In 2019, FDA’s OCE initiated Project Orbis to provide a framework for concurrent submission and review of oncology drug products. Project Orbis Partners will provide an update on their recent collaboration and answer questions from the audience.
Learning Objectives
Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative; Explain how sponsors can benefit from participating in Project Orbis.
Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
Senior Medical Officer - Oncology and Malignant Haematology Clinical Evaluation, Therapeutics Goods Administration, Australia
Dr. Sarah Golding is dual qualified; both as a medical doctor and a biomedical scientist with honours in biochemistry and molecular biology. Her 12 years' experience at Australia's Therapeutic Goods Administration (TGA) include 9 years in the clinical review and approval of oncology... Read More →
Senior International Policy Advisor, OGPS, OC, FDA, United States
Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →
Head of the Pharmaceuticals Registration Department, Medical Technology, Health, Israel Ministry of Health, Israel
Head of the Pharmaceuticals Registration Department at the Medical Technologies, Health Innovation, Information, and Research Directorate, Israel Ministry of Health. In charge of several units evaluating non-clinical and clinical data as part of MA applications and post-approval variations... Read More →
Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada... Read More →
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
Associate Director, Global and Regulatory Outreach, OCE, FDA, United States
Dianne Spillman is the Associate Director for Global and Regulatory Outreach in the FDA's Oncology Center of Excellence (OCE). She holds a Bachelor of Science in Biology from Northeastern University, Boston, MA. Her government service spans over 30 years, with the majority in FDA... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
