Drug Development ClusterDrug Development Cluster
“An Integrated Outsourcing Network”An Integrated Outsourcing Network
“From Innovation to Commercialization”
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This Workshop
“Outsourcing” = “Out‐License”
Hilde Windels – SepsPharma
Cost ReductionRi k l
Marc de Weer – Galapagos
Needs to get to clinicS l i fRisk control
Faster to MarketPharmaco economics
Selection of contractorsProject ManagementEfficiency
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New Outsourcing Modelg
“Smarter commercialization by integrated innovation ”
Serve virtual R&DReduce costReduce Time to MarketReduce risk
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Productivity and Team Integrationy g
65 5%65.5%
89.7%
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New Product Development, Robert G Cooper
Where is Pharma R&D taking place
Medicinal Chemistry
cGMPManufacturing
Drug SafetyEvaluation
Salt ScreeningPolymorphism
Drug ProductDevelopment
g p
Chemistry Manufacturing Evaluation Polymorphism Development
Contract LabsContract Labs
Pharma R&DUniversities Pharma R&DUniversities
HospitalsBiotechs
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Functional Walls in Drug Developmentg p
Statement: “Drug development R&D is a fragmented process”
• Big Company R&D is poorly integrated – too BIG to manage• Also independent service provider work in isolationAlso independent service provider work in isolation• Where are the autonomous, cross functional teams necessary for productive product development ?
cGMPMedicinal Drug ProductcGMPManufacturing
Medicinal Chemistry
Drug ProductDevelopment
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Large Pharma Melt‐Down
30% 60
Increased R&D expenditure… …Reduced output
1 %
20%
25%
of s
ales
40
50
5%
10%
15%
R&
D a
s %
10
20
30
• More complex scientific targets
0% 01995 1996 1997 1998 1999 2000 2001 2002 2003 2004* 2005* 2006* 2007* 2008* 2009*
• Inefficient innovation• Increased regulatory cost to avoid risk • Waste of time and money
Restructuring of Large Pharma R&DC t R d ti Bi t h I t
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Cost Reduction – Biotechs are Innovators
Restructuring R&D | 1. Cost Reduction
• R&D sites closed, moved, or sold to CROs Examples: Covance‐Sanofi Aventis, Aptuit‐GSK
• Portfolio maintenance by AcquisitionsOrganon‐MSD, Solvay‐Abbott, buy small biotechs
• Large Pharma are reducing R&D cost by skipping the early development work
Step in after POCpSave 7 years of R&D
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Biotech: The New Innovator
• In‐licensing, co‐development, risk sharing• Biotechs are filling the innovation gap• Biotech focus: Out‐license after POC (Phase II)
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Biotech focus: Out license after POC (Phase II)
Changing world for contractors
• Limited resources within Biotechs – virtual operation• Outsource full set of services from screening to the clinic• Outsource full set of services from screening to the clinic• Focus on cost reduction and reduced time to market• CROs are consulting ‐ Drug Development Black‐Box
Knowledge Flows
BiotechLarge Pharma
CRO
CRO
CRO
Old Situation New Situation
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Old Situation New Situation
Opportunity for new outsourcing modelpp y g
• Virtual Biotechs are the innovators• Consultative role for CRO Opportunity
D D l t Cl t
• Consultative role for CRO ‐ Opportunity• R&D must get cost effective and more efficient• Broader sets of work are outsourced – Opportunity
Drug Development Cluster :
• Offers broad set of services – “one stop multi shop”• Offers knowledge to get to POC g g• Integration saves R&D cost and time• Make life easier for virtual pharma
• Integrated multiple CROs a paradox ? How does it work ?• Integrated multiple CROs a paradox ? How does it work ?
References R&D Mash‐ups. Pharmaceutical Technology Europe, September 2010A Problem Shared. Worldpharma vol 2, 2010Lean Sigma in R&D. Drug Discovery Today, June 2009
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Outsourcing to multiple CROs
Core Process
Medicinal Chemistry
cGMPManufacturing
Drug SafetyEvaluation
Salt ScreeningPolymorphism
Drug ProductDevelopment
S t PSupport Process
AcquisitionTechnical discussionLegal aspectsShi i f l
AcquisitionTechnical discussionLegal aspectsShi i f l
AcquisitionTechnical discussionLegal aspectsShi i f l
AcquisitionTechnical discussionLegal aspectsShi i f l
AcquisitionTechnical discussionLegal aspectsShi i f lShipping of samples
Project ManagementProject UpdatesReporting
Shipping of samplesProject ManagementProject UpdatesReporting
Shipping of samplesProject ManagementProject UpdatesReporting
Shipping of samplesProject ManagementProject UpdatesReporting
Shipping of samplesProject ManagementProject UpdatesReporting
• Slioed non‐integrated process• Many overlapping activities
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Outsourcing to the Drug Development ClusterCore Process
Medicinal Chemistry
cGMPManufacturing
Drug SafetyEvaluation
Salt ScreeningPolymorphism
Drug ProductDevelopment
Shared Support Processpp
AcquisitionTechnical discussionLegal aspectsShipping of samples
jProject ManagementProject UpdatesReporting
• Faster process• Reduce wasting money
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Lean Sigma | Eight points of wasteg | g p
1 28Knowledge Waiting
Over production
237
8
456Movements Shipping
Stock
Rework Over optimisation
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Stock
Non value added activities | Project Startup| j p
Reduction of waste by combined activitiesQuantification of value streams
Finding CRO AcquisitionAcquisition Site visits CDA Exchange Kick offsA dit
Startup activitiesReduce with 64%
Audits Proposals
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Quantification of Value Streams | Execution
A l i l d lAnalytical development Safety assessments Shipping of samplesLab reproduction During project executionpTechnology transfer Project discussions Knowledge transfer
Reduce with 49%
Overall saving after reducing non‐value added activities:non value added activities:
76 days = € 80,000
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How does it work
• Project team tailor made for customer• Managed by dedicated project manager
l ibl d bli i• Flexible and no obligations• Working with the cluster is an option
• No extra money involved• Saves money• Saves money
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Parallel Development
Medicinal Chemistry Mercachem Candidate Nom
in
Clinic/IMPD
Route Scouting Mercachem
Drug Safety Studies NOTOX NOTOX
Salt Screening & Polymorphism Avantium
Process Development Cambridge Majornation
D
GMP Manufacturing Cambridge Major
Drug Product Development SEPS Pharma
Better project flowKnowledge build‐upAvoid over‐deliveryFlag pit‐falls in early phase of project
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Parallel development | Minimizing Risk
Real‐Life Pit‐Falls
• “ Wait too long with formulation problems ”• “ Run toxicology on non‐scalable synthesis”• “ During nomination the manufacturing cost is not evaluated ”• “ The salt form important for API manufacturing and formulation ”• “ Genotoxic impurities and residual solvents …
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Finalized Projects
Based on approx 10 projects for biotech companies
Lead Optimization – Solid State Chem – GMP ManufacturingLib S th i D S f t E l tiLibrary Synthesis – Drug Safety EvaluationGMP Manufacturing – Solid State Chem ‐ Drug Product Development
Saved up to 12 months of development timeSaved up to 12 months of development time
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Conclusion | Knowing the end‐game
62.1%
74.2%
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Conclusion | Knowing the end‐game
72.4%
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