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Combination Products Summit 2023

Combination Products Summit 2023

Presentations

Tue. November 28th, 2023 – Workshop

8:00 am – 1030 am

Notified Body Opinion Workshop – Experiences And Lessons For Combination Products In EU

View PDF Presentation

Leading Facilitators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; James Wabby, Global Head – Emerging Technologies, Combination Products, and Devices, Abbvie

Facilitators: 

  • Arabe Ahmed, Bsi Group; 
  • Timothy Chesworth, Senior Director Regulatory Affairs – Devices & Digital Therapeutic, AstraZeneca; 
  • Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie; 
  • Amanda Matthews, Senior Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer

10:30 am – 10:50 am

BREAK

10:50 am – 2:20 pm

Combination Products Risk Management: Integration Of ICH Q9(R1) And ISO 14971:2019

Leading Facilitators: Tine Albeck, Senior Quality Assurance Professional, ALK A/S
Facilitators: 

  • View PDF Presentation Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; 
  • View PDF PresentationRick Wedge, Compliance Lead / Associate Research Fellow, Pfizer; 
  • View PDF PresentationMilind Ganjawala, Division Director of Drug Quality II, Center for Drug Evaluation and Research (CDER), FDA

2:20 pm – 2:40 pm

BREAK

2:40 pm – 5:10 pm

Risk Management Application In Post-Market Safety & Other PMSR Hot Topics

Leading Facilitators: Khaudeja Bano, Vice President, Combination Product Quality, Amgen; Rich Wolf, Head of Pv Operations at CSL Behring
Facilitators: 

  • John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA; 
  • Fubin Wu, Co-founder, GessNet Safety Engineering; 
  • Kate Gillespie, Sr. Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson

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Wed. November 29th, 2023

8:00 am – 8:20 am

Let’s Make A Difference!

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

8:20 am – 9:05 am

The Solutions Exchange

View PDF Presentation

Moderators:

  • Fran DeGrazio, Executive Advisor, Kymanox
  • Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC;

9:05 am – 10:05 am

From The Desk Of The Office Of Combination Products: Strategic Priorities & Action

View PDF Presentation

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Speakers: 

  • James Bertram, Director of the Office of Combination Products (OCP), FDA; 
  • John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA

10:05 am – 10:25 am

BREAK

10:25 am – 11:25 am

Global Harmonization Opportunities In Combination Products

View PDF Presentation

Moderators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Khaudeja Bano, VP Combination Product Quality, Amgen
Speakers: 

  • Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance, European Medicines Academy(EMA); 
  • Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI; 
  • Joo Hee Kim, Professor, Regulatory Strategy center for Combination Products (RSCP), Ajou University; 
  • Mike Wallenstein, Global Head Regulatory Medical Devices, Combination Products & Precision Medicine, Novartis; 
  • John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA

11:25 am – 12:25 pm

Platform Drug-Delivery Devices: Regulatory And Technical Considerations

View PDF Presentation

Moderator: Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech
Speakers: 

  • Jiaying Shen, Distinguished Scientist, Merck; 
  • Kent Abrahamson, Director, Combination Product and Device Development, Abbvie; 
  • James Bertram, Director of the Office of Combination Products (OCP), FDA; 
  • Patricia Love, Deputy Director, FDA’s Office of Combination Products (OCP), FDA

12:25 pm – 1:25 pm

LUNCH

1:25 pm – 2:25 pm

Evolution Of Essential Performance Requirements

View PDF Presentation

Moderator: Rumi Young, Director, Regulatory Policy, BD
Speakers: 

  • Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals; 
  • Subhi Saadeh, Sr. Manager – Combination Products QA, Gilead Sciences; 
  • Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA; 
  • Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA; 
  • Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems, RA CMC
    Devices, AbbVie

2:25 pm – 3:25 pm

Use Of Non-Integral Medical Devices In Medicinal Product Clinical Studies

Moderator: Jason Lipman, Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi
Speakers:

3:25 pm – 3:45 pm

BREAK

3:45 pm – 4:45 pm

Use Of Emerging Digital Health Technologies For Combination Products

Moderators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie – View PDF Presentation
Speakers: 

  • No slides – Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie; 
  • View PDF PresentationMiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA; 
  • View PDF Presentation Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA; 
  • No slides – Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; 
  • No slides – Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

4:45 pm – 5:30 pm

Next-Generation Combination Products

View PDF Presentation

Moderators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Sandy Boyd, Independent Consultant
Speakers: 

  • Dan Groszmann, Director of Engineering, Amgen; 
  • Geoff Hamilton, Chief Executive Officer, Stemson Therapeutics; 
  • Steven Oh, Deputy Office Director, Office of Cellular Therapy and Human Tissue, Center for Biologics Evaluation and Research (CBER), FDA; 
  • James Wabby, Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow – Regulatory Science, Abbvie;

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Thu. November 30th, 2023

8:00 am – 8:15 am

Opening Day 2

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

8:15 am – 9:15 am

Navigating Combination Product Pathways: Industry Experiences And FDA’s Role

View PDF Presentation

Moderators: Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech; Rumi Young, Director, Regulatory Policy, BD

Speakers: 

  • Chelsea O’Connell, Director, Global & Regulatory and R&D Policy at Amgen; 
  • Kristina Lauritsen, Combination Product Policy Advisor, Center for Drug Evaluation and Research (CDER) FDA; 
  • Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA; 
  • Winifred Wu, President and Principal Advisor, Strategic Regulatory Partners, LLC

9:15 am – 10:05 am

Building Clarity To Address Regulatory Challenges Of On-Body Delivery

View PDF Presentation

Moderator: Fran DeGrazio, Executive Advisor, Kymanox
Speakers: 

  • Carolyn Dorgan, Director, Technical Services, Suttons Creek; 
  • Sujith Kallur, Regulatory Affairs Lead, Wearable Injectors, BD Medical Pharmaceutical Systems; 
  • Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA; 
  • Krishna Venugopalan, Vice President – Combination Products, Drug Delivery and Sterile Packaging, AbbVie

10:05 am – 10:25 am

BREAK

10:25 am – 11:40 am

Part 1 – Bridging And Leveraging Human Factors Data In Drug-Device Combination Products Development. Part 2 – Q&A And Discussion Of Final Guidance Of Application Of HF Engineering Principles For Combination Products

Moderator: Jiaying Shen, Distinguished Scientist, Merk
Speakers: 

  • Irene Chan, Deputy Director, Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research (CDER), FDA; 
  • Carrie O’Donel, Principal Device Engineer, Teva Pharmaceuticals; 
  • Jen Soosaar, Director of Human Factors, Core Human Factors, Inc; 
  • Colin Roscoe, Principal Human Factors Scientist, Teva Pharmaceuticals

11:40 am – 12:40 pm

Navigating The New Frontier In Cybersecurity: Technical And Regulatory Considerations For Managing Cybersecurity Risks For Combination Products

Moderator: Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie
Speakers: 

  • No slides – Edison Alvarez, Sr. Director, Regulatory Strategic Planning for Cybersecurity, BD; 
  • View PDF PresentationAftin Ross, Acting Deputy Director – Division of All Hazards Response, Science & Strategic Partnerships, Center for Devices and Radiological Health (CDRH), FDA; 
  • View PDF PresentationFubin Wu, Co-founder and President, GessNet Safety Engineering;

12:40 pm – 1:40 pm

LUNCH

1:40 pm – 2:30 pm

FDA & Health Authority Fireside Chat

No slides were used during this discussion

Moderators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca

Speakers:  

  • James Bertram, Director, Office of Combination Products; 
  • John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA
  • Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA
  • Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA;
  • Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA
  • Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA
  • Stephanie Shapley, Senior Advisor, Office of Combination Products, FDA
  • Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

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