IQ Forms New CMC Biologics Leadership Group
The IQ Consortium has formed an 11th Leadership Group to address CMC aspects of biologic development.
The IQ CMC Biologics Leadership, officially formed in the summer of 2016, will cover a variety of modalities with various levels of maturity (mature vs. new horizon), including protein based drugs such as ADCs (mature modality), vaccines (mature modality), cell-based therapies (new horizon), and gene therapies.
The primary impetus for formation of this new Leadership Group was to encourage and support development of global science-based regulations for biologics. Consortium members see IQ as uniquely positioned to address these issues because of its presence in the scientific and regulatory science areas, ability to facilitate data-sharing, and opportunities for partnerships with other organizations. The Leadership Group will also allow scientists within IQ to connect with each other to conduct benchmarking exercises and drive implementation of new, promising concepts and technologies, in addition to enabling scientists to learn from each other, thereby expanding their expertise.
In the coming years, the Consortium hopes to establish several working groups focused on a range of topics related to biologics. It is possible that many of these working groups will span multiple Leadership Groups within IQ as well as liaise where needed with other industry efforts, allowing for interdisciplinary exchange and knowledge sharing in the industry.