Workshop will discuss accelerated preclinical drug development and readying molecules for phase I
The Catalent Applied Drug Delivery Institute has revealed the latest in its series of educational workshops, From Discovery to Clinic: Getting Ready for Phase 1. It will discuss key considerations for the rapid and efficient transitioning of molecules from discovery, through to Phase 1 clinical trial readiness.
The event content will include API and formulation development, clinical study design and regulatory requirements, and is to be held in collaboration with One Nucleus, the international membership organisation for life science and healthcare companies, and will take place at Chesterford Research Park, Little Chesterford, April 20th, 2016.
The workshop agenda includes a presentation by Dr John Knight, head of Jkonsult, provider of expert advice on chemical and process research and development, and people development. He will discuss the key priorities in the developmental process.
Malcolm Boyce, medical director of Hammersmith Medicine Research, one of the largest early-phase clinical trials units in Europe, 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 (pictured), vice president, science and technology and Catalent Institute board member, who will discuss Early dose form selection: selecting and optimising formulation technologies for clinical success.
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.
To find out more information, or book a place at this event, visit http://www.eventbrite.com/e/from-discovery-to-clinic-getting-ready-for-phase-1-tickets-21628913663?aff=NEPR.