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Session 7: Best Practices to Inform National Policy Design and Implementation: Perspectives of
Key Stakeholders in the Biomedical and Public Health Communities
Phil Dormitzer: So I think we're ready to start. I seem to be mic'd as well. So welcome to the next session.
This one is on Best Practices to Inform National Policy Design and Implementation: Perspective of Key
Stakeholders in the Biomedical and Public Health Communities. So this process, I guess, started a couple
years ago now as a debating society, and things were pretty heated. And it's become much more
deliberative.
The next step is actually policy that will be made, although not by this group. However, I think what this
group says and discusses will have a very large impact, particularly the NSABB recommendations will
play a very large role in influencing what that policy is. So this is, I guess, a time to be quite concrete
about what you think would be important to inform that policy, what those policies might be. We're not
here to make policy, but, on the other hand, we've brought together key stakeholders so that that policy
can be informed by the views of key stakeholders of communities.
And I won't give everybody's bios here, because they are in the program, but I think when you read those
bios you'll see that these people are extremely well-qualified to comment from their individual
perspectives. Ethan Settembre has an industry perspective, he is part of a company that has been heavily
involved in pandemic response. Michael Callahan is a physician who organizes the treatment of very high
impact infectious diseases in the field and is also very deeply involved in biosecurity matters. Jonathan
Moreno is a bioethicist and not a biological scientist, but certainly has a lot to say about these issues. And
Robert Fisher is with the FDA, and also deals with medical countermeasures, emerging diseases, and
counterterrorism, and can provide the perspective of a regulator on some of the options for influencing
what goes on in laboratories and elsewhere.
So I guess we'll go in the order of the program. So, Michael, would you like to start? We'll have about ten
minutes per speaker, a brief panel discussion, and then open it up to comments from the audience.
Michael Callahan: Thank you, Philip. I think we're off to a good start because my slides are on a USB
drive which dropped into a boiling hot cup of coffee in Brazil 48 hours ago. And then the second thing
that happened is that all of the case studies that I'll be sharing with you today needed to be signed off for
host country concurrence or institutional concurrence.
The data that we're presenting to you today come from a number of international partners. And I think
what our hope is from our discussion, when our group met, was to expand our thinking here on the NSA
policy activities so we don't have to do it twice or 168 times for each country. But the efforts that are done
here are minimally revised in a way that they meet the cultural and scientific mores of where really the
burden of gain of function activities is really happening.
Many of you will consider that the truthfulness, if you work internationally and if you work in the
industry sector in particular, that the world is flat for bioinnovation. As we know with using our Chinese
colleagues as an example, they have sequenced more viral pathogens in four months than we have in the
entire history of Western Europe and the United States. So the pace and the rapidity of bioevolution and
the increased focus on sovereign health security are driving these unexpected types of gain of function
activities, which are largely beneficent or market-driven. I think we need to keep this in our perspective.
So I'm an ex-Fed, and so there's always a lawyer disclaimer slide, and now, within industry responsibility,
a Sarbanes-Oxley board of directors slide. But I think the humility that I have with you about gain of
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Session 8: International Governance: Opportunities for Harmonizing GoF Research Policy and
Practice
Welcome back to the last of the formal sessions. My name is Ron Atlas. I'm a member of the Steering
Committee, and this particular session is a follow-up to yesterday's session that Barry Bloom chaired on
the International or global aspects of the questions surrounding gain of function.
Yesterday, we really did hear the perspective from Europe primarily with a perhaps more global view
coming from the WHO. But it was very much a discussion of what has been a robust discussion within
Europe on gain of function.
In today's session, we extend our consideration into Asia and the Middle East and Australia. And given
that the three viruses that have been a central focus of discussion in the U.S. and focus of the pause of
funding -- being influenza and SARS and MERS -- it's very appropriate to gain the perspectives from
Asia and the Middle East since that's where those viruses are rapidly evolving naturally and where their
work is presumed to be helping in the eventual prevention of a pandemic caused by some of those strains.
Unlike the previous sessions, none of our speakers brought slides. We're just going to be talking heads-up
here; and we're going to start off with George Gao, China, and ask for his perspective on how, first of all,
China might harmonize with anything the U.S. does; how can there be cooperation; what are the
mechanisms for that; and also to press him a little bit on the perspective for SARS and influenza viral
work.
George?
Gao: First of all, I also would like to thank the organizers who wanted me to be here to share some of our
thoughts, maybe my thoughts, about gain-of-function research. So why do not I have any slides? Because
I found this slide is much better than mine, so I'd like to keep this one. It's the best; I keep it.
The first point I want to make and to discuss with you, I already made something yesterday. So we are
discussing something about the risks and the benefits what kinds of risks we would encounter, what
kind of benefits we can gain from all of this research. So I will give you an example. I mentioned it
yesterday a little bit, but I'll give you an example about H7N9 influenza, which we encountered in 2013.
When you think about the evolution or the mutations of any given viruses, like H7N9, because I'm a lab
guy, I did a lot of work on MERS, Ebola, and influenza for the whole (inaudible). When you try to spot
the mutations in the genome, you can imagine, based on whatever you obtained from previous research,
you thought, okay, this is the mutation, this is the amino acid that might be responsible for the mutation,
for example, for the H7N9 to switch from the avian receptor binding to the human receptor binding.
So then you say, okay, this time what we isolate are so many different kinds of viruses. So we see the
original one, the bind only avian receptor; at the later stage, we've got something better for the human
receptors. But then in place of all this, H7N9, H101, H2 and also the H3 -- so you imagine, the virus will
go that direction. If you have another mutation, that position of the gene, of the H gene, they might obtain
that transmission ability to human beings. But now four years -- it never happened.
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Session 9: Summing Up
Harvey Fineberg, Planning Committee Chair: Weve had a very full two days of discussion. Our plan in
this final session is to invite the moderators from the several sessions through the days to offer their
perspectives, summarizing and perhaps adding from their perspective points that were raised in each of
the sessions.
I do want to allow, then, an opportunity particularly for our friends from the NIH and NSABB for whom,
in effect, we are gathering ideas and assembling these thoughts. If there are any issues or topics or
questions that they would like to raise and invite further comment from those of us who are here in the
program today and in the audience.
And then well open the microphones for additional comments, suggestions, ideas that anyone present and
from the web would like to include in the record. So thats our plan. Im going to launch right in, in order.
Im going to turn first, therefore, to you Chuck, Chuck Haas, for the overview on the policy framework
and key questions.
Haas: Okay. Next slide. So I want to give some big picture summaries of my takeaways with one editorial
comment. So data gaps, particularly on laboratory safety, were thought to limit ability to do an absolute
risk assessment. And we had, I think, a good set of questions from the floor about the need to develop
scholarship and support for those studies. My comment is that those data are not totally absent, and it
might have been informative to use whatever data are out there even though its poor, not exactly in the
laboratories, were talking about how to bound the potential risks that could occur.
If a pure risk acceptable rule is used as a decision, we lack information on what the level of acceptability
should be.
Rocco presented an updated analysis using new data on seasonal versus 1918 influenza, which raises a
broader point, and that is risk assessments in general need to be living, need to be adaptable to new
information as it comes along. And then finally, leaving uncertainty out, and this is Adam Finkels direct
quote, is a violation of first principles. Next slide.
Another quote from Adam is the statement Is it safe is a vapid question meaning its a question
intrinsically without meaning absent a reference level. A hierarchy of potential judgment rules exists.
Both Tony Cox and Adam Finkel made that clear and the explicit judgment of what rule is to be used
needs to be made. Cara Morgan called this deciding how to decide,which seems to be missing is an
explicit statement from the discussion. And stakeholder input needs to be included to develop the decision
rules. he decision analysis community has rich scholarship which needs to be brought to bear, and again
thats from Cara. Next slide.
Tony called the fallacy of coherence. And I use the phrase because it has been accepted doesnt mean
its been acceptable. Just because risk has been accepted in the past does not mean that an informed
judgment going forward would make that same numerical risk acceptable. A useful task would be to
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