Most therapy developments are targeting indications with existing therapies in the market and/or in clinical development. Even patients with rare diseases that don’t have specific treatments still have a Standard of Care. Your therapy must be an improvement upon the standard of care. Typically, that means similar safety and improved efficacy, but exceptions exist. Understand what the Standard of Care is today, and what it is likely to be by the time your therapy reaches the market. Your therapy must be highly likely to be superior! N.B. that competition should be broadly defined. For an oncology biologic, chemotherapy, improvements in surgical techniques, and even trends in lifestyle changes are all competitive, and must be understood.