2018 PDA Europe Vaccines

PDA Europe Conference, Exhibition, Education

Vaccines The Parenteral Drug Association presents:

24-25 April 2018 Melia Hotel

Mรกlaga | Spain

LETTER FROM THE CHAIRS Dear Colleagues, SCIENTIFIC PL ANNING COMMIT TEE

• Cristiana Campa, Conference Chair, GSK Vaccines • Nancy Cauwenberghs, Conference Chair, Merck Sharp & Dohme • Martha Folmsbee, PALL • Thierry Gastineau, Sanofi Pasteur • Joachim Leube, Janssen Supply Chain • Annick Vandercammen, GSK Vaccines • Kerstin Wilken, PDA Europe • Sylvia Becker, PDA Europe,

Manager Programs & Events

We are delighted to invite you to the 2018 PDA Europe Vaccines conference to be held 24-25 April 2018.

The conference will address new trends in vaccine development and life cycle man­ agement, including (1) use of platform technologies, (2) prior knowledge, (3) dev­ elopment of novel vaccines comprising therapeutic vaccines and cancer vaccines, and (4) considerations on accelerated development scenarios.

In this context Quality by Design principles have now been embedded in various aspects of vaccine development and beyond. The conference will provide an over­ view of the applicability of QbD in various aspects, from product, analytics and process standpoint and considerations during life cycle management, as well as touch base on newer trends in the regulatory field such as ICHQ12.

We aim to continue the discussion around current CMC trends and regulatory stra­ tegies for emerging diseases, as started in frame of the Ebola vaccine some years ago and which has evolved since then.

We look forward to welcoming you to this special PDA Europe event in Spain!

Sincerely, the Chairs

Cristiana Campa, GSK Vaccines Conference Chair

Nancy Cauwenberghs, MSD Conference Chair

S C H E D U L E AT A G L A N C E 24 April

9:00 – 18:30

Vaccines

24 April

19:30

Networking Dinner

25 April

9:00 – 13:15

Vaccines

For latest information, please visit: pda.org/EU/Vaccines2018 2

pda.org/EU/Vaccines2018

Conference, Exhibition, Poster Session

Conference, Exhibition, Poster Session

WELCOME

TO MÁLAGA

pda.org/EU/Vaccines2018

3

CONFERENCE AGENDA 12 Apr 2018

Tuesday, 24 April 2018 9:00

Welcome and Introduction

Kerstin Wilken, PDA Europe Cristiana Campa, Conference Chair, GSK Vaccines Nancy Cauwenberghs, Conference Chair, MSD

Session 1: Regulatory Updates 9:10

Regulatory Convergence for Vaccines & Post Approval Changes

Heidi Meyer, Paul-Ehrlich-Institut

9:40

Harmonized Approaches for Vaccine Lifecycle Management

Richard H. Siggers, Health Canada

10:10

Ph. Eur. Hot Topics in the Field of Vaccines for Human Use

GwenaĂŤl CirĂŠfice, European Directorate for the Quality of Medicines & HealthCare, EDQM

10:40

Q&A, Discussion

11:15

Coffee Break, Poster Presentations & Exhibition

Session 2: Platform Technologies & New Products

Moderator: Kerstin Wilken, PDA Europe

11:45

A New TB Vaccine on the Horizon

Leander Grode, VPM

12:10

Next Generation of Glycan-based Vaccines

Arne v. Bonin, Vaxxilion

12:35

Use of Platform and Prior Knowledge to Advance Development of Adenoviral Vector-based Vaccines

Els van Deventer-Troost, Janssen J&J

13:00

Development and Optimization of Viral Platform Manufacturing Processes for Cost Effective and Faster Release of Vaccines

Anissa Boumlic, Merck KGaA

13:30

Lunch Break, Poster Presentations & Exhibition

Session 3: Accelerated Development and Prior Knowledge

4

Moderator: Thierry Gastineau, Sanofi

Moderator: Nancy Cauwenberghs, MSD

14:30

Prior Knowledge - Considerations for Vaccines

Mats Welin, MPA

15:00

Acceleration Strategies for Fast Access of Vaccines to Patients

Amin Khan, GSK Vaccines

15:30

A Vaccine for Ebola Virus - A Case Study on Approaches to Accelerate Joseph P. Califano, MSD Process Development and Characterization Studies

16:00

Q&A, Discussion

16:30

Coffee Break, Poster Presentations & Exhibition

pda.org/EU/Vaccines2018

CONFERENCE AGENDA

Session 4: Risk-based Approaches to Analytical Development and Facility Design for Vaccines

Moderator: Annick Vandercammen, GSK Vaccines

17:00

Application of the QbD Mindset to the Analytical Strategy The Key to Success

Thomas Jacques, GSK Vaccines

17:30

Challenges and Opportunities of QbD Integration in Vaccine Development and Manufacturing

Nausheen Rahman, Sanofi Pasteur

18:00

Risk-Based Biopharmaceutical Facility Design Approaches

Kavita Ramalingam Iyer, MSD

18:30

End of Conference Day 1

19:30

Networking Dinner

The Parenteral Drug Association is proud to invite you to a very special Networking Dinner.

Join us for a fabulous evening in a traditional restaurant.

24 April 2018 19:00h Meeting Point: Hotel Lobby Joint Walking Tour 19:30h Dinner, Restorante „Casa Juan Los Mellizos“, Calle de San Ginés 20, 29620 Torremolinos, Málaga 22:00h Walking Tour back to Conference Hotel

pda.org/EU/Vaccines2018

5

CONFERENCE AGENDA

Wednesday, 25 April 2018 9:00

Welcome

Kerstin Wilken, PDA Europe Cristiana Campa, Conference Chair, GSK Vaccines Nancy Cauwenberghs, Conference Chair, MSD

Session 5: Evolving Technical Challenges for Vaccine Manufacturing & Testing 9:05

Monocyte Activation Test: Predicting Pyrogenic Content without Animal Models

Sara Valentini, GSK

9:35

The Challenge of Process Parameters Categorization: A Comprehensive Ranking Process

Geoffroy Geldhof, GSK Vaccines

10:05

Process Validation and Continuous Process Verification of the Sterilization Process of Vaccines

Anton Mangold, tempris

Pre-fillable Syringe Selection Criteria for Vaccines: Technical Comparison of Several Syringe Types

Laurent Jeanmart, GSK Vaccines

10:35

11:05

Alexandre Cassis, GSK Canada

Christian Helbig, SCHOTT

Coffee Break, Poster Presentations & Exhibition

Session 6: Innovative Downstream Processing for Vaccines

Moderator: Martha Folmsbee, PALL

11:35

Case Studies and Successful Submissions: Sterile Filtration of Vaccines and Related Fluids

Erika Pfeiler, US FDA

12:05

Understanding the Sterile Filtration of Vaccine Nanosuspensions

Kalliopi Zourna, PALL

12:35

Filter-based Clarification of Viral Vaccines & Vectors

Youness Cherradi, Merck KGaA

13:00

Q&A, Discussion

13:15

Lunch Break, Poster Presentations & Exhibition

Session 7: Current Regulation & Industry Perspectives – Future Outlook

6

Moderator: Cristiana Campa, GSK Vaccines

Moderator: Nancy Cauwenberghs, Conference Chair, MSD

14:15

The Complexity of Post-Approval Change Management and New Regulatory Approaches: Relevance for Vaccine Products

Andrew Deavin, GSK Vaccines & Thierry Gastineau, Sanofi Pasteur

14:45

Vaccine Shortage - From Words to Action Vaccines Heads of Quality Perspective

Anders Vinther, Sanofi Pasteur & Marcello Colao, GSK Vaccines

15:15

Coffee Break, Poster Presentations & Exhibition

pda.org/EU/Vaccines2018

CONFERENCE AGENDA

15:45

Panel Discussion, Q & A Conference Highlights: Opportunities for Vaccine Development Panelists: Mats Welin, MPA Heidi Meyer, PEI Erika Pfeiler, US FDA Richard H. Siggers, Health Canada Gwenaël Ciréfice, EDQM

16:30

Summary & End of Conference & Farewell

Cristiana Campa, Conference Chair, GSK Vaccines Nancy Cauwenberghs, Conference Chair, MSD Kerstin Wilken, PDA Europe

2018 PDA Europe

Vaccines Committee and Speaker Biographies and many more....find them all online! https://goo.gl/mPZdCv

pda.org/EU/Vaccines2018

7

PDA Europe Poster Session Streamlined Approach

Interactive and

Development of a Mass

Application of QbD to

Automated Statistical

to Product and Process

Educational Tools to

Spectrometry Platform

Method Development

Reports to Support QbD

Development Pathway

Support Quality-by-

for OMV Protein

in Analytical Method

to Enable Early Clinical

Design in Vaccines

Characterization

Development

Proof of Principle

Development

1

2

3

4

5

Walter Hoyer, GSK Vaccines

Massimiliano Biagini, GSK Vaccines

Gael de Lannoy, GSK Vaccines

Walter Hoyer, GSK Vaccines

Challenges for the

Analytical Quality by

Potency Evaluation for

Key Enablers for

Early Integration of

Registration of Vaccines

Design

New Vaccines:

Accelerating External

Sterility Assurance

In-vivo vs in-vitro

Tech Transfer of

Concepts into the

Model Suitability

Vaccine Drug Substance

Design of Manufacturing

Evolution to Support

Intermediate

Processes

Daniela Stranges, Giovanna Campanella, GSK Vaccines

Worldwide: CTD Alignment

CQA Definition

6

Mic McGoldrick, MSD

8

pda.org/EU/Vaccines2018

7

Gerard Scheppink, Janssen J&J

8

Claudia Magagnoli, GSK Vaccines

9

Peter Tsai, MSD

10

Giovanna Campanella, GSK Vaccines

Don’t miss the

3 PDA Europe Annual Meeting rd

Global Healthcare of the Present & the Future

Register by 29 April 2018 and SAVE!

26-27 June 2018

pda.org/EU/Annual2018

Berlin | Germany

Marriott Hotel

FLOOR PLAN Exhibitor Veltek

Poster Presenters Daniela Stranges, GSK Vaccines Giovanna Campanella, GSK Vaccines

Veltek

Walter Hoyer, GSK Vaccines

R STE

PO

POSTER SESSION

Massimiliano Biagini, GSK Vaccines Gael de Lannoy, GSK Vaccines Mic McGoldrick, MSD

N

SIO SES

Gerard Scheppink, Janssen J&J Claudia Magagnoli, GSK Vaccines Peter Tsai, MSD

Table Top 2 m x 3 m (6 m2) Catering Poster Session

TO E X H I B IT: PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 1.895 Euro net (table-top).

For more information please contact gomez@pda.org 10

pda.org/EU/Vaccines2018

Over 1 billion containers annually are filled with vaccines for people around the world – made by SCHOTT. Join us at our talk on Wednesday, 25. April 2018, 10.35 am: Pre-fillable Syringe Selection Criteria for Vaccines Speech by: Laurent Jeanmart, GSK Vaccines, Christian Helbig, Head of Glass Syringes Wednesday, 25. April 2018, 10.35 am

SCHOTT AG, Pharmaceutical Systems, www.schott.com/pharmaceutical_systems

INFORMATION VENUE Melia COSTA DEL SOL Paseo Marítimo, 11 29620 Torremolinos Malaga | Spain Tel: (34) 952 38 66 77 Fax: (34) 952 38 64 17 https://goo.gl/Z2tnvg Special Rates Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.

D I R EC T I O N S

MELIA COSTA DEL SOL MÁLAGA

GENER AL ADDRESS PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 436 55 08-0 Fax: +49 30 436 55 08-66 CO N F E R E N C E R EG I S T R AT I O N H O U R S Tuesday, 24 April: 7:00 – 17:30 Wednesday, 25 April: 7:00 – 12:00 T O E X H I B I T: Exhibition and Sponsorship Opportunities are available.

PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highlyqualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.

S PEC I A L R E QU I R E M E N T S If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration-europe@pda.org.

© Google For directions click on the picture, scan the QR-code or go to https://goo.gl/maps/PYp1oKWDfLA2

CO N TAC T I N FO R M AT I O N Conference Inquiries Melanie Decker Director Events & Exhibitions decker@pda.org Conference Program Inquiries Sylvia Becker programs-europe@pda.org Registration Customer Care Tel: +49 30 436 55 08-10 registration-europe@pda.org Exhibition/Sponsorship Inquiries Nadjeschda Gomez-Stahl gomez@pda.org

Special offer: Discounted travel with Lufthansa Group Airlines Lufthansa Group Partner Airlines offer a comprehensive global route network linking major cities around the world. We offer special prices and conditions to participants, visitors, exhibitors, invited guests as well as employees of the Contracting partner and their travel companions. To make a reservation, please click on www.lh.com/event-flight-booking and enter the access code DEZJEPH in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if another promotional fare is available.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to lufthansa.mobility@dlh.de and providing the access code as a reference.

12

pda.org/EU/Vaccines2018

Vaccines

For contact at PDA Europe registration-europe@pda.org

24-25 April 2018 Málaga | Spain

3 WAYS TO REGISTER

1

1 ONLINE: pda.org/EU/Vaccines2018 2 FAX: +49 30 4365508-66 3 EMAIL: registration-europe@pda.org

Your Contact Information

This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.

If this form is an update to a previously submitted form, please check here.

Mr.

Ms.

Dr.

I want to become a PDA Member.

Please send me a subsription form

Nonmember PDA Member

Name (Last, First, MI) *

ID Number

Job Title * Company*

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Email *

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Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the member ship fee.)

* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.

Information about Visa Matters

• 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).

2 Registration

3 Payment Options

EARLY BIRD DISCOUNT

By Credit Card

Book by 4 March 2018 to receive € 200* off the conference fee only

American Express

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

Conference (24-25 April) PDA Member Nonmember** Govern./Health Authority/Academic**

net

*Early Bird 700 €

1595 1895 800

Poster Presenter please mark here (written approval required, conference fee applies)

MasterCard

VISA

For your credit card information safety: Please send your details by fax only (+49 30 4365508-66) or register online.

By Bank Transfer Beneficiary: PDA Europe gGmbH IBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany

By Purchase Order Purchase Order Number

PDA Europe VAT I.D.: DE254459362 **Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies).

The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation.

PDA Europe has secured a limited number of rooms at a special group rate.

Billing Address:

Same as contact information address above. If not, please send your billing address to: registration-europe@pda.org

Your Company VAT I.D.: This number starts by your country code with two characters (example: PDA Europe’s country code starts with: DE | followed by the number)

Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact us at registration-europe@pda.org. Other discounts cannot be applied.

Discount for Exhibiting Companies Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1095 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount). This special rate does not include one-year PDA membership.

Date

Mandatory Signature

CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 excl. VAT per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 24 March 2018 you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at registration-europe@pda.org or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.

pda.org/EU/Vaccines2018

13

2 0 1 8

P D A

E U R O P E

E V E N T S IG Berlin, Germany

13 April

Interest Group Meeting Visual Inspection

24-25 April

Vaccines

Málaga, Spain

8-9 May

Virus Forum

Florence, Italy

17 May

Annex 1

Dublin, Ireland

29-30 May

Pharmacopoeia Conference

Vienna, Austria

5-6 June

Advanced Therapy Medicinal Products

Amsterdam, The Netherlands

25 June 25 June 26-27 June

Interest Group Meeting Quality Systems Interest Group Meeting Freeze Drying 3rd PDA Europe Annual Meeting

15-16 October

Pharmaceutical Microbiology

Berlin, Germany

23-24 October

Visual Inspection Forum

Berlin, Germany

6-7 November

Outsourcing & Supply Chain - A 360° View

Seville, Spain

22 November

Project Management in the Pharmaceutical Industry – Challenges & Possibilities

Berlin, Germany

27-28 November

Pharmaceutical Freeze Drying Technology

Seville, Spain

27-28 November

11th Workshop on Monoclonal Antibodies

Seville, Spain

Subject to change

For latest info: europe.pda.org

Shortlist 12 Apr 2018

IG IG Berlin, Germany

Events with additional Education Program. More information – http://t1p.de/7p9z

General Information PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66

Conference Information Melanie Decker Director Events & Exhibitions Tel: + 49 30 4365508-19 decker@pda.org

Training Course Information Elke von Laufenberg Manager Training & Education Tel: + 49 30 4365508-21 laufenberg@pda.org www.europe.pda.org