CREATE Bio Example: Peptides or Protein Agent Profile Table

The following represents example categories to consider in describing your current results/status and desired results at the end of the funding period.

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Category

Parameters

Structure/Identity

Recombinant/Synthetic
Amino acid (AA) sequence
Post-translational modifications
Molecular formula/weight
Bioactivity (in vitro)
AA-sequence confirmed by aa-sequencing
3D structure
Aggregation

In vitro activity

Target binding: affinity/saturation
Bioactivity/potency
Stimulation of biological cascade
Tissue Selectivity
Selectivity/off-target effect to related target

In vivo activity (such as target
engagement/proximal downstream effect
or efficacy) Indicate dose and route of administration

Concentrations of testing agent in the serum and target tissue
Brain penetration
Serum half-life, AUC or other pharmacokinetic properties
Optimize Dose Selection and Schedule
ED50, Minimal effective dose, and Optimal effective dose
Treatment duration optimization
Treatment window optimization
Interactions with standard of care
Selectivity/off-target effect in vivo

Safety

Tolerability
Antibodies to virus or gene product
Tumorigenesis
Assess host immune response
Tissue Cross-Reactivity
Local reactogenicity
Cardiovascular, respiratory, renal and CNS safety pharmacology studies if any

CMC

Master/Working Virus Bank Status
Process development status
Analytical Assays for release testing with specifications
Scale-up feasibility
Formulation needs/development
Stability Analysis
Potency assays (in vitro/in vivo)
Delivery devices

GLP analytical method development/validation

Potency assays, assays for purity, pharmacokinetics and pharmacodynamics etc

Interactions with regulatory agencies

Pre-IND

Patent protection?