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2020ComboProducts-1988x680

2020 PDA Combination Products Workshop

Oct 12 - Oct 15, 2020
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online
  • The Americas

Overview

The PDA Combination Products Workshop is going Virtual!

Device development requires large financial, technical, and human resource investment. The expectations from the different global regulatory bodies may vary significantly, even when the intent is the to provide safe and effective medications.

The workshop will discuss a different global regulatory expectations and strategies for overcoming challenges through case studies and patient experiences. Learn from their experiences and solutions they have implemented during development, approval and life-cycle management of their Combination Products.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Monday, October 12

    9:00 a.m. – 10:30 a.m.
    P1 - Bridging/Leveraging Existing Information/Drug Delivery Combination Products
    Moderator: Matthew Huddleston, Enable Injections

    Platform technology consists of core building blocks that can be utilized, interchanged and preferably reused across multiple product applications. In combination product development, the ability to build and leverage delivery device platform technologies to deliver different drugs and/or support multiple companies can provide significant advantages including reduction in development risk, time to market, and product cost. In this session, we'll discuss the opportunities and challenges of leveraging platform technologies from the perspective of the device manufacture and the pharmaceutical company.

    9:00 a.m. – 9:05 a.m.
    Welcome, Opening Remarks from Program Planning Committee

    9:05 a.m. – 9:35 a.m.
    Strategies for using a Common Injector Technology for Multiple Drug Products Regulatory, Change Management and Design Control Considerations
    Suzette Roan, Sanofi

    9:35 a.m. – 10:05 a.m.
    How Novartis is using Platforms to reduce the time and effort to bring new Drug Delivery Combination Products to the Market
    Chris Muenzer,
    Novartis

    10:05 a.m. – 10:30 a.m.
    Q&A with Additional Panelists

    10:30 a.m. – 10:40 a.m.
    Break

    10:40 a.m. – 12:10 p.m.
    P2 - Human Factors
    Moderator: OneWorld

    10:40 a.m. – 11:10 a.m.
    Talk 1
    Speaker Invited

    11:10 a.m. – 11:40 a.m.
    Talk 2
    Speaker Invited

    11:40 a.m. – 12:10 p.m.
    Q&A Panel

  • Tuesday, October 13

    9:00 a.m. – 10:30 a.m.
    P3 - Digital Technology
    Moderator: Anthony Watson, Sanofi US

    Digital technologies have become more pervasive in the clinical and homecare arena. Specifically, these technologies are used in improving the way patients, caregivers, and healthcare providers manage their interactions and the monitoring and treatment of patients. These technologies are no longer the purview of technology companies and have been incorporated into the portfolio of pharma and biotech companies for a number of purposes, including clinical trials. However, these technologies pose challenges within companies who did not have core expertise in developing, manufacturing, and establishing appropriate compliance for them. This session will provide a platform to discuss the issues associated with developing these technologies for clinical trials. The session will also describe the challenges and solutions to addressing the regulatory requirements for digital health technologies beyond clinical trials. An example will be presented.

    9:00 a.m. – 9:30 a.m.
    Gretchen Vandal, Sanofi

    9:30 a.m. – 10:00 a.m.
    Paul Schultz, Bright Insights

    10:00 a.m. – 10:30 a.m.
    Q&A Panel

    10:30 a.m. – 10:40 a.m.
    Break

    10:40 a.m. – 12:10 p.m.
    P4 - Reliability
    Moderator: Lee Leichter, P/L Biomedical

    10:40 a.m. – 11:10 a.m.
    Mike Roe, Kaleo

    11:10 a.m. – 11:40 a.m.
    FDA Insight on Reliability Data for Emergency Injectors
    Regulator Invited

    11:40 a.m. – 12:10 p.m.
    Q&A Panel

  • Wednesday, October 14

    9:00 a.m. – 10:30 a.m.
    P5 - Globalization of Combination Products
    Moderator: Manfred Maeder, Novartis

    9:00 a.m. – 9:30 a.m.
    Speaker Invited

    9:30 a.m. – 10:00 a.m.
    Speaker Invited

    10:00 a.m. – 10:30 a.m.
    Q&A Panel

    10:30 a.m. – 10:40 a.m.
    Break

    10:40 a.m. – 12:10 p.m.
    P6 - Cross Labeling/Combined Use
    Moderator: Anthony Watson, Sanofi US

    The ecosystem of technologies which are used to treat patients today includes a mix of drugs, biologics, and medical devices. In the past, these were viewed independently through the lenses of the individual manufacturers and not much consideration was given to how they may overlap in terms of regulatory requirements. Over the last decade or so, much progress has been made to recognize the unique regulatory challenges that the combination of these technologies present. One area that poses particular challenges still is how to address the regulatory challenges when products are provided separately but are related in some way through labeling or use. Definitions of “cross-labeled” and the more recently coined “combined use” products raise questions of how to adequately ensure these products meet regulatory requirements and they meet the needs of patients and other users. This session will provide the audience an opportunity to explore these challenges and efforts to clarify expectations from the perspectives of both industry and FDA.

    10:40 a.m. – 11:10 a.m.
    Jonathan Amaya-Hodges, Biogen

    11:10 a.m. – 11:40 a.m.
    Barr Weiner, U.S. FDA

    11:40 a.m. – 12:10 p.m.
    Q&A Panel

  • Thursday, October 15

    9:00 a.m. – 10:30 a.m.
    P7 - Generics
    Moderator: Lee Leichter, P/L Biomedical

    9:00 a.m. – 9:30 a.m.
    Anil Sachdeva, Teva

    9:30 a.m. – 10:00 a.m.
    Regulator Invited

    10:00 a.m. – 10:30 a.m.
    Q&A Panel

    10:30 a.m. – 10:40 a.m.
    Break

    10:40 a.m. – 12:10 p.m.
    P8 - Safety Reporting
    Moderator: Khaudeja Bano, MD, Amgen, Inc.

    10:40 a.m. – 11:25 a.m.
    Khaudeja Bano, Biogen

    11:25 a.m. – 12:10 p.m.
    Q&A with Additional Panelist

Learning Objectives

At the completion of this workshop, attendees will:

  1. Identify and prospectively address key challenges in the development, approval and manufacture of Combination Products
  2. Recognize potential liabilities and opportunities within their organization
  3. Identify issues associated with digital technologies in clinical trials
  4. Explain unique issues and challenges in the development, approval and manufacture of Combination Products to peers and management

Registration Fees

Register Now
Registration Type Fee
Member $876
Non-member $876

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