Corporate Magazine 2012 - Boehringer Ingelheim

collaborate innovate accelerateTRANSCELERATE: COOPERATION WITH THE GLOBAL RESEARCH AND DEVELOPMENT COMMUNITY[ regulatory, public, government and industry-based entities are engaged. ]industryinitiativesregulatorybodiestransceleratebiopharma inc.research andcro communityhealthadvocacyACCELERATING THE DEVELOPMENTOF NEW MEDICINESClinical study execution has been identifiedas the initiative’s initial focus area.Five projects have been selected forfunding and development, including:Boehringer Ingelheim and nine other leading biopharmaceuticalcompanies have formed TransCelerate BioPharma Inc., a non-profitorganisation to accelerate the development of new medicines.GLOBAL INDUSTRY ALLIANCESTransCelerate’s work builds onexisting industry collaborationswhich closely align with projectactivities. We will involve industryalliances, including Clinical DataInterchange Standards Consortium(CDISC), Critical Path Institute(C-Path), Clinical Trials TransformationInitiative (CTTI) and InnovativeMedicines Initiative (IMI),regulatory bodies, including theUS Food and Drug Administration(FDA) and the European MedicinesAgency (EMA), and contractresearch organisations (CROs).TransCelerate BioPharma Inc. waslaunched to identify and solve commondrug development challenges, with thegoals of improving the quality of clinicalstudies and bringing new medicinesto patients faster.Shared research and solutionsTransCelerate aims to collaborate acrossthe global research and developmentcommunity and share research and solutions,which will eliminate inefficienciesthat drive up R&D costs as well assimplify and accelerate the delivery ofnew medicines for patients.• Development of a shared user interfacefor investigator site portals• Mutual recognition of study site qualificationand training• Development of risk-based site monitoringapproach and standards• Development of clinical data standards• Establishment of a comparator drugsupply model44 Boehringer Ingelheim annual report 2012