1. Goodwin, Peter M.

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New cancer drugs (and therapeutics in all branches of medicine) could be brought to the market quicker-and made available more equitably-through significant improvements in procedure that were evolved, tried, and agreed during the pandemic of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). So said radiation oncologist Stephen Hahn, MD, who was the Food and Drug Administration (FDA) Commissioner from 2019 to 2021 and is now Chief Medical Officer of Flagship Pioneering (based in Cambridge, Mass.)-the company behind the Moderna vaccine for COVID-19.

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"The vaccine trials were about double the normal size for the average size of a vaccine trial for U.S. approval," said Hahn at the World Cancer Leaders' Summit, a multi-national talking shop for key cancer decision-makers from around a hundred nations, that was held virtually in October 2021 by the Geneva-based Union for International Cancer Control and hosted by the American Society for Clinical Pathology.

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Recruitment of large study cohorts of volunteers in COVID-19 vaccine studies was achieved "incredibly quickly" because of the urgency of the situation, said Hahn. But there were also other factors that brought vaccines successfully into clinical use in record-time that could help form a blueprint for future drug development and approval.


Hahn told Oncology Times that, prior to the pandemic, the FDA would typically have communicated with drug innovators by telling each research center to send in a complete data pack so this could go through FDA approval for a Phase I trial. On completion and analysis of the resulting Phase I data, the FDA would then take a month or so to consider giving approval for Phase II to go ahead. The whole sequential process, eventually culminating in Phase III studies, could be protracted.


Hahn said that, while he was at the FDA (during some of the most threatening phases of the pandemic), they had decided this needed to be changed to expedite approvals. It had needed to be a rolling collaborative approval process. "It had to be interactive," he said. "We called it interactive sponsor engagement, and could be thought of as a rolling review."


The FDA put systems in place to respond to initial applications speedily. "You have some data: Come to us, talk to us. We'll tell you how to do this in real time," was their approach, said Hahn. The new FDA method was able to accelerate approval for any new agent, he noted. "The lesson here is: Regardless of whether it's COVID vaccines, therapeutics, new cancer drugs, whatever: An interactive engagement with the sponsors was really a way that the agency could expedite the process."


Cancer Medicines

Hahn was optimistic that cancer medicine could soon benefit from innovations derived from the pandemic experience. "Cancer medicine is poised to accept this interactive process-[with] engagement, transparency, communication," he said.


But he made a plea for ever clearer transparency. "It's got to be two-sided. There has to be a willingness to share information. We have to protect confidential commercial information, but there has to be transparency about it. The agency-and sponsors-must absolutely have full transparency about why decisions were made. In the absence of that-if it's a black box-there'll be a lot of questions raised by outside folks, and it won't be completely understood why a good decision had been made," he stated.


Hahn supported the use of surrogate endpoints in cancer clinical research to help expedite new agent approval-despite disappointments historically when surrogates had in some instances eventually been found lacking in the face of longer studies with hard endpoints and real-world evidence. "In my opinion, this is always going to be a risk/benefit ratio and a balance. How much does accelerating innovation in a lethal disease work? That's something that society has to decide," he said.


When Hahn was asked about one of the main themes of the World Cancer Leaders' Summit-inequity of cancer treatment-globally and within nations-he was firmly convinced that the private sector could be mobilized to correct this. Medicines for HIV/AIDS are now universally available and free or affordable thanks to international agreements that also guaranteed drug companies good profitability through economies of scale and a vastly increased size of the market. Similar deals could be brokered internationally for cancer treatments, he said.


"What we need to do is to incent [sic] the private sector to do this. Engage those who are under-served in the development process. Because I truly believe-based on my experience with COVID vaccines and therapeutics-that when you engage early and often with groups that have been traditionally under-served, you build trust. You break down the barriers. It's no longer a black box, this clinical development (this experimenting on people). You actually have a conversation, you describe what goes on in the safeguards, you involve people in the clinical trials," Hahn noted.


Hahn also supported the Summit's call for an international collaborative effort to beat cancer just as has been shown necessary to fight COVID-19 (if, sadly, still falling short of this ideal at the time of the conference). He put his trust in business incentives as the mechanism to make sure there was expanded access to the under-served.


"I think there are very novel ways that we could-legislatively and otherwise-incent the private sector to ensure that happens," he said. There was a need to come together and make recommendations about how to bridge the divide between those that have access to cancer treatments of all kinds and those that don't, he noted.


"Let's engage the private sector, let's engage academia, let's engage the scientific community, and-most important-let's engage advocacy groups. And let's find out if we can have a solution."


Peter Goodwin is a contributing writer.