Attachment 2. - GLIDE_Pitch Template v1.2.pptx

PPTX presentation 4 MB Posted Oct 29, 2024

Attached to: Groundbreaking Lymphatic Interventions and Drug Exploration
Opportunity number: ARPA-H-SOL-24-111
Issued by: Department of Health and Human Services

About this file

Written by GovTribe AI · Oct 30, 2024

This document is an attachment related to a federal grant opportunity from the Advanced Research Projects Agency for Health (ARPA-H). The attachment provides a pitch template for the Groundbreaking Lymphatic Interventions and Drug Exploration (GLIDE) program solicitation ARPA-H-SOL-24-111.

The key details include:

The GLIDE program is seeking proposals for physical device, pharmacologic, gene, or cell therapy interventions targeting rare and chronic disease indications related to the lymphatic system.
Applicants must address specific Heilmeier questions related to the technical merit, team qualifications, risks and mitigation strategies, program timeline and milestones, and cost of the proposed solution.
Applicants must provide a target product profile for their proposed solution, outlining key specifications, performance metrics, and considerations for affordability and accessibility.
The program timeline is up to 36 months for the Activator pathway or up to 18 months for the Accelerator pathway, with potential additional phases.
Eligible applicant types include individuals, for-profit organizations, nonprofits, higher education institutions, and small businesses.

From the source

Attachment 2

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Other files

File	Type	Posted
GLIDE FAQ 20250115.pdf	PDF	Jan 15, 2025
Attachment 3b. - ARPA-H COST PROPOSAL SPREADSHEET (Other Transaction).xlsx	XLSX spreadsheet	Oct 29, 2024
Attachment 3a. - ARPA-H COST PROPOSAL SPREADSHEET (Cooperative Agreement).xlsx	XLSX spreadsheet	Oct 29, 2024
Attachment 1. - GLIDE TPP Template and Examples.docx	DOCX document	Oct 29, 2024
GLIDE ISO ARPA-H-SOL-24-111 Final 29 OCT 2024.pdf	PDF	Oct 29, 2024
GLIDE ISO ARPA-H-SOL-24-111 Final 29 OCT 2024.pdf	PDF	Oct 29, 2024
GLIDE ISO ARPA-H-SOL-24-111 Amendment 1 - 7 NOV 2024.pdf	PDF	Oct 29, 2024
GLIDE ISO ARPA-H-SOL-24-111 Amendment 2 - 6 DEC 2024.pdf	PDF	Oct 29, 2024

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GLIDE Pre-Award Pitch Subtitle 3–7 Words Suggested Presenter Name and Title Date Sensitivity Label Placeholder

Submission #:

GLIDE Pitch Deck Cover Page

Solicitation #	ARPA-H-SOL-24-111
Solution Summary Title
Technical Approach (TA) Selection

(TA1 or TA2 – must select only one) Technical Pathway Selection (Activator or Accelerator)

Submitter Organization
Type of Organization and website URL if applicable	Choose all that apply: Large Business, Small Disadvantaged Business, Other Small Business, HBCU, MI, Other Educational, or Other Nonprofit
Technical Point of Contact (POC)	Name:

Mailing Address:

Telephone:

Email:

Administrative POC Name:

Mailing Address:

Telephone:

Email:

Total Estimated Budget	Total: $
Place(s) of Performance
Other Team Members (sub-performers, including consultants) if any	Technical POC Name:

Organization:

Organization Type:

What is your rare disease indication?

What is your chronic disease indication?

Submission Instructions Instructional slide - Do not include slide in submitted version

Go to the ARPA-H Solution Submission Portal: https://solutions.arpa-h.gov/ Log in using the username and password that was used for Solution Summary submission Select “Pitch Presentation”, and select the GLIDE ISO solicitation (ARPA-H-SOL-24-111) from the drop down in the form field.

Complete form fields and submit the pitch deck to complete the submission

Be advised:

It is recommended to review and respond to the ARPA-H Program Manager’s Solution Summary feedback in your pitch presentation.

Submissions will not be completed until all required files have been uploaded.

No revisions post submission will be allowed.

Received submissions will be invited to schedule a virtual presentation.

If you have questions, please email GLIDE@arpa-h.gov

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Neutral Colors #6F747A #4A4D52 #252729 #131314 #000000 Overall GLIDE Pitch Format and Logistics Instructional slide - Do not include slide in submitted version Project Submission # | Pre-Decisional – DO NOT DISTRIBUTE GLIDE Pitches will be virtual. Link will be shared with proposers selected and scheduled for pitch phase. Two people from each team will be allowed to attend the presentation.

GLIDE pitches will be 30 mins total including 20 mins presentation and 10 mins of Questions and Answers (Q&A).

Proposers are recommended to answer all ARPA-(H)eilmeier Questions (HQs 1-10) throughout the pitch slides where noted. Max 2 slides per HQs.

Proposers should include a Target Product Profile (TPP) for their proposed solution in either TA1 (Physical Devices) or TA2 (Pharmacologic, gene, or cell therapies).

Pictures and diagrams are encouraged in place of text where relevant.

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ARPA-H

Heilmeier Questions (HQs) 1 - 10:

Instructional slide - Do not include slide in submitted version

HQ1 : What health problem are you trying to solve?

What are your two disease indications (rare and chronic)?

HQ 2: How is it done today? What are the limitations of the current approaches?

What is the competitive landscape?

HQ 3: What is new about your approach? Why do you think it will be successful?

Is your study design inclusive with respect to demographics or social identities?

Have you considered collaborations that will expand the inclusivity of your study cohorts?

HQ 4: Who cares? If you succeed, what difference will it make?

Who will benefit from your solution?

What health outcomes are you accelerating?

HQ 5: What are the risks?

HQ 6: How long will the program take?

HQ 7: How much will the program cost?

HQ 8: What are the mid-term and final exams to check for success?

HQ 9: To ensure equitable access to all people, how will cost, accessibility, and user experience be addressed?

What is the expected target cost for the product?

Do you expect any health disparities to be reduced with your approach?

HQ 10: How might this program be misperceived or misused (and how can you prevent that from happening)?

ARPA-H: The hidden questions behind the Heilmeier Questions

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Neutral Colors #6F747A #4A4D52 #252729 #131314 #000000 Technical Merit

Project Submission # | Pre-Decisional – DO NOT DISTRIBUTE Explain your solution and how your solution has technical merit by answering these ARPA-H Heilmeier Questions :

HQ1. What health problem are you trying to solve?

What are your two disease indications (rare and chronic)?

HQ2. How is it done today? What are the limitations of the current approaches?

What is the competitive landscape?

HQ3. What is new about your approach? Why do you think it will be successful?

Is your study design inclusive with respect to demographics or social identities?

Have you considered collaborations that will expand the inclusivity of your study cohorts?

HQ4. Who cares? If you succeed, what difference will it make?

Who will benefit from your solution?

What health outcomes are you accelerating?

HQ9. To ensure equitable access to all people, how will cost, accessibility, and user experience be addressed?

What is the expected target cost for the product?

Do you expect any health disparities to be reduced with your approach?

PICTURE OF SOLUTION

The proposed solution should identify clear, measurable goals that have a reasonable chance of meeting the topic objectives. The potential of the proposed solution for technological innovation – whether the end-product or technology proposed would offer significant advantages over existing approaches, methodologies, instrumentation, or interventions currently used in research or clinical practice. Further, the proposed solution should align with the ARPA-H mission.

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Technical Merit (may add additional slide if needed to answer the HQ Question in previous slide)

Project Submission # | Pre-Decisional – DO NOT DISTRIBUTE More details on the technology Specifications/performance metrics Any IP held by company (or blockers identified by Solution Summary Review)

Reminder: Please address GLIDE program specific questions:

What are your two disease indications (rare and chronic)?

What is the competitive landscape?

Is your study design inclusive with respect to demographics, sex as a biologic variable or social identities?

Have you considered collaborations that will expand the inclusivity of your study cohorts?

Who will benefit from your solution?

What health outcomes are you accelerating?

What is the expected target cost for the product?

PICTURE OF SOLUTION

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Team

Description of the qualifications of the proposer team in terms of technical expertise and commercial acumen Please include the makeup of your leadership team and key personnel and provide a description of: designated roles and responsibilities, governance, and organizational structure, as well as that of the team’s supporting staff, consultants, advisors, and partners.

Team/company strengths and areas of support needed to be successful as a performer in the GLIDE Program.

Considerations and Reminders for GLIDE Program:

PI is required to be named, please list other members currently identified.

GLIDE strongly encourages teaming and strong collaboration. Consider opportunities with performers from GLIDE’s sister program LIGHT – Lymphatic Imaging, Genotyping and pHenotyping Technologies.

The final core performing team must include the following key members when identified: PI, project manager, Product Development Lead (PDL), JEDI, patient ambassador.

Are minority serving institutions (MSI) or Historically Black Colleges and Universities (HBCUs), or Partner Advocacy Organizations included on your team?

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Risks and Mitigation Strategies

What are the risks and associated mitigation strategies you already encountered? Please rank low, medium, high.

What are the risks and associated mitigation strategies you expect to encounter? Please rank low, medium, high.

What are your mitigation strategies to address ethical treatment and safety for populations with small sample size benefiting from technology?

ARPA-H Heilmeier Questions (HQs):

HQ5. What are the risks?

HQ10. How might this program be misperceived or misused.

And how can you prevent that from happening?

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Program Timeline & Milestones (Activator)

Phase I: Discovery and Development X months

(Up to 36 months)		Phase II: Pre-Clinical
18 months	Phase III: Clinical*

X months

Key Milestones	Months
	6	12	18	24	30	36	42	48	54	60

ARPA-H Heilmeier Questions

HQ6. How long will the program take?

HQ8. What are the mid-term and final exams to check for success?

Please use this specific table if you are self-selecting as an ACTIVATOR PATHWAY.

*Funding pending ARPA-H approval for Phase III – Clinical ; optional up to 6 months for Activator Pathway

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Program Timeline & Milestones (Accelerator)

ARPA-H Heilmeier Questions

HQ6. How long will the program take?

HQ8. What are the mid-term and final exams to check for success?

Please use this specific table if you are self-selecting as an ACCELERATOR PATHWAY *Funding pending ARPA-H approval for Phase III – Clinical ; up to 24 months for Accelerator Pathway Phase I: Discovery and Development X months

(Up to 18 months)	Phase II: Pre-Clinical
18 months	Phase III: Clinical

X months*

Key Milestones	Months
	6	12	18	24	30	36	42	48	54	60

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Cost

Please list the Rough Order of Magnitude (ROM) pricing that describes the basic unbundled prices including all costs associated with the proposed effort.

ARPA-H Heilmeier Question:

HQ7: How much will the program cost?

	Categories	Phase I Amount	Phase II
Amount	Phase III Amount	Total
	Direct Labor (including fringe)
	Subcontracts
	Materials
	Equipment
	Travel
	Other Direct Costs
	Indirect Costs
	Profit/Fee
	Total
	Cost Sharing

(if applicable/appropriate) Labor hours (in hours)

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TA1 Physical Interventions, Target Product Profile (TPP):

Blank Template

Product description/Therapeutic Modality
Product Target		Minimal Acceptable Results	Optimal Results
Primary Product Indication
Patient Population
Procedure Frequency
Delivery Mode
Quality of Life
Adverse Event Rate
Lymphatic Functional Efficacy Targets1 (pick ≥1)	Lymphatic Transport
	Lymphatic Pressure
	Lymphatic Vessel Contractility
	Volume/Displacement
Disease Specific Efficacy Targets2	Ex. Skin Thickness (Lymphedema)
	Ex. Stool Calprotectin Levels (IBD)
	Ex. Lesion Size (Lymphatic Malformation)
	Etc.
Product Specific-ations2
Ex. Product Dimensions
	Ex. Cost of Goods Manufactured (COGM)
	Etc.
Affordability and Accessibility	Device Cost (to purchaser)
	Procedure Cost (to patient)
	Training/Ease of use
	Accessibility

The example TPP, below, is meant to provide general guidance on how performers may complete a TPP for a specific disease indication. The specific targets outlined and the efficacy metrics in this example are not requirements or formal suggestions. Performers should tailor the TPP to their specific technology.

Performer’s choice:

Performer selects 2 lymphatic functional efficacy (requirement is ≥1).

Examples of efficacy targets related to the disease indications and product specification categories. This should be expanded and tailored to the proposed technology and disease indication.

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TA2 Pharmacologic, Gene and Cell Therapy, Target Product Profile (TPP):

Blank Template

Product description/Therapeutic Modality
Product Target		Minimal Acceptable Results	Optimal Results
Primary Product Indication
Patient Population
Treatment Duration
Delivery Mode
Quality of Life
Adverse Event Rate
Lymphatic Functional Efficacy Targets1 (pick ≥2)	Lymphatic Vessel Density/Vascular Area
	Lymphatic Transport
	Lymphatic Pressure
	Lymphatic Vessel Contractility
Disease Specific Efficacy Targets2	Ex. Skin Thickness (Lymphedema)
	Ex. Stool Calprotectin Levels (IBD)
	Ex. Lesion Size (Lymphatic Malformation)
	Etc.
Product Specific-ations2	Ex. Cost of Goods Manufactured
	Ex. Dosage Form
	Etc.
Affordability and Accessibility	Regimen
	Drug Cost (to patient)
	Stability/Shelf Life

Performer’s choice:

Performer selects 2 lymphatic functional efficacy (requirement is ≥2).

Examples of efficacy targets related to the disease indications and product specification categories. This should be expanded and tailored to the proposed technology and disease indication.

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Neutral Colors #6F747A #4A4D52 #252729 #131314 #000000 image20.png image1.png image18.png image19.svg image21.png image22.png

File details come from the government source that posted it. Updated Oct 30, 2024.