Cavazzoni paints CDER's post-pandemic future

Regulatory NewsRegulatory News | 21 May 2021 |  By 

Patrizia Cavazzoni

During an hour-long session at the annual meeting of the Food and Drug Law Institute (FDLI), the director of FDA’s Center for Drug Evaluation and Research (FDA’s CDER) went beyond a recap of the prior year’s challenges and wins, looking ahead to what CDER’s post-pandemic future will look like.
Summing up what she termed the “gestalt of the last 18 months,” CDER Director Patrizia Cavazzoni highlighted progress and trends in staffing, drug development and inspections that are likely to continue post-pandemic.
She also noted that user fee reauthorization processes moved along as parties held virtual negotiation sessions through the past several months. Public meetings will be coming later in 2021, and FDA’s user fee reauthorization packages should be ready for Congress on schedule, said Cavazzoni.
Reassuringly, attrition in CDER ranks has fallen and talent acquisition has continued despite the constraints of the pandemic. “That has been a bit of a surprise for me,” she added, noting that the division has been able to make gains in fields where hiring had been tough, such as medical reviewers and chemists.
Some of the gains in hiring and retention may be related to new remote work flexibilities the agency has been forced to adopt because of COVID-19 restrictions, noted Cavazzoni, adding that CDER now runs very well as a mostly virtual organization. “We are very good at this, and we are much better at interactive technology generally within the Center. We struggled a little bit initially,” she acknowledged, but the comfort and expertise CDER staff now have with the virtual work environment is, she said, “remarkable.”
However, FDA is alert to the reality that industry is now wooing staff who have become accustomed to this flexibility by promising them the opportunity for fully remote work. Noting that “industry and CDER share the same talent pool,” but federal employers can’t match industry’s pay scale, Cavazzoni said that the center is giving some hard thought to allowing more flexibility in its expectations for on-site attendance.
“We have also really witnessed the success of large platform trials and the use of clinical networks” for COVID-related development work, said Cavazzoni. “This is here to stay,” she said, citing a recently issued guidance on the use of master protocols.
The pandemic also forced sponsors to make progress in conducting decentralized trials, and CDER plans to guide those sponsors who would benefit from continuing, or beginning, this approach in their development programs.
“The pandemic and the work that we have done around the development of therapeutics and vaccines has really underscored the importance of enrolling a diverse clinical trial population,” said Cavazzoni. A key to effective expansion of the clinical trial population is to understand the barriers that keep under-represented individuals from trial participation. “We have really doubled down on this,” she said.
Nowhere has the pandemic affected CDER operations more than in the inspections arena. “We have expanded our tool belt to evaluate manufacturing facilities and investigative sites, and I think it’s great,” said Cavazzoni. She added the caveat that having boots on the ground is preferable, but new remote tools will now be available and “very useful” going forward, since unforeseen circumstances will still interrupt normal activities. In general, the way CDER is working with sponsors is now more streamlined and efficient than it was before the pandemic restrictions, she said.
“Finally, after talking about real-world evidence for seemingly forever, we have seen real-world evidence really come into its own during the pandemic,” she said. Real-world evidence was used for safety monitoring, but also for hypothesis generation in developing COVID-19 therapeutics.
In the question-and-answer session that followed her talk, Cavazzoni was able to give a more global assessment of how her CDER staff are faring in 2021. “I can tell you that the morale at the agency has really improved since January,” she said.


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