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Conference Documentation: Pre Filled Syringes America

Conference Documentation: Pre Filled Syringes America

The global prefilled syringe market is estimated to reach $6.9bn by 2018. This figure is reflective of manufacturers striving to improve their technologies to meet the increasing number of biologic drugs reaching the market. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology and with the focus still on the safety for the user, innovation improvements for device development and ease of use for the patient are key areas to be addressed.

SMi’s leading prefilled syringes conference will focus on a number of hot talking points that will no doubt cause controversy and debate and on reflection open the floor to discussion in our breakout sessions. In addition, with a new competitive market just around the corner for biosimilars we look at this new session for 2015 in addition to the vision and benefit of lyophilisation in a prefilled syringe.


Day 1
8:00
Registration & Coffee
8:30
Chairs Opening Remarks
William Beierschmitt, Associate Research Fellow, Pfizer, Inc.
8:40
The importance of the patient and how each individual differs
Edmond Israelski, Program Manager, Abbott Laboratories
9:20
Success Criteria – How can the FDA’s requirements be met?
Natalia Mazaeva, Sr. Usability Leader, Global Usability and Risk Management, Device Development, Sanofi-Aventis
10:00
End user needs and perspectives for device assembly
Dena Flamm, Product Manager, Bosch Packaging Technology
10:40
Morning Coffee
11:10
KEYNOTE ADDRESS - Convenience and compliance: empower the user through good design
Ben Bartfeld, Human Factors and Industrial Design Consultant,
11:50
What makes a prefilled syringes ergonomic?
Saikrishna Garrepalli, Procurement Management Representative , Beroe Inc
12:30
The New Frontier: Advancing the Quality and Functionality of Drug Delivery
Paul Chao, Core Team Leader, R&D Staff Engineer, BD Medical - Pharmaceutical Systems
12:30
The New Frontier: Advancing the Quality and Functionality of Drug Delivery
Justin M. Wright, Senior Director, Strategic Innovation, BD Medical - Pharmaceutical Systems
13:10
Design Control and Tech Transfer Strategy to Deliver Patient-Centric Therapeutics
Li-Chun Tsou, Global Device Technical Director, AstraZeneca
14:10
Networking lunch
14:50
Safety Evaluation of Leachables for Pre-Filled Syringe Drug Products
Stephen Barat, Senior Director, Toxicology and Operations, Actavis, Inc
15:30
Points for consideration from a toxicology perspective
William Beierschmitt, Associate Research Fellow, Pfizer, Inc.
16:10
Innovating for safety: let’s be sharp to protect end-users with safe injectable devices
Isabelle Delcroix, Business Development Director, Nemera
16:50
Afternoon Tea
17:20
Case Study: Identifying incompatibility causes and challenges
Kiran Singh, Associate Director, Sandoz Pharmaceuticals
18:00
Assessing the safety of needle devices
Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed Technologies
18:40
Chairs Closing Remarks and Close of Day One
William Beierschmitt, Associate Research Fellow, Pfizer, Inc.
Day 2
8:30
Registration & Coffee
9:00
Chairs Opening Remarks
Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International
9:10
Getting to market: Regulatory perspective
Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International
9:50
Round Table Discussion - Discussing the safety challenges surrounding prefilled syringes
Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed Technologies
10:30
Room Temperature Sterilization of Prefilled Syringes
Evan Goulet, Director, Sterilization Operations, Noxilizer, Inc.
11:10
Morning Coffee
11:40
Case Study: The partnership reviewed between a pharmaceutical company and the manufacturer/supplier
Shun Ogawa, Research Manager, Mitsubishi Gas Chemical Company Inc.
12:20
Combination Product Considerations- Starting with the End in Mind
Royce Brockett, Senior Product Manager, West Pharmaceutical Services, Inc.
13:00
Networking Lunch
14:00
Round Table Discussion - The partnership reviewed between a pharmaceutical company and the manufacturer/supplier
Witold Swiatek, Associate Director, Device Development, Merck Research Laboratories
14:40
Product Line Management, sustaining activities
Mark Tsai, Principal Engineer, Drug Delivery, Johnson And Johnson
15:20
Breakout session and opportunity to network
Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International
15:40
Afternoon Tea
16:10
Case Study: Process Development studies to optimize process parameters and finalize presentation format
Aarti Gidh, Principal Scientist, GlaxoSmithKline
16:50
Electronics and Mobile Apps role in drug delivery and dosage adherence
Chanderkanth Gautham, Domain Lead Medical Device Team, Beroe Inc
17:30
Chairs Closing Remarks and Close of Day Two
Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

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