U.S. Food and Drug Administration oncology chief Dr. Richard Pazdur.
U.S. and China health experts speaking at an online conference this month suggested that the two countries might be making progress toward an agreement to collaborate in the fight against cancer through multi-regional participation in clinical trials.
The discussions came after a summit between U.S. President Joe Biden and China President Xi Jinping in Indonesia in November in which the two leaders sought areas for potential improvement in a relationship strained by geopolitics and other differences.
Jingquan Bi, Executive Vice Chairman of China Center for International Economic Exchanges and a former commissioner of China Food and Drug Administration, expressed hope at the gathering held on Dec. 2 that the U.S. could help remove obstacles over a confidentiality agreement to pave the way for China’s participation in joining Project Orbis. Removing those obstacles would help to “promote simultaneous regulatory reviews between the two countries, and accelerate cancer drug approvals,” Bi said.
Project Orbis is an international program under the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence in which member countries agree to simultaneously review clinical trial data to shorten the time needed for cancer patients to gain access to new drugs and treatments. Eight countries – though not China — currently participate in Project Orbis, which was launched in 2019. The eight are the U.S. Canada, Australia, Switzerland, Brazil, Israel, Singapore and the UK. The FDA Oncology Center of Excellence is a signature accomplishment of President Biden’s White House Cancer Moonshot which first started in 2016. (See related post here.)
“I don’t think there are insurmountable difficulties in signing a confidentiality agreement between China and the U.S.,” said Bi, currently the executive vice chairman of the China Center for International Economic Exchanges in Beijing. “I hope the two sides can strengthen communication on this issue, and the drafting and signing of a confidentiality agreement,” he said.
Jingquan Bi is executive vice chairman of the China Center for International Economic Exchanges and … [+]
His former agency — the China Food and Drug Administration – has been restructured as the National Medical Products Administration. 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.
U.S. FDA oncology chief Dr. 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.
“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. “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.”
As 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.
“The success of this program really is unparalleled as far as fostering communication between the regulatory agencies obtaining uniform, regulatory standards,” he said.
“We welcome new partners,” Pazdur said, “However, we do have limitations, and some of these are just financial and logistic applications. All the partners have to have confidentiality requirements with all of the partners. So this does pose some problems of bringing in new countries to the Project Orbis,” he said, without mentioning China.
The complexity of confidentiality agreement approvals may yet need more time to work out between China and the Project Orbis members. “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. Since there are multiple counties involved with Project Orbis this may be a long-term goal.”
“A limited confidential agreement between our two countries on a specific application might be a way to jump-start China’s involvement,” he said in a follow-on email to Forbes.
One additional initiative to Project Orbis which could allow for China’s participation with other nations in the cancer fight could be a new effort launched by Pazdur’s center this year, “Project Pragmatica,” which aims to simplify clinical trials.
“One of the problems that I’ve noticed as far as being an oncologist for almost 40 years now is that our clinical trials have become increasingly and increasingly more complex,” Pazdur said. “There’s really a need sometimes to simplify clinical trials to attempt to use clinical trials which replicate what’s going on in the real world,” Pazdur said.
“China (has) already participated in multi-regional global trials so their participation in Project Pragmatica would entail the agreement of the pharmaceutical sponsor,” Pazdur wrote. “We would welcome China to participate in Project Pragmatica.”
Other event speakers lauded the effort to get China involved. More than 10 million people die annually from cancer; China and the U.S. rank No. 1 and No. 2 in the number of cancer patients and overall cancer burden.
“Collaboration in the fight against cancer represents an important opening for the U.S. and China to re-energize their relationship following the summit last month between U.S. President Joe Biden and China President Xi Jinping at the G20 gathering in Bali,” Asia Society CEO and former Australian Prime Minster Kevin Rudd told the online gathering.
“If we get this one right on cancer, it’s going to add this whole new positive dynamic to the overall framework of the U.S.-China relationship, which both presidents have signaled only last month needs to be re-energized,” he said. (See earlier post here.)
U.S. President Joe Biden, right, stands with Chinese President Xi Jinping before a meeting on the … [+]
Other speakers included Bob Li, physician ambassador to China and Asia-Pacific at MSK, Yi-Long Wu, president of CTONG, and Jing Qian, the founding managing director of the Center for China Analysis at the Asia Society Policy Institute in New York.
The event, viewed online by an audience of more than 20,000 in China, included discussion of international clinical trials with liquid biopsies, biomarker technology, and treatment of lung cancer.
See related posts:
Joint Fight Against Cancer Can Help Re-Energize U.S.-China Ties, Kevin Rudd Says
Meet The Scientist Leading Coordinating President Biden’s New Cancer Moonshot
“Why Is Cancer Less Important To Cure Faster Than Covid?”: Cancer Moonshot Pathways
Social Justice, Outreach, Global Collaboration: Cancer Moonshot Pathways
Break Through Barriers To Drive Progress: Cancer Moonshot Pathways
U.S. Food and Drug Administration oncology chief Dr. Richard Pazdur.