What is “Right Now” Medicine? www.eclipsecro.com 603.294.4580 rightnow@eclipsecro .com Right Patient Right Dose Right Now Random izatio n
Jun 14, 2015
What is “Right Now” Medicine?
Right Patient Right
Dose Right Now
Rand
omiz
ation
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” Medicine is:
• The application of panomic analysis and systems biology to analyze the cause of an individual patient's disease at the molecular level and then to utilize targeted treatments (possibly in combination) to address that individual patient's disease process.
• It employs a just in time on demand clinical supply strategy to minimize warehousing costs and wastage at investigational sites.
• It is coordinated via a state of the art IRT system that features integration from the Next Generation Sequencing lab to the on Demand depots
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” Key Therapeutic Areas:
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
75%
5%
5%5%
5% 5%
Oncology *Immunology/TransplantCNSPediatricsInfectious DiseaseCardiovascular
* Focus on Oncology at first with potential to expand into other areas
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” In Oncology:
• Oncology has the majority of existing biomarkers mapped out.
• Oncology presents opportunity to maximize control over clinical supply costs
eClipse has 20 years combined experience in the Oncology space
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” Medicine’s Biggest Benefits:
• Patient Focused Treatment
• Drug Supply Savings
• Robust IRT Abilities
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” Medicine in Action:
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
Patient
IRT
On Demand
DepotNGS
PATIENT
FOCUSED TREATMENT
Next Generation Genomic Testing is used to hone in on the best treatment
Treatment is tailored to the subject so they have the best odds for maximum efficacy
Right Patient gets the Right Kit Right Now
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” Efficacy vs. Traditional Trial Efficacy:
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
PATIENT
FOCUSED TREATMENT
Traditional Trial Ef-ficacy
Right Now Efficacy0%
10%20%30%40%50%60%70%80%90%
100%
Lack of EfficacyEfficacy
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” Drug Supply Savings:
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
Cost advantages over traditional studies due to minimum drug wastage
Eliminate the need for a deep stock shelf of IP that may never be assigned at a site
Traditional Trial Right Now Trial0%
10%20%30%40%50%60%70%80%90%
100%
Dispensed DrugWasted Drug
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” IRT Abilities:
• Specialized drug management sends shipments of IP based on subjects Next Generation Genomic Test Results
• Kit types assigned per NGS results
• Orders only generate for subjects when the is a screen pass
• Robust Data Transfer between IRT and Next Generation Sequencing Lab
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
Right Now, it’s the way we do business
Right Now transforms the way Patients are: Selected, Randomized, how Drug is Delivered and Clinical Trials are Designed
“Right Now” IRT Abilities - Continued:Specialized drug management sends shipment of IP based on subjects Next
Generation Genomic Test Results:
Copyright © 2014 eClipse Enterprise Solutions, LLC. All rights reserved.
IRT captures Lab Results
IRT generates Shipment request based on screen pass and lab results
On Demand Depot processes shipment
Subject’s visit recorded in IRT, kit assigned to subject
Site records subject asa screen pass in IRT
Lab evaluates DNA
IRT Calculates Kit type needed based on NGS results
NGS Data Loaded to IRT NGS Lab Tests SamplesShipment Request Generated to On Demand Depot
Right Pati ent
RightDose
Right
Now
Right Now, it’s the way we do business
Questions?Call us: 603.294.4580 Email: [email protected]