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2019 ATMPS

Advanced Therapy Medicinal Products

Jun 04 - Jun 05, 2019
Vilnius, Lithuania

Cell and Gene Therapy - From Promise to Cure

  • Conference
  • Europe

left to register

Program Highlights

PDA brings together high-level subject matter experts as speakers and attendants coming from industry, research organizations, and regulatory authorities to discuss the many challenges encountered along the path of getting ATMPs to the patient.

Quality of raw materials, tech transfer, testing, regulatory updates will be but some of the highlights of this very special two-day program.

Overview

Dear Colleagues,

We would like to invite you to submit a proposal for a podium or poster presentation at the 2019 PDA Europe Conference on Advanced Therapy Medicinal Products (ATMPs) to be held in Vilnius, Lithuania on 04-05 June 2019.

Abstracts must be non-commercial in nature, describing new developments or work that significantly contributes to the body of knowledge relating to manufacturing and use of ATMPs including virus safety considerations for raw materials.

PDA Europe specifically invites Start-Ups, CMOs and more experienced SME practitioners to contribute.
Case Studies are particularly desired.

Sincerely,

The Co-Chairs

Manuel Carrondo,
PhD, ibet, Conference Chair
Dayue Chen,
PhD, Eli Lilly, Conference Chair

Agenda

  • Day 1
  • Day 2
  • Tuesday, 4 June 2019

    9:00 – 9:15
    Welcome and Introduction
    Kerstin Wilken, PDA Europe
    Manuel Carrondo, ibet
    Dayue Chen, Eli Lilly

    9:15 – 9:45
    Keynote: Developing CARTs - The Kymriah Story
    Rosa Catera, Novartis

    9:45 – 10:45
    Opening Plenary: Regulatory Challenges and Perspectives for ATMPs
    Moderator: Dayue Chen, Eli Lilly

    9:45 – 10:15
    Development and the Use of ATMPs in EU / Lithuania
    Romaldas Mačiulaitis, Lithuanian University of Health Sciences

    10:15 – 10:45
    ATMPs System Wide Challenges from Innovation to Uptake – Pragmatic Supportive Regulation and Standards
    Alistair Gibb, MHRA

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

    11:15 – 13:00
    Session 1: Current Approaches: Rapid Detection
    Moderator: Margarida Menezes-Ferreira, Infarmed

    11:15 – 11:45
    From Individualized to Standardized Microbiological Quality Control in ATMP Manufacturing
    Isabelle Bekeredjian-Ding, Paul-Ehrlich-Institut

    11:45 – 12:10
    Next Generation Sequencing-based Testing of ATMPs
    Kai Sohn, Fraunhofer IGB

    12:10 – 12:35
    Analytical Development and Automation for Detection of Replication Competent Lentivirus (RCL)
    Rui Andre Saraiva Raposo, Oxford BioMedica

    12:35 – 13:00
    Panel Discussion with Regulators

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

    14:00 – 15:30
    Session 2: ATMP Development
    Moderator: Manuel Carrondo, ibet

    14:00 – 14:25 
    ATMPs in Europe – Are We There Yet?
    Christopher Bravery, Advanced Biologics

    14:25 – 14:50 
    Multi-Purpose CDMO Operating on ATMPs
    Raquel Fortunato, GENibet

    14:50 – 15:15 
    Clinical Data on Oncolytic Viruses in Treatment of Cancer
    Akseli Hemminki, University of Helsinki, Helsinki University Hospital

    15:15 – 15:30
    Q&A, Discussion

    15:30 –16:00
    Coffee Break, Poster Session & Exhibition

    16:00 – 18:00
    Session 3: Enabling New Cell Therapies
    Moderator: Fabio D'Agostino, Alira Health

    16:00 – 16:30
    Biomanufacturing of Cardiac Cells from Human Induced Pluripotent Stem Cells
    Sean Palecek, University of Wisconsin

    16:30 – 17:00
    Translating Pluripotent Stem Cell Therapeutics for the Heart, Brain and Blood
    Jennifer Moody, BlueRock Therapeutics

    17:00 – 17:30
    Bioengineering Approaches for Functional Maturation of Human Pluripotent Stem Cells Derived Cardiomyocytes
    Paula Alves, ibet

    17:30 – 18:00
    Q&A, Discussion

    18:00
    End of Day 1 and Networking Event


  • Wednesday, 5 June 2019

    9:00 – 11:15
    Session 4: Safety of Cell-Based Medicinal Products
    Moderator: Thomas R. Kreil, Takeda

    9:00 – 9:30
    Viral Safety of Cell-Based Medicinal Products
    Johannes Blümel, Paul-Ehrlich-Institut

    9:30 – 10:00
    Virus Testing of Cells: A New Method Based on Next Generation Sequencing
    Marc Eloit, PathoQuest

    10:00 – 10:30
    New Contaminant Detection Technologies to Allow Rapid Release of ATMPs
    Martin Wisher, Merck KGaA, BioReliance Services

    10:30 – 11:00
    Q&A, Discussion

    11:00 –11:30 
    Coffee Break, Poster Session & Exhibition

    TRANSITION TO PARALLEL TRACKS

    11:30 – 13:00
    Session 5A: Practical Approaches to ATMPs
    Moderator: Kerstin Wilken, PDA Europe

    11:30 – 11:55
    Regulatory, Clinical and Logistics Challenges of ATMP Trials
    Andrea Zobel, PAREXEL

    11:55 – 12:20
    Some Tools for Understanding and Navigating the European Regulatory Framework for ATMPs
    Giovanni De Grandis, University College London

    12:20 – 12:45
    QbD for ATMPs. Seeing the Big Picture – A QP Perspective
    Jasbir Rattu, CeutiQus

    12:45 – 13:00
    Q&A, Discussion

    11:30 – 13:00
    Session 5B: Manufacturing and Automation Strategies
    Moderator: Martin Wisher, BioReliance

    11:30 – 11:55 
    Automation Strategies for the Production of ATMPs: Planning is Half the Battle
    Andreas Traube, Fraunhofer IPA

    11:55 – 12:20
    Scale-Up of Allogeneic Cell Therapy Manufacturing in Single-Use Bioreactors
    Max Lee, PBS Biotech

    12:20 – 12:45
    Manufacturing and Characterization of mRNA Constructs for Clinical Trials
    Ulrich Blaschke, CureVac

    12:45 – 13:00
    Q&A, Discussion

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

    14:00 – 16:30
    Session 6: Viral Vector Production for Gene Therapy
    Moderator: Dayue Chen, Eli Lilly

    14:00 – 14:30
    Next Generation Lentiviral Vector Manufacturing – Opportunities, Challenges and Ways Forward
    Paul S. Carter, GSK

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

    15:00 – 15:30
    Manufacturing Process Design for AAV-based Gene Therapy Vectors
    Barbara Kraus, Takeda

    15:30 – 16:00
    Closing Summary by the Conference Co-Chairs
    Manuel Carrondo, ibet
    Dayue Chen, Eli Lilly

    16:00-16:30
    Closing Remarks and End of Conference


Highlighted Speakers

Isabelle Bekeredjian-Ding
Isabelle Bekeredjian-Ding
Paul-Ehrlich-Institut
Rosa Catera
Rosa Catera
Novartis
Raquel Fortunato
Raquel Fortunato
GenIbet
Barbara Kraus
Barbara Kraus
Takeda
Romaldas Mačiulaitis
Romaldas Mačiulaitis
Lithuanian University of Health Sciences, EMA/CAT Member
Margarida Menezes Ferreira
Margarida Menezes Ferreira
INFARMED
Jennifer Moody
Jennifer Moody
BlueRock Therapeutics
R. Andre Raposo
R. Andre Raposo
Oxford Biomedica

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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.

Radisson Blu Vilnius

Konstitucijos pr. 20
Vilnius, Lithuania
Phone: + 370 (0)5272 6272

Radisson Blu Vilnius
  • Accommodations

    Hotel Website

    The Radisson Blu Hotel Lietuva, in Vilnius, stands on the banks of the River Neris. The hotel is in the heart of Lithuania’s capital, near rich historic sites such as the Old Town and Vilnius Cathedral. Old Town is also the place for shopping. Wander around the cobbled streets and explore the wide range of stores and markets. You’re close to an array of transport options, including bus and train station, while the airport is just 9 kilometers away.

    The hotel’s Riverside restaurant serves a varied breakfast buffet and a selection of international and Scandinavian dishes. Guests can visit the Skybar, located on the 22nd floor and offering views of the Old Town.

    PDA Europe has reserved a limited number of rooms until the 15th April 2019.
    Book Your Room for the PDA Group Rate.

    Single Room € 120 per night*
    Double Room € 135 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
  • Amenities

How to Get Here

By Air

Nearest Airport: Vilnius International Airport - VNO
Airport Phone:
+370 612 44442

By Car

9 km, 17 min by car. The Radisson Blu Hotel Lietuva is located at Konstitucijos pr. 20, Vilnius.

Other Options

Train/bus: 8 minutes to downtown Vilnius. Then taxi or bus 5 km to Radisson Blu Hotel Lietuva on Konstitucijos pr. 20. You can also go by bus to the city center.

The Vilnius train station is about 5 km south of the hotel.

Just outside the station, you can easily find a bus that takes you to the hotel. Buses leave the station frequently and the ride to the hotel takes about 20 minutes. There’s a bus stop only 100 meters from the hotel.

Directions

Registration Fees

Early Registration
Registration Type Price by 07 April
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €750


Regular Registration
Registration Type Price after 07 April
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €850

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

* 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 registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, 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 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

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Training Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

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