Traditional drug development takes too long and costs too much. There are far too many expensive failures, especially in the clinical trial phases, where most drug R&D dollars are spent.
Certara’s mission is to transform this traditional process by using biosimulation to accelerate and improve drug discovery and development. For more than two decades, we have invested in our end-to-end platform powered by biosimulation and technology to advance drug programs from discovery and development to regulatory approval and market access.
Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored. Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. These challenges spurred the FDA’s Oncology Center of Excellence to develop a new guidance called “Project Optimus” to address issues relating to dose optimization in clinical trials assessing the safety and efficacy of oncology drugs. In this on demand webinar, Certara’s Dr. Julie Bullock addresses how Project Optimus may impact clinical trials in the oncology space, how the guidance may affect the current oncology drug pipeline, and whether it may lead to the FDA making other changes in the oncology clinical trial space.
For the past two years, the biotech sector saw a surge of venture funding and IPOs. Now, by contrast, the sector is cooling down along with a broader contraction in funding globally. While there is still funding available for biotech companies, investors are proceeding with more caution. Biotech companies, researchers, scientists, and business leaders must reassess their strategies and make the appropriate adjustments to achieve their next value inflection. In this on demand webinar, Drs. Fran Brown, Tina Morris, and Patrick Smith discussed the evolving funding landscape and provided recommendations on how to make every dollar count with smart, quality decisions.
Certara is committed to understanding, monitoring, and managing our social and environmental responsibilities and data privacy to support sustainable growth. Our Environmental, Social and Governance (“ESG”) strategy focuses on accelerating crucial medicines to patients, advancing scientific thought leadership, increasing engagement with employees. In this video, Nasdaq's Eric Vermeiren interviewed Dr. Patrick Smith to get his perspective on Certara's work to foster knowledge sharing within the pharmaceutical industry to have a positive impact on the world.