Download pdf - Biopharmaceutical manufacturing: strategic outsourcing and

Paolo Barbanti Biopharmaceutical manufacturing

Biopharmaceutical manufacturing:strategic outsourcing and

business opportunities

Paolo Barbanti Ph.D., MBA

Alma Mater StudiorumUniversità di Bologna


NCE's launchedper year

30

35

40

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50

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60

65

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Reducing R & D productivity

Annual R&Dexpenditure

($ billion)


New product developmentA risky and expensive proposition


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


Number of New Biotech / Big Pharmacollaborations 1993–2003


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


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


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


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


Biotechnology medicines in developmentby product category


Shorter preclinical development time andlower cost for monoclonal antibodies


Therapeutic focus on antibodiesPrograms targeting different diseases

CNS3%

ID9%

Oncology52%

AIID22%

Respiratory6%

CV3%

Other5%


Partnerships: deconstruction of the value chain


Top 12 biotechnology countries

USCanada

GermanyUK

AustraliaFranceSwitzerland

IsraelChina & HKIndia

NetherlandsDenmark

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