APV Outsourcing Conference Berlin 26 th January 2012 Philip Berry, EU Business Development Manager
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APV Outsourcing ConferenceBerlin
26th January 2012Philip Berry, EU Business Development Manager
1. Background to Almac Group
2. Pharmaceutical Development Services
3. Commercial Manufacturing and Packaging
4. Product Distribution and Launch Services
5. Considerations for Selecting a CMO
Presentation Agenda
Almac Group Key Facts
Ongoing investment of over $740M
Owned under the Almac Foundation
Employing 3400+ staff at seven global sites
Providing integrated services across biopharmaceutical marketplace
UK HQ located in Craigavon, NIUSA HQ located in Souderton, PA
Extended Almac Capabilities
UKHQ Facilities
non GMPnon GMPAPI API ManufManuf
& Solid & Solid StateState
Commercial Commercial ManufManuf & & Pack & Pack &
AnalysisAnalysis
GMP APIGMP APIManufManuf
PharmPharm DevDev
Clinical Clinical PackagingPackaging
RadioRadioLabellingLabelling
BiomarkersBiomarkers
Stores & Stores & DistributionDistribution
Commercial Commercial ManufManuf
Commercial Commercial ManufManuf
StabilityStabilityIVRSIVRS
Drug Drug Reconciliation Reconciliation & Destruction& Destruction
Stores & Stores & DistributionDistribution
Drug Drug Reconciliation Reconciliation & Destruction& Destruction
Non GMP Non GMP PharmPharm DevDev
NAHQ Facilities
Administration & Administration & Client Meeting RoomsClient Meeting Rooms
Clinical Manufacture Clinical Manufacture & Pack, Analytical & Pack, Analytical
Labs, Stores & Labs, Stores & DistributionDistribution
Pharma Services Overview
Pharma Services Overview
Over 350 direct employeesCombined floor space of 221,968ft2
Capabilities: Solid oral forms
Regulatory approvals:MHRAFDA inspected
Services: Pharmaceutical Development Commercial Manufacturing / PackagingProduct Launch & Distribution
Pharmaceutical Development
Pre-formulation
Early stage development
Scale-up and later stage development
Clinical trial manufacture (Ph 0 – IV)
Contained processing
Analytical development
Technical Capabilities
Commercial Manufacture & Packaging
Technical Capabilities
Manufacture of solid, oral dosage formsTablets, Capsules & Powders
Innovative primary packaging Blisters, Bottles, Sachets & Wallets
Labelling & customised packagingVial, Ampoules & Tubes
Packaging design & artwork
Serialisation & 2D matrix barcoding
Product Launch & Distribution Services
Service Capabilities
Providing access to the EU market for OEU product
EU product launch consultingEU import testing & QP releaseLabelling and packagingLate stage customisationOrder processing & Financial servicesStorage & Distribution
Capital Expansion
Non GMP Pharmaceutical Development facilities<15Kg scale across broad range of technologiesPotent handling capabilitiesTemp & RH controlStage 1 completion Q2 2012
Commercial packaging facilities in AudubonBottling, Blistering, Cartoning, Walleting & Vial LabellingCompletion scheduled Summer 2012
SELECTING A CMO
Stages of Outsourcing
There are 3 distinct phases to outsourcing:
Deciding whether to ‘make or buy’Selecting a CMO partnerManaging chosen partner
Choosing the right CMO is critical for success
Assessment Team & Selection Process
Nominate Assessment Team
Project LeadSubject Matter Experts
Define Selection Criteria
ObjectiveChecklist / scorecard
Scorecard examples
Screening Process
Quality Number one selection criteriaGood quality systems produce quality products Look for solid inspection history and competent, experienced personnel
CostValue for money Technical review of proposals
Screening Process
Capacity / ScaleAssess CMO schedule Reserve capacity? Capacity to scale up to late stage development and commercialisation?
CapabilityProcess / product experience Technical experience of personnel
Screening Process
LocationTime zone Travel and extra management costsLanguage barrier One-Stop-Shop
DeliveryPerformance metrics References
Screening Process
Financial StabilitySecure and thrivingLong-term commitmentMixture of clinical / commercial clientsInvestment in technology and staff
CultureSynergy with personalities and working practices
Screening Process
Project ManagementDedicated PM preferred point of contact?Does the CMO have a dedicated PM team? Number of PMs within the company & experience?How many projects a PM has ongoing at any one time?
THANK YOU FOR YOUR ATTENTION
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