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2018 PDA Drug Delivery of Injectables Conference

Nov 06 - Nov 07, 2018
Taipei, Taiwan

The 2018 PDA Drug Delivery of Injectables Conference will concentrate on primary packaging components, devices, and fill-finish procedures.

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Program Highlights

Immediately following the Conference, PDA is offering four training courses and the 2018 PDA Connectivity Workshop: Digital and Pharma. Extend your stay in Taipei!

Overview

The 2018 PDA Drug Delivery of Injectables Conference will kick off with an update on recent changes to regulations, focusing on the proposed revision to Annex 1 and other regulations relevant for parenteral packaging.

The Conference will concentrate on primary packaging components, devices, and fill-finish procedures. Relevant tests, such as visual inspection, container closure integrity, and extractables and leachables, will also be covered. A special session will address the use of electronics for pharmaceutical applications.

This Conference will go beyond the technical aspects of pharmaceutical manufacturing, with a special session devoted specifically to business-related aspects of the industry. In this session, critical considerations regarding such areas as marketing and the challenges of developing successful partnerships, especially for the manufacture of biotech/biosimilar products, and what needs to be in place for successful partnerships, will be addressed. And, hear directly from the experts how patient-friendly injection systems may impact market success.

The Conference agenda incorporates panel discussions and plenty of time for the presenters to answer your questions. An exhibition will highlight new products and services.

Plan to stay on after the Conference to take part in several training courses that will take a more in-depth look at some of the topics.

We are looking forward to seeing you in Taipei,
Magnus Fastmarken, Global Director Marketing, SHL Group, Co-Chair
Robin Hwang, Consultant, ICP Consulting Corp., Co-Chair

The Scientific Organization Committee

  • Magnus Fastmarken, Global Director Marketing, SHL Group, Co-Chair
  • Robin Hwang, Consultant, ICP Consulting Corp., Co-Chair
  • Markus Bauss, Managing Director, SHL Connect, SHL Group
  • Biotechnology & Pharmaceutical Industries Promotion Office (BPIPO), Ministry of Economic Affairs
  • Gabriele Peron, Senior Marketing Advisor, Stevanato Group
  • Mathias Romacker, Senior Director, Device Strategy/Marketing, Pfizer, Inc.
  • Wayne Wu, PDA Chapter President Taiwan, Intech Biopharm Corp.
  • Molly O’Neill Moir, CMP, Vice President, Programs and Meetings, PDA
  • Georg Roessling, PhD, Senior Consultant, Business Development, PDA

Agenda

  • Tuesday, 6 November

    8:00 – 17:00
    Registration Open

    9:00 – 10:15
    P1: Opening Plenary
    Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

    This opening plenary will set the stage for the conference and will describe the current trends for injectables in the pharmaceutical industry and the impact on primary packaging and devices. Special focus will be given to biosimilars with respect to market differentiation through patient friendly drug delivery devices.

    9:00 – 9:15
    Welcome and Opening Remarks
    Wayne Wu, PDA Chapter President Taiwan, and Vice President, Intech Biopharm Corp.
    Mr. Jong-Chin Shen, Minister of Economic Affairs (MOEA)
    Mr. Shih-Chung Chen, Minister of Health and Welfare (MOHW)

    9:15 – 9:40
    The Evolving Pharma Outlook on Primary Containers and Injection Devices
    Mathias Romacker, Senior Director, Device Strategy, Pfizer, Inc.

    9:40 – 10:00
    Parenteral (Injectable) Drugs Differentiated by Injection Devices
    Robin Hwang, Consultant, ICP Consulting Corp.

    10:00 – 10:25
    The FDA's Perspectives on Regulation of Combination Products
    Lana Shiu, MD, Executive Director | Medical Device Regulatory Affairs, Amgen, Inc.

    10:25 – 10:55
    Refreshment Break in Exhibit Area

    10:45 – 12:30
    P2: Regulatory Updates, Part 1
    Moderator: Mathias Romacker, Senior Director, Device Strategy, Pfizer, Inc.

    This session will take place in two parts and will share activities and observations of GMP inspectors in Taiwan and the Asia Pacific area. Regulatory representatives will discuss inspection observations in Asia Pacific and industry representatives will address current hot topics on Annex1/filtration and data integrity issues. Finally, a presentation will describe a case study for a global registration strategy of an autoinjector.

    10:55 – 11:20
    Activities of the Taiwan Inspectorate FDA Taiwan
    Ellen Ying-Hua Chen, GMP Inspector, FDA Taiwan

    11:20 – 11:45
    US FDA: Inspection Observations in Asia Pacific
    Alicia M. Mozzachio, MS, Senior Advisor, International Activities, CDER, U.S. FDA

    11:45 – 12:00
    Questions and Answers/Discussion

    12:00 – 13:00
    Networking Luncheon

    13:00 – 14:30
    P3: Regulatory Updates, Part 2
    Moderator: Mathias Romacker, Senior Director, Device Strategy, Pfizer, Inc.

    This session is a continuation of P2: Regulatory Updates

    13:00 – 13:30
    Annex 1: Current and Proposed Regulations of the Integrity Testing of Sterile Product Filters
    Michael Payne, Biosafety Technical Consultant, Merck

    13:30 – 14:00
    Data Integrity: How to Achieve Employee’s Compliance by the System and Awareness
    Jianchen Xu, Quality Specialist, Novo Nordisk China

    14:00 – 14:30
    Regulatory Strategy Considerations for a Novel Reusable Autoinjector: A Case Study for a Combination Product Registration
    Julia Yeh, Director, Regulatory Affairs, Amgen, Inc.

    14:30 – 15:00
    Refreshment Break in Exhibit Area

    15:00 – 18:00
    Concurrent Sessions

    Track A: Primary Packaging Components
    Moderator: Gabriele Peron, Senior Marketing Advisor, Stevanato Group

    This session gives an update on current primary packaging components and shares the trends in the industry. Materials are glass, polymers, and elastomers. The various aspects of further processing in the fill finish process will be discussed.

    15:00 – 15:30
    How to Mitigate and Control Biodrug Challenges for Glass Primary Packaging: A Manufacturing Approach 
    Alessandro Morandotti, Product Manager Syringes, OMPI

    15:30 – 16:00
    Considerations for Selection and Evaluation of Container Closure Systems
    Kok Li Kwang, Technical Support Manager, West

    16:00 – 16:15
    Questions and Answers/Discussion

    16:15 – 16:45
    Innovations in Glass Container Design: A Manufacturers Perspective
    Wenzel Novak, PhD, Global Senior Director Business Development Medical Systems, Gerresheimer

    16:45 – 17:15
    Enabling Speed to Market in Combination Product Development: A System Integration Approach for PFS, Safety, and Self-Injection Solutions
    Santosh Das, Greater Asia Commercial Development, Self-Injection and Safety, BD

    17:15 – 17:45
    Impact of Sterilization on Protein Aggregation and Degradation in a Polymer-Based Pre-Filled Syringe System
    Katsuyuki Takeuchi, Associate Product Manager – Pharmaceutical Solutions, Terumo

    17:45 – 18:00
    Questions and Answers/Discussion

    Track B: Manufacturing
    Moderator: Robin Hwang, Consultant, ICP Consulting Corp.

    This session gives an overview of the fill finish process of injectables. It starts with new facility concepts and addresses best practices of bioburden control in aseptic environments. Three presentations give details on novel approaches with highly flexible filling lines to cut change time and increase flexibility. The challenges of bubble-free filling of cartridges are presented in a case study. Finally, the latest developments are presented where the container is communicating with the filling line, capturing data which allow for complete traceability of the fill process.

    15:00 – 15:30
    Flexible and Modular Facilities
    Dennis Powers, Director of Sales Engineering, G-CON Manufacturing

    15:30 – 16:00
    Changing Production Strategies in Sterile Filling
    Kristian Slavik, Sales Director of Southeast Asia and Far East, Optima

    16:00 – 16:15
    Questions and Answers/Discussion

    16:15 – 16:45
    Bubble-Free Filling of Ready-to-Fill Cartridges
    Enrico Zanetti, Sales & Business Development Manager, Swissfillon

    16:45 – 17:30
    Intelligent Primary Packaging and Fill-Finish Operation
    Egmont Semmler, PhD, Director R&D Pharmaceutical Fill & Finish, Groninger

    17:30 – 18:00
    Questions and Answers/Discussion

    Wednesday, 7 November

    8:00 – 15:15
    Registration Open

    8:30 – 10:00
    Concurrent Sessions

    Track A: Devices
    Moderator: Magnus Fastmarken, Global Director Marketing, SHL Group

    Devices like pens, autoinjectors and wearables are the drug delivery systems for patient-friendly medicines. This session will give an overview on the technologies and their advantages. With the progress of miniaturization of electronic parts, new devices are being developed which allow it to communicate with the patient and to also collect data on the patient and injection process. Some of the latest developments will be presented and potential advantages for patients, doctors, and pharma industry will be discussed

    8:30 – 9:00
    Trends in Self-Injection: How Platform Products, Large Volume Injectors, and Connected, Smart Devices Support Patients and Industry
    Orfeo Niedermann, MBA, Business Development Director, Delivery Systems, Ypsomed

    9:00 – 9:30
    Autoinjectors: The Gold Standard in Self-Treatment with Biologics

    Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group

    9:30 – 10:00
    Questions and Answers/Discussion

    Track B: Testing
    Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

    To guarantee the quality of pharmaceutical products, many data must be measured and assessed. This must happen during development but also in routine production. The right selection of primary packaging components is needed to ensure that no leachables affect the quality, but to also ensure container closure integrity. Besides the right fit of the primary packaging components, the suitability for assembling into devices has to be tested. The presentations in this session will describe the latest developments in regulations and technology on container closure, extractables and leachables, and device testing. For any injectable, the visual inspection of the primary container is mandatory. An industry perspective will share the latest on visual inspection.

    8:30 – 9:00
    Current Best Practice in Bioburden Control
    James N. Polarine, Jr., MA, Senior Global Technical Service Manager, STERIS Corporation

    9:00 – 9:30
    Trends in Container Closure Integrity Testing
    Lei Li, PhD, Associate Senior Consultant Engineer, Eli Lilly and Company

    9:30 – 10:00
    Questions and Answers/Discussion


    10:00 – 10:30
    Refreshment Break in Exhibit Area

    10:30 – 12:00
    Concurrent Sessions

    Track A: Devices
    Moderator: Magnus Fastmarken, Global Director Marketing, SHL Group

    10:30 – 10:55
    Connectivity: Adding Value beyond Drug Delivery
    Markus Bauss, Managing Director, SHL Connect, SHL Group

    10:55 – 11:20
    Good Injection Device Can Add Values to Your Drugs
    Edgar Yeh, Project Manager, CC Biotechnology Corporation

    11:20 – 12:00
    Injection Device Assembly and Testing

    Gilbert Fluetsch, MBA, Director, Automation, SHL Group
    Lucy Chung, Director, Automation, SHL Group

    Track B: Testing
    Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

    10:30 – 11:00
    Extractables and Leachables
    Piet Christiaens, PhD, Scientific Director, Nelson Labs

    11:00 – 11:30
    Container and Device Testing
    Erik Berndt, Industry Manager Medical/Pharmaceutical, Zwick

    11:30 – 12:00
    Questions and Answers/Discussion

    12:00 – 13:00
    Networking Luncheon

    13:00 – 14:30
    P3: Lifecycle Management Approaches for a Successful Business
    Moderator: Robin Hwang, Consultant, ICP Consulting Corp.

    This session addresses the relevance of lifecycle management approaches for a successful business. Approaches might be changes in formulation or changes in the application system (e.g., change from vial to syringe).

    13:00 – 13:30
    Lifecycle Management Strategy for Her2 Family on Biosimilars Development 
    Dr. L-C Liu, CEO, EirGenix, Inc.

    13:30 – 14:00
    Drug Delivery System Life Cycle Management (LCM): Factors to Consider
    Amy Wang, PhD, Director, Drug Delivery and Device Development, Alexion Pharmaceuticals, Inc.

    14:00 – 14:30
    Polymeric Primary Containers for Mitigating Challenges in Therapeutic Protein Drug Products
    Bruce Eu, Engineering Director, Final Product Technology, Amgen, Inc.
    Risako Tanaka, Sales, Daikyo Seiko, Ltd.

    14:30 – 15:00
    Refreshment Break in Exhibit Area

    15:00 – 17:30
    P4: Electronics, Devices, and Pharma
    Moderators:
    Chung-Hsiun Wu, PhD, Director, Biotechnology & Pharmaceutical Industries Promotion Office, Ministry of Economic Affairs, Taiwan
    Markus Bauss, Managing Director, SHL Connect, SHL Group

    In the history of disease treatment, first there were pharmaceutical components only. With biological products, devices became increasingly important to improve convenience for patients. Recently there are approaches to make devices “intelligent” by integrating electronic features into them. This will potentially improve patients’ treatments by allowing the device to directly interact with the patient.

    This session will address the future in the interdisciplinary field of electronics, devices, and pharma. Taiwan is known to have very strong capabilities in semiconductor, electronics, information and communication technology (ICT), precision molding, metal processing, and mechanical engineering, which allow Taiwan to be a great partner for device manufacturing as well as for making devices “intelligent” for the pharma industry. As such, this session will also address what roles can Taiwan play and what opportunities are in Taiwan in this interdisciplinary field of electronics, devices, and pharma.

    Five short presentations will introduce into the topic of the panel discussion.

    15:00 – 15:15
    Roles and Opportunities of Taiwan in the interdisciplinary field of Electronics, Devices, and Pharma
    Chi-Feng Chang, PhD, Deputy Director, Biotechnology & Pharmaceutical Industries Promotion Office, Ministry of Economic Affairs, Taiwan

    15:15 – 15:30
    Taiwan’s Regulations on “Intelligent” Drug Delivery Devices: A Medical Device Prospective
    Jai-Yen Chen, PhD, Senior Reviewer in Division of Medical Devices, Center for Drug Evaluation

    15:30 – 15:40
    How Can DCB Help from Drug Discovery to Development, Biotech Incubation, and Digital Health Acceleration?
    Chia-Cheng Wu, PhD, Executive Director of Institute of Biologics, Development Center for Biotechnology

    15:40 – 15:50
    Perspective of a Representative of the Device Industry
    Markus Bauss,
    Managing Director, SHL Connect, SHL Group

    15:50 – 16:00
    Perspective of a Representative of the Pharmaceutical Industry
    Mathias Romacker,
    Senior Director, Device Strategy, Pfizer, Inc.

    16:00 – 17:30
    Panel Discussion
    The panel discussion wants to address:

    • What are the advantages for patient, doctors, pharma industry, insurance companies?
    • What are the challenges and hurdles?
    • What are drivers?
    • What are business opportunities for Pharma, electronics and IT industry?
    • What are the opportunities for Taiwan`s industry?

    Panelists:
    Jai-Yen Chen, PhD, Senior Reviewer in Division of Medical Devices, Center for Drug Evaluation 
    Alex Dee, Vice President, Product Marketing, FIC
    Kimmy Chang Chien, Sanofi Taiwan
    Artur Kadurin,
    Chief Executive Officer, Insilico Taiwan
    Mathias Romacker, Senior Director, Device Strategy/Marketing, Pfizer, Inc.
    Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group

    17:30
    Closing Remarks
    Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

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    SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. 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.

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