Complex Biologics include therapeutic modalities such as oligonucleotide therapies, monoclonal antibodies, engineered proteins and antibody fragments, bi-specific platforms, T-cell directed therapies, chimeric antigen receptor T-cell (CAR-T) therapies, antibody-drug conjugates, vaccines, gene therapies, and more. Because of their complex pharmacology, complex biologics tend to face additional challenges in clinical development and navigating regulatory pathways.
At Certara, we have the expertise and experience to help our clients navigate both pre-clinical and clinical development for various complex biologic treatment modalities.
We combine our deep knowledge of drug development with in silico modeling and simulation approaches to maximize program efficiency and increase the likelihood of success. We create and help clients execute on a Model-Informed Drug Development strategy, including:
- IND-enabling pre-clinical activities
- Early clinical development and regulatory strategy and program support, including Phase 1 and Proof-of-Concept trial design, and human dose projections for first-in-human trials.
- Opportunities to leverage in silico and quantitative methods for optimizing Phase II/III studies and streamlining post-marketing requirements.
Certara’s experts in pre-clinical, clinical pharmacology, pharmacometrics, regulatory, real-world evidence, and market access provide you with the guidance needed to achieve your key development milestones.
We are the leading drug development consultancy in Complex Biologics, having supported more than 116 programs since 2018.
Our experts can ensure that all regulatory aspects of a Complex Biologic program align with agency requirements globally. We have a track record that demonstrates successful application of Model-Informed Drug Development with regulatory agencies. Our Regulatory writing and operations team can handle high stakes global engagements across the full product development lifecycle in a wide range of therapeutic areas.
Our customer sought to correlate plasma drug exposure with tissue/target exposure and engagement but only had limited plasma data. As a solution, we designed a series of animal studies with a fusion protein conjugated to a mAb to bolster the data sets used to build a PK/PD model for predicting target engagement.
Another customer needed to determine which dosing regimens would be most likely to yield sRNA concentrations within the therapeutic window. We developed a PK model and performed simulations to explore various dosing regimens to inform their clinical dosing strategy.