Workshops

Past Workshops



Dermatological Drug Products

November 11–12, 2017 
San Diego Convention Center, San Diego CA

Drug Products: Developmental & Regulatory Considerations

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Immuno-Oncology Modeling

November 12, 2017  
San Diego Convention Center, San Diego

Immuno-Oncology Modeling: From Molecular Biology to Clinical Efficacy

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LBA and LC-MS

November 12, 2017 

San Diego Convention Center, San Diego


LBA and LC-MS: Why Incorporate Both for Large Molecule Drug Bioanalysis? 

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Workshop Details

Dermatological Drug Products: Developmental & Regulatory Considerations

Goals and Objectives

Skin is the largest organ of the human body. The basic structure is a semi–permeable membrane which can potentially function as an entry point for a host of therapeutic substances aimed at both local and systemic delivery l for diseases of the skin. This has resulted in dermatological drug products being a big industry (upwards of 30 billion USD). However, many of the active pharmaceutical ingredients (APIs) and excipients used in a typical formulation may interact among themselves, and adversely with the skin or other internal physiological systems. Hence, a mechanistic understanding of drug release from the formulation, partitioning and disposition kinetics of the API (drug substance) in the skin and the behavior of the final drug product are key to development of a successful dermatological drug product. The development, regulatory approval and subsequent commercialization of pharmaceutical drug products applied to the skin involve scientific knowledge from several disciplines. It requires a thorough understanding of the following functional areas:
  • Skin physiology, anatomy, and physicochemical/microstructural features
  • Skin diseases, their pathology, and implications for topical treatments
  • Understanding and controlling the permeation of APIs into and through the skin
  • In vitro assessment of different biopharmaceutical characteristics and their extrapolation in vivo
  • Key aspects of successful topical dermal formulations
  • Complex formulations and delivery modalities
  • Pre-clinical development and regulatory aspects
  • Clinical development and regulatory aspects
  • Regulatory view on bioequivalence
  • Modeling & Simulation of the behavior of the drug substance and the product
  • Bioanalytical aspects of measuring drug concentration in the skin

Who Should Attend

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.

Immuno-Oncology Modeling: From Molecular Biology to Clinical Efficacy

Goals and Objectives

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.

Who Should Attend

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).

LBA and LC-MS: Why Incorporate Both for Large Molecule Drug Bioanalysis?

Goals and Objectives

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.

Who Should Attend

Bioanalytical scientists in drug discovery and development.