Location: 3-5 Impasse Reille, 75014 Paris, France.
Date: 31st January 2019
Today’s scientists face significant pressure to accelerate their compound from discovery to the clinic. Such pressure can often lead research organisations to adopt short-term thinking and overlook the downstream realities of drug development. Comprehensively addressing API optimization, drug formulation, pharmacology issues and toxicology strategy at the pre-clinical stage can result in more robust Phase 1 studies and fewer problems down the line such as escalating timelines, costs, and regulatory issues. It is important to leverage the skills and experience of experts and connect the dots between competencies to minimise risks and improve the odds of success.
This free event will focus on a number of key considerations for transitioning a molecule from discovery to phase 1 readiness including API and formulation development, toxicology and safety pharmacology studies, clinical study design, and regulatory requirements.
09:00 – Registration and coffee
09:25 – Introduction – Arnaud Bathelier Account Director of Catalent
09:30 – Regulatory aspects of early stage drug development – Julien Massiot Project Manager at Leads to Development
- Regulatory landscape (EU/US)
- What do all these abbreviations mean?
- Regulatory guidance, one has does NOT fit all
- What makes up a high quality clinical trial application?
10.10 – Drug substance: important considerations in the early development of new clinical candidate – Dr. Eric Damen, Director of Process Research, MercachemSyncom
- Route selection for scale-up
- Interplay of analytical method development and chemical process R&D
- The importance of impurities
- Selection of a suitable API solid form
10.50 – Coffee and networking
11:10 – How to accelerate more molecules to clinic with novel drug development approach – Rob Harris, Chief Technical Officer, Oral Drug Delivery, Catalent Pharma Solutions
- Balancing the risks and opportunities in early stage development
- Strategies to optimize drug performance for oral delivery dosage forms
- Data driven parallel technologies screening for early stage development
11:50 – Toxicology/Pharmacology – Olivier Foulon Managing Director & Director of Operations of Citoxlab
- Pre-clinical toxicology studies in animal models
- Proper formulation/ preparation of API
- Understanding the PK/PD and how to extrapolate to human
12.30 – Coffee and networking
12.50 – Clinical – To be Confirmed
- Phase 1 trial design
13:30 – Networking Lunch and 1:1 Private Consultancy Appointments
Following the meeting, private, no-obligation discussions on specific programmes and challenges are available.
Please contact Arnaud Bathelier (firstname.lastname@example.org) to register for this event and advise if you have any specific dietary or building access requirements.