We welcome you to learn and collaborate with fellow pharmaceutical scientists through participation in an onsite workshop. Past workshop descriptions are listed below for reference. Topics have included dermatolological drug products, immuno-oncology modeling, and large molecule drug bioanalysis. Upcoming workshops will cover research on transporters and oligopeptides. Workshop registration is available through the AAPS registration site.
November 11–12, 2017 San Diego Convention Center, San Diego CADrug Products: Developmental & Regulatory Considerations
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November 12, 2017 San Diego Convention Center, San Diego Immuno-Oncology Modeling: From Molecular Biology to Clinical Efficacy
LBA and LC-MS: Why Incorporate Both for Large Molecule Drug Bioanalysis?
This workshop is intended for people who are interested in dermatological product development. Within that space, this is relevant for individuals who work in the following areas: Research & Development, Formulation, Engineering, Regulatory Affairs, Commercial. This is relevant for academia, pharmaceutical companies, and clinical research organizations.
The workshop will cover a broad range of topics with a focus on quantitative approaches, from systems pharmacology and agent-based modeling, to translational and clinical population analyses. The 1-day workshop will start with an overview of immuno-oncology and new definitions of PK and Exposure-Response, followed by a presentation on in-depth, multi-scale systems biology and agent-based models for checkpoint modulators. Translational considerations, clinical response modeling, and identification/evaluation of predictive markers for key immunotherapies will be presented by experts from leading biopharmaceutical companies. Regulatory considerations of implications of PKPD interaction for exposure-response analysis will be discussed. The workshop will end in a panel discussion of challenges and future directions of the modeling approach in the era of immunotherapy.
Modeling for cancer immunotherapies is rapidly evolving. Various approaches are being deployed by biopharmaceutical companies to characterize the tumoricidal activity and to facilitate the rational development of immunotherapies. The presenters and audience are expected to engage in active dialog and discussion throughout the workshop. Upon completion of the presentations, moderators and speakers will have a panel discussion with input from the audience. Regulatory considerations of exposure-response assessment for immunotherapies will also be presented and discussed.
Research and development scientists who are interested in the utilization of quantitative modeling approach to delineate and characterize the determinants of cancer immunotherapies: the immune system, checkpoint modulators, and cancer cells (tumor).
Large molecule biopharma pipelines include increasingly complex modalities presenting challenges for bioanalysis during drug discovery and development. Historically, LBA has been the primary platform available for large molecule drug bioanalysis, while LC-MS has the reliable workhorse for small molecule drugs. More recently, LC-MS approaches have also been successfully implemented for large molecule bioanalysis in both discovery research and regulated studies. These analytical platforms are often in different organizations within drug development, presenting challenges for co-ordinating approaches in a seamless manner. Recently, an industry group within the IQ Consortium, representing approximately 20 biopharma organizations, was formed to share experiences on the value of integrating multiple technologies and close collaborations.
Bioanalytical scientists in drug discovery and development.
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