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5 Questions with Nuventra’s Consultants

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.

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Brandon Burch, Ph.D.

Brandon Burch

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.

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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.

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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.

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Venkateswari (Eswari) Muthukrishnan, Ph.D.

We sat down with 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.

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Mary Barecki-Roach

We sat down with Mary Barecki-Roach, Nuventra’s Vice President of Quality Assurance to learn more about her career path into quality assurance, her predictions on major drug development changes in the next couple decades, and more.

Mary has more than 23 years of experience in the GLP-regulated pharmaceutical industry and 7 years of experience under GCP regulations. She has extensive experience in QC and QA as well as pre-clinical DMPK, nonclinical and clinical PK data analysis and interpretation, and report writing. At Nuventra, her main focuses are managing the QA unit, staying abreast of regulatory requirements, and maintaining compliance with the regulations, training, SOP development, and software validation activities.

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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 M.D. 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.

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Deborah (Debby) Ann Smith, Pharm.D.

We sat down with Debby Smith, Pharm.D., one of Nuventra’s senior consultants of pharmacokinetics and clinical pharmacology to learn more about her career path into clinical pharmacology consulting, what therapeutic areas she is passionate about, advice for new scientists, and more.

Debby has more than 30 years of leadership and experience in clinical development, clinical pharmacology and pharmacokinetics for small and large compounds from candidate selection through registration and beyond. Debby spent the majority of her career working in clinical pharmacology at GlaxoSmithKline, and prior to that worked at Glaxo Wellcome, Burroughs Wellcome, and SmithKline Beecham Corporation. Her therapeutic experience includes 20 years in oncology with a focus on cytotoxic and single transduction small molecules and immunotherapies.

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Bill Wargin, Ph.D.

We sat down with one of Nuventra’s co-founders, Bill Wargin, Ph.D., to learn more about his experience, favorite projects he’s worked on, and how drug development has changed during his career.

Bill has more than 30 years of experience working in clinical pharmacology, pharmacokinetics, biopharmaceutics, and scientific writing. In his career, Bill worked on over 20 approved drugs and authored or co-authored over 30 journal articles in pharmacokinetics and biopharmaceutics. Before he became a consultant in 2001, he served as an International Director at Glaxo Wellcome in Research Triangle Park (RTP). While Bill has improved patient health by bringing numerous drugs to market in the course of his career, his mentorship to the many scientists he has worked with has expanded his impact and scope of influence in the pharmaceutical development world.

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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.

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Jessie Zhou, Ph.D.

Jessie Zhou

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 Ph.D. 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

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More interviews coming soon…