Clinical Candidate Selection

When selecting a clinical candidate, it is a competitive advantage to have accurate, quantitative predictions that help answer strategic questions such as whether a program should be terminated, if a new lead generation campaign is needed, or what further assays need to be developed. This case studies outlines an example where systems pharmacology modeling helped save a clinical candidate from being terminated and instead accelerated it into the clinical where it is currently slated to be best-in-class.



Immuno-modulation in chronic inflammation

 

Customer situation:

        Customer targeting membrane bound protein using mAb

        Proliferation assay and whole blood biomarker assay appeared to be contradictory

        Competitor molecule 2 years ahead and a tighter binder

        Dosing administration and frequency are major Go/No-Go criteria

Customer’s Questions:

        How to interpret the two conflicting assays?

        Should project be terminated, especially given competitor head start?

        Should functional assays be refined?

        Should new lead generation campaign be started to find tighter binder?

Results:

        At least 6 months saved, 25% reduction in FTE, over $1m in direct cost savings (estimate by company VP)

        Customer molecule was not discarded, rather accelerated, and now positioned to be best-in-class

Related Case Studies


Early Feasibility Assessment

When designing a biological therapeutic agent, it is critically important to establish the feasibility of achieving a desired target product profile (TPP) as early in the program as possible, typically at the ‘New Target Proposal Stage’ or at the start of Lead Identification (LI). This case studies outlines an example of where systems pharmacology modeling and analysis helped eliminate targets with low developability and helped set up a screening funnel for top candidates.


Predicting optimal drug parameters and doses

In early drug development, quantitative systems pharmacology (QSP) modeling can provide decision support for many critical decisions such as what experiments to proceed with and what parameters have the most impact. It can also lend insight into a drug candidate's competitive landscape. This case study outlines an example where QSP modeling helped assess why the dosing regimens of the two anti-PD-1s are roughly similar and predicted optimal drug parameters for bispecific formats versus fixed dose combination.


Contact Us to Learn More!

The case studies shown on this page are only a sample of our work. We would be happy to discuss additional examples with you and explore with you how our services can best fit your need. Email us at bd@appliedbiomath.com or call 617-914-8800.


Phase-1 Interim Analysis

Once a drug candidate progresses into the clinic, quantitative systems pharmacology (QSP) modeling can be applied to help with critical issues such as observed variability in clinical data or how the candidate is fairing against competitors. The following case study is an example where QSP modeling was introduced into a project for the first time after Phase 1 for the purpose of explaining observed variability and nonlinearity which in turn saved a molecule from being discarded and helped position it as best-in-class.


Antibody drug conjugate (ADC) Pharmacokinetics

With an ever increasing focus on antibody drug conjugates (ADC), computational models are needed to better understand the complexity of the various design parameters and objectives of ADCs. The following case study is a computational exploration of mechanistic determinants of ADC pharmacokinetics using quantitative systems pharmacology (QSP) modeling strategies.