Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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Pharmaceutical Technology Regulatory Sourcebook October 2020 61 increase in collaborative opportunities, pharmaceuti- cal companies found themselves without a common forum to address challenging and evolving global regulatory and scientific issues. To address this gap, several companies began informally discussing the merits of an industry-based technical consortium dedicated to advancing innovation and quality in the research and development process of the biopharma- ceutical industry. By sharing best practices and speak- ing with one voice on scientific and technical chal- lenges, these companies believed a consortium would be better able to drive beneficial improvements to the research and development process than individual in- dependent efforts. As a result of these discussions, in April 2010, four leading global pharmaceutical com- panies founded the International Consortium for In- novation & Quality in Pharmaceutical Development (IQ Consortium or IQ) and established its vision to be "the leading science-based organization advanc- ing innovative solutions to biomedical problems and enabling pharmaceutical companies to bring quality medicines to patients" ( The IQ Consortium As a technically focused organization of phar- maceutical and biotechnology companies, the IQ Consortium's mission statement is "to advance science and technology to augment the capability of member companies to bring transformational solutions that benefit patients, regulators, and the broader research and development community." These foundational principles led the IQ Consor- tium to success during its first decade. When the IQ Consortium was formally launched in 2010, it had 13 members. Today, it has grown to nearly 40 member companies, and more than 1700 scientists participate in the Consortium. The IQ Consortium's governance structure in- cludes a Board of Directors composed of repre- sentatives from each member company. Four ex- ecutive committees—planning, communications, regulatory advisory, and symposium organiz- ing—manage day-to-day operations. Leadership groups report to the Board and manage a portfolio of projects as well as a number of Working Groups. Working groups are self-initiated and project fo- cused. The IQ Consortium has 10 leadership groups organized by chemistry and manufacturing controls, quality, life sciences, and statistics topic areas (Figure 1), with more than 90 working groups managed within these leadership groups. With a project champion serving as chair, a working group defines a project charter, timelines, deliverables, and a communication plan to report out results. The sponsoring leadership group reg- 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 FIGURE COURTESY OF IQ CONSORTIUM

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