2022 Combination Products Presentations

A summit focused on solutions for a dynamic industry with evolving regulations.

2022 Presentations

Presentation links are found immediately

after their listing in the schedule.


FDA Office Hours :
Meet privately with FDA Officials:

Thinh Nguyen

Director, Office of
Combination Products, FDA-OCP

John “Barr” Weiner

Associate Director for Policy in FDA’s
Office of Combination Products, FDA

Monday, November 7,
10 A.M. – 2:00 P.M.
Registered attendees only

All slots have been reserved!

Workshop
Managing Risks and Presentation Changes for Combination Products

Monday, November 7, 2022

Delivering a combination product to market and maintaining safety and performance on market requires a comprehensive understanding of regulatory requirements for risk management. Product risks can arise from design, manufacturing, and human factor considerations, however, there are also broader development risks impacting combination product development such as managing presentation changes in clinical and commercial phases. The following complimentary sessions will be delivered:

8:00 A.M. – 12:00 P.M.

Understanding and Managing Risk across the entire product combination Product lifecycle

The combined use of two or more differently regulated constituent parts with one another can present new and significant risks and risk management considerations. Combination product risk management therefore serves as the underpinning to both combination product development and lifecycle management, including post marketing modifications, surveillance and reporting.  In the first half of this workshop we will review combination product risk management expectations and best practices – drug-agnostic and combined use – working through examples together.  We will underscore the critical connections between development risk management activities and post market to ensure safe use of the combination product designed with a patient-centric approach.

Post Market Application of the risk management data to ensure a risk-based approach to Post Market Surveillance.

Content Covered:

The workshop will cover the following content:

  • Risk Management Fundamentals – Essential concepts for combination product
  • Overview of US FDA expectations
  • Review of case studies
  • Small group activities exploring risk management scenarios
  • Post Market application to make it a closed loop process
Speakers
  • Edwin Bills, Consultant
  • Khaudeja Bano, MD, Vice President Combination Product Quality, Amgen 

8:00 A.M. – 8:20 A.M.

Welcome to the workshop

Welcome to the Combination Products Summit Workshop!

Speakers
  • Cynthia Culmo, Program Lead, Combination Products and PharmaLink, AFDO/RAPS Healthcare Products Collaborative
  • John “Barr” Weiner, Associate Director for Policy, U.S. Food and Drug AdministrationOffice of Combination Products

8:20 A.M. – 8:50 A.M.

Introduction and Combination Product Risk Management Overview

Overview of key combination product Risk Management concepts – US FDA expectations

Speakers
  • Edwin Bills, Consultant

8:50 A.M. – 9:50 A.M.

Risk Management Best Practices for Combination Products

Presentation of Risk management across the product lifecycle.

Speakers
  • Edwin Bills, Consultant

9:50 A.M. – 10:05 A.M.

Break

10:05 A.M. – 10:50 A.M.

Real World Risk Management Challenges

We will address the workshop attendees challenges and review of combination product risk management challenges across the parenteral and inhalation drug delivery spaces, both drug-led / device-led applications.

Speakers
  • Edwin Bills, Consultant
  • Khaudeja Bano, MD, Vice President Combination Product Quality, Amgen 

10:50 A.M. – 11:50 A.M.

Post Market Application of Risk management concepts in Complaints and Safety

Applying Risk Assessment data to make effective post-market impact using a risk-based approach while using post market data effectively to inform the Risk management process in a closed loop process.

Speakers
  • Khaudeja Bano, MD, Vice President Combination Product Quality, Amgen 

11:50 A.M. – 12:50 P.M.

Lunch

12:50 P.M. – 3:40 P.M.

Bridging between Combination Product Drug Delivery Device Presentations: Strategies to leverage data and minimize patient burden

Download afternoon presentations

The safety and efficacy of combination products rely on both the pharmaceutical and device constituent parts performing properly. However, the realities of pharmaceutical and device constituent development are such that the availability of components for pivotal studies may be incongruent, or changes may need to be made to only one portion of the system. In some cases, it is not practical or in the best interest of patients to mandate the collection of new clinical data for changes in drug delivery device presentation that may not impact safety and/or efficacy of the combination product. For this reason, in 2019 the U.S. FDA issued a draft guidance on “Bridging for Drug-Device and Biologic-Device Combination Products” which describes a suggested approach for identifying the minimum viable data needed to bridge prior conclusions of product safety, efficacy, and performance between drug delivery device presentations.

This workshop will provide an overview of combination product bridging techniques and the U.S. FDA’s draft guidance, present case studies demonstrating the applications of those techniques, and provide the audience with opportunities to apply bridging tools to hypothetical product changes. 

Content Covered: 

The workshop will cover the following content:

  • Essential concepts for combination product bridging
  • Overview of recent U.S. FDA draft guidance on bridging
  • Presentation of available bridging tools
  • Review of case studies
  • Small group activities exploring bridging scenarios

Speakers:

  • Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
  • Jiaying Shen, Distinguished Scientist, Merck
  • John McMichael, Director of Devices & Digital Therapeutics, CMC Regulatory Affairs, AstraZeneca
12:50 P.M. – 1:20 P.M.

Introduction and Combination Product Bridging Overview

During this session we will provide an overview of key combination product bridging concepts and definitions and review of 2019 the US FDA issued a draft guidance on “Bridging for Drug-Device and Biologic-Device Combination Products”

Download Presentation

Speakers
  • Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca 

1:20 P.M. – 2:05 P.M.

Combination Product Bridging Toolbox

Presentation of each available combination product bridging tool (e.g. analytical, human factors, real world patient handling study) and provide recommendations for when the bridging tool is most appropriate.

Speakers
  • Jiaying Shen, Distinguished Scientist, Merck

2:05 P.M. – 2:20 P.M.

Break

2:20 – 2:50 P.M.

Bridging Challenges – Case Studies

Review of combination product bridging challenges via several case studies across the parenteral and inhalation drug delivery spaces.

Speakers
  • John McMichael, Director of Devices & Digital Therapeutics, CMC Regulatory Affairs, AstraZeneca

2:50 P.M. – 3:35 P.M.

Bridging – Tabletop Group Activity Working through Bridging Scenarios

The audience will split into small teams and apply knowledge learned in Sessions 1-3 to real-world combination product bridging scenarios.

Speakers
  • John McMichael, Director of Devices & Digital Therapeutics, CMC Regulatory Affairs, AstraZeneca
  • Jiaying Shen, Distinguished Scientist, Merck
  • Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca 

Day One

Tuesday, November 8, 2022

7:45 A.M. – 8:30 A.M.

Breakfast

Join your colleagues from around the globe as we kick off the Combination Products Summit with a complimentary hot breakfast!

8:30 A.M. – 8:45 A.M.

 Let’s Make a Difference!

Welcome to the AFDO/RAPS Healthcare Products Collaborative Combination Products Summit! This  purpose-driven summit will lead you to actionable learning and implementation plans!

Speakers
  • Cynthia Culmo, Program Lead, Combination Products and PharmaLink, AFDO/RAPS Healthcare Products Collaborative
  • Thinh Nguyen, Director, U.S. Food and Drug AdministrationOffice of Combination Products (FDA-OCP)

8:45 A.M. – 9:15 A.M.

The Solution Exchange

Start your day with solutions! This fast-paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues to address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you.

ModeratorS
  • Fran DeGrazio, President, Strategic Parenteral Solutions LLC | Advisor to C-Suite and Senior Executives 

9:15 A.M. – 10:15 A.M.

From the Desk of the Office of Combination Products – Strategic Priorities

The FDA’s Office of Combination Products serves as a liaison between industry and the necessary FDA Centers on the most pressing challenges faced by the Combination Products Industry. Learn firsthand what is being addressed by the FDA now, and what is planned for the future on traditional and complex products.

This is your chance to have your questions answered by FDA in a collaborative setting! What is at the top of your mind regarding combination products? Submit your questions and join us to hear their comments during the 2022 Combination Products Summit.

Moderator
  • Ryan McGowan, Director of Digital Devices and Combination Products within CMC Regulatory Affairs, AstraZeneca
Speakers
  • Thinh Nguyen, Director, U.S. Food and Drug AdministrationOffice of Combination Products (FDA-OCP)
  • John “Barr” Weiner, Associate Director for Policy, U.S. Food and Drug AdministrationOffice of Combination Products
10:15 A.M. – 10:30 A.M.

Break

10:30 A.M. – 11:15 A.M.

Successfully Navigating Global Regulatory Environments as they Evolve

Get insight from the FDA on Combination Products Global Evolving Regulatory Environment and Opportunities for Harmonization. Learn successful practices on how global organizations are managing and steps you can take to get your products to the patients who need them.

Moderator
  • Khaudeja Bano, MD, Vice President Combination Product Quality, Amgen
Speakers
  • Thinh Nguyen Director, U.S. Food and Drug AdministrationOffice of Combination Products (FDA-OCP)
  • John “Barr” Weiner, Associate Director for Policy, U.S. Food and Drug AdministrationOffice of Combination Products (FDA-OCP)
  • Manfred Maeder, VP Global Device & Packaging Development (GDPD) in Technical Research & Development (TRD), Novartis
11:15 A.M. – 12:15 P.M.

Needle-based Injection Systems Standard and Associated Regulatory Expectations – What you Need to Know!

After a long-awaited update, the ISO 11608 Needle-Based Injection Systems (NIS) standard is here. The NIS standard has been a cornerstone of combination product development addressing core requirements of injection devices, including those with mechanical, electronic, and/or automated functions. In addition to capturing the emerging category of On-Body Delivery Systems, the 2022 standard builds upon existing conditioning requirements for device constituents, introduces the concept of primary function, and discusses expectations for drug product compatibility testing. This session will explore important updates to the standard series, provide insight into FDA’s current thinking and expectations on the updated requirements, and highlight areas where the standard touches on key conversations surrounding EPRs and sequential conditioning.

Moderators
  • Inta Buhr, Associate Director Regulatory Affairs, CMC, Alkermes
  • Steve Vesole, Drug Delivery Systems Engineer, Janssen Research & Development
SPEAKERS
  • Alan Stevens, Assistant Director, U.S. Food and Drug Administration, Injection Devices, Division of Drug Delivery, General Hospital and Human Factors, FDA-CDRHView Presentation
  • Carolyn Dorgan, Director, Technical Services, Suttons Creek, Inc.View Presentation
12:15 P.M. – 1:10 P.M.

Networking Lunch

Sit with FDA officials, speakers, industry experts, and your colleagues to discuss topics that are important to you. Enjoy the discussion with others who share your passion. Tables will be set aside for these topics:

  • Component vs. Constituent Parts
  • Human Factors Validation
  • Digital Health QMS Challenges
1:10 P.M. – 2:10 P.M.

Genus Medical Technologies LLC v. FDA: Impact and considerations for combination product regulations

This panel discussion of FDA and industry experts will provide an overview of the Genus court case, recent FDA guidance and actions in implementing the Genus decision, overview of 21 CFR Part 4 requirements for combination products, and implications for combination product classification moving forward.

Moderator
  • Ryan Hoshi, Director of Regulatory Policy & Intelligence, AbbVie
Speakers
  • James Wabby, Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Combination Products and Devices, AbbVie
  • John “Barr” Weiner, Associate Director for Policy, U.S. Food and Drug AdministrationOffice of Combination Products (FDA-OCP)
  • Rumi Young, Director, Regulatory Policy, BD
  • Chelsea O’Connell, Director, Global Regulatory and R&D Policy, Amgen
2:10 P.M. – 3:10 P.M.

Connected Combined Use Products – Unique Technical and Regulatory Considerations

Join FDA and Industry experts as they discuss unique technical and regulatory considerations for connected combined use and combination products. How do you apply multifunction guidance? Learn successful practices that you can apply today.

Moderators
  • Rumi Young, Director, Regulatory Policy, BD
  • Chin-Wei Soo, FRAPS, Global Regulatory Head – CMC/Devices and Combination Products, Genentech
Speakers
  • Courtney Evans, Team Lead, Injection Devices, FDA-CDRH
  • Michael Fahmy, Exec. Director at Otsuka Pharmaceutical Development & Commercialization, Otsuka Pharmaceutical Companies (U.S.)
3:10 P.M. – 3:25 P.M.

Break

3:25PM – 4:10 P.M.

Quality Management System (QMS) Strategies for Device and Non-Device Digital Health Technologies in a Pharmaceutical Company

Digital health technologies are gaining significant momentum in the pharmaceutical industry. These technologies can be used for medical device and/or non-medical device purposes, depending on intended uses. The quality system practices associated with the life cycle management of these digital health technologies are important to ensure that they are developed in a responsible and compliant manner. Learn successful approaches to develop your strategy from global experts.

View Presentation

Moderator
  • Chin-Wei Soo, FRAPS, Global Regulatory Head – CMC/Devices and Combination Products, Genentech
Speakers
  • Charlotte Brandt, Senior Quality Lead, Digital Health Quality, Novo Nordisk
  • Mary Beth McDonald, VP, Regulatory & Quality Management | Medical Devices | ISO 13485 Quality Systems | Digital Mobile Health
4:10 P.M. – 4:55 P.M.

Leveraging Data in Human Factors Validation

Biopharmaceutical companies often leverage the same device technology for multiple drug products, though there is concern about the consistency with which the FDA reviews a submission for a new drug using that same technology. Learn how to leverage data from HF validation from industry experts with former FDA experience.

View Presentation

Moderator
  • Sandra Boyd, Associate Director, Biogen
Speakers
  • Shannon Hoste, President Agilis Consulting Group, Agilis
  • Shannon Clark, Founder & CEO at UserWise, Inc.
4:55 P.M. – 5:00 P.M.

Closing Remarks

Many successful practices were shared today! What resonated with you? Don’t forget to complete your ACT sheet and start thinking about what you can use to make a difference to the patients you serve. But for now, let’s have some fun … see you at the Networking Reception!

Moderator
  • Cynthia Culmo, Program Lead, Combination Products and PharmaLink, AFDO/RAPS Healthcare Products Collaborative

5:00 P.M. – 6:00 P.M.

Networking Reception

The summit will surely result in lots of energy as you and your colleagues explore the “what ifs” and “how tos” of Combination Products. Please stay with us for the summit networking reception to enjoy lively dialog, drinks, and hors d’oeuvres before closing out our first day!

Day Two

Wednesday, November 9, 2022

7:45 A.M. – 8:30 A.M.

Breakfast

Join your colleagues for a complimentary hot breakfast to jump-start your day and continue the stimulating topics begun yesterday and from the workshop on Monday.

8:30 A.M. – 8:40 A.M.

Day 2 Opening

Welcome Back! Participants will feel the difference at this purpose driven, action-oriented Combination Products Summit. We will start the day recapping the takeaway points from Day 1 through the Act-Change-Transfer process that will lead to the development of action plans for your key learnings. We insist that our content is meaningful and impactful, so you can’t help but walk away with practical applications to implement when you return to work!

Moderator
  • Khaudeja Bano, MD, Vice President Combination Product Quality, Amgen 
  • Fran DeGrazio, President, Strategic Parenteral Solutions LLC

8:40 A.M. – 9:40 A.M.

EU MDR – What is “Significant Change” and What you Need to Know about Notified Body Opinions (NBOp)

Understand the definition of a “significant change,” specifically, as it applies when an NBOp is required for a change to the device constituent of an approved integral medicinal product (combination product). Is an NBOp needed for the device constituent of a currently marketed and approved (in EU) combination product when the indications for use are being expanded? Does the expansion of indications for use for the combination product constitute a change to the intended use of the device constituent?

View Presentation  

Moderator
  • Jason Lipman, Senior Director of Global Regulatory Affairs for Devices and Combination Products, Sanofi
Speaker
  • Tim Chesworth, Senior Director Regulatory Affairs, Medical Devices & Combination Products, AstraZeneca
  • Pascal Venneugues, European Medicines Agency (EMA)
9:40 A.M. – 10:00 A.M.

Break

10:00 A.M. – 11:00 A.M.

Postmarket Safety Reporting (PMSR) – Key Themes to Consider for Your Patients

Join this panel of leading FDA and Industry experts in an interactive session regarding Malfunction Reporting: FDA expectations vs. Industry application. Through advanced Device-led and Drug/Biolgic-led case studies, panel discussions, and table discussions, you will understand:

  • The FDA’s use of malfunction device /drug constituent part information and its application, to help inform and enhance industry reporting practices.
  • How the FDA uses dashboard and analytical data across divisions, which can raise industry awareness and enhance data quality.
  • PMSR challenges.
  • Harmonization of severity of harms ratings in risk assessments across similar device platforms.
  • Lessons learned over the past couple of years including device malfunction requiring Field Alert Reports (FARs).
Moderator
  • Khaudeja Bano, MD, Vice President Combination Product Quality, Amgen
Speakers
  • Richard Wolf, Head of Pv Operations, CSL Behring
  • Charles Goldberg, Senior Director, Quality Assurance, Medical Devices and Combination Products, Pfizer
  • John “Barr” Weiner, Associate Director for Policy, U.S. Food and Drug Administration, Office of Combination Products (FDA – OCP)
  • Raj Gulati, Founder, REGUNALYS LLC
  • Michelle Rios, CDRH FDA
  • Andrew Yeatts, Regulatory Counsel, CDRH, FDA
11:00 A.M. – 11:45 P.M.

Lunch Networking by Topic

Sit with FDA officials, speakers, industry experts, and your colleagues to discuss topics that are important to you. Enjoy the discussion with others who share your passion. Tables will be set aside for: 

  • Platform Technologies
  • Bridging Requirements Challenges
  • What Keeps You Up at Night?
11:45 A.M. – 12:15 P.M

What keeps you up at night: A facilitated discussion on your most pressing issues

In follow up to the invigorating lunch discussions specifically around what is keeping you awake, we review some of the hot current topics of primary interest from today’s discussion, including but not limited to new impactful legislation (H.R.4128 – 117th Congress (2021-2022): VALID Act of 2021), CDx, etc.

Moderator
  • Khaudeja Bano, MD, Vice President Combination Product Quality, Amgen
12:15 P.M. – 1:00 P.M.

483’s, Warning Letters, and Watch Outs, Oh my!

Join us as FDA shares Combination Product case studies reflecting the impacts of evolving expectations. Case studies will address significant enforcement, e.g., latest 483’s, warning letters, and watch outs in the Combination Product Space. This engaging session will outline PMSR and recent themes in audits and inspections. We will address challenges and expectations that will increase your awareness and alert you to key “watch outs.”

Moderator
  • Khaudeja Bano, MD, Vice President Combination Product Quality, Amgen
Speakers
  • Jenn (Jinong) Li, Chemist U.S. Food and Drug Administration, Office of Pharmaceutical Quality (Invited)
  • Nazia Rahman, Policy Analyst, U.S. Food and Drug Administration, CDRH-FDA View Presentation
  • John “Barr” Weiner, Associate Director for Policy, U.S. Food and Drug Administration, Office of Combination Products (FDA-OCP)
  • Steven Hertz, Consumer Safety Officer, FDA

1:00 P.M. – 2:00 p.M.

Use of Medical Devices and Digital Health Technologies in Drug Clinical Programs – Regulatory Challenges and Solutions

The pharmaceutical industry is increasingly reliant on digital health technologies and medical devices to conduct clinical investigations of medicines. Digital drug endpoints and remote patient monitoring solutions offer the potential to transform clinical study design with the promise of more robust and sensitive data collection along with increased convenience and quality of care for the patient. However, from a regulatory perspective, the introduction of these products in drug clinical programs comes with challenges including how to demonstrate the technologies are fit for purpose and how to secure their independent investigational approval, where relevant. Join FDA and industry as they explore topics based on FDA’s recent draft guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.

Moderators
  • Ryan McGowan, Director of Digital Devices and Combination Products within CMC Regulatory Affairs, AstraZeneca
  • Ryan Hoshi, Director of Regulatory Policy & Intelligence, AbbVie
Speakers
  • Anindita Saha, Assistant Director, U.S. Food and Drug Administration, Digital Health Center of Excellence – View Presentation
  • Katie Chowdhury, Director, Global Regulatory Affairs, Medical Device Team, Emerging Technology Devices and Combination Products, AbbVie

2:00 P.M. – 2:15 P.M.

Break

2:15 P.M. – 3:45 P.M.

FDA Fireside Chat

In a world of uncertainty as it relates to combination product development, quality system readiness, product approval, evolving regulations, and expectations, our FDA panel members will take your questions in an informal, collaborative setting that gets to the heart of your most pressing challenges. Don’t miss this opportunity to engage with FDA and your industry colleagues in a session to remember.

This is your chance to have your questions answered by FDA in a collaborative setting! What is at the top of your mind regarding combination products? Submit your questions and join us to hear their comments during the 2022 Combination Products Summit.

Moderators
  • Rumi Young, Director, Regulatory Policy, BD
  • Ryan McGowan, Director of Digital Devices and Combination Products within CMC Regulatory Affairs, AstraZeneca
Speakers
  • Thinh Nguyen, U.S. Food and Drug Administration, Office of Combination Products (FDA-OCP)
  • John “Barr” Weiner, Associate Director for Policy, Associate Director for Policy, U.S. Food and Drug Administration, Office of Combination Products (FDA-OCP)
  • Alan Stevens, Assistant Director, U.S. Food and Drug Administration, Injection Devices, Division of Drug Delivery, General Hospital and Human Factors, FDA-CDRH
  • Courtney Evans, Team Lead, U.S. Food and Drug Administration, Injection Devices, FDA-CDRH
3:45 P.M. – 3:55 P.M.

Summit Close

Thank you for joining us. We look forward to advancing the industry with you throughout the year as you implement the successful practices you learned at the AFDO/RAPS Healthcare Products Collaborative, Combination Products Summit.

View Presentation

Moderator
  • Cynthia Culmo, Program Lead, Combination Products and PharmaLink, AFDO/RAPS Healthcare Products Collaborative