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.
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus
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.
Navigating the Biotech Funding Crunch: How to Achieve Your Next Value Inflection
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.
ESG in Action: Talking with Dr. Patrick Smith, Certara President, Integrated Drug Development
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.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.