Project Orbis
R. Angelo de Claro is a hematology-oncology physician and currently the Associate Director (Acting) for Global Clinical Sciences with the Oncology Center of Excellence. In this role, he leads OCE efforts to advance cancer drug development and regulatory science across the globe, including direction of Project Orbis. Dr. de Claro is also the Division Director for the Division of Hematologic Malignancies I in the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA.
Dianne Spillman is the Associate Director for Global Regulatory Outreach in the Oncology Center of Excellence. She holds a Bachelor of Science in Biology from Northeastern University, Boston, MA. Her government career spans 30 years, with 27 of those years with FDA oncology Divisions and Offices. Dianne started in 1990 as a research assistant with the Veterinary Research Program at the National Center for Research Resources, National Institutes of Health. In 1993, she joined the FDA/CDER Division of Oncology and Pulmonary Drug Products as a project manager. Between 2002-2005, she served as Special Assistant to Dr. Richard Pazdur, then the Director of the Division of Oncology Drug Products. From late 2005-early 2019, she was the Lead Project Manager for the Oncology Program in the Office of Hematology and Oncology Products. Currently, Dianne facilitates OCE interactions with foreign regulatory counterparts and was instrumental in the first international collaborative review between Australia, Canada, and the US under Project Orbis.
Lauren Tesh Hotaki is a Senior Regulatory Health Project Manager in the OCE. She holds a Doctor of Pharmacy degree from The Philadelphia College of Pharmacy, Philadelphia, PA, and board certification in Pharmacotherapy (2012) and Infectious Diseases from the Board of Pharmacy Specialties. Lauren has been in government service since high school as an intern at the Center for Veterans Enterprise, an agency of the Department of Veteran Affairs (VA) and as a pharmacy technician during pharmacy school at the Washington, DC VA Medical Center. Prior to FDA, Lauren was an Assistant Professor of Pharmacy Practice at the South College School of Pharmacy in Knoxville, TN, and completed two years of post-graduate pharmacy training in infectious diseases at Lee Health in Fort Myers, FL. She resumed her government career in 2014 as the Designated Federal Officer for the Oncologic Drugs and Antimicrobial Drugs Advisory Committees at the FDA. She joined OCE and the Project Orbis team in 2020. Currently, Lauren manages applications with foreign regulatory counterparts under Project Orbis, facilitates international communication and assists with OCE internal planning for advisory committee meetings.
Yinghua Wang is a Senior Regulatory Health Project Manager in the OCE. She holds a Doctor of Pharmacy degree from University of Maryland Baltimore School of Pharmacy, a Master of Public Health degree from Johns Hopkins University Bloomberg School of Public Health, and Regulatory Affair Certification. Prior to joining the FDA, Yinghua was the Managing Editor for a drug information database at Thomson Reuters. Yinghua started at FDA’s Center for Drug Evaluation and Research in 2008, first in the Office of Surveillance and Epidemiology as a safety evaluator, then in the Division of Advisory Committee and Consultant Management as a Conflict-of-Interest analyst, Designated Federal Officer, and Branch Chief of Advisory Committee Management. She joined the OCE International team in January 2021, managing Project Orbis applications and facilitating communication with our international regulatory counterparts.
Tina MacAulay is a Regulatory Information Specialist in the OCE. Tina joined the FDA/CDER in 2017 as a Project Specialist, Project Management and Analysis Staff servicing the Division of Hematology, Oncology Toxicology Products and Division of Pharm/Tox of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine. Currently within OCE, Tina manages tracking and correspondence of all Orbis applications with foreign regulatory counterparts.
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