Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`CURRICULUM VITAE
`
`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.
`
`Active Member of ISO TC 84 Devices for administration of medicinal products and
`catheters
`WG3
`WG 11
`WG 13
`WG 15
`
`Needle based injection systems - Injectors, containers and pen needles
`Syringes
`On-body delivery devices
`Device Change Management
`
`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
`
`WG4
`WG6
`
`Swiss Medic Delegate for EDOM WG16 (Pharm Eu. Chapter 3. Plastics)
`
`PDA James P. Agalloco Award for Excellence in Education; March 2019
`
`Regeneron Exhibit 1004.001
`
`
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`CURRICULUM VITAE
`
`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.
`
`Active Member of ISO TC 84 Devices for administration of medicinal products and
`catheters
`WG3
`WG 11
`WG 13
`WG 15
`
`Needle based injection systems - Injectors, containers and pen needles
`Syringes
`On-body delivery devices
`Device Change Management
`
`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
`
`WG4
`WG6
`
`Swiss Medic Delegate for EDOM WG16 (Pharm Eu. Chapter 3. Plastics)
`
`PDA James P. Agalloco Award for Excellence in Education; March 2019
`
`Regeneron Exhibit 1004.001
`
`
`
`Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`Since 03/2015
`
`HK Packaging Consulting GmbH
`
`CEO
`
`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 / Market Needs & Trends
`
`• Compendia! & Compliance Testing (Pharmacopeias / ISO)
`
`• Extractables and Leachables Study Proposals
`
`• Manufacturing Environment Support (Cleanrooms)
`
`• Certification Support for ISO 15378 / ISO 13485
`
`• Filing Support (DMF / CTD)
`
`• Customized lnhouse Trainings
`
`► Technical and Regulatory Support Pharma Companies
`
`• Design Review for submission documents on Combination Prdocuts
`
`• Specification Settings PFS Systems
`
`• Technical Support/ Test Methods PFS /Vials/ Cartridges
`
`• Siliconization Optimization for Cartridges/ PFS Systems
`
`• Syringe Materials/ Container Materials/ Components Evaluation
`
`• Compendia! and Compliance Testing (Pharmacopoeias/ ISO)
`
`• Design Verification / Design Validation
`
`• Submission Support
`
`• Risk Analyses
`
`• Manufacturing Process (Fill - Finish)
`
`• Syringe optimization for use in Autoinjectors / Devices
`
`• Customized lnhouse Trainings
`
`Regeneron Exhibit 1004.002
`
`
`
`Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`Job Expertise
`
`0312000 - 0212015 Schott Pharmaceutical Packaging
`
`2011 -2015
`
`Head of Technical and Quality Support Syringe Business
`St. Gallen Switzerland
`
`2009 - 2011
`
`Global Quality Manager Regulatory Affairs
`St. Gallen Switzerland
`
`2007 -2009
`
`Manager Scientific Advisory
`St. Gallen Switzerland
`
`2004 -2007
`
`Head of Scientific & Regulatory Advisory
`St. Gallen Switzerland
`
`2001 -2003
`
`Manager R&D and Quality Management
`St. Gallen Switzerland
`
`2000 -2001
`
`Head of Product Technology, New Products
`Mainz; Germany
`
`1994 -1999
`
`ABBOTT GmbH
`
`1995 -1999
`
`Supervisor Engineering Processes
`Wiesbaden-Delkenheim, Germany
`
`1994 -1995
`
`Research Technician
`Wiesbaden-Delkenheim, Germany
`
`Responsibilities: Tasks and Skills
`
`Regeneron Exhibit 1004.003
`
`
`
`Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`2000 - 02/2015
`
`Schott Pharmaceutical Packaging
`
`- 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
`including
`for new developments
`the stage gate process
`- Supporting
`industrialization phase and roll out of packaging systems to the manufacturing sites
`
`- 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
`
`- 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 Ill (packaging); US and Canada
`
`- CTD support for ROW customers
`
`-
`
`ISO member as technical expert for TC 76 (Syringes) and TC 84 (Needles,
`Syringes, Needle Based Injection Systems (NIS), Device Change Managemment)
`
`Regeneron Exhibit 1004.004
`
`
`
`Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`1999-1994
`
`ABBOTTGmbH
`
`- 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
`
`Presentations at conferences
`
`A3P
`Symposium
`
`2001 Biarritz / France
`■ Protein performance depending on container surfaces
`
`Concept Heidelberg/ ECA
`Packaging
`2011 Mannheim / Germany
`■ Barriere Verpackung
`
`2012 Berlin/ Germany
`■ Barrier Packaging
`
`2013 Mannheim/ Germany
`■ Barrier Packaging
`
`2014 Berlin/ Germany
`■ Barrier Packaging
`
`2015 Vienna/ Austria
`■ Pharmaceutical Packaging Systems
`
`2016 Hamburg/ Germany
`• Delamination
`• Combination Products
`
`2016 Mannheim/ Germany
`• Glass Packaging
`• Barrier Packaging
`
`2017 Heidelberg/ Germany
`
`Regeneron Exhibit 1004.005
`
`
`
`Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`• Delamination
`• Combination Products
`
`2017 Mannheim/ Germany
`• Glass Packaging
`• Development of Primary Packaging
`
`2018 - 2019 ContinuousTraining Programs
`• Development of Primary Packaging
`• Delamination
`• Trends in Primary Packaging
`• Combination Products
`Schott Pharmaceutical Packaging
`Symposium
`2004 Mainz/ Deutschland
`■ Opening up new possibilities with Schott TopPac® Containers
`
`Customer Day
`
`2006 St. Gallen / Switzerland
`■ Materials Extractables & Leachables
`
`Customer Day
`
`2007 Tokyo I Japan
`■ Current requirements of FDA / EM EA for the packing of parenterals
`
`Customer Day
`
`2008 Suzhou / China
`■ Current requirements of FDA / EM EA for the packing of parenterals
`
`PDA
`E&L
`
`2005 Paris / France
`■ Extractables & Leachables: Migration Study with Schott TopPac®
`Containers
`
`Syringes
`
`2009 Berlin/ Germany
`Interest Group Prefillable Syringes: Extractables & Leachables
`■
`
`Syringes
`
`2009 Venice / Italy
`■ Universe of Pre-fillable Syringes: SCHOTT TopPac® WFI Syringes
`
`Syringes
`
`2011 Basel/ Switzerland
`■ Universe of Pre-fillable Syringes: SCHOTT TopPac® SD Syringes
`
`Syringes
`
`2012 Las Vegas/ USA
`■ Universe of Pre-fillable Syringes: State of the art siliconisation for syringes
`
`Syringes
`
`2013 Basel/ Switzerland
`
`Regeneron Exhibit 1004.006
`
`
`
`Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`■ Universe of Pre-fillable Syringes: Workshop for Syringes
`
`Packaging
`
`Istanbul/ Turkey
`2014
`■ Parenterals Manufacturing: Workshop Packaging
`
`Syringes
`
`Syringes
`
`Syringes
`
`Syringes
`
`Syringes
`
`2014 Huntington Beach/ USA
`■ Universe of Pre-fillable Syringes: Poster on X-Ray Irradiation on TopPac®
`Syringes
`
`2015 Vienna/ Austria
`■ Universe of Pre-fillable Syringes: Workshop on Test Methods for PFS and
`Development and Manufacturing of PFS
`
`2016 Berlin/ Germany
`■ Annual Meeting: Workshop on Test Methods for PFS and Development
`and Manufacturing of PFS
`
`2017 Vienna/ Austria
`■ Universe of Pre-fillable Syringes: Workshop on Combination Products and
`Development and Manufacturing of PFS
`
`2018 -19 PDA conferences "Parenteral Packaging" and "Universe of Prefilled
`Syringes
`Continuous education program on Test Methods for PFS
`
`lntertec-Pira
`E&L
`2007 Berlin/ Deutschland
`■ Extractables & Leachables: Case Study I with COC Containers
`
`E&L
`
`E&L
`
`Rapra
`E&L
`
`2007 Washington/ USA
`■ Extractables & Leachables: Case Study I with COC Containers
`
`2008 Bethesda/ USA
`■ Extractables & Leachables: Case Study II with COC Containers
`
`2009 Barcelona / Spain
`■ Extractables & Leachables: Case Study II with COC Containers
`
`Management Forum
`Syringes
`2007 London/ UK
`■ Design and Functionality of Syringe Systems
`
`Regeneron Exhibit 1004.007
`
`
`
`Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`Syringes
`
`SMI
`Syringes
`
`London/ UK
`2015/2017
`■ Packaging of Syringe Systems
`■ Design Verification Testing on Syringes/Devices
`■ Regulatory Requirements
`
`2008 - 2016 London/ UK
`■ Master Class on Design and Functionality of Syringe Systems
`
`Syringes
`
`2019 London/ UK
`■ Workshop on Test methods for PFS
`
`Health Canada
`Syringes
`2008 Ottawa / Canada
`■ Design and Functionality of Syringe Systems
`■ Extractables & Leachables
`
`SRRT
`Cleanroom
`
`2009 Nidau/ Switzerland
`■ Qualification of cleanrooms (Medical Device Manufacturer)
`
`Apprentice and Study
`
`1988 - 1993 University of Applied Sciences Mannheim Dipl.-lng. (FH) Biotechnology
`Mannheim / Germany
`
`1985 - 1987 Work experience as medicinal technical assistant (MTA) at the Stadtischen Klinik
`Darmstadt /Germany
`
`1984 - 1985 Military Service
`
`1981 - 1983 Apprenticeship as medicinal technical assistant (MTA) at the private Lehranstalt
`Eckert
`Regensburg / Germany
`
`1971 - 1981 School: grade Mittlere Reife
`Furth im Wald / Germany
`
`Languages
`
`Regeneron Exhibit 1004.008
`
`
`
`Horst Koller
`Weinbergweg 1; 8730 Uznach; ~ (mobil) 079 9314663
`
`German
`English
`
`native
`fluent business English in oral and written
`
`Hobbies
`
`Guitar, travel, motorbike
`
`01 January 2020
`1forst '](offer
`
`Regeneron Exhibit 1004.009
`
`
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