EMA - EU Innovation Network November 16 th , 2018 Anton Ussi MSc - - PowerPoint PPT Presentation

EATRIS ERIC - European Infrastructure for Translational Medicine EMA - EU Innovation Network November 16th, 2018

Anton Ussi MSc Operations & Finance Director antonussi@eatris.eu Toni Andreu MD PhD Scientific Director toniandreu@eatris.eu David Morrow PhD MBA Scientific Programme Manager davidmorrow@eatris.eu

We support the development of biomedic ical discoverie ies into nto inte nterventi tions s for better health, e.g.

• nex

next t gene eneratio ion transla lati tional l to tools ls for better understanding of disease processes and drug performance

• st

standardisati tion an and qua uali lity ty in the translational medicine pipeline

• fos
• sterin

ing timely ly inte nteractio ion with regulators and stakeholders

Areas of interest and operations

A dist strib ibuted d inf nfra rastru ructu ture We coordinate 90 translational research institutes of excellence in 12 countries

• 45 University Medical Centres
• Latest in vitro and in vivo models, systems
• Deep and wide clinical expertise, patient cohorts

The Challenges

• Acce

ccess to reg egulatory exp expertise within academia not easy

• There is a lack

ck of inc ncentiv ive (fundin ing) for academia to perform valid idatio ion stu tudie ies and nd ef effectiv ive tr transit itio ion to cl clinic ic

• Many systemic

ic bo bottle lenecks ks are due to weak/non-existent cross- sector cooperation

• Accessing lat

atest tra ransla latio ional l to tools ls, e.g.

• Molecular imaging (cell tracking for CTs),
• The right potency assays,
• Assays addressing collateral effects of new therapies (e.g CRS from

ACT)

• EU mu

multi ltinatio ional l clin inic ical l research ch is com

• mple

lex; lead times underestimated

Industry Academia Regulators Clinicians

Cr Cross-sectoral l col collaboratio ion is s a a cr critic itical l succ success fac factor

Experience in interaction with reg. authorities

Regulators recognise that aca cademia ia ne need adv dvic ice ea earlie ier in the development life-cycle Aca cademia ia no not aware of opp pportunit itie ies to interact, lack access to experts that ‘speak the language’ Facil ilit itate ea early ly int nteractio ion EATRIS interacts with Regula lators through various mechanisms (e.g. MoU with NCAs) Activ ctive en engagement Participation of Regulators at EATRIS workshops, use of available platforms (e.g. EMA ITF and NCAs Innovation Offices)

Implementation

Academia Regulator

What can EATRIS offer to you to advance Regulatory Science?

Pub ubli licly y fund funded d inf nfra rast stru ructure Experienced in working with institutions focused on translational research Track Rec ecord Active relationship with NCAs and working with SMEs and Academics Cr Cross

• ss-sector

r coll

• llabora

ratio ion Act as a focal point for advancing Regulatory Science in consultation with regulators Coordinating a Research Agenda dedicated to developing next generation tools e.g.

• Platform for cell tracking
• Operational framework for adaptive platform trials (IMI EU-PEARL)
• Best practices, methodology, standardisation and quality in translational

research

Thank you for your attention and your engagement in Q&A

For further information and collaboration, please contact us davidmorrow@eatris.eu