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2021 ATMPs Conference

2021 PDA Advanced Therapy Medicinal Products Conference

Clearing the Hurdles and Winning the Race to Save Lives

Oct 26 - Oct 27, 2021
Eastern Standard Time | Online
  • Virtual
  • Conference
  • The Americas
Program Highlights
Now fully virtual! Don't miss out on the new and exciting session added this year: End-User Perspective.

Overview

As part of PDA’s ongoing commitment to the future of the pharmaceutical industry, the Program Planning Committee would like to warmly invite you to join us for the 2021 PDA Advanced Therapy Medicinal Products (ATMP) Conference on 26-27 October.

The aim of this 2-day event is to support all stakeholders that are involved in the development and commercialization of novel and effective cell and gene and tissue therapies.

This year’s theme of Clearing the Hurdles and Winning the Race to Save Lives puts a spotlight on solutions rather than strictly the challenges associated with cell-based medicines. This year we have added a view from the other side of ATMP manufacturing. Hear from medical experts who are on the frontline and how they navigate the various challenges and roadblocks. We also added a hot topic session on hiring and job retention to help understand what are the motivating factors of trained employees for staying or leaving.

The agenda includes sessions on both early and late product lifecycle management with an emphasis on risk assessment and tech transfer, end-to-end CM&C and its vital role in safeguarding product quality and process consistency, the question of investing internally or externally to meet manufacturing capacity, regulatory updates and what needs to improve to get more life-saving products from clinical trials to commercialization, and lessons learned from the pandemic on supply chain management.

The conference will be a virtual event. The live plenary sessions including Q&A will provide engaging discussions.


The Scientific Program Planning Committee

  • Lori Daane, bioMérieux – Chair
  • Dayue Chen, Genentech/Roche
  • Josh Eaton, PDA
  • Irving Ford, Bristol-Myers Squibb
  • David Geoghegan, Tmunity
  • Katherine Giacoletti, Merck
  • Peter Makowenskyj, G-CON
  • Darius Pillsbury, ValSource
  • MaryEllen Usarzewicz, Bristol-Myers Squibb
  • Agenda

    • Day 1
    • Day 2
    • Tuesday, 26 October

      09:00 – 10:10 | Plenary 1: End User Perspective

      Moderator: MaryEllen Usarzewicz, BMS

      The primary focus for ATMPs tends to be on the manufacturing process and a quick return of the product to the patient. Have you ever wondered what happens in between the manufacturing process and delivery of the product to the patient?

      This session will allow you to hear firsthand from medical experts who are on the frontline and who liaise between the manufacturing sites, the health care providers, and the patients.

      Join us as they share their unique role and the various roadblocks and challenges, they encounter in the world of ATMPs.
      Come and discover the ins and outs of the other side of ATMP manufacturing. You many never look at your process the same.

      Voice of the Treating Physician
      Matthew Lunning,
      U.S. Medical Affairs


      Break

      10:30 – 12:00 | Plenary 2: Product Lifecycle Management for ATMPs - Early

      Moderator: David Geoghegan, Tmunity

      Managing ATMP Products through the clinical development process and into commercialization presents unique challenges. As more of these products make clinical progress, identifying the potential solutions will help technical teams anticipate and plan for successful product development. The goals of this session are to discuss those challenges and approaches to handling them.

      Early Phase Considerations
      Jiwen Zhang,
      Head, QA and RA, Renvacor

      Qualifying Suppliers of Cellular Starting Materials: Accreditation Alone is Not Enough
      David Booth,
      Vice President, Quality and Regulatory Affairs, Be The Match BioTherapies

      Analytical Testing Strategies for Early Phase CAR-T Products
      Andrea Moore,
      Executive Director, Analytical Sciences, Tmunity

      Q&A


      Break

      12:20 – 13:50 | Plenary 3: Product Lifecycle Management for ATMPs - Later

      Moderator: Darius Pillsbury, ValSource

      On the heels of the commercialization of multiple ATMPs globally (including many within this past year) and the quickly increasing number of ATMPs rapidly moving through development, organizations are finding themselves faced with the many hurdles presented in the later stages of the product lifecycle. In this session many of these challenges of the later stages of the product lifecycle are presented and solutions are provided by the speakers.

      CMC Recommendations for Late-Stage Development of Cell & Gene Therapy Products
      Anna Kwilas, PhD,
      Lead Microbiologist, U.S. FDA

      Quality Risk Management for Cross Contamination of ATMPs
      Kelly Waldron,
      Senior Consultant, ValSource
      Virginia Andreotti-JonesConsultantValSource

      Learnings from Manufacturing Commercial Axicabtagene Ciloleucel: Process Improvement Perspectives
      Semsi Ensari, PhD,
      Sr. Director Process Technology and Materials Development, Kite Pharma

      Q&A


      Break

      14:10 – 16:10 | Plenary 4: End to End

      Moderator: Dayue Chen, Genentech

      It is universally recognized that CM&C for CGT products is significantly more challenging in comparison to traditional drug products. As a result, a comprehensive strategy is critical to ensure effective end-to-end control throughout the manufacturing process. This session provides some illustrations of the end-to-end manufacturing and its vital role in safeguarding product quality and process consistency.

      Key Considerations for the Development of Commercially Viable Cell-based Therapies
      Behnam Baghbaderani,
      Senior Director of Global Head of Process Development, Cell and Gene Technologies, Lonza

      What Clinical Labs Need to Know for Testing ATMP Products
      Anna Lau, PhD, D(ABMM),
      Chief, Sterility Testing Service, National Institutes of Health (NIH)

      ATMP Control Strategies Require New Thinking and New Approaches
      Karen Walker,
      Chief Technical Officer, Kyverna Therapeutics

      Q&A


    • Wednesday, 27 October

      08:30 – 09:30 | PDA ATMP Interest Group Update

      Moderator: Darius Pillsbury, ValSource

      This session will provide an update on the latest projects from the PDA ATMP Interest Group.


      09:50 – 11:20 | Plenary 5: Regulations

      Moderator: Lori Daane, bioMerieux

      This session will explore the current and future trends in cell and gene therapy and how they impact guidelines and regulations. Companies must understand and navigate the shifting regulatory landscape of global regulatory requirements in order to advance more life-saving therapies through clinical trials to commercialization. This session will address many of these challenges and will present solutions to help regulations keep pace with the science.

      Evolving regulations and What Needs to be Done to Keep Pace with the Science of ATMPs
      Bogna Lasia-Szkaradkiewicz,
      Health Canada
      Christina Meissner, AGES-Austrian Agency for Health and Food Safety>

      Preparing for an Evolving Regulatory Cell and Gene Therapy Landscape
      Monica Commerford, PhD,
      Head, Viral Vector Services, Regulatory Affairs, Thermo Fisher Scientific

      USP Expert Committee Update on USP Chapters 72 and 73
      Anthony Cundell, PhD,
      Consulting Microbiologist


      Break

      11:40 – 13:10 | Plenary 6: Risk Assessment/Tech Transfer

      Moderator: Katherine Giacoletti, Merck & Co., Inc.

      Successful technology transfer for ATMPs can be complicated by a number of factors, including material safety considerations, high manufacturing variability, availability of material during early phases for process and analytical development runs, necessary process changes to facilitate scale-up, and the transition of a product from an academic development setting often used in early clinical phases into a GMP manufacturing environment for later stage development.

      This session will dive into some of these challenges and possible solutions, such as Quality Risk Management tools, effective CDMO-sponsor collaboration, and leveraging the Lifecycle Approach to Process and/or Analytical Validation.

      Lifecycle Approach to Analytical Method Development & Validation for Gene Therapies
      Mark Galbraith, PhD,
      Head, Quality Control and Analytical Sciences, Spark Therapeutics

      Risk Assessments to Facilitate Transfer of Analytical Methods
      Jackie Kim,
      Kite Pharma

      Methods for Specification Development with Small Sample Sizes
      Tara Scherder,
      SynoloStats

      Q&A


      Break

      13:30 – 15:00 | Plenary 7: Supply Chain Management

      Moderator: MaryEllen Usarzewicz, BMS

      Supply Chain Management for ATMPs is always a challenge. The COVID-19 pandemic further complicated the challenge. Dealing with issues such as PPE and consumable shortages as well as contingency planning and emergency preparedness are topics that will be discussed during this session. Ultimately, the show must go on to ensure a consistent delivery of treatments to our patients.

      Navigating Cell Therapy Supply Chain Complexities During the COVID-19 Pandemic
      Joy Aho, PhD,
      Senior Product Manager, Be The Match BioTherapies

      What Do You Mean We Are Out of Shoe Covers?
      Jack Quirk,
      Associate Director, Warehouse and Compliance, GSCM, Novartis

      Q&A


      Break

      15:20 – 16:50 | Plenary 8: Manufacturing Network

      Moderator: Peter Makowenskyj, G-CON Manufacturing

      With companies of all sizes rapidly advancing their internal pipelines in the ATMP space there is a major lack of capacity to meet current and future demand. Companies large and small are faced with many difficult questions to address how they advance through the clinics and eventually to commercial manufacturing. We will look at some of these difficult to answer questions and evaluate what has been done within this space to leverage lessons learned.

      Clinical Phase Manufacturing Strategy: Critical Considerations & Challenges in Cell Therapy
      Faraz Siddiqui,
      VP, Process Development and Manufacturing Operations, Instillbio

      Interest in Intensification to a Factory of the Future
      William Whitford,
      Life Sciences Strategic Solutions Leader, DPS Group Global

      Q&A

    Highlighted Speakers

    Behnam A. Baghbaderani
    Behnam A. Baghbaderani
    Lonza
    Lori L. Daane
    Lori L. Daane
    bioMérieux
    Anna F. Lau
    Anna F. Lau
    National Institutes of Health
    Peter J. Makowenskyj
    Peter J. Makowenskyj
    G-CON Manufacturing
    Tara M. Scherder
    Tara M. Scherder
    SynoloStats
    MaryEllen E. Usarzewicz
    MaryEllen E. Usarzewicz
    Bristol-Myers Squibb
    Kelly Waldron
    Kelly Waldron
    Valsource LLC
    Jiwen Zhang
    Jiwen Zhang
    Renovacor, Inc.

    Learning Objectives

    At the completion of this conference, participants will gain skills to:

    • Understand the roadblocks and hurdles experienced by medical professionals and how they balance patient safety and manufacturing lead times
    • Anticipate and plan in early product lifecycle management leading to more successful clinical trials
    • Monitor the process control strategy and manage process changes in late product lifecycle management
    • Identify opportunities to leverage the lifecycle approach including risk assessments and tech transfer
    • Understand the role of clinical laboratories and the need for rapid release strategies and analytical development as part of the CM&C for ATMPs
    • Identify key regulatory hurdles and areas that slow down development & product release
    • Leverage lessons learned for managing the supply chain during a crisis
    • Determine when to make vs buy when scaling-up or scaling-out

    Who Should Attend

    Departments
    • Clinical
    • Engineering
    • Information Technology
    • Laboratory
    • Manufacturing
    • Product Development
    • Quality
    • Regulatory Affairs
    • Research/Development
    • Science
    • Training
    • Validation
    Job Function
    • Application
    • Executive Management
    • Management
    • Manufacturing
    • Project
    • Risk Management
    • Scientist
    • Supply Chain
    • Technical Services

    Registration Fees

    Register Now
    Registration Type Regular Registration
    Price after 30 September 2021
    Member $1,117 $1,436
    Non-member $1,312 $1,687
    Govern./Health Authority/Academic Member $490 $630
    Govern./Health Authority/Academic Non-member $560 $720
    Student Member $196 $252
    Student Non-member $217 $279
    Young Professional Member $559 $718

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