Sharp Clincal Services Capabilities 26 JUN

www.sharpservices.com

Sharp Packaging Services

www.sharpservices.com: Sharp Clinical Services

About UDG Healthcare plcAn International Healthcare Services Organization


UDG Healthcare plc

Founded in 1948

52 operating companies

FTSE 250 listed public company

€2.30 billion revenues in 2015

> €1.85 billion market capitalisation


UDG Healthcare Plc

UDG Healthcare employs more than 7,000 people across 20 countries…


- Medical information & Pharmacovigilance

- Sales channel solutions- Medical Communications- Patient support- Event Management

- Contract packaging solutions

- Serialisation services- Formulation Development- Analytical services- Label Design/Printing- Storage/Distribution- IRT Services- Regulatory Guidance

- Specialist healthcare & scientific products & services

- Outsourced sales & marketing

- Distribution & Engineering

UDG Healthcare Plc



www.sharpservices.com: Sharp Clinical Services8


Overview – Provide international commercial & clinical packaging and

supply chain services to the pharmaceutical industry– 1,400 employees

Facilities in- United States

• Allentown, PA• Conshohocken, PA• Phoenixville, PA

- Europe• Crickhowell, UK• Hamont-Achel, Belgium• Heerenveen & Oudehaske, Netherlands



United KingdomUnited States

BelgiumNetherlands

United States


Sharp Packaging Solutions


Packaging Capabilities

www.sharpservices.com: Sharp Clinical Services12

Multi-vac & Koch tray forming

Tyvek and film lidding

Multiple-component drug/device

combinations

- Vials

- Needles

- Needle connector

- Swabs

Specialised cartons

Kitting


Packaging & Graphic Design


Sharp Clinical Services

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End-to-End IntegratedClinical Supply Services


SHARP CLINICAL SERVICES: UK

Crickhowell, Wales, UK — 14 Production Suites

(Primary/Secondary)— Commercial production suite— Controlled drug storage— Warehouse— Cold storage

3 QPs’ on Sharp UK LicenseValidated SAP system


SITE LICENSES: UK

MHRA— Manufacturer’s MIA 10284 Importers License— Manufacturer’s Authorization (Investigational Medicinal

Products) MIA (IMP) 10284 — Manufacturer’s “Specials” License MS/10284— Wholesale Distribution License WL/10284— Home Office Controlled Drugs License (schedule II to V)

ISO accreditation— 9001 – commercial packaging— 13485 – medical devices


SHARP CLINICAL SERVICES: US

Phoenixville— 26 Production Suites

(Primary/Secondary)— Warehouse

DEA Licensed for Controlled Substances (I-V)Analytical & formulation developmentFDA Registered SiteValidated SAP system


SITE LICENSES: US

FDA Audited

DEA Registered—Analytical—Manufacturer—Distributer—Importer—Exporter


Formulation Development & Analytical Services


ANALYTICAL SERVICES

Seven Analytical Laboratories— Spectroscopy— Dissolution — Chromatography — Physical Testing — Sample Preparation — Development— Stability Storage Suite


ANALYTICAL SERVICES

Analytical Laboratory TestingTechniques

— HPLC (ID testing, assay, impurity)— GC (OVIs, assay,

extractables/leachables)— UV-Vis Spectroscopy (ID, assay)— FTIR (ID, characterization)— Performance Testing (Friability,

Hardness, Dissolution Testing)— TOC (cleaning verification)— Classical (pH, KF, MP)

Studies— Competitor Analysis for Unbiased De-

Formulation— Dissolution Profiling— Accelerated Drug Stressing— Hygroscopicity Studies— Method Development — Process Development Support— Reference Standard Qualification

Testing— Stability (ICH and Custom)


ANALYTICAL SERVICES

Stability Laboratory Testing

Stability and Storage TestingStability Study Protocol Design (ICH and Custom)Mapped Environmental Chambers Including:

— 25°C/60% RH— 30°C/65% RH— 40°C/75% RH— 25°C/20% RH — 25°C/30% RH / 5°C / Photo Stability


FORMULATION DEVELOPMENT

Fluid Bed Granulation

Wurster Particle Coating

High Shear Granulation

Dry Blending

Dry Powder Filling (pouches and bottles)

Aqueous Film Coating

API direct filling

Capsule FillingPowders

Beads

Pellets

Liquids

Over EncapsulationTablets

Capsules

Tablet Compression

Solution and Suspension Processing


FORMULATION DEVELOPMENT

Pre-Formulation ServicesExcipient CompatibilityPackage CompatibilityAPI Physical CharacterizationAPI Chemical CharacterizationAccelerated Degradation Prototype EvaluationsReverse Engineering

Formulation DevelopmentClinical trial materialsComparator blinding studiesMatching placebo developmentDevelopment of controlled release productsDevelopment of solid oral dose forms, semisolid and liquid products


Manufacturing, Packaging & Labelling


CLINICAL MANUFACTURING

Clinical Manufacturing Capabilities

Wet or Dry Granulation and Blending

Tablet Compression and Coating

Global Comparator Procurement

Manufacture Clinical Supplies

Blending and Encapsulation

Encapsulation and Over-Encapsulation

Phase I-IV Development and Reformulations

Placebo Manufacturing

Comparator Blinding


CLINICAL MANUFACTURING

Dosage Forms TypesTabletsCapsules PowdersLiquidsSuspensionsSemisolids

Manufacturing CapabilitiesWet granulating and Dry BlendingTablet Compression and CoatingEncapsulationOver-EncapsulationPlacebo Manufacturing


CLINICAL PACKAGING

Primary and Secondary Packaging Capabilities

Bottling (Solids / Semi-Solids)

Blister Packaging – Any Configuration— Coldform & Thermoform

Blister Card Sealing and Walleting

Pouching / Powder Filling

Label Application and Kit Assembly

Controlled Substance Packaging (Schedule I – V)

Ambient, Controlled Temperature, Refrigerated & Frozen Packaging

Blinding of canisters/syringes/vials/ampoules

Tube Filling

— Creams— Ointments


OVER-ENCAPSULATION: SPEED & SCALE

MG PLANETAAutomated encapsulation and over encapsulation machine

Rate: Up to 50,000 capsules per hour

Capsule size: 000 to 5 (0, 00, DB-A, DB-AA)

Range: powder/pellets, tablets, capsules

Single/multiple dose capsules

100% verification of each capsule

Universal tablet feeder


CLINICAL LABEL DESIGN & PRINT

Clinical Label Design & Print

Single & Multi-Panel Labels & Booklets

Single & Multi-Lingual

Randomized & Open

Regulatory and Translation Services

Sequentially Numbered

Variable Text

In house auxiliary variable data printing for outsourced booklet labels

32 Languages Fully Supported

Code Break & Randomization Generation

Client-Supplied Randomization Fully Supported

Annex 13 compliant & 21 CFR Part 11 Compliant PRISYM Software for Label Design

Cold room labelling

2D Barcoding capabilities

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http://www.prisymid.com/


Comparator / Ancillary Supplies Sourcing


COMPARATOR SOURCING

Experienced comparator and rescue medication sourcing including:- Shelf-life management- Cost effective procurement- Country specific formulations

Approved vendors from local pharmacist to global sourcing located in EU, North America and SwitzerlandMHRA Wholesaler Distribution Licence


QP Services


QP SERVICES

SCS UK offers QP services in accordance with EU regulations that govern all IMP manufactured or imported by MIA IMP licence holders

SCS UK has three Qualified Persons (QP) with experience in the manufacture and supply of IMP

IMPD submissions; collation and review of all processes and documentation for regulatory approval

Audit of 3rd party manufacturing sites

QP declarations for use in submission of clinical trials application


QP SERVICES CAPABILITIES

Audit of manufacturing sites within and outside the EU

Batch release certification

Auditing of the manufacturer’s quality system

Document and certification review of the manufacturer’s authorization to manufacture investigational medicinal products or comparators for export

Regulatory requirements for marketing authorization, GMP standards and any official verification of GMP compliance

Physical examination of packaging


Project Management


PROJECT MANAGEMENT

Customized communication plan

Planning & kick-off meetings

Business review meetings

Proactive innovation

Transparent communication & responsiveness


PROJECT MANAGEMENT

Measuring Success— Overall Performance— On-time Production / shipmentsDedicated Project Management — Globally and Site Specific (Sharp Locations)— Cross functional teamsLessons Learned— Review of Goals Reached & Attempted — Review of Metrics in Reaching Goals - Performance— Evaluation of Communication


Global Logistics & Supply Chain Management


DISTRIBUTION CAPABILITIES

Shipment integration with internal and external IRT vendorsSharp Clinical Services SAP Portal Capabilities with ability to view:- Drug inventory/expiry updates- Shipment updates via Fed Ex, World Courier, UPS

Storage and Distribution direct from Sharp facilities and via GDP audited partiesControlled temperature shipments

(15 to 25°C, 2 to 8°C, -20°C, -70°C and -80°C)Shipment temperature monitoring and data retrieval of transit conditions


DISTRIBUTION

Regional and global distribution capabilities include:- Direct to sites- Direct to customers- Bulk dispatches to 3rd party depots- On demand labelling and release- IRT and manual shipment request- Courier strategies


GLOBAL FOOTPRINT: 30 Depots

AMERICAS:USAArgentinaBrazilChileColombiaMexicoPeru

ASIAPAC:AustraliaChinaIndiaHong KongJapanMalaysiaPhilippinesSingaporeSouth KoreaTaiwanThailandVietnam

EMEA:GeorgiaBelarusSerbiaTurkeyRussiaUkraineIsraelUKLebanonSouth Africa


GLOBAL LOGISTICS & SUPPLY CHAIN MANAGEMENT

Customized Logistics Solutions

Import / Export of Clinical Trial Material

Depot Management

Conditions Supported:

Ambient

Refrigerated (2-8˚C)

Frozen (-20˚C, -70˚C, -80˚C)

Global Distribution Management

Specialized Logistics Project Management

Controlled Substance Management


RETURNS & DESTRUCTION

Global retrieval of clinical site returns

Customer and Project Specific Returns and Reconciliation

Protocols

Dedicated returns storage area

Regulatory Compliance and Documentation Support

Updated and Complete Documentation on Destruction

Project close out


Interactive Response Technology(IRT)


IRT SERVICES

Sharp IRT Services Sharp IRT offers a more streamlined and successful means of managing your clinical supply chain.

Primary Benefits— 24 Hours a Day / 7 Days a

Week— Streamlined Setup and

Validation of New Studies — Accelerated Process for Moving

from Protocol to User Acceptance Testing (UAT)

— Extensive Experience and Guidance

— Utilizes Statistical Scheme— Balance at Any Level— Accommodates Stratifications

Access via Phone/Web— User Friendly and Easy to

Use— Data Entry Direct from

Source— Toll-Free Phone Lines— Secure Entry— Available 24/7— Multilingual


IRT CAPABILITIES

Customized IRT system programmingPatient enrollment and randomization

Patient diaries

Site administration and tracking

Secure web-enabled reports

Clinical supply management including

automated supply and re-supply, site and

depot inventories, individual kit status and

activation notification, and expiry

management

Real-time reporting and tracking via web

Outbound fax and emails

Technical support and training for staff and

investigators

Adaptive trials

Predictive inventory

Supports multilingual voice recordings in an

unlimited number of languages


IRT CAPABILITIES

Industry leading IRT ServicesWorld-class speed for setup and validation of new studies – less

than four weeks from User Requirement Specification (URS) approvals to User Acceptance Testing (UAT)

Minimizes Per-Patient Cost of TrialRapid Scale Out for New Sites, Dial-In Locations (Point of

Presence)Easy to Validate, Easy to Purchase, and Easy to ModifyEase of Access to Study MetricsExtremely FlexiblePrevents Drug WastagePrevents Patient Over-Enrollment


IRT FLOW

Sharp WarehouseSharp IRT

Shipment Generated Orders

Processed, Confirmed, &

Shipped

Global IRT System Servers

Delivery to Sites


Why Sharp Clinical Services?


SHARP – SEAMLESS SERVICES DELIVERY

• Sharp provides end-to-end clinical supply services ‘under one roof’• Our IRT system is fully integrated with our SAP system – offering complete end-to-end

inventory management

IRTProduction

Storage

Shipment requests automatically sent to SAP

Global Sites

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End-to-End IntegratedClinical Supply Services

Documents

Sharp Clincal Services Capabilities 26 JUN