This workshop proved enormously popular when run in April 2018 and will be re-run in 2019. 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
John has been a consultant in the pharmaceutical sciences for over 6 years. Prior to that he had over 40 years’ experience in product development in the pharmaceutical industry. John is a chemist by training (PhD from Nottingham School of Pharmacy) and has analytical and formulation expertise gained from leadership roles in product line extensions, physical properties and early stage development in GlaxoSmithKline and other major pharmaceutical companies. He is a former vice president of the APS and is now a member of the APS Advisory Board.
Dr Eddie French
Eddie is an independent pharmaceutical consultant who specialises in therapeutic product design and development; working with biotechs, SME pharma and medtech companies. Eddie has over 25 years’ experience in the pharmaceutical industry. The majority of this time was spent with Pfizer as a director with Pharmaceutical Sciences, focusing on drug delivery and drug product development. Eddie has a PhD in transdermal drug delivery and prior to his industrial career, he was a lecturer in pharmaceutics at the University of Bath. Eddie is a previous chair of the APS and co-chairs the APS Inhalation Focus Group. He is an honorary professor at the University Nottingham.
Mei is a Senior Principal Scientist working at Pfizer in Sandwich, Kent. She is a Pharmacist by training and has been with Pfizer developing medicines for over 10 years. She has co-authored a chapter in the book ‘Oral Formulation Roadmap from Early Drug Discovery to Development’ (2017).
Chris is a Senior Research Fellow at Quotient Sciences Ltd, bringing over 20 years’ experience across pharmaceutical sciences and biopharmaceutics through a series of previous technical and leadership roles at Sanofi, Pfizer, AstraZeneca and Walgreens Boots Alliance. His expertise ranges from early pre formulation and biopharmaceutical assessments ensuring appropriate new chemical entity selection, through development of a wide range of dosage forms including preclinical and early clinical inhalation, topical, oral immediate release and modified release formulations, to maintenance and life-cycle management of existing marketed products. Chris’ role at Quotient involves designing science-led, robust, clinical study programs which maximise output for clients, in addition to providing scientific support throughout study delivery. Chris holds a Bachelor of Science degree in Medicinal Chemistry from Newcastle University and Postgraduate Certificate in Education from Nottingham Trent University.
Dr David Jones
David is an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London. Prior to joining the MHRA in 1996 he had 19 years as a toxicologist in CROs and the pharmaceutical industry. His role in the MHRA involves assessing non-clinical data for Clinical Trial Applications and offering regulatory advice to companies. He is one of the UK’s accredited non-clinical experts to support the CHMP and is the UK representative on the EU’s Safety Working Party (SWP). He represented the EU in the ICH revision of the M3 Guideline and on the new ICH S10 Guideline and is currently EU Rapporteur on the new ICH S11 (Juvenile Animal Studies) guideline and the Q&A document for ICH S3 (Toxicokinetics). He is a guest lecturer at a number of UK Universities
Dr David Elder
Dave has over 40 years of service within the pharmaceutical industry, with Sterling, Syntex and GSK. He is now an independent CMC consultant and has broad based experience in impurities and their control, excipients, drug product development and analytical method development. He obtained his PhD in crystallography from the University of Edinburgh and is a visiting professor at King’s College, London. He is a member of the British Pharmacopoeia. He is on the Board of JPAG (Joint Pharmaceutical Analysis Group) and is a past Chairman. He is a past member of the Analytical Division Council of the Royal Society of Chemistry and a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published over 140 papers in international journals and has given 19 webinars and nearly 160 presentations at international symposia. He has co-edited one book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities (with George Okafo and Mike Webb) and a second on the ICH Quality Guidelines – An Implementation Guide (with Andy Teasdale and Raymond Nims).
Dr David Berry
David is a pharmacist with a drug development background. David has over ten years’ experience of pharmaceutical R&D in the pharmaceutical industry (AZ) and as an academic within Durham University. He currently manages a laboratory within the National Formulation Centre focusing on the processing of Complex Particles. He has a number of papers and drug development patents to his name and is passionate about developing medicines for major diseases.
This is a popular work shop giving you the opportunity to connect with pharmaceutical industry, university research groups, UK and globally, professionals and influential experts, potential clients and new employees face to face. Use the exhibition space to demonstrate your services and products in dedicated networking sessions.
Friends House is centrally located, opposite Euston Station, and within walking distance of King’s Cross and St Pancras International stations. It is easily reached by all major rail, bus and tube services.
This event has been run several times and continues to be a popular event for pharmaceutical scientist to learn from a pharmaceutics and biopharmaceutics perspective what is required to assess a molecule in discovery and its suitability for ‘candidate selection.
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