BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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Page 21 of 47

22 BioPharm International eBook March 2021 Special Section: It Takes a Bio/Pharma Village T he proverb "it takes a village to raise a child" illustrates the importance of community involvement to help children develop in a safe environment. In the bio/pharmaceutical industry, researchers nur- ture new drugs through the development and manufacturing process internally or with support from external contractors and suppliers. Major science, technology, and regulatory challenges, however, require collaborative efforts from across the industry. Precompetitive research efforts between academia and industry have spurred innovations in analytical science and manufacturing. And efforts by expert industry volunteers—with the support of bio/pharmaceutical com- panies—have tackled, and continue to address, some of the pressing technical, scientific, and regulatory issues facing all drug companies. The following special section of this Regulatory Sourcebook, Quality Collaboration, features contributions from mem- bers of the International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium). The not-for-profit organization of pharmaceutical and biotechnology companies works collaboratively to develop solutions to common problems on a precompetitive basis. Through case studies and reports on working group activities, the authors share examples of how these organized collaborations can improve research and development efficiency, mitigate risks, and improve quality, while sharing costs for addressing scientific, technical, and regulatory questions. This section highlights the efforts of IQ Consortium working groups to address pharmacokinetic modeling, safe handling of biologic drugs by healthcare workers, phase-appropriate specifications for biologic drugs, extrapolating adult clinical trial data for pediatric studies, data integrity, and good laboratory practices. Other Consortium initiatives, not discussed here, address analytical practices, drug substance and drug product, good manufacturing practices, continuous manufacturing, dissolution, novel excipients, process analytical technology, accelerated drug development, and more. For more than a decade, the efforts of the member of the IQ Consortium have demonstrated that collabora- tion from a global bio/pharma village is essential to serve patients. BP Paulista - THE EDITORS OF BIOPHARM INTERNATIONAL Regulatory Sourcebook Quality Collaboration

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