March, 22 – 23, 2017, Cambridge, UK
The 2nd Developability Workshop organised by The Academy of Pharmaceutical Sciences will cover the formulation, analytical, toxicological and clinical requirements to progress a molecule from lead identification into GLP safety studies and clinical studies to Proof of Concept. The focus will be on small molecules for oral delivery.
The following topics will be covered:
- Target product profiles. What properties should a molecule have to be readily developable? (Including solubility, permeability, BCS / DCS classification, Lipinski’s rule, DMPK profile)
- In-vitro and predictive methodologies: benefits and limitations
- Overview of preclinical study requirements. Pre-clinical formulations, achieving the desired exposure, species considerations, preparation and GLP
- Assessment of the API in early development: physical properties, polymorphism, stability, impurities, specification setting
- Preparing for early phase clinical studies: formulation options, excipients, stability, chemical and physical test methods, manufacture and GMP, regulatory requirements
- Next steps: Minding the gap between early and late stage development, QbD, IVIVCs, tech transfer
- Which CROs and CDMOs can help progress an asset?
The workshop will be an interactive training with real life examples, lectures and the ability of attendees to raise issues with compounds they are working on. It is suited to individuals who want to understand what is required in the early stages of drug development.
The workshop will be run by highly experienced pharmaceutical scientists and one of the speakers will be Peter Scholes, our Chief Scientific Officer.
Peter will be describing the key considerations ahead of the First-in-Human clinical study and how early development programs can be integrated to accelerate both clinical Proof-of-Concept as well as the optimisation of drug product formulations for downstream development.
To find out more about the full programme visit here.