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! 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 Innovation Task Force - EMA/ SMEs Workshop 2011 2
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) Innovation Task Force - EMA/ SMEs Workshop 2011 3
Who is the ITF? Secretariat and core members Innovation Task Force - EMA/ SMEs Workshop 2011 4
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) Innovation Task Force - EMA/ SMEs Workshop 2011 5
I TF briefing m eetings: definition I TF briefing m eetings: definition Free- - of of- - charge inform al m eetings to open the dialogue on charge inform al m eetings to open the dialogue on Free 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 Innovation Task Force - EMA/ SMEs Workshop 2011 6
The briefing m eetings “ “profile profile” ” The briefing m eetings 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’ ’s scientists) s scientists) ( sponsor 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 office) or scientific procedures ( e.g. Scientific Advice, OMP office) or scientific procedures ( e.g. Scientific Advice, OMP SMEs 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 opportunities discussed ( all) opportunities discussed ( all) Innovation Task Force - EMA/ SMEs Workshop 2011 7
ITF briefing meetings: figures ITF cumulative briefing meetings organised Areas discussed at I TF briefing meetings ( 2005- 2010) (2005 - 2010) 35 35 30 30 2005 25 Pharmacogenomics 25 2006 Ot her 20 20 Gene t herapy 2007 Chemical 15 Cell based 15 2008 Borderline product 10 Biological 2009 10 5 2010 5 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 0 2005 2006 2007 2008 2009 2010 Innovation Task Force - EMA/ SMEs Workshop 2011 8
Types of applicants to ITF briefing Types of applicants to ITF briefing meetings meetings Type of applicants met by the ITF (2005-2010) Academic Top 20 7% 20% Other 43% SME 30% Innovation Task Force - EMA/ SMEs Workshop 2011 9
Briefing meeting with SMEs Type of products submitted to the ITF by SMEs (2005-2010) Other Biological Gene therapy 5% 16% 11% Chemical 3% Cell Based 65% Innovation Task Force - EMA/ SMEs Workshop 2011 10
The I TF coordination “ “W heel W heel” ” The I TF coordination SME Scientific Office Orphan Advice Safety & Com panies Efficacy European Quality Com m ission Other Risk international Managem ent Reg. authorities I TF Secretariat I nspection FDA W Ps Regulatory experts Affairs I T ( Unified Legal Collaboration) W Ps’ CHMP CAT secretariats secretariat secretariat Innovation Task Force - EMA/ SMEs Workshop 2011 11
I TF briefing m eetings: I TF briefing m eetings: the netw ork the netw ork Participation in I TF briefing m eetings ( 2 0 0 8 -2 0 1 0 ) 600 500 400 ITF at t endees EMA non- ITF at t endees 300 WP expert s Company at t endees 200 100 0 2008 2009 2010 Innovation Task Force - EMA/ SMEs Workshop 2011 12
CAT ATMP classification CAT ATMP classification Cumulative number of ATMP classification reports The CAT scientific recom m endation The CAT scientific recom m endation on review ed by I TF ( 20 09 -2 01 0) advanced therapy classification is optional 25 … but 20 15 Purpose: to determ ine w hether a given Purpose 2009 2010 product based on genes, cells or tissues 10 m eets the scientific criteria w hich define 5 Advanced Therapy Medicinal Products 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec ( ATMPs) Types of Applicants to ATMP classification Benefits: special support Benefits special support to ATMPs of (2009-2010) Top 20 Academic SMEs, identify and address early applicable applicable 5% 5% Other requirem ents, issues requirem ents issues of borderline w ith 35% other areas. To be done early early and before before SME orphan drug designation, scientific Advice, 55% Paediatric I nvestigation Plan ( PI P) , etc. Innovation Task Force - EMA/ SMEs Workshop 2011 13
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 o EMEA o EMEA Com m ission, regulatory advice to applicants on the eligibility t procedures as a Medicinal Product e.g. w here there are uncertainties on ties on procedures as a Medicinal Product e.g. w here there are uncertain w hether the concerned therapeutic product ( s) w ould qualify as w hether the concerned therapeutic product ( s) w ould qualify as Medicinal product( s product( s) . ) . Medicinal 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 . . Innovation Task Force - EMA/ SMEs Workshop 2011 14
For further information please contact: I TFSecretariat@em a.europa.eu Innovation Task Force - EMA/ SMEs Workshop 2011 15
Recommend
More recommend
