ASPR_Next_Innovation_Day.AUG2019.FULL_Deck.pdf

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Introduction

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ASPR’s Purpose: Unity of Command

Bringing Federal Medical & Public Health Assets in Support of State

& Local Authorities

UNCLASSIFIED

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ASPR Mission

Save Lives and Protect

Americans from 21st Century

Health Security Threats

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21st Century: An Increasingly Complex & Dangerous World

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21st Century Threats:

An Increasingly Complex & Dangerous World

Natural

• Extreme Weather

• Natural Disasters

• Pandemic and Infectious Diseases

Hybrid

• Exploiting System Vulnerabilities During:

• Extreme Weather/Natural Disasters

• Pandemic and Infectious Diseases Outbreak

Technological (human made/caused)

• Emerging and Disruptive Technology and

Cyber Attacks

• Adversaries and Malign Actors Poised for

Aggression

• Dam breach, Chemical spill, Water systems, Supply chain

Complex

• Adversaries and Malign Actor Aggression

• Chemical, Biological, Radiological, and Nuclear

Attacks (deliberate)

(Examples of threats identified in the National Health Security Strategy and the 2018 Worldwide Threat Assessment )

Planning for Readiness Limited Readiness

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ASPR’s Key Priorities

Foster Strong

Leadership

Build a Regional

Disaster Health Response

System

Sustain Robust and Reliable Public Health

Security Capabilities

Advance an Innovative Medical Countermeasures

Enterprise

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ASPR Enhances Medical Surge Capacity Through Multiple Initiatives

National Disaster Medical System

Medical Reserve Corps

Hospital Preparedness

Program

Regional Emergency

Coordinators

Critical Infrastructure

Protection

Secretary’s Operations Center

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WebEx Instructions

• The WebEx is monitored and controlled by an operator

• All WebEx callers will be muted upon entry and throughout the meeting

• Please hold all questions until Q&A

Questions will be fielded by those in the room first, then WebEx

• Have a question and on WebEx?

You must use the ‘Raise Your Hand’ feature so the operator can identify you as having a question, and unmute your line

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Rules of Engagement

• We are in a Pre-award state All requirements and information shared are subject to change

• ASPR is conducting market research and industry engagement

• Do not discuss or share any confidential, proprietary, or classified information

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Dr. Yeskey Intro

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ASPR Next - Overview

• ASPR Next is a new framework that will develop onramps across all ASPR Divisions to bring in novel solutions to address our core mission areas and unmet requirements.

ASPR Next will allow each Division a formal mechanism to rapidly develop new capabilities with the use of an organization-wide BAA ASPR Next will follow the typical process for acquisitions

RFI and Industry Engagement Establishing initial priorities Coordinating priorities with available funding Full BAA with initial focus areas advertised First performers on contract as early as 1QFY20

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Agenda August 7, 2019-Day 1

8:00AM to 9:00AM - Onsite Check-in 9:00AM-9:30 AM – ASPR Overview – Dr. Kadlec 9:30 AM to 10:00AM – Overview of ASPR Next and Introduction of AOI Panels – Dr.

Yeskey and Joe Hamel 10:00 AM – 11:00AM – AOI Panel 1 (AOIs 1-4) 11:00AM – 12:00PM – AOI Panel 2 (AOIs 5-9) 12PM – UTC – Independent Teaming Discussions on Own

August 8, 2019-Day 2 8:00AM to 9:00AM - Onsite Check-in 9:00AM to 12:00PM – Industry Lightning Talks (5 Mins Each) 12:00PM to 1:00PM – Break/Lunch 1:00PM to 4:00PM – Breakout Discussions with Performers

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Panel Discussions

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Panel 1 – AOIs 1-4

• AOI-1: Electronic Health

Records (EHR) for use in austere settings - Richard Catherina and Joe Lamana

• AOI-2: Priority Medicines on Demand - Joe Hamel, Brad Ringeisen, Anne Fisher, Amy Jenkins, Mike Angelastro and Mike Bourg

• AOI-3: Dialysis Care in Disaster Settings - Richard Catherina and Cynthia Rubio

• AOI-4: Medical Countermeasure Dispensing - DeLaine Black, Susan Gorman, and Tanima Sinha

ASPR Next Slides

Susan Gorman SNS Strategic Logistics Branch Chief

August 7, 2019

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Mission

Mass dispense medical countermeasures (MCMs) to a metropolitan area population within 48 hours of exposure

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Threat and Vulnerability

• Threat:

U.S. intelligence agencies assess that a large-scale aerosol release of anthrax is “well within the technical capability of foreign or domestic terrorist organizations.”

• Vulnerability:

Bacillus anthracis is easily found in nature, can be produced in a lab, and can last for a long time in the environment.

Aerial dispersion of anthrax over a large geographic area can be accomplished with commercially available equipment.

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MCM Response

• Experts emphasize that the administration of post-exposure prophylaxis MCMs in the first 48 hours following an anthrax incident is crucial to saving lives.

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Phased MCM Response Plan Supporting 60-day Prophylaxis

• SNS’ two-phase MCM deployment:

50-day unit-of-use oral antimicrobials and vaccines

Follow-on Response

10-day unit-of-use oral antimicrobials

Initial Response

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Initial Response 10-day Unit-of-Use Oral Antimicrobials

• SNS will provide state/local authorities the first 10 days of antimicrobials for the identified population for prophylaxis of anthrax within hours of approval to deploy.

• State and local government must make initial prophylaxis available to the affected population within 48 hours of exposure.

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Anthrax Prophylaxis

• Initial 10-day MCMs needed for 5 million people 521 pallets 25 trucks

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Follow-on Response 50-Day Unit-of-Use Oral Antimicrobials

• The remaining 50-day unit-of-use oral antimicrobial shipment begins immediately following the initial 10 day shipment.

• Affected jurisdictions should receive 50-day shipment no more than 8 days after the federal decision to deploy.

• The number of 50-day unit-of-use deployed will be based on the same population as the 10-day calculation unless epidemiologic data or investigations indicate otherwise.

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Anthrax Prophylaxis

• Follow-on prophylaxis for 5 million people 50-day unit-of-use

648 pallets 30 trucks

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Anthrax Vaccine Adsorbed (AVA)

• Storage requirements 2° to 8° C

• Initial delivery between day 2-8

• Second delivery in week 2

• Third delivery in week 4

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Distribution and Dispensing

• SNS will deliver MCMs to the predesignated state/local operated receive, stage, and store facility.

• State/local authorities are responsible for dispensing operations normally accomplished throughout points of dispensing.

• FDA may grant a mass dispensing order to avoid the need for individual prescriptions.

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Challenge and Potential Solutions

• Challenge State and local governments ability to mass dispense to an entire metropolitan area within 48 hours of exposure

• Potential Solutions Innovative distribution and dispensing modalities Alternative and innovative delivery systems for administering prophylaxis and vaccines

Alternative Routes of Administration (AoI 4)

Tanima Sinha, MSc, MScPH Lead Interdisciplinary Scientist

Influenza and Emerging Diseases Vaccines Branch Influenza and Emerging Infectious Diseases Division (IEIDD)

HHS/OS/ASPR/BARDA

August 7, 2019

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BARDA RFI-19-BARDA-ALT-FLU-IMMUNIZATION-0001

Alternative routes of administration Microneedles and/or patch technology or other needle free options No complicated device, no specialized training required Reduce the need for vials, needles and syringes Ease continuity of operations Other benefits

Potential uptake in immunizations Improved dissemination of vaccines to remote areas

Responses due by October 11, 2019 11:59 pm Eastern Please send white papers to Wendell Conyers at

Wendell.Conyers@hhs.gov mailto:Wendell.Conyers@hhs.gov

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Q&A

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Panel 2 – AOIs 5-9

• AOI-5: Distributed Power for

Disasters - Joe Lamana, Kristen Finne, Joe Hamel

• AOI-6: Real-Time Healthcare System Capacity Reporting - Joe Lamana, Sam Imbriale and Richard Catherina

• AOI-7: Disaster Response and Recovery Intelligence- Sam Imbraile and Diana Wong

• AOI-8: Advanced Medical Interventions for Disasters – Eric VanGieson, Joe Hamel, Renne Wegzyrn,

• AOI-9: Telehealth Applications

- Jonathan Greene, Brendan Carr, Gary Disbrow

Enabling MCM Platforms through Gene Editing

Safety by Design

Renee D Wegrzyn, PhD Program Manager

Biological Technologies Office

• Briefing prepared for ASPR Next Innovation Day

• 7 August 2019

Approved for Public Release, Distribution Unlimited

Guide RNA (gRNA)

Cas9

Genomic DNA

Tools to Edit Genomes CRISPR-Cas9

33 Rapid Pace of Genome Engineering Advancement Reading, Writing, and Editing Genomes Across Scales

Tools to Read and Write Genomes DNA Sequencing & Synthesis

10K

10B

10M

1M

0.5

0.05

G en om e

Se qu en ci ng

) G ene Synthesis ($/bp)

Human genome project $3B

$12/bp

<$0.10/bp

$999

2004 2008 2010 20162000

Adapted from George Church and Rob Carlson

VIRUS MICROBE INSECT HUMAN ECOSYSTEMS

50 nm

NEW OPPORTUNITIES (& VULNERABILITIES)

Approved for Public Release, Distribution Unlimited

Presenter Presentation Notes What does surprise look like in biological systems?

• build-in biosafety for new biotechnologies at their inception

• provide a toolkit to enable previously unattainable applications in synthetic biology

• create an understanding of what is possible, probable, and vulnerable with regard to emergent gene editing biotechnologies

Goals

Create biological capabilities that enable the safe pursuit of advanced gene editing applications and protect against potential engineered genetic threats

Vision

Safe Genes - A Toolkit for Innovation, Biosafety, and Biosecurity

Control of Genome Editing

Countermeasures & Prophylaxes

Genetic Remediation

Controller molecule

Inactive Active

Proteins

Nucleic acids Small molecules

Edit

Remediate

Models, Data, & Scalable PoC

Time

Fr eq ue nc y

Technical Challenges & Approaches

DoD-relevant Challenges Vector-borne Disease Mitigation First-in-class solutions to control vectors of ZIKV, DENV, WNV, CHIKV, and malaria

Novel MCMs and Therapeutics Novel Tx for natural and engineered threats

Fundamentals Fundamental understanding of gene editors and applications

Approved for Public Release, Distribution Unlimited

Presenter

Technical challenges and approaches - How is it done today? What is the new DARPA thing or idea? If you are completely successful, how does it change the world? (1 slide)

36 What’s Next?

Transient Gene Modulation – Safety by Design

DNA Cut

DNA

DNA nuclease (cuts DNA)

New DNA inserted

DNA editing

Gene activation

DNA

Turn genes

ON

Gene repression

X

DNA

Turn genes

OFF

Gene expression changed

Gene Modulating

RNA nuclease

DNA

Gene repression

RNA

RNA cut and inactivated

RNA editing

Non-permanent genome editing would enable targeted & tunable modulation of gene activity

Approved for Public Release, Distribution Unlimited

Presenter Presentation Notes Voicetrack: Future application space of genome editing technologies is enormous. Here are just a few possibilities with commercial potential.

Global CRISPR Market, 2016: $361M Global CRISPR Market, 2025: $6B (37% CAGR- [compound annual growth rate])

Source https://finance.yahoo.com/news/global-crispr-market-forecast-2017-175100289.html

PREPARE – Vision and Goals

Goals

• Enable transient and reversible modulation of gene expression for protection against threats

• Generate foundational knowledge concerning protection against public health threats

• Create novel clinical formulations to facilitate protection in vivo

• Create modular, scalable, & adaptable platforms for the broadest range of public health and national security threats

Vision Apply the tools of genome engineering to create potent, transient, and reversible medical countermeasures to combat biological, chemical, and radiological threats to public health and national security

38 What’s Next?

Beyond State of the Art in Medical Countermeasures

All protein structures: Protein Data Bank

Human butyrylcholinesterase tetramer Ngamelue et al., Acta Crystallogr. 2007

Toxins & ChemicalsViral Infections Ionizing Radiation

Human granulocyte colony stimulating factor Hill et al., PNAS 1993

Human Immunoglobulin Harris et al., Biochemistry 1997

Current strategies to design, test, manufacture, and administer MCMs are inadequate for public health and preparedness

• One threat/one MCM paradigm

• Suboptimal protection, kinetics, side effects

• Short half-lives; limited efficacy windows

• Costly manufacturing

Limitations of Existing MCMs We need a paradigm shift to enhance protection against health threats

• Highly effective & customizable protection

• Sustained, controllable activity

• Safe use in healthy individuals

• Inexpensive, scalable manufacturing

DNA & RNA Editing Targets Entire genome

Traditional targets Surface proteins

Neutralization of any virus

Viral particle, CDC

Guide RNA (gRNA)

Editor

Influenza A only

Non-targeting Cas13a

Combination targeting

Viral mRNA targeting

Viral genome targeting

Mock

Phil Santagelo (bioRxiv, 2018)

72h post infection

Vi ra l g en e co py n um be r ( M

5.00

10.0

15.0

0.00

0.50

0.25

0.20

0.10

0.15

Proof-of-concept Data CRISPR-Cas13a can protect human lung epithelia cells by reducing viral gene copy numbers by up to 6000x.

Paradigm Shift Beyond SoA Medical Countermeasures (MCMs) - Antivirals

Approved for Public Release, Distribution Unlimited

Single target, multiple genomes e.g., Influenza

H1N1 H5N2 H10N3

H3N2 H3N6 H5N1

H6N2 H10N6 H9N2

Universal targeting to high homology sequences

PREPARE – Customizable MCMs for Threat Response New Paradigm: PREPARE

On-demand Customizable Threat Response

Common gene activator and repressor components

(stockpile)

Goal: Single dose, temporal control, multi-threat protection, common manufacturing architecture

Current Countermeasures

Vaccine for viral threats

Neupogen injection for radiation therapy

Multi-dose, short-lived, single threat; complex storage and manufacturing

Programmable Gene Modulator MCM (PGM-MCM)

Unique & adaptable gene target signals for specific protections

(stockpile or just-in-time manufacture)

Atropine injector for organophosphate poisoning

Protection Against Threats PREPARE MCMs and prophylaxes can be used singly or in combination to afford broad threat protection

Deliver reagents to turn genetic protection on

Approved for Public Release, Distribution Unlimited

Presenter

New Paradigm:

Public Health and National Security Threat Focus Areas

PREPARE Threat Focus Areas

Influenza viral infection 36,000 deaths, 9-35M cases/yr (US)

Opioid overdose 42,000 deaths in 2016 (US)

Organophosphate (OP) poisoning 350,000 deaths in 2016 (Global)

Gamma radiation exposure 7.5M radiotherapy treatments (Global)

Presenter

New Paradigm:

www.darpa.mil

43 Safety by Design Accelerating future applications of genome editing

Custom animal modelsAgriculture Clinical applications Microbe engineering Drug development

Accelerating the path to market

• Ensure safety

• Develop new applications

• Improve regulations

• Expedite approval

Images: Wikimedia, British Pest Control Association (mouse)

44 DARPA Leading Technical Innovation – Safety by Design Safe Genes Highlighted as Exemplary Approach to Mitigating Gene Editing Risk

Richard Danzig Center for New American Security July 2018

National Academy of Sciences

National Academy of Sciences

Center for Health Security, JHU

Control of Genome Editing– Early Results Technologies that enable gene editing tools to be designed and used safely

0% 50% 100%

Optimized

CRISPR

design

Poor

CRISPR

design

% off-targets predicted

Adapted from Akcakaya et al., Nature 2018 promiscuous editing

42% promiscuous editing

0-0.1%

Approved for Public Release, Distribution Unlimited

Control of Genome Editing

Controller molecule

Inactive Active

Optimize gRNA

High off target

No off target

Inducible Editors

More Precise Editors

Approved for Public Release, Distribution Unlimited46

Gene Editor A. CjeCas9 B. NmeCas9 C. Sth1Cas9 D. SpyCas9VQR

E. SpyCas9

% Inhibition

Broad inhibition

Inhibitor homologs AcrIIA2 AcrIIA2-1 AcrIIA2-2 AcrIIA2-3 AcrIIA3 AcrIIA3-1 AcrIIA3-3 AcrIIA4 AcrIIA4-1 AcrIIA4-2 AcrIIA4-3 AcrIIA5 AcrIIA5-1 AcrIIA5-2 AcrIIC1 AcrIIC1-1 AcrIIC1-2 AcrIIC2 AcrIIC2-1 AcrIIC2-2 AcrIIC3 AcrIIC3-1

A B C D E

Specific inhibition

MGH/Joung, HIRI/Beisel

DNA Cut

DNA

CRISPR

cuts DNA

New gene inserted

DNA

Anti-CRISPR blocks CRISPR from cutting

Genome is protected

Editing the genome Protecting the genome

Proteins

Nucleic acids

Small molecules

Countermeasures & Prophylaxes

First-in-class inhibitors of gene editors

Gene Editing Inhibitors – Early Results Tools to protect genomes from unwanted genome editing

Presenter Presentation Notes Goal – turn genome editors on when/where you want them Limit activity at non-target genomic sites, limit activity in non-target tissues, and increase stability for long-term performance

Destabilizing domains Allosteric controls Riboregulators Generation counters Synthetic speciation Underdominance Population-specific alleles Self-exhausting constructs

Safe Genes: Self Limiting Gene Drives and Remediation in mosquito populations Offspring have desired traits e.g., disease resistance, programmed death

Engineer gene drive-controllable mosquito

No open release under Safe Genes

Introduce controllable mosquitos into wild population

Gene drive delivers desired traits

Built-in gene drive control control of gene editing

Halt spread of unwanted gene drive countermeasures & prophylaxis

Return to baseline genetic remediation https://marshalllab.github.io/MGDrivE/

Control of Genome Editing– Early Results Technologies that enable gene drive technology to be designed and used safely

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Q&A

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Breakout Groups – Day 1

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August 8, 2019-Day 2 8:00AM to 9:00AM - Onsite Check-in 9:00AM to 12:00PM – Industry Lightning Talks (5 Mins Each) 12:00PM to 1:00PM – Break/Lunch 1:00PM to 4:00PM – Breakout Discussions with Performers

52Saving Lives. Protecting Americans.

Rules of Engagement

• We are in a Pre-award state All requirements and information shared are subject to change

• ASPR is conducting market research and industry engagement

• Do not discuss or share any confidential, proprietary, or classified information

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ASPR Next Lightning Talks Time Organization Presenter 0910 Center for Advanced Sensor Technology; On-Demand

Pharmaceuticals; Latham Biopharm Govind Rao

0915 FORTS Medical Eli Pelman 0920 Radiation Injury Treatment Network (RITN) Cullen Case 0925 J. Craig Venter Institute Craig Venter 0930 C3.ai Rohan Oswal 0935 MDPnP Interoperability and Cybersecurity Lab at

Massachusetts General Hospital David Arney

0940 Shabas Solutions LLC. William Hauck 0945 Clean Energy Group Marriele Mango 0950 Transcendence, Inc. Dan Donovan 0955 virtru Joe Stuntz

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Time Organization Presenter 1000 TeleTracking, Inc. Scott Newton 1005 University of California San Diego Lucila Ohno-Machado 1010 TensorDRO Ed Powell 1015 EMS Innovations Inc. Joseph Ferko 1020 InTouch Health Herb von Winckelmann 1025 Southwest Synergistic Solutions, LLC Juan Cienfuegos 1030 10 Minute BREAK 1040 IBM Watson Health Jill Gyllensvaan 1045 Powered for Patients Eric Cote 1050 Chainbridge Technologies Chris Lee 1055 CareClix, Inc. Augustine Cowan

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Time Organization Presenter 1100 Beyond Lucid Technologies, Inc. Jonathon Feit 1105 Be The Match BioBank Jeff Wren 1110 Cerner Nick Messina 1115 MRIGlobal Craig Willis 1120 priority5 Gregg Lord 1125 Deloitte Consulting, LLP Missy Hyatt 1130 Favis, Inc Peter Conner 1135 Cognitive Medical Systems Julia Skapik 1140 University of Nebraska Medical Center James V. Lawler 1145 Center for Medical Interoperability Tommy Ragsdale

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Lightning Talks

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Liger for Advanced Sensor Technology;

On-Demand Pharmaceuticals; Latham Biopharm

Govind Rao

ASPR Next Innovation Day Govind Rao; grao@umbc.edu

Thursday, August 8 2019

CASTing Biologics on Demand

Rapid Expression via in vitro Translation (IVT) CHO Cells T7 RNA Polymerase

Nucleotides

ATP

DNA Template

Translation Translation Factors Amino Acids Ribosomes

ATP

RNA

Protein

• 15.0L+ Bioreactor Batch Culture

• Lysis (Cavitation)

• Differential centrifugation to isolate critical organelles

• Lyophilized

Presenter

Animation needs to be fixed here…

Unidentified Group Posing with Live Demo

Presenter

The cell has a pressure rating of 40 bar, a path length of 8 mm, and a volume of 14 µL. The built-in sensor uses Seti UVTOP TO18 LEDs at wavelengths 260 nm and 280 nm for dual wavelength light source, and Thor labs FGA71 photodiode for the detector. The board is custom-designed, utilizing a Texas Instruments MSP430F4x micro-controller.

Value Proposition

• Cycle time – Expression to purified protein ~8 hours

• Potency – Concept of “freshly squeezed = maximal activity”

• Cost – COGS based on list price of components <$2,000 (for single step purification)

• Breadth of Application –

• Research grade and Therapeutic proteins

• Antibodies and Antibody fragments

• Vaccines

• On-demand Production – Eliminates logistic challenges associated with sourcing proteins/reagents.

• Broad customer base - Academic (research labs, core facilities and higher education institutions for early education/adaptation), US and Allied Governments, NGOs and Industry

• Distributed Manufacturing – Point of Need

Upstream Process Downstream Process

Expression Setup •Reconstitu ting Lysate

•Injection into sterile cassette

Incubation •Set temperature to 30°C •Set agitation to 150RPM

Buffer Prep •Measure/Aliq uot reagents

•Adjust pH to appropriate spec.

Auto-Prime •Insert Syringe pumps with appropriate buffers

•Initiate pre-saturation

Insert Cassette into BioMOD •Remove cassette from sterile pouch and insert into BioMOD

•Start Bio-

MOD

Purification process

Purified Product •Collect final product in sterile tube and stored overnight in coldroom and delivered for injection at 8:00 am the following day

7:30AM 8:00AM 11:00PM 1:00PM 2:00 PM 4:00PM

CHO IVT Mix Injected into Sterile Cassette

Components of the CHO IVT system

Incubation at 30°C and 150RPM for 6 hours

Purification using BioMOD system Affinity Micro-column capture and Cation Polishing column

Flow Diagram of QC and Dose Formulation

Study Design and Timeline

Study Initiation October 24, 2018

Receipt of Animals November 14, 2018

Allocation of Animals November 13, 2018

Irradiation (D0) November 29, 2018

Treatment Initiation November 30, 2018

Dosing Completion December 15, 2018

Experimental (In-life) End

December 29, 2018

The study will enroll up to 40 animals exposed to sham or total body irradiation (TBI). Blood will be collected at baseline and at scheduled timepoints post-irradiation. Animals receiving test or control article will be treated beginning 24 ± 2 hours post-irradiation (D1) and treatment will continue daily until D16. Animals will be monitored for 30 days post-exposure.

Kaplan-Meier curves for 30-day survival

Treatment (Tx)

Group Radiation Exposure

Radiation Dose (Gy)

Group Size

Number of Survivors at

D30

No Tx Sham 0 10 10

Saline TBI 6.18 15 12

G-CSF-

His TBI 6.18 15 15

Conclusions

• This proof-of-concept efficacy study demonstrated BioMod-generated G-CSF accelerated recovery from neutropenia

• Accelerated recovery from neutropenia was associated with an improvement in survival

• Data are consistent with that generated in the non-human primate model by Farese et

al. Radiation Research 2013

• Future studies will determine the efficacy at a lethal dose of 50-70% over the first 60 days post-radiation

Farese A. Rad Res. 2013

BioMod-GCSF

IP Status – Issued, Licensed to On-Demand Pharmaceuticals (ODP) https://rdcu.be/2Jk8 https://rdcu.be/2Jk8

Example Platform Opportunities - USG

• Select product target(s) and advance through to pre-clinical and eventual clinical testing

• Validate the platform in relevant animal models

• Align with molecule of interest to USG

• Enter the clinic

• Develop platform as a rapid response tool to quickly respond to new/unknown pathogens

• Couple with DNA synthesizer, expedite development of candidates

• Move to traditional manufacturing after POC with this platform

• Demonstrate utility w/live-fire scenarios

• Distributed manufacturing capability as a rapid response tool

• Manufacture reagents, high yield/throughput, on-demand (diagnostic purposes)

• Continue developing platform to enhance capabilities (e.g. Robust on-board analytics, expand cell-line options, etc.).

• Long-term – Personalized medicine capability

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FORTS Medical

Eli Pelman

DIALYSIS

UNIT

4 connected

C-FORTS

Shelters to create larger structure bathroom modules which connect to the structure

FORTS MEDICAL FIELD DEPLOYABLE DIALYSIS SYSTEM

Multiple C-FORTS Units will be connected together utilizing our Direct Connection kit to create larger floor space for treatment.

The Dialysis System provides all of the necessary connections for each Dialysis Station (4 in total) including the dialysate system.

RAPID EMERGENCY DEPLOYABLE UNIT

954.949.3200 4650 Lyons Technology Parkway, Coconut Creek,FL 33073 info@fortsmedical.com |FORTSMEDICAL.com

Rapid Deployment Dialysis System

Longterm Clinic mailto:info@fortsmedical.com

DIALYSIS UNIT

Transport | Shipping

HVAC

Outlets

ADA Ramps

Hydraulic Unloading Systems

Furniture

The C-FORTS platform utilizes patented folding technology within the frame of a standard 8’ x 20’ ISO shipping container.

When deployed it creates 320 square feet of space and when closed it provides 450 cubic feet of storage area for furniture, medical equipment, and supplies.

This fully intermodal transport platform provides a comfortable, durable and flexible location for dialysis treatment.

Feature Overview Technology Integration

Utility Service Mobilizer

To meet the challenges of remote locations, the Utility Service Mobilizer not only delivers the C-FORTS Shelter but eliminates the time needed to unload, assemble and test various utility systems.

With medical utilities integrated into the

Mobilizer trailer, reliable power, medical gas, potable water, sanitary waste systems and hydraulics deliver critical utilities to one or multiple facilities immediately upon reaching a site.

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Radiation Injury Treatment Network (RITN)

Cullen Case

-Fortuna Favet Paratis-est. 2006

08Aug2019

Radiation Injury treatment Network (RITN)

• Cullen Case Jr., EMPA, CEM, CBCP, CHEP

• RITN Program Manager

• Operated by the National Marrow Donor Program/Be The Match

• CCase@nmdp.org www.RITN.net mailto:RITN@nmdp.org http://www.ritn.net/

What is RITN?

RITN Overview – ASPR Next Innovation Days August 2019 77

• Volunteer hospitals/cancer centers

• Care of patients with ARS

– ARS mimics what cancer center staff see daily

• Focused on a disaster in a distant city

• RITN = Hematology/Oncology/ Bone Marrow Transplant medical professionals

• RITN receives ARS patients through NDMS

Leveraging NMDP-Be The Match Capabilities

RITN Overview – ASPR Next Innovation Days August 2019

• The NMDP-Be The Match lab network is able to conduct over 44,000 marrow typings per month (via Buccal swab collection)

• Lab results are automatically sent to NMDP

• Facilitated over 92,000 transplants since 1987

• Access to 33 million volunteer marrow donors and over 765,000 stored cord blood units

Annual laboratory capacity

9,000,000 24,000,000

295,000

470,000

RITN Preparedness Efforts….

Exercises, Training and More….

RITN Overview – ASPR Next Innovation Days August 2019 79

Since 2006

725 exercises ***All exercise materials available on RITN.net

16,450 medical staff trained ***Free web-based courses available on RITN.net

18,400 dose of G-CSF, Peg G-CSF & GM-CSF on-hand ***Fluctuates throughout year, is sum of inventory at each RITN hospital

2,160 adult & 875 pediatric ARS inpatient beds w/in 24 hrs 2,825 adult & 1,130 pediatric ARS outpatient beds w/in 24 hrs

12,629 total blood stem cell transplants conducted ***during Fiscal 2018

74 hospitals and cancer centers

On the horizon

RITN Overview – ASPR Next Innovation Days August 2019 80

• Cytokine triage guidelines

• Lab surge workshops in three metropolitan cities

• Public Health training course in collaboration with ASTHO-NARR

• Tele-consultation

• Radiation injury triage/care module in EHR

• Growth of RITN in key cities

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J. Craig Venter Institute

Craig Venter

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C3.ai

Rohan Oswal

C3.ai

A Software Suite for Digital Enterprise Transformation

The C3 solution is…

© C3 2019 | CONFIDENTIAL- DO NOT COPY, REPURPOSE OR DISTRIBUTE

Digital Transformation

Internet of Things

Elastic Cloud Computing Big Data

AI/

Machine Learning

• A Platform as a Service

• A Data Integration Platform

• A Rapid AI and Application Development Platform

• A Massively Scalable Distributed Processing Platform

• Low Risk - Tried - Tested - Proven

• 10 Years of Software Engineering

• A $500 Million Software Investment

• Over 1 Million Lines of Java Code

• An Open, Extensible Software Platform

• Able to Leverage All Open Source Solutions and Point Solutions

C3 AI Suite for Digital Transformation

Da ta

In

In si gh ts

A ct io n O ut

C3 AI Suite

RDBMS

Key Value Store

NoSQL Storage

Distributed File System

HDFS

ML

Pipeline

Data Studio

ML

Studio

Applications Studio

DevOps Studio

TransformExpressions

Canonical Source

QueueBatch Map Reduce Stream

Authentication

Access Control

Roles & Responsibilities

Users

Auto Scaling

Monitoring

APIs

Time Series

Encryption

Logging

Multitenancy

Cloud Object Storage

Analytics

Systems Management

SchedulerAuditing

ProfilingDeployment

File Systems

Ex Machina

IoT

Data Integration

SAP Hana

Oracle

Salesforce

IBM Maximo

OSI PI

GE

AWS IoT

Amazon Kinesis

Azure Data Lake

Weather

Commodity Data

Data Persistence

Connectors, Extensions

Continuous Analytics Processing

Machine Learning Framework and Services

Platform Management Services Alteryx

Qlik

Domo

MicroStrategy

Tableau

UI and Data Visualization Tools

React

Angular

JS

UI Frameworks

Jupyter Eclipse

R Studio

Application Development Tools

C3 Integrated Development Studio (IDS)

• Elastic Cloud Computing

• Big Data

• AI

• Machine Learning

C3 Leveraged Technologies

• NLP

• Deep Learning

• Internet of Things – IoT

• A Model-Driven AI Architecture

• An Application Development Platform

• Application Operating Platform

• Machine Learning Platform

Processing Batch

Processing

Stream

Non Relational Database

Relational Database

Data Exploration Tools

Hadoop

Cloud Object Storage

Enterprise Application Infrastructure

Data Connectors

Security

C3 AI Suite

Machine Learning Framework and Services

Data Integration

Platform Management

UI and Data Visualization Tools

Application Development Tools

NoSQL Storage

API’s

An Open Source or Cloud Micro-Services Experiment

A Data Visualization Tool

A Closed “Black Box” Environment

A Replacement for Installed Enterprise Systems

C3 is NOT…

#1 in Analytics and Data

#1 in Security

#1 in Connect Functions

#1 in Partner Strategy

#1 in Strength of Market Offering

• Big Data

• Predictive Analytics

• IoT

• Time to Value in Weeks – Not Years

• Increases productivity by 10x – 100x

C3 Enterprise AI to Accelerate Digital Transformation

C3.ai Industry Applications

Financial Services

Healthcare Retail TelecomIndustrial / Manufacturing

Oil & Gas / Mining

Utilities Consumer Packaged Goods

Aerospace & Defense

Public Sector / Cities

Sensor Network (edge)

Product Design Engineering Manufacturing Supply Chain Billing Financials HR Industry SpecificExternal (social media, weather, traffic, prices)

D A T A S O U R C E S A C R O S S V A L U E C H A I N

C3 CRM™

C3 Predictive Maintenance™

C3 Energy Management™

C3 Sensor Health™

C3 Fraud Detection™

C3 Supply Network™

C3 Inventory Optimization™

C3 AI Suite

Awards and Recognition

A NextGen Platform for NextGen Apps

2018 National Category Winner

100Saving Lives. Protecting Americans.

MDPnP Interoperability and Cybersecurity Lab Massachusetts General Hospital

David Arney

Medical Device Plug-and-Play Interoperability and Cybersecurity Lab

Dave Arney darney@mgh.harvard.edu

MGH Medical Device “Plug-and-Play” Interoperability Research Program (MD PnP)

• Program established 2004, based on the MGH OR of the Future

• Lab opened 2006 for research on achieving safe, secure interoperable medical systems (standards technologies, products)

• Clinical, biomed, computer science, and IS subject matter experts

• Develops OpenICE open-source software www.openice.info

• Funding primarily from DOD, NIH, NIST and NSF

Presenter Presentation Notes http://www.openice.info/

Interoperability Lab Cybersecurity Lab

Biomedical Device-EHR Integration Lab

Conference Room

Entry

Connected care Testbed

Server Room

Please visit website for more information:

https://mdpnp.mgh.harvard.edu/ https://mdpnp.mgh.harvard.edu/

105Saving Lives. Protecting Americans.

Shabas Solutions, LLC

William Hauck

Capability Brief

Prepared By: Shabas Solutions, LLC 11166 Fairfax Blvd, Suite# 310

Fairfax, VA 22030 President: Mr. Somnath Mishra

Email: Somnath.Mishra@Shabas.net Phone: 571-243-0370 mailto:Somnath.Mishra@Shabas.net

Corporate Information - Summary

• Shabas Solutions, LLC (www.shabas.net) (“Shabas”) is a Virginia-based, Minority-Owned, Small Business Administration Certified Small Disadvantaged Business providing management consulting services. Our experts and staff members bring decades of experience in Defense and Health Supply Chain Management, Financial Services Industry Operations, CIO Advisory, and Pharmaceutical Quality Management.

We provide Management Advisory Services, Medical Logistics and Supply Chain Management Support, Financial Management Support and Training, and Communication and Outreach to Federal Government Agencies.

Corporate Credentials

DUNS: 178149998; CAGE: 4PAR3; PRIMARY NAICS:

541611

SBA Certified Small and Disadvantaged Business

DoD Cleared Top Secret Facility

DCAA-CertifiedAccounting System/DCMA-verified Financials;

ISO 9001:2015 Certified Quality Management System

GSA Customer Satisfaction Survey Open Ratings 95/100

MS Office 365 for Business-based Scalable Managed IT Cloud Infrastructure

NAICS Description 541611 Administrative Management and

General Management Consulting

541614 Process, Physical Distribution, and Logistics Consulting Services

611430 Professional Training Development

541512 Computer Design and Integration

541990 All Other Professional, Scientific, and Technical Services

541219 OtherAccounting Services http://www.shabas.net/

Shabas Has the Knowledge, and Depth to Support Key ASPR Areas of Interest We are a qualified small business with outstanding past performances, access to SMEs with institutional knowledge, and recognized industry partners. Our capabilities are best aligned with the following AOIs:

AOI-4: Medical Countermeasure Dispensing; AOI-7: Disaster Response and Recovery Intelligence

Program Management Logistics Management Quality Management Executive Advisory and Project Management Strategic Planning Studies and Analysis Survey and Benchmarking Integrated Planning (including

Outsourcing Transition Planning) Performance Management External and Internal Communications and Outreach Program Reporting Knowledge Management Process Improvement Financial Management

Asset, Medical Supply, and Operations Support Full Lifecycle Asset Management (Acquisition to

Retirement) Warehouse Management – Requisitioning, Receiving, Shipping & Inventory Cold Chain Storage & Temperature Monitoring Pharmaceutical Repackaging into Multi-Dose and

Unit-Dose Containers Medical Kitting/Co-Packaging Recall Management Support Customer Services/Help Desk Records Management and Administrative

Operations Logistics System Business Operations, and O&M Logistics Training Financials and Acquisition Support Business Analytics

Regulatory Affairs and Quality Assurance Support Regulatory Guidance at a Federal

Organization – cGMP, Controlled Substances, Transportation, HAZMAT

NDC Registration, SLEP, Drug Supply Chain Security Act (DSCSA) Implementation

Quality Investigations with Root Cause Analysis & CAPA Implementation

Risk Assessment using FMEA Equipment Qualification/Computerized

System Validation (21 CFR Parts 11, 211)

Supplier Qualification and Audit Program FDA, Customer Audits, Property Audits Quality Manual, SOP Development, Training and Implementation Quality Review Board Meetings

Our Advisors •Mr. John Handy (Retd. Maj, Gen USAF; Planning and Implementation of CDC Strategic National Stockpile)

• Mr. Steve Mahaney (ex-HHS Director of Logistics Policy)

• Dr. Ali Afnan (ex-FDA Scientific Adviser) 3

109Saving Lives. Protecting Americans.

Clean Energy Group

Marriele Mango

Clean Energy Group Marriele Mango, marriele@cleanegroup.org Resilient Power for Home Health Care:

How solar and battery storage can mitigate the impacts of power outages on home health patients and build broader community resilience

111Saving Lives. Protecting Americans.

Transcendence, Inc.

Dan Donovan

Innovative Technology for Rapid and Controlled Fluid Delivery

Presented by:

Presenter:

Dan Donovan, Lead Clinical Specialist

Point of Contact:

Leland Talbert, President/CEO

Email: leland.talbert@transcend-inc.com/Telephone: (334) 414-4266

An Introduction to:

August 8, 2019

LifeFlow® – The Product

• Exclusively distributed to the Federal market by Transcendence, a

Service-Disabled Veteran-Owned Small Business

• Created for rapid fluid resuscitation in cases of shock, sepsis, dehydration, hypotension, etc.

Faster, Easier, & More Controlled Fluid Delivery Enhances Care & Emergency Response

► Hand-operated rapid infusion system:

– Delivers 1 liter fluid bolus through a 20 G catheter in <5 minutes

– Provides greater control over fluid bolus volume

– Features contamination-reducing features Less handling during assembly Single-patient usage up to 24 hours Protected syringe

► Cleared by FDA and used in 30+ U.S. hospital systems

The LifeFlow Advantage

LifeFlow Offers Critical Advantages Over Traditional Fluid Delivery Methods

Why LifeFlow for Emergencies?

• Faster infusion

Two times faster than push-pull fluid delivery methods Four times faster than pressure bags

• Intuitive design requiring less set-up and training time

• Fully functional without power to deliver on-demand

• Compact hand-held design and packaging for:

Fast and easy set-up Enhanced mobility and transport/shipping Increased accessibility and easy storage in crash carts, rapid response carts, or Pyxis medical stations Use in areas/facilities with limited space

• No reliance on independent parts or integration with other systems required

Ideal Design, Size, & Functionality for First Response, Field Support, & Rescue Missions

For More Information Contact:

Transcending All Boundaries to Serve You!

Leland Talbert, President/CEO Transcendence, Inc.

leland.talbert@transcend-inc.com www.transcend-inc.com

60 Commerce Street, Suite 1240 Montgomery, AL 36104

(334) 414-4266 Mobile

(334) 460-4460 Fax

THANK YOU FOR YOUR INTEREST

117Saving Lives. Protecting Americans.

Virtru

Joe Stuntz

118Saving Lives. Protecting Americans.

Copyright 2019 Virtru Corporation

Securely Share and Generate Value from Protected Health Information

Joe Stuntz - Director of Federal

Secure sharing of PHI in office workflows like email, files, and applications

● Seamless end-to-end encryption, on-demand and easy to use

● Expire messages, control forwarding, add watermarks, and revoke access at any time

● View which recipients have accessed or forwarded protected emails and files

Improving Collaboration However Data is Shared

Privacy preserving analytics with persistent originator controls

● Encrypted data can be stored in a shared data lake with the data owners controlling the keys

● Data owners can then set rules for specific circumstances to run certain analytics, and audit key access to verify the agreement is being followed

Trusted Data Format (TDF)

● Data-agnostic, protective wrapper; enables secure and auditable information sharing

● No vendor lock-in or infrastructure constraints.

Invented by Virtru Co-Founder, Will Ackerly

● Published by ODNI for inter-organization data sharing & analysis in the Federal Government

Virtru has implemented TDF to the full specification

● Enables encryption of any data type, and binding of fine-grained attribute-based access control (ABAC)

● Protections travel with data, no matter how or where information is shared

Improving Collaboration Through Open Standards

121Saving Lives. Protecting Americans.

Copyright 2019 Virtru Corporation

Copyright 2019 Virtru Corporation 4

Thank You www.virtru.com http://www.virtru.com/

122Saving Lives. Protecting Americans.

TeleTracking, Inc.

Scott Newton

Disaster readiness program

AUGUST, 2019

HEALTH SYSTEM COORDINATION AT SCALE

““The TeleTracking system gave staff the ability to pull real-time, detailed reports on each of the shooting victims.

The ability to track each aspect of a patient’s care and movement through the length of their stay, and the ability to assess hospital capacity in real time, would prove to be critical in the response to the shooting rampage at the Aurora movie theater.”

UC Health

During Hurricane Harvey, our TeleTracking command center allowed us to respond to coastal area hospital evacuations.

Immediate bed visibility enabled us to accept many patients quickly.”

Dr. Ken Davis Christus Health, San Antonio, TX

CONTACT:

Scott M. Newton, DNP, RN, MHA scott-newton@teletracking.com

+1.410.463.5304

OUR MISSION IS TO ENSURE NO PATIENT EVER WAITS FOR THE

CARE THEY NEED.

DURING A DISASTER OUR MISSION BECOMES EVEN MORE

IMPORTANT.

TOGETHER WE STAND DISASTER READY.

mailto:scott-newton@teletracking.com

129Saving Lives. Protecting Americans.

University of California San Diego

Lucila Ohno-Machado

A

SPR

N ext Innovation D ay W ashington D C

8/8/19

Clinical Data Networks:

Their role before, during, and after disasters

Lucila Ohno-Machado, MD, PhD University of California San Diego

Can health surveillance processes used in research settings escalate to disaster situations?

Clinical Data Research

Network patient-centered Scalable National

Network for Effectiveness

Research

32 million people total

14 health systems

UC Davis 2.3M

UCSF

3.2M

UCLA

4.3M

UC Irvine 300k

USC Keck 2M

LA Children’s 200k

LA DHS 600K

UC

ReX

SCANNER

LA

VA VINCI

21M

UCSD

2.3M

Cedars- Sinai 2M

University of Washington

CTSA

CTSA hubNetwork

San Mateo Medical Center 77k

University of Colorado

Altamed 200k Chidlren’s Clinic 24k Queenscare 19k

Univ Texas Houston

Rutgers

Emory

Features of a distributed clinical data network

• Federated data for multivariate distributed analytics: no centralization of data

• No single point of failure

• Common data model

• Compatible institutional policies: Each institution has autonomy to decide whether their data should be included in a particular study

• HIPAA-compliant technical infrastructure using local enclaves and commercial clouds

User requests data for Quality Improvement or Research

•Identity & Trust Management •Policy enforcement

Trusted Broker(s)

Diverse Healthcare Entities in 3 different states (federal, state, private)

Distributed Computing

Wu Y et al. Grid Binary LOgistic REgression (GLORE): Building Shared Models Without Sharing Data.

JAMIA, 2012

Wu Y et al. Grid Multi-Category Response Logistic Models. BMC Med Inform Dec Making 2015

NIH U54HL1084600

Distributed Analytics across Horizontal and Vertical Partitions

Patient Age Sensor data A1 45 @#$(*$

A2 32 $&*$(@

Patient Age Sensor data B1 48 &*()*#*#

B2 72 #@$&*(@

Patient Age Sensor data

A1 45 @#$(*$

A2 32 $&*$(@

Li Y, et al. VERTIcal Grid lOgistic regression

(VERTIGO)

J Am Med Inf Assoc. 2015

Ohno-Machado L. To Share or Not To Share: That Is Not the Question. Science Translational Medicine, 2012 4(165)

HIPAA-compliant Environments for Clinical and Human Genome Data

NIH U54HL1084600

Presenter Presentation Notes Fig. 1. Data-sharing models. To avoid multiple pairwise agreements among institutions, a broker for data can be created. Data contributors specify their requirements for data access by users and sign a contributor data use agreement (DUA). Completing a quality assurance (QA) process is required for data, tool, and VM contributions. Data users also sign a DUA that complies with the requirements of the contributor, so that contributors do not have to negotiate every data-sharing engagement with different institutions. Three models of sharing are displayed. Model 1 is the traditional model, in which users download data for use in their local computers. In model 2, the remote desktop model, users connect to a center but access and analyze data within the center using existing, or their own, algorithms. Model 3 involves virtualization and distributed computation, in which users import software environments (virtual machines, or VMs) to analyze their data using their local computational infrastructures.

Privacy technology strategies can enable AI

Data-centric

• Add noise to data

• (e.g., differential privacy)

• Operate on encrypted data

• (e.g., homomorphic encryption)

• Multiparty computation

• (e.g., distributed analytics)

Institution/People-centric

• Data broker

(e.g., clinical data research networks)

• Patient-defined data sharing permissions (e.g., consent management)

Privacy Policies

Electronic H ealth R ecords

Big Data for Predictive Models (A.I.)

Learning models require a large amount of data Examples of clinical prediction and surveillance models

• Select best embryos for transfer in IVF

• Predict complications in coronary interventions

• Predict length of stay in the ICU

• Identify sepsis before obvious clinical presentation

• Predict rapid glaucoma progression

• Select biological to use in inflammatory bowel disease

California Precision Medicine Consortium for the All of Us Research Program

CAPMC We have recruited > 20,000 participants for this national NIH program

The goal of All of Us is to recruit 1 million people across the country

NIH OT2 OD026552

140Saving Lives. Protecting Americans.

TensorDRO

Ed Powell

Optimal Response Crowd | Cloud | AI

• AIO-7:

• Global Economic Optimization

• AIO-8:

• National Data Repository

• AIO-9:

• ValueBar

Optimization Platform

Tensor Approach AOI-7: Disaster Response and Recovery Intelligence

Develop capabilities that bring together deep learning, Artificial Intelligence (AI) and Machine Learning (ML) applications to forecast disaster impacts and automate replenishment of supplies during disasters.

Adoption of a Generalized Model-based AI Platform for use in a disaster/mass-casualty event to:

• Optimize response and recovery performance at all time-scales from long-term planning through real-time execution

• Adapt to dynamic environments seamlessly

• Maximize global effectiveness of response and recovery efforts

Neural Networks

Sy st em C om pl ex ity

System Uncertainty

Rule-based

Model-based

Genetic Algorithms

Integrated Framework | Generalized Approach

Operational Data

Economic Models

XML

Genetic Algorithms

Neural Networks

Linear Solvers

Heuristic Solvers

Analysis Platform

Modeling Platform

Prediction is the First Order

• Based on AMR Research

• 6% Forecast improvement improves the Order Fill Rate by 10% with a 12.5% reduction in inventory.

• Based on the Supply Chain Counsel research, Forecasting Accuracy is highly correlated to Fill Rates.

• Order Fill Rate (OFR) increased 4.5% for each 5% increase in forecast accuracy

• Delivery performance to request date (DPR) increased

2% for each 5% increase in forecast accuracy

• Delivery performance to commit date (DPC) increased

2.5% for each 5% increase in forecast accuracy

• Improved Forecast Accuracy is a high impact area for initial focus

“Prediction is very difficult … especially when it involves the future.”

-- Niels Bohr

Demonstrated Savings

• Annual Savings

• 22.5M Miles

• 980K Employee Hours

• $33.5M Earnings

AOI-8: Advanced Medical Interventions for Disasters

• Develop capabilities to address advanced health security vulnerabilities, establish trusted data platforms to secure health-related information and investigate linkages between clinical manifestation of disease and multi-omic indicators within dedicated US-based facilities to open new pipelines for medical countermeasure discovery.

National Data Repository

AOI-8: Advanced Medical Interventions for Disasters

• Creation of a National Data Repository by a private Digital Research Organization (DRO) that incentivizes PRIVATE and PUBLIC holders of key health and life science data to willingly allow data of National significance to be held in a new Private Public Partnership to ensure security, surety, and proper access to the critical data sets.

• Stores Data in a managed in an EXISTING Exascale infrastructure that allows analysis up to 30 Tb/s located near Washington DC

• Employs Best-in-Class cyber security practices will be employed to secure the data in way that optimizes innovation potential

• Deploys Best-in-Class Machine Learning / AI tools to ensure real-time analysis to generate insights for medical countermeasure discovery consistent with optimized deployment approach

• System will be instantiated utilizing existing infrastructure and platforms to ensure rapid deployment, low initial costs, and significantly reduced burden.

• In addition, the DRO will demonstrate existing Intellectual Property that allows the impact of each disparate dataset that contributes to an outcome to be identified and valued, thereby allowing:

Real-time confirmation by a physician / expert of the validity of the AI-enabled outcome; and

Enabling participation by data-owners in the potential monetization of a valuable outcomes / observations, thus ensuring greater participation, equitable financial benefits, and data security in “big…