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2022 ATMPs-1988x680

2022 PDA Advanced Therapy Medicinal Products Conference

Jun 22 - Jun 23, 2022
Brussels, Belgium

From Proof of Concept to Commercial Manufacturing: Moving Towards Best Practices

  • Conference
  • Europe

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Program Highlights

Look forward to our highlight presentations from Brian O'Mahony, Irish Haemophilia Society out of a personal perspective, Christine Meissner, GMP Inspector of the AGES Austrian Agency for Health and Food Safety, Chair of the PIC/s Annex 2A revision Working Group on Innovations in ATMPs and the Regulatory Framework and Marcel Hoefnagel on Toolbox Guidance on Scientific Elements and Regulatory Tools to Support Quality Data Packages for Early Access Approaches with a Focus on ATMP.

Join us for this onsite event to follow the 2022 PDA Virus Conference! We look forward to meeting you again in person!

Overview

Dear Colleagues,

On behalf of the Scientific Program Planning Committee and PDA, we proudly present you to the Advanced Therapy Medicinal Products Conference and warmly welcome you to Brussels, Belgium!It’s wonderful and exciting that we are able to meet in person after two long years of virtual-only meetings.

Despite the Covid-19 pandemic, the cell-and-gene therapy (CGT) pipeline continues to grow, expand, advance, and diversity in the last two years. The 2022 Conference aims to set a special focus on the specific considerations for the manufacture of ATMPs, to build a bridge between proof of concept and commercial manufacturing. During the opening, we will have a Patient talk, Regulatory Lifecycle, and Regulatory Framework of ATMPs including the attendance of GMP Inspectors. In total, six sessions will focus on Manufacturing with Lessons Learned, Solutions for Products and Hospital, Novel Applications, and the Control and Understanding of Critical Reagents.

Attendees can expect an interactive program and sessions including a panel discussion at the end of the Conference. Don’t miss valuable take-home messages and the important opportunity to engage with industry peers and experts on ATMPs.

We are excited to finally return to a live event, including an exhibition, poster session, and networking opportunities. We look forward to seeing you soon in Brussels!

Sincerely,

The Chairs

Dayue Chen, PhD, Genentech/Roche
Richard Denk,SKAN

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Dayue Chen, Genentech/Roche, Chair
  • Richard Denk, SKAN, Chair
  • Christopher Bravery, Advanced Biologicals
  • Manuel Carrondo, ibet
  • Fabio D’Agostino, Claris Ventures
  • Marco Fadda, Comecer
  • Irving Ford, Adaptimmune Therapeutics
  • Renske ten Ham, Uni Medical Center Utrecht
  • Josh Eaton, PDA
  • Falk Klar, PDA
  • Caroline Lynar, PDA, Junior Manager Programs & Events

Agenda

  • Day 1
  • Day 2
  • Wednesday, 22 June

    09:00

    Welcome and Introduction
    Falk Klar, PDA
    Dayue Chen, Genentech/Roche
    Richard Denk, SKAN

    Opening Plenary: Focus on the Patient
    Moderator: Richard Denk, SKAN

    09:15 | Keynote: Haemophilia Gene Therapy - A Personal Perspective
    Brian O'Mahony, Irish Haemophilia Society

    09:45 | From Development to the Patient: The Regulatory Lifecycle of ATMPs
    Lourens T. Bloem, Utrecht Science Park

    10:15 | Innovations in ATMPs and the Regulatory Framework
    Christina Meissner, Austrian Agency for Health and Food Safety

    10:45 | Q&A, Discussion

    11:15 - 11:45
    Coffee Break, Poster Session & Exhibition

    Session 1: Building a Growing Market of Cell and Gene Therapy Products
    Moderator: Marco Fadda, Comercer

    11:45 | Contamination Control Strategy for Cell Therapy Start-Up
    Aidan Harrington, DPS & Bertie Daly, Takeda

    12:05 | Unlocking Market Access for ATMPs
    Renske ten Ham, University Medical Center Utrecht

    12:25 | Building on Non-Gene Edited Approaches to Develop Allogeneic, Off-The-Shelf CAR-T Cells
    Emilie Gauthy, Celyad

    12:45 | Q&A, Discussion

    13:15- 14:15
    Lunch Break, Poster Session & Exhibition

    Session 2: ATMP Manufacturing
    Moderator: Dayue Chen, Genentech/Roche

    14:15 | Interactive Questionnaire
    Via Mentimeter

    14: 25 | Bio-Safety and GMP Manufacturing Requirements
    Richard Denk, SKAN

    14:55 | Overcoming Autologous Manufacturing by Adaptive Culturing. Metabolic and Environmental Control-based Automation, Machine Learning and IA with the Adva X3
    Ohad Karnieli, Adva Biotechnology

    15:25 - 15:55
    Coffee Break, Poster Session & Exhibition

    Session 3: ATMP Manufacturing Continued

    15:55 | Factors Holding Back Lights-out Manufacture of ATMPs
    David Wolton, Takeda

    16:15 | Regulatory Considerations for Decentralized Manufacture of ATMPs at POCare
    Chaya Mazouz, Orgenesis

    16:35 | Points to Consider for Microbial Control in ATMP Manufacturing - A New PDA Guidance Document
    Friedrich von Wintzingerode, Genentech/Roche

    16:50 | Q&A, Discussion

    17:20 End of Conference Day 1

  • Thursday, 23 June

    Welcome to Day 2
    Dayue Chen, Genentech/Roche
    Richard Denk, SKAN

    Session 4: Solutions for Products in Hospital and Decentralized Scalable Settings
    Moderator: Renske ten Ham, Uni Medical Center Utrecht

    09:00 | Development and Manufacturing of ATMPs at Academia
    Pauline Meij, Leiden University Medical Center

    09:20 | Routine Automated Manufacture of ATMPs in a Closed, Single Platform
    Ian Johnston, Miltenyi

    09:40 | The GEN2 Cocoon® Platform with Integrated Magnetic Selection
    Ido Nevo, LONZA

    10:00 Q&A, Discussion

    10:30 - 11:00
    Coffee Break, Poster Session & Exhibition

    Session 5: Emerging Technologies and Novel Applications
    Moderator: Marco Fadda, Comecer

    11:00 | Personalized Tissue Engineering that will Revolutionize Future Medicine
    Petter Bjorquist, VERIGRAFT

    11:30 | Novel Concept for Isolators to Manufacture ATMPs and Biologics
    Silvia Aldi, SKAN

    12:00 | Q&A, Discussion

    12:30- 13:30
    Lunch Break, Poster Session & Exhibition

    Session 6: Control and Understanding of Critical Reagents
    Moderator: Dayue Chen, Genentech/Roche

    13:30 | Physicochemical and Functional Characterization of Differential CRISPR-Cas9 Ribonucleoprotein Complexes
    Julien Camperi, Genentech/Roche

    14:00 | Improving Precision and Specificity of CRISPR Gene Editing with RGEN-seq and RGEN-mod
    Alexei Slesarev, Merck

    14:30 | Q&A, Discussion

    15:00 - 15:30
    Coffee Break, Poster Session & Exhibition

    Closing Plenary: Take Home Dreams for Fulfillment
    Moderator: Manuel Carrondo, ibet

    15:30 | Toolbox Guidance on Scientific Elements and Regulatory Tools to Support Quality Data Packages for Early Access Approaches with a Focus on ATMP
    Marcel Hoefnagel, MEB

    16:00 | Summary from the Session Moderators and Chairs

    16:15 | Panel Discussion

    16:55 | Closing Remarks & Farewell
    Falk Klar, PDA

    17:00 End of Conference

    Agenda is subject to change without notice, Speakers are invited, pending confirmation

Highlighted Speakers

Manuel Carrondo
Manuel Carrondo
ibet - Instituto de Biologia Experimental e Tecnológica
Dayue Chen
Dayue Chen
Genentech, Inc.
Richard  Denk
Richard Denk
SKAN AG
Marcel Hoefnagel
Marcel Hoefnagel
Dutch Medicines Evaluation Board
Christina Meissner
Christina Meissner
AGES - Austrian Agency for Health and Food Safety
Brian O'Mahony
Brian O'Mahony
Irish Haemophilia Society
Renske ten Ham
Renske ten Ham
University Medical Center Utrecht

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

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.

Tangla Hotel Brussels

Avenue Emmanuel Mounier 5
Brussels, Belgium

Make a Reservation
Tangla Hotel Brussels
  • Accommodations

    Tangla Hotel Brussels
    Avenue Emmanuel Mounier 5
    1200 Brussels
    Belgium
    Tel: +32 2775 2508

    Single Room: € 160 per night*
    Double Room: upon request*

    * Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply

    PDA Europe has reserved a limited number of rooms until 01 May 2022. 

    The PDA block of rooms are available on a first come basis and must be secured by the deadline included above to receive the PDA rate. After this date, rooms will be available at the prevailing rate based on availability.

  • Amenities

    The Tangla Hotel Brussels is located in Sint-Lambrechts-Woluwe, a neighbourhood in Brussels, and is near the airport and near the boardwalk.

How to Get Here

By Air

The main airports for Brussels are Brussels Zaventem Airport (BRU) and Brussels South Charleroi (CRL). Tangla Hotel Brussels Airport shuttle : 10 € per traveler upon reservation only from Monday through Friday.

By Car

Tangla Hotel Brussels can easily be reached by car. When calculating your commuting time, take into account that there are roadworks on the Nearby Woluwesteenweg that can cause slightly heavier traffic during rush hours. Take the highway E 40 (Brussels-Liège), take Exit 20 Kraainem and follow the signs for "UCL - St-Luc" or take the ring Road, Exit 2 "Wezembeek-Oppem" and follow signs for "UCL – St Luc/ Tangla Hotel Brussels". The hotel is opposite the windmill you encounter.

Other Options

Walking distance from metro station to hotel : 7 minutes. Nearest station: Alma

Directions

Registration Fees

Early Registration
Registration Type Price by 24 April 2022
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Early Career Professional (Member) €845
Regular Registration
Registration Type Price after 24 April 2022
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €945
Early Career Professional (Member) €945

* For this member type or discount, online registration is not available, please contact [email protected].

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.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Tel: +1 (301) 656-5900
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