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Transcript for EDO Plenary - Doane

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Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION

Title:

33rd Regulatory Information Conference (RIC):

Plenary Session with the NRC's Executive Director for Operations Docket Number: N/A Location: teleconference Date: Monday, March 8, 2021 Work Order No.: NRC-1420 Pages 1-37 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005 (202) 234-4433

1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 + + + + +

4 33RD REGULATORY INFORMATION CONFERENCE (RIC) 5 + + + + +

6 PLENARY SESSION WITH THE NRC'S EXECUTIVE DIRECTOR FOR 7 OPERATIONS 8 + + + + +

9 MONDAY, 10 MARCH 8, 2021 11 + + + + +

12 The RIC session convened via Video 13 Teleconference, at 12:45 p.m. EST, Margaret M. Doane, 14 Executive Director for Operations, OEDO presiding.

15 16 PRESENT:

17 MARGARET M. DOANE, Executive Director for Operations, 18 OEDO 19 JOHN MASCOLA, Director, Vaccine Research Center, 20 National Institute of Allergy and Infectious Diseases, 21 National Institutes of Health 22 RAYMOND FURSTENAU, Office Director, RES 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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2 1 P R O C E E D I N G S 2 12:45 p.m.

3 MR. FURSTENAU: Welcome back, everybody.

4 I hope you all had an enjoyable lunch break. There 5 is great weather in D.C. this afternoon, so, Margie, 6 hopefully we are not competing with the great weather 7 and people are staying inside to watch this plenary 8 session.

9 I am Ray Furstenau. I am the Director of 10 Nuclear Regular Research and I am very privileged to 11 introduce this afternoon's plenary session hosted by 12 our Executive Director for Operations, Margie Doane.

13 I will first introduce Margie and she'll 14 share some remarks with us and Margie will introduce 15 our guest, Dr. John Mascola, who is the Dale and Betty 16 Bumpers Vaccine Research Center Director, and he will 17 share his thoughts on what we can learn from the vaccine.

18 And so with that Margie Doane as most of 19 you know has been our Executive Director for Operations 20 since July of 2018 and before that she spent about 30 21 years with the NRC in various roles, our OGC, as well 22 as our international program.

23 So with that, Margie, I will turn it over 24 to you. Thank you.

25 MS. DOANE: Okay, all right. Thanks for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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3 1 that introduction, Ray, and hello. I am so excited 2 to be here with you today. I can't see you, but 3 hopefully I am coming in loud and clear at our first 4 ever virtual RIC.

5 So for this session I am going to begin 6 with a traditional look back to give you a sense of 7 the NRC's experience over the past year to provide you 8 a clear picture of the remarkable work carried out by 9 the NRC staff.

10 I am very grateful and extremely proud of 11 their resilience and incredible commitment to our 12 agency's important mission.

13 After this brief overview I will be joined 14 by our esteemed guest, Dr. Mascola, as Ray was saying.

15 Next slide, please. What a year it has been. For 16 us it was a year of feats and firsts.

17 We faced extraordinary circumstances with 18 the pandemic and other social issues that put us in 19 unchartered territory navigating a very dynamic 20 environment, yet this didn't stop us.

21 In time we found our footing and gained 22 confidence as we learned how to adapt and pivot to adjust 23 course. All across the agency we achieved some rather 24 remarkable feats and realized some first-of-a- kind 25 successes.

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4 1 For example, the all virtual environment 2 was wildly successful on day one due to the advanced 3 work we had been doing all year. We didn't just survive 4 last year, we hit our stride.

5 Next slide, please. Even if the pandemic 6 hadn't occurred this would have been a challenging year.

7 We had set numerous ambitious goals for the agency 8 and we were very successful with major accomplishments 9 while also continuing to do the routine work to meet 10 our important health, safety, and security mission for 11 the American people.

12 These successes were in part a result of 13 our ongoing transformation efforts which have become 14 a part of our agency's organizational fabric. Building 15 off the transformation infrastructure we have been 16 using tools we created earlier to help us work in new 17 ways.

18 I am very proud of all that we have 19 accomplished. I would greatly enjoy going over all 20 of our major accomplishments but with so little time 21 I can only highlight a few.

22 Next slide, please. Let me turn to the 23 area of reactors. In reactors we carried out licensing 24 and oversight activities virtually and in person and 25 innovated many of our processes.

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5 1 This slide lists some of them, including 2 issuing a first-of-a-kind design certification for the 3 NuScale SMR while working remotely and with a relatively 4 late design change, approving a new rulemaking plan 5 for licensing non-light-water reactor technologies 6 that can be tailored to each advanced reactor design, 7 and addressing, sometimes on immediate basis, issues 8 that arose during the pandemic to continue to protect 9 the health and safety of the NRC and licensee personnel 10 while still meeting our regulatory responsibilities.

11 Next slide, please. In the materials area 12 we continue performing licensing and oversight 13 activities in a hybrid manner, upheld our commitment 14 to public engagement in the regulatory process by 15 hosting several virtual public meetings, and identified 16 ways to streamline our rulemaking process.

17 Along with many others this slide lists 18 several accomplishments, including further developing 19 and following our plan to guide the eventual review 20 of advanced fuel designs and innovating our inspection 21 programs to help ensure resources are appropriately 22 focused on the most risk significant issues.

23 Next slide, please. In the corporate area 24 we streamlined business processes, enhanced our work 25 environment, and improved our information technology NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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6 1 and information management processes all while keeping 2 the staff safe and our building clean.

3 This slide shows a few of these 4 accomplishments, including launching an eBilling 5 system to improve the efficiency of the fee billing 6 process, completing numerous space planning and 7 facilities projects to improve our fiscal work 8 environment, and upgrading our information technology 9 software and user tools and platforms.

10 Next slide, please. Now I know the 11 Chairman talked this morning about transformation so 12 I am not -- I don't really have much time here to talk 13 about it, but also I don't need to say much more because 14 there has been a lot of discussion already, but let 15 me just give you a brief summary.

16 We have continued our journey to become 17 a modern risk-informed regulator. Our journey as you 18 might remember began three years ago when we conducted 19 a Futures Assessment and hosted our first ever all 20 employee virtual jam conversation across the agency.

21 We identified potential challenges, areas 22 for improvement, and how to best prepare for a 23 successful future.

24 From these efforts we identified four focus 25 areas, our people, risk, innovation, and technology, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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7 1 and we developed corresponding initiatives.

2 Some of our accomplishments include 3 building a best in class innovation program called 4 Innovate 2.0 by benchmarking other federal agencies, 5 like NASA, they have an incredible program, and powering 6 it with the IdeaScale technology platform. To date 7 over 70 percent of our staff has signed on.

8 Developing the Be riskSMART framework to 9 manage how we address risks in our decision making, 10 and this was key to us pivoting and being effective 11 during the pandemic at answering new and emerging issues 12 that arose.

13 Deploying a collaborative software and 14 holding numerous online training sessions to encourage 15 agency-wide technology adoption, which helped us 16 quickly transition to working remotely during the 17 pandemic.

18 Also, launching the Career Enhancement and 19 Employee Journey platforms to empower and encourage 20 staff to take control of their careers, and onboarding 21 our first nuclear regulatory apprenticeship network 22 class with graduating seniors. We call this NRAN.

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8 1 ability to leverage data.

2 Next slide, please. So there is so much 3 to check out and learn about our transformation journey 4 so we created a digital exhibit, and that's what this 5 slide is depicting.

6 It's called the NRC's Transformation 7 Journey and Interactive Timeline. As you can see on 8 the slide you see some circles, if you click on any 9 of those graphics you will hear from our NRC employees 10 about their initiatives and learn about the 11 transformation achievements.

12 Next slide, please. At the RIC two years 13 ago I was asked what I saw as some of the agency's most 14 significant challenges. I mentioned then that our 15 pipeline for new employees needed attention.

16 Since then we developed the new NRAN 17 program as I was just discussing and have developed 18 our first class, have onboarded our first class, and 19 increased our pipeline, but it will take years to get 20 to where we need to be in light of our downsizing and 21 the wave of retirements we anticipate in the future.

22 Our goal is a diverse and inclusive 23 workforce that also you heard from the Chairman this 24 morning, one that is ready for challenges of today and 25 tomorrow, but more than 40 percent of our workforce NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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9 1 is retirement eligible in five years.

2 The industry and other federal agencies 3 are facing the same statistics and so we have to compete 4 with them to continue to recruit and retain the skill 5 needed, so recruitment and retention remain a focus.

6 Our people are our most important asset.

7 Enhancing our decisions in the way we work 8 with the best data and technology will be crucial.

9 We are currently having success breaking down silos 10 in information and digitizing millions of old 11 documents. This is just a start.

12 We are currently working on an agency data 13 strategy and an IT roadmap that will ensure we are ready 14 for what the future brings. We have to continue to 15 be risk smart to make sure we are taking a balanced 16 approach across all technical, legal, and corporate 17 areas.

18 We especially need to continue to make good 19 regulatory decisions for the existing licensees but 20 also give the appropriate attention to important 21 projects like the Vogtle Project and make strides in 22 the areas of new and emerging technologies, including 23 advanced reactors, fuels, and medical technologies.

24 And, finally, we have to complete our 25 initiative on getting to the agency's desired culture, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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10 1 one that appreciates differing views and perspectives, 2 is diverse and inclusive and open to new ideas.

3 As I said I am very proud of the NRC staff 4 and all they have accomplished due to the teamwork, 5 the new emerging work, and to make tremendous strides 6 in our transformation during a pandemic. The American 7 people have been well served by their efforts.

8 Okay. Now let me transition because I want 9 to bring on our very distinguished guest. So that 10 concluded my prepared remarks. So our guest today is 11 Dr. John Mascola.

12 He is the Director of the Vaccine Research 13 Center at the National Institute of Allergy and 14 Infectious Diseases at the United States National 15 Institutes of Health.

16 He leads the scientific and clinical 17 research activities of the Vaccine Research Center 18 where he develops vaccine research programs for 19 diseases including HIV, influenza, Ebola, Marburg, 20 Malaria, and, of course, COVID-19.

21 Dr. Mascola serves as the Principal Advisor 22 to the Director of the National Institute of Allergy 23 and Infectious Diseases and is a recognized national 24 and international expert on the development of novel 25 vaccine and prevention strategies. Welcome, Dr.

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11 1 Mascola.

2 DR. MASCOLA: Margie, it's very good to 3 be here. I look forward to the discussion.

4 MS. DOANE: Okay. Well, we are so pleased 5 and grateful that you were able to take time to 6 participate in this year's RIC given how incredibly 7 busy you are right now.

8 I learned firsthand about how busy your 9 schedule is. I don't know if you know this, but I had 10 called your house to ask you to join our session today 11 and your wife, Lucy, very kindly told me that you weren't 12 available because Dr. Fauci had you working on the 13 so-called South African variant.

14 So all I could think of at that time was 15 I shouldn't be distracting you. So we cannot, you know, 16 we are just so thankful you are here and we can't begin 17 to imagine what it has been like to be catapulted into 18 the middle of an international health crisis, but I 19 know you are no stranger to this.

20 So I thought it would be interesting to 21 kick things off by having you share a bit about what 22 last year has been like for you.

23 DR. MASCOLA: Well, sure. Well, first of 24 all, thank you very much for the invitation, and it's 25 really a pleasure for me to take some time to talk to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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12 1 my federal colleagues.

2 When you first emailed I have to admit I 3 wondered if our experience would be that interesting 4 to all of you, but I hope so and I hope there is some 5 lessons learned.

6 Certainly the last year has been exciting, 7 it's been challenging, it's been gratifying. In many 8 ways it's something we should be prepared to do, like 9 in our center, at the NIH, the institute that we are 10 housed under it's called the National Institute of 11 Allergy and Infectious Diseases and we are a vaccine 12 research center.

13 So I hope that we had been thinking ahead 14 and preparing for the emergence of a new infectious 15 disease, and I think we were. So in many ways it was 16 an opportunity to show what we can do, but at the same 17 time it posed extraordinary challenges to pivot the 18 resources that were needed to really bring to bear what 19 needed to be done.

20 I can go into more of that, but I can't 21 think of a more challenging year in all of my years 22 of federal service.

23 MS. DOANE: Well I think hearing that from 24 you it's, I don't want to say comforting, but at least 25 we know that this was unusual and that it stressed even NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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13 1 the best experts, but, you know, we all can't imagine.

2 And, like I said, I think we can get more 3 into some of these issues and how we can learn from 4 your experience, so let me turn to some other areas 5 now. We really appreciate you sharing that, your 6 experiences with us.

7 So just a few minutes ago I ended my 8 presentation noting what's on the horizon for NRC, 9 including some challenges we need to be mindful of in 10 order to be best prepared for the future, whatever it 11 may bring.

12 And with that in mind I have some questions 13 I would like to pose to get your insights and ideas 14 on how as a senior government leader you are planning 15 to address these challenges at your own organization.

16 Okay, so I think -- You asked me to call 17 you John, so, John, I am going to turn to the area of 18 innovation.

19 DR. MASCOLA: Please.

20 MS. DOANE: The NRC, as you might have 21 heard from my brief discussion, is re-thinking how it 22 can conduct its regulatory mission in the future to 23 ready itself for reviewing new reactor technology for 24 existing facilities with new digital instrumentation 25 and controls and advanced reactor and fuel technology, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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14 1 and there is many other things, too, but the paradigm 2 is shifting in nuclear.

3 This has stretched our thinking to ensure 4 we are being open and innovative in how we meet these 5 new challenges. As your team worked to find a vaccine 6 it must have been and probably continues to be a very 7 stressful environment and yet it's my understanding 8 you collaborated globally and brought creative 9 solutions forward that eventually identified things 10 like the protein that led to the successful development 11 of the vaccines.

12 It would be very helpful to our staff and 13 the audience if you could share one or two 14 organizational efforts you pursued to spark creativity 15 and collaboration in your team especially during the 16 pandemic that necessitated social distancing. We 17 forget that you had to deal with the same thing we did.

18 DR. MASCOLA: Absolutely. So, you know, 19 innovation is at the heart of what we do. We are a 20 scientific discovery organization so we are an 21 interesting hybrid at the National Institutes of Health 22 in that generally speaking scientists at the NIH are 23 involved in basic science discovery, so that's 24 innovation, but we have a mission as a vaccine research 25 center which is to translate innovation, translate it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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15 1 into products.

2 Our mission is formally to do research that 3 leads to the development of vaccines and therapeutics 4 for infectious diseases.

5 So in a sense, as I mentioned earlier, this 6 is something that, responding to an epidemic is 7 something that we've thought about and tried to prepare 8 for. Even still it posed substantial challenges for 9 us.

10 So early on in the early days of 2020 we 11 heard about this new Coronavirus emerging and we had 12 been through prior examples of epidemics, it could be 13 Ebola and it could be Zika, and each time we had to 14 decide as an organization how much of our resources 15 would pivot to address that new threat, that new 16 problem, and at the same time maintaining all the other 17 mission areas that we are trying to accomplish.

18 So in our organization we are trying to 19 develop a universal influenza vaccine or a Malaria 20 vaccine or an HIV vaccine and I think as you all know 21 that resources and personnel are not infinite.

22 So we had discussions early on about how 23 much of our resources we would pivot and what we decided 24 as soon as it became apparent that we were in the middle 25 of an emerging global pandemic is that we would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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16 1 essentially take an all-hands approach.

2 We have scientists that do by their nature 3 discovery and innovate and we thought that the best 4 approach would be to take a fully integrated approach 5 to bring all scientific expertise that we had available, 6 so people who have expertise in virology and immunology 7 and making vaccines together, with our major programs, 8 we have programs in clinical trials and vaccine 9 development, and to come up quickly with a couple of 10 key mission areas of interest for us.

11 So develop a vaccine was one, bring it into 12 a clinical trial quickly was another. The third one 13 though was to quickly partner with the full spectrum 14 of the U.S. Government activities, which is what ended 15 up being Operation Warp Speed.

16 And so I think for us it was a balance of 17 allowing the scientists that we have to work, do their 18 discovery, but quickly integrate it all into a very 19 strategic sort of integrated approach to respond.

20 MS. DOANE: Wow. Well, it sounds, you 21 know, very similar to what we have been trying to do 22 to address some of our most difficult questions but 23 on a global and much larger scale and in a very short 24 timeframe, but that's incredible, John.

25 Okay. Let me turn to the area of risk.

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17 1 Both the NRC and NIH have missions that include 2 protecting public health and safety and this is a very 3 important responsibility that our organizations have 4 in common and I know inherent to any decision is risk 5 simply because it is impossible to predict outcomes 6 with absolute certainty yet we know not every decision 7 carries the same level risk and if we are not cognizant 8 timely decisions can become victim to, we say analysis 9 paralysis, but, you know, that might be too negative.

10 But sometimes when it's the more difficult 11 the decision the longer we spend on it and when you 12 don't have time, you know, you really, I'm sure you 13 have to use really different ways of approaching and 14 balancing all the issues you have before you.

15 So I think on this topic it would be really 16 helpful if we understand what you have done in your 17 organization to empower your employees at all levels 18 to feel comfortable and confident in integrating 19 well-managed risk into their decisions. I'm sure that 20 that may be different to do that.

21 DR. MASCOLA: Sure. So, you know, I would 22 say for us risk is an interesting hybrid. One never 23 knows in the infectious disease world what kind of 24 emerging virus may show of itself.

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18 1 assessment of the global risks out there and try to 2 be prepared, but no matter what you do it will never 3 be perfect.

4 So we have people in the organization, 5 often young scientists who have discovery projects and 6 their own research, and what we try to do at both the 7 leadership level and as an all-staff level is be pretty 8 transparent with our strategy, our strategic plan, so 9 that each of the parts that are integrated into that 10 in the long run understand where they would fit.

11 So what's risk to us is working on something 12 which ends up not being important, having a whole 13 portfolio of scientific discovery that doesn't come 14 to fruition, but an example is we took a risk on having 15 a Coronavirus program because we knew that there had 16 been other human coronaviruses even though they weren't 17 all that major, and they were SARS and MERS, which 18 everyone has heard of.

19 And so part of our risk mitigation strategy 20 was first at a leadership level to say given our 21 expertise and our mission how can we best be prepared 22 for emerging threats, and that was one of the areas 23 that we discussed not only as a leadership group, but 24 when we discussed it with our full staff we had younger 25 scientists fortunately who said, hey, that's an area NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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19 1 for me, there is not a lot going on in that area, but 2 I would like to develop a research program.

3 So for us, you know, and I could give you 4 examples of where we've forayed into areas where it 5 didn't end up that we needed to do very much and all 6 we did, and I say all we did, was we did some research 7 discovery.

8 But then there are other areas, and they 9 would be Zika, it could be Ebola, it could be 10 Coronavirus, where the research program was in the right 11 place at the right time and we could pivot towards a 12 public health indication.

13 So I think for us it's really a matter of 14 the strategic planning, thinking together about what 15 we want to do, and then communicating that broadly 16 enough that people they feel like no matter what they 17 are doing they understand how the parts fit together.

18 MS. DOANE: So let me follow up just a 19 little bit, did you already have sort of your eye on 20 coronaviruses as a general matter before the pandemic, 21 is that what you were --

22 DR. MASCOLA: Yes. So we've spent a lot 23 of time, we've put together a pretty robust strategic 24 planning and development group that helps us think 25 through scientifically what our areas of mission focus NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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20 1 should be.

2 So one can never do anything. We could 3 never be prepared for every possible threat. So we 4 have tried to take, again, an inclusive enough strategy 5 to have the potential to be prepared.

6 And when we look at a portfolio of what 7 could emerge as an epidemic one interesting aspect is 8 that if you take all the virus families in the world 9 that infect people it's actually a finite number.

10 It's not thousands and thousands. There 11 is about 20 or 25 major families of viruses that infect 12 people. So you could put Zika in one family and Ebola 13 in another family and Coronavirus is another family.

14 So one thing we said was if we are exploring 15 the discovery space and understand what we would want 16 to do in the vaccine space for these major high risk 17 virus families we'll at least be -- we won't know what 18 we'll emerge.

19 We'll never know it was this particular 20 coronavirus, but we can say, you know, a coronavirus 21 may be a problem and we'll be prepared, we'll know what 22 type of vaccine response, we'll understand already what 23 the spike protein of coronaviruses look like.

24 So we spend a lot of time, which is a little 25 bit unusual for NIH I think because NIH is mainly about NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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21 1 discoveries, we've spent a lot of time in strategy 2 sessions and strategic planning in deciding how we would 3 approach that particular problem.

4 MS. DOANE: That's incredible. And, you 5 know, that is a very good lesson, so thank you for 6 sharing that. It's a good lesson to think about how 7 important strategic planning is and to be open to things 8 that may not appear on the horizon to be there today 9 but to be, I mean it almost seems impressive.

10 I mean it's really impressive that you have 11 your, that NIH had the forethought to think in those 12 terms. It's amazing.

13 So once you got into the environment where 14 you were day-to-day trying to develop the vaccine and 15 it was getting more and more important to do that, I 16 know, you know, the whole nation really we were hanging 17 our hopes on the finding of the vaccine, how did it 18 affect your organization's experience?

19 You no doubt were under extreme pressure 20 and short deadlines, and so, again, how did you, you 21 know, just keep moving and make sure that people, you 22 know, knew that they shouldn't worry so much about 23 their, you know, that there are some risks that you 24 can take, right, some risks that you can take without 25 the mistake being so great that it undermines something NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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22 1 really important and you really have to do that, right, 2 you need an absence of fear.

3 So can you tell us a little bit about what 4 that was like in your experience last year?

5 DR. MASCOLA: Sure. You know, especially 6 early in 2020 this aspect of what you are asking about 7 was really quite stressful because the pressure was 8 intense to produce and generate data to test new 9 vaccines in the lab and get the right kind of data that 10 would allow the forward advancement, the clinical 11 advancement.

12 We were working on therapeutic antibodies 13 for COVID also. We needed people to working almost, 14 you know, in a non-COVID time more than full-time, and, 15 of course, we were at, you know, one-fifth or one-sixth 16 person space.

17 And so we really had to have intensive 18 communications with our group and our scientists to 19 say first and foremost if we do anything unsafe or if 20 we make a mistake and people get infected then we are 21 not going to be able to execute the mission.

22 So we have to really all understand and 23 work together to be safe. In the earlier days it wasn't 24 so clear what that means and it was a lot of personal 25 responsibility, so we emphasized that.

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23 1 And then, you know, when people understand 2 the mission, you know, we want to develop data so that 3 this vaccine can advance or this antibody can advance, 4 they were really remarkable about adjusting.

5 We essentially went to shift work, you 6 know, I'd probably say four or five, it's hard to even 7 know, I mean there were people who worked the midnight 8 to 6:00 shift.

9 We can't be in the same place at the same 10 time and we use, you know, biosafety cabinets to work 11 and these are confined laboratory spaces. The only 12 way to do that was to shift space.

13 And people also were working intensively 14 for weeks at a time, so the other thing we had to do 15 was come together, have people present updates on where 16 they were and say to the group sometimes, okay, now 17 take a few days break.

18 We know that you want to move on to the 19 next thing but you've done this part and we're going 20 to take a breath and then we're going to reset and go 21 on to the next thing.

22 So even really I think it was a constant, 23 it was sort of a constant work and effort with a really 24 great staff, and we have an associate director for 25 management and operations to work with me and our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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24 1 leadership to stay in constant contact with all staff.

2 MS. DOANE: That really is an incredible 3 story, John. So I could ask you a lot more questions 4 about risk, but I am going to push myself to pivot 5 because I am going to try to hit some of the areas where 6 I said our major challenges are going to be over the 7 next year.

8 Let me turn to technology. It's always 9 changing at an incredible pace and within the government 10 technology has been essential and you have talked about 11 some of the things that you've had to do to achieve 12 important objectives and missions.

13 So let me ask you, how does your 14 organization, and I think you've touched on this 15 somewhat, you know, you've told us about good strategic 16 planning that led to really you being prepared, like 17 maybe this had been years and years of preparing for 18 this very thing without knowing, you know, what exactly 19 is coming on the horizon, but how do you make sure that 20 your organization keeps it edge, you know, making sure 21 that you are using the best and logical solutions, how 22 do you do that?

23 DR. MASCOLA: Yes. Well, a couple things.

24 To me this has been -- Part of my job in leadership 25 is to make sure that we stay on the cutting edge of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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25 1 science and it's a balance because we have, and I think 2 in most areas of federal government, you have really 3 top tier scientists that are working, researchers that 4 know their field, and one has to allow a certain amount 5 of freedom to operate for a brilliant scientist.

6 First of all, or else they won't stay if 7 they're not, you know, they'll go elsewhere. And so 8 you have this balance of allowing people to innovate 9 and explore scientific space and yet having it 10 coordinated enough that we can execute a mission.

11 One of the ways we do that is I have always 12 taken what I think is a very, an inclusive management 13 and decision-making style, which is to say as a group 14 you are all innovating, you are making discoveries, 15 and we have certain areas that we agree.

16 We absolutely want to make a better 17 influenza vaccine and we want to be prepared for another 18 Disease X and how do we bring all of our expertise 19 together and then what we try to foster and what happens 20 is when you have a group of brilliant scientists working 21 towards a mission you get some crowdsourcing and then 22 you bring in the younger scientists, which we have 23 always found pivotal, you really want to engender them.

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26 1 do everything and certainly for the advanced 2 development of vaccines a lot of that technology lies 3 in the private sector.

4 So we have really focused in the last few 5 years in developing partnerships with the private 6 sector where we would jointly do scientific discovery.

7 We have our method or our mechanism is called a 8 Cooperative Research and Development Agreement where 9 we can work together.

10 If something emerges from that we would 11 have partnerships in several areas, first of all, where 12 there is back and forth innovation, they can innovate 13 in areas where we can't and vice versa, and, second, 14 there is an opportunity to advance a product.

15 That is harder to do in government. It 16 is better suited to the private sector.

17 MS. DOANE: Hmm. Well, okay. Well, let 18 me as a follow up to that, because you touched on a 19 little bit about that, you know, the talent and 20 competing for resources and that is across the 21 government.

22 We are having the same trouble, or I guess 23 I would say the same challenge is that, you know, we 24 compete with private companies to hire a relatively 25 small pool of individuals with very specialized NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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27 1 skillsets, you know, because nuclear also, you know, 2 and probably we might even have a smaller set.

3 So tell me your thoughts on how you attract 4 and retain a diverse and highly skilled workforce, 5 because I think we also share that same challenge?

6 DR. MASCOLA: We do a few things. I think 7 fortunately NIH retains somewhat of an aura of a place 8 of, you know, world class research and that does 9 continue to draw in young talent.

10 We also really work hard to facilitate and 11 allow resources that are hard to match. While we can't 12 always compete on certain areas, like salary or other 13 benefits, we can be almost second to none in scientific 14 resources and innovation that we can sort of have 15 available to young scientists to do their job and to 16 innovate.

17 Beyond that I think it's the mission that 18 people come, you know, into our center because they 19 have their own personal vision of wanting to contribute 20 to the public health to be able to develop a vaccine 21 and to see their work develop, to come to fruition.

22 And we emphasize that, that if you worked 23 on Ebola as a disease and it turns out that that work 24 ends up as it did, developing an antibody that can be 25 used to treat that disease, you can see your work come NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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28 1 to fruition because we have that capability to bring 2 it all the way to the clinic and partner and get it 3 developed.

4 So I think that combination of elements 5 helps us attract and retain some of the best scientists.

6 MS. DOANE: You know, we find something 7 similar in that we have, you know, we have a very 8 important mission and whenever we do surveys or anything 9 that we, any conversations that we have with the staff 10 that's one thing that we find that we are all joined 11 by this really important mission.

12 So I think that does go a long way because 13 like you said it's not going to be salary, and sometimes 14 it's not lifestyle when you are under a tremendous 15 pressure, but the mission, our staff is so committed 16 and I know yours is as well.

17 I know there is federal workers all over 18 the country with really the same dedication and 19 commitment.

20 So, okay, I am going to have to drag myself 21 away from this conversation with you, John, because 22 I would like to ask you a lot more questions, but, Ray, 23 I think it's probably time for us to take some questions 24 from the audience, is that right?

25 MR. FURSTENAU: Yes, that's right. So I'm NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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29 1 going to -- We've got a lot of questions so I might 2 combine a couple of them that are similar. This one 3 is for you, Dr. Mascola.

4 It's kind of a combination of a couple of 5 questions. With the COVID-19 vaccines that we are 6 hearing, you know, from Pfizer and Moderna and Johnson 7 & Johnson, what part did NIH play in that?

8 Were they discovered at NIH or were they 9 developed by the manufacturers? And in discussing that 10 how do you run, do you run into like proprietary issues 11 that you have to deal with as a federal agency and how 12 do you keep things moving when you have all of those 13 added complications with your public private 14 partnerships?

15 DR. MASCOLA: Sure. You know, this 16 particular story I think is a great story, especially 17 for those in federal service.

18 The NIH discoveries, and that includes some 19 of our academic collaborators at some major 20 institutions, for COVID was an understanding of exactly 21 how to design the vaccine.

22 So I think everyone understands now or sees 23 the great pictures of the Coronavirus and the spiked 24 protein on top. That spike protein in structural terms 25 is a metastable protein.

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30 1 It doesn't like to behave. It doesn't 2 hangout in the right shape. So it started out by 3 actually turning to structural biologists, 4 crystallographers, and cryo-EM structural biologists, 5 who solved the structure of that protein and looked 6 at it at the atomic levels and then you could look at 7 it in three dimensions as you all have seen.

8 And we could see why it is metastable and 9 why it doesn't stay together very well and that is part 10 of because of its function as a protein and by 11 introducing very specific mutations we learned how to 12 stabilize it in the laboratory and allow that it to 13 be encoded in the vaccine so then when you give it as 14 a vaccine it has the exact right shape that it needs 15 in the nature for the immune system to see it.

16 So that discovery of how to design the 17 vaccine was essentially adopted by most major vaccine 18 manufacturers. So whether they use RNA to encode the 19 gene in the protein or they just made the protein itself 20 they used the NIH design.

21 So I think that's a great story of how 22 scientific discovery can make a major impact. And then 23 just quickly in addition to that, we also partnered 24 with one particular company in our organization, which 25 was an RNA company, Moderna, where there was a lot of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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31 1 proprietary back and forth.

2 They had the RNA technology, we had the 3 design, and that partnership allowed for very rapid 4 movement where we could work together on the design 5 and they could move very quickly to make an RNA product.

6 So both basic discovery and partnerships 7 are part of the story there.

8 MR. FURSTENAU: All right. Thank you.

9 Margie, we had a question come in for you. I know Dr.

10 Mascola talked a little bit about how do they, you know, 11 recruit and retain top talent.

12 Now the question comes back to you, Margie.

13 Can you talk a little bit more about how the NRC can 14 recruit more by using a mission message kind of like 15 what NIH uses and how can we leverage that better to 16 recruit more people to the NRC?

17 MS. DOANE: Yes. So you know what I'm 18 going to talk really broadly, not just about from our 19 colleges and universities, but just broadly.

20 One thing that we like to do is we use 21 opportunities at job fairs and all kinds of different 22 public-facing opportunities where we can go out and 23 talk about our message and talk about the great work 24 that the NRC staff does and its important mission and 25 really talking about how broad our mission is, because, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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32 1 you know, we go from medical technology to reactor 2 technology, we have materials.

3 We start from, you know, when you first 4 take the materials out of the ground all the way until, 5 you know, storage and a repository eventually, so it's 6 a broad mission, and so we do talk in terms of just 7 how extensive our mission is, but also we try to make 8 sure that we are going out and getting a diverse pool.

9 So we try to hit a number of different areas 10 where we can really get a pipeline of diverse 11 individuals because you never know where the good idea 12 is, but you know you definitely need diversity so that 13 you get people that don't all think the same, so we 14 do a lot of that.

15 And, finally, our university program, 16 what's really interesting about that is that as you 17 know, Ray, we give grants and so we can find those 18 students that are already, you know, they have the bug, 19 right, they already know that this is a very interesting 20 field, and so by doing that we can really help them 21 to understand how important the mission is for the 22 American people.

23 And then I know from the NRAN class we had 24 quite a few, I'm not sure all, but maybe quite a few 25 had been in our university grant program, right, Ray?

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33 1 I don't know if you want to --

2 (Simultaneous speaking.)

3 MR. FURSTENAU: Yes. That's correct, 4 yes. Yes, that's our program for attracting talent, 5 but one of them is the integrated university program 6 providing grants, that's right, Margie. Thanks.

7 Dr. Mascola, we got a lot of comments 8 thanking you for joining us. I know your time is very 9 valuable. We had a question about a concern these days 10 about declining trust in science along with partisan 11 politicization of science.

12 Are you incorporating these concerns in 13 the strategic planning process you talked about or 14 addressing them in other ways and what overlaps might 15 you see in this regard with the work at the NRC?

16 DR. MASCOLA: Sure. I think one of the 17 things that happens at least for us in the setting of 18 a disease that is such public prominence is that we 19 leave the realm of our usual comfort zone, which is 20 discovery and development and saying here is a great 21 vaccine, and then all of a sudden our staff, myself 22 included, but some of our even more junior staff are 23 actually out doing community education because it turns 24 out people want to hear from scientists.

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34 1 to scientists who are actually doing the work. So we've 2 actually had to develop a media strategy where we 3 figured out how to best use our time and accept 4 interviews for normally our senior staff but some of 5 our younger staff who have been prominent because they 6 have been part of the discovery, and also they are very 7 good communicators.

8 It is amazing to see how well and 9 differently young people communicate. So it is a whole 10 new effort for us, but I think we have learned that 11 in certain situations it's just a key part of our job 12 to teach and educate the public.

13 MR. FURSTENAU: Great. Thanks. We have 14 time for one last question, Dr. Mascola, okay. Which 15 one, Pfizer, Moderna, or Johnson & Johnson, which one 16 should we take?

17 DR. MASCOLA: You know the answer to that 18 is the first one you can get. If you are like many 19 I know that are on the web trying to find that 20 appointment, when you can get that appointment, and, 21 truthfully, we have worked with the Operation Warp Speed 22 team and I have worked personally with them for much 23 of the year, and those trials were kind of our life's 24 work, so to speak, over the last year.

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35 1 scientific trials and those vaccines work so you should 2 take them, any of them.

3 MR. FURSTENAU: All right, thank you.

4 Thank you for that. So, Margie, would you like to close 5 the session?

6 MS. DOANE: Okay. So I can't believe that 7 we're -- This went so fast, and mainly because, John, 8 this has just been incredibly interesting for us and 9 you've given us a lot of things to think about.

10 So on behalf of the NRC and the audience 11 members thank you so much for taking time out of your 12 busy day, you know, your busy schedule, to participate 13 in our Regulatory Information Conference.

14 I have no doubt that the incredible 15 insights you shared will resonate among the audience 16 and serve as resources of inspiration for how we can 17 prepare ourselves in our organization for a successful 18 future, especially talking about how strategic you were 19 and how that helped you in the end when the pandemic 20 came.

21 So I know the audience joins me in thanking 22 you for your outstanding dedication and remarkable 23 efforts in working to find a vaccine and virus.

24 I want to say that on behalf of the NRC 25 all of the participants today, and really a grateful NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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36 1 nation, that we are very, very proud of your work and 2 just so appreciative, so I hope you will bring that 3 back to your --

4 DR. MASCOLA: I will accept that on behalf 5 of the many dozens of people who have poured their heart 6 and soul over the past year.

7 Thank you very much for the invitation.

8 It has been a pleasure.

9 MS. DOANE: Okay. I would be remiss if 10 I didn't thank Sarah Mroz and Jaclyn Storch and many, 11 many others who helped us do this session today. Thank 12 you for all of the people putting the RIC together for 13 us.

14 John, this ends our session and it was 15 fantastic. Thank you so much.

16 DR. MASCOLA: Thank you. Have a good day.

17 MS. DOANE: Bye.

18 (Whereupon, the above-entitled matter went 19 off the record at 1:26 p.m.)

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