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: 了解更多
- 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: 联系我们
- 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.
生物制剂
复杂生物制剂包括治疗方式，如寡核苷酸疗法、单克隆抗体、工程蛋白和抗体片段、双特异性平台、T 细胞定向疗法、嵌合抗原受体 T 细胞 (CAR-T) 疗法、抗体-药物偶联物、疫苗、基因疗法等。由于其复杂的药理学，复杂生物制剂在临床开发和应对监管途径中往往面临更多的挑战。在 Certara，我们拥有专业知识和经验，可以帮助我们的客户进行各种复杂生物治疗方式的临床前开发和临床开发。
