Clarus Therapeutics received FDA approval for an oral testosterone (T) replacement drug. This webinar will review how Phoenix NLME, population PK/PD M&S tool, and Trial Simulator supported this approval.
This webinar will explain both common pitfalls that sponsors experience and how clinical pharmacology study execution and operational support can increase the efficiency of your Phase 1 studies and improve the quality of data collected.
This webinar will explain lessons learned from preparing for and responding to viral outbreaks such as H5N1 and pH1N1 influenza and discuss how insights from model-informed drug development approaches can spur access to medicines for patients.
The adoption of outcomes based agreements (OBA) is growing given the urge among payers to reduce their exposure to risks of uncertain clinical value and budgetary impact, and the demand for drug manufacturers to demonstrate real world value to justify new, high-priced therapies and guarantee access to existing products exposed to increasing rebate levels. Prior to discussing practical considerations for the OBA implementation in this white paper, we’ve included the voices and rationales of two seasoned OBA pioneers and let you be party to their personal reflections.
Outcome based agreements (OBAs) are a type of value-based risk sharing agreement between payers and drug manufacturers. OBAs are a useful tool for managing uncertainty regarding a drug’s real world clinical benefit, the economic impact to a payer’s budget, and market penetration. Read this white paper to learn about a six-stage process that will put you on the right path for attaining a successful OBA!
Certara scientists performed helped a small biotech company create a clinical pharmacology package for their NDA submission for a novel oncology drug.
PRINCETON, NJ – Feb. 25, 2020 – Certara’s Simcyp Division Acquires Modeling and Simulation Platform for Neurodegenerative Diseases from In Silico Biosciences, Inc. Acquisition will spur the development of new drugs to treat complex neurodegenerative conditions, including Alzheimer’s and Parkinson’s disease.
This webinar will explain how pricing has evolved for the rare disease drug market and best practices for supporting value-based pricing.
PRINCETON, NJ – Feb. 10, 2020 – Arvinas Selects Certara to Advance Speed and Efficiency of its Targeted Protein Degradation Research
This webinar will explain how Certara expanded its PBPK Simcyp Simulator to incorporate an extensive dermal model— MPML MechDermA, a multi-phase, multi-dimensional dermal absorption model.
