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www.biopharminternational.com October 2020 BioPharm International eBook 47 cross-functional data sets, sci- entific positions, and conclu- sions with greater scope and impact than possible by any member company alone • Advance relationships w ith global professional organiza- tions, other consortia, academ- ics, and government research institutes to ensure scientific excellence and harmonization • P r o a c t i v e l y b u i l d c o n - s e n s u s w i t h g l o b a l r e g u l a t o r s o n i s s u e s a n d o p p o r t u n i t i e s t o advance innovation and quality in pharmaceutical development • Share the results of IQ ini- t iat ives w it h i nter nat iona l scientific and regulatory com- munities • Ensure the continued value of IQ t h roug h com m it te d leadership, focused and clear pr ior it y-set t ing, produc t ive cross-disciplinary collabora- tions, and active engagement by a diverse talent pool to plan for leadership succession. All leadership groups and work- ing groups map their projects to these objectives. On an annual basis, these objectives are reviewed by the Board of Directors to mea- sure the IQ Consortium's success in delivering on its mission and vision. Collectively, these objec- tives serve to enable innovation, preser ve h ig h- qu a l it y sc ience, improve probabilities of technical success, and speed the delivery of innovative treatments to patients. T h is v iew poi nt h igh l ights t he unique attributes that enable the IQ Consortium's success and allow it to advance its mission. A sum- mary of case studies demonstrat- ing IQ Consortium working groups activity is planned for a BioPharm International publication in 2021. VALUE THROUGH COLLABORATION AND TRANSFORMATIONAL CHANGE The IQ Consortium has advanced s c ie nt i f ic i nqu i r y a nd u nde r- sta nd ing on a ra nge of issues. Throughout its 10 -year histor y, IQ has generated significant sci- entific output and publications, and engaged in direct scientific exchange and targeted workshops with global regulators ( Table I). In 2015, the IQ Consortium added a Data Sharing Framework agree- ment that allows IQ members to create a unique database of vol- untarily contributed data, shared in a blinded fashion, to complete research projects and formulate sci- entific positions, conclusions, and recommendations. The Secretariat assists with the combination of data sets across companies for use in these defined research projects, the results of which are shared with all IQ Consortium members. Regulatory Sourcebook Quality Figure 1. The IQ Consortium has 10 leadership groups. The Quality and Statistics leadership groups are further divided into focus groups or forums. L I FE SC I E N C ES STA T I ST I CS QUA L I T Y CH E M I STR Y , M AN I FA C T UR I NG , A ND C ON TR O LS IQ Board of Directors Clinical Pharmacology Translational and ADME Sciences DruSafe 3Rs Translational and Predictive Sciences Biostatistics CMC Statistics GLP QA GMP QA Biologics CMC Drug Product Drug Substance Analytical Scientific output Regulatory influence Publications Symposia Webinars Conference presentations Comments on guidance documents 122 8 73 182 89 Table I. Value of IQ Consortium since inception in 2010. Figure courtesy of IQ Consortium