Pre-Filled Syringes West Coast 2017

Successful Incorporation of Human Factors in Prefi lled Devices08.30 - 12.30

Workshop Leader: Melanie Turieo, Director, Global MedTech Division, Cambridge Consultants

PLUS ONE INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPWednesday 7th June, Hyatt Regency, Mission Bay, San Diego, CA, USA

REGISTER BY 28TH FEBRUARY AND SAVE $300REGISTER BY 31ST MARCH AND SAVE $200REGISTER BY 28TH APRIL AND SAVE $100

Sponsored by:

Enabling quality excellence through innovation

SMi proudly present their 2nd annual conference and exhibition...

Pre-Filled SyringesWest Coast

5TH - 6TH

JUNE 2017Hyatt Regency, Mission Bay, San Diego, CA, USA Hyatt 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 [email protected]

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 prefi lled 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

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 ADDRESS09.10 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 confi rm compatibility between PLAJEX COP prefi llable 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

• Defi ning and establishing critical quality attributes for a combination product

• Utilizing a risk-based approach to defi ning 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 fi lled

auto-injector combination product platform • Challenges with a non-aqueous drug formulation

compatibility with PFS components • Challenges with manufacturing aseptically fi lled low

fi ll 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-fi lled 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 [email protected] or visit www.smi-online.co.uk/ts05.asp to register online

BIOLOGICS – CHALLENGES AND OPPORTUNITIES

Conference Chairman’s Welcome LetterDear Participants,

Pre-fi lled 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-fi lled Syringes may seem as simple products, but as each process and feature of the syringe increases the complexity of the product and needs signifi cant focus to achieve a successful launch on the market. From glass cane creation, syringe forming, siliconization, leachable and extractable studies, to device integration, regulatory fi ling 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 AffairsRegeneron Pharmaceutical, Inc.

Mike Stelmah, MBA, PMP, RAC (US & Global)

Pre-Filled Syringes West Coastwww.smi-online.co.uk/ts05.asp Day Two | Tuesday 6th June 2017

GIVING YOUR DEVICE A HUMAN TOUCH


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 prefi lled 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 specifi c challenges

presented by the silicone layer, and silicone oil free systems?

• Extrinsic particles: supplier to fi ll fi nish • 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 fi lled 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-fi lled syringes

• Introduction of a laser-assisted glass cutting technology resulting in reduced glass particle count, mechanically stronger and more dimensionally stable fi nger fl anges

• Features and benefi ts 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-fi llable Syringes, Nipro Pharma Packaging

Matteo Falgari, Business Development Manager Pre-fi llable Syringes, Nipro PharmaPackaging

16.40 Needle clogging in SIN-PFS fi lled with high concentration protein solution

• Understanding of the solidifi cation process of mAb solutions

• Infl uence 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


Successful incorporation of Human Factors in prefi lled devices

Overview of the workshop:This workshop will provide guidance and advice on how to successfully incorporate human factors into prefi lled devices. Improve your understanding of human factors for pre-fi lled 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-fi lled 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 fi rst-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


9.00 Workshop leaders’ opening remarks and introduction

9.10 Incorporating human factors into prefi lled 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 WorkshopWednesday 7th June 2017, Hyatt Regency, Mission Bay, San Diego, CA


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• Pfi zer

• Pfi zer CentreOne• Pharmacircle• Shire• Shire US Inc• Steris Corp• STERIS FINN-AQUA• Takeda Pharmaceuticals• Telefl ex• 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 Profi le

Networking opportunities at Pre-Filled Syringes West Coast

Regulatory 2% Vendors 20%

Pharmaceuticals & Biotechnology 78%

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 fi eld 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

NEMERANemera 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 prefi lled syringes to avoid accidental needle-sticks and Safelia®, a new generation of 2-steps auto-injector for fl uid 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 offi ces and lab services, Nipro offers an exceptional service platform. www.nipro-pharmapackaging.com

OVERLOOK INDUSTRIESOverlook Industries, Inc. believes that the future of liquid packaging lies in the fl exibility 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 fl exibility. Overlook Freedom Filler™ kits include all necessary components of the fl uid 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 specifi c requirements. www.terumo-ps.com

WORRELL Worrell is a design fi rm 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 offi ces 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

ZEONZeon Chemical’s Zeonex® and Zeonor® cyclo olefi n 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 OPPORTUNITIESSMi 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 specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: [email protected]

MARKETING OPPORTUNITIESWant 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: [email protected]

Offi cial 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

4 WAYS TO REGISTEROnline at www.smi-online.co.uk/ts05.asp

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Pre-Filled Syringes West Coast 2017

Health & Medicine

Transcript of Pre-Filled Syringes West Coast 2017