Ws from innovation to commercialisation marcel van der sluis

Drug Development ClusterDrug Development Cluster

“An Integrated Outsourcing Network”An Integrated Outsourcing Network

“From Innovation to Commercialization”

Confidentialwww.drugdevelopmentcluster.com

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


New Outsourcing Modelg

“Smarter commercialization by integrated innovation ”

Serve virtual R&DReduce costReduce Time to MarketReduce risk


Productivity and Team Integrationy g

65 5%65.5%

89.7%


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


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



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


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


Biotech: The New Innovator

• In‐licensing, co‐development, risk sharing• Biotechs are filling the innovation gap• Biotech focus: Out‐license after POC (Phase II)


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


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


Outsourcing to multiple CROs

Core Process

Medicinal Chemistry

cGMPManufacturing




S t PSupport Process

AcquisitionTechnical discussionLegal aspectsShi i f l




AcquisitionTechnical discussionLegal aspectsShi i f lShipping of samples

Project ManagementProject UpdatesReporting

Shipping of samplesProject ManagementProject UpdatesReporting




• Slioed non‐integrated process• Many overlapping activities


Outsourcing to the Drug Development ClusterCore Process

Medicinal Chemistry

cGMPManufacturing




Shared Support Processpp

AcquisitionTechnical discussionLegal aspectsShipping of samples

jProject ManagementProject UpdatesReporting

• Faster process• Reduce wasting money


Lean Sigma | Eight points of wasteg | g p

1 28Knowledge Waiting

Over production

237

8

456Movements Shipping

Stock

Rework Over optimisation

Confidential

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


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


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


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


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 …


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


Conclusion | Knowing the end‐game

62.1%

74.2%


Conclusion | Knowing the end‐game

72.4%


Ws from innovation to commercialisation marcel van der sluis

Health & Medicine

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