Leadership

Sunny founded A2-Ai in January of 2023, a venture dedicated to technology-driven clinical pharmacology and pharmacometrics using modern efficiency tools and automation. Previously, she spent time at Sanofi-Aventis, Amgen, and Pfizer. She co-founded her previous business (Ann Arbor Pharmacometrics Group, “A2PG”) in 2007 after Pfizer's departure from its site in Ann Arbor, Michigan. With A2PG, she worked on hundreds of regulatory submissions for clients throughout its highly successful 15 years of PK/PD consulting, until her company was acquired. As a unique leader who is well-versed in both scientific and business aspects of the drug industry, she frequently helps clients proactively find alternative development pathways.

Sunny received her PhD in PK/PD under the supervision of Dr. Veng-Pedersen at University of Iowa, and also completed her MS in statistics from University of Iowa. Her previous education was at Seoul National University in Pharmacy (BS) with an MS in pharmaceutical analytical chemistry. She is passionate about seeking creative and pragmatic solutions for preclinical and clinical drug development problems using quantitative tools and clinical pharmacology paradigm, which has led to numerous successful MIDD cases.

As CTPO of A2-Ai, Devin works with clients to deliver end-to-end solutions that support quantitative decision-making. Devin specializes in bridging the unique characteristics of each client's IT structure with the needs of the scientific team. Some of his focuses for clients include providing strategies to migrate from existing tools to more modern cloud-based workflows, and building prototype tools and dashboards to solve business challenges. Before joining A2-Ai, Devin worked as a principal solutions engineer to help dozens of organizations ranging from the FDA to small biotech and device manufacturers to develop and implement data science solutions.

Devin received his B.S. in Biochemistry from the University of North Carolina, Chapel Hill, his Master of Toxicology from North Carolina State University, and his PhD in Pharmaceutical Sciences from the University of Maryland, Baltimore. His doctoral training focused on the application of quantitative methods and regulatory strategy to accelerate the development of pharmaceutical products. In addition, he served as an ORISE fellow at the FDA, working to improve the agency's capability to analyze large datasets across disease areas for regulatory policy and decision-making. He then spent time consulting across many of the top 10 pharma companies on how to adopt novel data analysis toolchains, before joining Metrum Research Group, where he grew a new Technology Solutions group from the ground up. He led the development of a validated high-performance compute platform, designed novel analytics tools, handled data management and governance, and grew a technical consulting arm targeting various stages of the drug development lifecycle from genomic analysis through manufacturing quality assurance. Devin is a world-leading expert in the use of R and Python in controlled and validated environments. He has trained hundreds of scientists on how to do rigorous data science and has successfully guided dozens of organizations looking to adopt open-source data science tooling.

Yazdi joined A2-Ai after 25+ years at Pfizer, where he led development of investigational drugs across oncology, virology, and ophthalmology, leading to successful NDA submissions and drug approvals from various regulatory health authorities, including the FDA, EMA, and agencies across Europe, America, and Asia. In addition to his considerable tenure in the private sector, Yazdi is heavily involved in the academic pharmaceutical community, serving as an Assistant Clinical Professor at the UCSD Skaggs School of Pharmacy since 2005 and having published over 50 peer-reviewed articles. As Senior Executive VP of Clinical Pharmacology, Yazdi draws on his extensive knowledge of both the commercial and theoretical sides of drug development to help clients plan strategically throughout the drug development process.

Linh Nguyen, joining as Senior Vice President of Clinical Pharmacology, is a highly accomplished expert with over 23 years in pharmaceutical research and development. With a background in clinical pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), and drug metabolism and pharmacokinetics (DMPK), she has led significant advances in small- and large-molecule therapies across oncology, neuroscience, and inflammation. Linh's career includes pivotal roles at Treadwell Therapeutics, Arcus Biosciences, Exelixis, Pfizer, and Amgen. Her contributions to regulatory filings and her extensive publication record in clinical pharmacology and DMPK underscore her deep expertise and impact in the field. Linh holds a Ph.D. in Pharmaceutical Sciences from SUNY Buffalo.

Hongmei is a seasoned leader in clinical pharmacology, pharmacometrics, and DMPK, with a proven track record of delivering efficient clinical pharmacology and DMPK programs that fully meet regulatory requirements. She brings over 15 years of experience in drug development, spanning discovery, clinical development, and commercialization/post-marketing, across diverse therapeutic areas and modalities, including small molecules, peptides, and antibody-drug conjugates (ADCs). Hongmei has led multiple successful submissions across major health authorities, including the FDA, EMA, PMDA, Health Canada, and TGA. A leader in the field, her work has been published in over 40 peer-reviewed articles and presented at national conferences.

With over 20 years of DMPK and clinical pharmacology experience in big pharma, biotech and at FDA, George brings a unique combination of drug development expertise and regulatory insight in clinical pharmacology to A2-Ai. He is a member of AAPS, AACR, and ASCPT, has co-authored over 20 peer-reviewed articles. As SVP of Clin Pharm, George emphasizes data-driven development decisions and optimal development strategies while working with clients to advance drug development.

Dr. Jack Cook joined A2-Ai in June of 2023 as a Senior Vice President of Clinical Pharmacology. Previously, he spent 33 years at Pfizer, where he worked in a multitude of therapeutic areas. He holds adjunct faculty positions at the University of Michigan and Florida College of Pharmacy.

Dr. Cook received BS degrees in Applied Mathematics and Pharmacy from Ferris State College, and his PhD in Pharmaceutics from the University of Michigan. He is a fellow of the AAPS, has authored/co-authored over 80 peer-reviewed publications, and also served as an industrial representative for the US Food and Drug Administration's Pharmaceutical Science and Clinical Pharmacology Advisory Committees from 2012 to 2019. His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in drug development.

Rosa brings over 20 years of leadership in clinical pharmacology, DMPK, and bioanalysis across both early- and late-stage drug development. Her strategic oversight has supported multiple regulatory approvals, including Ingrezza, Orilissa, Ongentys, and Crenessity, and she played a pivotal role in advancing Paltusotine toward its anticipated U.S. and EU approvals. Rosa has led cross-functional teams spanning clinical pharmacology, pharmacometrics, and biomarker analysis, and has extensive experience designing and executing complex clinical pharmacology and early development studies in multiple therapeutic areas. Her work has shaped global regulatory submissions and interactions, and she is recognized for her forward-thinking, phase-appropriate strategies that integrate science, compliance, and innovation.

Emily is the VP of Pharmacometrics at A2-Ai, where she leads a team of scientists that supports industry clients at all stages of the drug development process. She has an extensive background in pharmacometrics and a passion for improving drug development processes and patient outcomes through modeling and simulation. By fostering collaboration with industry partners and regulatory agencies, she aims to shape the future of pharmacometrics and contribute to the development of safe and effective therapies.

Prior to her current position, Emily was a Senior Director of Pharmacometrics at Ann Arbor Pharmacometrics Group (acquired by Amador Bioscience). She holds a PhD in Pharmaceutical Sciences from the University of Michigan, where she has also taught pharmacometrics courses as an adjunct assistant professor.

Thuy excels in model-informed drug development, leveraging her keen understanding of clinical pharmacology and implementation of predictive models to guide strategic decision-making. With over 17 years of experience in pharmacometrics and clinical pharmacology and over 5 years in clinical research, Thuy has overseen the development of novel compounds across early and late phases and life cycle management, spanning diverse therapeutic areas. A member of ISoP, ASCPT, and Rho Chi Pharmacy Honor Society and author of 15 peer-reviewed publications, Thuy is an active member of the academic pharmaceutical community.

Ryan, VP of Pharmacometrics, brings over a decade of experience across clinical pharmacy practice and pharmacometrics, with extensive hands-on and leadership experience across modeling methods (PopPK, PK/PD, ER, c-QTc, Disease Progression, Translational), modalities (small molecules, mAbs, peptides, ADCs, oligonucleotides, etc.), and therapeutic areas. Ryan is passionate about building fit-for-purpose tooling, training, analysis workflows, and reporting to provide quantitative and timely insights to clients across all phases of development, from IND-enabling non-clinical studies through registrational clinical development programs.

Jeff brings extensive industry expertise to A2-Ai, with over 20 years of experience in DMPK in biotech and big pharma. Jeffrey is an expert in PK study design, analysis, and modeling, and has a proven track record of collaborating across teams to foster data-driven decision-making and accelerate drug candidates from discovery through clinical development.

Sergey is a seasoned technology leader with over 20 years of experience in the design, operation, and implementation of secure technical products and platforms across the enterprise, life sciences, and technology sectors. He brings deep expertise in infrastructure and systems architecture, cloud services, and security, and pairs strategic thinking with a hands-on, customer-first approach. With a strong track record of leading technical teams, onboarding clients, and managing technology through its full lifecycle, Sergey delivers secure, resilient, and scalable solutions that drive the success of internal and external customers.

Gordon brings over 30 years of experience in drug development to A2-Ai. Having led a diverse array of projects, spanning discovery to development, across varied therapeutic areas, Gordon has cultivated comprehensive expertise across the pharmaceutical sciences. In his capacity at A2-Ai, Gordon is known for bringing a broad perspective on drug development, grounded in a long career of real-world experience.