Biological drugs are playing an ever increasing role in the treatment of a range of diseases. In 2012, 7 of the top 10 best selling “drugs” were actually biologics. Although biologics have traditionally been used for hormone or cytokine replacement (eg rHuEPO, Factor VIIa, insulin) and treatment of cancers (eg trastuzumab, bevacizumab) and inflammatory conditions (eg anti-TNFs), they are now being developed in areas that traditionally have been the domain of small molecules (eg pain disorders, cholesterol-lowering). Therefore, there is a high likelihood that a clinical pharmacologist will be called upon to provide support to a biologics program. At times, it is not possible to conduct traditional healthy volunteer clinical pharmacology studies to complete the information package necessary for informing prescribing physicians and regulators. The clinical pharmacologist has to develop novel ways to assess the risks and develop plans to collect information from patient studies.