Presentation of dr. Marcel van der Sluis, Manager BD Drug Development Cluster at the Workshop 'From Innovation to Commercialisation' during the Dutch Life Sciences & Health Conference 2010

1. Drug Development Cluster
Drug Development Cluster
“An Integrated Outsourcing Network”
An Integrated Outsourcing Network
“From Innovation to Commercialization”
Confidential
www.drugdevelopmentcluster.com

2. This Workshop
“Outsourcing” = “Out‐License”
Hilde Windels – SepsPharma Marc de Weer – Galapagos
Cost Reduction Needs to get to clinic
Risk control
Ri k l Selection of contractors
S l i f
Faster to Market Project Management
Pharmaco economics Efficiency
Confidential
www.drugdevelopmentcluster.com

3. New Outsourcing Model
g
“Smarter commercialization by integrated innovation ”
Serve virtual R&D
Reduce cost
Reduce Time to Market
Reduce risk
Confidential
www.drugdevelopmentcluster.com

4. Productivity and Team Integration
y g
65.5%
65 5%
89.7%
New Product Development, Robert G Cooper
Confidential
www.drugdevelopmentcluster.com

5. Where is Pharma R&D taking place
gp
Medicinal cGMP Drug Safety Salt Screening Drug Product
Chemistry Manufacturing Evaluation Polymorphism Development
Contract Labs
Contract Labs
Universities Pharma R&D
Biotechs Hospitals
Confidential
www.drugdevelopmentcluster.com

6. Functional Walls in Drug Development
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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 isolation
Also independent service provider work in isolation
• Where are the autonomous, cross functional teams necessary for
productive product development ?
Medicinal cGMP Drug Product
Chemistry Manufacturing Development
Confidential
www.drugdevelopmentcluster.com

7. Large Pharma Melt‐Down
Increased R&D expenditure… …Reduced output
30% 60
25% 50
20% 40
R&D as % of sales
15%
1 % 30
10% 20
5% 10
0% 0
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004* 2005* 2006* 2007* 2008* 2009*
• More complex scientific targets • Inefficient innovation
• Increased regulatory cost to avoid risk • Waste of time and money
Restructuring of Large Pharma R&D
Cost Reduction – Bi t h are Innovators
C t R d ti Biotechs I t
Confidential
www.drugdevelopmentcluster.com

8. Restructuring R&D | 1. Cost Reduction
• R&D sites closed, moved, or sold to CROs
Examples: Covance‐Sanofi Aventis, Aptuit‐GSK
• Portfolio maintenance by Acquisitions
Organon‐MSD, Solvay‐Abbott, buy small biotechs
• Large Pharma are reducing R&D cost by skipping the early development work
Step in after POC
p
Save 7 years of R&D
Confidential
www.drugdevelopmentcluster.com

9. 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)
Confidential
www.drugdevelopmentcluster.com

10. 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
Biotech
Large Pharma
CRO
CRO
Old Situation
Old Situation New Situation
New Situation
Confidential
www.drugdevelopmentcluster.com

11. Opportunity for new outsourcing model
pp y g
• Virtual Biotechs are the innovators
• Consultative role for CRO ‐
Consultative role for CRO Opportunity
• R&D must get cost effective and more efficient
• Broader sets of work are outsourced – Opportunity
Drug Development Cluster :
D D l t Cl t
• 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 2010
A Problem Shared. Worldpharma vol 2, 2010
Lean Sigma in R&D. Drug Discovery Today, June 2009
Confidential
www.drugdevelopmentcluster.com

12. Outsourcing to multiple CROs
Core Process
Medicinal cGMP Drug Safety Salt Screening Drug Product
Chemistry Manufacturing Evaluation Polymorphism Development
Support Process
S tP
Acquisition Acquisition Acquisition Acquisition Acquisition
Technical discussion Technical discussion Technical discussion Technical discussion Technical discussion
Legal aspects Legal aspects Legal aspects Legal aspects Legal aspects
Shipping of samples
Shi i f l Shipping of samples
Shi i f l Shipping of samples
Shi i f l Shipping of samples
Shi i f l Shipping of samples
Shi i f l
Project Management Project Management Project Management Project Management Project Management
Project Updates Project Updates Project Updates Project Updates Project Updates
Reporting Reporting Reporting Reporting Reporting
• Slioed non‐integrated process
• Many overlapping activities
Confidential
www.drugdevelopmentcluster.com

13. Outsourcing to the Drug Development Cluster
Core Process
Medicinal cGMP Drug Safety Salt Screening Drug Product
Chemistry Manufacturing Evaluation Polymorphism Development
Shared Support Process
pp
Acquisition
Technical discussion
Legal aspects
Shipping of samples
Project Management
j
• Faster process Project Updates
• Reduce wasting money Reporting
Confidential
www.drugdevelopmentcluster.com

14. Lean Sigma | Eight points of waste
g | g p
Over production
Knowledge 1 Waiting
8 2
7 3
Movements
6 4 Shipping
5
Stock
Rework Over optimisation
Stock
Confidential

15. Non value added activities | Project Startup
| j p
Reduction of waste by combined activities
Quantification of value streams
Finding CRO
Acquisition
Acquisition
Site visits Startup activities
CDA Exchange
Reduce with 64%
Kick offs
Audits
A dit
Proposals
Confidential
www.drugdevelopmentcluster.com

16. Quantification of Value Streams | Execution
Analytical development
A l i ld l
Safety assessments
Shipping of samples
Lab reproduction
p During project execution
Technology transfer Reduce with 49%
Project discussions
Knowledge transfer
Overall saving after reducing
non value added activities:
non‐value added activities:
76 days = € 80,000
Confidential
www.drugdevelopmentcluster.com

17. 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
Confidential
www.drugdevelopmentcluster.com

18. Parallel Development
Medicinal Chemistry Mercachem
Candidate Nomin
Route Scouting Mercachem
Clinic/IMPD
Drug Safety Studies NOTOX NOTOX
Salt Screening & Polymorphism Avantium
Process Development Cambridge Major
D
nation
GMP Manufacturing Cambridge Major
Drug Product Development SEPS Pharma
Better project flow
Knowledge build‐up
Avoid over‐delivery
Flag pit‐falls in early phase of project
Confidential
www.drugdevelopmentcluster.com

19. 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 …
Confidential
www.drugdevelopmentcluster.com

20. Finalized Projects
Based on approx 10 projects for biotech companies
Lead Optimization – Solid State Chem – GMP Manufacturing
Library Synthesis – D
Lib S th i Drug Safety Evaluation
S f t E l ti
GMP Manufacturing – Solid State Chem ‐ Drug Product Development
Saved up to 12 months of development time
Saved up to 12 months of development time
Confidential
www.drugdevelopmentcluster.com

21. Conclusion | Knowing the end‐game
62.1%
74.2%
Confidential
www.drugdevelopmentcluster.com

22. Conclusion | Knowing the end‐game
72.4%
Confidential
www.drugdevelopmentcluster.com