On-going implementation of the Nanomedicine White Paper

Nanomedical Translation is becoming
reality:
On-going implementation of the
Nanomedicine White Paper
Laurent Levy, ETPN Vice-Chairman,
Nanobiotix, France
ETPN Annual Event– 15.10.2014 – San Sebastian, Spain
Disclaimer:
The following mentioned CSA and GMP Pilot Lines proposals
have been positively evaluated by the European
Commission‘s services and entered the finalisation stage.
Changes in the projects’ duration, consortium, budget or
activities may thus occur within the next months.
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On-going implementation of White Paper
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We started there:
White Paper
“Contribution of Nanomedicine to H2020”
Translation
Hub
Translation Advisory Board
Support to SME instrument
EU NCL
Pilot scale-up lines
Network of clinical centres
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On-going implementation of White Paper
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Nanomedicine Hub at the heart of Translation
Translation Hub
Translation Advisory Board
Support to SME instrument
EU NCL
Pilot scale-up lines
Network of clinical centres
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On-going implementation of White Paper
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To start becoming concrete:
Translation Hub
Translation Advisory Board
Support to SME instrument
EU NCL
Pilot scale-up lines
Network of clinical centres
TAB
ENATRANS:
Enabling NAnomedicine
TRANSlation
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On-going implementation of White Paper
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Translation Hub
Translation Advisory Board
Support to SME instrument
EU NCL
Pilot scale-up lines
Network of clinical centres
GMP PILOT
LINES
NanoFacturing:
Manufacturing of solide core
nanopharmaceuticals
NanoPilot – Synthesis of
polymer based
nanopharmaceuticals
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On-going implementation of White Paper
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Translation Hub
Translation Advisory Board
Support to SME instrument
EU NCL
Pilot scale-up lines
Network of clinical centres
• Submission Sept 2nd 2014
EU-NCL
5 months
project review
3 months Grant
Agreement
• At least two proposals submitted
• 5+ meetings with US-NCL, EMA and DG SANCO
(July 2014)
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On-going implementation of White Paper
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SME Instrument First Results
(source: EASME)
Phase I – Feasibility studies
First Cut-off (18/06)
- 2662 proposals  317 above threshold (12%)
 155 SMEs from 21 countries to receive 50 k€
 24 related to «Clinical research for the validation of
diagnostics devices and biomarkers»
 4 « Open disruptive innovation scheme » related to
Health
 2 « Nanotech(…) for manufacturing &materials » related
to Health
Translation Hub
Translation Advisory Board
Support to SME instrument
EU NCL
Pilot scale-up lines
Network of clinical centres
Second cut-off (24/09)
- 1944 new proposals
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On-going implementation of White Paper
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SME Instrument (2)
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On-going implementation of White Paper
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SME Instrument (3)
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ENATRANS – a Translational project open to
all the nanomedicine community
Translation
Hub
Translation Advisory Board
Support to SME instrument
EU NCL
Pilot scale-up lines
Network of clinical centres
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On-going implementation of White Paper
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Objectives
• Drive the emergence of a dynamic network of industrial,
academic, clinical and public stakeholders
• Improve knowledge about regulation, reimbursement
and business aspects such as standardisation in the
research community and especially SMEs
• Enhance innovation capacity of SMEs and academia
• Establish functional interfaces between the R&I (incl.
SMEs), clinical trial centres, investors and large
companies
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On-going implementation of White Paper
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ENATRANS AT A GLANCE
Access of SMEs to the nano-biomedical ecosystem
Bridging SMEs
with clinical
centres
Networking &
Community
Building
Translation Advisory Board (TAB)
Showcase of
SMEs to large
companies &
investors
Education & Training for SMEs and academics
Communication & Public Awareness
With a team of 7 partners
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On-going implementation of White Paper
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Networking
 Build on the Nanomed Map & organise events
to engage actors
 Analyse the field
to structure and understand the field
 Provide dedicated tools
to better interact and share information, experience and advice
SME² (SME Square)
Focus group dedicated to nanomedical SMEs to respond to specific concerns
when facing translation
Physical and virtual networking platform to promote exchanges and learn from
others’ individual experiences
Gateway to identify specific needs (training), opportunities, barriers, success
factors or best/bad practices
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On-going implementation of White Paper
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Improving knowledge and innovation capacity
With a set of tools:
• Compendium describing regulatory and approval issues along
the translation process
• Web based data bank with names and contact data of
relevant agencies to be contacted during translation
• Nanomedicine WikiPedia
With the involvement of the ecosystem
regulators, HTAs, healthcare payers, politics
With dedicated training & coaching offers
With the Translation Advisory Board as central instrument
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On-going implementation of White Paper
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Establishing functional interfaces
To understand, bridge, access, interact …




With clinical centres
With investors
With large companies
With users and the public
… and mutually benefit from innovative nanomedical products
• Showcase of high-potential nanomedicines to industrials
• Nanomedicine awards
• Series of events on dedicated diseases (NWCD-like)
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Translation Advisory Board (TAB)
•
•
•
What
• Promote and guide projects, provide strategic
advice, support and concrete recommendations
• Open access, free of charge, non-binding advice
• Link SMEs with large companies and facilitate industrial
take-up or access to clinical trials of projects for the most
promising/translatable projects
Who
Core experts: Team of industrial with broad expertise in
Translation
+ Pool of experts with specific knowledge, skills and
experience in marketing, regulation and approval, quality
assurance, manufacturing, clinical trials…
How
• 2 stage advice
• Bottom-up approach
• Additional advice to FP7 or H2020 R&D projects
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On-going implementation of White Paper
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TAB – Envisaged Process
TAB management
Unit
Continuous
online
application
2 Cut-off dates
per year
Stage 0
TAB Experts, PTE only if
required, on a case by case
basis
Face to face parallel meetings
Max. 2h individual sessions
2 events per year in different
cities (2 days’ events)
At least 2 experts per case
“First come first served” basis
Stage I
OpenTAB sessions
“Short ADVICE”
All process should start
end of Q1 2015
TAB management
unit and experts
Experts meetings:
*Defining projects
to be helped
further based on
an overall
consensus
*Sharing
experience for
recommendations
and experts’
training
Involvement of TAB
and PTE experts
In depth advice on
specific issues
On site advice
Opportunities to
showcase and link to
clinics and industries
Stage II
IN-DEPTH ADVICE
Feedback loop: Follow-up and validating TAB concept
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On-going implementation of White Paper
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Envisaged core Experts
Name
Function
Prof. Mike
Eaton
Retired from UCB
Paul Smit
Retired from Philips Healthcare Business Development
Former ETPN Chairman
Dr Rafi Koriat
Israeli National Nanotech Initiative
Prof. Rudiger
Iden
Dr. Eckhard
Schwenner
Dr. Laurent
Levy
Confirmation
of interest
Former Senior Vice-President BASF, Polymer Physics
Former Bayer Diagnostics
CEO of Nanobiotix
Eric Mayes
Endomagnetics
Magnus
Larsson
SP research Institute
David Bott
Retired, ex TSB director, chairman of Oxford Biomaterials Ltd
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Impacts on EU: 500+ SMEs in nanomedicine in
Europe
 Guide the efficient development of products and
projects through the translation process up to
clinical trials
 Help in removing barriers to commercialization
 Increase the quality of products under
development to reach the market
 Increase the diversity and quality (for
development) of projects at ideation
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On-going implementation of White Paper
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Looking forward to serving the nanomedicine community
Thank you for attention!
For more information, contact:
[email protected]

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