Top-Ranked Speaker Faculty Includes...

Event’s Highlights Include:

• An Ipsen case study in the sources and types of E&L and regulatoryguidance on interaction safety profiles

• Merck case study on a prefilled diluents syringe • Genentech focus on next generation PFS - high concentration mAbformulations and other biologics revealing design details on benchtop syringe filling units

• Novel uses for PFS - Point of care device case study showing usage inOvarian Cancer diagnostics

• Important regulatory updates - FDA regulations on device controlsand new cGMP rules for combination products

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 29th January 2014, Marriott Regents Park London, UK

Leachables and ExtractablesHosted by: Andrew Fieldon, Senior Consultant, Smithers Rapra

8.30am - 12.30pm

Large Volume Injectors – Technologies, Strategiesand Guidance

Hosted by: Stephen Augustyn Head of Mechanical Engineering, Team Consulting

1.30pm - 5.30pm

• Advait Badkar, Associate Research Fellow, Technolgy Lead,Pfizer

• Jason Creasy, Head of Extractables & Leachables Team,GlaxoSmithKline

• Bobbijo Redler, Principal Scientist, Merck & Co. • Joel Richards,Director, Ipsen• Christian Siegmund, Head of Prefilled Syringes and Liquid Vials,

Hoffmann La Roche Ltd • Yuh-Fun Maa, Principal Engineer, Genentech • Robert Schnepf, Molecule Leader, MPD CoE, Merck & Co. • Joan Malstrøm, Specalist, Novo Nordisk A/S

“The meeting improves each year and should become a fixed dateon the calendar for anyone interested in Pre-Filled Syringes.”Senior Director, Pharma Representative

SMi presents Europe’s Leading Event with 6 Years of Excellence 27th - 28th

JAN2014Marriott Regents Park Hotel, London, UK

Future applications for safer drug delivery

Pre-Filled Syringes

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www.pre-filled-syringes.comRegister online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

ACADEMIC & GROUPS DISCOUNTS AVAILABLE

SPECIAL £999 FOR FIRST 25 PHARMA COMPANIES

Register online at: www.pre-filled-syringes.com • Alternatively fax

Pre-Filled SyringesDay One | Monday 27 January 2014 www.pre-filled

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksAdvait Badkar, Group Leader - Senior Principal Scientist, Pfizer

PRE-FILLED PATIENT SAFETY AND QUALITY BY DESIGN

9.10 Quality by design in the manufacture of pre-filled syringes• PFS and quality by design assessment • Component preparation focus – PFS manufacturing • Operations and risk assessment review• Design and implementation for understanding parameters in PFS

Advait Badkar, Associate Research Fellow, Technolgy Lead, Pfizer

9.50 Merck case study – Introduction of a prefilled diluents syringe for preparation of a complex product • Common and uncommon technical challenges• End user voices are key to develop the right product• Case studyRobert Schnepf, Molecule Leader, MPD CoE, Merck & Co.

10.30 Panel Discussion – Specific considerations for PFS development •Start up of increased speed filling lines•FDA regulations on PFS controls •Operations and risk assessment •Case studyAdvait Badkar, Group Leader - Senior Principal Scientist, PfizerAdam Woolley, CEO, ForthTox

11.10 Morning Coffee

11.40 Improve medication safety in Hospital Care environment with Polymer Prefillable Syringes in combination with syringe pumps• Design requirements for COC prefillable syringe to be used incombination with syringe pumps

• Infusion performance due to pump specific system design• Project challenges and the solutions found within the FreseniusKabi AG and SCHOTT AG partnership

• Latest developments on polymer PFS• Recent roadblocks • Case studyAnil-Kumar Busimi, Head of Global Product ManagementSyringe Business, SchottAndreas Kerschbaumer, Manager, Fresenius Kabi

CONTAINER INTEGRITY AND SAFETY CONSIDERATIONS WITH LEACHABLES

12.20 Leachables and safety considerations in Pre-filled syringes and cartridges: Impact on drug product quality and safety profile for biologics• Sources and types of E&L in PFS and cartridges• Interactions of drug product with primary packaging andprocessing equipment

• Regulatory guidance• Case study: Impact on product quality and safety profile• Interaction on safety profileJoël Richard, Vice President Peptides, Ipsen

1.00 Networking Lunch

2.00 Toxicological evaluation of extractables and leachables with

reference to ICH M7

• The regulatory context of evaluation

• Endpoints of interest – especially genotoxicity

• Techniques for evaluation

• Interpretation of the results and risk assessment including

thresholds of concern

Adam Woolley, CEO and

David Woolley, Consultant, ForthTox

2.40 Session reserved for BD

Nicolas Morais, Product Manager, Europe, Prefillable Syringes,

BD Medical

3.20 Afternoon Tea

4.00 Techniques & processes for assessing the risk posed from

leachables in pre-filled syringes

• Appropriate risk assessment process for studying potential

leachables

• Consideration of all potential sources of leachables including

manufacturing systems and container closure

• Choosing the correct analytical methods for study

• GSK case study

Jason Creasy, Head of Extractables & Leachables Team,

GlaxoSmithKline

4.40 Development of HCLF Biologics in Pre-Filled Syringes

• Challenges for the development of HCLF biologics from

downstream to drug product

• Interactions with primary packaging

• Stability issues during manufacturing

• Medical application and considerations

Patrick Garidel, Associate Director Protein Science,

Boehringer Ingelheim

5.20 Ovarian cancer diagnostics – A novel point of care device using

Pre-filled syringes in the operating room

• Current status in Ovarian Cancer diagnostics

• Tumour marker discovery in ovarian cyst fluid

• Development of a point of care device using pre-filled

syringes to diagnose ovarian cancer in the operating room

• Case study

Khalil Razvi, Consultant, Southend NHS Trust

6.00 Chairman's Closing Remarks and Close of Day One

Who should attend?The Heads, VPs, Team Leaders, Consultants and Scientists involved in:

• Pre-Filled Syringes• Drug Safety• Medical Devices• Drug Delivery Systems

• Packaging & Labelling• R&D• Extractables & Leachables• Drug Formulation

• Clinical Trials• Bioprocessing• Sterile Manufacturing • Quality Assurance

Want to know how you can get involved?Interested in promoting your services to this market?

Contact Julia Rotar, SMi Marketing on +44 (0) 207 827 6088, or email: jrotar@smi-online.co.uk

your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Day Two | Tuesday 28 January 2014 d-syringes.com

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksJason Creasy, Head of Extractables & Leachables Team,GlaxoSmithKline

THE NEXT GENERATION OF PRE-FILLED SYRINGES

9.10 PFS filling of high-concentration mAb formulations – Parameter investigation and optimasation using small-scale filler• Technical details of of syringe filling are rarely published –particularly high concentration/ viscosity formulation

• Reveal design details of a bench top syringe filling unit• Identification and optimisation of critical process parameters• Apply leaning to practical filling operations• Case studyYuh-Fun Maa, Principal Engineer, Genentech

9.50 Understanding the risks and impact of offering both a prefilled syringes and a vial/stopper image• Drivers for offering both images• Considerations for materials selection• Impact to E&L study design when offering both imagesBobbijo Redler, Principal Scientist, Merck & Co.

10.30 Incorporating human factors and patient centric design into a novel safety device• Today, Injectable drugs in prefilled syringes require injectiondevices - how to choose the right one

• A clinically proven safety device has been adapted for theself-administration market

• Manual Injection control vs. automated injection supportAlexander Jaksch, Director, Marketing & CommercialDevelopment, Safety, BD Medical

11.10 Morning Coffee

11.30 Introduction to Medical Grade Cyclo Olefin Polymers (COP) for Pre-Filled Syringes• Key properties and features of COP - ZEONEX/ZEONOR• Protein Adsorption study with BSA, Insulin• Optical and Mechanical properties after exposure to gamma,steam, EOG and cryogenic temperature

• Moisture/gas barrier data• Residual metal and outgas dataReinhard Scheller, Commercial Manager Cyclo Olefin Polymers - COP, Zeon Europe GmbH

12.10 Silicone oil in prefilled syringes determined by NMR spectroscopy • Comparison of NMR data with MFI• Quantitative aspect of 1H-NMR spectroscopy• Method for determination and quantitation of Si-oilJoan Malmstrøm, Specialist Peptide Characterisation, Diabetes,Novo Nordisk A/S

12.50 Networking Lunch

1.50 Next Generation of Plungers for Prefilled Syringes – the Ideal Combination for Self-Injection Devices• Newly designed syringe components are increasinglyimportant in auto injectors

• Newly developed plunger design developed under QbDaspects

• Explination of developments of technologies into the design• Results presented on in-house functional performance of newplunger

Christina Janssen-Otten, TCS Manager Europe,West Pharmaceutical Services

PRE-FILLED UPDATES AND MANUFACTURING TRENDS IN PRE-FILLED SYRINGES

2.30 Implementation and start up of a pre-filled syringe isolator filling machine• Challenges during start up• Minimization of scratches• Integrated AIM (automated inspection machine)Christian Siegmund, Head of Prefilled Syringes and Liquid Vials,Hoffmann La Roche Ltd

3.10 Next generation Pre-filled Syringes• Advantages of pre-filled syringe presentations• Challenges developing pre-filled syringe presentations• Cross-linked silicone coating technology• Glass strengthening technologyRoja Narwal, Scientist I,MedImmune

3.50 Afternoon Tea

4.30 Regulatory perspective and case studies• Recent regulatory developments; • Interpretation of analytical results; • Useability and patient factors; • Regulatory case studiesBrij Patel, CEO, RegExcel Consulting Ltd

5.10 Panel Discussion – Extended Q&A • Potential problems with leachables as they stand• Opportunities for speakers to further clarify presentations• Potential road blocks’• Case studyJason Creasy, Head of Extractables & Leachables Team,GlaxoSmithKlineBobbijo Redler, Principal Scientist, Merck & Co.

5.50 Chairman’s Closing Remarks and Close of Day Two

POST-CONFERENCE WORKSHOP A9.00am - 12.30pm I Wednesday 29th January 2014 I Marriott Regents Park, London, UK

Leachables and ExtractablesHosted by: Andrew Fieldon, Senior Consultant, Smithers Rapra

Overview of workshop:It is becoming increasingly clear that for many research applications thatThree Dimensional (3D) cell culture and cell based assay approaches offerhuge advantages over the more conventional 2D cell culture and assaymodels. This workshop will provide an overview of the very latest 3D cell basedassay and culture technologies and techniques for use in biomedicalresearch and drug discovery and the key application areas for thesetechnologies with a focus on HTS and HCS. • To gain an insight into the issues surrounding this new area of research• The opportunity of discussing issues and ideas and sharing experienceswith other scientists

• Networking opportunities with peer scientists working in the same area

Key learning include:• Analyse current regulatory guidance and strategy management• Share insight with experienced specialists in the fields of leachables • and extractables• Learn about relevant cases studies in analysis and selection• Develop solutions to challenges in the field

About your wokshop leader:Dr Andrew Feilden joined Smithers Rapra as a principal consultant in June2011. He is specialising in extractable and leachable testing and the selectionand assessment of materials for medical and pharmaceutical applications.For the previous 12 years he was at AstraZeneca, leading their extractableand leachable testing. He has been working in the field of trace analysis usinghyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilstat AstraZeneca he was an active member of industry working groups, theIPAC-RS container closure group and he was the co-chair of ELSIE materialgroup. Andrew gained a degree and D.Phil from York University.

About Smithers RapraSmithers Rapra, part of the Smithers Group of companies, has beenrecognized as a world leading rubber and plastics consultancydelivering a comprehensive and strictly independent service sinceits establishment over 90 years ago. These services have beentailored to support the medical device and pharmaceuticalindustries where polymers are widely used. Much of our work for thissector is in the field of Extractables and Leachables testing for drugdelivery devices, immediate packaging and bioprocessequipment, however we are also able to support the developmentof medical and drug delivery devices and, where required,comprehensive failure diagnosis.

Programme

8.30 Registration and coffee

9.00 Welcome and introductions to E&L• What exactly are they?• The guidance available currently

9:20 Material Selection• What are the effects of differing materials• Analysis

10:10 E&L analysis including novel case stud

11:00 Morning tea

11:20 Testing on E&L• The current limits to testing• Methods of testing

12:30 Conclusions and close of workshop

POST-CONFERENCE WORKSHOP B1.30pm - 5.30pm I Wednesday 29th January 2014 I Marriott Regents Park, London, UK

Large Volume Injectors – Technologies, Strategies and GuidanceHosted by: Stephen Augustyn, Head of Mechanical Engineering, Team Consulting

Overview of workshop:Chronic conditions and the rise of biological drugs with large volumepayloads are driving pharmaceutical companies and devicemanufacturers to develop Large Volume Injectors (LVI). This workshopwill examine the pressures driving the creation of LVIs, the advantagesthey offer over traditional parenteral delivery systems and someguidance to help companies select or develop a device for their ownapplication.

Key learning include:• To understand what makes LVIs different from current parenteralsystems

• To gain an overview of the devices currently being presented fromdifferent device and pharmaceutical companies

• To better understand the standards that will affect LVIs• For insight into the technical and user challenges associated withthese products

About your wokshop leader:Stephen is responsible for the delivery of Team’s capability in deviceengineering and has over twelve years’ experience in medicaldevices. Since joining Team Consulting five years ago, Stephen hasbeen responsible for the management and delivery of a wide varietyof medical and surgical products. In addition to his work at Team,Stephen is a member of the TC84 ISO committee responsible fordefining new standards for injection devices.

About Team Consulting LtdTeam Consulting work globally for companies in the life scienceindustries, and we're acknowledged experts in medical and drugdelivery device development. To date, Team has helped clients todevelop over 20 injection devices and has worked for many of theworld’s leading pharma and device firms, including six of the 10largest pharmaceutical companies.

Programme1.30 Registration and coffee1.45 Welcome and Introductions 2.00 Context and Background

• Pressures driving creation of LVIs• Advantages over current parenteral systems

2.20 Market Overview• Examination of some of the leading productsin the public domain

• Predicate devices 3.30 Coffee and networking Break3.50 Technical and Human Factors

• Primary containers• Manufacturing• Human Factors and Industrial Design

4.40 Guidance and Predicate devices• Key performance markers• Appropriate standards• Defining or choosing your device

5.10 Summary and Questions5.30 Close of workshop

In asscociation with

In asscociation with

BD Medical Pharmaceutical Systems is a worldwide leader in supplying thepharmaceutical industry with quality drug delivery systems and safety-engineered devices. Our cutting-edge delivery systems are customizable tomeet patient needs, are market tested and are manufactured to meet thehigh quality standards that our customers expect. BD Medical -Pharmaceutical Systems provides a comprehensive range of prefillableinjection systems using clinically proven products that help deliver enhanceddrug or end-user benefits and results, and access to information anddistribution networks worldwide. For years we have also been one of the mostactive promoters of healthcare worker safety. www.bd.com

SCHOTT Pharmaceutical Systems is one of the world’s leading suppliers of glasstubing and primary packaging for the pharmaceutical industry. We provideour customers quality solutions while meeting their highest demands with ourmaterial expertise, specialized analytical lab services, and a broad productportfolio; including syringes, cartridges, vials, and ampoules made of glass andCOC polymer. With our extensive production network of glass tubing andpharmaceutical packaging, we offer safe supply and local service. Our state-of-the-art production facilities and our products comply with the highestinternational quality standards for pharmaceutical needs.www.schott.com/pharmaceutical_systems

West works side-by-side with its healthcare partners from concept to thepatient, designing and manufacturing packaging, diagnostic and deliverysystems that promote the efficiency, reliability and safety of their products.Every day, West is leading the way with cutting-edge technologies and qualitysystems, a thorough understanding of global regulatory compliance, and anunmatched and growing knowledge base of relevant pharmaceuticalproduct testing, development and packaging. Based in Exton, Pa., Westsupports its customers from sales, manufacturing, customer service andresearch and development facilities in North and South America, Europe, Asiaand Australia. www.westpharma.com

Zeon Europe GmbH is the European marketing/sales organisation of ZEONCORPORATION, Japan. Based on unique C4 and C5 extraction technologiesZeon developed an integrated production system and is striving to create newproducts and business areas by utilizing these core technologies. As part ofspecialty materials business Zeon produces Cyclo-Olefin Polymers (COP) underthe tradenames ZEONEX® and ZEONOR®. www.zeon.eu www.zeonex.com

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PRE-FILLED SYRINGES 2014Conference: Monday 27th & Tuesday 28th January 2014, Marriott Regents Park Hotel, London, UK Workshop: Wednesday 29th January 2014, London

4 WAYS TO REGISTERONLINE www.pre-filled-syringes.com