Certara's Role in Oligonucleotide Research and Testing
Oligonucleotide therapeutic development is complex. Certara pioneered support for the first FDA approval of an oligonucleotide therapy. Our team continues to bring value to the ever-expanding list of Oligonucleotide therapy programs by leveraging our expertise and experience within Clinical Pharmacology, Pharmacometrics, Regulatory Support, and Health Technology Assessments.
Oligonucleotide Therapeutics
In the last 3 years, Certara supported customer success of 23 Oligonucleotides programs by:
- Leveraging in-silico clinical trial modeling using applicable data to predict clinical outcomes.
- Optimizing the clinical pharmacology drug label claims.
- Incorporating Health Economic Outcomes research and strategies to ensure proper market access alignment in a competitive landscape
Real Examples of Oligonucleotide Complex Biologics Program Impact
“Whether you are developing RNAi, siRNA, miRNA or antisense oligos, Certara has experience/success developing these molecules”
- Example 1: The client needed to understand and determine the fate and delivery of their siRNA therapy, which was challenging due to its rapid degradation. We determined the organ of specific delivery and uptake, which was also the site of efficacy for the indication. We also developed models to assess the biomarker accumulation following repeated dosing. CTA: 詳細はこちら
- Example 2: The client sought to develop an oligonucleotide therapy that would knock down a key protein implicated in the pathogenesis of a neurological disorder. They needed to link plasma drug dosing with the resulting exposure and efficacy. Certara scientists developed PK & PK/PD Models to perform simulations to determine the dosages associated with optimal clinical outcomes. CTA: お問合せ
- Example 3: The client was struggling to correlate RNAi plasma exposure with tissue exposure and target engagement in their pre-clinical animal models. Certara’s team 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 from limited plasma data.
生物学的製剤
複合生物製剤には、オリゴヌクレオチド療法、モノクローナル抗体、人工タンパク質や抗体断片、二重特異性プラットフォーム、T細胞指向性療法、キメラ抗原受容体T細胞（CAR-T）療法、抗体薬物複合体、ワクチン、遺伝子治療などの治療様式が含まれます。複雑な薬理作用があるため、複雑な生物製剤は臨床開発と規制経路のナビゲートにおいてさらなる課題に直面する傾向があります。サターラは、さまざまな複雑な生物学的製剤の前臨床および臨床開発を支援するための専門知識と実経験を誇ります。
