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Parenteral Drug Association Connecting People, Science and Regulation ®

2016 PDA Universe of Pre-filled Syringes & Injection Devices

Oct 17 - Oct 18, 2016 |
Oct 18, 2016 |
Hyatt Regency Huntington Beach Resort and Spa | Huntington Beach, CA
  • Conference
  • Western Hemisphere Events
Exhibition: October 17-18
Post-Workshop: October 19
Courses: October 20-21
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Speaker Biographies

In today’s drug product development laboratories, the pre-filled syringe remains one of the most popular primary container systems under development in the biotechnology/pharmaceutical industries. Even though the pre-filled syringe is not a new technology, it is at the center of much innovation. New materials, modifications to existing materials, new devices, new safety and new connectivity features are applied to the basic pre-filled syringe.

With the expansive array of innovative options, which options should be implemented and how, and when? What will differentiate a product or what new innovation will enable or expedite product development? What are the current regulatory expectations? Beyond product development questions, concerns exist about manufacturing, outsourcing, patient experience and patient data.

The 2016 PDA Universe of Pre-filled Syringes & Injection Devices brings together industry and regulatory experts to share their experiences, new developments, regulatory considerations, challenges, and industry trends and best practices in this exciting area. The topics will benefit those looking for a basic understanding of pre-filled syringes and injection devices as well as those looking for a more in depth presentation of current challenges and developments. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing,  or marketing of  pre-filled syringes and injection devices.

Sessions will cover topics such as:

  • Navigating the Ecosystem of Connected Health
  • Ensuring the Patient is the Focus of Improving Drug Delivery Devices
  • Key Ingredients of Effective Partnerships
  • Connectivity: Data Collecting from Patient Behavior
  • Global Regulations & Standards Related to Prefilled Syringes & Injector Devices
  • International Regulatory Pathways for Auto-Injectors & Pens
  • Manufacturing Equipment Innovation

Learning Objectives

At the completion of this Conference, attendees will:

  • Discuss the market benefits of pre-filled syringes and injection devices
  • Identify critical attributes of end-user friendly devices
  • Explain how innovation is helping patients to have a positive experience in managing their therapies and assuring compliance to dose regime
  • Summarize manufacturing requirements of pre-filled syringes, injection devices, safety devices and final drug/device combo products
  • Discuss quality standards, regulatory and compliance concerns
  • List insights through case studies presented by industry experts
  • Discuss market, industry trends and new technologies

Who Should Attend

Business Development | Marketing | Operations | Regulatory Affairs | Manufacturing | Pharmaceutical Formulation and Process Development | Procurement | CMC | Distribution | Packaging | Quality Assurance/Control

Job Function
Manufacture of Parenteral Products | Packaging Scientists & Engineers | Stability Coordinators | Supply Chain | Logistics | Clinical Development | Business Development | Formulators | Device Engineers | Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals

Conference Inquiries

Molly O'Neill Moir, CMP
Director, Programs
Tel: +1 (301) 656-5900 ext. 132

Jason E. Brown
Senior Manager, Programs & Registration Services
Tel: +1 (301) 656-5900 ext. 131

Registration Inquiries

Tel: +1 (301) 656-5900 ext. 115

Education Course Series Inquiries

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151

Exhibition/Sponsorship Inquiries

David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160

Sunday, October 16, 2016

8:00 a.m. - 10:30 a.m.
PDA California Fun Run – Supporting the CSP Huntington Beach Youth Shelter
Sponsored in part by the PDA Southern California Chapter

3:00 p.m. - 6:00 p.m.
Registration Open

3:00 p.m. - 6:00 p.m.
Meet & Greet Reception

3:00 p.m. - 6:00 p.m.
Speaker Ready Room Open

5:00 p.m. - 6:00 p.m. (Invitation only)       
2016 PDA Universe of Pre-filled Syringes & Injection Devices Program Planning Committee Meeting

Monday, October 17, 2016

7:00 a.m. - 8:00 a.m.
Continental Breakfast

7:00 a.m. - 5:15 p.m.
Registration Open

7:00 a.m. - 5:15 p.m.
Speaker Ready Room Open

8:00 a.m. - 8:30 a.m.
Welcome & Opening Remarks
Olivia Henderson, PhD, Principal Engineer, Amgen, Inc. and Chair, 2016 PDA Universe of Prefilled Syringes & Injection Devices Program Planning Committee

8:30 a.m. – 10:00 a.m.
P1 - Navigating the Ecosystem of Connected Health
Moderator: Olivia Henderson, PhD,
Principal Engineer, Amgen, Inc.

Session Description: Innovation and connectivity are two watchwords that define our current times. When we combine the two in patient health, the opportunity to improve patient's health is enormous. But this new opportunity still needs to comply with regulatory standards, and this can be a difficult area to navigate through. This session's speakers will give us insights for guiding the new technologies through the existing requirements.

8:30 a.m. - 9:00 a.m.
A Value-Creation Framework for a Smart Device Ecosystem
Sundeep Kankanala,
Vice President, Research & Development, BD Medical - Pharmaceutical Systems

9:00 a.m. - 9:30 a.m.
Connectivity in Drug Delivery and Smart Administration: Improving Compliance, Patient Training and Supply Chain Visibility by Applying New Electronic Technologies
Markus Bauss,
Managing Director, SHL Connect, SHL Group

9:30 a.m. - 10:00 a.m.
Questions & Answers/Discussion

Markus Bauss, Managing Director, SHL Connect, SHL Group
Sundeep Kankanala, Vice President, Research & Development, BD Medical - Pharmaceutical Systems
LCDR Keith Marin, Senior Regulatory Review Officer, CDRH, FDA

9:45 a.m. - 3:45 p.m.
Exhibit Hall Open

10:00 a.m. - 10:45 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall Sponsored in part by Aptar Stelmi

Poster Presentations
The posters listed below will be presented during Monday’s refreshment breaks.

Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms Impacting Precision of Low-Volume Fill by Peristaltic Pump
Wendy Shieu,
Engineer II, Genentech, A Member of the Roche Group

Device Training Research - Simulating the Force Profile of a Prefilled Syringe
Joe Jensen,
Director of Marketing Communications, Noble

Silicone and Tungsten Differences among Various Syringes and their Impact on Functionality
Leigh Bohack,
Formulation Scientist, Pfizer, Inc.

Next Generation Packaging: Stability of a Bisphosphonate Drug in Barrier Coated Vials
Scott Arra,
Director, Product Development, SiO2 Medical Products

Feasibility Testing, Cycle Development and Validation Guidance for VHP Low Temperature Surfaces Terminal Sterilization - Possibilities to Improve Packaged Product Quality and Simplify Aseptic Packaging Process
Juha Mattila,
Senior Product Manager, Steris Finn-Aqua

The Effects of Surfactant on Protein Aggregation with a Silicone-Oil-Free Polymer based Syringe System
Hideaki Kiminami,
Research Manager, Terumo Corporation

Thermal Treatment of Hyaluronic Acid Pre-filled Syringes: Challenges to Overcome
Samantha Kay,
Microbiologist, Fedegari Technologies, Inc.

Component Selection Strategies for PFS- Risk Mitigation, Performance, and Larger Injection Volume Driving Innovative Solutions
Royce Brockett,
Senior Manager, Pre-filled Syringes, West Pharmaceutical Services, Inc.

Wearable Pumps: Assessment of a Novel Universal Injection Mechanism
Harshal Shah,
Vice President, Global Medtech Division, Cambridge Consultants

The Influence of Device Lubrication on Infusion Pump Response Time and Dose Accuracy
Jackson Thornton, PhD,
Associate Director of Research, TriboFilm Research, Inc.

Oxygen Permeation Rates Through Syringe Components
James Veale
, President, Lighthouse Instruments

Smart Material Selection for Complex Drug Delivery Devices
Willem Vos,
Medical Application Development Engineer, Celanese

The Value of Cyclic Olefin Copolymer in Designing Drug Containers for use within Autoinjectors - in Particular, for Delivery of Highly Viscous Drugs
Susanna White,
Mechanical Engineer, Oval Medical Technologies

Overcoming Connectivity Challenges Associated with Utilization of Glass Syringes with Needle Free Access Devices for IV Injections
Nicolas Deleuil,
New Product Development Core Team Leader, BD Medical - Pharmaceutical Systems

Adjusting and Controlling Injection Speed into an Auto-injector by Design. Could this Positively Impact Patient Pain Perception, Specifically for Viscous and Large Volume Injections?
Pascal Dugand,
Technology Product Manager, Nemera

Designing Medical Studies to Demonstrate Safe and Effective use of Medical Devices, while Assessing End-User Perception on Product Values at the Same Time
Karen Roesch
, Clinical Development Manager, BD Medical - Pharmaceutical Systems

Evaluation of a Rapid Method for Sterility Testing of an Extended-release Injectable Suspension in Pre-filled Syringes
Patricia Rule,
Senior Staff Scientist, Industry Affairs, bioMerieux

Integrating Patient and Therapeutic Needs: Characterizing and Optimizing Injection Depth to Improve Control of Drug Delivery and Patient Ease of Use
Florence Schwarzenbach, PhD,
World Wide Senior Clinical Development Manager, BD Medical - Pharmaceutical Systems

Stability of Pharmaceutical Proteins in Cyclo Olefin Polymer (COP)
Shotaro Suzuki,
Chief Researcher, Zeon Corporation

Addressing the Challenge of High Demanding Drug Introducing a New Generation of Glass Pre-fillable Syringe
Alessandro Morandotti,
Product Manager, Syringes, Nuova Ompi

Stability of Pharmaceutical Proteins in Cyclo Olefin Polymer (COP)
Shota Arakawa,
Researcher, Mitsubishi Gas Chemical Company, Inc.

Is it Really too Viscous to Inject? An Introduction to an Innovative Powerpack Technology that is Addressing the Challenge of how to Inject Highly Viscous Formulations
Steven Kaufman,
Global Business Development Lead, Bespak

10:45 a.m. - 12:15 p.m.
P2 - Ensuring the Patient is the Focus of Improving Drug Delivery Devices
Moderator: Adalberto Ramirez,
Vice President, Quality, Amgen, Inc.

Session Description: With an increasing trend towards self-administration and treatment outside of a clinical environment, it is becoming more critical to understand the needs of the patient, and ensure that drug delivery devices are designed and deployed with the patient in mind. This session will consider ways to improve patient outcomes through consideration of user needs analysis, design for affinity, human factors, training/onboarding and ways to improve patient adherence.

10:45 a.m. - 11:15 a.m.
A Branded Class I Mobile Medical App
Aaron Connor,
Consultant Engineer, Delivery Device Research & Development, Eli Lilly & Company

11:15 a.m. - 11:45 a.m.
Effective Patient Training and Onboarding for Wearable Injection Devices
Chris Evans,
Vice President, Research & Innovation, West Pharmaceutical Services, Inc.
Joe Reynolds,Research Manager, Design & Engineering, Noble

11:45 a.m. - 12:15 p.m.
Questions & Answers/Discussion

12:15 p.m. - 1:30 p.m.
Networking Lunch - Sponsored in part by Owen Mumford

1:30 p.m. - 3:00 p.m.
Concurrent Sessions

A1 - Key Ingredients of Effective Partnerships
Moderator: Christina Braden-Moore
, Marketing Director, BD Medical - Pharmaceutical Systems

Session Description: Developing innovative drugs is complexed and involves the seamless coordination of various industry players. This session will discuss how effective partnerships between drug and device manufacturers are critical for optimizing combination product development and time to market to ensure patients receive high quality drug treatments.

1:30 p.m. - 2:00 p.m.
Collaborative Partnership between Device Manufacturers and Pharmaceutical/Biopharma Companies to Ensure Optimized Combination Products for Injectable Drugs
Tom McLean,
Vice President, Delivery Systems, Research & Development, West Pharmaceutical Services, Inc.
Bill Rich, Vice President, Device Technologies, Amgen Inc.

2:00 p.m. - 2:30 p.m.
Three Months from Concept to Demo: Mobile Device Case Study
Amanda Black,
Strategic Account Manager, BD Medical - Pharmaceutical Systems
Andy Rogers, Director of Business Development, KeyTech, Inc.

2:30 p.m. - 3:00 p.m.
Questions & Answers/Discussion

B1 - Will Recent Advances in Secondary Packaging Help Meet the Challenges of Glass Breakage?
Moderator: Brigitte Reutter-Haerle,
Director, Corporate Marketing, Vetter Pharma International

Session Description: The choice of secondary packaging for today's increasingly complex compounds is crucial, requiring comprehensive expertise and sophisticated design in order to help achieve success in advanced injectable drug delivery. This is particularly true in the fill/finish and assembly process of glass cartridges when the complexity of combining primary and secondary packing can lead to defects and breakage. This session provides focus on the evolving injectable market and offers ideal solutions that help meet complex secondary packing challenges. Global market trends and recent technological advancements in design that help meet existing and unmet needs, as well as improvements in handling of glass cartridges are revealed. An examination of the growing healthcare cost curve and how device technology can make an impact in producing measurable patient outcomes is featured. Questions that focus on complex packaging challenges and how to achieve optimal market potential are addressed.

1:30 p.m. - 2:00 p.m.
Global Market Trends for Advanced Combination Products – How Innovations can Contribute to Better Patient Outcomes
Mathias Romacker,
Senior Director, Device Strategy, Pfizer, Inc.

2:00 p.m. - 2:30 p.m.
Case Study: Reduction of Glass Breakage in Pharmaceutical Process, a Systematic and Practical Approach
Mads Reedtz Espersen,
Principal Specialist,Primary Packaging Development, Novo Nordisk A/S

2:30 p.m. - 3:00 p.m.
Questions and Answers/Discussion

3:00 p.m. - 3:45 p.m.
Refreshment Break, Poster Presentations and Passport Raffle in Exhibit Hall - Sponsored in part by Aptar Stelmi

3:45 p.m. - 5:15 p.m.
Concurrent Sessions

A2 - Connectivity: Data Collecting from Patient Behavior
Moderator: Georg Roessling, PhD,
Senior Vice President, PDA Europe

Session Description: It started with hardware to improve convenience of drug application. From vials or ampoules to pre-filled syringes and as a next step syringes or cartridges into human factor designed devices like autoinjectors, peans and wearables. This session will give you insights into the developments how electronics can be implemented in devices, making them "intelligent." Electronics can help describing the application procedure and also can collect data how the application was performed.The collected data can be assessed and used e.g. to modify the application. Technical examples will be given and potentials for the future will be discussed.

3:45 p.m. - 4:15 p.m.
Hands-On Approach to Developing an Optimized Connected Drug Delivery Device System
Hans Jensen,
Senior Business Development Manager, Medicom Innovation Partner

4:15 p.m. - 4:45 p.m.
Smart Devices & Patient-Centered Design
Paul Upham, Senior Principle Manager, Genentech, A Member of the Roche Group 

4:45 p.m. - 5:15 p.m.
Questions & Answers/Discussion

B2 - Current Issues Regarding Silicone-Oil Induced Protein Aggregation: A Cause for Immunogenicity Effects?
Moderator: Christian Helbig
, Head of Global Business Development Syringe, SCHOTT Schweiz AG

Session Description: At a recent public EMA workshop the topic of immunogenicity caused by protein aggregates was discussed.
This session addresses one aspect which is the aggregation caused by silicon oil which is used as lubricant in syringes and cartridges. In-vitro data and clinical data will be presented to describe current knowledge in the field.

3:45 p.m. - 4:15 p.m.
Silicone-Oil Induced Protein Aggregation & Immunogenicity
John Carpenter, PhD,
Professor of Pharmaceutical Sciences, School of Pharmacy, University of Colorado

4:15 p.m. - 4:45 p.m.
A Structurally-Perturbed Model Protein Adsorbed to Silicone Oil Microdroplets Does Not Break Immunological Tolerance
Jack Ragheb, MD, Senior Medical Fellow for Immunogenicity, Eli Lilly & Company 

4:45 p.m. - 5:15 p.m.
Questions & Answers/Discussion

7:00 p.m. - 10:00 p.m.  
Seaside Social

Sponsored in part by Genentech, A Member of the Roche Group

Tuesday, October 18, 2016

7:00 a.m. - 8:30 a.m.
Continental Breakfast

7:00 a.m. - 5:30 p.m.
Registration Open

7:15 a.m. - 8:15 a.m.
Breakfast Sessions

Breakfast I: Fill/Finish Machinery  
Leader: Wenzel Novak, PhD, Market Development Director, Pharma, Optima Machinery Corporation

Session Description: To kick the session off, a case study on the importance of the sterilization method of prefillable syringe for the biopharmaceutical drugs based on the results of extractable/leachables study, protein oxidation and aggregation will be presented. Results from a comparison between the effects of an irradiated polymer syringe, Ethylene Oxide Gas (EtO) and steam sterilized syringes will be disscussed. The second presentation will address continued advances in ready to use components in  the pharmaceutical/biotechnology industry. A highly flexible filling and closing machine for the processing of Ready-to-Use components will be highlighted.  The systems can process all types of syringes, vials and cartridges in nested and bulk format and can encompass all dosing features to ensure high product yield. Equipped with an innovative transport system that process vials, syringes and cartridges without any format change parts, giving the end user the ultimate flexibility to quickly response to all market/production demands.

7:15 a.m. - 7:35 a.m.
The Impact of Sterilization Methods on Protein Stability in Polymer-Based Syringes
Koji Nakamura, PhD, Senior Manager, Business Development, Terumo Corporation

7:35  a.m. - 7:55 a.m. 
Changing Production Strategies: Latest Trends in Manufacturing Flexibility
Mevluet Yilmaz, Sales Manager, Optima Machinery Corporation

7:55 a.m. - 8:15 a.m.
Questions & Answers/Discussion

Breakfast II:  Even "Off the Shelf" Devices May Need Design Controls when Used as Part of a Combination Product
Moderator: David Haase, Senior Manager, Device Development, Genentech, A member of the Roche Group

Session Description:The first presentation in this session will compare difference between traditional medical device going through device development process (design control) with use of an OTS device for combination product. In addition, it will highlight three key points of consideration when selecting an OTS medical device.  Each of these three key points will be supported by a mini-case study which provide examples of the benefits of taking the OTS device through the design control process. The next presentation will focus on what's needed in early development to use an "Off the Shelf" device in early clinical trials. Selecting the right level of design control is key to being compliant to regulations while getting to the clinic quickly with the right system.

7:15 a.m. - 7:35 a.m.
Development Activities Associated with a One-Way Label Reference for a Device for Clinical Use  
Ariel Waitz, Senior Engineer, Device Development, Genentech, A member of the Roche Group

7:35  a.m. - 7:55 a.m.
How to Approach Design Controls when the Combination Product uses an Off-The-Shelf Device
Lilli Zakarija, President, EdgeOne Medical 

7:55 a.m. - 8:15 a.m.
Questions & Answers/Discussion

Breakfast III:  Particles in Injectables: How to Avoid and Inspect
Moderator: Georg Roessling, PhD, Senior Vice President, PDA Europe

Session Description: One of the major reasons of product recalls are particles in injectables. Such extraneous particles can come from the containers, elastomers and are introduced during the fill finish process. Therefore it is most important to avoid the introduction of particles and also have effective visual inspection procedures in place. In this session a laser-based glass cutting process will be presented which reduces the number of glass particles in the container and two presentations show approaches to detect particles in the visual inspection process.

7:15 a.m. - 7:30 a.m.
3D Inspection: A New Approach of an Old Challenge
Peter Grassl, Area Sales Manager, Seidenader Maschinenbau GmbH

7:30 a.m. - 7:45 a.m.
Implementation of Laser Treatment-Technology in the Manufacturing Process of Pre-filled Syringes (PFS)
Philippe Lauwers, Business Unit Director, PFS, Nipro PharmaPackaging

7:45 a.m. - 8:00 a.m.
Particle & Fiber Detection in CZ Plastic Cartridges & Syringes Filled with Viscous Products: A Practical Case
Al Goodwin, Principal Engineer, Global Manufacturing Science & Technology, Amgen, Inc.
Massimo Frasson, General Manager, Brevetti C.E.A. S.p.A.

8:00 a.m. - 8:15 a.m.
Questions and Answers/Discussion

8:30 a.m. - 10:00 a.m.
P3 - Global Regulations & Standards Related to Prefilled Syringes & Injector Devices
Moderator: Kathy Lee,
Senior Regulatory Advisor, Eli Lilly & Company

Session Description: The regulatory landscape for prefilled syringes and injector devices is complex. The US FDA regulates prefilled syringes and injector devices as combination products, where two quality systems must align. For legacy products this can be very challenging. What information should be update or created to meet regulatory expectations? Where should this information reside and how should it be provide and when? This session will focus on talks from the US FDA and a case study to help shed light on these important questions.

8:30 a.m. - 9:00 a.m.
Regulatory Perspectives on Healthcare Technologies
LCDR Keith Marin, Senior Regulatory Review Officer, CDRH, FDA

9:00 a.m. - 9:30 a.m.
Bridging Design and Documentation: A Look into Design Control Strategy for a Legacy Vaccine
Anelyn Tolentino,
Senior Manager, Process Development, Pfizer, Inc.

9:30 a.m. - 10:00 a.m.
Questions and Answers/Discussion

9:45 a.m. - 3:45 p.m.
Exhibit Hall Open

10:00 a.m. - 10:45 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall

Poster Presentations
The posters listed below will be presented during Tuesday's refreshment breaks.

In Vivo Model for Fluoroscopic Imaging of Large Volume Injections at a Range of Viscosities and Flow Rates
Natasha Bolick,
Manager, BD Technologies

Seizure of Piston Pump from High Viscosity mAb
Cassandra Mifkovich,
Senior Scientist/Engineer, Merck & Company, Inc.

Protein Aggregation Control in Parenterals
Oliver Valet, PhD,
Managing Director, Rap.ID Particle Systems GmbH

Industrialization of a Product for Pulmonary Arterial Hypertension
Peter Noymer, PhD,
Executive Vice President of Research & Development & Chief Technology Officer, SteadyMed Therapeutics

Protein Absorption and Aggregation Study for Glass and COP Pre-fillable Syringes
Yoshihiko Ikeguchi, PhD,
Manager, Taisei Kako Co.,Ltd.

Biopharmaceutical Drug Oxidation from Effects of Radicals upon Sterilization of Ready to Fill Polymer-Based Syringes
Sayaka Shinoda,
Research Scientist, Terumo Corporation

Enhancing Performance & Durability of Glass Syringes
Janice Adkins,
Marketing, Pharmaceutical Systems, BD Medical - Pharmaceutical Systems

Understanding and Improving Syringe Performance Through Finite Element Analysis
Susan Dounce, PhD,
Senior Manager, Business Development & Innovation, Datwyler

Single Use Technologies Require Close Collaboration between Technology Partners and End Users
Jessica Frantz,
Product Marketing Manager, Sartorius Stedim Biotech

Complete Characterization of a Biological and its Biosimilar by Integrating Multiple Particle Characterization and Biophysical Techniques
Aaron Krueger, PhD,
Postdoctoral Fellow, University of Colorado, School of Pharmacy

Demonstrating Highly Consistent Performance of an Autoinjector Incorporating a Novel Pre-filled Cyclic Olefin Container and Cup Seal and Foil Technology
Jonathan Lawson,
Design Engineer, Oval Medical Technologies

Cartridge Based Containment Systems: A Review of Component Fit and Functional Performance Data for Plungers and Lined Seals
Andrea Straka,
Supervisor, Scientific Communications, West Pharmaceutical Services, Inc.

Medical Device Assembly - End User Needs and Perspective on Market Trends
Kim Veng Christensen,
Area Sales Manager, Bosch

New CCIT Inspection Technology for all Parenteral and Biologic Products
Heinz Wolf,
General Manager, PTI Inspection Systems

Bolus Injection - High Volume High Viscosity Fluid delivery Challenges, Simulating the Patient's Skin Response to a Large Volume Injection
Uri Baruch,
Drug Delivery Sector Head, Cambridge Design Partnership

A Novel, Streamlined Approach to Instruction for Use Design and Development in Drug Delivery
Annie Diorio-Blum,
Principal Design Research Lead, Battelle

Breaking the 1mL Barrier: A New Pre-fillable Syringe for the Delivery of Higher Volumes of Injectable Biologics
Christian Herget, PhD,
Worldwide Strategic Marketing Leader, Biotech, BD Medical - Pharmaceutical Systems

How to Predict Formulation Instabilities in contact with Pre-filled Syringes
Tzvetelina Tzvetkova-Chevolleau
, Research & Development Senior Scientist, BD Medical - Pharmaceutical Systems

Rheumatoid Arthritis Patients and HCPs prefer using a Button-less Auto-injector: A Crossover Preference Study
Jennifer Soosaar, PhD, Director, Core Human Factors, Inc.

Impact of Delivery Systems on Manufacturing Strategies: A Look into Upcoming Aseptic Trends
Elizabeth (Lisa) Dorn, Associate, Senior Process Engineer, CRB

Human Factors Engineering of the Abatacept Pre-Filled Auto-injector for  the Subcutaneous Treatment of Rheumatoid Arthritis
Erik Jin, PhD, Principle Engineer, Concept Development, Bristol-Myers Squibb

Assessment of Risk to Sterility of Pre-filled Syringes due to Vacuum Conditions Experienced during Ground and Air Shipment at High Altitude
Lisa Rising, Associate Scientist, Biotherapeutic Formulation, Pfizer, Inc.

Combination Drug Delivery Products: Trust and Strong Relationships at the Heart of Successful Drug Delivery Device Development
Andy Wertheim, Senior Account Manager, Owen Mumford Limited

10:45 a.m. - 12:15 p.m.
Concurrent Sessions

A3 - Innovative Containment & Delivery Systems for Today's Challenging Biologics
Moderator: Shawn Kinney, PhD,
Chief Executive Officer, Berkshire Sterile Manufacturing

Session Description: With the advent of more sophisticated and challenging biologic drugs, the selection of appropriate containment systems becomes more critical. This session will explore innovations in the area of Prefilled syringe systems, focusing on the elimination of silicone oil, and the transition towards polymer container systems for enhances performance.

10:45 a.m. - 11:15 a.m.
Silicone-Free Pre-Filled Syringes: From Feasibility to Reality
Jeffrey M. Brake, PhD,
New Product Development Associate, W.L. Gore & Associates, Inc.
Nicolas Eon, PhD, Product Manager, Glass Syringes, SCHOTT Pharmaceutical Packaging

11:15 a.m. - 11:45 a.m.
Polymer Container Systems- Perspective from Biopharma Drug & Container Manufacturer
Ronald Forster, PhD,
Executive Director, Device & Final Drug Product Technologies, Amgen, Inc.
Scott Young, PhD, Vice President, Container Systems, West Pharmaceutical Services, Inc.

11:45 a.m. - 12:15 p.m.
Questions and Answers/Discussion

B3 - International Regulatory Pathways for Auto-Injectors & Pens
Moderator: Lee Leichter,
President, P/L Biomedical

Session Description: As we know, combination products are comprised of any combination of a drug and a device. This said combination product remains subject to the regulatory requirements associated with its constituent parts. As several pharmaceutical companies have successfully launched several similar combinations products embedding a prefilled syringe in different regions of the world, we assume that an original regulatory strategy support all these successes.

10:45 a.m. - 11:15 a.m.
Success in a Global Launch of Combination Products
Manfred Maeder, PhD,
Head, Device Development & Commercialization, Novartis Pharma AG

11:15 a.m. - 11:45 a.m.
Differences and Similarities between Europe & US Registration Strategies
Mark Chipperfield,
Principal Consultant & Company Director, Corvus Device Limited

11:45 a.m. - 12:15 p.m.
Questions and Answers/Discussion

12:15 p.m. - 1:30 p.m.
Networking Lunch - Sponsored in part by Owen Mumford

1:30 p.m. - 3:00 p.m.
Concurrent Sessions

A4 - Manufacturing Equipment Innovation
Moderator: Olivia Henderson, PhD,
Principal Engineer, Amgen, Inc.

Session Description: Innovation is the watchword recently, but it doesn't stop with cell phone apps, new materials of construction, or new ways of collecting and interpreting data. Innovation may also refer to new or more efficient manufacturing modalities. This session will present new manufacturing technology and innovative ideas that can increase efficiency and reliability, thereby enabling patients to maintain full accessibility to innovative medications.

1:30 p.m. - 2:00 p.m.
Innovative Sterile Manufacturing System for Multiple Primary Container Types, Sizes and Presentations
Shawn Kinney, PhD,
Chief Executive Officer, Berkshire Sterile Manufacturing

2:00 p.m. - 2:30 p.m.
Drug Product Cutting Edge Technologies and How Cutting Edge Technologies can Reduce Regulator Risk and Reduce the Validation Burden
Sean Goudy, PhD,
Associate Director, Biogen

2:30 p.m. - 3:00 p.m.
Questions and Answers/Discussion

B4 - Primary Container Innovation
Moderator: William Dierick,
Director, Technology Development, Terumo Europe N.V.

Session Description: Over the past decades, parenteral drug development has been driven by the rapid growth of therapeutic protein development, now one of the main technology developments of the 21st century. The production of biological drugs is a complex and inherently unstable situation, requiring special handling and storage. Therefore, there are important inter-related areas in the development of these drugs with the primary drug container system. This session will inform the audience about the progress of innovation related to primary drug containers in support of improving drug efficacy and patient safety.

1:30 p.m. - 2:00 p.m.
Extractables Study on COP Polymer Prefilled Syringes having a focus on Biotherapeutics
Kevin Constable,
Senior Director of Technology Development, Terumo Medical Corporation
Piet Christiaens, PhD, Scientific Director, Toxikon

2:00 p.m. - 2:30 p.m.
Next Generation Lubricant Technology for Parenteral Syringes and Cartridges
Christopher Weikart, PhD,
Director, Research & Development, SiO2 Medical Products

2:30 p.m. - 3:00 p.m.
Questions and Answers/Discussion

3:00 p.m. - 3:45 p.m.
Refreshment Break, Poster Presentations & Passport Raffle in Exhibit Hall

3:45 p.m. - 5:15 p.m.
P4 - Global Market Trends
Moderator: Wenzel Novak, PhD,
Market Development Director, Pharma, Optima Machinery Corporation

Session Description: Globalization covers more and more different requests by indication, regulatory and technical aspects on the same product. During all phases clinical studies have to consider worldwide aspects and differences. Two case studies will reflect the effective respond to the global market needs.

3:45 p.m. - 4:15 p.m.
Placebo Challenges in a Clinical Study using an Auto-injector: What are the Considerations and How to Pick the Right Placebo Formulation
Horst Koller,
Chief Executive Officer, HK Packaging Consulting GmbH
Oliver Kooistra, PhD, Project Manager, medac GmbH

4:15 p.m. - 4:45 p.m.
Specialized Injection Devices for Contraception & Nerve Agent Attacks
Kevin Wolter, MD, PhD, ​TA Group Lead, ​Pfizer, Inc.

4:45 p.m. - 5:15 p.m.
Questions and Answers/Discussion

5:15 p.m.
Closing Remarks and Adjournment
Olivia Henderson, PhD,
Principal Engineer, Amgen, Inc.. and Chair, 2016 PDA Universe of Prefilled Syringes & Injection Devices Program Planning Committee

Conference Registration | October 17-18


Before August 5, 2016

August 5- September 2, 2016

After September 2, 2016


Before August 5, 2016

August 5- September 2, 2016

After September 2, 2016

Government/Health Authority/Academic


Before August 5, 2016

August 5- September 2, 2016

After September 2, 2016


Before August 5, 2016

August 5- September 2, 2016

After September 2, 2016



Before August 5, 2016

August 5- September 2, 2016

After September 2, 2016


Before August 5, 2016

August 5- September 2, 2016

After September 2, 2016

Workshop Registration | October 19

Member | Nonmember


All prices in US dollars.

* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund and photo release policies for this workshop.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 5th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by August 18, 2016 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a nonmember substituting for a member, you will be required to pay the difference nonmember fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Workshop/Events: If your written request in received on or beforeAugust 18, 2016, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Recordings are prohibited at all PDA conferences.

Hyatt Regency Huntington Beach Resort and Spa
21500 Pacific Coast Highway
Huntington Beach, CA 92648
Phone: +1 (714) 698-1234

They will secure the lowest available rates at the best available hotels within walking distance of The Hyatt Regency Huntington Beach & Spa Resort.

Reservations processed by A Room With A View are automatically put on a waitlist for rooms at The Hyatt Regency Huntington Beach & Spa Resort should cancellations occur within The PDA group block.

A Room with a View can be contacted at 1-800-780-4343
Monday- Friday 8am – 5pm CST
International attendees can reach them at
This is a FREE SERVICE for all PDA attendees


Area Airports
John Wayne Orange County Airport (SNA) is approximately 10 miles from the hotel and all major carriers service this airport. One other airport in the vicinity serviced by all major carriers: Los Angeles International (LAX), 37.8 miles away.

Ground Transportation
Taxi fares from John Wayne Orange County (SNA) are approximately $28 one way, not including tip, and will take about 21 minutes. One way taxi fares from Los Angeles International (LAX) is approximately $90, not including tip, and will take about 46 minutes. 

Hyatt Regency Huntington Beach hotel is located on 21500 Pacific Coast Highway.

Hotel Parking
Valet Parking only, $35.00 overnight (car must be parked by 9:00 p.m.  Daily Valet is $20.00 for 12 hours.  Self-parking is available across street from hotel.

The 2016 PDA Universe of Pre-filled Syringes & Injection Devices will provide your company exclusive exhibit and sponsorship opportunities to gain access to and network with hundreds of key decision makers from the biopharmaceutical science and manufacturing industry. Become a sponsor and/or exhibit at this industry-leading event to connect with industry thought leaders, showcase new products and services, strengthen your brand image, increase your visibility, grow your business and show your company’s strong commitment to the industry. This is a must-attend event for all industry professionals involved in the development, manufacturing or use of pre-filled syringes and injection devices.

For exhibit and/or sponsorship information, please contact:

David Hall
Vice President, Sales
Direct: +1 (301) 760-7373 Cell: +1 (240) 688-4405 E-mail:

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