Global Event Calendar and Registration

2014 PDA Universe of Prefilled Syringes and Injection Devices

Improving Patient Outcomes through Innovation
Oct 06 - Oct 07, 2014 |
Oct 07, 2014 |
Hyatt Regency Huntington Beach Resort and Spa | Huntington Beach, CA
  • Conference
October 6-7
October 8
October 9-10
Networking Events

Listen to Shawn Kinney, PhD, Berkshire Sterile Manufacturing and Planning Committee Member, speak about the 2014 PDA Universe of Prefilled Syringes and Injection Devices.

Program Highlights

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This is the premier conference where industry leaders can meet with colleagues from drug and biologic manufacturing, suppliers, regulatory professionals and academicians from around the globe, who will discuss today’s challenges with drug delivery and packaging technologies, formulation development and improving patient outcomes.

Plenary sessions include expert talks from Ernst & Young, connectMeSmart, Amgen, Mylan, the U.S. FDA and the European regulators.

FDA’s Lana Shiu, MD, Director, Regulatory, Center for Device and Radiological Health, will speak in the third plenary session of the meeting to discuss challenges and pitfalls for marketing applications when prefilled syringes, auto-injectors and combination products are referenced. Just confirmed for Session B4 Binh Nguyen, Investigator, ORA, FDA address issues related to Supply Chain.

Speaker Biographies

With tremendous progress in the past decade, drug delivery continues to face challenges meeting the market needs of improving administration, compliance, safety, costs, and accuracy;  even more important, by taking an integrated approach to develop prefilled syringes and injection devices for tomorrow's success in assuring a positive patient experience.

New advances in materials of construction, manufacturing processes, injection processes and safety devices, and other technology improvements create a dynamic environment in the drug delivery device arena. Regulatory requirements, industry experience and evolving market trends are critical considerations to ensure a complete understanding of the application of pre-filled syringes and injection devices to drug delivery. The challenges of new product introduction and support of existing products require that companies be aware of new developments.

The topics at the 2014 PDA Universe of Pre-filled Syringes and Injection Devices 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, marketing or use of  pre-filled syringes and injection devices.

Sessions will cover topics such as:

  • Quality Infrastructure and Issues
  • New Technologies and Trends in Manufacturing Processes
  • Case studies
  • Human Factors/Usability
  • Injection Devices: Critical Attributes and Risk Management
  • Regulatory and Compliance Aspects Such as Combination Products
  • New primary Containers, Safety Devices, and Delivery Systems
  • Global Market Trends

Learning Objectives

At the completion of this conference, attendees will:

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

Who Should Attend

Department
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

Wanda Neal
CMP, Senior Vice President, Programs and Registration Services
Tel: +1 (301) 656-5900 ext. 111 
Email: neal@pda.org

Jason E. Brown
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 131 
Email: brown@pda.org

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition Inquiries

David Hall
Vice President, Sales 
Tel: +1 (301) 656-5900 ext. 160 
Email: hall@pda.org

Preliminary Program Agenda as of August 25, 2014

Sunday, October 5, 2014

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

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

5:00 p.m. - 6:00 p.m.
2014 PDA Universe of Prefilled Syringes and Injection Devices Program Planning Committee Meeting (Committee members only)

Monday, October 6, 2014

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

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

8:15 a.m. - 8:30 a.m.
Welcome and Opening Remarks
Adalberto Ramirez, Vice President, Quality, Amgen, Inc. and Chair, 2014 PDA Universe of Prefilled Syringes and Injection Devices Program Planning Committee

8:30 am. - 10:00 a.m.
P1 - Opening Plenary Session: Focus on Innovation
Moderator: Adalberto Ramirez, Vice President, Quality, Amgen, Inc.

The health care industry has made enormous progress in bringing new products to the market to improve patients’ quality of life. We are fortunate to see that innovation continues to flourish for the benefit of the patients. Despite all the challenges in the innovation process, the results are encouraging.  We still need to improve in the administration, compliance, safety, costs and accuracy of dosing by taking integrated approaches to develop drug delivery systems that help improve patient’s quality of life.  Aging populations, increased regulatory scrutiny, increased competition in global markets, cost pressures and protecting the supply chain are among the many challenges faced by our industry. New advances in materials of construction, automated manufacturing processes, injection processes, safety devices and technology improvements create a dynamic environment in the drug delivery device arena. You innovate or your business will face very difficult challenges.

In this session, we will share the reality of the industry through the Global Life Sciences report and will discuss the essential parts of innovation in combination products. The focus of these presentations is on the new developments that will help improve patient compliance and therefore improve their quality of life. We will share experiences, new developments, regulatory considerations, challenges and industry trends in this exciting area.

8:30 a.m. - 9:00 a.m.
Progressions: Pharma 3.0
Glen Giovannetti, Global Life Sciences Leader, Ernst & Young
Sponsored by Unilife

9:00 a.m. - 9:30 a.m.
Essential Parts of Innovation in Combination Products: Improving Patient Outcomes
Sheldon Moberg, Vice President - Drug DeliveryAmgen, Inc.

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

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

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

10:00 a.m. - 10:45 a.m. and 3:00 p.m. - 3:45 p.m. 
Preliminary Poster Presentation Listings
Poster presenters will be available at their displays to answer questions during refreshment breaks and the networking reception

50ml Device Evaluation: Observation of 1270 Infusions with Syringe Pumps Validating Better Infusion Performance and Improved Safety for the Patient and the Healthcare Worker
Cécile Berteau, Clinical Project Manager, Medical Affairs, BD Medical, Pharmaceutical Systems

Human Factors Usability Testing on a New Hollow Microstructured Transdermal System (hMTS) Injector
Allan Bohlke, PhD, hMTS Project Leader - MTS Technology and Product Development, 3M

Technical Data update on Cyclic Olefin Polymer (COP) 
Brian Cail, Vice President - New Business Development, Zeon Chemicals L.P

Safe Auto-Needles (SANs) Case Study: Market Research Uncovering Patients' Unmet Need and Usability Studies with Patients Using the SANs for this Unmet Need
David Daily, Chief Executive Officer, DALI Medical Devices

Factors Influencing the Selection and Development of Delivery Devices:  Can Device Features Help Reduce Patient Discomfort During Injection?
Mark Di Cioccio, Managing Consultant, Team Consulting Ltd.

Assessment of Acceptable Subcutaneous Injection Volumes and Flow Rates
Diane Doughty, PhD, Scientist II - Drug Delivery & Devices, MedImmune

Image filtering techniques and impact of light level on Automated Inspection
Massimo Frasson, General Manager, Brevetti CEA
Jean-Michael Tasserit,
Referent Mirage Automatique, Aspen

Comparing HPLC and UPLC Methods for the Determination of Related Compounds in a Compendial Adrenaline Injection Product
Edwin Hoppenbrouwers, Research & Development Technical Director - ADT, Catalent Pharma Solutions

Ethnographic Research for the Investigation of Compliance and Persistence Issues related to Various Treatment Indications
Felix Jiang, Human Factors Engineer, Genentech, Inc.

Achieving Successful Medical Device Design by Early Material Selection
Wim Vos, Application Development Engineer, Celanese

Sterilization Methods for Pre-fillable syringes (PFS)  X-Ray Sterilization  a More “Green” Alternative,  Case Study: X-ray Sterilization for COC Polymer PFS
Horst Koller,  Head of Techical and Quality Support Syringes, Schott Schweiz AG

A Novel, Wearable Pre-Filled System for Large Volume Drug Delivery
Peter Noymer, PhD, Executive Vice President of R&D and CTO, SteadyMed Therapeutics

Case Study: Precision Torque Monitoring & Precision Label Application for Pre-filled Syringe Assembly
Alex Wardell, Director, Kyoto America, Inc.


10:45 a.m. - 12:15 p.m.
P2 - What’s Hot in New Technologies & Devices? Are We Ready for Smart Phone Applications in the Industry?
Moderator: Brigitte Reutter-Haerle, Director, Corporate Marketing, Vetter Pharma International
This session offers attendees an opportunity to learn more about an exciting new PFS and microliter dosing technology system for the treatment of patients with age-related macular degeneration that offers significant advantages over conventional vials in regards to safety, efficacy, and compliance. A second presentation challenges attendees with thought provoking information, combined with supporting case studies, on the seemingly limitless use of smartphone apps with the potential to revolutionize our industry by improving patient safety and education, and improve upon on the overall effectiveness of drug devices. Guidance on their use and current regulatory oversight is reviewed.

10:45 a.m. - 11:15 a.m.
Drug Injections Into The Eye : Unmet Clinical & Compliance Needs, Opportunities for Novel Microliter Dosing PFS
Anil Busimi,  Head of Product Management - Syringe Business, Schott Schweiz AG
Gautam Shetty, PhD , Director and General Manager, Advanced Drug Delivery Systems, Unilife

11:15 a.m. - 11:45 a.m.
Connecting Drug Delivery Devices to Smartphone Applications and Mobile Medical Apps – Opportunities for Better Patient Compliance & Education or Regulatory Hurdle that Pharmaceutical Companies are Not Ready to Take? 
Marcus Bauss, CEO, ConnectMeSmart GmbH

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

12:15 p.m. - 1:30 p.m.
Lunch

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

1:30 p.m. - 3:00 p.m.
A1: Improving Patient Outcomes through Compliance and Adherence
Moderator: David Haase, Senior Manager, Device Development, Genentech, Inc.
1:30 p.m. - 3:00 p.m.
B1 - Trends and Challenges in Formulation & Development
Moderator:  Christina Braden-Moore, Director - Marketing, Pharmaceutical Systems, North America, BD Medical, Pharmaceutical Systems
For a patient new to taking a drug that requires use of a device , the event can be intimidating or not totally understood. That can lead to a sub-optimal patient outcome. This session will focus on how to effectively get the patient started and trained in a way that gives them confidence in properly using their device. In addition we will look at innovative features designed into some devices that encourage better adherence to their dosing regimen. Together these approaches can help the patient be more adherent and achieve the full benefit that the combination product can offer.

Successful commercialization of a product using a Contract Development and Manufacturing Organization (CDMO) requires a close partnership between the customer and the CDMO. In this session, the use of QbD principles for process development activities and challenges faced during technology transfer will be shared. A risk assessment based approach to evaluate the risk of specific unit operations on product quality will be discussed and an overall strategy for process validation including process review and robustness evaluation will be presented.

Small volume, high concentration liquid formulations are required for certain indications such as rheumatoid arthritis, diabetes and other indications with strict drug product design considerations.  The high concentrations present challenges for the manufacture, stability and delivery of the formulations.  There is evidence to support that long term storage of high concentration liquid formulation of biologics in prefilled glass syringes or plastic syringes is potentially feasible.  An evaluation of several drug product presentations of an IgG1 mAb at high concentrations will be discussed. Twenty four months of stability data on specifically, 140 mg/mL & 200 mg/mL of the mAb in two different buffers manufactured at small-scale and filled into glass syringes, polymer syringes, and glass vials will be presented.

1:30 p.m. - 2:00 p.m.
The Physiology of Patient Learning and the Impact of Device Training on Patient Onboarding, Adherence and Outcomes
Craig Baker, Executive Vice President, Noble
Tim McLeroy, Senior Manager, Abbvie

2:00 p.m. - 2:30 p.m.
Patient Adherence through Device Design
Bob Stabler, Senior Director of Business Development, Flextronics
Kevin Schmid, Vice President - Business Development & Advanced Technology, Insulet Corporation

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

1:30 p.m. - 2:00 p.m.
From Process Design to Continued Process Verification - A QbD Approach of Implementing a Syringe Product at a CDMO
Carolin Rether, Vetter Pharma Fertigung GmbH & Co KG

2:00 p.m. - 2:30 p.m.
Evaluation of High Concentration Liquid Formulations (upto 200 mg/mL) of a Monoclonal Antibody in Glass and Plastic Syringes
Prashant Varma, Scientist, GlaxoSmithKline

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

3:00 p.m. - 3:45 p.m.
Refreshment Break and Poster Presentations in Exhibit Area

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

3:45 p.m. - 5:15 p.m.
A2 - Improving Patient Outcomes through the Implementation of Human Factors
Moderator:  Joël Cotten, Business Development Director, Aptar Pharma
3:45 p.m. - 5:15 p.m.
B2 – Manufacturing Environment
Moderator:  Shawn Kinney, PhD, CEO, Berkshire Sterile Manufacturing

Human Factors is a critical input to the design process. More of our therapies are being designed to be delivered at home by the patient or the care giver. Effectively designing these device systems to be patient friendly and robust is key to the delivery of the therapy being successful. This session will present key learnings and innovations in the field of patient experience. Through device design we can help the patient be more adherent and thus achieve the promised outcome from the medication.

With the development of novel therapies, patients are requested to manage technical actions which were made in the past made by healthcare professionals (Injection, controls, reporting). Human factors considerations are key to ensure the success of these new therapies. This session will present key learnings or/and true new innovation in the field of the patient experience.  The ultimate goal for the patient is to be as compliant as it is possible with respect to his disease.

Parenteral drug products are often produced by sterile manufacturing processes when they cannot be terminally sterilized.  Recent failures at some compounding pharmacies have brought increased attention to sterile manufacturing.  Sterile manufacturing, places extreme emphasis upon equipment, personnel, quality systems, procedures and practices to obtain the largest sterility assurance possible.  The industry is developing technologies improve the sterility assurance of sterile manufacturing and approach the sterility assurance of terminal sterilization methods.  This session will consider new sterile manufacturing equipment, cleanroom/space design, rapid decontamination and transfer, and other technologies that promise to improve sterility assurance in sterile manufacturing and meet evolving regulatory requirements.

3:45 p.m. - 4:15 p.m.
Human Factors for Combination Product Development
Sherri Biondi, Associate Director - Device Development, Genentech, Inc.

4:15 p.m. - 4:45 p.m.
Human Factors Incorporated into Drug/Device Combination Products, an Auto-Injector Case Study
Evan Edwards, Vice President, Kaleo Pharma

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

3:45 p.m. - 4:15 p.m.
Aseptic Transfer Mechanisms and Processes of Pre-Sterilized Components Into an Isolator or RABS Syringe Fill Environment
Klaus Ullherr, Product Manager, Robert Bosch, GmbH Packaging Technology

4:15 p.m. - 4:45 p.m.
solutions for Flexible Fill/Finish Operations 
Paolo Golfetto, Business Development Director, Ompi

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

7:00 p.m. - 10:00 p.m.
PDA's Surf-Side Beach Bash (Sponsored by Genentech)
You're invited to 'Hang-Ten' or submerge yourself in some networking alongside the scenic Huntington Beach, California Lighthouse Courtyard. Come and enjoy this 'chillax' environment by wearing your best Tommy Bahama fashions and don't forget to polish up those spiffy flip-flops to finish off your beach themed attire! Once here, you will enjoy your choice of popular coastal cuisines served 'surfer-style'.

If you haven't had enough, let the second wave crash over you while you dry off near the campfire and construct your own S'Mores, nibble on some fruit, or make a 'rad' Galaffle - a town favorite that will knock your flip-flops off! Take it all in while grooving to the sounds of the "Surf Tones", a 'stellar' local band that will help you 'dive right in'!

Tuesday, October 7, 2014

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

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

7:00 a.m. - 8:15 a.m.
Concurrent Breakfast Sessions

7:00 a.m. - 8:15 a.m.
BR1 - Novel Plasma Coating Processes to Solve PFS Challenges
Moderator:  Shawn Kinney, PhD, CEO, Berkshire Sterile Manufacturing
7:00 a.m. - 8:15 a.m.
BR2 – Effective and Efficient Delivery of Parenterals: Injection Practice and Technology
Moderator:  Richard Levy, PhD, Senior Vice President - Science & Regulatory Affairs, PDA
7:00 a.m. - 8:15 a.m.
BR3 – New Dual Chamber Injector Device and Improvement Procedures for Combination Products 
Moderator:  Georg Roessling, PhD, Senior Vice President, PDA Europe

Session  description: This session will start with an overview of the current challenges that prefilled syringes face today, highlighting key characteristics of new plasma coating technologies to solve some of these. In the first presentation, a Parylene coating technology that offer solutions to existing interface incompatibilities and other performance related issues will be discussed. The second presentation, will investigate oxygen ingress rates for whole article PFS with detail  on how each individual component within the systems plays a role in total ingress (plunger, needle shield, barrel).  Comparisons will be shown for novel silicon oxide plasma coated COP, uncoated COP and glass syringe barrels. The data generated will provide a rationale to formulators and drug development programs to examine containers when faced with oxidation concerns.

Session  description: There has been an increasing interest in optimizing  the last stage of drug delivery using injection devices, the injection itself.  Effective delivery of drug product into the patient as well as patient comfort and compliance are paramount.  This session includes a clinical study completed to evaluate injection site leakage for SC injections as a function of volume, injection rate, and drug viscosity. This session will also highlight a new approach in needle manufacturing involving modifying and redefining the geometry of the cannula and needle point beveling.  When combined with prefilled syringes and other injection devices, this new technology allows for injection of higher viscose formulations. This session has two presentations. A new polymer based dual chamber autoinjector device is presented and a procedure describing criteria for assessing pen injector and autoinjector device changes. Such criteria are a necessity for continuous improvement while being in compliance with regulatory requirements.

7:00 a.m. - 7:30 a.m.
Vapor Phase Polymers for Addressing Interface and Barrier Challenges of Prefilled Syringes and Other Devices
Rakesh Kumar, PhD, V P of Technology, Specialty Coating Systems, Inc.

7:30 a.m. - 8:00 a.m.
A Systems Approach to Oxygen Permeation into a Pre-filled Syringe
Christopher Weikart, PhD, Director of Research and Development, SiO2 Medical Products

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

7:00 a.m. - 7:30 a.m.
Injection Site Leakage: How Much Does it Impact your Delivered Dose?
Joumana Zeid, Senior Engineer, Genentech Inc.

7:30 a.m. - 8:00 a.m.
Prefilled Syringes with Innovative Needle Technology Addressing Injectability Challenges and Patient’s Comfort
Kevin Constable, Director Technology Development, Terumo

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

7:00 a.m. - 7:30 a.m.
Next Generation, All-in-One, Dual-Chamber Autoinjector
Morten Mernoee, Founder & CEO, Injector ApS

7:30 a.m. - 8:00 a.m.
Injector Design Iteration to Promote Innovation 
John Towns, PhD, Principle Fellow, Eli Lilly and Company

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


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

This session will address recent regulatory trends and developments in both US and EU markets for prefilled syringes and injector devices.  Standards development in each region will also be covered.

8:30 a.m. - 9:00 a.m.
Challenges and Pitfalls for Applications Regarding Prefilled Syringes, Autoinjectors and Combination Products
Lana Shiu, MD, Senior Medical Advisor - Office of Device Evaluation, CDRH, FDA 

9:00 a.m. - 10:00 a.m.
European Regulations Panel Discussion
Ronald Forster, Executive Director, Packaging Design/Engineer, Amgen
Kathleen O'Sullivan, Associate Director, Regulatory Affairs, BD Medical, Pharmaceutical Systems
Rob Swift, Product Manager, Ompi of America - Stevanato Group 

9:45 a.m. - 4:00 p.m.
Exhibit Area Open

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

10:00 a.m. - 10:45 a.m. and 3:15 p.m. - 4:00 p.m.
Preliminary Poster Presentation Listing
Poster presenters will be available at their displays to answer questions during refreshment breaks

Getting it Right from the Start: Improving Drug-Container Instability Prediction with High Throughput Assays
Jean-Bernard Hamel, R&D Pharmaceutical Technology Senior Manager, BD Medical, Pharmaceutical Systems

Linking Component Selection to Drug Delivery Strategies in a Highly Competitive Market
Tibor Hlobik, Global Director - PFS Platform, West Pharmaceutical Services

Performance Benchmarking of New Cartridge Plungers and Cap Seals Coated with Fluoropolymers
Yen-Huei Lin, PhD, Principal Scientist, Teva Pharmaceuticals

Traditional and Novel Sterilization Methods
Mason Schwartz,
Operations Manager, Revox Sterilization Solutions

Evaluating Extractables and Leachables for Biologicals in Pre-Filled Syringes
James Scull, PhD, General Manager, NSF Health Sciences

Case Study - Experimental Evaluation of the Key Process Parameters (KPP) and their Impact on CQAs for the 1 mL Glass Syringe, on INOVA Syringe Fillers
Kiran Singh, Associate Director, Sandoz

Primary Packaging Enabling New Drug Product Development Paradigm
Peter Skufca, PhD, Technical Development Specialist, Independent Consultant

Breaking the 1ml barrier: Overcoming Challenges and Delivering Solutions for Subcutaneous Injection
Hervé Soukiassian, Worldwide Cluster Leader, BD Medical, Pharmaceutical Systems

Biotech Formulations and Modern Blow-Fill-Seal processing - Still a Contradiction?
Michael Spallek, Director - Research & Development, Rommelag

Device Training: Case Study on the Effectiveness of Multisensory Smart Training Devices to Traditional Training Materials for Patients’ Onboarding to New Therapies
Paul Sullivan, Senior Business Development Manager, Noble

Comparing the Impact to Drug Product from a Silicon Oil Free Polymer Based Container when Compared to a Siliconized System
Mitsuru Takahashi, PhD, Assistant Manager of Technology Development, Terumo Medical Corporation

Multilayer Plastic Vial and Syringe Made of Oxygen Absorbing Layer
Kashiba Takashi,
Team Leader, Mitsubishi Gas Chemical Company, Inc.

Comparison of Product Behavior During Lyophilization When Processed in Dual Chamber Cartridges and Tubing Vials 
Michael Thomas, Senior Research Scientist, Lyophilization Technology, Inc.


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

10:45 a.m. - 12:15 p.m.
A3 – Quality Aspects in Injectable Delivery Systems
Moderator: Georg Roessling, PhD, Senior Vice President, PDA Europe
10:45 a.m. - 12:15 p.m.
B3 – New Manufacturing Technologies: Methods and Processes
Moderator:  Wenzel Novak, PhD, Director - Pharmaceutical R&D, Groninger & Company GmbH

Delivery systems have become more complicated over the past decade.  To ensure a delivery system functions as intended quality must be designed into a delivery system from the concept phase.  This section will focus on how quality systems are utilized in the design and development of delivery devices.  It will also feature how quality systems are critical to monitoring device performance post commercialization.

Delivery systems are evolving and becoming more complicated and primary containers are no longer just simple vials and syringes.  At the same time, parenteral container manufacturers are being expected to deliver higher quality, particle free, defect free and in many cases ready to fill containers. The industry is moving towards smaller batch sizes, customized medication and ready to fill primary containers.  Rapid turnaround for a variety of sizes, containers, formats while maintaining high quality is required.  This flexibility must, at the same time, not compromise the sterile manufacturing environment.  How manufacturing developments are creating flexibility, addressing evolving delivery systems, maintaining sterility and implementing 100% automated inspection of some critical quality requirements will be discussed.

10:45 a.m. - 11:15 a.m.
Understanding Suitability of Materials and Components Used in Injectable Delivery Systems: The Extractables Leachables Factor
Diane Paskiet,
Associate Director, Scientific Affairs, R&D, West Pharmaceutical Services, Inc.

11:15 a.m. - 11:45 a.m.
Applying a Risk-Based Approach for Prefilled Syringe Vendor Evaluation
Ivy Lin, Senior Engineer, Genentech, Inc.

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

10:45 a.m. - 11:15 a.m.
High Voltage Leak Detection for Container Closure Integrity Testing of Liquid Filled Primary Containers
Craig Goldhammer, Consultant Engineer, Eli Lilly and Company

11:15 a.m. - 11:45 a.m.
Insight into Injectable Device Assembly
Dena Flamm, Product Manager, Bosch

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

12:15 p.m. - 1:45 p.m.
Exhibit Area Closed - A listing of local restaurants is available in your conference materials

12:15 p.m. - 1:45 p.m.
Optional Concurrent Lunch Sessions Sponsored by BD - Advanced registration is required and space is limited

12:15 p.m. - 1:45 p.m.
Lunch Session: Stream A – The Impact of
Packaging Choice and Design in Minimizing

Point of Care Risks and Optimizing Patient
Outcomes
Moderator: Georg Roessling, PhD, Senior Vice President, PDA Europe

12:15 p.m. - 1:45 p.m.                       
Lunch Session: Stream B – Enhancing Outcomes and Performance through Novel Drug Delivery Technologies
Moderator: Richard Levy, PhD, Senior Vice President - Science & Regulatory Affairs, PDA

Whether in a patient's or clinician's hands, the choice of device made by pharmaceutical companies for injectables can have a significant impact on patient outcomes, from minimizing point-of-care risks to helping ensure better chronic disease management. In this session, risk profile and human factors data,
agency perspective and case studies will be presented to illustrate this impact. 

In this session, various breakthrough PFS technologies developed to meet advanced delivery requirements will be discussed as well as design considerations for effective device integration and administration of large subcutaneous injections.

Ronald S. Litman, Professor of Anesthesiology and 
Pediatrics, Perelman School of Medicine at the 
University of Pennsylvania

Brian Lynch, Program Lead – Health Science
& Technology, Immunization,
BD Medical, Pharmaceutical Systems

Raza Ahmed, MD, Worldwide Director, Medical Affairs, Self-Administration Injection Systems,
BD Medical, Pharmaceutical Systems

Theresa Bankston, PhD, Manager, Bioanalytical & Pharmaceutical Development, BD Medical, Pharmaceutical Systems

Herve Soukiassian, Worldwide Cluster Leader, BD Medical, Pharmaceutical Systems

1:45 p.m. - 3:15 p.m.
Concurrent Sessions

1:45 p.m. - 3:15 p.m.
A4 – Partnership Approaches Along Drug Life Cycle to Improve Patient Outcomes
Moderator:  Christian Helbig, P Head of Global Business Development Syringe, SCHOTT Schweiz AG
1:45 p.m. - 3:15 p.m.
B4 – Supply Chain Security  
Moderator:  Adalberto Ramirez, Vice President, Quality, Amgen, Inc.

The industry is continuously fuelling innovations and improvements in the prefilled syringe space to improve patient outcomes. A critical success factor in implementation is how pharmaceutical company and supplier stem synergies through partnership. This session will share with attendees' partnership approaches that have been employed to get new / improved delivery devices to patients.

Supply Chain security continues to be a hot topic for our industry. Many news events in this area make evident the need to align efforts, create awareness and be vigilant. Promoting the global supply chain integrity is a responsibility shared among all stakeholders. In this session, we will discuss the latest events and different measures taken by the industry and regulators. In addition, we will discuss how and why criminals and unethical players have Infiltrated the medicines Supply Chain and what we can do to counter attack and eliminate or neutralize them.

1:45 p.m. - 2:15 p.m.
Translating a QbD PFS into Tangible Value for Biopharmaceuticals
Friedrich Haefele, PhD, Head of Biopharmaceuticals Fill & Finish, Boehringer Ingelheim Pharma GmbH & Co. KG

2:15 p.m. - 2:45 p.m.
From Supplier of Container Closure System Components to Strategic Partner for Combination Products: A New Integrated Development Era for Regulatory Affairs
Alice Maden, Regulatory Affairs Leader, BD Medical - Pharmaceutical Systems
Kathleen O'Sullivan, Associate Director, Regulatory Affairs, BD Medical, Pharmaceutical Systems

2:45 p.m. - 3:15 p.m.
Questions and Answers/ Discussion

1:45 p.m. - 2:15 p.m.
Industry Perspective on Supply Chain Security
Rod MacLea, Category Lead, Primary Containers, Amgen, Inc.

2:15 p.m. - 2:45 p.m.
Overview of FDA’s Supply Chain Security Pilot Program
Binh Nguyen, Investigator, ORA, FDA

2:45 p.m. - 3:15 p.m.
Questions and Answers/ Discussion

3:15 p.m. - 4:00 p.m.
Refreshment Break in Exhibit Area

4:00 p.m. - 5:30 p.m.
P4 - Global Market Trends
Moderator:  Graham Reynolds, Vice President - Marketing and Innovation, West Pharmaceutical Services, Inc.
There are many factors which will drive and shape our industry in the coming years, and this session is designed to review some of the major trends. Geographic expansion, increased access to healthcare, patient-centric solutions and the growth of biosimilars are examples of some of the topics to be explored.

4:00 p.m. - 4:30 p.m.
Biosimilar/Product Delivery Systems
Mateja UrlepConsultant, Tikhe Pharma

4:30 p.m. - 5:00 p.m.
Emerging Markets
Manoj Pananchukunnath, Head of Injectable Development, Mylan
Sponsored by West Pharmaceutical Services, Inc.

5:00 p.m. - 5:30 p.m.
Questions and Answers/ Discussion

5:30 p.m.
Closing Remarks and Adjournment
Adalberto Ramirez, Vice President, Quality, Amgen, Inc.

Before July 28, 2014 July 28-August 26, 2014 After August 26, 2014
Member $1,795 $1,995 $2,195
Nonmember $2,044 $2,244 $2,444
Government/Health Authority Member $700 $700 $700
Government/Health Authority Nonmember* $800 $800 $800
Academic Member $700 $700 $700
Academic Nonmember* $800 $800 $800
Student Member $280 $280 $280
Student Nonmember* $310 $310 $310

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 and course.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the conference 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 registration@pda.org 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 7, 2014 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 non-member substituting for a member, you will be required to pay the difference non-member 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 Conference/Events: If your written request in received on or before August 7, 2014, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site 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 cancellation. For more details, contact PDA at info@pda.org 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 this event, I authorize PDA the right to record and photograph me 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 recording/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

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

Overflow Hotels within Walking Distance to The Hyatt Regency Huntington Beach Hotel

        Please note: PDA is not holding rooms.  All rates and rooms are based on availability.

Shorebreak Hotel – A Joie de Vivre Hotel
Address: 500 Pacific Coast Highway, Huntington Beach, CA 92648
Phone: 714-861-4470
Proximity from the Hyatt: Walking - .91 miles

The Waterfront Beach Resort – A Hilton Hotel
Address: 21100 Pacific Coast Highway, Huntington Beach, CA 92648
Phone: 714-845-8000
Proximity from the Hyatt: Walking - .39 miles

Hotel Accommodations

To make reservations at the Hyatt Regency Huntington Beach Resort & Spa, please call the Hotel at +1 (714) 714-1234 and reference the 2014 PDA Universe of Pre-filled Syringes and Injection Devices Conference to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 11:00 a.m.

Individual Cancellation
Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6 p.m. on the date of arrival otherwise specified on your reservation information.

Travel

Area Airports 
Orange County / John Wayne Airport (SNA) is approximately 13 miles from the hotel and all major carriers service this airport.  Additionally, there are two other major airports in the vicinity. Long Beach Airport (LGB) is approximately 18 miles and Los Angeles International Airport (LAX) is approximately 38 miles.  All major carriers service these airports.

Ground Transportation 
Taxi fares from SNA are approximately $35 one way, not including tip, and will take about 25 minutes. One way taxi fares from LGB is roughly $50 and from LAX is approximately $110.  

Super Shuttle: $24 from SNA and $33 from LGB.  Each additional passenger is $9.00.

Driving
The Hyatt Regency Huntington Beach Resort & Spa is located on Beach Boulevard just off of Center Avenue in Huntington Beach, CA.

Hotel Parking 
Self-parking is available across the street at Huntington Beach City Parking. Overnight parking is available; however, cars must be parked by 9:00 p.m. and obtain an overnight parking pass from hotel valet. The cost is $15.00 per day.

  • Valet parking - $34.00 per night
  • Daily parking - $19.00 per 12 hours
  • Complimentary validated parking for restaurant and spa guests
  • City street parking - $14 per day
Diamond Sponsor Genentech Platinum Sponsors BD SHL Group Terumo Europe Gold Sponsor Owen Mumford Silver Sponsors Mitsubishi Gas Chemical Ompi Media Sponsors Drug Development Drug Development Drug Development Drug Development Drug Development

The 2014 PDA Universe of Pre-filled Syringes and Injection Devices conference brings together industry and regulatory experts to share their experiences, new developments, regulatory considerations, challenges and industry trends 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, marketing or use of pre-filled syringes and injection devices.

Find new customers, discuss ongoing projects, discover new opportunities, and reconnect with current clients by exhibiting at or sponsoring the industry’s leading conference and exhibition in this dynamic field. Extended, dedicated exhibit hall hours will allow ample time for information exchange with attendees and industry subject matter experts from manufacturing, packaging, formulation, process development, engineering, procurement, quality, supply chain, distribution, and clinical development. Many high profile, cost-effective sponsorship options are available to help your company increase exposure, build awareness, and stand out from the crowd. Become a sponsor and/or exhibit at the PDA Universe of Pre-filled Syringes &Injection Devices Conference and strengthen your brand image, increase your visibility, and gain access to hundreds of leaders in the industry.

For exhibition and sponsorship inquiries, please contact:

David Hall, Vice President, Sales
Tel: +1 (301) 760-7373 | Cell: +1 (240) 688-4405
Email: hall@pda.org

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    Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.