75N99223R0003 NITRO Proposers Day Slides.pdf

Making Joints Heal Themselves Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO)

Advanced Research Projects Agency for Health (ARPA-H)

Dr. Ross Uhrich, Program Manager

Health Science Futures (HSF), Mission Office (MO)

June 15, 2023

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Amy Jenkins, PhD Director, Health Science Futures Office

Transforming Health for All

The ARPA-H Model

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President Biden’s Vision

“ARPA-H will pursue ideas that break the mold on how we normally support fundamental research and commercial products in this country.”

“Ideas so audacious that people say they just might work only if, only if, we could try. Well, we’re about to try in a big way.”

— President Biden Remarks, March 18, 2022 https://www.whitehouse.gov/briefing-room/speeches-remarks/2022/03/18/remarks-by-president-biden-before-a-discussion-with-researchers-and-patients-on-advanced-research-project-agency-for-health-arpa-h/

Accelerate better health outcomes for everyone.

Mission

ARPA-H Organization within HHS

• Independent component of HHS within NIH; not an Institute

• ARPA-H Director reports directly to HHS Secretary

• No internal research labs; disease agnostic

• $2.5B initial appropriation;

budget independent from NIH

• Generally funds contracts, not grants

• Ability to directly reimburse FDA

HHS

Secretary

ARPA-H

Director

NIH

Director

Initial Mission Focus Areas

Health Science Futures Expanding what’s technically possible

Accelerate advances across research areas and remove limitations that stymie progress towards solutions. These tools and platforms apply to a broad range of diseases.

Resilient Systems Building integrated healthcare systems

Create capabilities, business models, and integrations to weather crises such as pandemics, social disruption, climate change, and economic instability. Systems are sustained between crises—from the molecular to the societal—to achieve better health outcomes.

Proactive Health Keeping people from being patients

Preventative programs will create new capabilities to detect and characterize disease risk and promote treatments and behaviors to anticipate threats to Americans’ health, whether those are viral, bacterial, chemical, physical, or psychological.

Scalable Solutions Reaching everyone quickly

Address health challenges that include geography, distribution, manufacturing, data and information, and economies of scale to create programs that result in impactful, timely, and equitable solutions.

Advancements in cell-free systems that enable rapid prototyping, modularity, and easier manipulation

New detection modalities that are more precise, sensitive, and have broader capabilities than existing methods

Digital cellular twin capabilities that are accurate surrogates for wet lab testing and can drive training data for AI/ML tools.

Novel techniques to improve the efficiency and cost of manufacturing gene and cell therapeutics from small batch to scale-up

Focus Areas Unlock new ways to collaborate and attack problems

Health Science Futures Expand What’s Technically Possible Develop approaches that bring radically new insights and paradigms. These innovative tools, technologies, and platforms can apply to a broad range of diseases that affect large populations, rare diseases, or diseases with limited treatment options.

Examples include:

• Novel molecular platform approaches ⎯ Modulation of host systems ⎯ Delivery to targets with special and temporal precision ⎯ Mitigation of off-target effects to accelerate interventions

• Approaches to accelerate mammalian and microbial cellular engineering to enable next generation therapeutic applications.

• Interventions that target and reverse disease pathogenesis or enhance plasticity to address degenerative diseases.

• Advances in genetic, cellular, tissue, and organ replacement therapies.

ARPA-H Health Ecosystem

Healthcare Providers

NGOs

Private Investors

Federal Partners:

FDA, CMS, HRSA, et al

NIH

The Public

Patient Groups

Academia

Industry

PERFORMERS

CUSTOMERS

STAKEHOLDERS

(and many others …)

The Program and Program Manager Flywheel

PROGRAM MANAGERS SOLUTIONS

PM joins with their vision to advance health outcomes

The ARPA-H portfolio is:

(1) a reflection of the PMs

(2) dynamic, and

(3) will — and should! — change frequently

ARPA-H Model: Program Formation

Challenge The challenge should NOT be easily solvable through traditional activities.

Program Launch A Program Manager seeks — and oversees — several groups of performers aiming to solve the same problem in unique ways.

Program Manager Program Manager identifies a difficult health-related challenge that is ripe for solving.

Performers Performers compete to carry out their potential innovative solutions to the challenge

ARPA-H Model: Support and Evaluation

Support ARPA-H will provide contracts – not grants – for projects with well-defined endpoints. Additional support will be provided by Program Managers, partners, and ARPA-H offices to ensure the best chance of success throughout the process.

Performance Contract performance will be regularly evaluated to allow ARPA-H to concentrate resources on the most effective approaches to reaching the desired goals. Valuable lessons are learned and shared from each project.

Performer

Performer

Performer

First Program Launch!

Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO)

Vision: To eradicate OA through targeted, regenerative therapeutics that will revolutionize the care algorithm, prevent pain, decrease the economic burden, and eliminate the need for repeat joint surgery.

Technology focus areas

• Needle-based and/or non-invasive bone regeneration

• Needle-based and/or non-invasive cartilage regeneration

• Replacement joints built from human cells

How to apply

• Submit abstract and, if invited, full proposal

• Visit arpa-h.gov for more information about NITRO and applying to the BAA or email: NITRO@arpa-h.gov

Important Dates

• Today! Proposers' Day for interested research teams

• Program BAA will close on July 28, 2023, at 11:59pm ET

What if we could make our joints heal themselves?

Craig Gravitz, JD Director, Project Accelerator Transition

Innovation Office (PATIO)

Path to Success

Accelerated Transition

Distribution Unlimited

The Path to Success for Health Solutions is Complex solutions that transition & commercialize

Pull-through effect

Project Accelerator Transition Innovation Office (PATIO) Increase the probability - at each step - that solutions can drive positive health outcomes & “survive in the wild"

SERVICES DURING PROGRAM LIFECYCLE

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Program Design

• Identify opportunities and gaps

• Market/IP assessment

• Regulatory assessment

BAA Development

• Who are possible performers? Innovation Hubs?

• Develop technical areas

• Validate transition potential

Early Program Performance

• De-risk for investors

• Design MVPs to drive adoption

• Demystify regulatory process

Mature Projects

• Safeguard IP

• Help company formation

• Business strategy, legal and marketing services

Transition and Commercialize

• SBIR/STTR

• Transition partner/third-party investment

• Ongoing mentorship

• Access to key customers and investors

Core Approach: Design Framework Three Vectors

Feasibility (technical)

Viability (markets)

Desirability (people)

ARPANET-H

DVF in Practice

The 2023 Consolidated Appropriations Act directs the agency to establish sites in at least three geographic areas.

The hub and spoke model will form a network of people, institutions, and capabilities across the country.

• Hub: To ensure the active transition of health innovation in an expedient, cost-effective, accessible and sustainable manner that reaches all Americans.

• Spoke: To ensure that Americans in every community benefit from ARPA-H solutions. Spokes are connected to appropriate hubs on an ongoing basis.

Hub and Spokes to enable a Nationwide Network ARPA-H projects will run through the hubs with members in various locations across the country

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Customer Experience Hub

Investor Catalyst Hub

Stakeholder and Operations Hub

FDA Coordination

CMS Coordination

Other federal partners

Data commons as data layer across network

National Capital Region

Project

Project

Project

Project

Project

Project

Experts in Residence Program: Private sector expertise Increase viability through expert advisors & support

Allows ARPA-H to provide highly specific and customized services to support ARPA-H, PMs, and their programs for transition and commercialization.

• Horizon scanning to forecast emerging trends

• Analyses that address market dynamics, consumers, pricing, IP, regulatory, barriers to entry, and more

• Commercial-focused XIRs for ongoing development and support

Health Ecosystem Engagement Access the resources & expertise of the health ecosystem through a network on demand

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Allows ARPA-H to provide leverage the institutional knowledge, and innovations in the broader health ecosystem.

• Impactful events with the health ecosystem to develop new partnership opportunities

• Two-way street for program managers to gather customer insights, and for stakeholders to learn about new developments at the agency

• Institutional knowledge and connections over time for future program managers

Novel Innovations for Tissue Regeneration in Osteoarthritis

N I T R O

A Possible Challenge to Solve

Raising our quality of life and eradicating the disease

#3 Cause of disability

Debilitating

Decreased Mood

Everyday activity

Sleep quality

Osteoarthritis

• OA highest for Multi-Racial Non-Hispanic and Native American / Native Alaskan populations

• OA 2x more common in women

• By 2030, half of the US will be obese and 24% will be severely obese, increasing OA

• OA increases the risk of heart disease by 50%

• USA knee OA population generates $14.0 billion in opioid-related costs

Prevalent

78.8M 1.9B

32.5M 242M

2023 2040

US

Global

Individuals with OA

Over 45Total

Percent of US Population

Painful

High Pain

Expensive

Data in the US alone & annually

Total cost

$10.3BAbsenteeism

$11kPer capita

$136B

No OA, 74

OA, 26

No OA, 22

OA, 88

Set Up for Success with Room for Improvement

MACI and Other Regenerative Therapy

LIMITATIONS

• Two Surgeries Required

• Provider-Dependent Outcomes

• 6-8 weeks Between Surgeries

• Arthrofibrosis and/or Ankylosis

• Graft Failure

Total Joint Replacement (TKAs and THAs)

LIMITATIONS

• Infection (26%)

• Hardware failure (~26%)

• Range of motion limitations

• Persistent pain

• Nerve damage

• Thrombosis

Current OA Treatments Require Open Joint Surgery & Typically Proceed to Full Replacement

TKA: Total Knee Arthroplasty; THA: Total Hip ArthroplastyMACI: Matrix-Induced Autologous Chondrocyte Implantation

3,500,000 TKAs by 2040

Eradicate osteoarthritis (OA) through targeted, regenerative therapeutics that will revolutionize the care algorithm, prevent pain, decrease the economic burden, and eliminate the need for repeat joint surgery with equitable access for all Americans.

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Vision for the Future Novel Innovations for Regeneration in Osteoarthritis

ARPA-H's first Health Science Futures program-specific BAA seeks funding proposals for research aiming to:

No Pain

Everyday activity

Prevalence & Cost

Sleep quality

Improved Mood

• N I T R O is powered and backed for program success.

Equitable Access

• Designated Equity Officer

• Established Key Performance Indicators

• Developed Road Map to Equity

• Enforced Insurance Action Plan

• Defined demographics Requirements

• Partnered with Affordable Care Act

HHS: Department of Health and Human Services PATIO: Project Accelerator Transition Innovation Office

Help All Americans

The ARPA-H NITRO program will revolutionize the entire field of regenerative medicine.

Eradicating the Disease

• Reversing Damage

• Eliminating reliance on replacements

• If replacement needed, no revisions necessary

Deliberate, Efficient, and Effective Forward Progress

• OA Clinical Trial Stakeholders

• Community-wide OA Model Symposium

• Immediate FDA Involvement

• Accelerated Transition from PATIO

• Public Market buy-in

• Integrated Equity Metrics

Novel Innovations for Tissue Regeneration in Osteoarthritis

N I T R O “The ERA of ARPA-H is here.”

— Secretary Becerra, HHS

NITRO within the ARPA-H Model

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Program Manager

6. Contracting

7. Cost Proposals

• Performers must meet Program Goals and Metrics and GNG Milestones

Topics covered today

• Informational talks

• Teaming opportunities

• Abstract and proposal due dates released

1. Technical Areas

(TA)

2. Program Goals and Metrics

3. Go/No-Go (GNG)

4. OA Model

Symposium

5. Equity Officer (EO)

ARPA-H

Challenge

NITRO BAA

Release

Proposers’ Day

Applications Reviewed

Program Launch

Performers and NITRO Team

Transition to Practice

Groups of performers compete to carry out their potential innovative solutions to the challenge.

The challenge should NOT be easily solvable through traditional activities.

Identifies a difficult health-related challenge that is ripe for solving.

Performers meet metrics and GNG milestones then transition with

PATIO support.

Program informational session and opportunity for establish proposal teams.

NITRO team selects and manages performers aiming to solve the problem.

Official announcement to seek proposals to solve the NITRO challenge.

Abstracts welcome and full proposals

(40-pages) are strongly recommended.

TA1: Needle-based and/or non-invasive subchondral (SC) bone regeneration Development of an intra-articular (IA) therapeutic to fully regenerate SC bone in all synovial joint(s) in all cases of primary OA as well as trauma- and obesity-induced secondary OA.

TA2: Needle-based and/or non-invasive cartilage regeneration Development of therapeutics (both IA and systemic) to fully regenerate cartilage in all synovial joints in all cases of primary

OA as well as trauma- and obesity-induced secondary OA.

TA3: Allogeneic and autogenous non-immunogenic, load-bearing and osteochondroinductive total replacement joints Development of autogenous and allogeneic, non-immunogenic, osteo- and chondro-inductive, load-bearing total knee replacements that requires no permanent foreign body implantation and performs at or above the current standard set for artificial total knee implants.

NITRO Technical Areas (TA)

Board of Potential NITRO Approaches

TA1

Performers may propose a variety of approaches to regenerate SC bone (separate or combined) that may include but are not limited to:

Implantable scaffolds

Genetic engineering

Cell therapy

Nanoparticles

Small molecules

Injectable biomaterials or biologics

TA2

Performers may propose a variety of approaches to regenerate cartilage (separate or combined) that may include but are not limited to:

Chondrospheres

Therapeutic proteins

Implantable scaffolds

Genetic engineering

Cell therapy

Nanoparticles

Small molecules

Injectable biomaterials or biologics

TA3

Performers must generate allografts and autografts using a variety of approaches (separate or combined) that may include but are not limited to:

Computerized numerical control (CNC) multiscale milling

Bioreactors (in vivo and/or in vitro)

Genetic engineering

Off-the-shelf products

3D and/or bio-printed constructs

Anatomical materials

Multi-functional designs

Cell therapy

• Teams can include academia, small business, large business, contract research organizations, manufacturers, and more!

• Teaming is considered necessary to accomplish the program goals and metrics.

Teams Must Address Specific TAs

TA1 TA2 TA3

TA1

TA2 TA3

Advanced Research to Transition Timeline

Pre-Clinical 18 months

Therapeutic Discovery 24 months

Phase 1 Clinical Trial 18 months

Revolutionized Standard of Care

• 24 months

Surgical procedures

Recovery time

Pain

Replacement necessity

Treatment lag time

Permanent fixation

Standard of Care

NITRO Metrics

Predictions, not factual data.

Normalized to 100% of the standard of care. Critical size defects: those that would not spontaneously heal completely

Metrics Designed to Supersede the Standard of Care and Advance Transformative Therapeutics

• Variety of approaches for disease heterogeneity:

Intraarticular (IA) or intravenous (IV) single-joint and/or multi-joint approaches

• Standardized delivery with minimal repeat procedures:

Needle-based and/or non-invasive with no recipient harvest (single procedure) and minimal dosing

• Effective across the entire disease spectrum: End-grade OA to Grade 0 with reduced pain for defects at and beyond critical size

• Advancing bio-mimics to the clinic and departing from a titanium past: Patient-specific and osteochondroinductive with no permanent fixation or immunogenicity

• Meeting diverse patient needs at their doorstep: Allograft in <24hours and autograft in <30 days for rapid load-bearing, graft manufacturing

• Accelerated recovery time & long-term stability:

Functional recovery windows better than standard of care

• From the gate, ready for successful commercialization:

Mandatory investigational new drug (IND) application and good laboratory/manufacturing/clinical practice

(GLP/GMP/GCP)

TA1 Metrics

Pre-Program Phase 1 (24 Months) Phase 2 (36 Months)

FY23 FY24 FY25 FY26 FY27 FY28

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Timeline Therapeutic Discovery & In Vitro (24mo) Pre-Clinical (18mo) Phase I Clinical Trials (18mo)

TA1 Metrics (SC Bone)

SJ & MJ

Produce ≥1 therapeutic for IA bone regeneration

• No Surgical Donor/Recipient Harvest

• Regenerate Defects At AND Beyond

“Critical Size Defects”

• Regenerate End-Grade OA to Grade 0 in

ALL Synovial Joints

• Needle-Based (including arthroscopic) and/or

Non-Invasive Approach

• Ideally ≤1 dose per year (in tandem with TA2)

Meets/Exceeds All Prior Criteria

Using Appropriate OA Large Animal Model:

• Sustains physiologically-relevant* load (per ICS 11.040)

• Full function ≤3mo post-op with

≥85% success

• Pain < 3/10

Meets/Exceeds All Prior Criteria in Human Clinical Phase I Trials

Abstract and Proposal Options:

A) TA1 and TA2 –or- B) TA3 –or- C) TA1, TA2, and TA3

*Physiologically relevant load = ISO 14243 knee

TA2 Metrics

Pre-Program Phase 1 (24 Months) Phase 2 (36 Months)

FY23 FY24 FY25 FY26 FY27 FY28

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Timeline Therapeutic Discovery & In Vitro (24mo) Pre-Clinical (18mo) Phase I Clinical Trials (18mo)

TA2 Metrics (Cartilage)

• No Surgical Donor/Recipient Harvest

• Regenerate Defects At AND Beyond “Critical Size

Defects”

• Regenerate End-Grade OA to Grade 0 in ALL

Synovial Joints

• Needle-Based (including arthroscopic) and/or

Non-Invasive Approach

• Ideally ≤1 dose per year (in tandem with TA2)

Meets/Exceeds All Prior Criteria

Using Appropriate OA Large Animal Model:

• Sustains physiologically-relevant* load (per ICS 11.040)

• Full function ≤3mo post-op with

≥85% success

• Pain <3/10

Meets/Exceeds All Prior Criteria in Human Clinical Phase I Trials

Abstract and Proposal Options:

A) TA1 and TA2 –or- B) TA3 –or- C) TA1, TA2, and TA3

SJ

Produce ≥1 IA therapeutic for cartilage regeneration

MJ

Produce ≥1 systemic therapeutic for cartilage regeneration

TA3 Metrics

Pre-Program Phase 1 (24 Months) Phase 2 (36 Months)

FY23 FY24 FY25 FY26 FY27 FY28

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Timeline Therapeutic Discovery & In Vitro (24mo) Pre-Clinical (18mo) Phase I Clinical Trials (18mo)

TA3 Metrics (Total Joint)

• Load-bearing TKA allograft AND autograft

• Patient-Specific

• No permanent fixation

• Osteoinductive/Chondroinductive

Meets/Exceeds All Prior Criteria

• Allograft: Custom osteochondral graft in <24 hours

• Autograft: Custom osteochondral graft in <30 days

• Full function ≤4-6 weeks post-op ≥85% success

• Sustains physiologically-relevant* load (per ICS 11.040) Stability of the implant ≥12mo

Meets/Exceeds All Prior Criteria in Human Clinical Phase I Trials

Abstract and Proposal Options:

A) TA1 and TA2 –or- B) TA3 –or- C) TA1, TA2, and TA3

TKA = Total knee arthroplasty

Metrics for all TAs Abstract and Proposal Options:

A) TA1 and TA2 –or- B) TA3 –or- C) TA1, TA2, and TA3

Pre-Program Phase 1 (24 Months) Phase 2 (36 Months)

FY23 FY24 FY25 FY26 FY27 FY28

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Timeline Therapeutic Discovery & In Vitro (24mo) Pre-Clinical (18mo) Phase I Clinical Trials (18mo)

Requirements Across

ALL TAs

• Begin IND Application

• Identify Potential GLP and cGMP Manufacturing

Partners

• By Q4 FY24: Submit INTERACT meeting package and incorporate feedback

• By Q3 FY25: Submit Pre-IND meeting package and incorporate feedback

• GLP Manufacturing

• GCP & cGMP material for 20-100 patients

• Complete IND-enabling studies & application

• Ensure scalable cGMP manufacturing partner for Phase II/III/Commercial (1000+ patients)

Commercialization Plan

Work with PATIO assets to develop commercialization plan (including an engagement plan with XIR/EIRs)

Use PATIO assets to commence commercialization plan, secure IP, streamline regulatory pathway (FDA consultants), scale manufacturing capabilities etc.

Use PATIO assets to commercialize therapeutics and exit Program

Equity Requirements for all TAs

*GNG: Go/No-Go; Multi-Racial Non-Hispanic; Native American / Native Alaskan; Non-Hispanic White; Non- Hispanic Black; Latino; Asian American Pacific Islander

Pre-Program Phase 1 (24 Months) Phase 2 (36 Months)

FY23 FY24 FY25 FY26 FY27 FY28

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Timeline Therapeutic Discovery & In Vitro (24mo) Pre-Clinical (18mo) Phase I Clinical Trials (18mo)

Equity Requirements

• Define Equity KPIs, >5 demo-specific listening sessions

• Prepare “Road Map to Equity” Report (Deliver at Equity Symposium)

• Create Insurance Action Plan (CMMI, CMS, IHS)

• Partner with Animal Care Act Stakeholders

• Co-Manage Equity Symposium and publish the proceedings

• Ensure prior KPIs enforced

• ***Clinical Trial GNG DEMOGRAPHIC REQUIREMENTS ENROLLMENT:

>50% women; (±5%): 20.7% Multi-NH; 20.1% Native Am/AK; 18.6% NHW; 18.2%

NHB; 12.7% LAT; 9.7% AAPI*

Goal: Integrated Equity Officers (EO) develop and enforce equity plans and ensure complete ownership of equitable research and transition

There will be one EO per performer team. The EO for each team will be responsible to guiding performers towards successfully meeting the equity metrics in the BAA. The information here is only a summary and does not encompass all of requirements in the BAA.

De-Risk Translation: NITRO OA Model Symposium

Goal: Establish early consensus surrounding the ideal OA model to mitigate risk for translation

The first Symposium will take place on September 6, 2023. We strongly recommend all potential performers plan to attend. The below information is only a summary and does not encompass all of requirements in the BAA.

• Who will attend ⎯ Academia to industry, members of the Food and Drug Administration

(FDA), veterinarians, contract research organizations (CROs), and manufacturers.

• What will be discussed ⎯ The current data and technology for OA Models to provide consensus surrounding the ideal OA model for translation.

• Outcomes ⎯ Single large animal model of OA to streamline preclinical testing and regulatory approval ⎯ Publication on the consensus OA model ⎯ Risk mitigation for NITRO performers and the broader OA research community in translational studies

NITRO Commercialization

PATIO

Hub & Spoke

Goal: Performer and Program Transition

• ARPA-H PATIO team

• Expert/Entrepreneur in Residence (XIR & EIR) Network

• Minimum Viable Product (MVP) Testing for Market Adoption

• Scalability with Hub and Spoke

• Venture Capital (VC) Panel

• Successful exit from NITRO means established path towards patient care with product(s) entering market

NITRO Broad Agency Announcement

Vision ARPA-H's first Health Science Futures program-specific BAA seeks funding proposals for research aiming to:

eradicate osteoarthritis (OA) through targeted, regenerative therapeutics that will revolutionize the care algorithm, prevent pain, decrease the economic burden, and eliminate the need for repeat joint surgery.

How to apply

• Visit arpa-h.gov for more information about NITRO and applying or email: NITRO@arpa-h.gov

• Abstracts (6-pages) are optional

• Full proposals (40-pages) are strongly encouraged and should investigate unconventional approaches and challenge accepted assumptions to enable leaps forward in science, technology, systems, or related capabilities.

Important Dates

• Today! Proposers' Day for interested research teams

• The NITRO BAA will close on July 28, 2023, at 11:59pm EDT and up until then, submissions will be received on a rolling basis.

• Inaugural NITRO OA Model Symposium will take place on September 6, 2023, in Washington DC.

Significant Dates and Times

Event Date Time

Abstracts due June 23, 2023 5:00 PM EDT

Full Proposals due

July 28, 2023 5:00 PM EDT

OA Model Symposium

September 6, Location:

Washington, DC

The information on this page is only a summary and does not encompass all the requirements in the BAA.

Traci Newsom, Contracting Officer Business Innovation Division

The Application Process

Acquisitions Details

Distribution Unlimited.

NITRO Solicitation/Funding Opportunity Basics

• BAAs are a flexible and recognizable method to solicit proposals for R&D

• The NITRO BAA provides for a competitive process while complying with all Funding Opportunity Notice requirements of 45 CFR Part 75 and 2 CFR Part 200 for Cooperative Agreements.

• ARPA-H anticipates meaningful proposals with varying technical/scientific approaches

• BAA technique allows for a variety of award instruments

75N99223R0003 Basics

Award Types

• Awards will be Cooperative Agreements and Other Transactions.

• Selection of award type will be based on best fit for the project.

Award Timeline

• Estimate full proposal evaluations to be complete by 11 September. At that point, ARPA-H will begin negotiating award instrument SOWs and T&Cs with selected proposers.

Award Funding

• There is no funding limit for individual awards, no ceiling or award range for individual awards, or an overall ceiling for the BAA.

Award Types – Cooperative Agreements

Financial Assistance

• Financial assistance mechanism where the principal purpose is to carry out a public purpose authorized by a U.S. law rather than to acquire supplies/services for the benefit of the Government.

Substantial Involvement

• Cooperative Agreements are distinguished from grants because of the Government’s substantial involvement. This is broadly outlined in the BAA (e.g., 6.3 Reports) and will be specifically established in the Terms and Conditions of each award.

Benefits

• Parties work together to achieve a specific set of objectives or outcomes.

• Flexibility and discretion in project design and implementation, allowing for more innovative and customized solutions to complex problems.

• Enhanced accountability and transparency.

Award Types – Other Transactions (OT)

OTs are agreements

• Mutual assent, expressed by a valid offer and acceptance; adequate consideration; capacity;

and legality (i.e., these are contracts, but not FAR procurement contracts.)

• Leverage commercial business practices more so than traditional FAR procurements.

Collaborative

• Increased collaboration and partnership, leading to more effective use of resources and knowledge sharing.

Flexible

• Many typical contract laws and regulations don’t apply (e.g., CICA, FAR, CAS).

• Greater flexibility in project design and implementation.

• May fully negotiate data rights, patents, payment structure, etc.

Evaluation and Selection (BAA page 41)

• The Government will review each conforming abstract against criterion 1, and each full proposal against criteria 1–4.

• Selection for award will be made as outlined in the BAA.

Abstract Submission (BAA page 28)

• OPTIONAL

• Length should not exceed 6 pages

(excludes cover page & ROM).

• Abstract should include all sections as specified in the BAA.

• Abstract evaluation criterion – scientific and technical merit.

• All Abstracts to be submitted in eCPS

Full Proposal (BAA page 30)

• Government will recommend or discourage submission based on abstract review.

• Submitted in eCPS for OTs

• Submitted in Grants.gov for Cooperative

Agreements

• Summary of Proposal & Detailed

Proposal Info – no more than 40 pages in length (excludes SOW).

Process Overview

Evaluation Criteria

Overall Scientific and Technical Merit (Abstract and Full Proposal)

• Innovative, feasible, achievable, and complete.

• A final outcome that achieves the goal can be expected as a result of award

• Risk identification with mitigation strategy.

Proposer’s Capabilities and/or Related Experience (Full Proposal)

• Team expertise and experience.

• Experience in managing similar efforts.

Potential Contribution and Relevance to the ARPA-H Mission (Full Proposal)

• Future application, including unmet needs within biomedicine and to improve health outcomes.

• Potential for interdisciplinary approach.

Evaluation Criteria (continued)

Reasonableness/Realism/Funding Availability/Affordability (Full Proposal)

• Submissions must include the specified spreadsheets

- Amendment forthcoming to provide both in SAM.gov

• Price Reasonableness

• Cost Realism

• Availability/Affordability

⎯ May only acquire goods or services that meet needs and are within budgetary constraints.

⎯ IP considerations.

Final Application Guidance

Continue to monitor SAM.gov

• Amendment posted 14 June

• Anticipate next Amendment week of 26 June to provide the required Cost Proposal Spreadsheets

Posting in Grants.gov

Conform to all BAA Requirements

• Eligibility (BAA pg. 25).

• Special requirements for cooperative agreement awardees (BAA pg. 39).

Any/all changes to the BAA will be made in formal Amendments posted online at SAM.gov

• No information discussed or viewed at Proposers' Day shall be construed as modifying the terms and conditions of the BAA

Joshua Brown (CTR), Business Finance Manager

Templated Spreadsheet

Cost Proposal

ARPA-H Cost Proposal Spreadsheet

Purpose: assist the Government in completing a rapid analysis of your proposed costs and, if your proposal is selected for award, speeding up the negotiation and award execution process..

Approved for Public Release: Distribution Unlimited

• The basis and rationale for all proposed costs should be provided as part of the proposal.

• Using the cost proposal spreadsheet:

⎯ Enter the proposed cost detail for Phase 1 and Phase 2.

⚬ The tab entitled, "Total Amount" will automatically calculate from the Phase 1 and Phase 2 tabs.

⎯ Data entry: Yellow and Clear cells.

⎯ References or formulas: Gray cells.

⚬ Do not change, unless the formula does not match your organization's business rules.

⚬ If you change these formulas, you must ensure the change does not affect the final outputs.

⎯ Proposers may add additional specific cost categories (Sub-proposers, ODC types, etc.) as needed but must ensure those new cost categories track to the Total Amount tab.

⎯ If a row, column, or worksheet in this spreadsheet is not needed for your proposal, either ignore it or Hide it;

do not delete it.

Round 1 3 minutes with a hard stop to stay on schedule

1 speaker only per lightning talk

Lightning Talks