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64 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Quality Future goals of the IQ Consortium The IQ Consortium is poised to engage and ad- dress global trends impacting the pharmaceuti- cal industry through the sharing of best practices, engagement of global regulators, and partnership with other industry associations. As industry trends have moved from focusing on the United States, Japan, and Western Europe for initial global submissions to near-simultaneous global submission across most geographies, the need for a harmonized understanding of the science be- hind pharmaceutical research and development has been amplified. Additionally, globalization of key capabilities required for drug discovery and development, complexity of supply chains, and the evolution of clinical trial conduct create new opportunities to support innovation and quality through the IQ Consortium. As understanding of the human biology expands, the pharmaceutical industry has witnessed the rise of new, more personalized modalities such as gene and cell therapies. Traditional development, man- ufacturing, and manufacturing paradigms may not be suitable for these new modalities. Similarly, advances in artificial intelligence to support drug discovery, a renewed focus on sustainability, and the digital transformation of the manufacturing environment create new challenges for industry, academia, and government. Collaboration on is- sues of science and regulation within the IQ Con- sortium can help meet these challenges and sup- port continued innovation in the pharmaceutical research and development process. While celebrating the accomplishments of the first decade of the IQ Consortium, IQ Consortium members continue to preserve and refine the at- tributes that have been important for its success. The IQ Consortium is well equipped with ex- cellent technical depth across many disciplines. The frequency and magnitude of change in the broader scientific community is unprecedented, and the IQ Consortium is well positioned to con- tinue as an inf luential presence across the broad scientific landscape of pharmaceutical research and development. The IQ Consortium's past achievements and publication record demonstrate that innovation and quality in pharmaceutical development remain its foundation, a goal that will continue to drive the consortium well into its next decade. References 1. O. J. Wouters, M. McKee, and J. Luyten, JAMA, 323 (9), 844-853 (2020). 2. J.S. Altshuler, et al., Sci Transl Med, 2 (52) 1-4 (2010). 3. S. Holmes, et al., Inhalation (February 2016). 4. H. Laverty and M. Goldman, Biotechnol J, 9 (9) 1095-6 (2014). 5. R. Ormiston, J. Schumacher, and L. Shtohryn, Inhalation (Oc- tober 2011). 6. G. Paillard, et al., Drug Discov Today, 21 (1) 97-102 (2016). 7. J. M. Vergis, et al., LC GC North America, 33 (4) 270-281(2015). 8. J. A. Wagner, et al., Clin Pharmacol Ther, 87 (5) 539-42 (2010). 9. C. J. Welch, et al., Organic Process Research & Development, 21 (3) 414-419 (2017). 10. J. Woodcock, et al., Nat Rev Drug Discov, 13 (11) 781 (2014). 11. M. Patlak, J Natl Cancer Inst, 102 (12) 841-3 (2010). 12. N. Savage, Nature, 533 (7602) S56-8 (2016). 13. J.A. Wagner, Clin Pharmacol Ther, 87 (5) 511-5 (2010). 14. J. Woodcock, Clin Pharmacol Ther, 87(5) 521-3 (2010). 15. American Association of Pharmaceutical Scientists (AAPS), www.aaps.org. 16. International Society for Pharmaceutical Engineering (ISPE), https://ispe.org. 17. Pharmaceutical Research and Manufacturers of America (PhRMA), www.phrma.org. 18. European Federation of Pharmaceutical Industries and Associa- tions (EFPIA), www.efpia.eu. 19. American Society for Clinical Pharmacology and Therapeutics (ASCPT), www.ascpt.org. 20. J.M. Vergis and D.E. Vanderwall, Pharmaceutical Technology, Analytical and Bioanalytical eBook (3) 29-31 (2014). PT The IQ Consortium is well equipped with excellent technical depth across many disciplines.