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.

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?