PDA Combination Products Workshop 2024

Thursday, 24 October MDT

• 07:45 – 08:45

  Continental Breakfast
• 07:45 – 17:00

  Registration Open
• 08:45 – 10:30

  P1: Navigating the Complexities of Risk Management for Combination Products

  • Moderator: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

    

    Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
    

    Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
    
    Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
    
    Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.

  Join us for an in-depth exploration of risk management complexities specific to combination products. This session will provide strategies for ensuring the safety and efficacy of these innovative therapies, drawing from key guidelines including AAMI TIR 105, ICH Q9, and ISO 14971. We will address system risks, with a particular focus on the interactions between drugs and devices. Experts will share their expertise, offering practical guidance and real-world examples to help you navigate the complexities of risk management for combination products. Enhance your understanding and skills to better manage risks and ensure the successful development and deployment of these advanced medical solutions.

  • 08:45 – 09:00

    Welcome and Opening Remarks from Workshop Chair

    • Chair: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

      

      Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
      

      Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
      
      Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
      
      Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.

  • 09:00 – 09:15

    Overview and Introduction

    • Presenter: Edwin Bills, Principal Consultant, Edwin Bills Consultant

      

      Edwin Bills, Principal Consultant, Edwin Bills Consultant
      

  • 09:15 – 09:45

    Practical Application of Risk Management Part 1: Intraocular Injections

    • Presenter: Edwin Bills, Principal Consultant, Edwin Bills Consultant

      

      Edwin Bills, Principal Consultant, Edwin Bills Consultant
      

  • 09:45 – 10:15

    Practical Application of Risk Management Part 2: On-Body Injectors

    • Presenter: Mahendran Ravichandran, Director (Assoc.) R&D Combination Product Development, AbbVie (INVITED)

      

      Mahendran Ravichandran, Director (Assoc.) R&D Combination Product Development, AbbVie (INVITED)
      

  • 10:15 – 10:30

    Report Out and Discussion
• 10:30 – 11:00

  Networking Break in the Exhibit Area
• 11:00 – 12:30

  P2: Building a Strong Foundation: Defining Comprehensive Product Requirements

  • Moderator: Flora Felsovalyi, PhD, Associate Director, Lonza

    

    Flora Felsovalyi, PhD, Associate Director, Lonza
    

    Flora Felsovalyi has 18 years of experience and a deep passion for leading combination product development in the medical device and pharmaceutical industries, specializing in parenteral drug delivery. She has contributed to various stages of the development lifecycle: from conceptualizing and inventing new subcutaneous injection devices to commercial implementation of dual chamber and ocular injection devices.
    
    She currently works in Drug Product Services at Lonza, and holds the position of Head of Pharmaceutical Services. Her team is responsible to developing and offering device-related services offerings to customers. Prior to Lonza, Flora worked at Roche for 8 years both as an early stage formulation scientist and device team leader.
    
    Flora holds a Bachelor’s Degree in Agricultural and Biological Engineering from Cornell University, a Master’s degree in Biomedical Engineering, and a PhD in Chemical Engineering from Columbia University in the City of New York.
    

  Join us for an engaging session on how to build robust sets of requirements with only limited information to begin with. We'll explore the essentials, starting points, and tools you need before formally starting development, along with considerations and sources for establishing requirements. We will then explore how to develop design inputs and specifications, including Essential Performance Requirements (EPRs), through practical case studies. Learn how to create precise requirements for scenarios like intraocular and high-volume injections. These actionable strategies and valuable insights will enhance your approach to product development.

  • 11:15 – 11:45

    Case Study on Developing Inputs and Specifications Part 1: Intraocular Injections

    • Presenter: Geoffrey Wise, Medical Device Platform Lead, Genentech

      

      Geoffrey Wise, Medical Device Platform Lead, Genentech
      

  • 11:45 – 12:15

    Case Study on Developing Inputs and Specifications Part 2: High Volume Injections

    • Presenter: Matthew J. Huddleston, MS, Chief Commercial Officer, Enable Injections

      

      Matthew J. Huddleston, MS, Chief Commercial Officer, Enable Injections
      

      Mr. Matthew J. Huddleston serves as Chief Commercial Officer for Enable Injections, responsible for leading Enable’s current marketing and business development operations and expanding commercial infrastructure. He is an experienced medical device professional with more than 30 years of experience in startup environments with emphasis in project management, design, development, manufacturing, regulatory, and intellectual property. He has several issued and pending patents in the medical device field, including soft tissue and cardiovascular fixation devices and delivery instruments, histologic automated embedding systems, laparoscopic visualization devices, and automatic injection devices. He is a professional engineer and a licensed patent agent. Matt holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Biomedical Engineering from The Ohio State University.

  • 12:15 – 12:30

    Report Out and Discussion
• 12:30 – 13:30

  Networking Lunch in the Exhibit Area
• 13:30 – 15:00

  P3: Technical Considerations for Health Authority Submissions

  • Moderator: Lee Leichter, RAC, MBA, President, P/L Biomedical

    

    Lee Leichter, RAC, MBA, President, P/L Biomedical
    

    Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 30. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. He has been a subject matter expert working with the ISO and AAMI committees on drug delivery devices and Combination products, and convenor for the just published ISO On-Body Delivery Systems Standard. He is currently the PDA IG Leader for Combination Products.

  Combination products, with their unique blend of drugs, devices, and/or biologics, present distinct challenges in the regulatory arena. Understanding the intricacies of these products is crucial for ensuring compliance and expediting approval. In this interactive session, seasoned experts delve into the complexities of combination products and share invaluable insights into navigating the regulatory landscape and providing a comprehensive submission to health authorities.

  • 13:30 – 13:45

    Overview and Introduction
  • 13:45 – 14:15

    Defining Expectations and Best Practices Part 1: Intraocular Injections

    • Presenter: Fran DeGrazio, President & Principal Consultant, Strategic Parenteral Solutions LLC

      

      Fran DeGrazio, President & Principal Consultant, Strategic Parenteral Solutions LLC
      

      Fran DeGrazio has 35+ years in vial container closure systems and prefillable systems for combination products. Currently Fran is President & Principal Consultant for Strategic Parenteral Solutions LLC. In her role she advises executives on strategy, growth, technical and regulatory opportunities. She is also Executive Editor for Drug Delivery Leader and Chief Client Solution Advisor to GessNet , producers of QMSpace software for the industry. Prior to this she held numerous strategic & technical roles at West Pharmaceutical Services, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories, Marketing and Scientific Affairs. Her final role prior to retiring from West was as Chief Scientific Officer. Fran has presented and published numerous technical articles and book chapters, the latest being a chapter within The Combination Products Handbook-A Practical Guide for Combination Products and other Combined Use Systems published in May 2023 by CRC Press. She is an active member of the PDA Combination Product steering committee, ISPE Combination Products COP, and the AFDO/RAPS Combination Products Summit Steering committee. She is the recipient of the PDA Packaging Science Award for 2021, Philadelphia Business Journal 2018 Healthcare Innovators and the Healthcare Businesswoman’s Association Luminary Award for West in 2017.

  • 14:15 – 14:45

    Defining Expectations and Best Practices Part 2: High Volume Injections

    • Presenter: Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services

      

      Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services
      

      As Director of Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This complements her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine has been an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87, is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, and is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances.

  • 14:45 – 15:00

    Report Out and Discussion
• 15:00 – 15:30

  Networking Break in the Exhibit Area
• 15:30 – 17:00

  P4: Mastering Tech Transfer and Product Launch Readiness

  • Moderator: Flora Felsovalyi, PhD, Associate Director, Lonza

    

    Flora Felsovalyi, PhD, Associate Director, Lonza
    

    Flora Felsovalyi has 18 years of experience and a deep passion for leading combination product development in the medical device and pharmaceutical industries, specializing in parenteral drug delivery. She has contributed to various stages of the development lifecycle: from conceptualizing and inventing new subcutaneous injection devices to commercial implementation of dual chamber and ocular injection devices.
    
    She currently works in Drug Product Services at Lonza, and holds the position of Head of Pharmaceutical Services. Her team is responsible to developing and offering device-related services offerings to customers. Prior to Lonza, Flora worked at Roche for 8 years both as an early stage formulation scientist and device team leader.
    
    Flora holds a Bachelor’s Degree in Agricultural and Biological Engineering from Cornell University, a Master’s degree in Biomedical Engineering, and a PhD in Chemical Engineering from Columbia University in the City of New York.
    

  In this dynamic session, industry leaders share their expertise and practical guidance on navigating the complexities of tech transfer and preparing for a successful product launch. From establishing robust transfer protocols and optimizing manufacturing processes to ensuring regulatory compliance, participants will gain insights into every facet of the tech transfer and launch readiness journey.

  • 15:30 – 15:50

    Navigating a Successful Product Launch

    • Presenter: Subhi Saadeh, Sr. Manager, Quality, Gilead Sciences

      

      Subhi Saadeh, Sr. Manager, Quality, Gilead Sciences
      

  • 15:50 – 16:40

    Hands-On Exercise: Preparing your Tech Transfer

    • Presenter: Subhi Saadeh, Sr. Manager, Quality, Gilead Sciences

      

      Subhi Saadeh, Sr. Manager, Quality, Gilead Sciences
      

  • 16:40 – 17:00

    Report Out and Discussion
• 17:00 – 18:00

  Networking Reception in the Exhibit Area

Friday, 25 October MDT

• 08:00 – 09:00

  Continental Breakfast
• 08:00 – 12:30

  Registration Open
• 09:00 – 10:30

  P5: Impact of Post-Market Changes to the Medical Device and Best Practices for Submitting Variations in the European Market

  • Presenter: Akshay R. Kamdar, PhD, Senior Director, Eli Lilly and Company

    

    Akshay R. Kamdar, PhD, Senior Director, Eli Lilly and Company
    

    Akshay Kamdar is the Sr. Director in the Chemistry, Manufacturing and Controls (CM&C) Project Management organization at Lilly where he is responsible for providing strategic and cross-functional leadership for drug development activities from portfolio entry to launch. Akshay joined Lilly in 2009 after receiving his Doctorate in Polymer Science and Engineering from Case Western Reserve University and his Masters in Materials Science and Engineering from Rochester Institute of Technology. Prior to his current role, he has held various technical and functional leadership roles within Lilly’s Delivery and Device organization focusing on novel container closure systems, combination product development, materials and process engineering from innovation through commercialization. He was also responsible for leading Lilly’s device and packaging sustainability efforts.

  This session focuses on the intricacies of post-market changes for combination products marketed in Europe with real-world case studies. Attendees will work together in a small group interaction to define appropriate strategies and plans for successful submission in the European market. This hands-on approach provides valuable insights and practical experience, helping participants gain skills in managing post-market changes and navigate the complex regulatory landscape.

  • 09:00 – 09:20

    Overview and Introduction

    • Presenter: Anurag Patel, PhD, Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.

      

      Anurag Patel, PhD, Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.
      

  • 09:20 – 10:10

    Developing Strategies for Successful EU Market Submissions: A Hands-On Exercise

    • Presenter: Anurag Patel, PhD, Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.

      

      Anurag Patel, PhD, Director, Regulatory Affairs-CMC Device and Drug-Device Combinations, Merck & Co., Inc.
      

  • 10:10 – 10:30

    Report Out and Discussion
• 10:30 – 11:00

  Networking Break in the Exhibit Area
• 11:00 – 12:30

  P6: Navigating the Future: Unveiling Emerging Trends

  • Moderator: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

    

    Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
    

    Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
    
    Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
    
    Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.

  Explore the future trajectory of our industry through new and emerging trends. Our panel of experts will engage in a thought-provoking discussion, sharing insights and perspectives shaping our industry's landscape. This diverse exploration will provide you with a comprehensive understanding of the emerging forces driving innovation and change. We invite active participation from the audience, encourage feedback on the trends and welcome contributions on additional insights. This interactive exchange ensures that we collectively create a holistic view of the evolving dynamics within our industry. Don't miss this opportunity to gain valuable insights, engage in meaningful discussions, and contribute to shaping the future of our industry.

  • 11:00 – 11:15

    Unlocking Opportunities Through PDA Activities

    • Presenter: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

      

      Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
      

      Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
      
      Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
      
      Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.

  • 11:15 – 11:40

    Exploring Key Trends with Expert Insights
  • 11:40 – 12:25

    Interactive Discussion
  • 12:25 – 12:30

    Closing Remarks from Workshop Chair

    • Chair: Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

      

      Maggie Bandel, MBA, Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson
      

      Maggie Bandel has extensive industry experience covering diagnostics, medical devices, combination products, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products and processes throughout her various leadership roles.
      
      Maggie spent the last three years leading a team of industry experts that formed the PDA Combination Products Steering Committee, providing input and oversight into critical areas within the industry. After spending the last few years leading various start-up R&D organizations, Maggie now leads a global team for lifecycle management activities in advanced therapies at Johnson and Johnson.
      
      Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from UNC/NC State University.

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