Clinical Investigators Need to Know the Privacy Rules

The vaccine rollout may be progressing too slowly, but that there’s a vaccine so soon at all is a tribute to the single-focus of scientists and the biotech industry.

The way the Pfizer and Moderna vaccines were developed “are revolutionary,” says Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization.

In a wide-ranging interview with Steve Forbes and published on Forbes online, she said, “The platforms that have shown success — for example, the MRNA platform that has been used in both the Pfizer and Moderna vaccine — are revolutionary in that they will forever change how we think about developing new vaccines.”

Because of what scientists have learned, “When it comes to preventing the next pandemic — when it comes to even preventing the next iteration of Covid, because we know it’s constantly mutating and evolving — we are incredibly prepared.”

The breakdown in getting a vaccine, she says, is not the development. “We have seen that the science is not our barrier; that often it’s the bureaucracy, it’s the miscommunication and misalignment, and it’s the lack of resources.”

McMurry-Heath laments the lack of effective planning for the distribution of the vaccines and the therapeutics that have been shown effective in treating patients. “There’s no excuse for this. This is not rocket science. We’ve done mass vaccination programs before,” she said.

The pandemic and how the nation responded to it have shown us, she says, that, “The things I think we’ve learned that are most impactful don’t even have to do with infectious diseases.”

Looking ahead, she told Forbes, it’s important the “high-touch-and-rapid-response approach” of the Food & Drug Administration continues. Another lesson is “that we need a new approach to clinical trials.”

“We need to look at our national clinical trial networks and ask ourselves, why are they not more easily mobilized for these massive public health concerns? And why is it so hard to get diverse patient populations through them?”

Says McMurry-Heath, “These are critically important questions that we are just starting to ask. But they’ll be very important, not just for infectious diseases, but for every disease out there that’s awaiting a cure.”

Photo by Macau Photo Agency

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