1. Home
  2. About FDA
  3. FDA Organization
  4. Oncology Center of Excellence
  5. Project Orbis
  1. Oncology Center of Excellence

Project Orbis

A framework for concurrent submission and review of oncology products

Image
Project Orbis

The FDA Oncology Center of Excellence (OCE) initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners.

Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval. Pivotal clinical trials in oncology are commonly conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of cancer drugs for approval in the United States. Future drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials.

Since its inception, Project Orbis has received many oncology marketing applications and led to the approval of numerous oncology drugs for patients across the world. For more information, please refer to the Project Orbis approval report.

Learn more about Project Orbis

Dr. Angelo De Claro

Dr. Angelo de Claro is the Director of the FDA’s Oncology Center of Excellence (OCE), leading the center’s efforts to develop and execute an integrated regulatory approach that enhances the cross-center coordination of oncology product clinical review. OCE was established in 2017 to leverage the combined skills of the FDA’s regulatory scientists and reviewers with expertise in drugs, biologics, and devices to expedite the development of novel cancer products.

He began his government career with the FDA Office of Hematology and Oncology Products, Division of Hematology Products as a Medical Officer in 2010, was promoted to Medical Officer team leader in 2012, followed by promotion to Division Director in Office of Oncologic Diseases (OOD) in 2019. Since March 2025, he has held dual roles as Deputy Office Director for OOD and Deputy Center Director for the Oncology Center of Excellence.

Dr. de Claro has made significant contributions to programs across OCE and OOD. He has led OCE’s global clinical sciences program since 2019, including coordination for Project Orbis, an OCE program to facilitate the submission and review of oncology marketing applications across several partner regulatory agencies. He has provided leadership for the oncology cluster and bilateral meetings with Australia, Brazil, Canada, European Union, Israel, Japan, Singapore, Switzerland, and the United Kingdom. In addition, he was instrumental in the launch of the Real-Time Oncology Review (RTOR) program.

Dr. de Claro received his B.S. in Basic Medical Sciences (magna cum laude) and his M.D. (magna cum laude) from the University of the Philippines. He completed his internal medicine residency at Baylor College of Medicine in Houston, Texas and hematology-oncology fellowship at University of Washington in Seattle. He then joined the hematology-oncology faculty at University of Washington/Harborview Medical Center. He is an expert in his field and has published widely, with more than 60 peer reviewed articles.

Dianne Spillman

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 Hotaki

Lauren Tesh Hotaki is a Senior Health Scientist 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.

Ynghua Wang

Yinghua Wang is a Senior Health Scientist 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

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 shared information and oversees project implementation for international collaboration, Project Orbis, pharmacy student rotations, ODAC member, and travel.

Michael Gu

Michael Gu is a Senior Health Scientist in the OCE. Michael joined the FDA/Center for Tobacco Programs in March 2011, and joined the OCE in June 2025. Currently Michael manages Project Orbis applications, facilitates communication with our international regulatory counterparts, assists with OCE internal planning for advisory committee meetings, and manages other OCE projects.

Project Orbis Partners

The U.S Food and Drug Administration together with the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC) took part in the first Project Orbis collaborative review. Since then, other countries have joined and become Project Orbis Partners (POP).

Select News, Presentations and Publications

Frequently Asked Questions

Orbis Documents

Orbis Approvals

Additional Information

Contact Information

For additional questions please contact ProjectOrbis@fda.hhs.gov

 

Back to Top