Since there are multiple counties involved with Project Orbis this may be a long-term goal.” “I would be happy to further discuss participation of China in Project Orbis.” However, he continued, “the sticking point is the confidential agreement that would need to be signed. The complexity of confidentiality agreement approvals may yet need more time to work out between China and the Project Orbis members. So this does pose some problems of bringing in new countries to the Project Orbis,” he said, without mentioning China. All the partners have to have confidentiality requirements with all of the partners. “We welcome new partners,” Pazdur said, “However, we do have limitations, and some of these are just financial and logistic applications. “The success of this program really is unparalleled as far as fostering communication between the regulatory agencies obtaining uniform, regulatory standards,” he said. “So we asked the pharmaceutical companies to have simultaneous submissions to countries that had this delay, and then we would work with these countries to review these applications in a relatively expeditious fashion.”Īs of the end of 2021, the Project Orbis network had been part of 75 FDA drug applications tied to cancer care 35% were aimed at new types of cancer-related molecules, and a total of 250 applications had been submitted globally across the eight partner countries, said Pazdur, who oversees Project Orbis in his capacity as director of the Oncology Center of Excellence at the FDA in Washington D.C. “Many times this delay was in the matter of months, but many times it was years that patients were delayed getting important cancer drugs,” he said. Richard Pazdur told the meeting organized by New York-headquartered Memorial Sloan Kettering Cancer Center, or MSK, and Guangzhou-based Chinese Thoracic Oncology Group, or CTONG, that member nations in Project Orbis sought progress by “asking pharmaceutical industries to do simultaneous submissions to countries where there was a significant delay” in new drug approvals. Bi made a mark there by regulatory reform on clinical trials data transparency and in 2017 led the Chinese agency to join the International Council for Harmonization, ushering a new regulatory environment in China adopting global standards. Today, in our thirtieth year of saving sight, ORBIS focuses on building greater global vision care by maximizing the impact of our time-tested interventions.His former agency - the China Food and Drug Administration – has been restructured as the National Medical Products Administration. Soon thereafter, ophthalmic telemedicine Cyber-Sight was created and integrated into ORBIS's program portfolio. This was followed by the establishment of long-term eye care capacity development programs in Asia and Africa starting 1999 and in the Latin America and Caribbean region in 2002. As ORBIS continued to grow over the years, specialized training programs and fellowships were introduced to offer additional skills-building opportunities to eye care professionals in developing nations. Represented by an expert international team of ophthalmologists, nurses, anesthesiologists and technicians, the plane has circled the globe each year, enabling the ORBIS team to transfer state-of-the-art eye care skills to medical professionals in developing nations. A technological wonder and an ambassador of goodwill, the ORBIS Flying Eye Hospital has been the world's only eye care training and treatment center housed on board an aircraft. Established in 1973 - ORBIS literally took flight in 1982, with the launch of its Flying Eye Hospital's first sight-saving mission to Panama.
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