Case Studies

Case Study I - Formulation

Situation:
Large US biotech wanting to establish proof of concept for an inhalation product before finalising product formulation
Limited availability of manufacture (time / cost)
Special patient population (CF)

Nucleus Network Solution:
Final stage formulation and batch release performed by NN / Alfred to GMP requirements
Recruitment of CF patients via specialist PI and NN direct recruitment

Outcome:
Proof of principle study completed to GCP / GMP standards
Accelerated formulation selection (12 month time saving)
Significant direct and indirect cost reduction
Focussed IND to be filed to achieve rapid approval

Case Study II - Japanese Bridging Study

Situation:
Multi-national Pharma needing to rapidly conduct a Japanese / caucasian bridging study
Targeted at regulatory approval
Special patient population (Japanese with documented ancestry)

Nucleus Network Solution:
Targeted recruitment of Japanese population in Melbourne based on multi study experience
Japanese trained and speaking Principal Investigator
Subject care tailored for cultural requirements to ensure retention of subjects to completion

Outcome:
Rapid ethical approval
Rapid recruitment, study conduct and database closure

Case Study III - Biomarkers

Situation:
Large US biotech wanting to conduct a first in man biological study with study specific biomarker assays
Unknown stability of samples for biomarker

NN Solution:
Rapid approval through experienced phase I (including first-in-man biologicals) – utilising external toxicology & immunology review in parallel to ethics review
Local conduct of cytokine stimulation assay under CO^₂ incubation based on sponsor trained and validated methodology

Outcome:
Rapid study start up
Rapid dose escalation decisions through fast data turn around
Accelerated development plan through subsequent IND filing including initial patient data and cytokine stimulation results

Case Study IV - Biomarkers

Situation:
Australia biotech wanting to establish proof of concept for a vaccine within a FTIH study via an ELISPOT assay
Assay needed to be conducted to GLP standard for future licencing
Special patient population (coeliac disease)

Nucleus Network Solution:
Source a GLP standard ELISPOT assay within immediate precinct
Conduct of vendor qualification audit
Genetic pre-screening of disease subjects

Outcome:
Proof of principle study completed to GCP / GLP standards
Significant value adding step conducted to high quality standards for low input costs
Focussed IND to be filed to achieve rapid approval

Case Study V - MRS/MRI

Situation:
Large pharma company requiring large numbers of MRI and MRS scans and long subject confinement
Magnetic Resonance Spectroscopy needed to be centrally vaildated
Difficult to source MRI/MRS time

Nucleus Network Solution:
Nucleus Network sourced access to a dedicated research MRI (3T) machine that was capable of being validated to MRS standards
Large scale volume discount negotiated and pre-booking of slots to allow for rapid screening & recruitment

Outcome:
Validation of MRS achieved rapidly
Screening and enrolment conducted without delays in scheduling MRI/MRS
Part I study closed ahead of schedule, allowing earlier move to multi-dose studies