Biotechnology companies are battling Covid-19 and numerous other diseases such as Alzheimer’s. In this particularly timely segment of What’s Ahead, we discuss these and other subjects with Dr. Michelle McMurry-Heath, who was recently appointed president and CEO of the Biotechnology Innovation Organization, the world’s largest science and public advocacy association.
In early 2020 BIO debuted the Coronavirus Collaboration Initiative, helping to break down traditional barriers, which led to pharmaceutical companies, universities, regulatory agencies and independent laboratories creating vaccines and treatments for Covid-19 in record time.
Dr. McMurry-Heath’s extraordinary career made her the right person at the right time to lead this critical group. She was the first African-American to graduate from the Duke Medical Scientist Training Program, where she earned both an MD and a Phd degree. Her focus was molecular immunology. She was the founding director of the Aspen Institute’s health and science program. She has held major posts at the FDA and at Johnson & Johnson. Years ago she even wrote a paper on combatting bioterrorism for Senator Joe Lieberman.
Our wide-ranging conversation covers not only the challenge of finding cures for numerous other diseases and physical afflictions than coronavirus but also other crucial subjects such as how we better serve underserved communities; promoting diversity; the make-up of clinical trials, since disease outcomes differ, depending on race, gender and ethnicity; and the pricing of drugs.
We also discuss the need for the public and our political leaders to better understand the nature of research and the crucial role life-science companies play in a better standard of living.
Innovation: a lifesaving engine
“Scientists are single-focused, that’s what makes them such amazing scientists. They are focused on that problem that keeps them up at night and they’re passionate about finding that. But they often forget to look up and figure out how the broader social context is impacting them. And so I really see our role at BIO as serving as that voice, that platform for them, and that bridge to the broader cultural conversation about what science can do.
“Science is the social justice issue of our age. It is so critically important because when I think about those communities I grew up with in Oakland, what they needed was access to clean water. They needed access to nutritious foods. They needed clean air, and they needed to know that not only did they have access to healthcare, but once they got in the door of the doctor’s office they would actually have solutions in the medicine cabinet that would help them. And you only get all of those things through applying biotechnology to all of those problems and working without relenting. So this is what’s so critically important. We’ve seen this year with Covid that the rate of speed of developing a new Covid vaccine or Covid therapeutics has a disproportionate negative impact on communities of color because they’re disproportionately impacted by the illness. So every week we save in developing a new Covid vaccine is going to, by proportion, save more Black and Brown lives than it will others, although it’s important for all. And so it’s not to say that it’s more important for one community than the other, but it’s to say that it’s not enough for us just to focus on access to healthcare, although that is critically important when we’re talking about social justice. It’s also important that we’re talking about not slowing down, not giving up on that innovation engine because that innovation engine is lifesaving.”
There’s no excuse for the state we’re in
“Well, let’s be clear. There is no excuse for where we find ourselves today. My mother-in-law lives in Germany, and she had an appointment in the middle of December for when she was going to get her first Covid vaccine. This is unbelievable that we would put this much attention into developing the vaccines and developing the therapeutics, and yet here we sit in January with the same therapeutics that were able to rescue the President sitting in freezers unused and vaccines being disposed of at the end of the day, because all of the content of the vial cannot be used because we cannot organize our response. It is astounding, and it is heartbreaking to watch.
“There’s no excuse for this. This is not rocket science. We’ve done mass vaccination programs before. And the CDC—the Centers for Disease Control and Prevention— [had] been saying for months what would be necessary for the States to be able to actually deliver the vaccine, get shots in arms, but they weren’t given the resources. They weren’t given the attention it deserved. So States are just now, this week, getting their hands on the resources they need. We’ve been speaking to governors across the country. And, you know, we heard from one governor who said, ‘Well, I have boxes of the vaccine delivered, on pallets, and I have some resources to fund setting up clinics to deliver them. But I don’t have any funding, for example, to set up and train people on the IT system needed to track all the doses of the vaccine.’
“Particularly important in a two-dose vaccine situation, you need to be able to track who has had the vaccine, but it’s also critically important because, lest we forget, these vaccines are authorized under emergency use authorization, which by definition means we don’t yet know everything about what we’ll see when the vaccine goes into the majority of the population. And so it’s important to track all of that information so that we can fully understand it. Now, that being said, I don’t want anyone to mistake my words. These vaccines have been under more scrutiny than any vaccines in history. They’ve been in tens of thousands of people before they were ever released across the country. And we have the utmost confidence at BIO [in] the safety and efficacy of both the Moderna and the Pfizer vaccines and the ones to come.”
On the importance of streamlining processes in the future
“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 platforms that have shown success—for example, the MRNA platform that has been used in both the Pfizer and [the] Moderna vaccine—are revolutionary in that they will forever change how we think about developing new vaccines. We also, I think, have learned a lot about early-warning systems and how seriously we need to take those early calls and the public health measures that work and don’t work. But the things I think we’ve learned that are most impactful don’t even have to do with infectious diseases. 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. And being focused on the solution and having a market for that solution at the end of the day, that will deliver cures faster and better to patients. And that’s what I hope we don’t lose sight of.
“The Food & Drug Administration showed amazing flexibility in the context of Covid. We had manufacturers saying, ‘Well, what normally takes me two to four weeks to get a response to FDA in a formal letter, now I’m able to get them on the phone and really able to work in real time towards adapting our plans to make sure they meet FDA’s demands.’ We should never settle for less again, but that’s going to take resourcing the FDA to be able to have that high-touch-and-rapid-response approach.
“We’ve also seen, interestingly enough, that we need a new approach to clinical trials. It is telling that [with] the two vaccines, Moderna and Pfizer, one used the more federalized clinical trial approach to go through the process and one did not. And the federal approach didn’t necessarily save time. And so 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? 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.”