biopharmaceutical manufacturing: strategic outsourcing and ... · paolo barbanti biopharmaceutical...
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Paolo Barbanti Biopharmaceutical manufacturing
Biopharmaceutical manufacturing:strategic outsourcing and
business opportunities
Paolo Barbanti Ph.D., MBA
Alma Mater StudiorumUniversità di Bologna
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Paolo Barbanti Biopharmaceutical manufacturing
NCE's launchedper year
30
35
40
45
50
55
60
65
85 86 87 88 89 90 91 92 93 94 95 96 97 980
5
10
15
20
25
30
35
40
Reducing R & D productivity
Annual R&Dexpenditure
($ billion)
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Paolo Barbanti Biopharmaceutical manufacturing
New product developmentA risky and expensive proposition
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Paolo Barbanti Biopharmaceutical manufacturing
BiotechnologyCompanies
HealthcareProviders &
GovernmentsInvestors
PharmaceuticalCompanies
STRATEGIC ALLIANCES
•demand for growth •new products•lower cost•public expectations
•patent expiry•time to market
•need new products•consolidation•cash rich
•provide innovation•need cash
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Paolo Barbanti Biopharmaceutical manufacturing
Number of New Biotech / Big Pharmacollaborations 1993–2003
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Paolo Barbanti Biopharmaceutical manufacturing
Diseaseselection
Gene tofunction
Functionto
TargetTargetto Hit
Hit toLead
Leadoptimisation
Drugcandidates Phase I Phase II Phase III
Combinatorial Chemistry
MolecularPharmacology
Molecular Biology
In vitro assays
LibraryDesign
In vivo pharmacology/ PK
Development
Rational DrugDesign
HTS
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Paolo Barbanti Biopharmaceutical manufacturing
Once upon a time ….
Manufacturing
Research
Development
Trials/Testing Services
Tech A
Tech E
Tech B
Tech F
Tech C
Now ….
Tech D
Tech G
A new business model
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Paolo Barbanti Biopharmaceutical manufacturing
ResearchProcess
DevelopmentPre-ClinicalTesting
ClinicalTrials
Manufacturing &Marketing
Academia
Biotech companies
Bioparks
CRO’s
Services
Tech Companies
Know-how
Hospitals
Research centers
IRCCS
CRO’s
Contractmanufacturing
Players: core competences,positioning on the value chain
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Paolo Barbanti Biopharmaceutical manufacturing
ExternalFocused
LocalSuppliers
SupportiveLocalInfrastructure
University ResearchCenters
Federal Labs Industry/Firms
Incubators &Eco Develop
LocalVenture Cap
ContractResearch
Legal/Accounting
Entrepreneurs Manufacturers Equipment Sales& Servicing
Transportation Facilities andRelated Spaces
State Agencies
Teamwork
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Paolo Barbanti Biopharmaceutical manufacturing
Biotechnology medicines in developmentby product category
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Paolo Barbanti Biopharmaceutical manufacturing
Shorter preclinical development time andlower cost for monoclonal antibodies
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Paolo Barbanti Biopharmaceutical manufacturing
Therapeutic focus on antibodiesPrograms targeting different diseases
CNS3%
ID9%
Oncology52%
AIID22%
Respiratory6%
CV3%
Other5%
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Paolo Barbanti Biopharmaceutical manufacturing
Partnerships: deconstruction of the value chain
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Paolo Barbanti Biopharmaceutical manufacturing
Top 12 biotechnology countries
USCanada
GermanyUK
AustraliaFranceSwitzerland
IsraelChina & HKIndia
NetherlandsDenmark
0 200 400 600 800 1000 1200 1400 1600