On June 28, 2022 Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the hiring of Jan M. Van Tornout, M.D., MSc., as chief medical officer, and Gordon Schooley, Ph.D., as chief regulatory officer (Press release, Elevar Therapeutics, JUN 28, 2022, View Source [SID1234616351]).
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Van Tornout, an accomplished hematologist-oncologist, genetic epidemiologist and pharma-biotech executive, joins Elevar after serving as acting chief medical officer of biotechnology company Tyme Technologies, Inc. since March 2021. He brings more than 25 years’ experience in the medical industry and related academia, including over 15 years successfully developing drugs across the full spectrum of hematological, oncological and immuno-oncological indications from pre-investigational new drug (IND) meeting through Phase 4.
"Jan Van Tornout’s broad experience and demonstrated leadership in every phase of the clinical development process, and his interest in the potential of drugs that address gaps in critical medical treatments, make him an ideal addition to the Elevar team," said Dr. Saeho Chong, chief executive officer of Elevar. "We are pleased to add him to our leadership team."
Van Tornout’s clinical management and development experience includes work for Moleculin Biotech, Inc., Bright Peak Therapeutics, Cyclacel Pharmaceuticals, GlaxoSmithKline, Puma Biotherapeutics, Maverick Therapeutics, ERT Inc., HUYA Bioscience Int’l, Gradalis Inc., Inovio Pharmaceuticals, Natera Inc., Bristol-Myers Squibb and Amgen. He played an instrumental role in two successful NDAs, led several INDs and has expertise in all phases of clinical trials.
Van Tornout previously held academic appointments at the University of Southern California (USC), with a clinical appointment as attending pediatric hematologist-oncologist at Children’s Hospital Los Angeles. He earned his Doctor of Medicine from the Katholieke Universiteit Leuven (KUL), Leuven, Belgium, a Master of Science in classical philosophy from KUL and a Bachelor of Science from the Faculté Notre-Dame de la Paix, Namur, Belgium. He obtained his certification as a pediatrician from the Gasthuisberg University Hospitals, KUL, and completed his training as a pediatric hematologist-oncologist at Children’s Hospital. Van Tornout earned a Master of Science in applied biometry from USC and completed a post-doctoral fellowship in molecular epidemiology at USC.
Schooley, a global regulatory leader with more than 30 years of drug development experience, joins Elevar after nine years as chief regulatory officer for BeyondSpring Pharmaceuticals Inc., a global, clinical-stage biopharmaceutical company that develops immuno-oncology cancer therapies.
"Careful navigation of the road to regulatory approval is so critical to the clinical development process and Gordon Schooley has demonstrated his leadership in this discipline throughout his distinguished career," said Chong. "His addition to the Elevar team adds valuable perspective with respect to both regulatory strategy and execution, and will bolster our efforts to fulfill the unmet needs of patients awaiting new therapeutic options."
Schooley has spent more than a quarter century at the vice president level or higher, working in both startup and large company environments. He’s led global development teams through every clinical development milestone; worked closely with regulatory bodies in several different countries; overseen successful breakthrough designations and accelerated approvals; and managed complex label negotiations for initial product approvals.
Prior to BeyondSpring, Schooley spent seven years as a consultant for drug development activities related to clinical development, biostatistics and regulatory affairs. He previously worked at SkyePharma PLC/Pacira Pharma, Alliance Pharmaceuticals and Allergan/Herbert Labs.
Schooley holds a doctorate in biostatistics from the University of Michigan School of Public Health. He earned a Master of Science in statistics and Bachelor of Science in business management at Brigham Young University.