Latest / Making Medicine / How Research Universities Power America’s Innovation Engine | How America Makes Medicine Ep. 2

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How Research Universities Power America’s Innovation Engine | How America Makes Medicine Ep. 2 · Making Medicine

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Speaker 1: At Making Medicine. We're reporting on the headlines, not making
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Speaker 1: medical recommendations. For personal health questions, always ask your doctor.
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Speaker 1: Nothing in this episode constitutes investment, financial, or legal advice.
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Speaker 1: Consult your own advisors before making decisions.
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Speaker 2: It's interesting to see policymakers that are so concerned with
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Speaker 2: maintaining market conditions and not understanding that there is a
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Speaker 2: market for talent. There is a market for scientific talent
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Speaker 2: and the market response to a number of leavers. Policemakers
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Speaker 2: are only waking up to that and seeing how much
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Speaker 2: of an impact potential destabilization policies can make. Uncertainty and
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Speaker 2: anxiety changes the market, and it changes the market for
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Speaker 2: human capital, just like it does for investment.
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Speaker 1: Welcome back to the Making Medicine podcast or Science Policy
1:00
Speaker 1: and Innovation Meet. I'm your host John Stanford. On today's show,
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Speaker 1: we'll continue our How America Makes Medicine series celebrating two
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Speaker 1: hundred and fifty years of pharmaceutical innovation. For the next
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Speaker 1: several episodes will be breaking down different elements of the
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Speaker 1: ecosystem and the relay race of drug development that makes
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Speaker 1: it all happen. Today, we're lucky to have Kate Hudson,
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Speaker 1: who joins us from the American Association of Universities to
1:26
Speaker 1: kick off our relay tracing how federally funded university research
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Speaker 1: became the launchpad for America's pharmaceutical breakthroughs. Let's get into
1:34
Speaker 1: the show. Throughout our How America Makes Medicine series, we'll
1:39
Speaker 1: be adding in little history lessons before we bring in
1:41
Speaker 1: our excellent guests to talk about their element of the ecosystem.
1:45
Speaker 1: And today we're talking a little history because the story
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Speaker 1: of American research universities starts a lot earlier than most
1:52
Speaker 1: people realize. Higher education in this country goes back over
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Speaker 1: three hundred years. William and Mary and full disclosure, that's
2:00
Speaker 1: my alma mater, was chartered in sixteen ninety three by
2:03
Speaker 1: King William the third and Queen Mary the second, making
2:06
Speaker 1: it the second oldest college in America after Harvard. But
2:09
Speaker 1: schools like William and Mary and Harvard weren't founded to
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Speaker 1: do research. They were built to train clergy and civil servants,
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Speaker 1: teaching divinity, philosophy, and the classics. That shift towards research
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Speaker 1: didn't happen until more than one hundred years later in
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Speaker 1: eighteen sixty two, and the middle of the Civil War.
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Speaker 1: When President Lincoln signed the Moral Act handing states federal
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Speaker 1: land to build public colleges focused on agriculture, science, and engineering.
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Speaker 1: That was a turning point, and that's where schools like Cornell,
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Speaker 1: MIT and Ohio State come from. It was the first
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Speaker 1: time the federal government invested directly in practical technical education
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Speaker 1: for the American public. The bigger turning point came during
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Speaker 1: World War II. An MIT engineer named Van var Bush
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Speaker 1: convinced President Roosevelt that America's scientific talent needed to be mobilized,
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Speaker 1: and out of that came a landmark report Science the
3:07
Speaker 1: Endless Frontier.
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Speaker 3: As we'll talk about with Kate.
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Speaker 1: It became the blueprint for federal agencies like the NIH
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Speaker 1: and NSF to fund basic research inside university labs. That's
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Speaker 1: the moment American universities became the launchpad for the research
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Speaker 1: that leads to new medicines. It's hard to overstate the
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Speaker 1: transformational moment World War II played in turning America's academic
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Speaker 1: engines into research engines. There are a few other dates
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Speaker 1: throughout history that celebrate the Moment's universities played a bigger
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Speaker 1: role in the world of medicine, beginning back in seventeen
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Speaker 1: sixty five at the University of Pennsylvania, where Penns School
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Speaker 1: of Medicine became the first medical school in the thirteen
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Speaker 1: American colonies, founded by John Morgan, establishing formal university based
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Speaker 1: medical training in America for the first time. Almost one
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Speaker 1: hundred years later, in eighteen forty six, it would be
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Speaker 1: Harvard University and Massachusetts General Hospital, or William T. G.
4:04
Speaker 1: Morton's public demonstration of anesthesia at the Harvard Teaching Hospital
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Speaker 1: transformed surgery from an agonizing high mortality ordeal into a
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Speaker 1: survivable procedure. Fifty years later, in eighteen ninety three, it
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Speaker 1: was JOHNS. Hopkins University that opened its School of Medicine
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Speaker 1: on the German research model, which became the very template
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Speaker 1: American universities would follow to turn laboratory science into medical discovery.
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Speaker 1: In nineteen fifty five, at the University of Pittsburgh, Jonas
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Speaker 1: Salk developed and tested the first effective polio vaccine and
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Speaker 1: in decades of a disease that had crippled and killed
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Speaker 1: American children in the tens of thousands and in this century.
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Speaker 1: As we'll talk about in the episode with Kate, the
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Speaker 1: University of Pennsylvania and a team there were awarded a
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Speaker 1: Nobel Prize for their work developing mRNA platforms that would
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Speaker 1: go on to be the basis for both Pfizer and
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Speaker 1: Maderna's COVID nineteen vaccines. The story of American universities and
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Speaker 1: the story of American medicine are intertwined with incredible steps
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Speaker 1: along the way that have shown how America makes medicine. Kate,
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Speaker 1: Welcome to the show.
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Speaker 4: Hi, great to be here. Thank you for having me.
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Speaker 1: Well, you're here's part of our America two fifty series
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Speaker 1: where we're looking at all the elements of the ecosystem
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Speaker 1: that have made American pharmaceutical innovation so dynamic. Obviously, universities
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Speaker 1: play a critical role, and we'll get into that. But
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Speaker 1: for those who don't know AAU, can you start by
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Speaker 1: talking about both the organization and your work there.
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Speaker 4: Absolutely so.
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Speaker 2: The AAU is the Association of American Universities. We are
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Speaker 2: comprised of sixty nine US and two Canadian top level
5:48
Speaker 2: research universities. My universities represent the majority of recipients of
5:54
Speaker 2: I'm sorry, the recipients of a majority amount of federal
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Speaker 2: funding across the spectrum, not just in life sciences and
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Speaker 2: biomedical research, but across the entire federal funding spectrum, and
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Speaker 2: so my seventy seventy one member universities really represent a
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Speaker 2: really phenomenal chunk of the overall US academic research enterprise.
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Speaker 2: We are founded in nineteen hundred, so we've been around
6:21
Speaker 2: quite a while. We're celebrating one hundred and twenty six
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Speaker 2: years this year, and our work, especially my team here
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Speaker 2: in DC, is to provide advocacy in that voice and
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Speaker 2: representation and visibility for research universities across the country. Here
6:39
Speaker 2: in DC on a number of issue areas that require advocacy,
6:44
Speaker 2: and my portfolio specifically deals with intellectual property, technology transfer,
6:49
Speaker 2: export controls, open and public access to research publications, and
6:55
Speaker 2: a number of other items. However, I also as counsel,
6:59
Speaker 2: I also provide legal support across the spectrum of our
7:03
Speaker 2: issues that hits a number of other higher.
7:05
Speaker 4: Education traditional higher education issues.
7:08
Speaker 2: Like Title nine. We also track very closely all immigration
7:15
Speaker 2: updates policy updates as well, because there is a massive
7:18
Speaker 2: component of the immigration discourse that affects research universities both
7:22
Speaker 2: from a student perspective and a faculty perspective, So we
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Speaker 2: really cover the waterfront here at AU in terms of
7:29
Speaker 2: issues in DC that are of most relevance to research universities.
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Speaker 1: Generally, no kidding, I think that is a pretty broad spectrum.
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Speaker 1: And yes, you know a little bit of these episodes
7:42
Speaker 1: are history themed. And so you mentioned being a little
7:46
Speaker 1: over one hundred and twenty years old. Obviously you and
7:50
Speaker 1: I weren't around then. But what do you think led
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Speaker 1: to at that moment of time? So clearly something's going
7:55
Speaker 1: on at the turn of the twentieth century that says
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Speaker 1: research universities need to get organized. What do you think
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Speaker 1: that moment was that catalyzed the launch of AAU.
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Speaker 2: And we know that this was started by a group
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Speaker 2: of graduate deans in the Ivy League to really be
8:11
Speaker 2: a convening place for them to talk about not the
8:14
Speaker 2: advocacy agendas that and issues that we deal with. Now
8:17
Speaker 2: as AAU, we've definitely evolved into this kind of an organization,
8:22
Speaker 2: but it really originally started as graduate deans trying to
8:25
Speaker 2: get together to talk about the issues that all of
8:27
Speaker 2: their universities were facing, everything from teaching pedagogy to recruiting
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Speaker 2: to you know what types of research, you know, all
8:37
Speaker 2: of those kinds of issues that were really salient for
8:39
Speaker 2: them as a small group, and that's really what kicked off,
8:43
Speaker 2: you know.
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Speaker 4: The AAU origin story, and it started from there.
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Speaker 2: But it was a place for peer institutions to get
8:50
Speaker 2: together to talk about things that were that we they
8:53
Speaker 2: that they were facing, and to improve and to really
8:56
Speaker 2: improve higher education as a whole, not only in their commune,
9:00
Speaker 2: to what could what could happen outside of of that
9:03
Speaker 2: first convenient group of graduate deans.
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Speaker 1: And as it's grown, so too has universities, especially our one,
9:12
Speaker 1: their role in the research ecosystem. So yes, for the layman,
9:18
Speaker 1: paint a picture of why universities are so critical and
9:22
Speaker 1: also how it works. We have NSF, N, I H
9:25
Speaker 1: other pots of money. Why do they need to go
9:29
Speaker 1: to universities. Why isn't it doctor tom is getting a
9:33
Speaker 1: grant directly? Or is that how it works? Walk us
9:36
Speaker 1: through the role the university plays. It's so critical.
9:39
Speaker 4: Part of how.
9:40
Speaker 2: Our US scientific enterprise as a whole evolved is that
9:44
Speaker 2: after the after the Second World War, Uh, there was
9:47
Speaker 2: really this national level, uh you know, discourse of how
9:51
Speaker 2: are we going to you know, a remake.
9:54
Speaker 4: Our economy after World War two?
9:55
Speaker 2: How are we going to continue to build on the
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Speaker 2: scientific discoveries and the operas operationalization of private industry in
10:05
Speaker 2: partnership with universities that happened during World War Two.
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Speaker 4: Many of those you know now now famous.
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Speaker 2: You know, think Oppenheimer, I think uh, you know a
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Speaker 2: number of other uh uh, you know historical collaborations that
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Speaker 2: came out of post World War two, and really this
10:21
Speaker 2: conversation about what does that look like in the future,
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Speaker 2: how are we going to advance science? Is the is
10:27
Speaker 2: the US government going to be the one performing all
10:30
Speaker 2: of the science? Who best is going to be equipped
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Speaker 2: to do this? And what you ended up with was
10:36
Speaker 2: a really a partnership between the government and universities, and
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Speaker 2: government would provide the funding and universities would perform the
10:45
Speaker 2: research on behalf of the federal government. Under the auspice
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Speaker 2: is that those findings would then, you know, if if
10:52
Speaker 2: there to be a publication, those would be made widely
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Speaker 2: available to advance our body of knowledge as a whole
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Speaker 2: and to help continue that curiosity driven research and innovation
11:04
Speaker 2: that it would lead to into the future. If you
11:06
Speaker 2: want some nightstand reading the nineteen forty five report Science
11:10
Speaker 2: the Endless Frontier, which is getting a lot of play
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Speaker 2: now in the press again because we have a recent
11:17
Speaker 2: document received put out by OSTP and the White House
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Speaker 2: about another big, you know, kind of landmark science report
11:27
Speaker 2: about where we go from here, and so people are
11:30
Speaker 2: revisiting vanover Bush's, you know, nineteen forty five report, and
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Speaker 2: so in that report, it basically sets the guardrails that
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Speaker 2: the federal government funds the research, the universities perform it
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Speaker 2: on behalf of the federal government.
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Speaker 4: It is a public good. It is to advance the body.
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Speaker 2: Of knowledge in whatever direction that goes right. We don't
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Speaker 2: know what the outcome of research is going to be
11:53
Speaker 2: at the beginning, you know, we can investigate, we can
11:57
Speaker 2: look into it, but this is to advance our basic
12:00
Speaker 2: knowledge forward as a whole to benefit American society and
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Speaker 2: now and by virtue of our global connections, global society
12:09
Speaker 2: as well.
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Speaker 4: The funding engines.
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Speaker 2: Behind this are really the federal agencies individually. So for example,
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Speaker 2: NIH is the primary engine for biomedical research. Funding is
12:21
Speaker 2: at about roughly forty seven billion in f y twenty six,
12:24
Speaker 2: and the large majority of that goes out the door
12:28
Speaker 2: as extramural grants to outside institutions, most of which are
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Speaker 2: universities NSF for example, funds the foundational science across disciplines.
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Speaker 2: Much of that research is upstream of biomedicine, like biomedical
12:43
Speaker 2: biotechnological tools, engineering computation that later feeds into medicine. And
12:50
Speaker 2: in practice, you know, it's not just you know, doctor Joe,
12:53
Speaker 2: you know, asks the federal government for money and then
12:56
Speaker 2: he just goes from there. It's actually a very a
13:00
Speaker 2: rigorous process of application. So in practice, a faculty investigator
13:05
Speaker 2: writes a grant application to a specific notice of funding opportunity.
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Speaker 2: It goes through a competitive peer review by other scientists
13:13
Speaker 2: called a study section that perform that for the federal government,
13:17
Speaker 2: and a fraction of those a fractional affractions of those
13:22
Speaker 2: applications actually get funding. It's very competitive process, very rigorous,
13:27
Speaker 2: and typically multi year awards fund a number of things
13:30
Speaker 2: in that grant. They fund people, they fund equipment, and
13:34
Speaker 2: they fund experiments in the university lab with the results
13:37
Speaker 2: to be published openly. And this is kind of a
13:41
Speaker 2: timely context for US is that you know, there were
13:45
Speaker 2: proposed cuts to NIH proposed by the administration, but Congress
13:49
Speaker 2: has rejected that in a really rare bipartisan signal of
13:53
Speaker 2: just how valuable that pipeline truly is for the US,
13:59
Speaker 2: and so that's really how it fundamentally operationally works, that
14:03
Speaker 2: partnership between the federal government and universities, and then the
14:08
Speaker 2: third stool is our industry partners.
14:11
Speaker 1: A testament to you and your colleagues because there were
14:14
Speaker 1: these propose cuts and they were thoroughly rejected.
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Speaker 3: So a lot of credit to AAU.
14:19
Speaker 1: Along with other actors to be sure that Congress quickly
14:23
Speaker 1: said absolutely not. This nearly fifty billion is a part
14:27
Speaker 1: of our research enterprise. But I want to pose a
14:31
Speaker 1: question and not bury the lead, because I think in
14:33
Speaker 1: this populist moment, we forget some of the institutional benefits
14:38
Speaker 1: of things like basic research. And so it's good to
14:41
Speaker 1: harken back to World War two and say we discovered
14:44
Speaker 1: in that moment universities academia really brilliant scientists do incredible
14:49
Speaker 1: things that, but for the taxpayer dollar, may not have
14:54
Speaker 1: been invested in. But how do you answer the question
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Speaker 1: of what we won't the free market just take care
15:01
Speaker 1: of it? And that may not even be the right
15:03
Speaker 1: question you get, but I just feel on both sides
15:06
Speaker 1: of the aisle we're in this hyper populous moment. I
15:09
Speaker 1: want it, I want it now, and I don't want
15:10
Speaker 1: to pay for it. Why do we have to invest
15:13
Speaker 1: in this? How do you answer to stakeholders and policymakers
15:17
Speaker 1: on the hill that, yes, you're not going to get
15:21
Speaker 1: something out of this investment, and you're not going to
15:24
Speaker 1: get it tomorrow, You're going to get it in two
15:25
Speaker 1: decades or and even to get the thing you want,
15:28
Speaker 1: you need a tool that measures it, and no one's
15:31
Speaker 1: going to pay for that.
15:32
Speaker 3: How do you answer that question?
15:34
Speaker 2: That is probably one of the most difficult things that
15:36
Speaker 2: we do is explaining that, And the way that we
15:42
Speaker 2: most tangibly do that with policymakers is to point to
15:46
Speaker 2: the major innovations and discoveries that have already happened as
15:51
Speaker 2: a result of.
15:53
Speaker 4: Taxpayer funded research.
15:56
Speaker 2: Understanding that the definition of ROI return on investment has
16:01
Speaker 2: taken a little bit of a different definition than it
16:04
Speaker 2: has in the past. Particularly, you know policymakers that, like
16:08
Speaker 2: you said, you want, they want something in their hands
16:11
Speaker 2: and they want it in two years, right, and that's
16:13
Speaker 2: you have to break down and break it down and
16:15
Speaker 2: say that's you know, that's not going to be feasible,
16:18
Speaker 2: that's not possible.
16:19
Speaker 4: And even if it.
16:20
Speaker 2: Was that two year timeline draws on decades of research before.
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Speaker 2: A really great example of that is the mRNA vaccine
16:30
Speaker 2: during the COVID pandemic and Operation Warp Speed. That did
16:34
Speaker 2: not happen in eighteen months. mRNA as a platform was
16:38
Speaker 2: a subject of two decades of research for which Caitlyn
16:42
Speaker 2: Kerrica won the Nobel Prize. And so that is a
16:46
Speaker 2: really great illustration is that if we did not have
16:48
Speaker 2: that research being performed, we could never have had that
16:52
Speaker 2: discovery and never operationalized it in a way so quickly
16:56
Speaker 2: under Operation Warp Speed with the industry partners with the
16:59
Speaker 2: private sector to bring that to people's clinics in such
17:03
Speaker 2: a short amount of time.
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Speaker 4: That's a perfect example of it.
17:06
Speaker 2: We were able to the government was able to capitalize
17:10
Speaker 2: on previous investments in federally funded research to universities and
17:16
Speaker 2: the development of the m RNA platform. And it also
17:18
Speaker 2: is not a one off. That is a vaccine platform,
17:21
Speaker 2: that is not a one time discovery. We are now
17:25
Speaker 2: scientists are now exploring further ways to utilize that platform
17:29
Speaker 2: to cure other diseases, other chronic conditions. And so it
17:32
Speaker 2: wasn't it wasn't even a one time thing, it's going
17:35
Speaker 2: to continue to pay in returns overall. It's a really
17:38
Speaker 2: great example of precisely that kind of story that we
17:41
Speaker 2: need to break down for policymakers on top of many
17:45
Speaker 2: that are not, you know, super visible in the public sphere.
17:49
Speaker 4: So talking about the outcomes and the things.
17:51
Speaker 2: That we currently already enjoy that are a product of
17:54
Speaker 2: it is really part of the best way that we
17:57
Speaker 2: that we talk about that. And it's not only a
18:00
Speaker 2: that talks about it. Folks like the Vidoal Coalition has
18:02
Speaker 2: the Thesis of American Innovation Award AA you also participates
18:06
Speaker 2: and has been a long time sponsor of something called
18:09
Speaker 2: the Golden Goose Award, which shows the link between really
18:13
Speaker 2: funny sounding science and really phenomenal advances in our knowledge
18:18
Speaker 2: base that have led to major advances across the board
18:22
Speaker 2: in the scientific fields. It's really difficult to explain it,
18:27
Speaker 2: but we try, and we talk about how it's a slow,
18:31
Speaker 2: low value overhead duplicating what industry would do, industry what
18:36
Speaker 2: industry would do. Anyway, that is a bad narrative, that is,
18:39
Speaker 2: and that's actually not a reflection of the reality. In fact,
18:44
Speaker 2: university research does the earliest the highest risk, the longest
18:48
Speaker 2: horizon science that no rational private investor would fund precisely
18:54
Speaker 2: because most of it doesn't pan out in the terms
18:58
Speaker 2: of commercial six sess. Most of it does not pan
19:02
Speaker 2: out right. But we still need to invest those dollars
19:06
Speaker 2: into that research and build on continue to build on
19:09
Speaker 2: our bodies of knowledge, and pay it forward to future
19:12
Speaker 2: generations for the things that they will be able to
19:14
Speaker 2: develop based on that science itself.
19:18
Speaker 4: That is a large part of our job, and it is,
19:20
Speaker 4: like I said, one of the most difficult components of it.
19:23
Speaker 1: Are the research universities just keeping the bench warm, and
19:27
Speaker 1: then we think of the private sector coming in and
19:29
Speaker 1: picking the right player at the right time to take
19:31
Speaker 1: further put on the field, score a goal. And the
19:35
Speaker 1: what the research universities are enabling is that we are
19:38
Speaker 1: constantly ready trying to make sure that we can tackle
19:43
Speaker 1: your mRNA example, but it really could be anything. Because
19:47
Speaker 1: I also think that the systems and metrics and tools
19:53
Speaker 1: you need. Someone's like, well, I want to build the
19:55
Speaker 1: next iPhone. Okay, Well, to build the next iPhone, you're
19:59
Speaker 1: going to need to measure X, Y and Z component
20:02
Speaker 1: of the phone. And no one wants to invent that
20:04
Speaker 1: no one wants to pay to invent that because the
20:07
Speaker 1: ROI isn't on that invention, it's on the iPhone, and
20:10
Speaker 1: that's where you're just keeping this bench warm. I don't know,
20:13
Speaker 1: does that analogy make any sense?
20:14
Speaker 2: I wonder if it's less keeping the bench warm. It's
20:19
Speaker 2: everything behind building the bench.
20:21
Speaker 4: In the first place.
20:22
Speaker 2: Okay, it's the farm team. It's the scouts that go
20:26
Speaker 2: out and recruit, you know, very young soccer players to
20:31
Speaker 2: go to academies and learn their craft and learn their
20:34
Speaker 2: trade and build on that body of knowledge, and creating
20:38
Speaker 2: the bench, creating the infrastructure itself, creating the stadium that
20:42
Speaker 2: it'll happen in. I'm not saying that universities create the market,
20:46
Speaker 2: but the ecosystem and the research infrastructure in which the
20:51
Speaker 2: research itself takes place is built by the university. So
20:54
Speaker 2: building the field as well as the bench itself, and
20:58
Speaker 2: everything that gets the those players and those innovations in
21:02
Speaker 2: those discoveries to the bench in the first place. And
21:04
Speaker 2: universities also act as the coach. Private industry does not
21:09
Speaker 2: have scientists and people to employ without universities, how are
21:14
Speaker 2: these discoveries going to be taken off the bench? If
21:18
Speaker 2: there are not talented, highly sophisticated researchers that are then
21:25
Speaker 2: able to do the further research and development. So not
21:28
Speaker 2: to hijack your analogy, but it's actually much greater than that.
21:35
Speaker 2: And it's interesting that you brought that up because it
21:38
Speaker 2: is there is a handoff component to it to private industry,
21:42
Speaker 2: but universities are responsible for so much of the equation
21:45
Speaker 2: just getting to the bench.
21:46
Speaker 1: Well, and before we get into that handoff, because I
21:48
Speaker 1: do want to spend some time there, you mentioned the people,
21:54
Speaker 1: and I think this is critically important for another topic
21:58
Speaker 1: that we won't dwell too much on here, but that
22:01
Speaker 1: is competition with China, and I think some policymakers are
22:06
Speaker 1: pretending there's a magic lever out there that slows China's
22:12
Speaker 1: rise or levels the playing field. But I think what
22:16
Speaker 1: you hit on is a really good example that we
22:19
Speaker 1: need the people. We need really brilliant, well trained people.
22:25
Speaker 1: You can't wake up one morning and say I'm going
22:27
Speaker 1: to synth the size of protein, and so I think
22:29
Speaker 1: it's important to remember that the universities are the ones
22:33
Speaker 1: who get the PhDs to be ready to contribute, whether
22:37
Speaker 1: that's in the public sector or private sector. And that's
22:39
Speaker 1: a place where we're lagging behind, not just China, but
22:42
Speaker 1: a lot of places in the world.
22:44
Speaker 4: You're precisely correct.
22:45
Speaker 2: It's interesting to see policymakers that are so concerned with
22:50
Speaker 2: maintaining market conditions and not understanding that there is a
22:54
Speaker 2: market for talent. There is a market for scientific talent.
22:58
Speaker 2: There is a market for researchers, and the market responds
23:05
Speaker 2: to a number of leavers. Labor responds to a number
23:11
Speaker 2: of different market factors itself, and it exists in high
23:17
Speaker 2: quality scientific research, just like it does in any other area.
23:23
Speaker 2: And those are really we're only police speakers are only
23:28
Speaker 2: waking up to that and seeing how much of an
23:32
Speaker 2: impact potential destabilization policies can make. Uncertainty and anxiety changes
23:39
Speaker 2: the market, and it changes the market for human capital,
23:41
Speaker 2: just like it does for investment.
23:44
Speaker 3: That's well to the production team.
23:46
Speaker 1: We found our clip because it's so perfectly well said.
23:51
Speaker 3: Well, let's stay there.
23:52
Speaker 1: We'll come back to the handoff, because I think the
23:54
Speaker 1: handoff's perfect. But we can't pretend you're not in a
23:57
Speaker 1: particularly challenging environment with regards to some specific issues, and
24:03
Speaker 1: one that you've been doing some education around is this
24:06
Speaker 1: OMB proposal, and I think I put in a broader
24:11
Speaker 1: bucket of how government is treating research institutions grants.
24:19
Speaker 3: And this is a tension.
24:20
Speaker 1: That plays out well above even universities of government as
24:26
Speaker 1: a grant maker, whether it's for low income housing or
24:30
Speaker 1: whether it's for basic education, whether it's for university research. Yes,
24:35
Speaker 1: all of it tell us a little bit about your perspective,
24:38
Speaker 1: because I know you've been working on this, with this
24:41
Speaker 1: proposal that's come out of OMB.
24:44
Speaker 2: Yeah, it was a really you know that proposal dropping
24:48
Speaker 2: is it represents a really a shift in approach, not
24:55
Speaker 2: only for research universities, but as you said, anyone who
24:59
Speaker 2: receives federal financial assistance in the form of grants. So
25:04
Speaker 2: I think it is very important as we talk about
25:06
Speaker 2: this to realize that this is a much larger challenge
25:10
Speaker 2: in the US than just universities. I mean, we've definitely
25:14
Speaker 2: been having a difficult, difficult eighteen months, a lot of
25:18
Speaker 2: a lot of new challenges, a lot of old challenges
25:21
Speaker 2: being brought back out, those kinds of issues. But this
25:24
Speaker 2: is the O and B proposal doesn't just affect us,
25:26
Speaker 2: and it's very very important for people to understand that
25:29
Speaker 2: this is changing the terms of all federal financial assistance
25:32
Speaker 2: or attempting to, I should say.
25:34
Speaker 4: And so.
25:36
Speaker 2: The O and B proposal, which was joined by roughly
25:40
Speaker 2: forty federal grant making agencies, because again it's not just
25:43
Speaker 2: NIH and NSS, is proposing to change what's what we
25:48
Speaker 2: have known as the government wide rulebook for every federal
25:52
Speaker 2: grant right and replacing it with a new binding grants regulation,
25:57
Speaker 2: the UG morphing from the UG to the UG are
26:01
Speaker 2: and three changes matter most for you know, folks in
26:06
Speaker 2: your audience. So first of all, it converts guidance agencies
26:11
Speaker 2: had flexibility and discretion to implement into direct binding regulation
26:17
Speaker 2: at the OMB level and not the agency level.
26:20
Speaker 4: That is huge.
26:22
Speaker 2: Federal agencies that are delegated their authority by Congress each
26:26
Speaker 2: have really unique missions and the way they are authorized
26:33
Speaker 2: to accomplish those missions that is created by Congress. Right.
26:38
Speaker 2: What this does is takes away a lot of that
26:40
Speaker 2: flexibility and discretion to adapt those regulations on federal financial
26:44
Speaker 2: assistance to their specific missions. And now it seeks to
26:49
Speaker 2: uniformly hold that control and that power at OMB as
26:54
Speaker 2: opposed to as at the agencies.
26:56
Speaker 1: The needs of Noah and the needs of NIH and
27:00
Speaker 1: the needs of HUD housing and urban development.
27:03
Speaker 2: Are extremely different, very very very very different, even in
27:07
Speaker 2: just this context of federal grant making, even just in
27:11
Speaker 2: the grant can make in complexes or context itself. An
27:15
Speaker 2: NIH grant is very very different than a USDA grant
27:19
Speaker 2: for food sustainability.
27:21
Speaker 4: In a rural area.
27:23
Speaker 2: So they have two different they have two different missions,
27:26
Speaker 2: they have two different outcomes and the way that they're measured.
27:30
Speaker 2: And so that is the first really massive change that
27:34
Speaker 2: the UGR proposes. Second, it inserts senior political appointees into
27:40
Speaker 2: pre issuance review of individual of each individual grant alongside
27:45
Speaker 2: scientific peer review. We are used to having scientific peer
27:49
Speaker 2: review last seventy years. Basically, that really, as I said before,
27:55
Speaker 2: it's the competitive grants process so that we fund the best,
27:58
Speaker 2: most rigorous science that can be developed and really move
28:03
Speaker 2: our research endeavor along by rewarding that that really strong science. Right.
28:09
Speaker 2: And so what this does is places political review above
28:14
Speaker 2: that scientific peer review itself, so the study section and
28:19
Speaker 2: the panels that choose the grants to be funded can
28:23
Speaker 2: be overridden their advices is just to be as advisory basically,
28:27
Speaker 2: and you now have a senior political appointee who will
28:30
Speaker 2: change with every administration or potentially change multiple times in
28:33
Speaker 2: an administration, is the one that has the actual final
28:37
Speaker 2: call on whether something gets funded. That's a massive change.
28:42
Speaker 2: It was first rolled out in an executive order last August,
28:46
Speaker 2: and this is basically the implementation of that scientific review
28:51
Speaker 2: through the regulatory infrastructure. And Third and what has been
28:56
Speaker 2: what has received a lot of attention and is truly
28:59
Speaker 2: the most destabilizing and creates the most uncertainty in in
29:06
Speaker 2: research right now and through throughout the federal financial assistance community,
29:10
Speaker 2: is it significantly expands discretionary authority to terminate and suspend
29:15
Speaker 2: grants that are already underway. So you know, you have
29:20
Speaker 2: a five year, multi year funded grant and a new
29:24
Speaker 2: political administration comes in and decides we are no longer
29:27
Speaker 2: are going to fund that, and you get a termination
29:30
Speaker 2: notice with no right to appeal, no recourse, end of story.
29:35
Speaker 4: You're done.
29:36
Speaker 2: It no longer aligns with the national interest or the
29:40
Speaker 2: administration's priorities. And those are the key terms that are used,
29:44
Speaker 2: and that's very destabilizing.
29:46
Speaker 1: Fifty million dollar award to go deep into vector generation
29:51
Speaker 1: for next gen self therapy, something where we are frankly
29:56
Speaker 1: lagging behind different actors around the globe. Yes, and new
30:03
Speaker 1: administration comes in and says, you know what, we don't
30:07
Speaker 1: like the cell therapy stuff. We want to look in
30:09
Speaker 1: a different direction. We're going to cut this off. But
30:12
Speaker 1: in the process of building that fifty million dollar grant,
30:17
Speaker 1: one of the goals was to recruit the three best
30:21
Speaker 1: sell therapy scientists in the world to develop this at
30:25
Speaker 1: home capability. They're not going to move here, They're not
30:29
Speaker 1: going to choose to do this because they're going to
30:31
Speaker 1: say political lack of clarity or instability means it's not
30:37
Speaker 1: really a fifty million dollar grant, it's a maybe fifty
30:41
Speaker 1: and it could be terminated for a random example. Is
30:44
Speaker 1: that a good capture of that uncertainty is going to
30:47
Speaker 1: prevent us from actually developing cell vector lines?
30:53
Speaker 4: Yes?
30:53
Speaker 2: I mean the short answer is that level of destabilization
30:57
Speaker 2: and uncertainty, both from the individual level. Who's going to
31:01
Speaker 2: build a career yeah off of that, right, I mean,
31:05
Speaker 2: we're we're rational actors here. Who is going to take
31:08
Speaker 2: that risk knowing that they could wake up next week
31:13
Speaker 2: and receive a termination notice And it doesn't even have
31:16
Speaker 2: to change administrations. It can just be you know, for
31:20
Speaker 2: really the discretion is so broad. And the problem with
31:25
Speaker 2: this is that research is least resilient to exactly this
31:30
Speaker 2: kind of instability, and you cannot easily restart, as you said,
31:34
Speaker 2: you know, a five year for example, a cell line therapy,
31:37
Speaker 2: cell line study, or a clinical cohort. Imagine having a
31:40
Speaker 2: clinical cohort and waking up on a Tuesday and it's
31:44
Speaker 2: been terminated. Oh wait, they come back six months later.
31:47
Speaker 2: Oh wait, wait wait, we would like to restart that, right.
31:51
Speaker 1: I think we've seen this actually in the last a
31:54
Speaker 1: lot of our friends in this space have said, well,
31:58
Speaker 1: I had to turn something off, turn back on, and
32:01
Speaker 1: the patients are gone, the data is gone.
32:02
Speaker 3: The yeah, it's gone.
32:04
Speaker 4: And this fidelity, the fidelity.
32:07
Speaker 2: Of the data and the research is gone because you
32:09
Speaker 2: haven't had a clinical cohort for six months, right, So
32:12
Speaker 2: you would have to start all over again. And if
32:14
Speaker 2: a multi year grant can be pulled mid project on
32:17
Speaker 2: non scientific grounds, I mean to be clear, to be
32:20
Speaker 2: absolutely clear in cases where there is a research integrity issue,
32:25
Speaker 2: right or you know, a transparency issue auditiy, that is
32:30
Speaker 2: not what is happening now. There are already processes in
32:34
Speaker 2: place that allow the government to cancel a grant. This
32:39
Speaker 2: is those that already exists. Those processes have been in
32:42
Speaker 2: place for decades.
32:45
Speaker 4: But if.
32:47
Speaker 2: Something can be pulled mid project on non scientific grounds,
32:50
Speaker 2: that unpredictability discourages the long horizon, high risk basic research
32:56
Speaker 2: that produces the breakthroughs in the first place. It will
32:59
Speaker 2: prevent us from ever making that innovate that discovery in
33:04
Speaker 2: the first place. And the best way to never get
33:06
Speaker 2: another new drug is to prevent discovery of the mechanism in.
33:10
Speaker 4: The first place.
33:11
Speaker 1: I think listeners can certainly take away aau's position on
33:15
Speaker 1: the O and B proposal, And this is something that's circulating.
33:19
Speaker 3: But I want to switch gears a.
33:20
Speaker 1: Little bit as we close out absolutely to that handoff
33:25
Speaker 1: and tee up where we're going to go in future conversations.
33:29
Speaker 1: Universities do this incredible work, but there there's a stopping point.
33:35
Speaker 1: What is that stopping point? And how do you feel
33:39
Speaker 1: that handoff is going? Is that something that America does
33:43
Speaker 1: really well? Because I feel like it is. I feel
33:45
Speaker 1: that commercialization is something. So where does a research university say,
33:50
Speaker 1: you know what, it's time for this to go on
33:54
Speaker 1: to an entrepreneur?
33:55
Speaker 2: So once three things exist at the same time. So
33:58
Speaker 2: we've got an intellectual prop piece of intellectual property that
34:02
Speaker 2: can be owned and exclusively licensed or non exclusively in
34:05
Speaker 2: many cases, enough proof of concept data something like sell
34:09
Speaker 2: studies or animal models that will de risk it for
34:13
Speaker 2: private investment, and a clear freedom to operate position.
34:16
Speaker 4: Once those three.
34:17
Speaker 2: Things exist, that is when the university can say, okay,
34:23
Speaker 2: we are ready to license this to an industry commercial partner. Right,
34:28
Speaker 2: and the vast majority of firms that university is licensed
34:31
Speaker 2: to are small and medium sized firms that will then
34:35
Speaker 2: do the follow on research and development. Right. The university
34:39
Speaker 2: is not just sitting with a product ready to have
34:42
Speaker 2: packaging developed by any means. We have to hand that
34:46
Speaker 2: off to our industry partners for a lot further research
34:49
Speaker 2: and development. That is why industry are in d levels.
34:52
Speaker 2: You know, you look at those dollar amounts and you gasp.
34:54
Speaker 2: You're like, oh my god, that's a lot. Yes, it
34:57
Speaker 2: takes a lot to further development to develop that discovery.
35:02
Speaker 2: And because many of our discoveries we don't know what
35:05
Speaker 2: the use is for. We see potential. But there are
35:09
Speaker 2: many discoveries that have been licensed in different ways and
35:12
Speaker 2: have become different products in different sectors altogether. Right, that's
35:16
Speaker 2: what basic and fundamental science does, curiosity driven research. We
35:21
Speaker 2: don't know what direction it's going to go in, and
35:23
Speaker 2: then we hand off to our private sector partners. And
35:27
Speaker 2: many times that looks like an affiliation. You know, it's
35:30
Speaker 2: a startup that spins out of the lab with some
35:32
Speaker 2: grad students and the faculty researcher and a number of
35:36
Speaker 2: other private sector partners that work together to further do
35:39
Speaker 2: that research and development, and then industry takes it from there.
35:43
Speaker 2: That gap between the interesting basic finding that we've made
35:48
Speaker 2: and the investible asset, as I'm sure you talk about
35:51
Speaker 2: on this show, is often called the valley of death.
35:53
Speaker 4: And this is why my.
35:55
Speaker 2: Earlier comment about so much of it doesn't pan out.
35:58
Speaker 2: This is where that happens, is when the handoff between
36:01
Speaker 2: the university and the industry partner happens, and it cannot
36:07
Speaker 2: get off the ground, right, But no industry partner is
36:12
Speaker 2: going to come in and fund that basic and fundamental
36:15
Speaker 2: research in the first place, and that's why universities need
36:18
Speaker 2: to reperform that with federal funding. And then that is
36:21
Speaker 2: what leads to the licensing to our private sector partners.
36:24
Speaker 2: And that process is called technology transfer.
36:28
Speaker 1: And as we go back to global competitiveness, is it
36:32
Speaker 1: as simple as to say we want as many shots
36:37
Speaker 1: on goal people entering the valley or what. It's a
36:40
Speaker 1: game of numbers. And if our federal funded dollar pie grows,
36:48
Speaker 1: we probably have more innovation leading to more commercialization. If
36:53
Speaker 1: it shrinks, there's no amount of industrial effort can make
37:00
Speaker 1: up that gap.
37:01
Speaker 2: And at best, what you would see is not curiosity
37:04
Speaker 2: driven lines of research. You would see the goals and
37:09
Speaker 2: sought outcomes of industry guiding where that research goes. You
37:14
Speaker 2: would miss a lot of the field of basic and
37:19
Speaker 2: fundamental research.
37:20
Speaker 1: Yeah, it's I forget what the We wouldn't have a
37:23
Speaker 1: polio vaccine, we'd have a really sophisticated iron lung.
37:27
Speaker 2: Yes exactly. Yes, Well that's actually a really good analogy.
37:33
Speaker 3: You can have that one.
37:35
Speaker 4: Yeah, I will take that one.
37:37
Speaker 1: I want to close out with something we're going to
37:39
Speaker 1: ask everyone in these series. Clearly universities have played a
37:45
Speaker 1: key role in getting us to where we are today,
37:49
Speaker 1: Right to the extent we can zoom out of the
37:51
Speaker 1: moment and omb and political pressures. Where do you see
37:56
Speaker 1: universities continuing to contribute over the next two hundred and
38:01
Speaker 1: fifty years. Are we do we have the right formula
38:04
Speaker 1: right now that universities are the place this transformational basic
38:10
Speaker 1: research fundamental research should happen. Do we have it right
38:14
Speaker 1: or are there some tweaks that you want to see
38:16
Speaker 1: made to make the next two hundred and fifty years successful.
38:19
Speaker 2: There are certainly tweaks to the system that we have.
38:22
Speaker 2: There are areas that we could definitely improve and streamline,
38:26
Speaker 2: make more efficient. Introducing instability and anxiety and uncertainty is
38:31
Speaker 2: not a great tweak to that system, if I can
38:34
Speaker 2: just say that. But I know that the system that
38:37
Speaker 2: we have is the best way to go because it
38:40
Speaker 2: is the system that is emulated globally. You can also
38:45
Speaker 2: see peer level countries that made different decisions about the
38:50
Speaker 2: creation of just this kind of system that did not
38:53
Speaker 2: achieve anywhere near the same levels of success. The European
38:57
Speaker 2: model looks very different than the US model, looks very
39:00
Speaker 2: different than the Japanese model, looks very different than the
39:02
Speaker 2: Chinese model. What is the model that the countries are
39:05
Speaker 2: now emulating?
39:06
Speaker 4: Ours?
39:07
Speaker 2: Ours is the model that is being emulated. We did
39:09
Speaker 2: not get to talk about the Bidole Act. But because
39:12
Speaker 2: that undergirds all of this system. But the Bidole Act
39:16
Speaker 2: has been recreated in more than sixteen countries since it
39:20
Speaker 2: was passed in nineteen eighty.
39:22
Speaker 4: That's how you.
39:23
Speaker 2: Know you have a good model, one that is really
39:27
Speaker 2: leading to the types of innovative success. To me, I
39:30
Speaker 2: know that I am biased in that I represent research universities,
39:34
Speaker 2: but to me, research universities really are a very telling
39:40
Speaker 2: instance of American exceptionalism. We have knocked it out of
39:44
Speaker 2: the park post World War Two and creating this innovative ecosystem.
39:48
Speaker 2: Are there changes to be made?
39:50
Speaker 4: Sure? Absolutely, we are in a.
39:52
Speaker 2: Very different world than we were in nineteen forty five
39:54
Speaker 2: and that will just continue.
39:56
Speaker 4: And so there is certainly ways to reform.
39:59
Speaker 2: There are ways to streamline different components of the process,
40:04
Speaker 2: ways to make the science better and and to and
40:08
Speaker 2: to bring those that knowledge more openly across the globe.
40:12
Speaker 2: But this is this is something that the US does
40:16
Speaker 2: extremely well. And we know that because as the what
40:20
Speaker 2: is the the Oscar Wild quote, Imitation is the sincarious
40:23
Speaker 2: form of flattery, right, and it is being imitated and
40:27
Speaker 2: in fact, our model is being improved upon by our competitors,
40:30
Speaker 2: most notably China. China has seen, yes, this the research
40:36
Speaker 2: university driven model is the way to go, and they
40:39
Speaker 2: have done nothing but absolutely dump more funding at the
40:43
Speaker 2: national level of China into their research universities, cultivating their
40:47
Speaker 2: next generations of scientists, rewarding those scientists and making sure
40:52
Speaker 2: that they can build careers with certainty and stability in
40:56
Speaker 2: those labs, and funding the next level, the next generation
41:00
Speaker 2: of innovation across both basic, fundamental and applied research. That
41:08
Speaker 2: that's my answer to it to that question. We are
41:13
Speaker 2: universities are going to be an integral part of the
41:15
Speaker 2: next two hundred and fifty years of the United States.
41:19
Speaker 2: It's a really great system that will continue to grow
41:22
Speaker 2: and evolve as our society grows and evolves. But universities
41:26
Speaker 2: have an incredible role to play. We continue to seek
41:31
Speaker 2: to be great partners both to our federal government funding
41:36
Speaker 2: agencies as well as our industry partners. And if anything,
41:39
Speaker 2: many of the challenges that we're currently experiencing will draw
41:43
Speaker 2: industry and university closer together and me as a tech
41:47
Speaker 2: transfer in intellectual property person that heartens me because that.
41:52
Speaker 4: Is really an area where I think we.
41:54
Speaker 2: Can move into the next level of innovation. Is even
41:57
Speaker 2: closer collaborations than we already have with our private sector partners.
42:02
Speaker 1: If we do our job right in the longevity space,
42:05
Speaker 1: we'll have you back on in two hundred and fifty
42:07
Speaker 1: years and we'll see you now.
42:09
Speaker 2: I really need you to get on that, and I'd
42:11
Speaker 2: love to come back on the show in two hundred
42:13
Speaker 2: and fifty years and we'll see.
42:14
Speaker 4: If I was right.
42:15
Speaker 1: I think we'll have you back on much before that.
42:17
Speaker 1: Thank you Kate for taking some time with us and
42:20
Speaker 1: the incredible work you and AAU do on behalf of
42:23
Speaker 1: the innovation ecosystem.
42:25
Speaker 4: Great, thank you so much for having me.
42:27
Speaker 1: That wraps up this episode of the Making Medicine podcast special.
42:31
Speaker 1: Thanks to Kate and to AAU for being a part
42:33
Speaker 1: of our How America Makes Medicine series. Be sure to
42:36
Speaker 1: subscribe on YouTube and follow us on other channels so
42:39
Speaker 1: you don't miss an episode. Thanks for listening, and as always,
42:43
Speaker 1: keep innovating.