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2023 ATMPs

2023 PDA Advanced Therapy Medicinal Products Conference

Jun 07 - Jun 08, 2023
Baltimore, MD

Navigating through CMC Challenges

  • Conference
  • The Americas

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Program Highlights

Don't miss out on hearing directly from U.S. FDA representatives and industry experts on hot topics relating to the development and advancement of cell and gene therapies!

Tiffany Lucas
Tiffany Lucas, PhD
Gene Therapy CMC Reviewer, OTP, CBER, U.S. FDA
Brenton McCright
Brenton K. McCright, PhD
Biologist, OTP, CBER, U.S. FDA
Mikhail Ovanesov
Mikhail V. Ovanesov, PhD
Branch Chief, OPPT, OTP, CBER, U.S. FDA


The Program Planning Committee would like to warmly invite you to join us for the 2023 PDA Advanced Therapy Medicinal Products (ATMP) Conference on 07-08 June in Baltimore, MD.

This year, hear from industry leaders and experts on challenging topics such as current best practices for the development of suitable control strategies, lessons learned from working with CMOs and other partners and the required technology transfers. We will also cover the evolving landscape of global regulatory regulations and expectations.

The intent of this 2-day event is to share valuable lessons learned from the development and commercialization of novel and effective cell and gene and tissue therapies. The set-up of interactive panel sessions will facilitate the discussion and understanding of challenging topics and their possible resolutions. The agenda will include sessions on topics such as product development, risk assessments, technology transfer, suitable control strategies, and evolving best industry practices and regulatory expectations. Join us for this exciting event, network with peers and leaders, and hear about valuable lessons learned from leading ATMP experts!


  • Stephan Krause, Bristol Myers Squibb (Co-Chair)
  • Friedrich von Wintzingerode, Genentech, Inc. (Co-Chair)
  • Michael Blackton, Electrofi
  • Dayue Chen, Genentech, Inc.
  • Lori Dingledine, Spark Therapeutics, Inc.
  • Richard Denk, SKAN AG
  • Darius Pillsbury, ValSource, Inc.


  • Day 1
  • Day 2

    07:00 – 17:30 | Registration Open

    07:00 – 08:00 | Continental Breakfast

    08:00 – 09:45 | P1: Advancing Innovation from Research to the Clinic
    Moderator: Friedrich von Wintzingerode, PhD,
    QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech, Inc.

    In this session, we will begin with an overview of the science of cell therapy and how that science is continually evolving in an effort to address challenges across many indications. The session will conclude with a discussion of how clinical and regulatory strategies intersect with CMC  in order to advance these promising therapies toward approval and beyond.

    08:00 | Welcome Remarks from Co-Chairs
    Stephan O. Krause, PhD,
    Executive Director, AS&T, CT Global Quality, Bristol Myers Squibb
    Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech, Inc.

    08:15 | Living Drugs for Patients with Cancer: Cell Therapy, Past, Present, and Future
    Kimberly Noonan, PhD, MPH, CEO/CSO, WindMIL Therapeutics/Nacelle Bio

    08:45 | Mind the Gap: Regulatory Considerations for Clinical and CMC Product Development
    Eric Dollins, PhD,
    VP, Head of Global Regulatory Affairs, Adaptimmune

    09:15 | Q&A

    09:45 – 10:30 | Networking Break in the Exhibit Hall

    10:30 – 12:00 | P2: Managing Complex Manufacturing Networks for ATMPs
    Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    Managing complex cell and gene therapy networks involves coordinating and optimizing a variety of interconnected processes and stakeholders involved in the development, manufacturing, and delivery of cell and gene therapies.

    Some key considerations for managing complex cell and gene therapy networks include:

    1. Collaborative partnerships: cell and gene therapy networks often involve multiple stakeholders, including academic institutions, research organizations, manufacturers, and regulatory bodies.
    2. Regulatory compliance: cell and gene therapies are subject to a variety of regulatory requirements, including those related to safety, efficacy, and manufacturing.
    3. Manufacturing process optimization: the manufacturing of cell and gene therapies is a complex process that often involves multiple steps and technologies.

    10:30 | Managing a Complex Global Network for Internal and External QC Testing for Autologous Cell Therapies
    Stephan O. Krause, PhD
    , PDA ATMP Advisory Board Chair

    11:00 | The Regulatory View: Maintaining Control of ATMP Manufacturing and Drug Products
    Tiffany Lucas, PhD, Gene Therapy CMC Reviewer, OTP, CBER, U.S. FDA

    11:30 | Q&A

    12:00 – 13:15 | Lunch

    13:15 – 14:45 | P3: Cell Banking and ATMP Development
    Moderator: Dayue Chen, PhD, Head of Cell Therapy Technical Development, Genentech, Inc.

    As in the case of biologics, establishment of cell banking systems is essential for the development of many ATMP products such as stem cell-based (e.g., iPSC) allogeneic products and viral vector-based gene therapies. It is a critical element of the overall control system that assures consistent product quality and robust process performance. While a master cell bank alone is sufficient in supporting the early phase of clinical development and manufacturing, a two-tiered cell banking system composed of master cell bank (MCB) and working cell bank (WCB) is needed to support commercial manufacturing. However, the topic of cell banking has not received much public attention in the ATMP community. In this session, our presenters will discuss various aspects of cell bank systems in the context of ATMP development and commercialization with the focus on regulatory expectations, MCB/WCB manufacturing, MCB/WCB testing and characterization, and timing of MCB and WCB manufacturing.

    13:15 | Testing Recommendations for Cell Banks Used to Manufacture Cellular Therapies
    Brenton K. McCright, PhD, Biologist, OTP, CBER, U.S. FDA

    13:45 | Key Considerations for Banking and Characterization of cGMP Compliant Human Induced Pluripotent Stem Cells
    Darrin Kuijstermans, MSc, PhD, Associate Director of Cell & Gene Therapy Process Development, Lonza

    14:15 | Q&A

    14:45 – 15:30 | Networking Break in the Exhibit Hall

    15:30 – 17:00 | P4: Supply Chain Considerations Specific for ATMPs
    Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech, Inc.

    ATMPs pose a unique challenge to companies' supply chains. This session will provide insight into ATMP supply chain complexity and challenges to building scale into the supply chain, the importance of ATMP cost-of-goods (COGS), as well as specific examples and case studies related to maintaining quality across multiple outsourced partners and material shortages and long lead times.

    15:30 | Building Quality Systems for a Virtual and Decentralized Manufacturing Model
    Krisha Patel, Co-Founder, Assurea

    16:00 | CGT Supply Chain Complexity, Scaling CGT Supply Chains, and Challenges to Addressing COGS
    James Andrew Case, MBA, Head of Supply Chain - Cell & Gene Therapies, Genentech, Inc.

    16:30 | Q&A

    17:00 – 18:00 | Networking Reception in the Exhibit Hall

    07:00 – 17:30 | Registration Open

    07:00 – 08:30 | Continental Breakfast

    07:00 – 08:15 | Breakfast Session: Points to Consider When Delivering ATMPs to Patients
    Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech, Inc.

    This session provides an insight into the challenges companies face when manufacturing ATMPs and delivering them to patients. We will hear how an evolving global regulatory environment is challenging CAR-T manufacturing and items to consider when building a vein-to-vein program for ATMPs under the U.S. FDA’s Expanded Access Program.

    07:00 | Considerations Operationalizing a Sponsor’s Expanded Access Program for Manufacturing Facilities
    Heidi Davis, Executive Director, Quality Systems & Compliance, Bristol Myers Squibb

    07:25 | Understanding an Evolving Global Regulatory Landscape for CAR T Manufacturing 
    Scott R. Nichols, PhD,  
    Associate Director - Global Quality Compliance, Kite, a Gilead Company

    07:50 | Q&A

    08:30 – 10:00 | P5: Industry and Agency Perspectives for Analytical Method Lifecycle Steps
    Stephan O. Krause, PhD, Executive Director, AS&T, CT Global QualityBristol Myers Squibb

    This session will cover industry and agency perspectives for suitable analytical method development and lifecycle approaches for accelerated ATMP product development and commercialization processes. Phase-appropriate method development, validation, transfers, and change/improvement strategies will be discussed with regarding to data expectations, and other critical points to consider for successful regulatory submissions. Valuable lessons learned from working in an accelerated development environment with a common goal to bring life-saving therapies to patients will be provided from industry and agency SMEs.

    08:30 | Risk-Based Analytical Staging during Product Development  
    Mikhail V. Ovanesov, PhD, Branch Chief, OPPT, OTP, CBER, U.S. FDA

    09:00 | Phase-Based Method Development for Cell Therapy Drug Products
    Carmen WarrenDirector, Immune Cell Attributes, Kite, a Gilead Company

    09:30 | Q&A

    10:00 – 10:45 | Networking Break in the Exhibit Hall

    10:45 – 12:15 | P6: Raw Material Management and Control
    Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc.

    Raw materials for ATMPs can be a unique challenge as some of the materials we work with may be from single sources, may come from non-GMP facilities and process, and may have an evolving supply chain. How do we help our organizations develop a strategy to navigate these challenges from development through commercialization while leveraging our quality systems, material controls, and risk assessments? This session will cover industry examples of approaches to raw materials, from sourcing through testing and release in accelerated environments. 

    10:45 | Overcoming Challenges for CGT Raw Materials
    Philip Garibaldi, Quality Control Raw Materials Manager, Lonza Cell and Gene Therapy

    11:15 | A New PDA Points to Consider Document in the Making: Materials for ATMP Manufacturing
    Ryan Murray, MS, Senior Consultant, ValSource, Inc.

    11:45 | Q&A

    12:15 – 13:30 | Lunch

    13:30 – 15:00 | P7: Manufacturing Process Design and Implementation: A Risk-Based and Science-Driven Approach
    Moderator: Darius Pillsbury, Senior Consultant, ValSource, Inc.

    This session will focus on the design of novel processes for the manufacture of ATMPs and the many challenges encountered in the implementation and monitoring of those processes through the product lifecycle. The employment of science-driven and risk-based approaches to the management of these processes including considerations of the unique quality and technical challenges that must be addressed through clinical and then commercial manufacturing stages will be explored, as well as the many factors that are important to the development of successful control strategies.           

    13:30 | Quality Considerations and Challenges in Development and Manufacturing of ATMPs
    David P. Geoghehan, MBA, Vice President, Spark Therapeutics, Inc. 

    14:00 | Points to Consider for the Manufacturing of ATMPs
    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    14:30 | Q&A

    15:00 – 15:45 | Networking Break in the Exhibit Hall

    15:45 – 17:00 | P8: Panel of Experts
    Moderator: Stephan O. Krause, PhD, Executive Director, AS&T, CT Global Quality, Bristol Myers Squibb

    Were there questions you didn’t have a chance to ask during the past two days? Now is your chance to get them answered! Join us for our final panel discussion to hear directly from our industry and regulatory experts. 

    15:45 | Panel Discussion
    Heidi Davis, Executive Director, Quality Systems & Compliance, Bristol Myers Squibb
    Tiffany Lucas, PhD, Gene Therapy CMC Reviewer, OTP, CBER, U.S. FDA
    Mikhail V. Ovanesov, PhD, Branch Chief, OPPT, OTP, CBER, U.S. FDA
    Carmen WarrenDirector, Immune Cell Attributes, Kite, a Gilead Company

    16:45 | Closing Remarks from Conference Co-Chairs
    Stephan O. Krause, PhD, 
    Executive Director, AS&T, CT Global Quality, Bristol Myers Squibb
    Friedrich von Wintzingerode, PhD, QC Lead iNeST (Individual Neoepitope Specific Therapy), Genentech, Inc.

Networking Opportunities


  • 09:45 – 10:30 | Break in Exhibit Hall
  • 14:45 – 15:30 | Break in Exhibit Hall
  • 17:00 – 18:00 | Networking Reception in Exhibit Hall


  • 10:00 – 10:45 | Break in Exhibit Hall
  • 15:00 – 15:45 | Break in Exhibit Hall

Highlighted Speakers

James Andrew Case
James Andrew Case
Genetech, Inc.
Heidi Davis
Heidi Davis
Bristol Myers Squibb
Eric Dollins
Eric Dollins
Adaptimmune, LLC
Tiffany Lucas
Tiffany Lucas
Brenton K. McCright
Brenton K. McCright
Mikhail V. Ovanesov
Mikhail V. Ovanesov
Krisha Patel
Krisha Patel
Carmen Warren
Carmen Warren
Kite, a Gilead Company

Additional Information

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

Got a Question? We have answers

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PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hyatt Regency Baltimore Inner Harbor

300 Light Street
Baltimore, MD

Make a Reservation
Hyatt Regency Baltimore Inner Harbor
  • Accommodations
    Rate: $229 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Monday, 20 March 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 16:00
    Check-Out: 11:00

    Click on the reservation link above
    Phone: +1 (410) 528-1234, make sure to give the PDA Group Code, G-GDBD, to receive the discounted conference rate

    Individual Cancellation
    48 hours prior to 23:59 local time the day of arrival or 1 night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.
  • Amenities
    Experience an exceptional stay at the Baltimore Inner Harbor hotel designed for business and vacation travelers. Discover a unique blend of urban luxury and local hospitality with stylish rooms and suites that give you a sense of home and tech savvy enhancements that keep you productive. The convenient location makes it easy to walk to area museums, historic landmarks and attractions like the National Aquarium and Camden Yards. Enjoy what happens when convenience meets charm at Hyatt Regency Baltimore Inner Harbor.

How to Get Here

By Air

Baltimore/Washington International Thurgood Marshall Airport (BWI) is approximately 12 miles (20km) from the hotel and all major carriers service this airport. Taxi fares from BWI are approximately $35 one way, not including tip, and will take about 20 minutes.

By Car

Hyatt Regency Baltimore Inner Harbor is located at 300 Light Street, Baltimore, MD 21202. Both valet and self-parking are available.

Other Options

Hyatt Regency Baltimore Inner Harbor is conveniently located only four blocks from the Metro subway system and only three blocks from the Lightrail. BUS-MTA picks up right outside the hotel, making it easy to explore the area.


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Early Registration
Registration Type By 09 April 
Member $1,995
Non-Member $2,395
Gov./Health Authority/Academic (Member Only) $795
Early Career Professional (Member Only) $1,295
Student (Member Only) $495
Regular Registration
Registration Type After 09 April 
Member $2,495
Non-Member $2,895
Gov./Health Authority/Academic (Member Only) $895
Early Career Professional (Member Only) $1,395
Student (Member Only) $595

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.

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