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Towards a Real World Data - Informed Drug Development and Disease Control Programs

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Contributors

  • Christina Mack, PhD, MSPH, FISPE

    Christina Mack is VP of Epidemiology and Clinical Evidence at IQVIA and Adjunct Associate Professor at UNC Chapel Hill. Mack’s work has been widely published in top journals including CDC’s MMWR, JAMA Internal Medicine, Annals of Internal Medicine and AJSM on topics covering sports medicine, medical product effectiveness, infectious disease, and research methods. She frequently advises organizations such as FDA, CDC, the NFL, NBA, International Olympic Committee and biopharmaceutical companies on data science, global health, injury surveillance, and disease prevention. Dr. Mack co-chairs the Scientific Oversight Committee for FDA Medical Device EpiNet and the RAPID Safety Signal Discernment and Biostatistics workgroup, is a Fellow of the International Society for Pharmacoepidemiolog and serves on the Advisory Board of the Carolina Health Informatics Program, Nutrimedy, a next-gen clinical nutrician company, and the ISPE Real-World Evidence task force. Featured in media by the New York Times, Wall Street Journal, and Forbes among others, she was dubbed a Top 20 Influencer in the 2020 NFL Season by NBC Sports, and referred to as the COVID-19 “SWAT Epidemiologist” by the Washington Post. Dr. Mack has been recognized by the Healthcare Business Woman’s Association for leadership and innovation, is a frequently invited speaker on careers in science and technology, and a mentor for the World Economic Forum Global Shapers “Transformative Role of Women and Girls” initiative.

  • LCDR Kenneth Quinto M.D., M.P.H.

    LCDR Quinto is the Senior Medical Advisor in the Real World Evidence Analytics Staff in the Office of Medical Policy at FDA’s Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, evaluates real world evidence use cases, and contributes to medical policy development mandated by the 21st Century Cures Act. LCDR Quinto has held various positions at different U.S. Department of Health and Human Services’ agencies including as a medical officer at FDA’s Office of Pediatric Therapeutics, a medical officer/claims analyst at the Centers for Medicare and Medicaid Services, an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention’s National Center for Health Statistics while providing medical expertise in epidemiology, pediatrics, allergy and immunology, and analytical support. In 2012, LCDR Quinto was commissioned in the U.S. Public Health Service and holds the rank of lieutenant commander. He completed his allergy and immunology fellowship and pediatric residency at the University of California, San Diego, earned his M.D. from the University of California, San Francisco, his M.P.H from University of California, Berkeley and his B.S. from the University of California, Los Angeles.

  • Sook Wah Yee, PhD

    My research project focuses on genetic determinants of antidiabetic drug response using electronic health records in a large population-based cohort and using genomewide genotyping data for association studies. In addition, my research also focuses on determining endogenous roles of membrane transporters through data from genomewide association studies and functional studies in cells. I collaborate with investigators at UCSF on several projects, this include using real-world data to predict transporter-mediated drug-drug interactions.

  • Chukwunonso Nwabufo, MSc. (Moderator)

    Chukwunonso is a PhD student in Pharmaceutical Sciences at the Leslie Dan Faculty of Pharmacy, University of Toronto. His doctoral research is focused on the improvement of the clinical efficacy and safety profile of drugs that are being repurposed for the treatment of COVID-19. He is also a Junior fellow at Massey College. Prior to joining the University of Toronto, Chukwunonso worked for over 2 years as a Senior Research Associate at Gilead Sciences Alberta Canada. During his over four years’ experience in drug development across academia and the pharmaceutical industry, he contributed to the development of drugs for several indications including Parkinson’s disease, HIV, and COVID-19. In his tenure at Gilead Sciences, he contributed to the development of Remdesivir for the treatment of severe COVID-19, and a long-acting antiretroviral drug for HIV. He has received over 20 awards and recognitions culminating in over $100K in funding for research, academic, and leadership accomplishments.

    Chukwunonso is a leader in several scientific communities including severing as an Editorial board member and Guest Editor of Drug Metabolism Reviews, Section Editor of Journal of Applied Bioanalysis, Secretary for American Association of Pharmaceutical Scientists Pharmacokinetics, Pharmacodynamics, and Drug Metabolism community, and Reviewer for PLOS ONE. Chukwunonso has authored about 8 scientific manuscripts and 10 industry scientific papers in support of drug development programs. Chukwunonso has developed keen interest in advancing Canada’s Pharmaceutical sector and recently wrote an op-ed in the Hill Times proffering expert opinion on strategies that policymakers could adopt to improve the development of made-in-Canada therapeutics.

July 19, 2022
Tue 12:00 PM EDT

Duration 2H 0M

This live web event has ended.

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