Applicant Contact Information and RFP Response
In this content, you will find detailed information regarding the applicant's response to an RFP, including their contact details, overview of the assay, system performance, alignment with critical requirements, roadmap for clinical provision, proposed pricing model, commercialization plan, and business assessment. The content delves into key aspects such as assay features, validation studies, critical product requirements, pricing model, commercial strategies, and business strengths.
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Presentation Transcript
Applicant Name Address Contact Information RESPONSE TO RFP
OVERVIEW OF ASSAY Summary of technology Key assay features Time to result Existing assay menu Current specimen types accepted Assay readouts (incl. quantitative results) Images of platform, assay Stage of development (i.e., specify TRL) 2
PERFORMANCE OF SYSTEM Description and results of validation and/or verification studies of relevant assays and/or instrument (internal or external) Summary of relevant publications (i.e., RUO studies) Correlation of biomarker with long-term clinical outcomes Evidence of test menu expansion (i.e., detailed quantitation, detection of TB, DR- TB, etc.) Potential for platform to be open enabling other manufacturers to develop assays. Potential to run assay on multiple platforms Repeatability and reproducibility 3
ALIGNMENT WITH CRITICAL REQUIREMENTS Evidence of Performance in Critical Product Requirements (especially those denoted with a Weight of 3 in the sheet titled Technical Assessment in the Assessment Matrix). 4
ROADMAP/CLINICAL PROVISION PLAN Timeline of key deliverables and milestones (for clinical provision given award) 5
PROPOSED PRICING MODEL COGS model (direct costs associated with production only) Illustrate volume tiers and expected COGS per tier Describe business model (I.e., reagent rental, capital purchase, etc.) Describe what is included in a fully-loaded COGS estimate (@1M tests in yr1). For example (can be expressed as a percentage): Expected production COGS Estimated liabilities: SG&A, OpEx, debts, Royalties, etc. Expected distributor margin Estimated service & maintenance Instrument amortization (if applicable) 6
COMMERCIALIZATION PLAN Sales force (global) Distribution plan Service & maintenance plan 7
BUSINESS ASSESSMENT Strength of Management Team Summary of IVD experience, LMIC experience Financial viability Fundraising to date, existing investors, oher grant/funding mechanisms Evidence of IVD processes QMS and ISO standards Commercial strengths Existing IVD products, current worldwide install base, existing worldwide sales force Existing distributors or sales channels ex US, ex EU Existing manufacturing capacity (HIC or LMIC) Manufacturing volume of current system Total existing capacity 8
THANK YOU THANK YOU 9
