Bioanalytics covers the science of quantitative measurement of selected analytes in biological fluids and tissues after a therapy is administered to animals or humans. It is broadly used across all therapeutic modalities (including small molecule, biologic, and gene and cell therapies). Bioanalytics also covers the measurement of immunogenicity (immune response) to those therapies and the measurement of endogenous molecules (biomarkers) whose concentrations are representative of the disease or the biological effect of the therapy. Bioanalytics are also applied to address new challenges with legacy products and in support of overall lifecycle management.

This track combines the manufacturing and analytical characterization of source materials (API) and drug products for small molecules, biologics, and gene and cell therapies. It covers the critical aspects of API and drug product manufacturing for both new therapies and modalities and well-characterized products (life-cycle management). Synthetic and biologics manufacturing processes are both considered. In addition, it explores different analytical characterization procedures to assure quality, safety, and efficacy throughout the product development and lifecycle. New analytical approaches, including those that measure multiple product attributes (MAM), as well as questions around the establishment and measurement of critical quality attributes (CQAs) are considered here as are regulatory and compendial compliance developments, including questions of international harmonization among ICH, WHO, and others. This track also covers life cycle management and issues that arise with new requirements for legacy products.

This track focuses on the key challenges surrounding pharmaceutical formulation, in which different excipients and the pharmaceutically active drug substance are combined to produce a suitable drug product. The delivery aspect explores novel devices and non-traditional formulations that overcome challenges that cannot be addressed using more traditional formulation approaches.

In the dynamic world of pharma, possessing a profound understanding of business intricacies is a game-changer for career advancement. Blend your scientific expertise with business savvy to make astute decisions and carve out a thriving career path in the industry. A well-developed technical set of goals coupled with business knowledge will prepare scientists to become leaders in tomorrow’s environment.
The following examples are provided to help submitters develop proposal ideas. The Career Development Committee will consider any proposal that fits the track theme and description above.