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CMO Relationships from a Small Company Perspective

CMO Relationships from a Small Company Perspective. Steve Pondell May 25, 2005. Discussion Topics. Client Resources People Financial Geographic Considerations Decision Making Priorities. Discussion Topics. Contract Manufacturers Services You Can Expect Strengths of CMOs Limitations.

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CMO Relationships from a Small Company Perspective

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  1. CMO Relationships from a Small Company Perspective Steve Pondell May 25, 2005

  2. Discussion Topics • Client • Resources • People • Financial • Geographic Considerations • Decision Making • Priorities

  3. Discussion Topics • Contract Manufacturers • Services You Can Expect • Strengths of CMOs • Limitations

  4. Encysive Background • Small company (150 people) • In-house compound • Orphan drug, small volume, small molecule • NCE NDA filing imminent • Commercialization planned and underway • Suppliers selected and under contract

  5. Resources – PeopleClient • Small companies = few people • CMC group small (3-10 people) • Group also dealing with internal development • May only be one expert on process

  6. Resources – PeopleClient • Experts may be limited in breadth of experience • Heavier use of consultants and reliance on them • No backup for key people

  7. Resources – FinancialClient • Feast or famine • Manufacturing costs probably not major piece • Cash flow will direct timing of decisions

  8. Geographic ConsiderationsClient • Dependent on stage and size of drug • More control necessary in earlier phases • Few people – time to travel and time out of office are important factors • May or may not have local representation • Very dependent on background of person • Language

  9. Decision MakingClient • Not many layers, few decision makers • Analyses of decision may be shallow • Relationships vital • First proposals may be only chance • First impressions critical • May be short-term focused

  10. PrioritiesClient • Money • Company success and survival! • Time to market • Clinical results • Big tasks can paralyze multi-tasking in small company

  11. Services You Can ExpectContract Manufacturer • Analytical development • Process/formulation development • Process justification • Scale-up and commercial strategy

  12. Services You Can ExpectContract Manufacturer • Method validation • Process/formulation validation • Cleaning validation • Regulatory support • Package design • Quality systems

  13. StrengthsContract Manufacturer • Experience • Flexibility • Relationships with clients • Contacts with sub-suppliers

  14. LimitationsContract Manufacturer • Size • Plant situation – small relative to large company • Multiple clients with varying needs • Establishment and flexibility of their systems

  15. LimitationsContract Manufacturer • Limited resources • Many promises, less execution • Caveat emptor • Most have strengths, many claim soup to nuts

  16. Keys to Success • Know what you want and need • Reach for help - consultants • Select companies that “do this for a living” • Assure that both you and your supplier can prosper

  17. Conclusions • The pathway is the same for large or small companies • Decision process may be different • External priorities may drive decisions • Relationships are critical

  18. Thank You! Questions?

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