6th IABS Statistics Workshop:
Approaches for Improving Statistical Partnership in CMC Development,
Manufacturing, and Regulation of Biologicals
CMC statisticians work in partnership with development, manufacturing, and regulatory colleagues providing solutions and leadership to the biologicals industries. This 6th IABS Statistics Workshop will explore both hurdles and achievements related to successful administration of sound statistical practices in the planning and implementation of development studies, in the advancement of strategic lifecycle management plans, and in contributions to the regulatory landscape. Areas of exploration will include the roles of CMC statisticians as practitioner, teacher, student, and leader, and how this may differ from institution to institution and across an organization. Special attention will be given to organization and communication skills required for the CMC statistical community to be successful in integrating into the broader biologicals culture. Synergies and distinctions among statisticians, data scientists, and software will be evaluated, while timely topics such as p-values, equivalence testing, reproducible research and Bayesian analysis will be explored. The workshop will invite viewpoints from CMC statistics management and personnel, from development and manufacturing partners, and from organizations such as CROs, compendia, and regulatory authorities. Rounds of presentations will be accompanied by panel discussions where workshop participants can engage the speakers and other experts on the value of and pathways to improvement of partnership between CMC statisticians and the rest of the biologicals community.