Issue link: https://www.e-digitaleditions.com/i/1302985
Pharmaceutical Technology Regulatory Sourcebook October 2020 63 shops. IQ has also engaged with the Pharmaceu- ticals and Medical Devices Agency (PMDA) in Japan and the Brazilian Health Regulatory Agency (ANVISA) on selected topics and is expanding its engagement with industry and regulatory profes- sionals in China and Europe. The IQ Consortium continues to reach out to the broader pharmaceu- tical community through relationships with other organizations focused on improving the research and development process (15–19). From its inception, the IQ Consortium enabled scientists across its member companies to collabo- rate in a precompetitive manner not driven by title or hierarchy but by their passion to advance trans- formational solutions for the industry. Ideas for IQ Consortium projects are presented, debated among peers, and prioritized based on their alignment with IQ's strategic objectives, the level of interest from member companies, and a clear articulation of the value of the projects to the pharmaceuti- cal industry and patients. The selected initiatives benefit from the combined engagement of SMEs across IQ Consortium member companies, allow- ing the consortium to drive change that would be challenging for a single company to achieve alone. An openness to collaboration is one of the or- ganization's true assets. Through collaboration, IQ has become a leading scientific consortium in the biopharmaceutical industry in a single decade. Through open dialogue, a functional structure, and a strong foundation of scientific excellence, the IQ Consortium members created a remarkable community that leverages the best scientists and expertise across member companies to collabora- tively address industry-wide challenges. Much of the information that has resulted from IQ's work is publicly available through the IQ Con- sortium website including information about con- sortium events, leadership groups, working groups, a publications directory for IQ publications, com- ments submitted to regulatory authorities, and presentations accessible to the public. Each year, an annual report summarizes the consortium's progress, facilitating greater visibility into recent accomplishments and ongoing activities. IQ also serves as a sandbox for new consortia to explore, develop, and establish a strong foundation. IQ has served as an incubator of ideas and a forum to explore distinct pharmaceutical and biotech- nological issues, resulting in the establishment of two new consortia separate from IQ: the Allotrope Foundation (7, 20) and the Enabling Technologies Consortium (9). Further, from time to time, mem- bers conclude that the consortium should estab- lish special affiliated initiatives to better address challenging regulatory and scientific issues with more Secretariat support and separate funding. The IQ Drug-Induced Liver Injury Initiative (IQ DILI) and the IQ Microphysiological Systems Af- filiate (IQ MPS) are two such affiliates, and involve scientists representing a cross-section of IQ com- panies. The ability of IQ to identify the value of these efforts and allow them to mature within the consortium, while leveraging the IQ community and Data Sharing Framework, has been critical to ensure the success and sustainability of these new affiliated initiatives. Table I. Value of IQ Consortium since inception in 2010. Scientific output Regulatory influence Publications Symposia Webinars Conference presentations Comments on guidance documents 122 8 73 182 89