There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk … Continued
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, … Continued
PRINCETON, NJ – Mar. 12, 2018 – Certara today announced that it is partnering with faculty at the UNC Eshelman School of Pharmacy to launch the Model-informed Drug Development (MIDD) Gran Prix at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.
Watch this webinar with Dr. Graham Scott, Senior Director of Clinical Pharmacology at Certara Strategic Consulting, to learn why you should invest in “apocalyptic clinical pharmacology.”Dr. Scott presented case studies that illustrate how sponsors can benefit from a clinical pharmacology strategy that uses model-informed approaches to inform and “fill in the gaps” of clinical trials.
Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results … Continued
Orphan drugs affect 350,000 people worldwide, including 10% of the US population and 1 in 25 Europeans. Model-informed drug development (MIDD) approaches, such as PBPK and PopPK have been embraced by sponsors and regulators, and play a key role in modernizing and accelerating orphan drug development.
Watch this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA.
