Nanotechnologies in Medicine Challenges and new concepts The European Technology Platform Nanomedicine Furio Gramatica Polo Tecnologico, Fondazione Don Carlo Gnocchi ONLUS IRCCS - PowerPoint PPT Presentation

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Nanotechnologies in Medicine Challenges and new concepts The European Technology Platform Nanomedicine Furio Gramatica Polo Tecnologico, Fondazione Don Carlo Gnocchi ONLUS IRCCS

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Title: Nanotechnologies in Medicine Challenges and new concepts The European Technology Platform Nanomedicine Furio Gramatica Polo Tecnologico, Fondazione Don Carlo Gnocchi ONLUS IRCCS


1
Nanotechnologies in Medicine Challenges and new
concepts The European Technology Platform
NanomedicineFurio GramaticaPolo Tecnologico,
Fondazione Don Carlo Gnocchi ONLUS IRCCS
Le nanobiotecnologie tra ricerca e sviluppo
dimpresa Palazzo delle Stelline - Milano, 23-24
Giugno 2011
2
  • Founded 50 yrs ago
  • Covering areas of health, research, ageing,
    disability, education, international cooperation
  • 29 research rehabilitation hospitals and
    centres in 9 italian regions (clinics and
    adv.tech. for biomedicine, ageing, disabilities,
    etc.)
  • 3.5 million/yr patients access our centres
  • 4000 beds, 6000 operators
  • main seat in Milan (IT)
  • Private but in national public network

3
TECHNOLOGY TRANSFER
RESEARCH DEVELOPMENT
RESEARCH AREAS/ THEMATIC LABS
INDUSTRY
Biophysics and nanomedicine
BUSINESS DEVELOPMENT
Bioengineering applied to cardiovascular system,
to wearable sensors and to telemedicine
Assistive technologies
CLINICAL ADVISORY COMMITTEE
Bioengineering applied to neuromotor system
CLINICS
Technologies for ergonomics and industrial
medicine
REGULATORY ASPECTS
TRANSVERSAL LABS
Biosignal analysis
Medical imaging
ICT, electronics and integration
RESEARCH
  • Polo Tecnologico is, since 30 years, the
    Biomedical Technology Department of Don Gnocchi
    Foundation,It is located within the research
    hospital (IRCCS) S.Maria Nascente di Milano.
  • Polo Tecnologicos main goal is technological
    research for biomedical applications and its
    exploitation through a suitable technology
    transfer process of ots results towards industry.

4
PHYSICS, CHEMISTRY HOW NATURE WORKS
ENGINEERING HOW TO BUILD
NANOSCIENCE HOW NATURE WORKS AT MOLECULAR LEVEL
BIOMEDICAL SCIENCES HOW LIFE WORKS
NANOTECHNOLOGY HOW TO BUILD AT MOLECULAR LEVEL
THE NANOTECH TREE OF KNOWLEDGE
NANOTECH NON-BIO
NANOBIOTECH
AGRO-FOOD
ENVIRONMENT
NANOMEDICINE
5
Nanomedicine definition
Nanomedicine definition according to Vision Paper
of ETP Nanomedicine (Sept. 2006)
and its three challenges
  • What happens down there ? NANODIAGNOSTICS
  • How can we treat exactly there ? TARGETED DRUG
    DELIVERY
  • If lost or broken, how can we rebuild it ?
    REGENERATIVE MEDICINE

6
Nanomedicine key to diagnostic and preventive
treatment
Current, Symptomatic Medicine
Clinical Symptoms
Symptoms
Preventive Medicine
Preventive Treatment
Early Diagnosis
Screening
time
  • Through screening and early diagnosis ? identify
    disease early ? and intervene early

7
The ETPN Mission ..
  • Drive the development of Nanomedicine in Europe
  • Educate, guide communicate on the real value of
    the nanomedicine
  • Identify RD Industrial risks in order to
    better position Europe
  • Reinforce and facilitate the co-development
    between academia industry
  • Create new opportunities for funding (eg
    infrastructures, technology Clinical platforms)
  • Identify opportunities set the priorities on
    the most promising projects
  • Drive Nanomedicine into clinical practice based
    on industry needs
  • Accelerate transfer commercialization of novel
    ideas through an extensive clinician-industry
    interface

To make it happen in Europe
8
History, Status and Achievements
Report 09
  • ETPN was started in 2005 (initiated by EC)
  • Driven by Philips Med, Siemens Med, EC (Uta Faure
    Research Directorate General)
  • First Vision Paper in September 2005
  • Accepted as ETP in 2006
  • Strategic Research Agenda in November 2006
  • General Assemblies in Padua 06, Greece 07,
    Madrid 08, Paris 09, Milan 10
  • ETPN Secretariat established in 2008
  • Membership fee since 2008

SRA 06
FP7 National programmes Position papers reports
Vision Paper 05
Ezio Andreta
Renzo Tomellini
9
The 5-steps way
A backwords, society-targeted way of planning
research in high-tech applied to medicine
THE METHOD
10
Example research priorities in neuroscience by
ETP Nanomedicine
FP7 is taking this into account
11
ETPN Analysis of status quo Many challenges!
  • History of lack of communication between Pharma
    Academia, unlike diagnostics - mirrored with
    regenerative medicine
  • Translational capacity often poor (Bench to Bed)
  • Limited number of accessible safety labs
  • Poor respect of GxPs
  • Some academic fields have grown for decades
    without thought about translation ? industry will
    not engage easily.
  • Paperwork administration for FPx participation
    is tremendous
  • Larger company guidance is essential for EC
  • Need to engage with best academics, this is also
    an industrial priority

tell us your issue!
12
Tasks of the ETPN
4
Support EC MS
  • Provide contact to industry, academia, etc

3
Federate the Community
  • Organise events, fora, etc

2
Nanomedicine Strategy Think-Tank
  • Develop NM strategy,
  • Prioritise topics, etc.

1
Services support to the members
  • Provide 1st-hand info,
  • support consortia, collect feedback, etc.

13
The Basis of all the ETPN member institutions
14
The ETPs structure
Regenerative Medicine Nanotechnology for
regenerative medicine
Nano Pharmaceutics Nanotech for drug delivery,
Nanodevices
NanoDiagnostics Nanotechnology based diagnostics
and imaging
Next WG meetings at ETPN Forum 19-21 October,
Barcelona
Next WG meetings at ETPN Forum 19-21 October,
Barcelona
Next WG meetings at ETPN Forum 19-21 October,
Barcelona
Ethical and Social Aspects of Nanomedicine
Regulatory Framework
Intellectual Property Rights
3 technical working groups3 joint advisory groups
15
ACTORS AND ROLES
EUROPEAN TECHNOLOGY PLATFORM NANOMEDICINE
EUROPEAN COMMISSION
NANO-INNOVATION STAKEHOLDERS
MARKET STAKEHOLDERS
16
ETPN as mediator the translation triangle
  • Bring nanomedicine into clinical practice via
    industry
  • Align up-stream RD with industrial needs
  • Bridge academia and industry and clinicians on
  • Market needs
  • ST bottlenecks
  • Approval process
  • Technology roadmaps
  • Suggest industry inspired call topics to the EC
    and to ERANET EuroNanoMed

Clinic
Clin. trial
Clin. trial
Academia
Industry
Translation
17
The (Nano)medicine value chain
ETPN facilitates guides
OPEN INNOVATION
Patient Needs!
Basic Research
Applied RD
Industrial Implement.
ClinicalImplement.
  • Clinical
  • Translation
  • Regulatory Issues
  • Reimbursement
  • Qualified products and services
  • Qualified products and services

CLINAM aids
EMEA regulates
18
Federating synchronising the Nanomed Community
Past
CLINAM
more
Today
more
  • Clinam 2011
  • ERA Net
  • Workshops

CLINAM
CLINAM
Tomorrow
  • Nanomed 2012
  • Funding Prgs
  • Infrastructure

CLINAM
19
ETPN Strategy documents Roadmap Report 2009
  • Revision of status and on upcoming critical
    issuesin Nanomedicine
  • Identification of industrially relevant roadmaps
    topics in
  • Diagnostics
  • Drug Delivery
  • Regenerative Medicine
  • Integration of topics into a coherent concept and
    long term strategy
  • Taking into account regulatory and reimbursement
    issues
  • Defining upcoming FP7/8 work programmes
  • Ultimately driving clinical value and business
    success

To be updated!
20
Key conclusions from the Report
  • Patients needs are the driver for future
    opportunities for European research in
    Nanomedicines.
  • Nanomedicine as a translational science has the
    goal to provide cost effective novel therapies
    and diagnostics using the expanding world of
    Nanotechnology
  • Open Innovation concept needs to be implemented
    (or improved)

21
ETPN Think Tank towards FP8/ CSFRI
  • ETPN contribution to the Innovation Union /
    European Innovation Partnership on Active and
    Healthy Ageing concept
  • Analysis of future needs and Nanomedicine
    contribution
  • ETPN Consultation document in preparation
  • Online consultation on needs for the CSFRI Common
    Strategic Framework for future EU Research and
    Innovation Funding (FP8)

22
The ETP Nanomedicine Action Plan
  • Goal ? address todays needs for translation to
    make Europe competitive tomorrow
  • Part A Initiative
  • Defining Nanomedicine Programme
  • Allocation sufficient funding
  • Definition of comprehensive roadmaps
  • Part B Community
  • Uniting the Nanomedicine Community
  • Interact with Regulatory Bodies (EMA National)
  • Involve Patient Groups
  • Part C Infrastructure
  • Build Nanomedicine translation RD
    Infrastructures
  • Part D Measures
  • Regulation
  • Open Innovation approaches
  • New approches

to be published
23
A new model of development to be organized
developedOpen Innovation for nanomedicine RD
business
24
We need tug-boats from RD towards industry
  • Small enough to be agile, old enough not to be
    naif
  • Understanding research contents
  • Recognizing novelty and added value
  • Assessing market interest
  • Feeding back RD with steering information
  • Designing realistic scenarios for product
    development
  • Raising funds for transfer
  • Helping in negotiation
  • Earning mostly from successful technology
    transfer

25
Tug-boats
  • Their culture is an industrial one, not a
    not-for-profit one and this could initially be
    a obstacle but they earn from success and
    not-for-profit world is a formidable reservoir of
    new resources
  • TT offices born in not-for-profit world often try
    to do technology push only, in an unfocused (and
    uneffective) way. In case of success, a
    master-slave relationship is established with
    big industry.

EXPLORING MORE DEEPLY THE INDUSTRIAL WORLD IS A
NEW TASK
26
AN ETHICAL APPROACH
  • To play own role is the most ethical action,
    doing it in a not sustainable way (without taking
    into account due input and output) is
    definitively unethical.
  • We MUST think of a sustainable model, allowing
    the highest achievable goal in favour of the
    largest number of patients
  • This can only be done passing through industry,
    in a conscious way, with the full awareness of
    the respective roles and missions.

27
How to get started with OI?
  • Define roles in the Health(care) industry value
    chain
  • Identify core competencies internally and
    externally
  • Outsource all non-core activities
  • Learn to collaborate internally and externally
  • Become the leader in your chosen competency
  • and and and

The Solution ? Innovation to survive!
28
ETPN membership Who should join
  • Focus on companies
  • Which are committed to achieve a leadership in
    Nanomedicine
  • Which are willing to bring nanotechnology to
    patients and market
  • Seeking advise on EU RD support
  • Academia and healthcare providers are essential
    partners for the development of Nanomedicine
  • Projects focused on translational research
  • Focusing on diseases with significant economic
    impact
  • Addressing the open innovation environment
  • ? All those that understand that Europe will only
    by competitive by working together

29
Become involved
  • visit www.etp-nanomedicine.eu to
  • Download report
  • Find further information
  • Become a member

30
ETP Nanomedicine Annual Forum 2011
Dates 19 October - General Assembly 20-21
October - Annual Forum Location Hospital Clinic
Barcelona
  • Main Topics
  • Regenerative Medicine
  • Nanopharmaceutics
  • Nanodiagnostics
  • Open Industrial Challenges
  • European Programmes and Initiatives

Further information and registration on
www.etp-nanomedicine.eu
31
For more information visitwww.etp-nanomedicine.
euor contactsecretariat_at_etp-nanomedicine.eu
MyselfFurio GramaticaHead of Department, Polo
TecnologicoFondazione Don Gnocchi, Milano
(IT)fgramatica_at_dongnocchi.it
Thank you
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