CRED Practical Document Writing and Management

Regulatory Input into Product Development

Gene - Function - Target Association

Life- cycle manage- ment

Disease selection Target family selection

Candidate selection to FTIH

PoC to commit to Phase III

Phase III

Target to Lead

FTIH to PoC

File & Launch

Lead to Candidate

During Development Can we get Orphan Designation? Eligible for Accelerated Designation Do we need a Paediatric Investigational Plan

How do we maximise life cycle management?

Following Initial Opportunity Assessment What lessons can we learn from previous development projects?

Prior to Submission Does the data support the proposed labelling? What can we learn from competitor’s experiences?

Initial Product Profile What studies will be needed? What are the issues we need to discuss with reg authorities?

Prior to Large Scale Clinical Trials Have we agreed our development plan with Regulators? Does the trial design meet regulatory/clinical end points?

Prior to First Time in Human What do the animal data tell us? Do we need to amend our target group on the basis of tox findings?