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Changing Paradigms in
    Outsourcing
    An Investor’s Perspective
       Elizabeth Stoner, M.D.
    MPM Capital, Managing Director

             January, 2012
Outsourcing in Biotech
TRADITIONAL
• Command and control from Headquarters
  – Strong oversight and project management
  – Internal staff with redundant expertise to
    manage CRO
  – No leverage, due to small size of contract
  – CRO choice based on limited data
    (e.g. cost and experience)
New Paradigm for Outsourcing
• Capital efficiency is key
  – Choose a CRO with expectation for volume-based
    discounts and appropriate management focus
  – Relegate functions to trust-worthy CRO
     • CROs providing temporary experienced staff
  – Minimize oversight from HQ:
     • but must retain key decisions internally
  – Explore potential to increase leverage
     • ?consolidate with other portfolio companies
VC Investing Strategy
VCs seek                           VCs provide                         VCs expect
• Novelty (with IP                  • Funding for research             • Return to investors
  protection)                         and infrastructure                 to leverage history
• Potential to meet
  medical needs                     • Experience in drug               • Sharp focus with
• Rational health                     development                        clear goals
  economics
• Risk sharing                      • Engine for biotech               • Lean organization
                                      innovation




                      Build companies to fill large-pharma pipelines
CRO Strategy in the Consolidated Market
CROs seek                         CROs provide                       CROs expect
 • Clients committed to             • Experience in drug              • Repeat customers
   outsourcing                        development
 • Clients with pipeline                                              • Client “partners” with
   of quality products              • Talented
                                                                        active involvement in
                                      scientists, technician
 • Experienced, VC-                                                     R&D strategy
                                      s, state-of-the-art
   validated clients                  facilities
 • Clients with sufficient          • Capital efficient R&D           • Clarity of needs of
   cash flow to support                                                 clients
   contracted work




                       VC partnership can help develop growing and
                                  lasting customer base
New Paradigm- Off-Shore Solutions

• ? Which region of the world
• Cost vs. Quality, patient access considerations
• Ethnic diversity needed for ultimate regulatory
  approvals
• Important to link to prevailing
  epidemiologic/medical practice
Key Drivers for Investors to Minimize Risk

• Quality
              Highly linked
• Cost
• Timelines

No tolerance for variability in quality of
deliverables
Models to Consider

• Outsourcing trial management & execution is
  strategy of choice
• Design and decisions must reside with company
• Can pool of portfolio companies provide
  leverage?
  – Pre-clinical services amenable to single partner
  – Experiment not very successful for clinical
     • Therapeutic diversity is a challenge
     • CEO endorsement
     • CMO resistance
  – Company must remain the client
Venture Capital
   Institutional money invested with the sole focus of aiding the
growth and success of the company with an eye on an lucrative exit.

• Venture Capital players have become increasingly more
  sophisticated
   ― Industry “mature” veterans are being recruited into smaller companies
   ― Willing to take on complicated development paths
   ― V C’s have evolved from investment to investment/operational management
The Virtual, Capital Efficient Company of Today

•   Deep expertise in key functions
•   Dependable outsourcing partners
•   Internal personnel with broad experience
•   Strong project management
•   Support functions provided by fractional-time
    experts (e.g. Finance, etc.)
New Paradigm for Outsourcing
             Conclusion

• Companies need to stay lean to survive
• Relegate control
• Trust
New Paradigm for Outsourcing
             Conclusion

• Companies need to stay lean to survive
• Relegate control
• Trust…VERIFY

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Changing Paradigms in Outsourcing, Liz Stoner

  • 1. Changing Paradigms in Outsourcing An Investor’s Perspective Elizabeth Stoner, M.D. MPM Capital, Managing Director January, 2012
  • 2. Outsourcing in Biotech TRADITIONAL • Command and control from Headquarters – Strong oversight and project management – Internal staff with redundant expertise to manage CRO – No leverage, due to small size of contract – CRO choice based on limited data (e.g. cost and experience)
  • 3. New Paradigm for Outsourcing • Capital efficiency is key – Choose a CRO with expectation for volume-based discounts and appropriate management focus – Relegate functions to trust-worthy CRO • CROs providing temporary experienced staff – Minimize oversight from HQ: • but must retain key decisions internally – Explore potential to increase leverage • ?consolidate with other portfolio companies
  • 4. VC Investing Strategy VCs seek VCs provide VCs expect • Novelty (with IP • Funding for research • Return to investors protection) and infrastructure to leverage history • Potential to meet medical needs • Experience in drug • Sharp focus with • Rational health development clear goals economics • Risk sharing • Engine for biotech • Lean organization innovation Build companies to fill large-pharma pipelines
  • 5. CRO Strategy in the Consolidated Market CROs seek CROs provide CROs expect • Clients committed to • Experience in drug • Repeat customers outsourcing development • Clients with pipeline • Client “partners” with of quality products • Talented active involvement in scientists, technician • Experienced, VC- R&D strategy s, state-of-the-art validated clients facilities • Clients with sufficient • Capital efficient R&D • Clarity of needs of cash flow to support clients contracted work VC partnership can help develop growing and lasting customer base
  • 6. New Paradigm- Off-Shore Solutions • ? Which region of the world • Cost vs. Quality, patient access considerations • Ethnic diversity needed for ultimate regulatory approvals • Important to link to prevailing epidemiologic/medical practice
  • 7. Key Drivers for Investors to Minimize Risk • Quality Highly linked • Cost • Timelines No tolerance for variability in quality of deliverables
  • 8. Models to Consider • Outsourcing trial management & execution is strategy of choice • Design and decisions must reside with company • Can pool of portfolio companies provide leverage? – Pre-clinical services amenable to single partner – Experiment not very successful for clinical • Therapeutic diversity is a challenge • CEO endorsement • CMO resistance – Company must remain the client
  • 9. Venture Capital Institutional money invested with the sole focus of aiding the growth and success of the company with an eye on an lucrative exit. • Venture Capital players have become increasingly more sophisticated ― Industry “mature” veterans are being recruited into smaller companies ― Willing to take on complicated development paths ― V C’s have evolved from investment to investment/operational management
  • 10. The Virtual, Capital Efficient Company of Today • Deep expertise in key functions • Dependable outsourcing partners • Internal personnel with broad experience • Strong project management • Support functions provided by fractional-time experts (e.g. Finance, etc.)
  • 11. New Paradigm for Outsourcing Conclusion • Companies need to stay lean to survive • Relegate control • Trust
  • 12. New Paradigm for Outsourcing Conclusion • Companies need to stay lean to survive • Relegate control • Trust…VERIFY

Notas del editor

  1. Need to add my name, title, date..as on prior presentations more bold investor