1. Challenges of a First Commercial Product Launch Steve Pondell January 8, 2008

2. Focus of Discussion Single product company First launch Virtual supply chain Commercialize without partners

3. Overall Launch Timeline Ph IIPh III Analysis & Preparation Launch! Filing Technical Regulatory Logistics/Business Organizational

4. Technical Aspects

5. Technical Timeline Ph IIPh III Analysis & Preparation Launch! Filing Technical Commercial Supply Chain Tech Transfer Scale-up Validation 1-2 years prior to launch

6. Commercial Supply Chain Points to Consider –How much do you need? –How much is it worth? –Fit of your need to suppliers’ competencies –Single source or multiple vendors –Geographic considerations

7. Technical Transfer Transition from development expertise to commercial expertise Companies may be competitors Takes longer than expected More expensive than expected

8. Scale-up Leave enough time to react to surprises Have enough materials for extra runs Understand critical parameters You may be dealing with a new supplier as well

9. Process Validation Hands-on interaction with supplier’s experts Each company has own standards Be involved at every step Bring in your experts if needed

10. Regulatory Aspects

11. Regulatory Timeline Ph IIPh III Analysis & Preparation Launch! Filing Technical Regulatory Preparation Inspections Follow-ups 6-18 months prior to launch

12. Preparation of CMC and Packaging Sections Very large focus by technical, commercial and quality groups Several months needed, even with consultants Common Technical Document format Make ample use of consultants Assure that consultants are well qualified and experienced

13. Expert Review Identify experts in particular market to review these sections –Not generalists, but experts in CMC

14. Preparations for Inspections Pre-inspection visits to suppliers’ sites Be on site for inspections, if allowed Let the supplier lead, support as necessary

15. Follow-up Questions from Regulatory Agencies Focused effort Quicker turnaround All-consuming when they occur

16. Logistics and Business Aspects

17. Logistics/Business Timeline Ph IIPh III Analysis & Preparation Launch! Filing Technical Regulatory Logistics/Business Contracts Technical Agreements Distribution Channels 3-18 months prior to launch

18. Contracts –Suppliers, distributors, agents, key consultants –Get key points in place early –Negotiate while there are still options –Make it a priority

19. Technical (Quality) Agreements Tie into contracts Critical in ex-US dealings Checklist or contract format Intracompany agreements Issues –Product Release –Degree of Control –Regulatory Audits

20. Distribution Channel Define model –Central market vs localized –Consignment vs partnership Pricing Transfers and shipment terms Customs and shipping

21. Organizational Aspects

22. Organizational Timeline Ph IIPh III Analysis & Preparation Launch! Filing Technical Regulatory Logistics/Business Organizational Functional People 0-18 months prior to launch

23. Functional Organization Identify subsidiary strategy early Local experts to identify requirements Things to consider –Incorporation –Physical address –Bank account –Wholesaler or manufacturer’s licenses

24. People Organization Hire into subsidiaries and key central functions as early as possible Sales and Marketing Logistics Distribution Technical support Finance and accounting

25. People Qualifications Broad experience –Marketing, manufacturing, general management Prior start-up experience Big picture and detail oriented

26. Summary Many things happening at same time Bring on support staff early Stay involved Prepare for surprises and knowledge gaps Use experts

27. Thank you! Steve Pondell spondell@umich.edu (281) 253-7088