Suhasini Iyer,

Group Leader

Genentech, Inc

Protein therapeutics, especially monoclonal antibodies are now standard of care in several disease areas in particular the areas of oncology, transplantation and inflammatory diseases where novel, life-changing treatment alternatives were very limited. More than 20 monoclonal antibodies and derivatives including fusion proteins and antibody fragments are currently available for different therapies. The ability to selectively target disease-related molecules has not only resulted in enhanced safety profiles in patients but has also allowed us to get good understanding of biological and patho-physiological mechanisms / targets of disease. Given the complex interaction of target expression, mechanisms of disease and drug clearance that ultimately impacts PKPD of monoclonal antibodies, efforts are made in preclinical development to guide first-in-human dose levels and dosing strategies in the clinic. This presentation will cover some aspects of these strategies