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  1. Pre-Filled Syringes and Related Systems: World Market Outlook 2010-2025

    Pre-Filled Syringes and Related Systems: World Market Outlook 2010-2025

    The market for pre-filled syringes has achieved growth in recent years. In 2009, an estimated 2 billion pre-filled syringe units were sold and the market for that technology was estimated to be worth up to $2.5 billion. There is a trend towards pre-filled drug injection systems, away from vials/ampules, for both new and existing products. Examples are filled glass and plastic syringes, pens and low-volume auto-injection devices, including refills. That sector has shown growth of 10-15% in recent years, forming one of the fastest-expanding sectors in the pharmaceutical industry. In our new report, we predict that the pre-filled drug delivery market will grow steadily from 2010, as the number of products launched in pre-filled injectable forms increases.

    ...more details

CONFERENCE

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3rd Pre-filled Syringes

3rd Pre-filled Syringes

Innovative solutions for injection devices and parenteral packaging systems

25th - 27th October 2010, BSG Conference Centre, London, UK

  1. Background Info
  2. Workshop
  3. Day 1
  4. Day 2
  5. Partners
  6. Past Papers
  7. Venue Info
  8. Speakers
Associate Sponsors
  • Nuova Ompi
  • BAUSCH + STROEBEL
Media Partners
  • PharmiWeb.com
  • BIOTECHNOLOGY EUROPE
  • Future Pharmaceuticals
  • InPharm
  • Pharma Connections Worldwide

Background Info

Key Speakers
• Todd Stephens, Global Marketing Director, Merck Serono
• Stefan Sundström, Director, Sterile Aseptic Manufacturing, Engineering and Maintenance, Technical Lead Sterile Process Systems, AstraZeneca
• Lars Kreye, Associate Director, Boehringer Ingelheim Pharma
• Ian Thompson, Director of Business Development, Ypsomed
• Klaus Ullherr, Product Manager, Packaging Technology, Robert Bosch Packaging
• Jim Spolyar, Sales and Technical Director, Skan US
• Gabriele Peron, Marketing Manager, Stevanato Group - Glass Division
• Thomas Zelmer, Director, Groninger
• Sterling Kline, Director of Project Development , Integrated Project Services
• Shawn Kinney, Chief Executive Officer, Hyaluron
• Elliot Lawrence, Associate Director of Regulatory Affairs, ERA Consulting
• Daniel Wheeler, Lecturer in Anaesthesia, University of Cambridge

With more injectable biological drugs in use than ever, the pre-filled syringes market will sustain its inexorable growth, with total revenues of $6bn by 20251.

Pre-filled syringe and autoinjection devices remain the primary methods for parenteral drug delivery, from oncology to autoimmune diseases. Soaring annual growth rates topping 10% will continue as stakeholders move towards the greater accuracy, safety and convenience afforded by pre-filled devices. However, challenges and threats continue to bedevil manufacturers, including including siliconisation, stability and bioavailability issues.

Visiongain is proud to present its 3rd Pre-filled Syringes conference, with keynote presentations from the market’s main players. Case studies and interactive discussions will address new developments in manufacturing, quality control, regulation, inspection, and use. Act now to register your participation amongst the industry's finest for three intensive days of learning, networking and business opportunities.

Whether your interests lie in drug formulation, process engineering or strategic partnering, attending this conference will enable you to:
• Overcome challenges arising from silicon-drug solution interaction
• Troubleshoot heavy-metal induced drug precipitation and microbiological contamination
• Improve dosing accuracy and enhance patient compliance with next-generation electronic devices 
• Learn about novel pre-filled syringes for biotech products and auto injector devices
• Understand pre-filled syringe processing with RABS, Isolators, E-beam & Alternatives
• Examine factors and recent developments in processing syringe nests
• Analyse new developments in COC, COP, glass, and elastometric components
• Offset the impact of extractables and leachables on product performance
• Assess the impact of new post-market surveillance regulations on pre-filled medical devices 
• Develop new strategies to remain competitive
• Obtain the latest market analysis, and meet manufacturers showcasing their leading products

Who should attend:

Presidents, Chief Executives, Chief Scientific Officers, Chief Operating Officers, Vice Presidents, Heads, Directors, Clinicians, Principal Scientists, Managers, Project/Team Leaders in:
• Packaging and Labelling
• Vaccine, Antibody and Protein Manufacturing
• Product design
• Technical support
• Drug product process development
• Drug device process development
• Pharmaceutical sciences
• Safe medication practice
• Drug discovery & delivery
• Clinical product resourcing
• Supply outsourcing
• Contract manufacturing and management 
• Process development
• Strategic alliances
• Investment and venture capital

1Visiongain, (2010). Pre-Filled Syringes and Related Systems: World Market Outlook 2010-2025. Pp. 44-80. 

Workshop

Pre-conference Workshop, Monday 25th October, 2010

Legal updates concerning pre-filled syringes

Led by: Alexander Denoon, Partner, Lawford Davies Denoon, London
Erik Vollebregt, Of Counsel, Greenberg Traurig LLP, Amsterdam
Mathias Klümper, Partner, Lützeler und Partner, Rechtsanwälte, Düsseldorf 

Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 17:00 Workshop
Timing includes lunch and refreshment breaks

The purpose of the workshop is to allow you to engage in knowledge sharing with your peers in a smaller, less formal environment than the main conference. As such, the audience size will typically be no more than 20 participants in order to enable maximum interaction between the workshop leader and the delegates. The format is also more interactive, with less emphasis on ‘lecture-style’ presentations and more emphasis on group discussions, exercises and Q&A sessions.

The session will overview the legal and regulatory issues applicable to pre-filled syringes and some of the more pressing or challenges concerns regarding their sale and use. These will include:
• Product liability
• Reuse
• Control of supply and distribution chains (including parallel imports, pharmacovigilance and post marketing surveillance)
• A regulatory overview

About your workshop leaders

Alexander Denoon
Alex has both a science degree (human genetics) and a law degree. He qualified as a solicitor (in Australia) in 1995. Alex spent more than five years in- house, including as general counsel and company secretary of Biotech Australia.

Alex advises clients in relation to the development of strategies for the protection, defence and commercialisation of intellectual property. This involves the development of strategies and the drafting of a wide array of commercial agreements from licences to joint ventures. Alex also advises in relation to the regulation of pharmaceuticals, medical devices and advanced therapy medicinal products.

Alex has a breadth of international experience structuring, negotiating and drafting commercial agreements. Both as a corporate advisor and as in house counsel.

Erik Vollebregt
Erik's practice focuses on (medical) technology, marketing, healthcare and life sciences. He has broad experience both in litigation and in transactional work in these areas, as well as in the application of anti-trust law to high technology and pharmaceutical products.

Mathias Klümper
Mathias worked as a lawyer and core member of the industry group "Healthcare, Life Sciences and Chemicals" at the Düsseldorf office of Clifford Chance from 2004 until 2008.

He advised clients from the pharmaceutical, medical device and biotechnology industry in all regulatory matters. He focussed on advising clients on healthcare fraud and abuse prevention (business compliance) and the implementation of employee guidelines and processes.

He does not only know the perspective of a lawyer but also obtained a comprehensive insight into the in-house perspective within two client secondments in the European legal department of an international medical device company in Switzerland and a German pharmaceutical company.

He is author of a number of publications on regulatory themes relating to pharmaceuticals and medical devices as well as co-author of the “Handbuch des Arzneimittelrechts” (textbook on pharmaceutical law, in prep.).

Furthermore, he holds lectures and speeches on current subjects from the pharmaceutical and medical device area.

About Lawford Davies Denoon
LDD (www.lawforddaviesdenoon.com) was established to focus on advising clients in the Life Sciences sector – namely the pharmaceutical, medical devices, reproductive and regenerative medicine industries. Together we bring more than 25 years experience advising clients in the sector. Our particular areas of legal expertise include regulatory matters, compliance programmes, public law and judicial review, intellectual property, commercial contracts and due diligence. 
 

Day 1

Day One, Tuesday 26th October, 2010

09:00 Registration and refreshments

09:30 Opening address from the Chair

Lars Kreye
Associate Director
Boehringer Ingelheim Pharma

09:40 Future development trends and technical considerations for autoinjectors
• Development drivers for devices and the drug reservoir
• Interactions between the drug reservoir and injection device
• Pharma and patient expectations of self-injection systems

Ian Thompson
Director of Business Development
Ypsomed

10:20 The Japan experience - supplying prefilled syringes to the Japanese market
• How we got started
• Specific challenges
• Processes involved
• Examples of process improvements
• Quality of packaging material- a key topic

Lars Kreye
Associate Director
Boehringer Ingelheim Pharma

11:00 Morning refreshments 

11:20 Achieving extra high quality production of glass primary packaging: building a manufacturing concept flow based on a streamlined process
• OMPI case study / optimised process
• Defining criteria for excellence in glass containers for pharmaceutical products
• Successfully managing critical aspects (particle control, high tolerances, contact free, silicon, traceability)

Paolo Golfetto
R & D Manager, Glass Division
Nuova OMPI

11:40 Opportunities and challenges for novel primary drug containers in autoinjectors
• Analysis of suitability and weaknesses of current syringe platforms for use in autoinjectors
 • Opportunities and challenges for cyclic olefins in novel primary drug containers for autoinjectors
• One approach: Oval’s novel primary drug containment technology

Matthew Young
Chief Executive Officer
Oval Medical Technologies

12:20 Extractables study on the innovative Injentle syringe system
• Purpose of study
• Methods of snalyses
• Results and conclusion of extractable study

Horst Koller
Regulatory Affairs and Quality R&D PP
SCHOTT forma vitrum

12:40 Networking lunch

14:00 Microbiological and particulate contamination risks in the manufacture of parenterals
• Elucidating contaminant dispersion routes when producing parenterals
• Risk-based methods to evaluate contamination risks
• Methods for calculating contamination risks (to determine viability and non-viability)

Stefan Sundström
Director, Sterile Aseptic Manufacturing, Engineering and Maintenance, Technical Lead Sterile Process Systems
AstraZeneca

14:40 Pre-filled syringe processing with RABS, isolators, e-beam & alternatives
• Isolator technology with latest E-Beam design features
• Comparison of RABS vs Isolators
• Expansion of the areas of application of syringe technology

Jim Spolyar
Sales and Technical Director
Skan US

15:20 Afternoon refreshments

15:40 Minimising the risk of sterility breach from stopper movement
• Intra-syringe gas bubble movement permits breach of product sterility
• Determining the maximum allowable gas bubble for a given syringe and stopper combination using a risk based approach

Shawn Kinney
Chief Executive Officer
Hyaluron

16:20 Panel discussion: Improving performance, safety and reliability in pre-filled devices- where are we and what are the prospects for the future?
Topics discussed will include: how advances in materials science can aid drug stability, overcoming siliconisation and drug precipitation, and maintaining sterility. Minimising contamination, preventing drug interactions, reducing needle stick injury, and improving patient compliance will also be discussed.

16:40 Closing remarks from the chair

16:50 Networking drinks

Day 2

Day Two, Wednesday 27th October, 2010

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Why we need pre-filled syringes (but might not be getting them...)
• Drawing up drug solutions is fraught with risks to patients
• Mistakes are common and medication errors are frequent
• Pre-filled syringes address many, but by no means all, of these issues
• Reports of the death of the ampoule may have been greatly exaggerated...

Daniel Wheeler
Lecturer in Anaesthesia
University of Cambridge

10:20 The impact of advanced aseptic technology on facility design
 • Harmonisation of EU and FDA guidance for room classifications
• Isolators versus RABS risk and cost impact
• Recent case studies

Sterling Kline
Director of Project Development
Integrated Project Services

11:00 Morning refreshments

11:20 A fully integrated nested syringe filling line
• New tub outer surface decontamination system based on plasma technology
• Combi filling module suitable for peristaltic pump filling and time pressure filling as size parts change
• Combi stoppering station suitable for vent tube stoppering and vacuum stoppering as size part change
• In-line check weighing system

Thomas Zelmer
Director
Groninger

Wenzel Novak
Director, Pharmaceutical Research and Development
Groninger

11:50 Future oriented processing of nested syringes
• FXS 5100 high-performance machine with output of up to 600 syringes per minute
• Innovative line concept for fully automated processing of pre-sterilized, pre-filled nested syringes
• Integrated automatic bag and tub openers

Klaus Ullherr
Product Manager, Packaging Technology
Robert Bosch Packaging

12:30 Developments in the secondary packaging of pre-filled syringes
• Identify the principal requirements of a package for pre-filled syringes
• Identify two alternative methods of packaging pre-filled syringes
• Identify features and benefits of both systems
• Identify future trends in the packaging of pre-filled syringes

Andrew Longworth
General Manager
KÖRBER MEDIPAK UK & RoI

12:50 Networking lunch

14:10 Next generation injection devices for high-cost, long-term medications
• Improving compliance to injectable therapies- a ongoing challenge
• Easypod: an empowering, patient-friendly option
• Applications to growth hormone, multiple sclerosis and fertility treatments

Todd Stephens
Global Marketing Director
Merck Serono

14:50 Best practices on the current and future demands on finishing
• Validating unit operations
• Ensuring resilience during transportation
• Maintaining photostability to preserve product quality  

15:30 Afternoon refreshments 

15:50 Regulatory issues versus requirements for biological medicinal products in pre-filled syringes
• Overview of the regulatory requirements and guidelines
• Data package required
• Case studies: potential issues to consider

Elliot Lawrence
Associate Director of Regulatory Affairs
ERA Consulting

16:30 Chair’s closing remarks

16:40 End of conference

Partners

Associate Sponsors:

Nuova Ompi
Nuova Ompi produces glass tubing containers for pharmaceutical and cosmetic use. Standard production from neutral glass includes vials (penicillin and insulin, screw neck, pilfer-proof, blow back, pill), cartridges (pen and dental cartridges), syringes (bulk and sterile) and ampoules. Ompi supplies prefillable syringes EZ-fill™ clean, sterile and packaged in nested tubs.
Nuova Ompi has started to supply vials EZ-fill™ clean, sterile and ready to fill offering the market the advantages of the EZ-fill™ concept for other major container types, including vials and cartridges. This allows clients to continue the trend of delegating services to partner suppliers while improving operational efficiency. www.ompi.it, www.ez-fill.com

BAUSCH + STROEBEL
The BAUSCH + STROEBEL product range specializes in machines for pharmaceutical primary packaging, including equipment for washing, sterilizing / depyrogenating, filling, closing and labeling of containers such as disposable syringes, ampoules, cartridges, disposable syringes, vials and bottles of all kinds. Our systems are designed to comply with the latest FDA and GMP requirements and are available for all capacity ranges, starting from laboratory testing and clinical batches to fully integrated commercial production. With more than 40 years of experience and over 10,000 machines delivered BAUSCH + STROEBEL is a leading manufacturer of high-quality equipment for the pharmaceutical industry. For further information, please visit www.bausch-stroebel.com

Media Partners:

PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Pharma Connections Worldwide
Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical, Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. For further information please visit www.pharmaconnections.com

Enquiries

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 3rd Pre-filled Syringes Conference, please contact:
Ronald Magali, +44 (0)20 7549 9934
ronald.magali@visiongainglobal.com
 

Past Papers

Speaker presentations are free to delegates. If you are unable to attend the event, the presentations are published two weeks after the event and are available to purchase. 

Venue Info

The visiongain event is to be held at BSG House, London. The address of the venue is:
BSG House, 226-236 City Road, London EC1V 2QY
Click for Google maps.

Directions to the venue:
The nearest airports are:

London/Heathrow - LHR
• By train: take the Heathrow Express to Paddington. Change onto the London Underground - Hammersmith & City Line (pink) to King’s Cross, change to the Northern Line (black) to Old Street
• By taxi: Approx. distance: 20 miles / 33KM. Approx. cost: GB£50.00. Approx. time: 1hour 20 mins

London/Gatwick - LGW
• By train: take the Gatwick express to Victoria. Change onto the London Underground - Victoria Line (light blue) to King’s Cross, change to the Northern Line (black) to Old Street.
• By taxi: Approx. distance: 35 miles / 56KM. Approx. cost: GB£60.00. Approx. time: 1hour 20 mins

London City – LCY
• By train: take the Docklands Light Railway to Bank station. Change onto the London Underground - Northern Line (black) to Old Street.
• By taxi: Approx. distance: 6 miles / 9KM. Approx. cost: GB£25.00. Approx. time: 45 mins
Please note these timings and prices are given only as an indication. During peak hours they are subject to increase.
If you wish to pre-arrange travel by taxi and prices with a local taxi company, Addison Lee can be contacted on +44 (0) 20 7387 8888

Eurostar St Pancras International
By train: Change onto the London Underground at King’s Cross – Northern Line (black) to Old Street.
By taxi: Approx. distance: 1.8 miles / 2.89 KM Approx. cost: GB £7.00 Approx. time: 5 minutes
Please note these timings and prices are given only as an indication. During peak hours they are subject to increase.

The nearest major train stations are:
• King’s Cross – take the London Underground - Northern line (black) to Old Street
• Liverpool Street – take the London Underground – Hammersmith & City (pink), Circle (yellow) or Metropolitan lines (maroon) to Moorgate. Change onto the Northern line (black) to Old Street
• Waterloo – take the London Underground – Jubilee line (grey) to London Bridge. Change onto the Northern Line (black) to Old Street

Walking from Old Street station:
Take exit 8 from the station and follow the green line on the floor to Moorfields Eye Hospital, continue on past there for 3-4 minutes, you will see a blue sign on the side of the building saying BSG. This is BSG House, 226-236 City Road.

Venue facilities include:
BSG House features wi-fi internet access and the possibility of using additional meeting rooms. Please contact visiongain for further information.

Local Accommodation:

Here are a list of recommended local hotels
Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340
Approximately a 10 minute walk to BSG House and close to Old Street tube station and Moorgate which is just 0.5 miles away. The hotel has a breakfast restaurant area and is close to a range of bars and restaurants with attractions including the Globe Theatre and St Pauls Cathedral close by.
Jury’s Inn Islington, 60 Pentonville Road, Islington, London N1 9LA. Tel: +44 (0) 207 282 5500
This hotel is a short journey, or 20-minute walk, away from the conference venue. It is a few minutes walk from Angel tube station and close to King’s Cross, and Euston stations. Also close by is Upper Street (Islington) which has many restaurants, cafes and bars. The rooms offer satellite TV, and internet connections. The hotel has both a bar and restaurant. Standard double room – Single occupancy £98, including breakfast £105, Double occupancy only £98 including breakfast £112. Call reservations on +44 (0) 207 282 5500 and quote Visiongain on booking. This offer is subject to availability.
Hilton London Islington, 53 Upper Street, Islington, London, N1 0UY Tel: +44 (0) 207 354 7700
Probably the furthest from the venue of all of our recommended hotels, but probably the most up-market of the local hotels. Close to Upper Street (Islington) which has plenty of dining and drinking options. Also nearby to Angel tube station and a short cab ride from King’s Cross. The hotel offers wi-fi and a business centre, and a restaurant and bar. Each guest room offers internet access, satellite TV channels and a desk.
London City Holiday Inn Express, 275 Old Street, London, EC1V 9LN Tel: +44 (0) 207 300 4300
Approximately a 10 minute walk to BSG House and close to Old Street tube station, this hotel offers a restaurant and a range of business services, including high-speed internet access in all rooms and the lobby area. The hotel is ideally located for the fashionable bars and restaurants of areas of Hoxton, Shoreditch and Clerkenwell.

The best to see in your host city:

Places to eat:
• Fifteen, 15 Westland Place, N1 7LP T: +44 (0)871 330 1515 – Italian/Fusion
• Carluccio’s Caffe, 305-307 Upper Street, N1 2TU, T: +44 (0) 207 359 8167 – Italian
• Hanoi Café, 98 Kingsland Road, E2 8DP, T: 020 7729 5610 – Vietnamese
• Isarn, 119 Upper Street, N1 1QP, T: 0207 424 5153 – Thai
• Moro, 34-36 Exmouth Market, EC1R 4QE, T: 020 7833 8336 - Spanish

Places to drink:
All of the bars listed do serve food during peak hours
• The Eagle, 2 Shepherdess Walk, City Road, London N1 7LB, T: +44 (0) 20 7553 7681
• Cantaloupe Bar, 35-42 Charlotte Street, London, EC2A 3PB T: +44 (0) 20 7613 4411
• Bavarian Beerhouse, 190 City Road London EC1V 2QH, T: +44 (0) 20 760 80 925
Also Upper Street in Angel Islington, just a short taxi ride away, has a large number of bars and restaurants offering a wide range of cuisine.

If you have the time:
St Pauls Cathedral (1 MI / 1.61 KM )
British Museum (1 MI / 1.61 KM )
Oxford Street * Great for shopping * (1.5 MI / 2.41 KM )
Tower of London (2 MI / 3.22 KM )
Tate Modern (2 MI / 3.22 KM )
London Eye (2 MI / 3.22 KM )
Westminster Abbey (2.5 MI / 4.02 KM )
Houses of Parliament (2.5 MI / 4.02 KM )

Please note: The information contained herein is intended for guidance purposes only. The responsibility to ensure accuracy of the details before visiting remains that of the individual. Visiongain can not be held responsible for any losses resulting from actions taken on the above information.
 

Speakers

Speaker bios: 

  • Andrew Longworth

    Andrew Longworth

    General Manager

    KÖRBER MEDIPAK UK & RoI

    Andrew Longworth is General Manager of the local office for UK and Ireland of Körber Medipak, a group dedicated to the supply of packaging systems to the pharmaceutical industry world-wide. Dividella AG and MediSeal GmbH are companies of Körber Medipak GmbH. The group has operations in Germany, Switzerland, USA and Czech Republic. Andrew Longworth holds a degree in Mechanical Engineering and has been engaged in the field of pharmaceutical packaging and production equipment for over 20 years.

  • Dr. Lars Kreye

    Dr. Lars Kreye

    Associate Director

    Boehringer Ingelheim Pharma

    Lars Kreye is a chemist and received his PHD in biotechnology in Münster and Hanover working on enzymatic processes. After two and a half years in development of depth filters at PallSeitzSchenk, Bad Kreuznach, Gemany, Lars Kreye started working in pharmaceuical industry in 1999 at Behring Werke in Marburg. Since 2003, he joined Boehringer Ingelheim Pharma in Biberach, Germany. Having started career in pharmaceutical industry with focus on quality assurance, he took over responsibility for a aspetic filling line for prefilled syringes in 2006.

  • Horst Koller

    Horst Koller

    Regulatory Affairs and Quality R&D PP

    SCHOTT forma vitrum

    Mr. Koller started his professional career in 1994 to work for Abbott Diagnostics GmbH managing the Process Engineering Group.
    In 2000 he joined Schott in the business segment Pharmaceutical Packaging. He has been a key player in building the manufacturing unit for the Schott TopPac polymer syringe within Schott forma vitrum ag. He held different positions including Quality Manager, Head of R&D and Manager Scientific Advisory. In his current position he is responsible for Regulatory Affairs and Quality R&D for Schott Pharmaceutical Packaging worldwide.
    He is an active member as expert of ISO/TC 76/WG2 working group.
    He holds a degree as Dipl. Ing (FH) in Biotechnology.

  • James J. Spolyar

    James J. Spolyar

    Sales and Technical Director

    Skan US

    James Spolyar founded Aseptic Barrier Systems in November 2002. Aseptic Barrier is the exclusive agent for the Americas, for SKAN AG, a Swiss Corporation. He was deeply involved in the formation of SKAN US, INC and in the development of sales for both SKAN US and SKAN AG. He was Director of Sales for Carlisle/Walker Barrier Systems from June 1996 to November 2002. Prior to joining Carlisle Barrier Systems, Jim served as Chief Operating Officer of La Calhene, Inc. from 1988 until April of 1996, involved in manufacturing and sales of isolation products for the pharmaceutical industry. He has been deeply involved in the design, sales and applications of containment and aseptic isolators, with all of the above companies. He received a JD degree from the University of Michigan Law School in 1964 and received his B.A. from the University of Michigan College of Literature, Service & Arts in June 1961.

  • Stefan Sundström

    Stefan Sundström

    Director, Sterile Aseptic Manufacturing, Engineering and Maintenance

    AstraZeneca

    Dr. Stefan Sundström received his PhD degree (licentiate degree) in engineering 2009. He started working as a consultant within clean room technology and contamination control. He has spent the past 10 years in the pharmaceutical manufacturing field specializing in the areas of clean room technology and contamination control at AstraZeneca. He is currently working at AstraZeneca, Global Engineering as a Technical Lead in the Sterile Manufacturing field. He is also conducting research at The Royal Institute of Technology (KTH).