Bringing an innovative drug substance or the active pharmaceutical ingredient (API) to a Drug Product is a complex process and requires a clear definition of the Target Product Profile (TPP). Hear from Rajiv Nayar, PhD, President of HTD Biosystems, will define the critical items that need to be identified in the TPP before formulation development can begin. TPP encapsulates the essential criteria that define the ideal characteristics of a potential therapeutic agent. The key parameters include dosage form, route of administration, target patient population, cost, scalability, etc.
The importance of the TPP is to facilitate communication and collaboration among multidisciplinary teams within the pharmaceutical organization, regulatory agencies, and investors/stakeholders. By establishing clear goals and benchmarks, the TPP enhances and reduces the likelihood of misinterpretation or misalignment throughout the drug development continuum. In addition, the TPP provides a framework for resource allocation, risk assessment, and prioritization of activities. Participants will learn how to apply this framework with various case studies taken from products HTD Biosystems has helped bring to from the bench to the clinic.
Lunch will be provided at this free event. Register on Eventbrite.