Pros and Cons of inhouse

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Pros and Cons of in-house Clinical
Manufacturing Unit vs CRO
Anil Kane, Ph.D Patheon Inc. akane_at_patheon.com
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Clinical Manufacturing Contract vs In-house

• Decision usually based upon
• Development budget
• Product pipeline (one off or first of many)
• General company culture
• Confidence
• Intellectual Property

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Clinical Manufacturing Contract vs In-house

• Pros of In-house Manufacturing
• Easier Tech Transfer
• Retain Control of invention
• Not reliant upon others competencies
• Overall project focus

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Clinical Manufacturing Contract vs In-house

• Cons of In-House Manufacturing
• High Capital requirement
• Lab space
• Resources
• Costs immediate and recurring maintenance
• Timeline
• Design to manufacture 24-48 months
• Heavy investment in support, regulatory
  infrastructure

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Clinical Manufacturing Contract vs In-house
Pros of Contract Manufacturing

• Lowered Capital requirement
• Can concentrate on core competencies
• Increases partnering potential
• Lowered risk

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Clinical Manufacturing Contract vs In-house

• Pros of Contract Manufacturing (contd.)
• Smart Sponsors recognize that they are buying
  both hands
• and minds when they contract work with
  experienced
• contractors.
• Sponsors can demand higher quality standards or
  better
• systems at a contractor.

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Clinical Manufacturing Contract vs In-house

• Cons of Contract Manufacturing
• Loss of value of invention
• Higher cash burn rate
• Dependent on partners objectives / priorities
• Dependent on contractors competencies
• Tech transfer more difficult

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Clinical Manufacturing Contract vs In-house

• Cons of Contract Manufacturing (contd.)
• Loss of IP opportunities
• You pay through the nose and have nothing to
  show for it at the end, but a couple of lots
• Perception contractors take away all the money
  while sponsor sits back and watches
• Does the contractor share the passion for
  the clinical program?
• Does the contractor wish to capture ROI at the
  first opportunity?

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Clinical Manufacturing Contract vs In-house

• Outsourcing clinical manufacturing can be a
  valuable part of
• companys business strategy so long as the
  partnership is
• constructive and mutually satisfying.
• Ultimate Goal
• take multiple steps to strengthen financial
  picture
• collaborations / outsourcing
• position company to advance multiple development
  
• programs

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