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