Suliman Al-Fayoumi, Ph.D., M.B.A
We sat down with Nuventra’s new Senior Consultant of Clinical Pharmacology, Suliman Al-Fayoumi, Ph.D., M.B.A., to learn more about his career path into drug development consulting, his predictions and insights for the future of drug development amidst the COVID-19 pandemic, and more.
Suliman has over 20 years of experience in regulatory science and the pharmaceutical industry. He has experience in clinical pharmacology, biopharmaceutics, pharmacology, toxicology, and translational sciences. Suliman spent 8 years as a Senior Reviewer at the FDA. He also spent over 4 years at Novartis Pharma and 8 years at two small biotech companies. He has extensive experience in designing, executing and overseeing nonclinical and clinical pharmacology study protocols, reports, and programs. He has supported several regulatory submissions in his role as a consultant and has extensive experience interacting with key regulatory authorities.
Brandon Burch, Ph.D.
We sat down with Nuventra’s Associate Director of Scientific Writing and Regulatory Affairs, Brandon Burch, Ph.D., to learn more about his career path into drug development consulting, advice for new scientists, insight into what often gets overlooked by sponsors, and more.
Brandon currently oversees Nuventra’s regulatory affairs and medical writing department. Brandon has participated in numerous IND, NDA, and BLA submissions across a multitude of drug classes, routes of administration, and therapeutic areas. His experience includes overall regulatory strategy, client representation at FDA meetings, on-site assessments, and gap analyses for client development programs. He has also authored clinical, non-clinical, quality, and administrative modules of regulatory submissions, and has authored a diverse array of other regulatory, scientific, and technical documents.
Venkateswari (Eswari) Muthukrishnan, Ph.D.
We sat down with Venkateswari (Eswari) Muthukrishnan, Ph.D., to learn more about her life as a consultant, her advice for how non-clinical studies can support clinical development, and her predictions on how COVID-19 will impact the future of drug development.
Eswari has 19 years of broad experience in various stages of drug development with a focus in DMPK, PK/PD modeling and simulations, IVIVC model development, and clinical pharmacology. She has contributed to 2 approved drugs and to 2 clinical development programs entering Phase 3 studies. She has authored several PK/TK (GLP) study reports for first-in-class INDs and has contributed to nonclinical and clinical sections of various international regulatory submissions. She also has extensive experience as a trainer for PK/PD modeling software.
Mark Sale, M.D.
We sat down with Mark Sale, M.D., to learn more about his experiences in drug development, favorite projects he’s worked on, and his advice for new scientists.
Mark received his MD from The Ohio State University and an MA in Biostatistics from Georgetown University. In addition to earning his two graduate degrees, he completed a Fellowship in Clinical Pharmacology at Stanford University and became an Assistant Professor of Medicine and Pharmacology at Georgetown University. In 1998, Mark joined GlaxoSmithKline and rose to the level of Global Director of Research Modeling and Simulation. In 2006, he started an independent consultancy in population PK, modeling, and simulation. Mark has extensive experience conducting complex population PK analyses across diverse therapeutic areas and is one of the pharmaceutical industry’s thought leaders in modeling and simulation.
Devin Welty, Ph.D.
We sat down with Devin Welty, Ph.D., to learn more about his predicted changes in drug development, favorite projects and therapeutic areas he’s worked on, and his advice for new scientists.
Devin has more than 25 years of experience in preclinical and clinical pharmacology. He has extensive experience leading organizations and project teams from early discovery to approval and commercialization. Most recently, he served as the Global Head of DMPK for Shire. He has supported the successful submission of dozens of INDs, CTAs, NDAs, MAAs, and BLAs for molecules, biologics, and gene therapy therapeutics. He has extensive experience in pharmacokinetics, pharmacodynamics, systems pharmacology, and adopting model-informed approaches for candidate nomination and efficient clinical pharmacology strategy.
Jessie Zhou, Ph.D.
We sat down with Jessie Zhou, Ph.D., to learn more about her predicted changes in drug development, her advice for a brand new pharmacometrician, and her favorite project she’s worked on at Nuventra.
Jessie has more than 6 years of professional experience in clinical pharmacology, pharmacokinetics, and pharmacometrics. Her expertise includes designing, analyzing, and interpreting clinical PK studies and developing clinical pharmacology strategic plans. She also has experience in conducting population PK and PK/PD analyses, authoring NDA sections and addressing responses to regulatory agencies. Jessie received her PhD in Experimental Clinical Pharmacology from the University of Minnesota Twin Cities. Before that, she received her Master of Science in Biomedical Engineering in Shanghai, China
Betty Hussey, Pharm.D.
We sat down with Betty Hussey, Pharm.D., to learn more about her drug development experience, discuss her advice for new scientists, favorite projects, & life as a consultant.
Betty has over 30 years of extensive leadership and experience in clinical development, clinical pharmacology, and pharmacokinetics. Her work spans across many therapeutic areas and she has worked in all phases of development—from candidate selection to post-marketing commitments. Betty spent most of her career at GSK, where she held various management and team leadership roles including early development lead for a number of assets. Prior to joining Nuventra, she worked at Brickell Biotech as VP of Product Development. In her career, she has worked on numerous INDs, first-in-human trials and about a dozen approved drugs.
Mark Bush, Ph.D.
We sat down with Mark Bush, Ph.D., to learn more about his experience in drug development, favorite projects he’s worked on, and some of his thoughts about upcoming changes in drug development.
Mark is Nuventra’s Vice President of Clinical Pharmacology & Pharmacokinetics. Dr. Bush has more than 20 years of experience in clinical pharmacology with a focus on study design and interpretation, as well as modeling and simulation. He received his Ph.D. in Pharmacokinetics from UNC-Chapel Hill. He previously served as Director of Clinical PK for GlaxoSmithKline and he also spent 3 years as an Assistant Professor of Pharmacy for Wingate University School of Pharmacy.
More interviews coming soon…