APS Developability Workshop
Alderley Park Conference Centre, Cheshire
Tuesday 30 - Wednesday 31 January 2018
This workshop proved enormously popular when run in March 2017 and will be re-run in 2018 with a choice of Northern or Southern venues. In it you will learn from a pharmaceutics and biopharmaceutics perspective what is required to assess a molecule in discovery and its suitability for ‘candidate selection’; determine how ‘developable’ it is with associated risk, time and cost implications and what is needed to progress it through pre-clinical studies and into Phase 1 and 2a clinical studies to achieve Proof of Concept. The workshop will focus on the formulation and analytical aspects of early stage product development for small molecules for oral delivery in particular and put these activities into context with the other disciplines required to progress an asset.
The workshop will be interactive with real life examples, lectures and the ability of attendees to raise issues with compounds they are working on. 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
- Designing and delivering a Phase 1 clinical programme – considerations, requirements and objectives
- Next steps: Minding the gap between early and late stage development, QbD, IVIVCs, tech transfer
- Which CROs and CDMOs can help progress an asset?
Who should attend this workshop?
This workshop is suitable for individuals who:
- Are involved with start-up pharma and biotech companies who need to know what is required to progress their asset through to Proof-of-Concept
- Work for pharma companies and wish to gain a broader understanding of the multi-disciplinary interplay in early drug development
- Work in early development and want to understand how to design and implement science-driven, time-efficient programmes
- Work for CROs or CDMOs and want to broaden their experience
- Are academics or new graduates entering the Pharma industry and who want to relate theory to practice
- Are involved with the drug development process and wish to increase their knowledge of the pharmaceutical development aspects
Some of the feedback from 2017:
‘I would highly recommend this workshop. I found it really useful to get a better understanding of the developability process.’
‘Great learning opportunity. Put many pieces together and understand better the sequence of events.’
‘Very informative across a range of topics. A good overall basis for early phase.’
‘Comprehensive planning of the drug development pathway and challenges that pharma face. Good training to bring up to speed.’
Local hotel is
De Trafford Hotel Alderley Edge
You should book directly with the hotel. Accommodation is not included in the course fees.
The venue's website is at
REGISTRATIONS FOR THIS EVENT CLOSE ON FRIDAY 19TH JANUARY