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Harvey Fineberg: This is a scientific symposium, organized by the National Academies at the request of
the National Institutes of Health to assist the NSABB and the Nation in preparation for dealing with Gain
of Function research. Over the course of these two days, we'll have an opportunity to speak with one
another about this challenging problem. Our aim is to try to assist the NSABB to prepare its
recommendations to help the nation, and indeed, other nations of the world to deal with the problem. At
this point, I want to welcome, not only those of you that are here, but also all who are listening in on the
Web cast. Look forward to an active and engaging two days with you. To begin our program, we have an
opportunity to hear a welcome and some opening comments from individuals who represent a variety of
pertinent organizations, who are related to the sponsorship and oversight of the work that we're doing in
the course of these two days. First, it's my great pleasure to introduce and to welcome the President of the
National Academy of Sciences, Dr. Ralph J. Cicerone. Ralph, the floor is yours.
Ralph Cicerone: Thank you, Dr. Fineberg. Welcome to the National Academy of Sciences building. Over
the years, in this building, there have been convened any number of discussions, such as this, on
important topics of the day, and sometimes of the decade, where scientific underpinnings of an area with
great potential benefit also lead to complexities. So, in one sense, this kind of discussion is common here.
Nonetheless, we're very, very happy to host all of you from so many different countries, and different
parts of the United States, as well as the Web presence that Dr. Fineberg just mentioned. The meeting is
sponsored by the National Institutes of Health Welcome Trust, and the McArthur Foundation, we're very
appreciative of their stepping forward on these occasions. Excuse me. I am aware of some of the
controversies in GoF research and policy brought forth by people with very different points of view who
see different ways to weigh the potential benefits versus the potential risks of this kind of research, so the
discussion should be very interesting today.
And, as Dr. Fineberg just said, a major goal of this gathering is to allow people to discuss these different
points of view, and to respond to draft policies from the National Scientific Advisory Board on
Biosecurity, which we refer to as NSABB, because they definitely want to hear from scientific
community medical professionals and the public to find out how policies might maximize the benefits of
this research, while minimizing the risks. Well, here at the National Academy of Sciences, and the
National Academy of Medicine, and our National Academy of Engineering, we're very pleased to do a
small part in convening this distinguished group, and we look forward to the discussions. There's nothing
like informed public opinion to hone public policies, and occasionally to review them. So, thank you once
again, and Dr. Fineberg, thank you for the opportunity to be here.
Thank you very much, Ralph. It's now my pleasure to call upon Margaret Hamburg, the Foreign Secretary
of the National Academy of Medicine for greeting, on behalf of the NAM. Thank you.
Peggy Hamburg: Well, thank you very much. It's a pleasure to be here. I want to echo the welcome of
Ralph Cicerone, the distinguished President of the National Academy of Sciences. And, I'm representing
Victor Dzau, the President of the National Academy of Medicine, formerly known as the Institute of
Medicine, and as was mentioned, I am now the Foreign Secretary. The topic of this meeting is one that is
enormously important with ramification for other areas of research, and certainly for other parts of the
world as well. It's one that I've actually been involved with for a number of years from a number of
different perspectives, and I was just reflecting that actually, back in 2002, I worked for a foundation that
funded a project, a committee on research standards and practices to prevent to prevent the destructive
application of bio-technology, that then released a report in 2004, that became finally known as the Think
Report. But, it was that report that actually made a recommendation, a set of recommendations, but that
led to the creation of the NSABB.
Harvey Fineberg: We can move directly into our first session, which is an overview of the draft NSABB
policy framework, and the key questions that we're going to be trying to come to grips with in the course
of our time together today and tomorrow. As was evident from Carrie's remarks particularly, the NSABB
is moving down the final common pathway toward the development of guidelines and recommendations
for the conduct of GoF research, its support and, indeed its dissemination. All of these were factors of
consideration in the NSABB deliberations, and we're very fortunate to be able to begin this session with
an overview presentation about the NSABB state of progress, by Samuel Stanley, who is the chair of the
NSABB. Dr. Stanley, the floor it yours. After you finish, stay up here and we'll have a conversation.
Thanks.
Sam Stanley: So, good morning everyone. I want to begin also by thanking the National Academies for
organizing this meeting. I think the first GoF symposium, hosted by the Academies, played a very
important role in informing NSABB's recommendations for the risk benefit assessment, and I'm really
looking forward to a very informative meeting over the next two days. Am I audible OK in the back? Yes?
Great, thank you. So, I'm going to be discussing NSABB's progress towards developing recommendations
about the funding, and oversight of GoF studies. Since the (inaudible) process, over one year ago as
you've heard, the board has been extremely busy. In January, we released and discussed our draft report,
which contains our preliminary findings and recommendations. I'm going to provide a brief overview of
that report. I would also point out to you the entire report, which I think has been available, both in front,
and is available on our website. I have to tell you that a tremendous amount of effort went into that report,
I'm very pleased with it at this stage, but of course it's not finished. It's a draft, as we said, and the
discussions today and tomorrow will be critical to our deliberations moving forward, and I hope will help
us to finalize our recommendations.
At the end of my presentation, I'm going to present a few outstanding issues that hopefully will be
discussed over the next few days. And again, these are vital to our deliberations. As you've heard on
October 2014, the NSABB was issued a two-part charge related to GoF studies. First we were asked to
advise on and design the conduct of risk and benefit assessments for GoF studies. The board
accomplished this task in May of last year, when we approved our framework for conduction risk and
benefit assessments. This framework served to guide Gryphon Scientific, as they conducted the risk and
benefit studies. Our second task was to provide recommendations to the United States government on a
conceptual approach for evaluating proposed GoF studies. My presentation, today, focused on these draft
findings and recommendations. The major elements of the NSABB draft reports are shown here. In
addition to our findings and recommendations, it also describes our analysis of the risk benefit
assessment, and our examination of the current policy landscape. We also devote a section to the
discussion of ethical values that are important to consider when funding certain GoF studies. The report
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Barry Bloom: The next session, please. It is very gratifying that much of the discussion of the earlier
sessions focused on questions regarding not only U.S. policy but the implications of that policy more
globally, and the recognition that science can be done in so many different places, with the potential for
good and harm; that it really is important to think about how, if there are possibilities for harmonizing
policies, regulations, and approaches to the questions of gain of function and other kinds of research.
First off, I would like to say we have an extraordinarily distinguished panel, and I wanted to thank each of
them for coming long distances to be able to participate in this meeting. Basically what I would like to
have them do, if they would, is to talk about how their agencies, organizations, councils, or countries have
thought about this issue, and their policies that have been developed, and recognizing that not only are the
gains and benefits from biomedical research universal but so are the risks for the people in different parts
of the worlds who have not contributed to the science or given their permission to do these experiments.
So we have both global opportunities and obligations.
And so if they would comment on how their organizations and agencies have thought about it. And if they
thought there were possibilities for harmonization of those, I would ask to what extent is whatever
policies the NSABB of the United States government agrees upon, to what extent will that be helpful and
influential, and to what extent, if there were such defined policies, they think there could be some
harmonization.
So with that is an introduction, I'd like to introduce Dr. Ruxandra Draghia-Akli from the European
Commission, if she would make a presentation of how they felt about it.
Draghia-Akli : Thank you very much for the introduction, and thank you for inviting us to give our
perspective, and, from my point of view, the European perspective on the issues linked to the gain of
function and dual use.
So I will start with a very brief presentation of our Research and Innovation Program because probably
many of you are not familiar with the intricacies of that, then the funding, or, to be more precise, the nonfunding of the gain of function, and we'll use research in this context. The ethics review, which is
intrinsically component of our review, not only for the gain of function and dual use but by and large for
all the projects that are submitted for funding under our programs, and then some considerations related to
the member states, the stakeholders in Europe, and their perspective on gain of function and dual use.
So Horizon 2020 is a very nice name for the European Union programs for research and innovation for
the period of 2014 to 2020. It has a budget of about $80 billion Euros, and, indeed, it has rationale that
research and innovation is very complex. This program is not addressing issues that can be addressed at
the national level, but, rather, a part is looking at funding similar to the National Science Foundation in
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