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Perspectives on Client-Contract Manufacturer Relationships in Small Companies

Explore the dynamics of client-CMO relationships from a small company's standpoint, covering topics like resources, decision-making, strengths, and limitations of CMOs. Understand the challenges and strategies involved in leveraging contract manufacturing services effectively in a small company setup.

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Perspectives on Client-Contract Manufacturer Relationships in Small Companies

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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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