Sesión III. Moderador : D. Jose Alberto San Román

Gestión de la investigación en un centro de Investigación MixtoD. José Carlos Pastor – Instituto Universitario de Oftalmología Aplicada

Instituto Universitario de Instituto Universitario de OftalmobiologOftalmobiologííaa Aplicada (IOBA)Aplicada (IOBA)

[[EyeEye InstituteInstitute]]UniversityUniversity ofof ValladolidValladolid

ValladolidValladolidSpainSpain

Historia resumida del IOBAHistoria resumida del IOBAPropuesto a la Junta de Gobierno de la Uva en 1989Instituto de la Universidad en Noviembre de 1989Dos divisiones:

Oftalmología 17 investigadores clínicosFarmacología 7 investigadores clínicos2 técnicos de laboratorio, 2 PASPresupuesto 12.000 €

Instituto LRU en Diciembre de 19941ª Evaluación de la Junta de Castilla y León 1999 2 Evaluación de la Junta 2005Traslado edificio Campus Miguel Delibes 2007 y 20008

IOBA 2009IOBA 2009ApprovedApproved by by thethe SpanishSpanish GovernmentGovernment in in DecemberDecember19941994LocatedLocated atat ourour ownown buildingbuilding sincesince 2007 (FEDER 2007 (FEDER fundedfunded: 4,5 : 4,5 MM€€): 4.000 m): 4.000 m22

MoveMove endedended NovemberNovember 20082008

SelfSelf--financedfinancedBudgetBudget 2009: 4 M 2009: 4 M €€ (2,6 (2,6 MM€€ clinicalclinical activitiesactivities, 1,4 , 1,4 MM€€researchresearch))

AroundAround 100 100 membersmembers (60 (60 contractscontracts): ): threethree areasareas: : clinicalclinical, , researchresearch andand teachingteaching activitiesactivities

IOBA 2009IOBA 2009Clinical area:14 ophthalmologists (comprehensive and sub-specialized Ophthalmology)18.000 out-patients clinic attendances in 20084,000 newnew patients

41% private24% insurance companies35% National Health Service

1,400 day surgeriesQuality certified since 2006 (ISO 9000)

ResearchResearch structurestructure4 major research groups

Ocular SurfaceRefractive Surgery and Quality of VisionRetinaGlaucoma

5 major horizontal programsDry Eye Disease Program (sponsored by Allergan)Cell Therapy ( Advanced Therapies) in OphthalmologyApplied Genetics in OphthalmologyLow Vision and RehabilitationTelemedicine

Common labs and unitsCell Culture labImmunology labOcular Pathology labBiostatistics UnitClinical Trial Unit

99 basicbasic seniorsenior investigatorsinvestigators12 12 clinicalclinical investigatorsinvestigators10 10 basicbasic predoctoral predoctoral investigatorsinvestigators10 10 studentsstudents PhDPhD programprogram7 7 technicianstechnicians

Ocular Ocular PathologyPathology lablabClinicalClinical diagnosis diagnosis andand researchresearch supportsupportProf. Forteza, MD, PhD academicdirectorProf. Cuevas, MD, PhD coordinator ofteaching activitiesDenise Hileeto, MD (Residency in Pathology at Yale University) Two techniciansMore More thanthan 7,000 ocular 7,000 ocular samplessamples (2009)(2009)

Ocular Ocular PathologyPathology lablab: : projectsprojects in in 20102010

Adquisition of a digital microscope ASIC IIIIntegration in a Telepathology Network

Proposed as part of an Ophthalmic BIOBANK

ClinicalClinical TrialsTrials UnitUnitCreatedCreated in 2001: 12 in 2001: 12 clinicalclinical trialstrials sincesince thenthenMemberMember ofof EVI.CT.SEEVI.CT.SE sincesince 20062006FullyFully certifiedcertified in 2008in 2008

coordination of “independent”clinical trials supported by Carlos III Institute

Triamcinolone acetonide for DME (alreadyfinished 2009)Avastin for Myopic choroidalneovascularization (recruitment period closed2009)Avastin for macular edema after reinal veinocclusion (EVOBER) (starting in 2009)

TeachingTeaching activitiesactivities (post(post--graduategraduate))Masterships recognized by EU:

InteruniversityInteruniversity VisionVision ResearchResearch MastershipMastership((alreadyalready verifiedverified by ANECA: U Complutense by ANECA: U Complutense Madrid, Santiago, Murcia, Coimbra, CSICMadrid, Santiago, Murcia, Coimbra, CSIC)RetinaOcular Surface and ImmunologyOculoplastic surgeryANECA ANECA verifiedverified in 2009in 2009

Masterships of the University:GlaucomaClinical OptometryVisual Rehabilitation (proposed as an official Master in 2009)Ophthalmic Nursing

Continous Education Program in Ophthalmology

Angola´s project

Since 1995Over 1,6 M€44 people travellingBiopsies processed and informed atValladolidResidency in OphthalmologyMastership in Ophthalmic Nursing20092009--20112011State Grant to Angola’s GovernmentProphylaxis of neonatal conjunctivitis

IOBA is a member of the most outstandingbiomedical research structures created by

Spanish Government: Associated Unit CSIC, CIBER-BBN,

Thematic Network 0062, TerCel Network, Network Center for Regenerative Medicine

and Cell Therapy of Castilla and Leon

International cooperations (officialagreements)

McGill University (Montreal, Canada), BaylorCollege (Houston, USA), Texas University atDallas (USA) UCL (London, UK), Roma Campus Biomédico (Italia), University ofHälle (Germany), IBILI (Coimbra, Portugal), Moorfields Eye Hospital (London, UK), University of Porto (Portugal), Rotterdam EyeHospital (Netherlands), Vienna Eye Hospital (Austria), University of Lisbon (Portugal), Instituto Gama Pinto (Lisbon, Portugal)

International cooperations (in discussion)

Heilderbeg (Germany)Liverpool and Bristol (UK)Institute de la Vision (Paris, France)Universidade Federal de Sao Paulo (Brasil)Beijing Eye Institute (China)

CoordinationCoordination ofof clinicalclinical networksnetworks

Risk factors for PVR development (Retina 1)Efficacy and safety of intravitreal TA for DME (Retina 3)Genetic approach to PVR (Retina 4)Avastin ® for CNV in pathologic myopia(Macula 2)Autologous limbal transplantation vsconjunctival rotation for pterygiumAutologous expanded limbal stem cellstransplantationGraft vs host disease (ocular manifestations)

•Instituto Oftalmológico de Alicante. Alicante•Clínica Barraquer. Barcelona•Hospital Universitario Vall d´Hebró. Barcelona•Hospital Reina Sofía. Córdoba•Hospital San Millán. Logroño•Hospital Ramón y Cajal. Madrid•Hospital Donostia. San Sebastián•Grupo de Retina IOBA, Valladolid•Hospital Pío del Río Hortega, Valladolid•Hospital Universitario de Valladolid•Hospital General Universitario de Valencia•Hospital Universitario de Canarias•Fundación Oftalmológica del Mediterraneo•Hospital Universitario de Salamanca•Hospital General Yagüe de Burgos•Hospital Universitario de Coimbra. Coimbra. PORTUGAL•Hospital de San Joao. Oporto. PORTUGAL

RETINA 1: multicentric study

Red Temática de InvestigaciónCooperativa Sanitaria 03/13

Data: February-2005 March 2008: 1,339 RD2 papers already published in BJO

450 blood samples:450 blood samples:312 Primary RD without PVR 3 months follow up 312 Primary RD without PVR 3 months follow up 138 PVR after primary RD138 PVR after primary RD

Centro Total/centro DR VRPHospital Clínico Universitario 60 28 32

Hospital del Río Hortega 17 10 7

Hospital Universitario de Donostia 42 35 7

Hospital Universitario Reina Sofía 14 9 5

Hospital Vall d'Hebrón 95 75 20

Instituto Barraquer 43 35 8

Instituto Oftalmológico Vissum 129 98 31

IOBA 50 22 28

Total 450 312 138

Multicentric study

RETINA 4 (Red TemRETINA 4 (Red Temáática 03/13)tica 03/13)

Retina 4Retina 4TNF TNF ααTNFRTNFR--22SMAD7SMAD7PIKPIK··CGCG

PatentPatent pendingpending 200702532200702532ProcedureProcedure forfor dtectingdtecting highhigh riskrisk ofofdevelopingdeveloping PVR PVR basedbased onon SNPsSNPs

Retina 4Retina 4DuplicationDuplication andand validationvalidation

800 800 samplessamplesRetina 1 Retina 1 projectproject centerscentersMoorfieldsMoorfields EyeEye HospitalHospitalRotterdamRotterdam EyeEye HospitalHospitalViennaVienna EyeEye Hospital Hospital

OctoberOctober 2009 460 2009 460 samplessamples

PreliminaryPreliminary data data publishedpublished in IOVSin IOVS

IOBAIOBA’’ss appliedapplied researchresearch achievementsachievementsSpin-off: Vision I+DControlled enviromental chamberPatentsRegistriesTransference of technologiesContracts with industries

C. E. C. E. ChamberChamberTemperatureTemperature, , humidityhumidity andand pressurepressure controlledcontrolledPossibilitiesPossibilities: : clinicalclinical studiesstudies in normal in normal volunteersvolunteers andandpatientspatients withwith ocular ocular inflammatoryinflammatory processesprocessesSpecificSpecific diagnosticdiagnostic testtest underunder controlledcontrolled conditionsconditionsShouldShould be be operativeoperative by by NovemberNovember 20092009

Pressure 400 mbarTemperature 15 to 30 ºCHumidity 5%-80%

17.000 kg of steel

Patents10 in 12 years(3 in process)2 registries1 transference of technology

IOBA IOBA -- CiberCiber BBNBBN

Ciber BBN prototype. Rigid gas permeable contact lens

Pub. No.: P200801822

Pub Date. Jun. 6, 2008

Material: Biocompatible polymer

Next year’s tasks:

Soft contact lens of material HEMA or HSi

Sensor could be polimerized withthe contact lens materialPA

TE

NT

Patent pending 2008

Contracts with industries:Allergan (2004-2011) $1, 8 M $1, 8 M Ocular inflammationAlcon (2006-2009) polymers as drug releasesystemsThea- TransphytoAJL-Ophtalmics

ChairsChairs fundedfunded by by enterprisesenterprises::AlconEsteveNovartisTopcon

AgreementsAgreements withwith: : Lilly, Essilor, Zeiss, Bioftalmik, Cellerix

Ceguera de origen Ceguera de origen cornealcorneal: Reconstrucci: Reconstruccióón de la superficie ocular n de la superficie ocular mediante terapia celular e ingeniermediante terapia celular e ingenieríía de tejidosa de tejidos

Ensayo clEnsayo clíínico en pacientes con Snico en pacientes con Sííndrome de Insuficiencia ndrome de Insuficiencia llíímbicambica

Ceguera de origen Ceguera de origen cornealcorneal: Reconstrucci: Reconstruccióón de la superficie ocular n de la superficie ocular mediante terapia celular e ingeniermediante terapia celular e ingenieríía de tejidosa de tejidos

Ensayo clEnsayo clíínico en pacientes con Snico en pacientes con Sííndrome de Insuficiencia ndrome de Insuficiencia llíímbicambica

UPCIBGM, UVa

New project, starting 2009Development of customized intraocular lensesfor petsLeon Veterinarian SchoolAJL-Ophthalmics (Vitoria, Spain)

FutureFoundationBioBank ocular diseases orientedExpand European relationsCreation of 2 new spin-off

E-DiagnosticsCritical Health

Eye care products market $ 14,5 bnOphthalmic Pharmaceuticals market$ 10 bn in 20072009-2023 will grow steadily driven by increasing prevalence of ophthalmic disordersamongst an expanding population of olderpeopleContact Lens market1,2 bn € in 2008

Proposal: creation of a biomedicaltranslational research structure based

on eye and vision: consortium?Universities

ValladolidSalamancaLeonCarlos IIICSIC (Optics andPolymers Institutes)

Technological centers:INASMETCIDETEC

Companies:•AJL Ophthalmics•Progenika•Bioftalmik•Vision I+D

Pipe-lineOcular surface research

Dry eye , allergy and inflammationDiagnostic testsTherapeutical targets

Cell therapyProtocolsPatents

Technological developmentFilters and aids for low visionOcular lens for estimating intraocular pressureAutomatic image analysis

RetinaAdvanced therapies