Gianni Benzi Pharmacological Research Foundation. Key concepts and Course presentation

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2 Gianni Bnzi Pharmacological Rsarch Foundation Ky concpts and Cours prsntation Halthcar biotch is alrady bnfiting mor than 350 million patints around th world through th us of biotch mdicin to trat and prvnt vry day acut and chronic illnsss including hart attacks, strok, multipl sclrosis, brast cancr, cystic fibrosis, lukamia, diabts, hpatitis, tc (Byond bordrs, 2012). Nvrthlss, as strssd in th Europan Mdicins Agncy (EMA) Road Map to 2015, an important public-halth challng currntly facd is th lack of mdicins for unmt mdical nds. For xampl, today in Europ, dspit th vidnt nd, thr is still a dramatic lack of tratmnts for 30 million Europans affctd by any of th 5,000 to 7,000 rar disass. In addition, spcial population including ldrly and childrn hav fw thraputic options tailord for thir mdical unmt nds. This yar th annual Forsight Training Cours of th Gianni Bnzi Pharmacological Rsarch Foundation will tak its cu from th advancmnt in biotchnology to addrss patint nds and is dsignd around th following topics: Rol and Rlvanc of Biotchnology in th procss of Drug Innovation Biotchnology covring thraputic nds Rgulatory Controvrsis and Novltis Th Cours will b th occasion to discuss biotch rsults and challngs by diffrnt stakholdrs points of viw: in particular th Cours will focus on th promiss of th markt and th rlvanc of th partnring of small companis with Big Pharma, on th ffcts (risk and bnfits) of th ongoing rgulatory initiativs in th pharmacutical sctor, on patints xpctancis and, ovrall, on th acquird and on-going scintific rsults. THE COURSE IS ORGANISED IN THE CONTEXT OF THE: Th Cours will provid 22,2 Italian ECM crdits for Halthcar Profssionals, and will b hld in Bari, on th initiativ of th Gianni Bnzi Pharmacological Rsarch Foundation and th High-Tch District Biotchnology and Halth (H-BIO Puglia).

3 COURSE PROMOTERS Gianni Bnzi Pharmacological Rsarch Foundation Th Gianni Bnzi Pharmacological Rsarch Foundation is a rgistrd not-for-profit Scintific Rsarch Organisation, foundd on 9 Novmbr, Th mission is to contribut to th advancmnt of pharmacological rsarch in thos filds whr th scintific hritag of Prof Gianmartino Bnzi has bn mor prominnt thus focusing on Innovativ Mdicins, mdicins for rar or nglcting disass and mdicins for spcial populations including childrn. Whil supporting pharmacological rsarch, th Foundation is spcially committd to provid ducational support and to st up activitis in th Rgulatory Scinc sctor having as rfrnc th Europan dimnsion as th natural framwork to favoring innovation, to dfining common ruls and adquat procdurs, to nsuring quality of accss to fficacious and saf tools and mdicinals to all Europan citizns. Th Forsight Training Courss, annually organizd by th Gianni Bnzi Pharmacological Rsarch Foundation ar short courss for rsarchrs and xprts in th fild of Rgulatory Scincs that aim at contributing to satisfy th incrasing knowldg nds of th sctor. High-Tch District Biotchnology and Halth (H-BIO Puglia) H-Bio Puglia is a High Tchnology District in th fild of halth and biotchnology with th aim of nhancing innovation in th manufacturing systm in th Italian Rgion of Apulia. Th activitis will b implmntd by an important ntwork involving univrsitis, rsarch cntrs and biotch companis, with th intntion to rspond to fundamntal nds: on th on hand th nd of th citizns to safguard thir right to vr mor advancd and innovativ thrapis, and on th othr hand th nd of rsarch and dvlopmnt that try to mt this dmand. Th main aras of intrst of th District ar rprsntd by th dvlopmnt of prsonalisd mdicin (mainly basd on biomarkrs drivd by th DNA/RNA tchnologis), advancd thrapis (including gn thrapy, cllular and tissu thrapy), innovativ diagnostics (including drug discovry and drugs dlivry) and nw manufacturing procsss. Th High-Tch District H-BIO Puglia was stablishd as Consortium on Sptmbr 14th 2012 and involvs a total of 36 public and privat partnrs.

4 COURSE COORDINATORS Adriana Cci Gianni Bnzi Pharmacological Rsarch Foundation Prsidnt Maria Svlto H-BIO High Tchnology District Prsidnt COURSE SCIENTIFIC COMMITTEE Enrico Boson - SIAR, Italian Socity for Rgulatory Activitis (Italy) Vito Michl Fazio - IRCCS Ospdal Casa Sollivo dlla Soffrnza (Italy) Viviana Giannuzzi - Gianni Bnzi Pharmacological Rsarch Foundation (Italy) Mark Migdal - Childrn s Mmorial Halth Institut Warsaw (Poland) Vincnzo Salvator - Univrsity of Insubria (Italy) ORGANISING SECRETARIAT Gianni Bnzi Pharmacological Rsarch Foundation Via Abat Eustasio 30, Valnzano (BA) Italy - VAT: IT Taxpayr s cod: IT www. bnzifoundation.org Administrativ offic: Via Putignani 178, Bari Italy - Tl / fax [email protected] Oprational offic: Tcnopolis, S.P. Casamassima Km Valnzano (BA) Italy - Tl / Tl.-Fax [email protected] for furthr information plas contact Bonka Gorgiva - [email protected] or Rosy Piaggion - [email protected]

5 3 0 S p t m b r 9,30 am WELCOME SESSION INSTITUTIONAL REPRESENTATIVES INTRODUCTORY SESSION Introduction of th Cours (A. Cci, Gianni Bnzi Foundation Prsidnt) Th H-BIO District: challngs and opportunitis (M. Svlto, H-Bio Puglia Prsidnt) Rgulatory Scinc rlvanc and Biotchnology (W. Bianchi, SIAR Prsidnt) Innovation in th Pharmacutical fild (A. G. Dl Santo, Farmindustria-Biotchnology Group) 11,00 am I SESSION Rol and Rlvanc of Biotchnology in th procss of Drug Innovation Chairs of th sssion: M. Svlto - A. Cci EATRIS, th Europan Infrastructur for translational rsarch in Europ (G. Migliaccio, EATRIS) Trnds in th Europan Biotchnology Markt (A. Irion, Ernst & Young) Innovativ Mdicins Initiativ, th largst public-privat initiativ to boost pharmacutical innovation in Europ (G. Rubrti, CNR) High Tchnology Districts and Clustrs in th national and intrnational framwork (F. Coniclla, Bioindustry Park) Big Pharma, SMEs and Acadmy collaboration to fostr Biotchnology innovation (M. L. Nolli, Assobiotc)

6 2,30 pm II SESSION Biotchnology to covr thraputic nds Chairs of th sssion: M. Saviano - S. Cotcchia Towards th Prsonalisd Mdicins: microrna targting Nuroblastoma (M. Saviano, CNR-Institut of Crystallography) Thraputic vaccins (D. Criscuolo, Gnovax) Stm clls us in childrn (B. Dmbowska-Baginska, COMP-EMA) 3 0 S p t m b r Gn thrapy in hamatological disordrs (S. Acuto, AOR Villa Sofia-Crvllo/P. Cutino Foundation) 4,30 pm III SESSION Biotchnology in oncology Chairs of th sssion: V. Fazio - G. Migliaccio Advancmnt in biotchnological rsarch in oncology (V. M. Fazio, IRCCS Ospdal Casa Sollivo dlla Soffrnza) Gnomic approach to discovr human cancr pathways (M.T. Landi, NIH USA) Cancr Stm Clls (A. Vscovi, IRCCS Ospdal Casa Sollivo dlla Soffrnza) Prognostic microrna/mrna signatur and prsonalisd mdicin (S. Volinia, Univrsity of Frrara) Biomarkrs and Companion Diagnostic Tsts in targtd Drug Dvlopmnt (Ann Mathiu-Bou, Novartis Oncology) Monoclonal Antibodis in cancr (M. Allgrtti, Dompè)

7 1 O c t o b r 9,00 am IV SESSION Innovation in Padiatrics and Thraputic Nds Chairs of th Sssion: A. Costscu - P. Rossi Th EU promots padiatric rsarch (A. Costscu, EU Commission) Translating rsarch in drugs dvlopmnt: th lsson from th EU fundd padiatric rsarch for drug dvlopmnt (A. Cci, Gianni Bnzi Foundation; PDCO-EMA) Exprincs from: NoMro - Europan multicntr ntwork to valuat PK, safty and fficacy of Mropnm in nonatal spsis and mningitis (I. Lutsar, Univrsity of Tartu, Estonia; PDCO-EMA) DEEP - DEfripron Evaluation in Padiatrics (D. Bonifazi, Consortium for Biological and Pharmacological Evaluation) 11,00 am V SESSION Padiatric Ntworks to improv rsarch Chairs of th sssion: M. Migdal - V. Giannuzzi Th Padiatric Ntworks improving padiatric rsarch (C. Giaquinto, GRiP Ntwork Coordinator, TEDDY Ntwork Co-Coordinator) InNrMD-I-Ntwork - Inhritd NuRoMtabolic Disass Information Ntwork (F. Bonifazi, Gianni Bnzi Foundation) Padiatric Nds ar w going th right dirction? (A. Nubrt, Univrsity Hospital Erlangn) Padiatric trials: how to dal with th missing data? (M. Catapano, Italian Group for Pharmacoconomic Studis) How to involv childrn in th rgulatory dcisions (E. Davis, Elin Haf Davis Enabling Rsarch, Empowring Childrn)

8 2,30 pm VI SESSION Biotchnology and coagulopathis Chairs of th sssion: P. Giordano - F. Houyz Rcnt progrss in th fild of inhritd coagulopathis (P. Giordano, Univrsity Bari Aldo Moro ) Advancs in hamophilia (P. Mathw, Bayr HalthCar) 1 O c t o b r Nw trnds in childrn anticoagulation (A. C. Molinari, IRCCS G. Gaslini) Expanding th Boundaris of Hamophilia Car: nw drugs in dvlopmnt (S. Srmtis, Novo Nordisk) 4,30 pm VII SESSION Agd popl and thraputic Innovation Chairs of th Sssion: M. Scatigna - R. Brnabi Thraputic nds in aging : th EMA griatric mdicins stratgy (N. Marchionni, EMA GEG, Univrsity of Firnz) Th CHMP rol for a sustainabl drug dvlopmnt for old popl (A. Gyurasics, CHMP-PDCO - tbc) Ongoing pharmacological rsarch and xpctd rsults (A. Gnazzani, Univrsity Pimont Orintal ) Unmt nds and thraputic Innovation in Alzhimr disas (V. Lpor, Univrsity of Bari Aldo Moro )

9 2 O c t o b r 9,00 am VIII SESSION Outstanding rgulatory and lgislativ issus -1 Chairs of th Sssion: V. Salvator - A. Natz How to dal with rgulatory controvrsis: th V Forsight Cours Lsson (E. Boson, Clgn) GCP and Pharmacovigilanc: a challng for Biotch studis and Rsarch (A. Dl Vcchio, AIFA) Th nw Rgulation on Clinical Trials (A. Altavilla, Espac Ethiqu Méditrranén) A padiatric updat: th 5-yar rport and th public consultation (M. Migdal, PDCO- EMA) Clinical Trials: th Transparncy of rsults and th accss to data (V. Salvator, Univrsity of Insubria) 11,30 am IX SESSION Outstanding rgulatory and lgislativ issus -2 Chairs of th Sssion: G. Banfi - A. Dl Vcchio Pric Rgulation in Europ (A. Natz, EUCOPE) Rgulation on Privacy and Data Protction (G. Buttarlli, EDPS) Exprts without conflict of intrst: an incrasing problm? (A. Cislik, Polish NCA) Mdicin supply shortags (F. Houyz, EURORDIS) Partnrships in biotchnology: what Big Pharmas want th vaccin prospctiv (L. Tollri, Novartis Vaccins and Diagnostics) Closing Rmarks 2,30 pm

10 LIST OF CHAIRS AND SPEAKERS Santina Acuto AOR Villa Sofia-Crvllo/P. Cutino Foundation (Italy) Marcllo Allgrtti Dompé, Rsarch and Dvlopmnt Dirctor (Italy) Annagrazia Altavilla Espac Ethiqu Méditrranén - Aix-Marsill Univrsity, Associat Snior Lcturr of Biotics (Franc) Giuspp Banfi Scintific Dirctor Galazzi Milan, Gnral Dirctor of th Cntro San Raffal Foundation (Italy) Robrto Brnabi Univrsity Cattolica dl Sacro Cuor, Profssor of Intrnal Mdicin; Univrsity Hospital A. Gmlli, Dpartmnt of Griatrics and Rhabilitativ Mdicin, Dirctor; Board Mmbr of th Europan Acadmy for Mdicin of Aging (EAMA). Waltr Bianchi Prsidnt of SIAR; Mmbr of th Gianni Bnzi Foundation s Board of Dirctors (Italy) Donato Bonifazi Consortium for Biological and Pharmacological Evaluations, Managing Dirctor; DEEP Projct Managr (Italy) Fdl Bonifazi Gianni Bnzi Pharmacological Rsarch Foundation, Vic Prsidnt; InNrMD-I-Ntwork, Projct Managr (Italy) Enrico Boson SIAR Board of Dirctors Rprsntativ (Italy) Giovanni Buttarlli Europan Data Protction Suprvisor (EDPS) (Blgium) Mariana Catapano Italian Group for Pharmacoconomics Studis, Dirctor (Italy) Adriana Cci Gianni Bnzi Pharmacological Rsarch Foundation, Prsidnt (Italy); Europan Mdicins Agncy (EMA), Mmbr of PDCO Anna Cislik Offic for Rgistration of Mdicinal Products, Mdical Dvics and Biocidal Products, Dirctor of Dpartmnt of Assssmnt of Mdicinal Products Documntation (Poland) Fabrizio Coniclla Bioindustry Park Silvano Fumro SpA, Dirctor Businss Dvlopmnt and intrnational projct; Coordinator at th biopmd Innovation Clustr (Italy) Alxandru Sorin Costscu EU Commission Susanna Cotcchia Univrsity of Bari Aldo Moro, Profssor of Pharmacology; Consortium for Biological and Pharmacological Evaluations, Prsidnt (Italy) Domnico Criscuolo Gnovax S.r.l., Chif Excutiv Officr (Italy) Elin Haf Davis Elin Haf Davis Enabling Rsarch - Empowring Childrn, Dirctor (UK) Antonio Giuspp Dl Santo Farmindustria-Biotchnology Group (Italy) Angla Dl Vcchio Italian Mdicins Agncy (AIFA), Dirctor Good Clinical Practic and Pharmacovigilanc Inspctorat (Italy) Boznna Dmbowska-Baginska Th Childrn s Mmorial Halth Institut, Vic Chair, Profssor at Th Dpartmnt of Pdiatric Oncology; Europan Mdicins Agncy (EMA), Mmbr of COMP (Poland) Vito Michl Fazio Spcialist in Oncology; Univrsity Campus Bio- Mdico, Ara of Gnral Pathology, Chairman (Italy) Armando Gnazzani Univrsity Pimont Orintal, Profssor of Pharmacology (Italy) Viviana Giannuzzi Gianni Bnzi Pharmacological Rsarch Foundation, Had of thics and ducation unit (Italy) Carlo Giaquinto GRIP and PENTA Ntworks Coordinator Paola Giordano U.O. Pdiatria F. Vcchio - Univrsity Hospital, Policlinic of Bari (Italy) Agns Gyurasics Europan Mdicins Agncy (EMA), Mmbr of PDCO and CHMP; National Institut of Pharmacy, Chif Advisor to th Gnral Dirctor (Hungary)

11 LIST OF CHAIRS AND SPEAKERS Francois Houyz Europan Rar Disass Organisation (EURORDIS), Halth Policy Dirctor (Franc) Antonio Irion Ernst&Younng, Advisory Lif Scinc Ladr Maria Trsa Landi National instituts of Halth (NIH), Gntic Epidmiology Branch Division of Cancr Epidmiology and Gntics National Cancr Institut, Snior Invstigator (USA) Vito Lpor Consorzio Mario Ngri Sud, Dpartmnt of Clinical Pharmacology and Epidmiology, Laboratory of Epidmiology of Dlivrd Car and Informatics Systms, Had (Italy) Irja Lutsar Profssor of Mdical Microbiology, Univrsity of Tartu (Estonia); Europan Mdicins Agncy (EMA), Mmbr of PDCO Niccolò Marchionni Univrsity of Firnz, Profssor of Grontology and Griatrics; EMA GEG Chair (Italy) Prasad Mathw Vic Prsidnt, Global Mdical affairs - Hmatology, Bayr Halth Car; Profssor of Pdiatrics, Pdiatric Hmatology/Oncology Univrsity of Nw Mxico (USA) Ann Mathiu-Bou Novartis Oncology, Rgion Europ, Mdical Affairs, Snior Mdical Dirctor, Pi3 Kinas Inhibitors Mark Migdal Europan Mdicin Agncy (EMA), Mmbr of PDCO; Childrn s Mmorial Halth Institut, Dputy Had, PICU, Had of Long Trm Car Unit (Poland) Giovanni Migliaccio Europan Advancd Translational Rsarch Infrastructur in Mdicin (EATRIS), Scintific Dirctor (Th Nthrlands); Italian Institut of Halth (ISS), Had of th Gn and Cll Thrapy Sction (Italy) Anglo Claudio Molinari Giannina Gaslini Childrn s Hospital, Thrombosis and Hmostasis Unit and Hmophilia Trating Cntr, Dirctor (Italy) Alxandr Natz Europan Confdration of Pharmacutical Entrprnurs (EUCOPE), Scrtary-Gnral Antj Nubrt Univrsity Hospital Erlangn, Dpartmnt of Padiatric and Adolscnts Mdicin, Had Padiatric Clinical Study Cntr (Grmany) Maria Luisa Nolli Assobiotc, Mmbr of th Excutiv Committ; Mmbr of th EuropaBio Board; Arta Intrnational, Foundr and Chif Excutiv Officr (Italy) Paolo Rossi Childrn s Hospital Bambino Gsù, Dpartmnt of Padiatrics, Chairman (Italy); Europan Mdicin Agncy (EMA), Mmbr of PDCO Giovina Rubrti National Rsarch Council (CNR), Rsarch Dirctor, Institut of Cll Biology and Nurobiology MIUR Dlgat IMI-JU Vincnzo Salvator Univrsity of Insubria Vars, Profssor of Intrnational Law (Italy) Michl Saviano Dirctor Institut of Crystallography (IC)-CNR, Prsidnt of Italian Crystallographic Association (AIC) (Italy) Marco Scatigna Sanofi-Avntis, Mdical and Scintific Dirctor, Gnral Managr S. A. Foundation (Italy) Stphani Valri Srmtis Novo Nordisk, Corporat Vic Prsidnt and Chif Mdical Officr Hmophilia R&D Portfolio (USA) Vittorio Silano Univrsity of Rom II; Chair ESCO Working Group, EFSA Europan Food Safty Authority; Chair of th Gianni Bnzi Foundation s Scintific Committ Maria Svlto High Tchnology District H-Bio Puglia, Prsidnt (Italy) Lornzo Tollri Novartis Vacinis and Diagnostics, Businss Dvlopmnt Snior Managr (Italy) Anglo Luigi Vscovi IRCCS Casa Sollivo dlla Soffrnza, Scintific Dirctor (Italy) Stfano Volinia Univrsity of Frrara, Dpartmnt of Morphology and Embryology (Italy)

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15 HOW TO REACH BARI By plan Thr ar dirct flights from Bari to: BARCELLONA, BOLOGNA, BRUSSELS CHARLEROI, BUCAREST, BUDAPEST, CAGLIARI, CATANIA, CLUJ, DUSSELDORF WEEZE FRANKFURT HAHN, GENOVA, IBIZA, KARLSRUHE-BADEN, LONDON GATWICK, LONDON STANSTED, LUXEMBOURG, MAASTRICHT, MALTA, MIKONOS, MILANO LINATE, MILANO MALPENSA, MILANO-BERGAMO, MUNICH, MOSCHOW DME, MOSTAR, PALERMO, MAIORCA, PARIS PARIS BEAUVAIS, PISA, PRAGUE, RIGA, ROMA CIAMPINO, ROMA FIUMICINO, SANTORINI, SEVILLE, STUTTGART, TIRANA, TORINO, TRIESTE, VALENCIA, WARSAW CHOPIN, WARSAW MODLIN, VENEZIA, VENEZIA-TREVISO, VERONA, ZURIGO. COURSE LOCATION VILLA ROMANAZZI CARDUCCI Via Capruzzi Bari - Italy Tl.: [email protected]

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