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46 BioPharm International eBook October 2020 www.biopharminternational.com tr y, academia, and government a g e n c i e s c a n l e v e r a g e b r o a d te c h n ic a l e x p e r t ise, st a nd a rd- ize methods and data, share best practices, and partner to enhance global regulatory strategies (2–10). Establishing and managing con- sortia for precompetitive collabo- rations presents several challenges, including ensuring the ability to sha re infor mat ion across com- panies, safeguarding intellectual property, and obtaining commit- ment from required subject matter experts (SMEs). When successfully executed, however, precompetitive collaboration confers valuable ben- efits that far exceed those achieved by the independent operations of industry, academia, and govern- ment agencies. The benefits of precompetitive industry collaborations focused on common scientific, technical, and regulatory issues became bet- ter known in the past 20 years (2, 11–14). However, in 2009, notwith- standing the increase in collabora- tive opportunities, pharmaceutical companies found themselves with- out a common forum to address challenging and evolving global regulatory and scientific issues. To address this gap, several compa- nies 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 biopharmaceutical industr y. By sharing best prac- tices and speaking with one voice on scientific and technical chal- lenges, these companies believed a consor t iu m wou ld be bet ter able to drive beneficial improve- ments to the research and devel- opment process than individual independent efforts. As a result of t hese d isc u ssion s, i n Apr i l 2010, four leading global phar- maceutical companies founded t he I nte r nat iona l C on sor t iu m for I n nov at ion & Q u a l it y i n Pharmaceutical Development (IQ Consortium or IQ) and established its vision to be "the leading sci- ence-based organization advancing innovative solutions to biomedical problems and enabling pharma- ceutical companies to bring qual- ity medicines to patients" (https:// iqconsortium.org/). The IQ Consortium has 10 leadership groups organized by chemistry and manufacturing controls, quality, life sciences, and statistics topic areas. THE IQ CONSORTIUM As a technically focused organi- zation of pharmaceutical and bio- technolog y 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, regu- lators, and the broader research and development community." These foundational principles led the IQ Consortium 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. T he IQ Consor t iu m's gover- nance structure includes a Board of Directors composed of representa- tives from each member company. Four executive committees—plan- ning, communications, regulatory advisory, and symposium organiz- i ng— ma nage day-to - day oper- ations. 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 focused. The IQ Consortium has 10 leader- ship groups organized by chemistry and manufacturing controls, quality, life sciences, and statistics topic areas ( Figure 1), with more than 90 work- ing groups managed within these leadership groups. With a project champion serv- i ng as cha i r, a work i ng g roup defines a project charter, timelines, deliverables, and a communica- tion plan to report out results. The sponsoring leadership group reg- ularly monitors progress on each working group within its portfo- lio, and all activities are reviewed annually by the IQ Consortium Board of Directors. IQ members designate volunteer SMEs to join the working group and execute the project. Depending on the proj- ect, the results may be reported as a peer-rev iewed publication, oral presentation, symposia, white paper, webinar, case study, or other method. Finally, to ensure that there is an effective operating model that enables scientists to focus on and drive innovation and quality, the IQ Consortium's Secretariat, Faegre Drinker Biddle & Reath, LLP ("Faegre Drinker"), provides legal support, oversees compliance with antitrust laws, and effectively serves as the "back office" for the Consortium, allowing IQ participants to focus on the scientific and technical projects within the IQ Consortium. To deliver on its mission state- ment, the IQ Consortium estab- lished five strategic objectives: • Collaborate across IQ mem- b e r c o m p a n i e s t o c r e a t e Regulatory Sourcebook Quality