Attachment 1. - GLIDE TPP Template and Examples.docx
DOCX document 43 KB Posted
- Opportunity number
- ARPA-H-SOL-24-111
- Issued by
-
Department of Health and Human Services
About this file
This document contains a Target Product Profile (TPP) template and example for a federal grant opportunity related to the Groundbreaking Lymphatic Interventions and Drug Exploration (GLIDE) program.
The TPP template outlines the minimum expectations for performers to submit, including details on the product description, target patient population, delivery mode, quality of life metrics, adverse event rates, and various lymphatic functional efficacy targets and disease-specific efficacy targets. An example TPP for breast cancer-related lymphedema is provided to illustrate how performers should tailor the TPP to their specific technology.
The related federal grant opportunity, posted by the Advanced Research Projects Agency for Health (ARPA-H), is seeking innovative solutions for the GLIDE program. The funding opportunity has a variety of eligible applicant types, including individuals, for-profit organizations, higher education institutions, nonprofits, and small businesses. The funding activity categories include science, technology, and other research and development. Key details on the solicitation number, funding instruments, and the ARPA-H program under which this opportunity is assigned are also provided.
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TA1 Target Product Profile (TPP): Template Performers must submit a TPP for each disease indication with their submission detailing the technologies capabilities. The template below outlines GLIDE’s minimum expectations but should be expanded and tailored to fit the specific disease indications selected.
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
Steps Required:
1. Define the healthy or therapeutic range of ≥1 lymphatic functions in their indication and propose to restore function to that target range.
2. Include additional minimal and ideal results specific to the claim and indication of use for the targeted disease. Listed examples are not requirements or formal suggestions.
TA2 Target Product Profile (TPP): Template Performers must submit a TPP for each disease indication with their submission detailing the technologies capabilities. The template below outlines GLIDE’s minimum expectations but should be expanded and tailored to fit the specific disease indications selected.
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 (Inflammatory Bowel Disease)
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
Steps Required:
1. Define the healthy or therapeutic range of ≥2 lymphatic functions in their indication and propose to restore function to that target range.
2. Include additional minimal and ideal results specific to the claim and indication of use for the targeted disease. Listed examples are not requirements or formal suggestions.
TA1 Target Product Profile (TPP): Example - Breast Cancer Related Lymphedema 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.
| Product description/Therapeutic Modality |
| Novel implantable medical device |
| Product Target |
| Minimal Acceptable Results |
| Optimal Results |
| Primary Product Indication |
| Mitigate the volume of a swollen limb by one clinical stage in BCRL. |
| Complete curative therapy for BCRL. |
| Patient Population |
| All patients with breast cancer related lymphedema (BCRL) |
| All patients with breast cancer related lymphedema (BCRL) AND patients at risk for BCRL |
| Procedure Frequency |
| Once (Lifetime implant) |
| Once (Lifetime implant) |
| Delivery Mode |
| Implanted as an adjunct procedure to axillary lymph node dissection |
| Minimally invasive procedure |
| Quality of Life |
| >75% of patients experience at least a 3-point improvement (LYMQOL) |
| >95% of patients experience at least a 3-point improvement (LYMQOL) |
| Adverse Event Rate |
| <10% of patients develop adverse events (≥ Grade II) |
| <1% of patients develop adverse events (≥ Grade II) |
| Lymphatic Functional Efficacy Targets1 (pick ≥1) |
| Lymphatic Transport |
| >60% clearance of injected interstitial lymphatic tracer within 24 hours |
| >80% clearance of injected interstitial lymphatic tracer within 24 hours |
Lymphatic Pressure
Lymphatic Vessel Contractility
| Volume/Displacement |
| >20% reduction in LE arm volume (~100-150ml) |
| 40% reduction in LE arm volume (>250ml) |
| Disease Specific Efficacy Targets2 |
| Skin Thickness |
| <25mm (caliper measurement) |
| <13mm (caliper measurement) |
| Bioimpedance |
| >0.95 bioimpedance ratio (LE arm: Healthy arm) |
| >0.99 bioimpedance ratio (LE arm: Healthy arm) |
| Inflammation |
| <17pg/ml GM-CSF (plasma) |
| <12pg/ml GM-CSF (plasma) |
Etc.
| Product Specific-ations2 |
| Ex. Product Dimensions |
| < 2cm x 2cm x 1cm (HxWxD) |
| < 1cm x 2cm x 0.5cm (HxWxD) |
| Ex. Cost of Goods Manufactured (COGM) |
| < $5,000 |
| < $ 3,500 |
Etc.
| Affordability and Accessibility |
| Device Cost (to purchaser) |
| Class III: <$7,000 |
| Class III: <$5,000 |
| Procedure Cost (to patient) |
| < $1,300 (target out of pocket expense) |
| < $650 (target out of pocket expense) |
| Training/Ease of use |
| An experienced surgeon/user should be competent in the intervention with ≤ 2 weeks of training. |
| An experienced surgeon/user should be competent in the intervention with ≤ 5 days of training. |
| Accessibility |
| Available at community hospitals and healthcare centers |
| Available at rural hospitals and healthcare centers |
Performer’s choice:
1. Performer selects 2 lymphatic functional efficacy (requirement is ≥1).
2. Examples of efficacy targets related to BCRL and product specification categories. This should be expanded and tailored to the proposed technology and disease indication.
TA2 Target Product Profile (TPP): Example - Inflammatory Bowel Diseases (IBD)
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.
| Product description/Therapeutic Modality |
| Novel small molecule therapy |
| Product Target |
| Minimal Acceptable Results |
| Optimal Results |
| Primary Product Indication |
| Treatment of mild to moderate IBD and mitigation of abdominal pain |
| Complete curative therapy of IBD. |
| Patient Population |
| Adults with Crohn’s Disease OR Ulcerative Colitis |
| All IBD patients (Crohn’s Disease AND Ulcerative Colitis) |
| Treatment Duration |
| Lifetime use |
| <1 year |
| Delivery Mode |
| Achieves >30% cumulative dosing directly into the mesenteric LS in first 12 hours |
| Achieves >45% cumulative dosing directly into the mesenteric LS in first 12 hours. |
| Quality of Life |
| >75% of patients improve by ≥32 points (IBD Questionnaire) |
| >95% of patients improve by ≥32 points (IBD Questionnaire) |
| Adverse Event Rate |
| <5% of patients develop adverse events (≥ Grade III) |
| <3% of patients develop adverse events (≥ Grade II) |
| Lymphatic Functional Efficacy Targets1 (pick ≥2) |
| Lymphatic Vessel Density/Vascular Area |
| >100% increase of lymphatic vascular area in colon |
| >200% increase of lymphatic vascular area in colon |
| Lymphatic Transport |
| 6-hour postprandial tracer levels in blood: >18 mg/dL |
| 6-hour postprandial tracer levels in blood: >25 mg/dL |
Lymphatic Pressure
Lymphatic Vessel Contractility
| Disease Specific Efficacy Targets2 |
| Disease Activity Score |
| Crohn’s Disease Activity Index < 220, Mayo <5 |
| Crohn’s Disease Activity Index < 150, Mayo <2 |
| Stool Calprotectin Levels (IBD) |
| <50μg/g |
| <25μg/g |
Etc.
| Product Specific-ations2 |
| Ex. Cost of Goods Manufactured |
| < $2.50/pill (therapeutic dose) |
| <$1/pill (therapeutic dose) |
| Ex. Dosage Form |
| Delayed Release Tablets |
| Delayed Release Tablets |
Etc.
| Affordability and Accessibility |
| Regimen |
| Oral: Daily |
| Oral: Monthly |
| Drug Cost (to patient) |
| < $100/month for management; |
| < $5,000 to cure |
| Stability/Shelf Life |
| Stable for 1.5 years at room temperatures (20-25C) |
| Stable for 5 years at room temperatures (20-25C) |
Performer’s choice:
1. Performer selects 2 lymphatic functional efficacy (requirement is ≥ 2).
2. Examples of efficacy targets related to IBD and product specification categories. This should be expanded and tailored to the proposed technology and disease indication.
File details come from the government source that posted it. Updated .