Title: Why Oncology Global Safety Teams Should Develop the Safety Section of the Study’s Target Product Profile (TPP)

Abstract:

A Target Product Profile (TPP) highlights the clinical and safety attributes of a developmental product that if realized would enable successful marketing.  A TPP can be developed for a study or even for the addition of a study arm.  The TPP, in essence, establishes boundaries for Go-No Go decisions around a product or products in combination treatment.  The World Health Organization (WHO) has adopted the TTP to attempt to define characteristics required in new health products that if realized would address the greatest public need for developing nations.  The Food and Drug Administration (FDA) has attempted to generate guidance to industry related to TPP development.  Involvement of the Oncology Global Safety Team in producing a well-researched and evidenced based TPP safety section allows the team to develop knowledge around the drug(s) studied or added to a study arm.  The increased use of umbrella and platform studies for early phase oncology trials allows an excellent resource for the use of clinical data to estimate the risk of developmental drugs combined to treat a given oncology indication.  To shorten time to marketing, companies are including developmental products with novel mechanisms early within their development cycles.  Antibody Drug Conjugates (ADCs) and Bi-Directional Antibodies are a few examples of products combined in arms of a platform or umbrella study early and: therefore, with only immature clinical data available.  This talk will share a novel analytical approach for safety teams to develop a well thought-out and defendable safety section to the TPP.  Strategies to estimate the risks associated with combination therapies will be brought forward.  The advantages of having the safety team involved early in the benefit/risk, Go-No Go decisions for a study or the addition of a study arm will be detailed.

Biography:

Michael Kieffer is a Pharm.D. with 12 years of experience in patient safety, pharmacovigilance and clinical trial oversight obtained from serving in positions at the Food and Drug Administration, Amgen, and AstraZeneca.   He has a proven tract record of driving safety enhancements, leading cross functional teams, leading risk mitigation efforts, and improving safety functional teams.  Throughout his career, he has enthusiastically honed his skills in safety signal detection, safety assessment, and regulatory compliance to ensure the highest standards of patient safety across all stages of drug development.  He is currently a freelance consultant and President of his own business, Focused Consulting, Staffing, and Drug Safety.  In this capacity, he has consulted on topics centering around risk management and trial safety.