Cambridge, UK, workshop to discuss accelerated preclinical drug development and readying molecules for Phase I

The event content will include API and formulation development, clinical study design and regulatory requirements.

The workshop starts at 9.00 a.m., and the agenda includes a presentation by Dr John Knight, head of Jkonsult Ltd., providers of expert advice on chemical and process research and development, and people development, who will discuss the key priorities in the developmental process; and Malcolm Boyce, Medical Director of Hammersmith Medicine Research, one of the largest early-phase clinical trials units in Europe, who will draw upon his experience of being involved in over 670 Phase I clinical trials and present “First-in-man studies: what we can achieve”. Also speaking will be Julien Meissonnier, Vice President, Science and Technology and Catalent Institute Board Member, who will discuss “Early dose form selection: selecting and optimizing formulation technologies for clinical success”; and Judith Jones from Catalent’s European Regulatory Affairs Department, who will present “Best Practices for preparing the IMPD quality section”.

The workshop will be the third in an ongoing series being held in European biotech research clusters. Previous events in Oxford, UK, and Copenhagen, Denmark, have brought together guest speakers including prominent academics, consultants, and technology representatives, alongside Catalent Institute and drug delivery and formulation experts. The agendas of each event have been designed to give the opportunity for biotech and life science companies to interact with industry experts and discuss some of the challenges faced by research teams within preclinical phases, to ensure drug candidates progressed to the clinic have the greatest chance of success at later stages of development.

There will also be an opportunity for companies attending the events to discuss active developmental programs in private with Catalent’s science and technology leaders.