Session – Mitigating risks associated with API suppliers Jim Stout has over 25 years of experience in biopharmaceutical process development, manufacturing sciences, and technology with large biopharmaceutical and smaller biotechnology companies and is currently working for Shattuck Labs. He has utilized all the tools gained from the advanced training to enter into biopharmaceutical process development and manufacturing, where he started at Alexion Pharmaceuticals and continued advancing bioprocess and people leadership at Medarex, Inc.; Abbott Bioresearch Center; Amgen; Shire HGT; Immunogen; Natrix Separations, Inc./EMD Millipore_Sigma; HOST Therabiomics, Inc.; and BioVectra, Inc./Mallinckrodt Pharmaceuticals. Jim managed many different recombinant protein programs at various stages from Research, all Clinical Phases, and Commercial and was privileged to contribute to the advancement of commercial Humira® and Enbrel®. He received his B.S. in Chemistry from Denison University and a PhD in Biochemistry (with a minor in Analytical Chemistry) from the University of Cincinnati. Jim extended his education in protein chemistry and separation science with an NIH post-doctoral Fellowship at the University of Cincinnati College of Medicine in the Department of Pharmacology & Cell Biophysics (mostly working with animal-derived membrane proteins from tissues) and further expanded his knowledge/ experience at the Blood Research Institute, The Blood Center of Southeastern Wisconsin, in the Department of Immunochemistry (working on human systems, Red Blood Cells and membrane proteins).