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Parenteral Drug Association Connecting People, Science and Regulation ®

Advanced Therapy Medicinal Products

Jun 05 - Jun 06, 2018 |
Jun 06, 2018 |
Novotel Amsterdam Schiphol Airport | Amsterdam, The Netherlands
  • Conference
  • Europe
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Speaker Biographies

Dear Colleagues,

Welcome to the 10th Anniversary of the 2018 PDA Europe Conference on Advanced Therapy Medicinal Products (ATMPs)!

It is with great pleasure for us to present you with an outstanding conference agenda and training course over the next few days in Amsterdam.

PDA prides itself in connecting people, science and regulation. The following three days should provide you with ample opportunity to do exactly that.

Please take advantage of the impressive panel of speakers and come introduce yourself to us, the Chairs of this meeting as well as our fellow planning committee members, and your fellow attendees.

Over the past ten years, PDA Europe’s ATMPs conference has become a fixture in the calendar of professionals working in the field of cell and gene-therapy-based drug products. It has reliably offered all participants an open forum for exchange of current best-practice approaches all along the path from R&D through Manufacturing to the clinical application of Advanced Therapies and Medicinal Products.

Handling, testing, and quality control of raw materials, novel approaches to flexible facilities, a thorough update and review of EU GMP Regulations for ATMPs as well as a look at Organ-on-Chip technologies and their relevance for the future of cell and gene therapies will be only some of the highlights in this very special two-day program.

Joint lunches, coffee breaks and a fun Networking Event all aim to facilitate connecting you with the PDA family!

We look forward to spending two amazing conference days with you in Amsterdam!

Sincerely,

The Co-Chairs,

Lutz Uharek, Prof. Dr., Head of the Stem Cell Facility, Charité Berlin

Wilfried Dalemans, PhD, Chief Technical Officer, TiGenix

Download Call for Papers

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Tuesday, 5 June 2018

9:00
Welcome: Opening Remarks & Introductions
Falk Klar, PDA Europe
Lutz Uharek, Conference Chair, Charité
Wilfried Dalemans, Conference Chair, Tigenix

9:15 - 13:00
Opening Plenary: Current Regulatory Status
Moderator: Wilfried Dalemans, Tigenix

9:15
Evolution of the Regulatory Environment: A Decade of ATMPs
Margarida Menezes-Ferreira, INFARMED, Portugal

9:45
ATMPs in Clinical Trials - News and Views
Ilona Reischl, AEGES

10:15
European Pharmacopoeia Hot Topics in the Field of Cell-based and Gene Therapy Medicinal Products
Emmanuelle Charton, EDQM

10:45 – 11:15
Coffee Break, Poster Session & Exhibition

11:15
Update on Genetically Modified Cells in Europe
Marcos Timón, AEMPS

11:45
New EU GMPs Regulations for ATMPs – Industry Considerations for Implementation
Florence Salmon, Novartis

12:15
Panel Discussion:

  • Adaptive Approval and GMP for ATMPs
  • EU Regulations for Gene Therapy
  • Role of Quality Control
  • Collaboration of Industry and Health Care Institutions

13:00 – 14:00
Lunch Break, Poster Session & Exhibition

TRANSITION TO PARALLEL TRACKS

14:00 - 16:00
Session 1A: Handling of Raw Materials
Moderator: Tongtong Wang, Eli Lilly

14:00
Making the Grade: Untangling the Myths of Raw Materials used for the Manufacture of ATMP
Christopher Bravery, Advanced Biologicals

14:30
Container Closure Integrity of Drug Product Containers During Deep Cold Storage
Derek Duncan, Lighthouse Instruments

15:00
Biopreservation: The Connecting Thread in Cold Chain
Alireza Abazari, BioLife Solutions

15:30
Q&A, Discussion

14:00 - 16:00
Session 1B: Approaching the Market
Moderator: Fabio D'Agostino, Alira Health

14:00
A Decade of Marketing Approval of Gene and Cell-based Therapies in the United States, European Union, and Japan
Delphi Coppens, Utrecht University

14:30
Industry Perspective: Challenges and Evolution, Experiences and Prospects
Zaklina Buljovcic, PharmaLex

15:00
Precision Medicine: The Breakthrough is Close - Are We Prepared?
Thomas Solbach, Strategy&

15:30
Q&A, Discussion

16:00 – 16:30
Coffee Break, Poster Session & Exhibition

16:30 – 18:30
Session 2A: Understanding the Human
Moderator: Dirk Groenewegen, Cells4Therapy

16:30
Future of Preclinical Studies: Multi Organ Chip Platforms
Beren Atac, TissUse

17:00
Organ-on-Chip in Europe: Promise for the Future
Janny van den Eijnden, human organ and Disease Model Technologies (hDMT)

17:30
Human Brain Project: Artificial Intelligence in Healthcare
Marc-Oliver Gewaltig, EPFL

18:00
Q&A, Discussion

16:30 – 18:30
Session 2B: Testing & Quality Control
Moderator: Manuel Carrondo, ibet

16:30
Rapid Alternatives to Conventional Sterility Testing
Lauren Drage, GSK

17:00
Implementation of Matrix Specific Rapid Methods for Sterility Testing on ATMPs
Thomas Meindl, Labor L+S

17:30
Raman Trapping Microscopy for Manufacturing and Quality Control of Advanced Therapy Medicinal Products
Karin Schütze, CellTool

18:00
Q&A, Discussion

18:30
End of Day 1 & Networking Event

19:00
Networking Event: Dinner & Amsterdam Canal Cruise

Wednesday, 6 June 2018

9:00 – 12:00
Session 3A: Manufacturing Considerations
Moderator: Lutz Uharek, Charité

09:00
Developing a Standardized Prefabricated Approach to ATMPs
Peter Makowenskyj, GCon Engineering

09:30
Flexible Gene Therapy Facilities – Current Best Practice
John Dougherty, DPS Group

10:00 – 10:30
Coffee Break, Poster Session & Exhibition

10:30
Process Development for T-Cell Expansion in a Stirred-Tank Bioreactor System
Ruth McDermott, Sartorius Stedim Biotech

11:00
Industrialization of Viral Vector Manufacturing for Gene Therapies
Clive Glover, Pall Biotech

11:30
Q&A, Discussion

9:00 – 12:00
Session 3B: Approaching the Market
Moderator: Valerie Pimpaneau, Voisin Consulting

09:00
Quality Aspects of a Cell-based Therapy for Cartilage Repair
Giulietta Roël, CO.DON

09:30
Allogeneic Gene Edited CAR T-Cells: Challenges for Quality Control of Clinical Batches
Stephan Reynier, Cellectis

10:00 – 10:30
Coffee Break, Poster Session & Exhibition

10:30
Cell Therapy Control Strategy – Overview of the PDA Task Force Technical Report
Jean Stanton, Janssen, J&J

11:00
Q&A, Discussion

12:00 – 13:00
Lunch Break, Poster Session & Exhibition

13:00 – 16:30
Session 4: Cell & Gene Therapy Perspectives: Manufacturing Perspectives
Moderator: Wilfried Dalemans, Tigenix

13:00
Manufacturing Challenges and Future of Stem-Cell-Based Gene Therapy
Christine Günther, Apceth

13:30
Manufacturing Strategies for Allogeneic and Patient-Scale Cell Therapies
Uwe Gottschalk, LONZA

14:00
Vector Safety
Theresa Wardell, Oxford BioMedica

14:30 – 15:00
Coffee Break, Poster Session & Exhibition

15:00
A Case Study Approach to Applying Quality by Design Principles to the Characterization of Multiple Gene Therapy Vector Manufacturing Processes for ATMPs
Jacek Lubelski, uniQure

15:30
rAAV Vector Development and Large-Scale Manufacturing Using BEVS Technology
Sterling Wall, bluebird bio

16:00
Cost of Goods and Supply Chain Economics Analysis for Allogeneic and Autologous Cell Therapies
Suzanne S. Farid, University College London

16:30
Closing Panel Discussion, Q&A

17:00
Closing Remarks and End of Conference
Falk Klar, PDA Europe
Lutz Uharek, Charité
Wilfried Dalemans, Tigenix


3 Ways to register

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 15 April 2018
1.395 Euro

After 15 April 2018
1.595 Euro

Nonmember

By 15 April 2018
1.695 Euro

After 15 April 2018
1.895 Euro

Govern./Health Authority/Academic

By 15 April 2018
700 Euro

After 15 April 2018
800 Euro

All fees given in Euro and excluding VAT (21%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Exterior

Novotel Amsterdam Schiphol Airport Hotel
Taurusavenue 12,
2132 LS Hoofdoorp,
The Netherlands
Tel: +31 23 7470338
Hotel Website

Drop your bags at Novotel and relax. Novotel Amsterdam Airport Schiphol is a beautifully designed hotel at a very convenient location, within walking distance of Hoofddorp Station, 4 minutes by train from Amsterdam Airport Schiphol and 20 min by train from Amsterdam's city centre. It is the perfect hotel to explore Amsterdam and the region or for organizing a meeting or congress. Discover the excellent service and first class facilities of this brand new flagship property.

Thanks to its location close to Amsterdam Airport and with quick access to the city centre this hotel is the perfect spot to explore Amsterdam and the rest of the region. It is also the perfect venue for a good night sleep before an early flight. Nice walking and cycling tracks are located just outside the hotel and bikes are available for rent. You can also jump on the train and visit one of the many museums in Amsterdam or take a tour on the canals. In spring, the famous Keukenhof is a must-see.

PDA Europe has reserved a limited number of rooms until the 30th March 2018.
Book your room for the PDA Group Rate.

For reservations, please email: H7060-sb@accor.com

Single Room € 159 per night*
Double Room € 179 per night*

*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 Charge will apply

How to Get There

Amsterdam Airport Schiphol – AMS
Airport Phone: +31 20 794 0800

Hotel direction: 3.9 miles

Parking

  • Public indoor parking (Paying)

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4053

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