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`CURRICULUM VITAE
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`Summary of expertise
`Extensive knowledge in the development, manufacturing and quality management of
`primary packaging systems especially for syringe systems made out of plastic and glass,
`including the regulatory requirements for raw materials and finished product.
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`Active Member of ISO TC 84 Devices for administration of medicinal products and
`catheters
`WG 3
`WG 11
`WG 13
`WG 15
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`and TC 76: Transfusion, infusion an injection, and blood processing equipment for
`medical and pharmaceutical use
`WG 2
`Rigid container system and related accessories for parenterals and
`injectables (Convenor: Horst Koller)
`Elastomeric parts and components and related secondary packaging
`Primary packaging systems for medicinal products
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`Needle based injection systems – Injectors, containers and pen needles
`Syringes
`On-body delivery devices
`Device Change Management
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`Horst Koller
`Weinbergweg 1; 8730 Uznach; (mobil) 079 931 4663
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`WG 4
`WG 6
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`Swiss Medic Delegate for EDQM WG16 (Pharm Eu. Chapter 3)
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`Regeneron Exhibit 1004.001
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`Horst Koller
`Weinbergweg 1; 8730 Uznach; (mobil) 079 931 4663
`_____________________________________________________________________________________
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`Since 03/2015
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`HK Packaging Consulting GmbH
`CEO
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`Extract List of current projects supported by HK Packaging Consulting
` Technical and regulatory support for Primary Packaging Manufacturers
`• Choice of Container Material and Components (vials & syringes)
`• Specification Settings
`• Compendial, Compliance Testing and E&L (Pharmacopeias / ISO)
`• Filing Support (DMF / CTD)
` Technical and Regulatory Support Pharma Companies
`• Design Review for submission documents
`• Specification Settings
`• Technical Support / Test Methods
`• Syringe Materials / Container Materials / Components Evaluation
`• Compendial and Compliance Testing (Pharmacopeias / ISO)
`• Design Verification / Design Validation
`• Submission Support
`• Risk Analyses
`• Manufacturing Process (Fill – Finish)
`• Syringe optimization for use in Autoinjectors / Devices
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`Job Expertise
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`03/2000 – 02/2015 Schott Pharmaceutical Packaging
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`2011 – 2015
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`Head of Technical and Quality Support Syringe Business
`St. Gallen Switzerland
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`2009 – 2011
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`Global Quality Manager Regulatory Affairs
`St. Gallen Switzerland
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`Regeneron Exhibit 1004.002
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`Horst Koller
`Weinbergweg 1; 8730 Uznach; (mobil) 079 931 4663
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`2007 – 2009
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`Manager Scientific Advisory
`St. Gallen Switzerland
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`2004 – 2007
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`Head of Scientific & Regulatory Advisory
`St. Gallen Switzerland
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`2001 – 2003
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`Manager R&D and Quality Management
`St. Gallen Switzerland
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`2000 – 2001
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`1994 – 1999
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`ABBOTT GmbH
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`1995 – 1999
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`Supervisor Engineering Processes
`Wiesbaden-Delkenheim, Germany
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`1994 – 1995
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`Research Technician
`Wiesbaden-Delkenheim, Germany
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`Schott Pharmaceutical Packaging
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`Head of Product Technology, New Products
`Mainz; Germany
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`Responsibilities; Tasks and Skills
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`2000 – 02/2015
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`- Support of the global syringe business unit regarding questions of technical product
`requirements, specification and life cycle management
`- Support of the global packaging development group for primary and secondary
`packaging systems in regards to technical, quality and regulatory requirements
`the
`- Supporting
`the stage gate process
`for new developments
`including
`industrialization phase and roll out of packaging systems to the manufacturing sites
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`Regeneron Exhibit 1004.003
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`Horst Koller
`Weinbergweg 1; 8730 Uznach; (mobil) 079 931 4663
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`- Participation in cross functional teams: R&D, manufacturing, product management,
`business development, customer quality etc.
`- Participation as Innovation Expert in the Innovation Management Team
`- Defining and performing scientific test programs for packaging systems especially
`for glass and polymer syringe systems including machine and packaging validation.
`- Coordination of test programs with external partners for i.e. extractables &
`leachables, material testing, label migration etc. as technical and regulatory advisor
`- Supporting the global business development team with customer education
`programs and customer visits
`- Supporting the global product management, marketing and sales group through
`technical lectures and product trainings
`- Gain knowledge of technical and regulatory trends for primary packaging materials
`- Project management for polymer syringes from idea to mass production in Europe
`and the US
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` Certification of SCHOTT Schweiz AG according to ISO 9001 and ISO 13485
`inclusive annex II and annex V (93/42/EEC) for the SCHOTT TopPac® Syringes
`- Drug Master File generation Type III (packaging); US and Canada
`- CTD support for ROW customers
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`ISO member as technical expert for TC 76 (Syringes) and TC 84 (Needles,
`Syringes, Needle Based Injection Systems (NIS), Device Change Managemment)
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`1999 – 1994
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`ABBOTT GmbH
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` Head of process engineering group
`- Maintenance, calibration of all equipment for manufacturing and R&D
`- Optimization of existing packaging lines for blister, fill & label
`- Validation of machines according to GMP guideline
`- Leading the cleaning & sterilization centre for glass equipment
`- Fermentation and purification of HIV / HCV antigens
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`Regeneron Exhibit 1004.004
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`Horst Koller
`Weinbergweg 1; 8730 Uznach; (mobil) 079 931 4663
`_____________________________________________________________________________________
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`Presentations at conferences
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`A3P
`Symposium 2001 Biarritz / France
` Protein performance depending on container surfaces
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`Concept Heidelberg / ECA
`Packaging
`2011 Mannheim / Germany
` Barriere Verpackung
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`2012 Berlin / Germany
` Barrier Packaging
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`2013 Mannheim / Germany
` Barrier Packaging
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`2014 Berlin / Germany
` Barrier Packaging
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`2015 Vienna / Austria
` Pharmaceutical Packaging Systems
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`2016 Hamburg / Germany
`• Delamination
`• Comination Products
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`2016 Mannheim/ Germany
`• Glass Packaging
`• Barrier Packaging
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`2017 Heidelberg / Germany
`• Delamination
`• Comination Products
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`2017 Mannheim / Germany
`• Glass Packaging
`• Development of Primary Packaging
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`Regeneron Exhibit 1004.005
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`Horst Koller
`Weinbergweg 1; 8730 Uznach; (mobil) 079 931 4663
`_____________________________________________________________________________________
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`Schott Pharmaceutical Packaging
`Symposium
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`2004 Mainz / Deutschland
` Opening up new possibilities with Schott TopPac® Containers
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`Customer Day
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`Customer Day
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`Customer Day
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`2006 St. Gallen / Switzerland
` Materials Extractables & Leachables
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`2007 Tokyo / Japan
` Current requirements of FDA / EMEA for the packing of parenterals
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`2008 Suzhou / China
` Current requirements of FDA / EMEA for the packing of parenterals
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`PDA
`E&L
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`Syringes
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`Syringes
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`Syringes
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`Syringes
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`Syringes
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`Packaging
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`Syringes
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`Syringes
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`2005 Paris / France
` Extractables & Leachables: Migration Study with Schott TopPac®
`Containers
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`2009 Berlin / Germany
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`Interest Group Prefillable Syringes: Extractables & Leachables
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`2009 Venice / Italy
` Universe of Pre-fillable Syringes: SCHOTT TopPac® WFI Syringes
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`2011 Basel / Switzerland
` Universe of Pre-fillable Syringes: SCHOTT TopPac® SD Syringes
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`2012 Las Vegas / USA
` Universe of Pre-fillable Syringes: State of the art siliconisation for syringes
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`2013 Basel / Switzerland
` Universe of Pre-fillable Syringes: Workshop for Syringes
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`2014 Istanbul / Turkey
` Parenterals Manufacturing: Workshop Packaging
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`2014 Huntington Beach / USA
` Universe of Pre-fillable Syringes: Poster on X-Ray Irradiation on TopPac®
`Syringes
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`2015 Vienna / Austria
` Universe of Pre-fillable Syringes: Workshop on Test Methods for PFS and
`Development and Manufacturing of PFS
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`Regeneron Exhibit 1004.006
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`Horst Koller
`Weinbergweg 1; 8730 Uznach; (mobil) 079 931 4663
`_____________________________________________________________________________________
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`2016 Berlin / Germany
` Annual Meeting : Workshop on Test Methods for PFS and Development
`and Manufacturing of PFS
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`Syringes
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`Syringes
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`2017 Vienna / Austria
` Universe of Pre-fillable Syringes: Workshop on Combination Products and
`Development and Manufacturing of PFS
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`Intertec-Pira
`E&L
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`2007 Berlin/ Deutschland
` Extractables & Leachables: Case Study I with COC Containers
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`E&L
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`E&L
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`2007 Washington/ USA
` Extractables & Leachables: Case Study I with COC Containers
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`2008 Bethesda/ USA
` Extractables & Leachables: Case Study II with COC Containers
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`Rapra
`E&L
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`2009 Barcelona / Spain
` Extractables & Leachables: Case Study II with COC Containers
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`Management Forum
`Syringes
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`2007 London / UK
` Design and Functionality of Syringe Systems
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`London / UK
`2015/2017
` Packaging of Syringe Systems
` Design Verification Testing on Syringes/Devices
` Regulatory Requirements
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`Syringes
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`SMI
`Syringes
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`2008 - 2016 London / UK
` Master Class on Design and Functionality of Syringe Systems
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`Health Canada
`Syringes
`2008 Ottawa / Canada
` Design and Functionality of Syringe Systems
` Extractables & Leachables
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`Regeneron Exhibit 1004.007
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`Horst Koller
`Weinbergweg 1; 8730 Uznach; (mobil) 079 931 4663
`_____________________________________________________________________________________
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`SRRT
`Cleanroom
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`2009 Nidau/ Switzerland
` Qualification of cleanrooms (Medical Device Manufacturer)
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`Apprentice and Study
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`1988 – 1993 University of Applied Sciences Mannheim Dipl.-Ing. (FH) Biotechnology
`Mannheim / Germany
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`1985 – 1987 Work experience as medicinal technical assistant (MTA) at the Städtischen Klinik
`Darmstadt /Germany
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`1984 – 1985 Military Service
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`1981 – 1983 Apprenticeship as medicinal technical assistant (MTA) at the private Lehranstalt
`Eckert
`Regensburg / Germany
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`1971 – 1981 School: grade Mittlere Reife
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`Furth im Wald / Germany
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`Languages
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`German
`English
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`native
`fluent business English in oral and written
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`Hobbies
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`01 January 2018
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`Guitar playing, travel, motorbike
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`Regeneron Exhibit 1004.008
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