Changing the Paradigm for Drug Development Through Cell Modeling in Software
The BioPharma industry is challenged with high failure rates in clinical trials resulting in unacceptably low FDA approval rates and correspondingly high R&D costs. A big part for these increasing costs is complexity of disease, and a lack of full visibility into how a drug works. Clinical trials attempt to select a homogeneous population but disease heterogeneity and drug complexity result in a high failure rate.
Cellworks' Therapy Response Index (TRI) is the doorway to successful drug development and predictable clinical trial outcomes. It evaluates each potential participant for their inclusion in the trial based on their genomic profile and pharmacokinetics of the drugs through metabolic pathways. This predictive computational biosimulation model for pre-screening can effectively predict drug response in the patient, thus improving response rates, reducing the sample size needed, and most importantly, optimizing clinical trial costs.
Cellworks’ AI-enhanced biosimulation platform tests millions of variables virtually, making it indispensable in pharmacological drug design – the new paradigm in drug discovery.
High Response Clinical Trials
The ability of Cellworks to assist thorough patient qualification allows your translational team to craft an appropriate clinical trial design. Increasing your response rate can often result in better coverage of your drug by payers, reduce trial costs, and speed the FDA approval process.
Rescue a Recently Failed Drug
If a drug has demonstrated a strong safety profile via a successful Phase I trial, we believe you a have a ‘good’ efficacious drug, for some patient. The challenge is finding that patient. Cellworks can also help identify an FDA-approved companion molecule, for each patient, that will provide additional efficacy when combined with the experimental molecule.
Repurpose and Differentiate
You already have a validated and marketed drug. Why not expand the use of that drug into newer indications? Cellworks can play a vital role in your drug repurposing efforts by creating therapeutic combinations using on- and off-label FDA-approved molecules. We can discover new indications for your drug.
May We Assist in Drug Discovery?
Extensive qualification and validation of designs through massive simulation has become the norm in industries with high success rates. Cellworks can help significantly shorten drug development time by biosimulating human phenotypes and disease physiology in software, that runs extensive 'what-if' scenarios and predicts clinical outcomes.
Cellworks’ biosimulation predictions have been validated through cell-line studies, animal studies, human ex vivo experiments, retrospective clinical studies and prospective clinical trials, with biomarker and phenotype trends in lab and clinical settings.
- Participated in more than 50 global scientific collaborations
- Conducted over 3000 prediction validations
- Produced over 100 peer-reviewed papers and abstracts
Participate in this Paradigm Shift
We can model your drugs and provide you more insight than you have today. Perhaps, a new indication for your drug, or a higher response rate clinical trial leading to higher reimbursement, or rescuing a recent Phase II/III failure. Allow us to surprise you.