The document discusses key aspects of developing a global regulatory strategy for drug development and registration. It outlines the long development timeline and costs to bring a drug to market. It also describes the regulatory approval processes in the US, EU and Japan, including application formats, timelines and opportunities to expedite review of important new drugs. Developing an integrated global strategy from early research can help optimize the development plan and registration across regions.

1. The Importance of Developing a Global Regulatory Strategy Towards the Goal of Registration Carlos Langezaal, PhD Director, Global Regulatory Affairs Eisai, Inc.

2. From Compound to Drug 10 - 12 Years $7500-3000M 1 DRUG 10 GO INTO MAN 100 INTO DEVELOPMENT 1000 SCREENED FOR ACTIVITY 10000 COMPOUNDS

3. New Drug Development Process and Strategy Pre-Clinical Research Synthesis and Purification IND / CTA NDA / MAA Clinical Research Post- Marketing Animal Testing Phase 1 Phase 2 Phase 3 Accelerated Approval Potential Regulatory Meetings Phase 4 PMRs REMS / PSUR

4. Regulatory Affairs and the Product Life Cycle Renewal Pharmacovigilance Advice on Product Development Variations Advertising Approval / Cleared Submit MAA /NDA Regulatory Questions MAA/ NDA Approval CTA/IND Extensions/Updates CTA/IND

5. Regulatory Input into Development Life- cycle manage-ment File & Launch Phase III PoC to commit to Phase III FTIH to PoC Candidate selection to FTIH Lead to Candidate Target to Lead Gene - Function - Target Association Disease selection Target family selection 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 toxicity findings? Initial Product Profile What studies will be needed? What are the issues we need to discuss with regulatory 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 Submission Does the data support the proposed labeling? What can we learn from competitor’s experiences? How do we maximize life cycle management? Following Initial Opportunity Assessment What lessons can we learn from previous development projects?