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48 BioPharm International eBook October 2020 www.biopharminternational.com The IQ Consortium has ongo- ing dialogue with FDA through scientific roundtables and work- shops. IQ has also engaged with the Pharmaceuticals and Medical D e v i c e s A g e n c y ( P M D A ) i n Japan and the Brazilian Health Regulatory Agency (ANVISA) on selected topics and is expanding its engagement with industry and reg- ulatory professionals in China and Europe. The IQ Consortium con- tinues to reach out to the broader p h a r m a c e u t i c a l c o m m u n i t y through relationships with other organizations focused on improv- ing the research and development process (15–19). F r om it s i nc e p t ion, t he IQ C onsor t iu m enabled sc ient ists across its member companies to collaborate in a precompetitive ma nner not d r iven by t it le or hierarchy but by their passion to advance transformational solu- tions for the industry. Ideas for IQ Consortium projects are pre- sented, debated among peers, and prioritized based on their align- ment with IQ's strategic objectives, the level of interest from member companies, and a clear articula- tion of the value of the projects to the pharmaceutical industr y and patients. The selected initia- tives benefit from the combined engagement of SM Es across IQ Consortium member companies, allowing the consortium to drive change that would be challenging for a single company to achieve alone. An openness to collaboration is one of the organization's true assets. Through collaboration, IQ has become a leading scientific consortium in the biopharmaceu- tical industry in a single decade. Through open dialogue, a func- tional structure, and a strong foun- dation of scientific excellence, the IQ Consortium members created a remarkable community that lever- ages the best scientists and exper- t ise ac ross member compa n ies to collaboratively address indus- try-wide challenges. Much of the information that has resulted f rom IQ's work is publicly available through the IQ C onsor t iu m website i nc lud i ng i n for mat ion about consor t iu m events, leadership groups, working groups, a publications directory for IQ publications, comments sub- mitted to regulatory authorities, and presentations accessible to the public. Each year, an annual report summarizes the consortium's prog- ress, 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 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 dis- tinct pharmaceutical and biotech- nological issues, resulting in the establishment of two new consor- tia separate from IQ: the Allotrope Foundation (7, 20) and the Enabling Te c h nolog ie s C on s or t iu m (9). Further, from time to time, mem- bers conclude that the consortium should establish special affiliated initiatives to better address chal- lenging regulatory and scientific issues with more Secretariat sup- port and separate funding. The IQ D r ug- I nduce d L ive r I nju r y Initiative (IQ DILI) and the IQ Microphysiological Systems Affiliate (IQ MPS) are two such affiliates, and involve scientists representing a cross-section of IQ companies. The ability of IQ to identify the value of these efforts and allow them to mature within the consortium, while leveraging the IQ commu- nity and Data Sharing Framework, has been critical to ensure the suc- cess and sustainability of these new affiliated initiatives. FUTURE GOALS OF THE IQ CONSORTIUM The IQ Consortium is poised to engage and address global trends i mpac t i ng t he pha r maceut ic a l i ndu st r y t h roug h t he sha r i ng of best practices, engagement of globa l reg ulators, a nd pa r t ner- ship with other industry associ- ations. As industr y trends have move d f r om fo c u si n g on t he United States, Japan, and Western Europe for initial global submis- sions to near-simultaneous global submission across most geogra- phies, the need for a harmonized u nde r st a nd i n g of t he s c ie nc e behind pharmaceutical research and development has been ampli- fied. Additionally, globalization of key capabilities required for drug discovery and development, complexity of supply chains, and the evolution of clinical trial con- duct create new opportunities to support innovation and qualit y through the IQ Consortium. As understanding of the human biolog y e x pa nds, t he pha r ma- ceutical industr y has witnessed the rise of new, more personal- ized modalities such as gene and cell therapies. Traditional devel- o p m e nt , m a nu f a c t u r i n g , a nd ma nu fac t u r ing pa rad ig ms may not b e su it able for t hese new modalities. Similarly, advances in artificial intelligence to support drug discovery, a renewed focus on sustainability, and the digital Regulatory Sourcebook Quality