Project no. 674909 Author: Dr. E. Kostewicz Date: 6

th September 2016

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 674909.

Page 1 of 7

Programme

H2020 ITN PEARRL project (no.674909) Kick-off Meeting

Date 30th - 31st October.2016

Schedule Day 1 19:00 Dinner

Day 2 8:00- 17:00 Kick-off Meeting

Location Bad Homburg (Frankfurt), Germany

Address

Forschungskolleg Humanwissenschaften

Am Wingertsberg 4

61348 Bad Homburg

www.forschungskolleg-humanwissenschaften.de/index.php/en/kolleg/about-us

(Conference venue is located approximately 30 km NE from Frankfurt airport)

Dinner 30th October 2016, 19:00

Schreinerei Pfeiffer Bad Homburg

Arrival Individually

Project no. 674909 Author: Dr. E. Kostewicz Date: 6

th September 2016

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 674909.

Page 2 of 7

Map

Kick-off Dinner

Schreinerei Pfeiffer Bad Homburg (A touch of wood carpentry history mixed with Hessian cuisine)

30th October 2016, 19:00

Audenstraße 6 61348 Bad Homburg Tel. +49 6172 / 20168

Menu

Credit cards can be used for transactions over 20€, otherwise EC or cash

Dinner Schreinerei Pfeiffer

Maritim Hotel

Steinberger Hotel

Hotel Haus am Park

Meeting Location Forschungskolleg Humanwissenschaften

Project no. 674909 Author: Dr. E. Kostewicz Date: 6

th September 2016

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 674909.

Page 3 of 7

Hotel Suggestions

Steigenberger Hotel Bad Homburg

Kaiser-Friedrich-Promenade 69-75 61348 Bad Homburg Tel. +49 6172 181-0

Website

Room prices are 89€ (Superior double room); 114€ (Deluxe Rooms) includes free Wi-Fi

650 m - 8 min walk to conference centre

Maritim Hotel Bad Homburg

Ludwigstraße 3, 61348 Bad Homburg Tel. +49 6172 660-0

Website

Room prices range upward from 79 € (Classic room) includes free Wi-Fi, breakfast costs 21€

800 m - 10 min walk to conference centre

Hotel Haus am Park

Paul-Ehrlich-Weg 3, 61348 Bad Homburg Tel. +4917670723260

Website

Room prices are 81€ (Double room); Single rooms are fully booked; includes free Wi-Fi and breakfast is included

350 m - 5 min walk to conference centre

Project no. 674909 Author: Dr. E. Kostewicz Date: 6

th September 2016

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 674909.

Page 4 of 7

Welcome Note Dear PEARRL -off meeting participant, Welcome to Frankfurt, Germany for our first PEARRL network-wide event: the kick-off! PEARRL is a Marie Sklodowska-Curie European Training Network offering a

comprehensive training program addressing the challenges of developing emerging

drug candidates into new licensed medicines with innovative drug formulation

strategies and in vitro and in silico development tools tailored to facilitate earlier

access to medicines.

PEARRL brings together European pharmaceutical industry, academia and regulatory agency partners together as a

multi-sectorial team to deliver a unique research and training programme for 15 Early Stage Researchers (ESR).

Each ESR position in PEARRL allows the researcher to register for a PhD

at one of the academic partners. There are 15 fully funded PhD

studentships in total. The candidates will be recruited within 2016 for

a duration of 36 months. Every ESR will work on an independent

research project which will be flexible enough to match the

competence and goals of the candidate.

The main research

objectives of the PEARRL

programme are to develop

novel bio-enabling

formulations and new biopharmaceutics tools to predict their in vivo

performance as a means to improve efficiency and cost competitiveness

in drug development, thus facilitating earlier access of patients to

“breakthrough therapies”. PEARRL will create innovation in all three

areas (bio-enabling formulations for oral administration, biopharmaceutics tools and patient-tailored PBPK models)

to ensure streamlined molecule-to-market time-lines for poorly soluble drugs and thus ensure the future

competitiveness of Europe’s Pharma industry. Outcomes will benefit the Pharma industry and, in particular, our

industry partners. PEARRL interactions will facilitate collaboration with and among regulatory bodies, including our

Partner Organisations EMA, HRPA, BfArM and MHRA, and our joint research will further strengthen Europe`s

scientific excellence in academia at our Universities.

We hope that this kick-off will be a rewarding experience for all those attending the meeting and a first step in a successful career for the early stage researchers. Welcome to the PEARRL kick-off meeting, Dr. Edmund Kostewicz Prof. Jennifer Dressman Dr. Brendan Griffin

Project no. 674909 Author: Dr. E. Kostewicz Date: 6

th September 2016

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 674909.

Page 5 of 7

Participant list

Participants Organisation Short

name

Name(s) Confimred

attendance

Y/N

B1 University College Cork UCC Brendan Griffin

Caitriona O‘Driscoll

Niklas Köhl (ESR1)

Laura Henze (ESR9)

Y

Y

Y

Y

B2 Johann Wolfgang Goethe

University

JWGU Jennifer Dressman

Edmund Kostewicz

Chara Litou (ESR6)

Rafael Paraiso (ESR8)

Ioannis Loisios-

Konstantinidis (ESR13)

Y

Y

Y

Y

Y

B3 National and Kapodistrian

University of Athens

UoA Christos Reppas

Maria Vertzoni

Rallia Velliou (ESR7)

Marina Statelova (ESR11)

Y

Y

Y

Y

B4 University of Bath UBAH Nikoletta Fotaki

Mariana Guimarães (ESR12)

Angela Effinger (ESR15)

Y

Y

Y

B5 University of Applied

Sciences and Arts

Northwestern Switzerland

FHNW Martin Kuentz

Felix Ditzinger (ESR2)

Sandra Jankovic (ESR5)

Y

Y

Y

B7 Merck KGaA Merck Anita Nair

Christoph Saal

Daniel Price (ESR3)

Y

Y

Y

B9 PHARMATHEN SA Pharmaten Lida Kalantzi

Georgia Tsakiridou(ESR4)

Y

B10 Sirius Analytical Sirius Karl Box

Patrick O'DWYER (ESR10)

Y

N

B11 Janssen Janssen Rene Holm Y

P5 accelopment AG ACCEL Jeanette Müller

Julia Götz

Y

Y

Project no. 674909 Author: Dr. E. Kostewicz Date: 6

th September 2016

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 674909.

Page 6 of 7

P1 Bundesinstitut für

Arzneimittel und

Medizinprodukte (BfArM)

BfArM Jobst Limberg Y

P2 European Medicines

Agency

EMA Evangelos Kotzagiorgis Y

P3 Health Products Regulatory

Authority

HPRA Mike Morris, Jayne Crowe,

Una Moore, Caitriona Fisher

2 attending

P4 Medicines and Healthcare

products Regulatory

Agency

MHRA Sean Jones

Colm Reddington

Y

Y

P6 Biorelevant.com Ltd.

(BioRel)

BioREl Steven Leigh; Mark Berlin;

Louis Leigh, Daryl Leigh

P7 UCB Biopharma SPRL (UCB) UCB Jérôme Mantanus

P8 University of Basel, Faculty

of Natural Sciences

(UNIBAS)

UNIBAS Prof Dr Georgios Imanidis

EXTERNAL Patricia Rischitor (Marie Curie Project Officer) TBD

Project no. 674909 Author: Dr. E. Kostewicz Date: 6

th September 2016

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 674909.

Page 7 of 7

Programme Day 1 (30th October 2016):

Time Session Theme Location Session Title

19:00 Dinner Networking & Management

Restaurant in Bad Homburg (TBA)

Reception

Programme Day 2 (31st October 2016):

Time Session Theme Guide(s), ESRs Objectives, content & ESRs` contribution

8:00 Arrival & Coffee Networking Registration

8:30 Welcome Management Jenny/Edmund

8:45 Overview of the PEARRL Project

Management Brendan Introduction, Partners, Introduction of Work Packages, Management structure

09:00 WP1: Design of “bio-enabling” formulations

Research coordination

Martin/ Christoph, ESR 1, 2, 3, 4, 5

ESRs to introduce themselves (e.g. 3-4 slide presentation on background, relevant experience and motivation and give a short verbal description of their projects. If not present, the PI can describe the project. The team will then discuss how we can link the various projects in PEARRL

09:30 WP2: Biopharmaceutics tools for assessing oral drug formulations

Research coordination

Christos/Karl, ESR 7, 9, 10, 11, 13

As above

10:00 Coffee Networking

10:15 WP3: In silico approaches for predicting formulation performance in vivo

Research coordination

Jenny/Nikoletta, ESR 6, 8, 12, 15

As above

10:45 WP4: Scientific, Regulatory and non-scientific training

Training coordination

Brendan, Regulatory Partners

Introduction of regulatory partners and discussion of regulatory contributions to the Training program including secondments and contributions to training through Annual Meeting Regulatory Days and other mechanisms e.g. webinars

12:15 WP5: Public engagement, dissemination & exploitation (PEDE)

Outreach Nikoletta/Rene, Julia / Jeanette

Quiz on hot PEDE topics

13:00 Lunch Networking

13:45 WP6: Management and Coordination

Management Jeanette/ Brendan, ESR reps

ETN Project Management in a nutshell (admin, finances, IP and many more topics(financial reports and Audit preparation); roles and responsibilities; board meetings

15:15 Coffee Networking ESR to mingle with secondment advisers

15:30 Planning/ scheduling & AOB

Management Jeanette/ Brendan, ESR reps

Planning/scheduling Discussion on secondments planning Election of ESR rep to PSB AOB

16:15 Wrap up Management Brendan/Jenny Actions and follow-ups

17:00 End of meeting