2020 PDA Combination Products Workshop

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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.

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

Standard Registration

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See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Day 1


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

Day 2


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

Day 3


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

Day 4


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

Agenda is subject to change.

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