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                Oncology Center of Excellence

Oncology Center of Excellence

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          Project OrbisOncology Center of Excellence Project Orbis
  
  					A framework for concurrent submission and review of oncology products
	
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              Project OrbisThe 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

Meet the Team
	Dr. Angelo De Claro
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
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 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.

Ynghua Wang
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
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.

Project Orbis Partners
	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).

Australian Therapeutics Goods Administration (TGA)
	Brazil's National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária [ANVISA])
	Health Canada (HC)
	Israel Ministry of Health (IMoH) Pharmaceutical Administration
	Singapore Health Sciences Authority (HSA)
	Switzerland Swissmedic
	United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA)

Select News, Presentations and Publications
	Select News, Presentations and Publications

FDA Ground Rounds: Project Orbis by R. Angelo de Claro, MD
	FDA News Release: FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
	FDA News Release: Strengthening International Collaboration for Oncology Product Reviews, Faster Patient Access to Innovative Therapies
	Publication: Project Orbis: Collaborative Review Program

Frequently Asked Questions
	Frequently Asked Questions

Project Orbis FAQs
	Project Orbis Types

Orbis Documents
	Orbis Documents

Assessment Aid (AAid)

	Please contact the review division for most current template.
	Sponsor Authorization Letter (SAL) Template
	Instructions:
		FDA Component Contact Name: Office of Oncologic Disease Division Director
			Each agency should have a separate authorization and include the appropriate contacts from the respective agency.
			For the [insert description of purpose] section: this should be state “...the review by FDA and [ANVISA, HC, HSA, MHRA, IMoH, Swissmedic, TGA] of the [product established name] applications.”
			For the information to be shared section: this should state, “Any data or information regarding NDA/BLA/supplement xxxxxx”
	Global Submission Plan (GSP) Template
	General Agency Contacts
		Australian TGA:PMABinternationalevaluations@health.gov.au
			Brazil ANVISA: projectorbis@anvisa.gov.br
			Canada HC: collaboration@hc-sc.gc.ca
			Israel MoH: project_orbis@MOH.GOV.IL
			Singapore HSA: HSA_TP_Enquiry@hsa.gov.sg
			Switzerland Swiss Medic: ProjectOrbis@swissmedic.ch
			United Kingdom MHRA: Orbis-MHRA@mhra.gov.uk
			U.S. FDA: ProjectOrbis@fda.hhs.gov

Orbis Approvals
	Orbis Approvals

Project Orbis Approvals (as of November 1, 2023)
	Please note:
	This report will be updated quarterly.
		FDA approval dates do not necessarily reflect Project Orbis Partner (POP) approval dates.
		A product might be approved in a POP country through a different approval pathway and will not be listed here if it was not part of Project Orbis.
	POP Approval Websites
	Australia’s Therapeutic Goods Administration
		Australian Register of Therapeutic Goods
			Prescription medicines registration database
		Brazil's National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária [ANVISA])
		Medicines (Portuguese only; use Google Chrome to translate into English)
		Health Canada
		The Drug and Health Product Register
			Drug Product Database: Access the database
		Israel’s Ministry of Health (Pages below published monthly in Hebrew; use Google Chrome to translate into English)
		New Drugs
			New Or Updated Indications
			Israeli Drug Registry
		Singapore’s Health Sciences Authority
		Online Infosearch- Register of Therapeutic Products
		Swissmedic
		Initial approvals of NASs/BLAs
			Indication extensions are published in the monthly Swissmedic Journal (SMJ)
			Access Consortium work-sharing authorisations
			Swiss Database of Product Information for Professionals and Patients
			Swiss Public Assessment Reports for New Active Substances
		United Kingdom’s Medicines and Healthcare products Regulatory Agency
		Marketing authorisations
			Approved Products

Additional Information

FDA Oncology Center of Excellence
	Real-Time Oncology Review
	FDA: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority ReviewContact Information

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

                                                                                  Content current as of:
      11/01/2023
              
              
Regulated Product(s)
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						  OncologyOncology Center of Excellence

          
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