Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!

1. Successful Incorporation of Human Factors in Prefilled Devices
08.30 - 12.30
Workshop Leader:
Melanie Turieo, Director, Global MedTech Division, Cambridge Consultants
PLUS ONE INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 7th June, Hyatt Regency, Mission Bay, San Diego, CA, USA
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Sponsored by:
Enabling quality excellence through innovation
SMi proudly present their 2nd annual conference and exhibition...
Pre-Filled Syringes
West Coast
5TH - 6TH
JUNE
2017Hyatt Regency, Mission Bay, San Diego, CA, USAHyatt Regency, Mission Bay, San Diego, CA, USA
CHAIR:
• Mike Stelmah, Senior Manager, Combination
Products Regulatory Affairs, Regeneron
KEYNOTE SPEAKERS:
• John Smith, Director, Global Regulatory Affairs, Allergan
• Anand Subramony, Vice President Drug Delivery & Device
Development, MedImmune
• Benir Ruano, VP, Global Manufacturing and Technical
Operations, Xeris Pharmaceuticals
• Ron Forster, Executive Director, Amgen
• Sara McNew, Director, Human Factors and Industrial
Design, Eli Lilly
• Alasdair Young, Device Engineer, Genentech
• Lori de los Reyes, Global Regulatory Affairs, Amgen
• Ariel Waitz, Senior Engineer, Genentech
• Aaron Chesterman, Principal Engineer, Device
Development, Genentech
• Tina Rees, Associate Director – Human Factors, Ferring
• Mayumi Bowen, Senior Engineer, Genentech
• Monica de Bardi, Postdoctoral Researcher, Roche
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184,
Fax +44 (0) 20 7827 6185, email fbegum@smi-online.co.uk
or visit www.smi-online.co.uk/ts05.asp to register online @SMIPHARM
#smipfsusa
HIGHLIGHTS IN 2017:
• Explore and harness the global regulatory ecosystem;
global compliance requirements for product safety and
risk analysis
• Assess data bridging and risk based control strategies
for combination products
• Map the importance of Human factors and patient
centricity in device design
• Highlight the emerging trends of connected health and
the future of patient centric drug delivery
• Cutting edge industry insight on silicone free devices,
virtual reality, and laser cutting in the design and
manufacture of prefilled devices
Enabling quality excellence through innovation
CHAIR:
• Mike Stelmah, Senior Manager, Combination
Products Regulatory Affairs, Regeneron
KEYNOTE SPEAKERS:
• John Smith, Director, Global Regulatory Affairs, Allergan
• Anand Subramony, Vice President Drug Delivery & Device
Development, MedImmune
• Benir Ruano, VP, Global Manufacturing and Technical
Operations, Xeris Pharmaceuticals
HIGHLIGHTS IN 2017:
• Explore and harness the global regulatory ecosystem;
global compliance requirements for product safety and
risk analysis

2. Pre-Filled Syringes West Coast
Day One | Monday 5th June 2017 www.smi-online.co.uk/ts05.asp
08.30 Registration & Coffee
09.00 Chairman’s Session Opening Remarks
Mike Stelmah, Senior Manager, Combination Products
Regulatory Affairs, Regeneron
OPENING ADDRESS
09.10 Navigating the global regulatory ecosystem
• Taking into account regulatory requirements for USA,
Europe and ROW to ensure your product’s success on
a global market
• Update on key points from different regulatory bodies
• What to consider when seeking approval; safety
assessments, human factors considerations
John Smith, Director, Global Regulatory Affairs, Allergan
09.50 Navigating technical complaints, product safety and
regulatory requirements
• Taking into account regulatory requirements for product
safety and complaint handling
• Update on key product failures and challenges
• What to consider while planning safety assessments, risk
analysis and complaint handling for clinical studies and
commercial
Mike Stelmah, Senior Manager, Combination Products
Regulatory Affairs, Regeneron
10.30 Morning Coffee and
Networking Break sponsored by
11.00 Large volume subcutaneous infusion devices; in vivo and in
vitro challenges
• Drivers for large volume subcutaneous delivery
• Technical criteria when evaluating devices for large
volume subcutaneous delivery
• Use of large volume subcutaneous devices in clinic,
including potential complicating factors
Ariel Waitz, Senior Engineer, Genentech
Aaron Chesterman, Principal Engineer, Device
Development, Genentech
11.40 PLAJEX with safe ‘n’ sound; safe delivery of biotherapeutics
• Polymer PFS are developed for providing an
appropriate primary drug container, particularly for
biopharmaceuticals
• A platform of add-on passive sharps injury protection
devices for PFS are serving the patients and healthcare
providers for minimizing the risks of needle-stick injuries
• A cooperation to establish and confirm compatibility
between PLAJEX COP prefillable syringes and the
Safe’n’Sound device platform
William Dierick, Director of Technology Development, Terumo
Adrien Tisserand, Global Category Manager – Parenteral &
CMO, Nemera
12.20 Networking Lunch sponsored by Worrell
13.30 Combination product data bridging
• Guidance on clinical bridging, examples of when clinical
bridging may be necessary
• Clinical home use study design
• Examples of FDA feedback on the need for clinical home
use
• Leveraging pre-existing data and human factors
Lori de los Reyes, Director, Global Regulatory Affairs, Amgen
14.10 Combination product, a need for innovative and
customizable drug delivery devices
Adrien Tisserand, Global Category Manager - Parenteral &
CMO, Nemera
14.50 OXYCAPT™ multilayer plastic vial & syringe with glass-like
gas barrier for biologics
• Glass vs. plastic
• Disadvantages of plastic
• How to overcome the disadvantages of plastic
Shota Arakawa, Researcher, Mitsubishi Gas Chemical
15.30 Afternoon Tea and
Networking Break sponsored by
16.00 An approach to developing risk-based control strategies for
combination products
• Defining and establishing critical quality attributes for a
combination product
• Utilizing a risk-based approach to defining a control
system
• A case study on deployment of the control strategy
process for a combination product
Alasdair Young, Device Engineer, Genentech
16.40 Glucagon synthetic peptide formulation in PFS filled
auto-injector combination product platform
• Challenges with a non-aqueous drug formulation
compatibility with PFS components
• Challenges with manufacturing aseptically filled low
fill volume PFS
• Challenges with an international supply chain
Benir Ruano, VP, Global Manufacturing and Technical
Operations, Xeris Pharmaceuticals
17.20 Panel Discussion: Combination products
– challenges and opportunities
• On the road to patient-centric drug delivery -
understanding the patient’s interaction with
the delivery system to be able to incorporate
features which promote adherence to treatments
• Identifying the good manufacturing regulations that
apply to combination products
• Technical challenges for developing and manufacturing
combination products
• Regulatory hurdles in obtaining approval for pre-filled
syringes and pens in human factors studies
Moderated by: John Smith, Director, Global Regulatory
Affairs, Allergan
Anand Subramony, Vice President Drug Delivery & Device
Development, MedImmune
Tina Rees, Associate Director - Human Factors, Ferring
Sara McNew, Director, Human Factors and Industrial Design,
Eli Lilly
18.00 Chairman’s Closing Remarks and Close of Day One
REGULATION & STRATEGY
DESIGN CONSIDERATIONS FOR PFS
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185,
email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online
BIOLOGICS – CHALLENGES AND OPPORTUNITIES
Conference Chairman’s Welcome Letter
Dear Participants,
Pre-filled syringe (PFS) role in pharmaceutical industry has become more
critical in the recent years. Syringes are no longer used just as a standalone
product, but are key aspects of autoinjectors and safety systems that provide
improved usability and safety for the patients. With these improvements,
come the technical, regulatory and drug development challenges
associated with using a PFS.
Pre-filled Syringes may seem as simple products, but as each process and
feature of the syringe increases the complexity of the product and needs
significant focus to achieve a successful launch on the market. From glass
cane creation, syringe forming, siliconization, leachable and extractable
studies, to device integration, regulatory filing and functional testing; all
play a vital role to make a functional product approved on the market and
safely used by patients. It is critical to develop working relationships and
collaborations, as an industry, to bring knowledge to the suppliers and drug
developers worldwide, so that we can address these challenges. Thank
you to everyone who contributes to this goal and looking forward to your
participation at the conference.
Sincerely,
Mike Stelmah, MBA, PMP, RAC (US & Global)
Sr. Manager, Combination Products Regulatory Affairs
Regeneron Pharmaceutical, Inc.
Mike Stelmah, MBA, PMP, RAC (US & Global)

3. Pre-Filled Syringes West Coast
www.smi-online.co.uk/ts05.asp Day Two | Tuesday 6th June 2017
GIVING YOUR DEVICE A HUMAN TOUCH
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Mike Stelmah, Senior Manager, Combination Products
Regulatory Affairs, Regeneron
09.10 Creating patient centric combination products
• Patient centricity
• Connected health
• Drug delivery
Anand Subramony, Vice President Drug Delivery & Device
Development, MedImmune
09.50 How Mixed Reality will drive the future of drug delivery
product development
• What does virtual reality mean for ethnography and
human factors testing?
• How can we use augmented reality to impact device
development & sales?
• How can we apply this to the frontlines of healthcare?
Derek Mathers, Director of Advanced Applications
Development, Worrell
Matt Gottschalk, Medical Device Consultant, Worrell
10.30 Morning Coffee and
Networking Break sponsored by
11.00 Giving the device a human touch
• The role of patient centricity in drug delivery and device
development
• Successfully incorporating human factors into device
design
• Human factors regulations and guidelines for successful
approval
Sara McNew, Director, Human Factors and Industrial
Design, Eli Lilly
11.40 Human factors implications of innovative delivery systems
for biologics
• Overview of alternatives to prefilled syringes in parenteral
drug delivery, such as autoinjectors, patches, pumps,
and pens
• Performing formative and summative human factors
studies with alternative delivery systems
• Examples of development and human factors validation
of innovative delivery systems
Tina Rees, Associate Director, Human Factors, Ferring
12.20 Networking Lunch sponsored by Worrell
13.30 Driving Particles to Zero
• Intrinsic particles: what are the specific challenges
presented by the silicone layer, and silicone oil free
systems?
• Extrinsic particles: supplier to fill finish
• Considerations for combination products
• Case study examples of silicone free devices; what are
the pros and cons?
Ron Forster, Executive Director, Amgen
14.10 COP- Technical data update
• Key properties of COP – demonstrating the value and
characteristics of COP compared with glass
• Case study: Study on protein adsorption/aggregation with
actual protein drug – COP vs. glass
• Case study: study on delamination with glass syringe vs.
COP syringe
• Leachable data on COP syringe with various chemicals
Toshiro Katayama, Senior Product Manager, Zeon
14.50 Controlled depth radiation sterilization for external surface
of ocular syringes
• Challenges for external surface sterilization for syringes
filled with biologics
• Technology concept of controlled depth radiation
• Study results: effect of controlled depth radiation on
lethality, biologic quality, and syringe discoloration
Mayumi Bowen, Senior Engineer, Genentech
15.30 Afternoon Tea and
Networking Break sponsored by
16.00 Innovative technologies in the manufacturing process of
glass pre-filled syringes
• Introduction of a laser-assisted glass cutting technology
resulting in reduced glass particle count, mechanically
stronger and more dimensionally stable finger flanges
• Features and benefits of an innovative X-ray inspection
unit addressing increasing regulatory requirements for CCI
and for drug delivery systems safety
Philippe Lauwers, Business Unit Director Pre-fillable Syringes,
Nipro Pharma Packaging
Matteo Falgari, Business Development Manager Pre-fillable
Syringes, Nipro PharmaPackaging
16.40 Needle clogging in SIN-PFS filled with high concentration
protein solution
• Understanding of the solidification process of mAb
solutions
• Influence of water vapour diffusion through the RNS
during storage
• Considerations on RNS leachables migrating in the drug
product
Monica di Bardi, Postdoctoral Researcher, Roche
17.20 Panel Discussion: The future of parenteral
drug delivery
• Addressing the need and challenges of high
volume injectables:
- Commercial opportunity and challenges
- User considerations
- Technologies: wearable injectors, hand held auto-
injectors & syringes etc.
• Connectivity and connected devices:
- Are they the future of parenteral drug delivery?
Moderated by: Mike Stelmah, Senior Manager,
Combination Products Regulatory Affairs, Regeneron
Derek Mathers, Director of Advanced Applications
Development, Worrell
18.00 Chairman’s Closing Remarks and Close of Day Two
MANUFACTURING DEVELOPMENTS & OPPORTUNITIES
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185,
email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online

4. Successful incorporation of Human Factors in prefilled devices
Overview of the workshop:
This workshop will provide guidance
and advice on how to successfully
incorporate human factors into prefilled
devices. Improve your understanding of
human factors for pre-filled syringes in
the context of the whole user interface;
including instructional material, training
and packaging. Learn to succeed in
the application of human factors in pre-
filled devices to enable delivery of high
quality, market leading devices.
Why should you attend this workshop:
• How to successfully incorporate
human factors into device
development
• Considerations for design and
evaluation
• Navigating regulations and seeking
approval
• Ensuring success; case study examples
• How to balance safety, usability and
commercial success
About the workshop leader:
Melanie Turieo is a Director in Cambridge
Consultants’ Global MedTech division,
and Department Leader for Human
Centered Design. Melanie has over 20
years’ experience providing Human
Factors expertise to the design and
development of regulated and safety-
critical items, including medical, military
and consumer products. Her technical
expertise has focused for the last 10
years on human factors engineering
in the design and development of
medical products, and she has extensive
experience designing and conducting
user research for medical devices,
especially drug delivery systems including
injection and inhalation technology.
About the organisation:
Cambridge Consultants develops
breakthrough products, creates IP,
and provides business consultancy in
technology-critical issues for clients
worldwide. For more than 50 years,
they have been helping clients turn
business opportunities into commercial
successes, from launching first-to-market
products, entering new markets to
expanding existing markets through new
technologies. Their auto-injector, inhaler
and injection device development
programs extend from concept creation
through to industrialisation, with a ‘quality
by design’ approach and full compliance
with international regulatory standards.
www.cambridgeconsultants.com
Programme
8.30 Registration & Coffee
9.00 Workshop leaders’ opening remarks
and introduction
9.10 Incorporating human factors
into prefilled device development
• What to consider when making your
device human
- Design intent
- Tests and evaluations
- Seeking regulatory approval – what to
provide to gain regulatory approval
9.40 Case study examples
– common pitfalls vs success stories
10.10 Discussion
10.30 Morning Coffee
11.00 The bigger picture; human factors
as an ecosystem consideration
• Human factors is not a stand-alone
consideration
• Balancing safety, usability and
commercial success
12.00 Discussion
12.30 Workshop leader’s comments
and close of Workshop
Half-Day Post-Conference Workshop
Wednesday 7th June 2017, Hyatt Regency, Mission Bay, San Diego, CA
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185,
email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online
Melanie Turieo,
Director, Human
Factors & Industrial Design,
Cambridge Consultants
List of past attendees:
• Abbott Laboratories
• Alkermes
• Allergan
• Amgen
• Anteris Medical GmbH
• Baxalta
• Baxter Healthcare
• Bayer Healthcare
• Bayer HealthCare AG
• BCM Group LLC
• Biogen Inc
• Boehringer Ingelheim
• Boehringer Ingelheim
Pharmaceuticals
Incorporated
• Bosch Packaging
Technology
• Bristol-Myers Squibb Co
• Cambridge Consultants Ltd
• Centurion Medical Products
• DDL
• Eli Lilly
• Emergent BioSolutions Inc.
• ENCO Pharmaceutical
Development, Inc. (EPDI)
• Epione BioPharmaceuticals
• FDA
• Genentech
• Genentech, Inc.
• Getinge A B
• Gilead Sciences
• Gilead Sciences Inc
• Insulet Corp
• IntraCellular Therapies Inc
• Ionis Pharmaceuticals, Inc.
• KBI Biopharma
• LoneStar Heart Inc
• Maeda industry Co Ltd
• Merck, Sharp & Dohme Corp.
• MITSUBISHI GAS CHEMICAL
COMPANY, INC
• Mitsubishi Gas Chemical
Singapore Pte Ltd
• Noxilizer, Inc.
• PAREXEL International
• Pfizer
• Pfizer CentreOne
• Pharmacircle
• Shire
• Shire US Inc
• Steris Corp
• STERIS FINN-AQUA
• Takeda Pharmaceuticals
• Teleflex
• Terumo Americas Holding, Inc
• Terumo Medical
Corporation
• Teva Pharamceuticals
• Teva Pharmaceuticals
• UserWise
• Versartis, Inc.
• W.L. Gore & Associates, Inc.
• Xcelthera
• Xeris Pharmaceuticals
• Xeris Pharmaceuticals, Inc.
• ZebraSCI
• zebrasci inc
• Zeon Chemicals L.P.
Pre-Filled Syringes 2015/2016
Conference Attendee Profile
Networking opportunities at Pre-Filled Syringes West Coast
Regulatory 2%Vendors 20%
Pharmaceuticals
& Biotechnology 78%

5. Pre-Filled Syringes West Coast
Online at www.smi-online.co.uk/ts05.asp
MITSUBISHI GAS CHEMICAL
Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies.
Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe
having excellent oxygen and water vapor barrier. The products make it possible to replace glass with plastic for
injectable drugs. www.mgc.co.jp
NEMERA
Nemera is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical,
biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal,
Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal. Nemera leverages decades of experience in
the parenteral device segment from full development to pure contract manufacturing, through customized solutions.
Nemera developed: Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-
sticks and Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations. www.nemera.net
NIPRO PHARMAPACKAGING
Nipro PharmaPackaging is specialized in developing and manufacturing advanced pharma packaging products
and complete packaging solutions for early development drugs or enhancement of packaging solutions of existing
drugs. With a worldwide manufacturing footprint of 19 plants, multiple sales offices and lab services, Nipro offers an
exceptional service platform. www.nipro-pharmapackaging.com
OVERLOOK INDUSTRIES
Overlook Industries, Inc. believes that the future of liquid packaging lies in the flexibility to adapt to ever changing
product and customer demands. Overlook Freedom Filler™ kits embody our eighteen year heritage of maximizing
productivity, while providing the ultimate in customization and flexibility. Overlook Freedom Filler™ kits include all
necessary components of the fluid path and can be provided particularly cleaned, multi-bagged and gamma
sterilized per customer requirements. www.ovlk.com
TERUMO PHARMACEUTICAL SOLUTIONS
Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical
technology. In addition to offering our valued products, our specialized team also provides customized and dedicated
solutions designed to meet your specific requirements. www.terumo-ps.com
WORRELL
Worrell is a design firm focused on healthcare innovation. Since 1976, our team of impassioned creatives has applied
the principles of design to the practice of medicine. Today, our clients look to us for our expertise in digital health,
medical device and emerging markets to create better health outcomes. With offices in Minneapolis, Minnesota
and Shanghai, China we are uniquely equipped to apply research, strategy, user experience and industrial design,
engineering, prototyping and human factors engineering capabilities to some of the most complex healthcare
problems globally to meet the needs of patients and providers. www.worrell.com
ZEON
Zeon Chemical’s Zeonex® and Zeonor® cyclo olefin polymers (COP) allow for advanced, break-resistant syringes,
vials and lyophilization containers for protein-based, peptide-based biopharmaceuticals, high viscosity drugs, and
contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water adsorption, and superior
moldability, as well as overcome protein absorption and pH shift concerns. www.zeonex.com
PROUDLY SPONSORED BY:
Supported by
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join
the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk
Official Media Partners

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VENUE Hyatt Regency, Mission Bay, San Diego, CA, USA
PRE-FILLED SYRINGES WEST COAST
Conference: Monday 5th & Tuesday 6th June 2017, Hyatt Regency, Mission Bay, San Diego, CA, USA Workshop: Wednesday 7th June 2017, San Diego, CA, USA
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