This is a 1-day course in preclinical drug development with a focus on moving interesting ideas from the lab to the clinic. This will include an overview of the key success criteria for selecting a lead candidate, the nonclinical steps needed to approach human trials and developing an effective early clinical-regulatory strategy. Significant time will be allotted to discussion of case studies and first-hand experience of good practices. Attendees are encouraged to bring their real-life problems for discussion and debate.
- Using a target product profile as the foundation of your development plan
- Candidate selection to address unmet medical needs
- Planning your IND-enabling studies with long term focus
- Goals for your pharm/tox and ADME studies
- Tailoring pre-IND studies to the specifics of your candidate
- Working with CROs
- Using consultants to your benefit
Alistair Stewart PhD brings over 20 years of experience in biopharma R&D. After initial academic research in the UK, France and Ontario, Alistair made the transition to an industrial setting in 1996. From that point onwards he has been in positions of increasing responsibility in small to medium sized pharmaceutical or biotech companies. After moving to Vancouver in 2000, he has worked with some of the best teams in BC biotech, building a strong background in moving novel therapeutics into clinical development.
While preclinical development has been the focus of Alistair’s work at Allon Therapeutics, QLT Inc., Paladin Labs and others, he has been at the core of teams managing projects that cover all stages of development. This includes taking on personal responsibility for pre-commercial planning, Phase 1 through 3 study execution, FDA interactions and strategic development planning. Since 2015, he has led his own consultancy, helping guide drug development plans for companies at very different stages of the process.
Neuroscience has been a focus for the last few years but a great deal of exposure has been gained in other indications including cancer, diabetes, liver disease and ocular therapeutics.
|Student Ticket:||$250.00||— Sold Out|
|Basic Member Ticket:||$650.00||— Sold Out|
|Group Tickets (5+):||$555.00||— Sold Out|
|Pro/Pro Member Plus Ticket:||$575.00||— Sold Out|