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2020 PDA Combination Products Workshop

Building on the Past, Looking to the Future

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


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.


  • Day 1
  • Day 2
  • Day 3
  • Day 4

    9:00 a.m. – 10:30 a.m. | P1 - Bridging/Leveraging Existing Information/Drug Delivery Combination Products
    Matthew J. Huddleston, MS, CTO, 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. | Welcome and Opening Remarks from Workshop Chair
    Lee H. Leichter, MBA, RAC, President, P/L Biomedical

    9:05 a.m. | Strategies for Using a Common Injector Technology for Multiple Drug Products: Regulatory, Change Management, and Design Control Considerations
    Suzette M. Roan, JD, Senior Director, GRA Devices, Sanofi

    9:35 a.m. | How Novartis is Using Platforms to Reduce the Time and Effort to Bring New Drug Delivery Combination Products to The Market
    Christopher H. Muenzer, Team Lead, Novartis Pharma AG

    10:05 a.m. | Q&A with Additional Panelists
    Mark A. Destefano, Director, Combination Products and Devices, Teva Pharmaceutical Industries Ltd.
    Serkan Oray, Vice President, Head of Device, Packaging, and Wearable Technologies, UCB Pharma

    10:30 a.m. – 10:40 a.m. | Break

    10:40 a.m. – 12:10 p.m. | P2: Human Factors – Patient Support
    Joseph Blechl, MBA, Executive Vice President, One World DMG

    The application of Human Factors as it pertains to drug delivery has moved well beyond usability and has expanded to utilizing and optimizing patient-centric design methods before drug approval. Identifying and implementing patient-focused strategies is critical to launching a safe and successful product experience – all designed to enhance patient satisfaction and compliance. This session will be a mix of live streaming and pre-recorded segments from industry experts, health care professionals, and possibly patient user groups and patients, all focused on their perspectives on patient advocacy and support

    10:40 a.m. | A Personal Viewpoint on the Patient Experience
    Brooke E. Pelczynski, Artist and MS Patient, One World DMG

    10:45 a.m. | Patient Friendly Product Ideation, Development, and Patient Experience Support Considerations
    Shannon Hoste, Enable Injections

    10:50 a.m. | Human Factors, Design, Verification, and Validation Activities
    Christoph Jordi, MSc, Director Usability and Human Factors, Ypsomed AG

    10:55 a.m. | How Companies Can Address Delivery Device “Patient Centricity” and Also Meet FDA Expectations
    Douglass S. Mead, III, MSBME, Principal Consultant and President, CP Pathways LLC

    11:00 a.m. | How Education and Follow Up Affects Patient Experience, Outcomes, Readmission, and Reimbursement
    Dawn B. Cicchetti, BSN, RN, MPA, CCM, Executive Director of Case Management, Crozer Keystone Health System

    11:05 a.m. | Tailoring Education to the Needs of Patients: Explaining the Hows and Whys of Injectables
    Heidi Holden, Diabetes Educator

    11:10 a.m. | Panel Discussion

    11:40 a.m. | Q&A and Daily Remarks from Workshop Chair

    9:00 a.m. – 10:30 a.m. | P3: Reliability
    Moderator: Lee Leichter, P/L Biomedical

    The reliability of delivery systems to safely deliver the drug has always been important. The assurance that these devices will deliver the medication under the conditions of use, throughout the product lifetime, is been established though design validation and ongoing monitoring and controls. However, for products that deliver lifesaving drugs, where a failure to deliver can result I patient death, there is an expectation of a higher quality level. In the USA, the FDA has provided individual guidance as to what level of reliability must be established prior to approval, and what level of control be implemented to maintain that level. This extends from the suppliers, components, manufacturing process and any element that could cause a potential failure. The FDA has also issued a draft guidance. This session will include a presentation from FDA and from a company that has been through the process and is marketing multiple lifesaving delivery products.

    9:00 a.m. | Reliability for Emergency-Use Medical Injectors: Industry Experience
    Michael J. Roe, PE, Senior Director, Development and Industrialization, Kaleo

    9:30 a.m. | FDA Insight on Reliability Data for Emergency Injectors
    Matthew Ondeck, MS, RAC, Biomedical Engineer, CDRH, U.S. FDA

    10:00 a.m. | Q&A

    10:30 a.m. – 10:40 a.m. | Break

    10:40 a.m. – 12:10 p.m. | P4: Digital Technology
    Moderator: Gretchen L. Vandal, MS, MBA, Director, Global Regulatory Affairs – Devices, 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.

    10:40 a.m. | Establishing a Digital Strategy for Drug Development
    Nicholas E. Wong, MS CQE, Associate Director of Regulatory Affairs - Digital Health and Medical Devices, Sanofi US

    11:10 a.m. | The "2nd Wave" of Connected Combination Products in The Commercial Setting
    Paul P. Schultz, Senior Director Commercial Development, BrightInsight

    11:40 a.m. – 12:10 p.m. | Q&A and Daily Remarks from Workshop Chair

    9:00 a.m. – 10:30 a.m. | P5: Globalization of Combination Products
    Moderator: Lee H. Leichter, MBA, RAC, President, P/L Biomedical

    This session will provide an update of the spread of the recognition and regulation of Combination Products around the world including the impact of the EU Medical Devices Regulation (MDR) set to take effect next May.

    9:00 a.m. | Marc Rohrschneider, PhD, Head New Technologies, Novartis Pharma AG

    9:30 a.m. | Mark A. Chipperfield MSc, BEng(Hons), AMIMechE, MTOPRA, Company Director and Principal Consultant, Corvus Device Limited

    10:00 a.m.| Q&A

    10:30 a.m. – 10:40 a.m. | Break

    10:40 a.m. – 12:10 p.m. | P6: Cross Labeling/Combined Use
    Moderator: Anthony D. Watson, Global Regulatory Affairs - Devices, Sanofi Inc.

    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. | Cross-Labeling and ‘Combined Use’ – Industry Perspective
    Jonathan W. Amaya-Hodges, ASQ CQE, CMQ/OE, Associate Director, Regulatory Affairs, Biogen

    11:10 a.m. | John (Barr) Weiner, Associate Director for Policy, Office of Combination Products, OC, U.S. FDA

    11:40 a.m. | Q&A

    9:00 a.m. – 10:30 a.m. | P7: Complex Generic Combination Products
    Moderator: Lee Leichter, P/L Biomedical

    To be approved as a generic drug, suitable for substitution for the reference listed drug (RLD), the FDA requires the demonstration of a legal concept of “sameness”.  The method analytical and clinical methods for establishing sameness have been well established for the drug constituent, but they are not as clear for the device constituent part.  The two speakers, one from FDA and one from industry, will discuss the regulatory and scientific framework for determining equivalence and challenges that arise with the review and approval of abbreviated new drug applications (ANDAs) for generic drug combination products.

    9:00 a.m. | Complex Generic Combination Product Substitutability: A Device Perspective
    Henri M. Akouka, PE, Director, Biopharmaceutical Development and Engineering, Teva Branded Pharmaceutical Products R&D, Inc.

    9:30 a.m. | Overview of Generic Drug-Device Combination Products
    Lisa Bercu, Regulatory Counsel, CDER, U.S. FDA

    10:00 a.m. | Q&A

    10:30 a.m. – 10:40 a.m. | Break

    10:40 a.m. – 12:10 p.m. | P8: Post-Marketing Safety Reporting (PMSR) for Combination Products
    Moderator: Khaudeja Bano, MD, Executive Medical Director, Amgen, Inc.

    In this session post-marketing safety reporting (PMSR) for combination products will be discussed, including post-implementation key takeaways from industry. Participants will gain insights into some challenges faced by industry and recommended best practices. A simple AE/PC case discussion for a PFS from intake to submission will be reviewed.

    10:40 a.m. | Adverse Safety Reporting in Combination Products
    Khaudeja Bano, MD, Executive Medical Director, Combination Product Safety Head Global Patient Safety, Amgen, Inc.

    11:25 a.m. | Q&A with Additional Panelist
    Regulatory Panelist Invited

    12:10 p.m. | Closing Remarks from Workshop Chair

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

Registration Type Fee
Member $876
Non-member $876

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