2016 PDA Universe of Prefilled Syringes & Injection Devices October 17-18, 2016 | Hyatt Regency Huntington Beach Resort & Spa | Huntington Beach, CA As of October 10, 2016

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 am. - 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 buzz words 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. The speakers in this session 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, PhD, Vice President, Research & Development, BD Medical - Pharmaceutical Systems 9:00 a.m. - 9:30 a.m. Connectivity in Drug Delivery & Smart Administration: Improving Compliance, Patient Training & 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 Panelists: Markus Bauss, Managing Director, SHL Connect, SHL Group Sundeep Kankanala, PhD, 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 & 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 LowVolume 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

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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 Multilayer Plastic Vial & Syringe Made of Oxygen Absorbing and COP Layers 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 & 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.

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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 packaging can lead to defects and breakage. This session provides focus on the evolving injectable market and offers ideal solutions that help meet complex secondary packaging 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. 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

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 & Answers/Discussion

3:00 p.m. - 3:45 p.m. Refreshment Break & Poster Presentations 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

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.

Session Description: It started with hardware to improve convenience of drug application. From vials or ampoules to prefilled 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

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

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

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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

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.

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

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

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

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

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

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

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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.

7:30 a.m. - 7:45 a.m. Implementation of Laser TreatmentTechnology 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 & 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 & Answers/Discussion 9:45 a.m. - 3:45 p.m. Exhibit Hall Open 10:00 a.m. - 10:45 a.m. Refreshment Break & 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

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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 Prefilled 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

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

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

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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 & Answers/Discussion

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

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 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.

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 st developments of the 21 century. The production of biological drugs is a complex and inherently unstable situation, requiring special handling and storage. Therefore, there are important interrelated 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 & Cartridges Christopher Weikart, PhD, Director, Research & Development SiO2 Medical Products 2:30 p.m. - 3:00 p.m. Questions and Answers/Discussion

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

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

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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 &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 & Answers/Discussion 5:15 p.m. Closing Remarks & Adjournment Olivia Henderson, PhD, Principal Engineer, Amgen, Inc.

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