DEPARTMENT OF HEALTH AND HUMAN SERVICES • National Institutes of Health • National Cancer Institute

Frederick National Laboratory is a Federally Funded Research and Development Center operated by Leidos Biomedical Research, Inc., for the National Cancer Institute

Ethan Dmitrovsky, M.D.American Cancer Society Professor

President, Leidos Biomedical Research and LaboratoryDirector, Frederick National Laboratory for Cancer Research

Frederick National Laboratory

Operations During the Pandemic

Session Objectives

• Review Frederick National Laboratory’s response during the

pandemic and how operational support was provided to NCI, NIAID

and other critical programs.

• As a Federally-Funded Research and Development Center (FFRDC)

our mandate is rapid public health response. Examples are cited.

• Describe the Emergency Operations Center and how vital functions

were sustained even as we look ahead to future work.

• Answer your questions.

Frederick National Laboratory Responsibilities During an Emergency

During an emergency, Frederick National Laboratory has this

contractual responsibility:

”The Contractor shall maintain an emergency management program

that encompasses laboratory activities and infrastructure, to include

emergency planning, preparedness, response and readiness,

assurance procedures, elements of which inform the Continuity of

Operations Program (COOP).”

We have two operational missions: (1) Maintain minimal essential

services and (2) Continue without disruption vital clinical, animal

husbandry and laboratory services supporting the clinical enterprise.

Contractual Responsibility: Continuity of Operations and the Emergency Operations Center

Continuity of Operations (COOP)Objective is to keep mission-critical functions operating despite any situation.

Emergency Operations Center (EOC)Provides structure and focus to ensure minimal essential functions are activated.

EOC is based on FEMA’s National Incident Management System guidelines.

This was the first time the EOC was activated for a full and extended time.

Assess lessons learned.

Leadership

(NCI and FNL)

Command

Terri Bray

Operations

Medical, Safety, and Security

Planning

Technical Support, Documentation,

Mission Essential Function Groups

Logistics

Communications, Facilities, Supplies,

Environmental Waste

Finance and Contracts

Costs, Subcontracts,

Purchasing

Public Affairs

(NCI and FNL)

NCI Liaison – EHS COR

Collaboration, communication and rapid response.

Frederick National Laboratory Operational Response to the Pandemic

5

Support of Operations• Finance, Project Management and Contracts staff teleworking and delivered Task Order proposals.• Enhanced communications with program staff via weekly teleconferences.• Initially, biweekly Executive Leadership Team meetings.

Personnel• Operations and Maintenance staff prioritized mission critical and safety areas (staff at 50% of levels).• Logistics, warehouse, and travel staff used Discretionary Leave (no financial effect on government).

Frederick National Laboratory Clinical and Scientific Response to the Pandemic

Support of Personnel and Facility• Activated the Emergency Operations Center.• Deployed laptops with VPN accounts for teleworking. • Established 60+ Microsoft Teams to optimize teleworking. • Configured remote “jump” boxes for scientific team telework.• Developed custodial strike teams.

Support of Clinical Care and Science• Prioritized Institutional Biosafety Committee work on COVID-19.• Excess and aging N-95 respirators distributed.• Focus clinical laboratory on support of COVID-19 efforts.• Pilot Plant produced hand sanitizers.

Continuity of Veterinary and ClinicalServices During the Pandemic

Dr. Ethan Dmitrovsky

and Executive

LeadershipTeam

Dr. Barry Gause

Clinical Research

Directorate (CRD)

Dr. Stephen Jones

Dr. Stephen Jones

Laboratory Animal

Sciences Program

(LASP)

Dr. Michael

Baseler

Applied and

Developmental

Research

Directorate

(ADRD)

Beth Baseler

Clinical Monitoring

Research Program

(CMRP) Dr. David Lindsay

Vaccine Clinical

Materials Program

(VCMP)

Dr. Stephen Jones

Laboratory Animal

Sciences Program

(LASP)

Dr. Barry Gause

Clinical Research

Directorate (CRD)

Dr. George Mitra

Biopharmaceutical

Development

Program (BDP)

Case Study: Continuity of Essential Services for Laboratory Animal Sciences

LASP (pre-pandemic) LASP (during pandemic)

NCI vivarium (Bethesda and Frederick)

essential veterinary and husbandry services

standard work schedule split shifts / elongated workweek

Team A

Team B

Team C

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Frederick National Laboratory Pivot with National

Cancer Institute to Combat COVID-19

Identifying genetic

determinants of

SARS CoV 2

susceptibility and

outcome

Testing and

validating

serologic assays

for SARS CoV 2

High throughput

screening for

small molecule

inhibitors of SARS-

CoV 2 proteins

Technology Developed

by RAS Initiative

Pivot and sustain

Serology Laboratory of Vaccine,

Immunity, and Cancer Program

(Dr. Ligia Pinto)

Identify space

Implement flexible

infrastructure and network

assess cyber security needs

Cancer Genomics

Research Laboratory

Pivot and sustain

Pivot to

COVID-19

Response

► Identifying

► Testing

► Screening

COVID-19 Publications●Liu, G., et al. Cell Sys., In press,

2020.

●Beigel, J.H. et al. New Engl. J.

Med. (in press).

●Hicks, J., et al. medRxiv

doi: https://doi.org/10.1101/2020.06

.22.20137695

●Klumpp-Thomas C., et al.

medRxivdoi: https://doi.org/10.110

1/2020.05.21.20109280.

●Esposito, D., et al.. Protein Expr

Purif. 2020 Jun 4;174:105686. doi:

10.1016/j.pep.2020.105686.

Recent Major

Publications Beyond

COVID-19●Petersdorf, E.W., et al, J. Clin.

Oncol., in press.

●Li, Z., et al, Nat Struc & Molec

Biol. In press.

●Pérez-Guijarro E, et al. Nat

Med, 2020

●Kriemer, A.R., et al. J Natl

Cancer Inst, 2020.

●Yan, W., et al. Cell Reports. In

press.

●Liu J, et al. Cell, 2020.

Collaborations between National Institute of Allergy and Infectious Diseases and Frederick National Laboratory

Support of the international multi-center

placebo-controlled randomized remdesivir

trial in high risk COVID-19 patients (those

who are hospitalized and oxygen-dependent

or on a ventilator).

Conduct of the international Zika

trial (including production of the

vaccine).

Support of Ebola relief efforts and the four-

arm trial in the Democratic Republic of Congo

(including production of one of the successful

agents) leading to fast-track status by the

FDA.

NIAID COVID-19 Trials and Frederick National Laboratory

An International Multi-Center Randomized Placebo Controlled Trial of Remdesivir.

Those hospitalized with COVID-19 with lower respiratory tract disease (radiographic infiltrate, oxygen requirement, or mechanical ventilator).

1

1063

ACTT-1 Enrollment

1250

1000

750

500

250

0

NIAID DMID COVID-19 ACTT-2 Trial and Frederick National Laboratory

4

1034

ACTT-2 Enrollment

200

1000

800

600

400

0

N=71

Main Sites

International Multi-Center Randomized Placebo Controlled trial of Remdesivir +/- Baricitinib.

Trial Closed 6/30/2020

53

11

22

43

5

COVID-19 Treatment Guidelines Website

• Partnership with HHS, NIH, NIAID, FNL and subcontractor to develop and manage public-facing NIH COVID-19 treatment guidelines website.

• Dissemination of updates and changes to NIH treatment guidance.

• Facilitation of NIH information security certification and accreditation for National Institute of Standards and Technology moderate classification.

• Establishment of communication modes (Twitter, GovDelivery) and downloadable reference materials.

DateUsers

Sessions PageviewsUS International

Week 1 (4/21 – 4/27) 161,547 118,030 360,669 1,184,572Week 2 (4/28 – 5/4) 43,892 26,928 89,145 278,947Week 3 (5/5 – 5/11) 27,525 18,019 56,692 177,032Week 4 (5/12 – 5/18) 27,024 22,057 60,884 151,770Week 5 (5/19 – 5/25) 21,090 21,050 51,340 121,498Week 6 (5/26 – 6/1) 23,798 18,826 50,949 115,213Week 7 (6/2 – 6/8) 12,275 16,875 35,974 83,429Week 8 (6/9 – 6/15) 17,568 21,957 48,180 108,641Week 9 (6/16 – 6/22) 15,952 20,586 44,321 101,166Week 10 (6/23-6/29) 28,195 28,128 68,094 140,008Week 11 6/30 7,710 5,788 14,906 27,449

7/1 6,043 6,396 13,554 25,827Week 11 Subtotal 13,753 12,184 28,460 53,276

Total 378,866 312,456 866,248 2,462,276Users – the number of new and returning people who visit the site

Sessions – a visit to the website. Note that if a person returns within a 30-minute timeframe, it will still count as one session. If they return after 30

minutes, it will count as a new session.

Pageviews – total instances of any page on the website being loaded (or reloaded) in a browser

Overview of Website Activity

4/21/20 - 7/1/20

External Partnerships and Contractor Responsibilities

● “The Contractor maintains relationships with the broader

research community to enhance the intellectual vitality and

research relevance of the Laboratory.”

● “The Contractor actively develops and pursues collaborative

engagement with public and private partners… with the goals of

discovery, innovation and improvement of human health. The

Contractor is to work with civic, academic and private organizations

to advance biomedical research, scientific discovery, and the

mission of the Frederick National Laboratory.”

Partnerships at the Frederick National Laboratory for Cancer Research

• 159 unique partners

• 53 executed cCRADAs

Government / Other

4%

Industry23%

Research Institute

25%

Universities 48%

cCRADA, mcCRADA, MOU, and TSA Partners

Partnering Since March, 2020- 4 new cCRADAs

- 14 technical service orders

- 1 new research collaboration

- Added a new service to the

Technical Services Program

- Participated in the Bio Digital

International Convention, meeting

with ~90 organizations

- Organized a virtual Biotech

Connector event (>100 participants)

- Held a partnership informational

webinar with nearly 200 participants

Nano 12%

HPV10%

HIV/AIDS 15%

Other25%

RAS 38%

cCRADAs by Research Area

Recent Frederick National Laboratory Collaborations with Extramural Community

• HPV Serology Laboratory led by Dr. Ligia Pinto is partnering with the London School of Hygiene and Tropical Medicine School and Gates Foundation to investigate immune responses to HPV vaccine in Tanzania.

• HPV Serology Laboratory evaluates participants’ immune response by determining HPV-16/18-specific antibody levels in blood and its avidity.

• The AIDS and Cancer Virus Program led by Dr. Jeff Lifson is collaborating with Beth Israel Deaconess Medical Center and the Gates Foundation to identify potential viral reservoir biomarkers in SIV-infected macaques.

• This study is a multi-center funded collaborative project through the Gates Foundation to understand how HIV persists despite antiretroviral therapy and how it reignites systemic infection when therapy stops.

New Partnerships

Recent Educational InitiativesHood College with Leidos Biomedical Research held first meeting in

2019: “Imaging Science and Cancer Biology”

Next Meeting: “Artificial Intelligence in Cancer Research and Clinical Care: Turning Promise into Reality” April 27-29, 2021.

Keynote

Speakers

Dr. Keith YamamotoExecutive Vice Chancellor for

Research, UCSF

Dr. Maurizio VecchioneExecutive Vice President,

Global Good Research

Organizing Committee:Len Freedman (FNLCR)Eric Stahlberg (FNLCR)Monica Slate (FNLCR)

Debbie Ricker (Hood College)Lovetta Corson-Morgan (Hood

College)

Advisory Committee:Ethan Dmitrovsky (FNLCR)

Len Freedman (FNLCR)Eric Stahlberg (FNLCR)

Peter Choyke (NCI)Jonas De Almeida (NCI)

Amber Simpson (Queens Univ.)Marti Head (ORNL)

Warren Kibbe (Duke)Daniel Rubin (Stanford)Kristin Swanson (Mayo)

Frederick National Laboratory and National Cancer Institute

Cancer Survivorship Seminar

• Connects our scientists with cancer survivors.

• Our first guest was Mr. Dewey Stringer.

• Hosted by Drs. Hook and Dmitrovsky in February.

ATOM Update and Status ReportLeadership Updates

● ATOM advisory board formed to broaden engagement and assist leadership.

● Dr. Freedman joins Governing Board; Dr. Stahlberg assumes ATOM co-lead.

● Three National Laboratories join ATOM (Argonne, Oak Ridge, and Brookhaven).

Path to Sustainability

● ATOM strategy prioritizes open data and open models.

● Consortium meeting with legal counsel to consider 501c3.

Broadened Reach

● ATOM virtually hosting pharmacy interns.

● Four manuscripts already accepted or published.

● Workflow publicly available on GitHub; Algorithms released.

Administrative Support of Frederick National Laboratory During Pandemic

FFRDC Contract PortfolioTask Order Portfolio

• 5 Operational Task Orders - Benefits of services are recurring with annual funded appropriations.

• NCI Task Order also provides the infrastructure supporting NCI-Frederick

• 3 NIAID Task Orders supporting different NIAID Divisions

• 1 Lease Task Order

• 84 Non-operational Task Orders

• 72 in Scientific or Clinical Groups

• 12 Facility Refurbishment Task Orders

• 5 Supplemental Funding Task Orders (Moonshot or COVID-19)

Conclusions

● Cited Frederick National Laboratory’s rapid response to this

threat to the public’s health (administrative and scientific).

● Discussed how the National Laboratory pivoted to combat

the pandemic while assuring continuity of essential services.

● Described strategies to position ourselves for current and

future success.

● Emphasized partnerships with the cancer science and

cancer care community to serve the public’s health.

Acknowledgements

We thank our NCI, NIAID, and NIH colleagues as well as these Key Staff,

Directorate Heads and their teams for their service during the pandemic.

Dr. Kathy Terlesky, Chief Operating OfficerDr. Leonard Freedman, Chief Science OfficerDr. Barry Gause, Chief Medical OfficerBeth Baseler, Clinical Monitoring Research ProgramDr. Michael Baseler, MS, Applied and Developmental ResearchFrank Blanchard, Public Affairs and Communications Terri Bray, Environment, Health and SafetySue Bruce, MBA, Financial OperationsDr. Mary Carrington, Basic Science ProgramDr. Bernard Courtney, Project Management OperationsBeverly Hayes, Contracts and AcquisitionsDr. Claudia Haywood, Esq., Intellectual Property and Strategic AgreementsShannon Jackson, Chief Ethics and Compliance OfficerDr. Jeffrey Lifson, AIDS and Cancer Virus Program

Dr. Stephen Jones, Laboratory Animal Sciences ProgramDr. David Lindsay, Vaccine Clinical Materials ProgramChris March, Human ResourcesDr. George Mitra, Biopharmaceutical Development ProgramDr. Dwight Nissley, Cancer Research Technology ProgramRich Pendleton, Business ServiceDr. Vladimir Popov, Partnership Development OfficeBrett Smith, Business Enterprise SystemsDr. Eric Stahlberg, Biomedical Informatics and Data ScienceDr. Dante Tedaldi, Facilities Maintenance and Engineering