16 December 2016 EMA/853948/2016

Agenda – “Optimising the development of ATMPs to meet patient needs”. The fifth annual regulatory conference organised by EBE, in collaboration with the European Medicines Agency (EMA) 16 December 2016, CCT Venues, 40 Bank Street, Canary Wharf, London Item

Agenda item

Time

Welcome & Introduction 1.



Guido Rasi, EMA



Andrea Chiesi, EBE

10:00-10:15

Session 1: Initiatives to improve ATMPs access to patients What initiatives have been recently launched to foster the development and registration of ATMPs and improve patient access? EMA Initiative Presenter: Ana Hidalgo-Simon, EMA (15 min) 2.



IMI Initiative

10:15-11:15

Presenter: Salah-Dine Chibout, Novartis (15 min) •

FDA Initiative

Presenter: Ke Liu, OTAT, CBER, FDA (15 min) •

Panel discussion (15 min)

Moderator: Paula Salmikangas, Chairperson, CAT Panelists: All presenters Session 2: Specific requirements for gene therapy medicinal products What are the challenges in developing and bringing gene therapy medicinal products to the market (biosafety issues, environmental agencies assessment of GMOs, market access)? How do developers respond to these challenges? How can regulators and innovators work 3.

together to foster patient access? •

Environmental risk assessment for clinical trials with GMO-based

11:15-12:45

ATMPs Presenter: Ann Gorman, Amgen (10 min) •

National Competent Authorities experience with environmental risk assessment before setting clinical trials −

Procedure and experience in France Presenter: Nils Braun, HCB; Jean-Christophe Pagès, HCB (10

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Item

Agenda item

Time

min) −

Procedure and experience in Germany Presenter: Brigitte Anliker, PEI (10 min)



Update on gene therapy medicinal products guideline Presenter: Christiane Niederlaender, member, CAT (10 min)



Industry presentation on market access Presenter: Sven Kili, GSK (15 min)



Panel discussion (30 min)

Moderator: Ilona Reischl, member, CAT Panelists: All presenters and Alec Orphanidis, uniQure Lunch

4.

12:45-14:00

Session 3: Meeting specific standards for development and commercialisation of ATMPs What are the manufacturing challenges encountered during early development and to set up clinical trials (definition of starting materials, import of raw materials, process validation…)? How are they handled? How are scale-up challenges covered? How are post-marketing conditions such as registries put in place? 5.



Update on investigational ATMP concept paper guideline Presenter: Ilona Reischl, member, CAT (10 min)



14:00-15:10

Overview of manufacturing challenges for ATMPs Presenter: Steven Howe, GSK (15 min)



Industry experience with registries for ATMPs Presenter: Diego Ardigo, Chiesi (15 min)



Panel discussion (30 min) Moderator: Esther Choi, BMS Panelists: All presenters and Marit Hystad, member, CAT Coffee Break

6.

15:10-15:30

Session 4: Listening to the stakeholders of innovative medicinal products Innovative products address areas of high unmet medical need. When in the development process should users be involved in risk/benefit discussions, risk level acceptability? •

Viewpoint from a patient organization (10 min): Martine Pergent, IPOPI

7.



Viewpoint from a health care professional (10 min): Prof Christoph

15:30-16:40

Höller, Medical University of Vienna •

Viewpoint from a payer (10 min): Dr Anna Bucsics, University of Vienna



Viewpoint from an investor (10 min): Joep Muijrers, LSP VC



Panel discussion (30 min)

Moderator: Joep Muijrers, LSP VC Panelists: All presenters Closing remarks 8.

Paula Salmikangas, Chairperson, CAT

16:40-17:00

Andrea Chiesi, EBE

Agenda – “Optimising the development of ATMPs to meet patient needs”. The fifth annual regulatory conference organised by EBE, in collaboration with the European Medicines Agency (EMA) EMA/853948/2016

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