Global Health Crisis Provides Learning Opportunities Moving Forward

Despite ongoing challenges following the COVID-19 pandemic, there is a lot of optimism about the future of drug research.

In the discussion: “Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It,” held at the 14th Annual Summit for Clinical Ops Executives (SCOPE) meeting in Orlando, members of a panel noted the challenges imposed on clinical trials because of the COVID-10 pandemic. The panel, moderated by Balazs Flink, senior director of clinical development operations at Daiichi Sankyo, included:
Gaurav Sawhney, VP, head, clinical partner management, Takeda Pharmaceuticals Inc.; Deborah Profit, PhD, VP of clinical management & applied innovation, Otsuka America Pharmaceutical, Inc.; Ken Getz, MBA, founder of CISCRP; deputy director of the Center for the Study of Drug Development, Tufts University School of Medicine, and Bryan O’Neill, global head of clinical supply operations at Daiichi Sankyo, Inc.

Profit said that Otsuka leveraged quantitative and qualitiative data during the pandemic to respond to the pandemic, shifting resources when necessary from more impacted areas to less. She said they also gathered data on how their employees were impacted, as well as site trial areas to make decisions about research.

“This is our moment, quite honestly,” said Profit. “This is our opportunity to take what we’ve learned through the pandemic to do better.”

Getz noted that while there are opportunities for improvement, “the long-term outlook is remarkably positive and optimistic.”

He noted that pipelines are growing by three to four percent a year, with major areas of focus centering on rare diseases and personalized medicines. “Sixty percent of all drugs approved are relying on biomarker or genetic information to really target a therapy and there’s huge promise there.”

While there is no shortage of optimism for the future, the experts agreed that there is still room to grow.

“What we still need to understand are the intangible ways that we collaborated as a team,” said Getz. “We are often trying to draw lessons from how we handled and succeeded in addressing a global pandemic.”

In addition to the challenges that Getz spoke about, O’Neill also discussed ongoing supply chain issues.

“When supply chain staff are stricken with COVID-19 protocols, we all of the sudden have a very high touch process that is not very vendor friendly, especially when they are trying to deal with personnel challenges,” said O’Neill. “For me, there was a great deal of learning during the pandemic and figuring out what would work to keep the supply chain flowing.”

Reference

Flink B, Profit D, Sawhney G, O'Neill. Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It . Presented at: SCOPE; Feb. 6-8, 2022; Orlando, Fla.