Project Highlights
Targeted Cancer Therapeutics
Population PKPD Clinical Trial Modeling- Autoimmunity biotherapeutic clinical trial modelling to determine optimal trial dose, biomarkers of responders vs. non responders, and drug resistance.
Apoptosis Mechanisms in Cancer Cells
Identifying Apoptosis Mechanisms in Cancer Cells- Study performed on the induction of apoptosis in the treatment of cancer by modelling the two main apoptotic pathways, capsize & mitochondrial.
Clinical Trial Modeling of HCV Therapeutics
Utilization of clinical trial data to inform trial design and predict key outcomes while understanding mechanism-of-action and biological effects.
QbD Submissions to FDA for Manufacturing
Fulfills Quality by Design mandate advanced by the FDA in the Production of Pharmaceutical APIs by assigning statistical probabilities to outputs in Design Space Maps
Go/No-Go Decisions in Route Selection
Go/No-Go Decisions During Candidate Route Selection- Gain valuable insight for go/no-go decisions despite limited data in early phase process development through model-guided experimental design, saving time and money.
Increasing Yield & Reducing Costs
Increasing Yield & Reducing Costs During Development- Providing optimal conditions across several critical process parameters to maximize product while minimizing Impurities.
Scope:
Identify New Drug Targets. Treatment Strategies. Validate New Methodologies. Mechanism-of-action
Scope:
Drug Design Improvement, Next-Gen Drug Design, Experimental Design, Drug-Failure Analysis, PBPK Models
Scope:
Optimal Dose,
Dose Schedule,
Predict Effect Size,
Inclusion/Exclusion Critera, Biomarkers of Response
Scope:
Routes of Synthesis,
Crystallization,
Morphology Control,
Scale-Up,
Process Optimization
Drug Discovery &
Development
RES has deep expertise in the fields of drug discovery and development, helping our pharmaceutical partners bring new and innovative drugs to market.
Scope of Expertise:
Possible Causes
Mechanism of Action
Disease Progression
Treatment Possibilities
Novel Drug Target Identification
Drug Failure Analysis
Next-Gen Drug Design
Disease Area Expertise:
Cancer (Multiple Subtypes)
Autoimmunity
Parkinson's Disease
Alzheimer's Disease
Cardiovascular Disease
Chronic Pain
Osteoporosis & Bone
Remodeling
Lipoprotein Metabolism
Signal Transduction
Clinical Trials
Often the most important and costly step in the pharmaceutical developmental cycle, RES scientists can help extract insight from often-underutilized clinical trial data. These insights are then leveraged toward better design of subsequent clinical trials and in some cases, better next generation drug design.
Clinical Trial Expertise:
Drug Design/Revision
Drug Administration
Drug Distribution
Effectiveness
Safety
Optimal Dose
Trial Duration
Inclusion/Exclusion Criteria
Biomarkers of Response
Expected Effect Size
New PKPD Algorithm Development
PBPK Models of Drug Distribution
