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2020ATMPs-1988x680

2020 PDA Advanced Therapy Medicinal Products Conference

Jun 24 - Jun 25, 2020
Washington, DC

Cell and Gene Therapy - From Promise to Cure

  • Conference
  • The Americas

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Program Highlights

SPEAKER ANNOUNCEMENT!

Peter Marks, MD, PhD, Director, CBER, U.S. FDA to present on Global Regulatory Convergence for ATMPs!

Overview

As part of PDA’s ongoing commitment to the future of the pharmaceutical industry, the 2020 PDA Advanced Therapy Medicinal Products (ATMPs) Conference will provide a broad overview of current innovations with a focus on successful stewardship of cell and gene therapies toward approval and beyond. The Conference will be an ideal forum for sharing best practices and learning how industry is applying novel approaches to product development, manufacturing, and regulatory compliance for long-term success. 

Plenary sessions will discuss the current state of the science and emphasize real-world challenges companies face as they integrate process development, quality, manufacturing, regulatory strategies, and supply chain given the unique requirements of ATMPs. The sessions will provide insight into industry best practices including next generation processing, analytical methods, quality systems implementation, control strategy and its link to product realization, quality risk management, aseptic processing, and regulatory compliance. 

Don’t miss out on this important learning opportunity. Make plans now to attend the 2020 PDA Advanced Therapy Medicinal Products Conference.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Tuesday, June 23

    4:00 p.m. – 6:00 p.m.
    Registration Open

  • Wednesday, June 24

    7:00 a.m. – 6:30 p.m.
    Registration Open

    7:00 a.m. – 8:15 a.m.
    Continental Breakfast

    8:00 a.m. – 9:45 a.m.
    P1: Promise Fulfilled: How Innovative Therapies are Transforming Lives
    US Moderator: Michael N. Blackton, MBA,
    Vice President, Quality, Adaptimmune LLC
    EU Moderator: Dayue Chen, PhD, Head of T-cell Engineering Process Development, Genentech, a Member of the Roche Group

    Simulcast Session with EU ATMP Conference

    8:00 a.m. – 8:15 a.m.
    Welcome and Opening Remarks from Conference Co–Chair
    Michael N. Blackton, MBA, Vice President, Quality, Adaptimmune LLC

    8:15 a.m. – 8:45 a.m.
    Engineered T Cell Therapies: Development, Global Regulatory Approvals, and Future Trends
    Bruce Levine, MD

    8:45 a.m. – 9:15 a.m.
    Industry Representative Invited

    9:15 a.m. – 9:45 a.m.
    Q&A Panel

    9:45 a.m. – 10:30 a.m.
    Refreshment Break in Exhibit Hall

    10:30 a.m. – 12:00 p.m.
    P2: Regulating a Harmonized Plan of Attack to Progress Cell and Gene Therapies
    US Moderator:
    Irving Ford, MSc, Head, CAR-T QC Laboratories, Bristol-Myers Squibb
    EU Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    To “B” or Not to “B”. Is it acceptable from a risk-based approach to have a Grade A BSC with a Grade B room? This is just one of the million-dollar questions that continues to create divergence among cell and gene therapy manufacturers. As more and more companies are transitioning into the cell and gene manufacturing, it is imperative that global regulatory bodies effectively collaborate to ensure consistent approaches are taken which allows for an acceptable risk-based approach is applied and enforced. This session will highlight global regulatory challenges, current regulatory thinking, and efforts that are being proposed/taken to transition towards a harmonized global regulatory approach for cell and gene therapy manufacturing.

    Simulcast Session with EU ATMP Conference

    10:30 a.m. – 11:00 a.m.
    Moving Toward Global Regulatory Convergence for Advanced Therapy Medicinal Products
    Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA

    11:00 a.m. – 11:30 a.m.
    Current Regulatory Challenges: European Perspective
    European Medicines Agency Representative Invited

    11:30 a.m. – 12:00 p.m.
    Q&A Panel

    12:00 p.m. – 1:30 p.m.
    Lunch

    1:30 p.m. – 3:00 p.m.
    P3: Regulatory Strategy
    Moderator: Marsha L. Steed, Director, Global QC Microbiology and Contamination Control, bluebird bio

    1:30 p.m. – 2:00 p.m.
    Lesson Learned from an RMAT Designation Request
    Stephen Westover, Cook Myosite

    2:00 p.m. – 2:30 p.m.
    Dennis Williams, PharmD, Senior Vice President, Late Stage Development, Adaptimmune LLC

    2:30 p.m. – 3:00 p.m.
    Q&A Panel

    3:00 p.m. – 3:45 p.m.
    Refreshment Break in Exhibit Hall

    3:45 p.m. – 5:15 p.m.
    P4: The Need for Speed: A Risk-Based Approach to Optimize Time and Patient Safety
    Moderator:
    Lori L. Daane, PhD, Director of Scientific Affairs, bioMérieux

    Cellular therapy production is a complex process that occurs over several days and involves multiple aseptic processing steps. Time is critical for both product efficacy and patient survival. The final product cannot be terminally sterilized and there is no time for traditional sterility testing, therefore a risk-based approach to microbial contamination and control is being adopted. 

    In this session we will first describe a risk-based approach and learn to identify and mitigate risk of contamination for cellular therapy production. A detailed case study will be presented that includes the resources needed for success and the most common risk factors that require extra attention. Lastly, an extensive comparative study will be presented that identifies an ideal and cost-effective testing combination to maximize sensitivity, reduce risk, and minimize labor.

    3:45 p.m. – 4:05 p.m.
    Risk Assessment Approach to Microbiological Controls of Cellular Therapies
    Tony Cundell, PhD, 
    Principal Consultant, Microbiological Consulting, LLC

    4:05 p.m. – 4:25 p.m.
    Microbial Control Strategy Case Study for Cell and Gene Therapy: How to Ensure Sterility Assurance for Patient Safety
    Marsha L. Steed, Director, Global QC Microbiology and Contamination Control, bluebird bio

    4:25 p.m. – 4:45 p.m.
    Comparative Performance Evaluation of USP<71>, BacT/ALERT Dual-T, and Bactec FX for Contaminant Detection in Cell Products, Viral Vectors, and Radiolabeled PET-Drugs
    Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health

    4:45 p.m. – 5:15 p.m.
    Q&A Panel

    5:15 p.m. – 6:30 p.m.
    Networking Reception



  • Thursday, June 25

    7:00 a.m. – 5:15 p.m.
    Registration Open

    7:00 a.m. – 8:30 a.m.
    Continental Breakfast

    7:15 a.m. – 8:15 a.m.
    Cell and Gene Therapy Interest Group Breakfast Session
    Moderator:
    Darius D. Pillsbury, Senior Consultant, Valsource LLC

    7:15 a.m. – 7:25 a.m.
    Introduction to the Cell and Gene Therapy Interest Group
    Darius D. Pillsbury, Senior Consultant, Valsource LLC

    7:25 a.m. – 7:35 a.m.
    Updates on Cryopreservation
    Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc.

    7:35 a.m. – 8:00 a.m.
    Statistical Solutions for the Data Challenges of ATMP
    Katherine Giacoletti, Partner, SynoloStats

    8:00 a.m. – 8:15 a.m.
    Q&A Panel

    8:30 a.m. – 10:00 a.m.
    P5: EU Research and Development Highlights
    EU Moderator: Dayue Chen, PhD,
    Head of T-cell Engineering Process Development, Genentech, a Member of the Roche Group 
    US Moderator: Shane D. Killian, MS,
    Senior Director, Licensing, Acquisition & Early Development, Janssen R&D Quality & Compliance

    Simulcast Session with EU ATMP Conference

    8:30 a.m. – 9:00 a.m.
    Using Clinical Data for Manufacturing Design and Release Criteria to Improve the Quality of a Cell-Based ATMP for Cartilage Repair
    Giulietta Roël, PhD, Head of Product Development, CO.DON

    9:00 a.m. – 9:30 a.m.
    Qualification of Illumina Next Generation Sequencing to Facilitate Mycoplasma Out-Of-Specification Investigations in Kymriah CAR-T Cell Therapy
    Marthi Pretorius, PhD, Analytical Project Lead, Novartis

    9:30 a.m. – 10:00 a.m.
    Q&A Panel

    10:00 a.m. – 10:45 a.m.
    Refreshment Break in Exhibit Hall

    10:45 a.m. – 12:15 p.m.
    P6: Enhancing Flexibility and Compliance for ATMP Manufacturing Facilities
    Moderator: Peter J. Makowenskyj, MEng, Director of Sales Engineering, G-CON Manufacturing 

    Currently, speed to market for ATMPs is critical due to lack of capacity in this emerging field. Often, facilities are being designed and built while process development is still undergoing. How can one maintain speed while also taking into account efficient use of capital or process safety? In this session, we will perform a deep dive into drug product manufacturing and facility design, discerning how one can truly enhance flexibility while also ensuring due diligence in the process design.

    10:45 a.m. – 11:15 a.m.
    Flip or Flop? Creating Transformative Multi-Product Facilities
    Allan Bream, CRB 
    Emily L. Thompson, PE, Process Engineer,CRB

    11:15 a.m. – 11:45 a.m.
    Case Study: Realization of Fill/Finish Project for an Oncolytic Immunotherapy ATMP
    Laura Moody, Bosch

    11:45 a.m. – 12:15 p.m.
    Q&A Panel

    12:15 p.m. – 1:45 p.m.
    Lunch

    1:45 p.m. – 3:15 p.m.
    Concurrent Sessions

    A1: Cell Therapy/Process Development
    Moderator: Vijay R. Chiruvolu, PhD, Senior Vice President, Process Development, Kite Pharma, a Gilead Sciences Company

    1:45 p.m. – 2:15 p.m.
    The Challenges of Manufacturing Pluripotent Stem Cell-Based Therapies and Engineered Tissues
    Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc.

    2:15 p.m. – 2:45 p.m.
    Challenges of Scaling-Up Cell-Based Processes to Meet Phase-Appropriate Requirements
    Kelly Kemp, PhD, Director, Process Development, ViaCyte

    2:45 p.m. – 3:15 p.m.
    Q&A Panel

    B1: Recent Breakthroughs in Gene Therapy Using AAV Delivered DNA
    Moderator: EJ Brandreth III, MBA, Senior Vice President, Quality, Inovio Pharmaceuticals

    1:45 p.m. – 2:15 p.m.
    rAAV Vector Development and Large-Scale Manufacturing Using BEVS Technology
    Scott Jeffers, UniQure

    2:15 p.m. – 2:45 p.m.
    Product Development and Commercialization of AAV Gene Therapy for Hemophilia A
    Biomarin Representative Invited

    2:45 p.m. – 3:15 p.m.
    Q&A Panel

    3:15 p.m. – 4:00 p.m.
    Refreshment Break in Exhibit Hall

    4:00 p.m. – 5:15 p.m.
    P7: Panel Discussion
    Moderator:
    Darius D. Pillsbury, Senior Consultant, Valsource LLC

    4:00 p.m. – 5:00 p.m.
    Panel Discussion
    Peter W. Marks, MD, PhD,
    Director, CBER, U.S. FDA
    Industry Representatives Invited

    5:00 p.m. – 5:15 p.m.
    Closing Remarks from Conference Co-Chair
    Darius D. Pillsbury, Senior Consultant, Valsource LLC



Highlighted Speakers

Tony Cundell
Tony Cundell
Microbiological Consulting, LLC
Peter W. Marks
Peter W. Marks
U.S. FDA
Emily L. Thompson
Emily L. Thompson
CRB

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this conference, participants will be able to:

    1. Learn how industry colleagues manage the complex manufacturing, regulatory and quality requirements for ATMPs.
    2. Gain insight into how the industry can effectively manage phase-appropriate quality systems in the dynamic regulatory environment faced by ATMPs.
    3. Interpret the latest trends in microbiological and adventitious agent control strategies.
    4. Identify advanced analytical approaches that can be applied for quality control and real time release.
    5. Explain delivery system design and manufacturing logistics for patient-centered therapies and precision medicine.
    6. Summarize best practices for identifying and introducing new technologies.
    7. Explore challenges in the “vein-to-vein” supply chain for autologous therapies.
  • Who Should Attend

    Who Should Attend

    Job Function:

    Scientist | Entry-level to Executive and Mid-Level Management | Project Management | Technical Services | Supply Chain | Manufacturing | Application | Risk Management

    Departments:

    Manufacturing | Product Development | Quality | Research & Development | Regulatory Affairs | Engineering | Laboratory | Science | Analytical Development & Quality Control | Information Technology | Validation | Training | Clinical

Got a Question? We have answers

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Travel

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.

Washington Marriott Wardman Park

2660 Woodley Road, NW
Washington, DC
Phone: 877-212-5752

Make a Reservation
Washington Marriott Wardman Park
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Marriott Wardman Park Hotel. The rate is $269 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Tuesday, May 26, 2020. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

    To make reservations, individuals may click on the reservation link above or call the Wardman Park Hotel at +1 (877) 212-5752. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities
    Washington Marriott Wardman Park is perfectly situated in the historic center of D.C. Our hotel is conveniently located in iconic Woodley Park and adjacent to the Metro. Take on all of D.C. and enjoy our Adams Morgan neighborhood with ease from our hotel. Our grand hotel is the ideal place to enjoy the sophistication of Washington, D.C. style, coupled with modern design and amenities. Our redesigned ballroom, hotel rooms and thoughtful perks are designed to serve the needs of every traveler. Let us bring your vision of success to reality as our meeting rooms, collaboration spaces, and pop-up lounges come to life. Attendees will delight in a haven in the city as they enjoy beautifully landscaped grounds, modern guest rooms, newly redesigned ballroom, exceptional restaurants, and newly redesigned lobby bar.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 7 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 25 miles away, and Baltimore-Washington International Airport (BWI), 30 miles away.

Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 30 minutes. One way taxi fares from IAD is approximately $60 and from BWI about $88.

By Car

The Wardman Park Hotel is located at 2660 Woodley Park Road NW, Washington, DC 20008.

$48 (per day) Self-Parking. $55 (per day) Valet Parking.

Other Options

The Hotel is located .1 mile from the Woodley Park-Zoo/ Adams Morgan (Red line) Metro Station. Metro fare from Reagan National Airport (DCA) is $1.7 (one-way).

Directions

Registration Fees

Early Registration
Registration Type Price by April 14
Conference Conference + Workshop
Member $1,995 $2,940
Non-member $2,274 $3,219
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Student Member $280
Student Non-member* $310










Regular Registration
Registration Type Price after April 14
Conference Conference + Workshop
Member $2,595 $3,640
Non-member $2,874 $3,919
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Academic Member $700
Academic Non-member* $800
Student $280
Student Non-member* $310










* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by May 22, 2020, no fee will be charged. After May 22, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by May 22, 2020, a full refund will be given minus a $200 fee. After May 22, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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This one-day workshop will provide hands-on, practical exercises in control strategy development for those involved in the cell therapy manufacturing field.

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