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Conference Documentation: Pre-Filled Syringes West Coast 2016

Conference Documentation: Pre-Filled Syringes West Coast 2016

SMi proudly presents its inaugural event of the premier Pre-Filled Syringes series to San Diego in June 2016!

The prefilled syringes (PFS) market is poised to account for exponential growth and account for $6 billion revenue by the end of 2020.* The market has witnessed continual advancements in device design with enhanced safety and usability by patients through human factor engineering. Nonetheless, challenges surrounding biologic drug stability, manufacturing and competition from other drug delivery technologies remain key concerns amongst pharma and medical device manufacturers.

Emulating on SMi’s successful PFS series, we are bringing this must-attend event to the West Coast, where we will focus more on the innovative technologies. Join us today to discuss with your industry colleagues to accelerate PFS development!

San Diego has been known for being a hub of healthcare and biotech innovation center. As of 2013, San Diego has the second-largest biotech cluster in the US, below the Boston area and above the San Francisco Bay Area.

More than 400 biotech companies are homed in the region. Major companies like Neurocrine Biosciences and Nventa Biopharmaceuticals are headquartered in SD, while many other established biotech companies - including BD Biosciences, Biogen Idec, Merck, Pfizer, Celgene and Vertex, also have their offices and R&D facilities in the heart of area, this provides the optimal setting for our premier Pre-Filled Syringes Conference & Exhibition, which you will meet like-minded Pre-Fillled Syringes experts at this meeting!


Day 1
8:00
Registration & Coffee
8:30
Chairman's Opening Remarks
Edmond Israelski, Former Director Human Factors; Co-Convener, Abbvie; ISO/IEC Joint Working Group on Usability Standards for Medical Devices
8:40
Regulatory Updates – Navigating Global Expectations for Drug Delivery Systems
Suzette Roan, Regulatory Affairs CMC, Combination Products & Medical Devices, Biogen Inc
9:20
Regulatory Hurdles and Challenges for Approval of Drug Delivery Devices
Edmond Israelski, Former Director Human Factors; Co-Convener, Abbvie; ISO/IEC Joint Working Group on Usability Standards for Medical Devices
10:00
Pre-Filled Syringes – The Conventional Thinking and Challenges Ahead
Shirish Ingawale, Senior Engineer - Drug Delivery & Device Technologies, Amgen
10:40
Morning Coffee & Networking Break
11:10
Why Do We Do Formative Studies for Pre-Filled Syringes?
Lisa Nilsson, Human Factors Manager, Teva Pharamceuticals
11:50
Challenges and Design Considerations for Developing PFS and Devices to Deliver Viscous Formulations
Diane Doughty, Scientist II - Drug Delivery & Devices, MedImmune
12:30
Application of Quality by Design (QbD) to Combination Product Development
Jeffrey Givand, Director of Device Development, Merck, Sharp & Dohme
13:10
Networking Lunch
14:10
Syringes for the Sterile Field: Nitrogen Dioxide Sterilization as a Solution
14:50
Rethinking the Delivery Platforms – Can PFS Contribute Added Values?
15:30
Afternoon Tea & Networking Break
16:00
Measuring H2O2 Residuals and Mitigating Product Exposure on Isolator and RABS Filling Lines
Aaron Hubbard, Process Development Engineer, Genentech
16:40
PLAJEXTM Polymer-Based PFS with a Tapered Needle for Use in Autoinjectors
Kevin Constable, Senior Director, Technology Development, Terumo Americas Holding, Inc
17:20
Panel Discussion: The Cost and Returns of PFS as a Device
Edmond Israelski, Former Director Human Factors; Co-Convener, Abbvie; ISO/IEC Joint Working Group on Usability Standards for Medical Devices
17:50
Chairman’s Closing Remarks and Close of Day One
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Dhairya Mehta, Associate Director, Shire Inc.
9:10
Enhancement in Drug Delivery Devices - From PFS to Advanced Devices
Dhairya Mehta, Associate Director, Shire Inc.
9:50
Key Properties of COP Update
Toshiro Katayama, Product Manager, Zeon Chemicals L.P.
10:30
The Next Generation of Auto Injectors and Pens to Support Combination Products
Benir Ruano, Vice President, Global Manufacturing & Technical Operations, Xeris Pharmaceuticals
11:10
Morning Coffee & Networking Break
11:40
Combination Products and Devices - Creating and Maintaining the Design History File
Maria Toler, Senior Manager, Quality Assurance Technology and Innovation, Pfizer
12:20
Trouble-Shooting Syringe Filling Equipment
Paul Tyson, Principal Engineer, Aseptic Filling & Packaging, Boehringer Ingelheim Pharmaceuticals Incorporated
13:00
Networking Lunch
14:00
Challenges of Pre-Filled Syringes Manufacturing
Jennifer Vandiver, Senior Process Scientist, Alkermes
14:40
OXY-CAPT Multilayer Plastic Pre-Filled Syringe with Glass-Like Gas Barrier
Fumihiro Ito, Researcher, MITSUBISHI GAS CHEMICAL COMPANY, INC
15:20
Wearable Injector Technology
16:00
Afternoon Tea & Networking Break
16:30
Needle-Less Injection Device for Transdermal Delivery
17:10
Patient Training and On-Boarding Program – The Last Step of the Journey
17:50
Chairman’s Closing Remarks and Close of Day Two

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