A Novel Device for Reconstitution and Administration
Patrick Grandt, Medical Device Engineer, Genentech, Inc.
A Packaging Platform for Pre-Filled Syringes and Self-Injection Devices; How Unit-Level Compliance Can Improve Treatment Outcomes
Peter Gompper, MSc, MBA, Co-founder, Rubitel
An Iterative Process Utilizing Real World Data Collection to Improve Support for Patients with Diabetes
Chelsea Williams, MPH, Manager of Digital Health, SHL Medical
Characterizations of Plunger Stopper Movement
Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc.
Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes
Xi Zhao, Senior Scientist, Merck & Co., Inc.
Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery
Iain Simpson, Commercial Director, Phillips-Medisize
Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs)
Juergen Metzger, Product Specialist, Sartorius North America Inc..
Design & Customization of Lubricants and Related Materials to Meet the Diverse Needs of the Parenteral Drug Delivery Industry
Christopher Andreola, PhD, Sr Product & Innovation Manager - MEDICAL, Nye Lubricants, Inc. (FUCHS Group)
Development of a Submucosal Injection Device for an Oral Biotherapeutic Delivery System
Cheryl Stork, Scientist II, Preclinical Translation, Biora Therapeutics
Drug-Device Combination Products (DDCP) Development and Lifecycle Planning
Diego Zurbriggen, Sr. Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc.
Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission?
Elizabeth Moroney, Principal Scientist, Bristol Myers Squibb
Effects of Manufacturing Date on Silicon Oil Particles in Prefilled Syringes
Guangli Hu, Principal Scientist, Merck & Co., Inc.
Elastomer Plungers with Fluoropolymer Barrier Films – Utility for Emerging Drug Products
Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc.
Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance
Arjun Manoj, Bio-Medical Engineer, Portal Instruments
Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings
Mark Tunkel, Global Category Director - Services, Nemera
Evaluation of Syringe Plunger Functional Performance to Secure PFS and Auto-injector Integration and Machinability on Filling Lines: Case Study with PremiumCoat® 1-3mL Syringe Plunger
Sébastien Cordier, Technical Product Manager, Aptar Pharma
From the User’s Perspective: The Use of Eye Tracking Technology in Human Factors Studies to Assess and Improve Injection Device Usability
Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb
Getting the Most from Life Cycle Assessment in Product Development
Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford
How to Ensure Syringe-Autoinjector Compatibility? An Insight from PFS Manufacturing for AI
Stefano Pilati, Technical Evaluation and Product Development Coordinator, Stevanato Group
How to Leverage Your Device Supply Chain and Bring Unique Combination Products and Medical Devices to Market Quicker
Mark Zimmerman, Business Development, Kimball Electronics
How to Partner for Wins
Mark Zimmerman, MBA, Business Development, Kimball Electronics
How to Study and Characterize the Container Closure Integrity of Glass Prefilled Syringes During Deep-Cold Storage Cycles
Ludovic Gil, R&D Engineer, BD
Human Factors Approach to Incorporating Connectivity into Medical Device Connectivity
Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford
Importance of 2.25ml Autoinjector Rod to Plunger Design Space – an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage
Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc.
Incorporating Sustainability Considerations Within the Device Selection Process
Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc.
Jake Keeler, Sr. Manager, R&D, Product Sustainment, West Pharmaceutical Services, Inc.
Innovative Methodologies to Accelerate the Development of Combination Products for Novel Drug Products Involving Delivery of High Dose High Viscosity Formulations
Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC
Integration of New Technologies with Existing Systems – Challenges and Opportunities
Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC
Key Design Considerations for an Emergency-use Injection System
John Burke, Senior Consultant, Team Consulting
Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies
Wendy Woodley, Staff Scientist II, BD
Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards
Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc.
Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc.
Max Fill Volume Evaluation for Pre-filled Syringes
Leilei Zhang, Associate Principal Scientist, Merck & Co., Inc.
Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector
Rob Hall, Design Team Manager - Product Design, Owen Mumford
Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R
Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc.
Peter Nelson, Manager, R&D Verification Lab, West Pharmaceutical Services, Inc.
Needle-Tissue Interactions in Relation to Design of Autoinjectors
Anne-Sofie Staples, MSc, Industrial PhD Student, University of Copenhagen/Novo Nordisk A/S
New Materials and Advanced Manufacturing Techniques of Films for Sterile Injectables Processing and Finished Dosage Form Through a Re-engineered Supply Chain
Amir Genosar, CEO, Aktiv Pharma Group
Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs
Thomas James, Mechanical Engineer, Key Tech
Shear Damped Auto-injector – a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals
Peter Holst, Co-Founder and CEO, FPrin, LLC
Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform
Juan Cheng, Principal Scientist, Merck & Co., Inc.
The Art of Filling and Processing a Pre-filled Syringe
Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
The Beneficial Feedback Loop of the “Digital Twin”
Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc.
Using Regulatory Grade CM&S of a Drug Delivery Systems to Accelerate Device Development
Maggie Reiff, Vice President, Development, ApiJect Corp