SMi Group's Pre-filled Syringes East Coast 2020
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This document announces an interactive workshop on combination product development taking place on April 29th, 2020 in Boston, USA. The workshop will consist of three sessions focused on key topics in combination product development: combination product development strategies, drug delivery device testing solutions, and human factors validation studies. Speakers will include experts from major pharmaceutical companies such as AstraZeneca, Eli Lilly, Biogen, and regulatory agencies. The workshop aims to provide attendees insights and strategies for navigating challenges in combination product development from concept to approval.
SMi Group's Pre-filled Syringes East Coast 2020
- 1. PLus tHree interactive Post conference WorksHoPs Wednesday 29tH aPriL 2020, sHeraton boston HoteL, boston, usa HigHLigHts for 2020: • Explore how digital connectivity is being used in the PFS industry • Gain insights into control strategies for DDC developments • Hear key regulatory updates from the FDA and industry experts • Understand how patient centricity is being incorporated into device development • New for 2020: Interactive workshop day cHair for 2020: Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca featured 2020 sPeakers incLude: • Tina Kiang, Director, Division of Drug Delivery and General Hospital Devices, and Human Factors, Food and Drug Administration • Alie Jahangir, Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceutical • Delma L Broussard, Director, Medical Device & Combination Products PV Expert, CSL Behring • Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson • Diane Doughty, Senior Scientist, Dosage Form Design & Development, AstraZeneca • Jennifer Hefele Wald, Director Global Regulatory Affairs Devices & Combination Products, Pfi zer • Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen • Krystin Meidell, Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen • Michael Friedman, Combination Product Lead, Amgen ... And Many More! www.pfsamericas.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 ACADEMIC & GROUP DISCOUNTS AVAILABLE @sMiPHarM #smipfsusa Sheraton Boston Hotel, Boston, USA SMi Group Proudly Present the 7th annual... CONFERENCE: 27TH - 28TH WORKSHOP DAY: 29TH APRIL 2020Innovations in parenteral device and product development Pre-Filled Syringes East Coast A: Combination Product Development – A roadmap for success Workshop Leader: Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca 08.30 - 12.00 B: Drug Delivery Device Testing Solutions Workshop Leader: Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell 13.00 - 15.30 C: How to pass a Human Factors Validation study Workshop Leader: Marc Egeth, PhD, Senior Director, Core Human Factors, Inc. and Pati Anderson, Mse, Senior Associate, Core Human Factors, Inc. 16.00 - 18.20 REGISTER By 13TH DECEMBER AND SAVE $400 REGISTER By 31ST JANUARy AND SAVE $300 REGISTER By 28TH FEBRUARy AND SAVE $200 sPonsored by
- 2. 08.00 Registration & Coffee 09.00 Chair’s Opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca digitaL connectivity in tHe Pfs industry oPening address 09.10 Wearable and digital devices – a hybrid view between pharmaceutical and medical devices • How lessons learned from medical device can help with wearable device development • Electronics, batteries, and IEC requirements – let’s not reinvent the wheel • Testing approach for novel / unique devices Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca 9.50 Digital health: The evolving regulatory landscape • Overview of recent changes in regulation and guidance • Case Study: Connected Integrated Injector • Case Study: Sensor/App for Inhaler • Case Study: Dose Calculator App Krystin Meidell, Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen 10.30 Morning Coffee – Sponsored by 11.00 Simulation driven analysis in Product development • Cloud based Numerical simulation. • Scripted simulation to achieve design optimization Lin Li, Senior Consultant Engineer, Delivery Devices and Connected Solutions, Eli Lilly and Company drug Product forMuLation and controL strategies 11.40 Challenges and opportunities in developing a system-wide stability program for combination products • Combination Products • Stability Indicating Attributes • Design Control process • End-to-End Stability • Drug/Biologics- Device Interactions Alie Jahangir, Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceuticals 12.20 Consideration for defi ning the administration procedure for nano-dose drug in clinical studies • Adsorption phenomenon • Dose recovery considerations • Mitigation strategies Michael Zhou, Investigator, Pharmaceutical Development- Sterile CoE, gsk 13.00 Networking Lunch 14.00 Technical overview of COP for prefi lled syringes • Key properties of COP • Case Study (New): - Protein Adsorption of Abatacept – COP vs Glass - Immunogenicity test of the aggregates • Case Study: Protein Adsorption of Humira, Embrel, Remicade – COP vs Glass • Case Study: Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass • Leachable data on COP syringes Larry Atupem, Sr. Business Development Specialist, Zeon Specialty Materials 14.40 Combination Product Risk Management • Introduction of ICH Q9 and ISO 14971 • Challenges of completing a comprehensive Hazard Analysis for combination products • Design Risk Assessments for off the shelf components • Integrating current drug development risk assessments to meet ISO 14971 compliance Tanner Barnes, Design Control Engineer II, Pfi zer 15.20 Qualifi cation and validation of VH2O2 industrial low temperature terminal sterilizer process and equipment - Case study on process control and monitoring • Brief introduction to VH2O2 sterilization process, technology and applications • Discuss validation and meeting ISO14937 standard requirements - and looking at the scenario of future VH2O2 specifi c standards • Present the essential process variables forVH2O2 sterilization • Case study on testing and comparing performance of various hydrogen peroxide concentration measurement methods – and proposing an applicable approach Juha Mattila, Director, Sterilization Technologies, STERIS Corporation 16.00 Afternoon Tea – Sponsored by REGULATORy OUTLOOK – PART 1 sPotLigHt Presentation 16.30 A regulatory outlook and update of the combination product industry • Affect of TPLC re-organization in CDRH on combination product review (premarket and compliance) • New guidance updates Tina Kiang, Director, Division of Drug Delivery and General Hospital Devices, and Human Factors, Food and Drug Administration 17.10 EU MDR impact on premarket regulatory requirements for combination products • Overview of new requirements of EU MDR Article 117, which could result in signifi cant changes in practice, and potential impact to product development timelines • Collaborations between industry regulatory networks and EMA and Notifi ed Bodies to clarify requirements • Discussion of recognized issues in interpreting Article 117 requirements and potential paths forward to meet new requirements Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen 17.50 Chair’s Closing Remarks and Close of Day One 18.30 End of Day One Networking Dinner - Invitation Only Register online at www.pfsamericas.com Pre-Filled Syringes East Coast Conference DAy ONE | MONDAy 27TH APRIL 2020 www.pfsamericas.com
- 3. 08.30 Registration & Coffee 09.00 Chair’s Opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca Lifecycle Management for Combination Products OPENING ADDRESS 09.10 Combination products integrated development • Combination Products Regulations are evolving globally • One consistent undercurrent to this dynamic regulatory environment is the drive for successful practices and control strategies throughout the combination product lifecycle, to assure public health, ensuring risk is commensurate with product complexity and patient needs • In this presentation we’ll review combination products integrated development and risk management considerations and essential performance requirements to support robust product development and lifecycle management Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, JJ Combination Products CoP, Johnson Johnson 09.50 Combination product lifecycle management • Why is it important to incorporate risk management and design controls into the LCM of Combination products? • How to manage change through design controls • Use of platforms for optimization of development time and costs • Regulatory standards to consider Michael Friedman, Combination Product Lead, Amgen 10.30 Morning Coffee – Sponsored by 11.00 Lifecycle management of combination products - a regulatory perspective • Regulatory’s role in the product change assessments and DHF deliverables • Handling legacy combination products • What should be submitted for legacy and new combination products? Jennifer Hefele Wald, Director Global Regulatory Affairs Devices Combination Products, Pfizer Regulatory Outlook – Part 2 11.40 Regulatory Perspective on Human Factors Requirements for Combination Products • Overview of human factors topics including platform approaches, training programs, and Instructions for use • Importance of risk analysis and risk considerations in development of human factors studies and communication of results • Best practices for incorporating human factors studies results into regulatory filings Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen 12.20 FDA postmarketing safety reporting for combination products guidance • Reporting requirements for combination products under PMSR final rule • Overview of report types based on constituent parts • Hypothetical examples of report types Delma L Broussard, Director, Medical Device Combination Products PV Expert, CSL Behring 13.00 Networking Lunch Device Development PANEL DISCUSSION 14.00 Combination products evolving trends • What are some of the significant challenges that people face in implementation of combination product regulations? • Is there anything uniquely challenging from a drug-led manufacturer versus a device-led manufacturer? • Can you comment on Post-Marketing Safety Reporting for Combination Products as it relates to risk management? Panel Moderator: Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, JJ Combination Products CoP, Johnson Johnson Panelists: Jennifer Hefele Wald, Director Global Regulatory Affairs Devices Combination Products, Pfizer Delma L Broussard, Director, Medical Device Combination Products PV Expert, CSL Behring Alie Jahangir, Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceuticals Leonel Vanegas, President/Principal, Resmedica 14.40 Latest date of oxycapt multilayer plastic vial syringe • Comparison among OXYCAPT, COP and Glass • Excellent Oxygen Ultraviolet Barrier • Oxidation and Aggregation Studies of Antibody • Development of Staked Needle Syringe Shota Arakawa, Researcher, Mitsubishi Gas Chemical Company, Inc. 15.20 Afternoon Tea – Sponsored by 15.50 Design considerations for optimizing the user experience of prefilled syringes and injection devices • Device features of prefilled syringes and injection devices to support candidate device selection • Design considerations for minimizing pain upon injection • Case study of exploratory clinical study to evaluate injection parameters Diane Doughty, Senior Scientist, Dosage Form Design Development, AstraZeneca 16.30 How quality can help drug-device combination teams become agile in a changing regulatory landscape • The role of quality and CMC during drug-device combination products evolution • Five steps towards becoming agile and flexible anticipating formulation changes before NDA/BLA filings • From pre-filled into a different presentation format after marketing approvals • Life-Cycle Management considerations (e.g. data you’ll need to demonstrate to the regulatory agencies) Leonel Vanegas, President/Principal, Resmedica 17.10 Chair’s Closing Remarks and Close of Day Two Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Pre-Filled Syringes East Coast Conference Day TWO | TUESday 28th APRIL 2020 www.pfsamericas.com Hear from pharma and regulatory KOLs leading the way in Pre-Filled Syringes Engage in case studies, regulatory outlooks and panel discussions exploring the industry We keep networking at the forefront when it comes to our attendees. Expand your community, benefit from the right people and secure future collaborations
- 4. Overview of the workshop: As more and more drug products are being developed as combination products, device development plays a critical role. To successfully develop a combination product, it requires collaboration and consideration from multiple angels. In this workshop we will dive into each of these factors from primary container and device selection to how to manufacturing considerations and ways to platform and streamline development activities without running into regulatory risks. Some of the areas we will explore include • Drug product and primary container interaction and impact on device selection and development • How to select the right device and utilizing design control and strategic approaches to minimize development risks and timeline. • Design verifi cation, biocompatibility, extractable and leachables • Packaging and manufacturing consideration • Stability and controls strategy Reasons to Attend: • Learn about interlinked relationship between drug product, primary container, device, and packaging. • Consideration and ways to minimize device development risks • Dive into design verifi cation, biocompatibility, EL, and control strategies • Role packaging play in successful combination product • Process development and consideration About the workshop Leader: Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University. Combination Product Development – A roadmap for success Post conference WorksHoP a 08.30 - 12.00 Register online at www.pfsamericas.com Post Conference Workshop Day Wednesday 29th April 2020, Sheraton Boston Hotel, Boston, USA www.pfsamericas.com Workshop Leader: Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca Post conference WorksHoP b 13.00 - 15.30 Drug Delivery Device Testing Solutions Overview of the workshop: In the drug delivery device, testing world, the regulatory requirements add complexity to the simplest of test. What occurs when the testing moves from the simple to multifaceted is an exponential amount of effort to meet industry demands. Finding the best partner starts with a full understanding of your internal and external requirements. Uncovering the unknowns is an arduous task but a crucial one to your success. About the workshop leader: Michael Goehring, Medical Pharmaceutical Industry Manager, ZwickRoell BSEE – Instrumentation and Systems – University of Connecticut Field Systems Engineer for materials and component test systems Territory Manager for Laboratory Information Management Systems District and Regional Sales Manager for materials and component test system North America Sales Manager for material preparation and analysis Industry Manager – Medical Pharmaceutical. ZwickRoell has years of experience in delivering innovative solutions for drug delivery systems that reduce operator infl uence, which increases accuracy, repeatability, reproducibility and traceability of test results. Post conference WorksHoP c 16.00 - 18.20 How to pass a Human Factors Validation study Overview of the workshop: Hear expert opinions on how to structure a human factors program from product conceptualization and early design through risk analysis development and iterative usability testing in order to pass a human factors validation study on the fi rst attempt. Reasons to Attend: • Learn how to build and optimize your company’s human factors and usability engineering process and how that can be applied to every development project in order to reduce development delays and improve the chances of fi rst-time success • Discuss the regulatory imperative of HFE, and the focus on use-related harm, as well as other uses of HFE • Discuss how HFE as an RD activity, not a documentation activity • Discuss development and testing of instructions for use (IFU) • Discuss how to scale HFE programs and how programs vary from product to product About the workshop leaders: Pati andMarc manage all aspects of human factors projects at Core Human Factors. Our experience includes hundreds of different types of medical devices and combination products. We have worked on every phase of HF work, run studies all around the world, and helped dozens of different companies manage their HF programs and navigate regulatory pathways. Part of our work includes IFU design, development and testing. Core Human Factors, Inc. (Core) is a consulting group based outside of Philadelphia, PA, staffed by human factors specialists with a wide variety of backgrounds. We specialize in human factors testing for medical devices and health care systems. Core has helped hundreds of products successfully navigate FDA review and gain CE marks, and our researchers have published dozens of publications in peer-reviewed journals. In addition to user testing, we also assist in the design of products, instructional materials, and training programs; risk analyses; user needs documentation; and ideation sessions to facilitate invention and human- centered design in health care and medicine. Programme 16.00 Scaling HFE - Doing More with Less • Regulatory imperative and focus on safety • Time and cost tradeoffs in iterative design • Can you be a biosimilar or generic? • Making changes after a Validation 16.35 Human Factors Protocols that Work • Valid assessments of risks • Non-biasing study designs and interview techniques • Pivoting from a pilot • Pre-submission process 17.10 Instructions for Use, a Human Factors Perspective • Why IFUs should be considered early and often • Initial design • Iterative development • The good, the bad, and the ugly 17.45 Case Studies • Case study #1 • Case study #2 • Case study #3 • Case study #4 Programme 13.00 Drug Delivery Device Testing Overview • Importance of a URS (User Requirements Specifi cation • Functional Design Specifi cation 13.35 (Prefi lled) Syringe testing and spring simulation (power pack) • Glide Force New ISO 7886-1 • ISO 11040-4, -6, -8 • ISO 80369-7, -20 14.10 Auto injector and pen injector testing – wearable device testing • ISO 11608-1 (Pen), ISO 11608-2 (Needle), ISO 11608-3 (Cartridge) • ISO 11608-2 (Needle) • ISO 11608-3 (Cartridge) • ISO 11608-5 (Full Function test on Auto Injectors) • ISO 11608-6 (Wearables) 14.45 Device testing – regulatory demands • 21 CFR Part 11 – Traceability (When, Who, What, Why and Who is Responsible) • DQ, IQ, OQ and why not PQ. MDR Europe 15.20 Session Recap 15.30 Afternoon Tea Workshop Leader: Michael Goehring, Medical Pharmaceutical Industry Manager, ZwickRoell Workshop Leaders: Marc Egeth, PhD, Senior Director, Core Human Factors, Inc. Pati Anderson, Mse, Senior Associate, Core Human Factors, Inc. Programme 08.30 Registration and Coffee 09.00 Session 1 • Primary Containers Components • Drug Product and Primary Container interaction and considerations • Extractable and Leachables 09.35 Session 2 • Device selection and characterization • Considerations from process, manufacturing, packaging, and usability standpoint • Key drivers for success and novel devices 10.10 Morning Coffee 10.30 Session 3 • Process and manufacturing overview considerations (clinical, commercial, and automation) • Packaging considerations and risk reduction • Risk Assessment, Controls strategy and DV testing 11.05 Session 4 • Design Verifi cation and Validation • Stability approaches • Future trends, digital health, wearables, and novel technology 11.45 Session Recap 12.00 Networking Lunch
- 5. ProudLy sPonsored by: sPonsorsHiP and exHibition oPPortunities SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conference please call: Alia Malick, Director, on +44 (0) 20 7827 6168 or email: [email protected] Marketing oPPortunities Want to know how you can get involved? Interested in promoting your services to this market? Contact Jinna Sidhu, Marketing Manager, +44 (0) 20 7827 6088 or email: [email protected] Pre-Filled Syringes East Coast Conference www.pfsamericas.com Register online at www.pfsamericas.com Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. www.aptar.com/pharma Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specifi c therapeutic markets. www.credencemed.com Mitsubishi Gas Chemical is a leading company in the fi eld of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs. www.mgc.co.jp/eng/products/abd/oxycapt.html Polyplastics is the leading maker of TOPAS COC (cyclic olefi n copolymer), a glass-clear, incredibly pure, break-resistant plastic for drug delivery, including syringes, vials and cartridges. The benign COC medical polymer presents a nonreactive surface for advanced molecules. Additionally, TOPAS COC offers high moisture and chemical resistance, barrier and UV transmission. https://topas.com STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control. Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs. With offi ces located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world. www.sterislifesciences.com The Weiss-Aug Group is your global partner for the design support, development, engineering and manufacture of medical devices and drug delivery components and sub-assemblies. With specialized knowledge and state-of-the-art equipment, The Weiss-Aug group delivers the latest technologies for Disposable Safety Products, Drug-Delivery Products, Orthodontics, Ophthalmic Disposables and Devices, Electrosurgery. www.weiss-aug.com/ ZEON’s Zeonex® and Zeonor® cyclo olefi n polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. www.zeonex.com ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials. www.zwickroell.com Pre-Filled Syringes East Coast Past Attendee Breakdown 110+ Industry professionals from Europe and beyond 7+ Dedicated hours of networking Business Development Manager 22% Senior Engineer 21% Director 17% Project Manager 15% Senior Device Manager 12% Senior Principal Scientist 13% Breakdown of attendee - Job function suPPorted byofficiaL Media Partner key Media Partners Attendee Geography: USA 78% Europe 12% United Kingdom 4% Asia Pacifi c 2% Africa 1% Canada 3% Pre-Filled Syringes Series save tHe date Conference: October 2020 Sheraton Boston Hotel, Boston, USA Wearable Injectors and Connected Devices USA Conference: 15th - 16th June 2020 Hyatt Regency Mission Bay, San Diego, CA, USA Pre Filled Syringes West Coast Conferences: 14th-15th September 2020 San Francisco, USA Pre Filled Syringes San Francisco neW for 2020 neW for 2020
- 6. PRE-FILLED SyRINGES EAST COAST 2020 Conference: Monday 27th Tuesday 28th April 2020, Sheraton Boston Hotel, Boston, USA Workshops: Wednesday 29th April 2020, Sheraton Boston Hotel, Boston, USA 4 WAyS TO REGISTER www.pfsamericas.com fax your booking form to +44 (0) 870 9090 712 PHone on +44 (0) 870 9090 711 Post your booking form to: Events Team, SMi Group Ltd, India House, 45 Curlew Street, London, SE1 2ND, UK If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at [email protected] Unique Reference Number Our Reference P-315 docuMentation I cannot attend but would like to Purchase access to the following Document Portal/ Paper Copy documentation. Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-315 and the delegate’s name. 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