The I nnovation Task Force ( I TF) EMA/ SMEs Workshop 2011 - - PowerPoint PPT Presentation

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Sep 23, 2023 448 likes •611 views

The I nnovation Task Force ( I TF) EMA/ SMEs Workshop 2011 Presented by: Marisa Papaluca Amati ITF Chair Scientific Support & Projects Section Head An agency of the European Union W HY w e have the I TF? I nnovation: a m oving target!

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An agency of the European Union

Presented by: Marisa Papaluca Amati ITF Chair – Scientific Support & Projects Section Head

The I nnovation Task Force ( I TF)

EMA/ SMEs Workshop 2011

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W HY w e have the I TF?

I nnovation: a m oving target!

Set up in 2 0 0 1

– to provide an inform al “soft landing zone” to initiate and facilitate dialogue w ith applicants developing innovative m ethods and m edicines – to ensure Agency-w ide coordination in innovative areas of interest to support the scientific com m ittees – to prom ote know ledge sharing and preparedness – to com plem ent and prepare for form al procedures – to contribute to and catalyze dialogue w ith stakeholders on innovation

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W ho is the I TF? W ho is the I TF?

A m ultidisciplinary group w ith “flexible design”

– I TF secretariat ( operational and scientific coordination) – I TF core m em bers and specialised EMA staff (com petences and consistency) – Experts from the EMA netw ork ( scientific expertise)

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Who is the ITF? Secretariat and core members

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Current areas of activities

– Biom arkers ( special focus on genom ics) and personalised m edicine – ATMPs and regenerative m edicine – Borderline and com bined products – Nanotechnology applications – Em erging therapies and technologies ( including synthetic biology)

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I TF briefing m eetings: definition I TF briefing m eetings: definition

Free Free-

of
f-
charge inform al m eetings to open the dialogue on

charge inform al m eetings to open the dialogue on regulatory, technical and scientific issues. regulatory, technical and scientific issues. Scope Scope : : > I nnovative therapies, m ethods and technologies, borderline and > I nnovative therapies, m ethods and technologies, borderline and com bined products com bined products Objectives Objectives: : > Contribute to preparedness of both EMA and Applicants > Contribute to preparedness of both EMA and Applicants > Com plem ent and reinforce existing form al regulatory procedures > Com plem ent and reinforce existing form al regulatory procedures

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The briefing m eetings The briefing m eetings “ “profile profile” ”

Profile of the product/ technology ( sponsor

Profile of the product/ technology ( sponsor ’ ’s scientists) s scientists)

Developm ent strategy/ program : quality, safety, efficacy,

Developm ent strategy/ program : quality, safety, efficacy, m anufacturing, RMP ( as applicable at the tim e of the m eeting) m anufacturing, RMP ( as applicable at the tim e of the m eeting) ( sponsor ( sponsor’ ’s scientists) s scientists)

Key scientific or regulatory areas ( all)

Key scientific or regulatory areas ( all)

Guidance tow ards relevant related guidelines, services ( e.g.

Guidance tow ards relevant related guidelines, services ( e.g. SMEs SMEs office) or scientific procedures ( e.g. Scientific Advice, OMP

ffice) or scientific procedures ( e.g. Scientific Advice, OMP

designation) in line w ith the presented strategy of the com pany designation) in line w ith the presented strategy of the com pany ( all) ( all)

I dentified areas for further reflection and on the regulatory

I dentified areas for further reflection and on the regulatory

pportunities discussed ( all)
pportunities discussed ( all)

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ITF briefing meetings: figures

ITF cumulative briefing meetings organised (2005 - 2010)

5 10 15 20 25 30 35 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

2005 2006 2007 2008 2009 2010

Areas discussed at I TF briefing meetings ( 2005- 2010)

5 10 15 20 25 30 35 2005 2006 2007 2008 2009 2010 Pharmacogenomics Ot her Gene t herapy Chemical Cell based Borderline product Biological

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Types of applicants to ITF briefing Types of applicants to ITF briefing meetings meetings

Type of applicants met by the ITF (2005-2010)

Academic 7% Other 43% SME 30% Top 20 20%

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Briefing meeting with SMEs

Type of products submitted to the ITF by SMEs (2005-2010)

Biological 16% Cell Based 65% Chemical 3% Gene therapy 11% Other 5%

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The I TF coordination The I TF coordination “ “W heel W heel” ”

Scientific Advice

Com panies

European Com m ission

Other international

Reg. authorities

FDA W Ps experts

I T ( Unified Collaboration)

W Ps’ secretariats CAT secretariat CHMP secretariat Legal Regulatory Affairs I nspection

Risk Managem ent

Quality Safety & Efficacy Orphan SME Office I TF Secretariat

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I TF briefing m eetings: I TF briefing m eetings: the netw ork the netw ork

100 200 300 400 500 600 2008 2009 2010

Participation in I TF briefing m eetings ( 2 0 0 8 -2 0 1 0 )

ITF at t endees EMA non- ITF at t endees WP expert s Company at t endees

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CAT ATMP classification CAT ATMP classification

The The CAT scientific recom m endation CAT scientific recom m endation on advanced therapy classification is optional … but Purpose Purpose: to determ ine w hether a given product based on genes, cells or tissues m eets the scientific criteria w hich define Advanced Therapy Medicinal Products ( ATMPs) Benefits Benefits: special support special support to ATMPs of SMEs, identify and address early applicable applicable requirem ents requirem ents, issues issues of borderline w ith

ther areas. To be done early

early and before before

rphan drug designation, scientific Advice,

Paediatric I nvestigation Plan ( PI P) , etc.

Cumulative number of ATMP classification reports review ed by I TF ( 20 09 -2 01 0) 5 10 15 20 25 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2009 2010

Types of Applicants to ATMP classification (2009-2010)

Academic 5% Other 35% SME 55% Top 20 5%

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CHMP Scientific recom m endation on eligibility to the Agency’s scientific services

The I TF provides, in conjunction w ith the CHMP and the European The I TF provides, in conjunction w ith the CHMP and the European Com m ission, regulatory advice to applicants on the eligibility t Com m ission, regulatory advice to applicants on the eligibility t o EMEA

EMEA

procedures as a Medicinal Product e.g. w here there are uncertain procedures as a Medicinal Product e.g. w here there are uncertainties on ties on w hether the concerned therapeutic product ( s) w ould qualify as w hether the concerned therapeutic product ( s) w ould qualify as Medicinal Medicinal product( s product( s) . ) . Regulatory advice frequent areas of uncertainty : Regulatory advice frequent areas of uncertainty :

Medical Practices ( e.g. transplantation)

Medical Practices ( e.g. transplantation)

Medical devices

Medical devices

Food supplem ents

Food supplem ents

( Medicinal) substances incorporated in m edical devices for w hich

( Medicinal) substances incorporated in m edical devices for w hich the the m edicinal and ancillary functions are borderline m edicinal and ancillary functions are borderline . .

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