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Project TitleProject Title

Investigators

To see TIPS and FAQS for each slide, please look at this template in Notes view.

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Two Year Goal StatementTwo Year Goal Statement

Your two year goal will frame the following assessment.

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• Brief background for team members and their roles on this project.

• Include relevant past experience, if any.• Identify unfilled roles needed.

Project TeamProject Team

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Briefly, introduce background science.

What is the problem worth solving?

What is your solution? Why is it novel?

Scientific Background and OpportunityScientific Background and Opportunity

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Describe additional research data needed but which is outside the scope and capability of the investigator’s laboratory.

Research PlanResearch Plan

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1. Describe your target and biological pathway

2. Does biochemical assay exist?

3. Does a cell-based readout exist?

4. What are assay readouts for all assays (e.g. luminescence, fluorescence intensity, image-based, others)?

5. What is your level of experience with the assays?

6. Are all critical reagents for the assays currently available?

Assay Feasibility AssessmentAssay Feasibility Assessment

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1. Target location(s): extracellular, intracellular, CNS, etc. and tissue type.

2. Can the protein be reliably expressed and purified? How?

3. Does crystal structure of target exist, resolution and RCSB code.  If no, what are the closest homologs with crystal structure coordinates?

4. Predicted binding pocket affinity of target (YCMD determined); i.e., is the target druggable?

5. Are small molecule inhibitors known?

6. Synthetic accessibility (conducted after HTS analysis)

Med. Chem. Feasibility AssessmentMed. Chem. Feasibility Assessment

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1. Is the biology (i.e. pathway) well characterized?

2. Has modulation of the pathway been shown to correlate with changes in disease burden (e.g. phenotype of KO mice, relevant animal studies, GWAS)

3. Is there precedent for the MOA for similar disease targets?

4. Is there a reliable and predictive animal model that has a history in translating compounds to the clinic?

5. Does a clinically relevant biomarker exist?

6. Competition: Examine approved claims (efficacy and safety) of competitors. Examine the competitive environment for compounds currently in development.

Clinical Correlation AssessmentClinical Correlation Assessment

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1-2 slides addressing

Scope of unmet medical need• Number people affected by disease (target population)• Current standard of care and market size (commercial potential)• Unique needs of the target population• Phase II proof of mechanism and patient stratification strategy

Clinical Need/Potential MarketClinical Need/Potential Market

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• 1 slide describing the desired characteristics of the proposed therapeutic for the intended indication

• What is the specific value of your drug/approach to patients? What advantages does it offer over existing or competing approaches? How your product meets the needs of your global market based upon performance features, costs, robustness, etc.

Targeted Product AttributesTargeted Product Attributes

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1 slide addressing Office of Cooperative Research/Technology Commercialization Services disclosure and patentability status

Intellectual Property PositionIntellectual Property Position