao

Treasurer

Dr. Wei Gao is the Head of Clinical and Quantitative Pharmacology at Moderna, where she leads clinical pharmacology and quantitative pharmacology strategies across multiple therapeutic areas to advance the mRNA platform and therapeutic pipeline.

Before joining Moderna, Dr. Gao was the Global Head of Pharmacometrics and Oncology Portfolio Section Head in Quantitative Pharmacology at EMD Serono. In this role, she was responsible for shaping pharmacometrics strategies across the portfolio and driving clinical pharmacology strategies in immuno-oncology and targeted therapeutics, including antibody-drug conjugates (ADCs) and bispecifics.

Earlier in her career, Dr. Gao held key leadership roles, including serving as the Neuroscience Therapeutic Area Head and Pharmacometrics Group Director within the Department of Quantitative Pharmacology & Pharmacometrics at Merck Research Laboratories.

Dr. Gao’s dedication to advancing the field of quantitative clinical pharmacology is evident in her impactful contributions, both individually and collaboratively, as well as her leadership in scientific societies. She has published 33 peer-reviewed journal articles and presented over 80 conference abstracts. Notably, she served as the Chair for the ACoP 2024 conference and currently serves as a Board of Trustees member for the International Society of Pharmacometrics.

Dr. Gao earned her PhD from the State University of New York at Buffalo, where she focused on disease progression modeling and mechanistic PK/PD modeling of Type 2 Diabetes under the mentorship of Dr. William Jusko.

Anja Henningsson

Trustee

Anja Henningsson started her journey in Pharmacometrics at Uppsala University with a Ph.D. in Population PK and PKPD modeling in oncology in 2005. She continued gaining experience from model-informed drug development by doing regulatory reviews in multiple therapeutic areas at the Medical Products Agency, working as a Pharmacometrician within the Pharma Industry and as a Consultant in Pharmacometrics and Clinical Pharmacology at qPharmetra for the past 10 years. Anja also has extensive experience in management. She joined the executive management team of qPharmetra in 2018, and since 2020, Anja has been the Chief Executive Officer. Anja has been on the ISoP board since 2022.

Bernd Meibohm

Trustee

Bernd Meibohm, Ph.D. is a UTHSC Distinguished Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the College of Pharmacy, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.  He also serves as Chair of the University of Tennessee Department of Pharmaceutical Sciences and holds the Harriet S. Van Fleet Endowed Professorship in Pharmaceutics.

Dr. Meibohm received his pharmacy degree and doctorate in pharmaceutics from Technical University Carolo-Wilhelmina, Braunschweig, Germany. After completion of a clinical pharmacology research fellowship at the University of Florida in 1997, he joined the faculty of the University of South Carolina, and in 1999 the University of Tennessee. 

Dr. Meibohm’s scientific interests include bacterial and viral infectious diseases, pediatric pharmacotherapy, and the application of quantitative modeling and simulation techniques in preclinical and clinical drug development, with specific focus on therapeutic proteins.  His research has resulted in over 210 scientific papers and book chapters (>12,000 citations; h-index 53), three textbooks, 200 abstracts, and over 240 invited scientific presentations to national and international audiences.

Dr. Meibohm is a Fellow of the American Association of Pharmaceutical Scientists (AAPS) and the American College of Clinical Pharmacology (ACCP). He was the President of ACCP 2014-2016 and served on its Board of Regents 2008-2018. He also served as 2010 Chair for the ‘Pharmacokinetics, Pharmacodynamics and Drug Metabolism’ section of AAPS, as 2016-2019 Member-at-Large on the Board of Directors of AAPS, and currently as Member of the Board of Trustees of the International Society of Pharmacometrics (ISoP).

Pavan Vaddady

Trustee

Pavan Vaddady currently serves as an Executive Director, Quantitative Pharmacology & Pharmacometrics - Immuno/Oncology at Merck & Co., Inc. During his career, he led several early and late-stage development programs across multiple therapeutic areas both as a clinical pharmacologist and a pharmacometrician and applied model informed approaches to impact key drug discovery and development decisions. Prior to his current role, he was the Head of Advanced Pharmacometrics, Quantitative Clinical Pharmacology at Daiichi Sankyo, Inc., where he led a global team of scientists working on pharmacometrics deliverables for submissions along with advanced modeling projects involving multiple oncology assets. Pavan is passionate about teaching and mentoring colleagues and currently holds the positions of Adjunct Professor at the University of Tennessee Health Science Center and Member of the Board of Trustees at the International Society of Pharmacometrics (ISoP). His hobbies include professional photography, primarily for non-profit organizations, recording music, and playing guitar for their newly formed indo-progressive rock band!   

Hao Zhu

Trustee

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

Trustee

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 Sachs

Trustee

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.

Jennifer Monroy

Executive Director

Jennifer Pastore Monroy, CAE joined ISoP in 2023 with 15+ years of non-profit experience. Jenn is a lover of education and is dedicated to continuing professional development. She holds a Bachelor of Arts in History and Spanish Language from American University and a Masters in City and Regional Planning from Rutgers University. In 2019, she earned the Certified Association Executive designation demonstrating her commitment to continuing professional development and excellence. Today, she continues to explore learning in areas of organizational leadership, data science, and futures studies.

Jennifer Redmond

Senior Manager

Jennifer Redmond joined the ISoP staff as Senior Association Manager in January 2024. She has worked in the association industry for the past six years. Prior to joining ISoP, Jenn worked for an association management company as an executive director for a nursing association and a certification organization. She was responsible for board management, strategy, certification management, and operations. Jenn graduated from Penn West Edinboro University with a B.A. in Speech Communications with a focus in Public Relations.

Damien Salamacha

Associate

Damien Salamacha is the Technology & Marketing Associate for ISoP. Damien is a Certified Digital Marketing Professional through the Digital Marketing Institute and holds an AMA Professional Certified Marketer PCM in Digital Marketing certificate through the American Marketing Association.

Barbara Mock

Meeting Planner

Barbara Mock is the President and Founder of BJM Events, the company which oversees the planning and execution of the American Conference on Pharmacometrics (ACoP). With over 25 years of experience, she has proven expertise in event planning by providing insights on meeting logistics and creative services for companies in the healthcare, pharmaceutical and consumer industries. During her career, Barbara has worked with marquee brands including: Kohler, Novartis Consumer Health, International Society of Pharmacometrics, inVentiv Health, Monster.com, Novo Nordisk, Biovail, Johnson Controls, Revlon, Thermo Fisher Scientific, Linotype, Molnlycke Health Care, Merck, and Boehringer Ingelheim.


Professional Management Associates, Inc. 

ISoP is managed by Professional Management Associates, LLC, a full-service, AMC Institute accredited, association management company providing services to state, national and worldwide professional societies, membership organizations, trade associations, foundations and business networks. As an accredited association management company, we exceed the requirements by the Institute which include a strong commitment to quality, as well as professionalism and best practices through evaluating and improving internal operating procedures and service delivery methods to our clients.