Oncology Global Safety Teams (GSTs) are usually not tasked with the development of the risk section of the products Target Product Profile (TPP). This fact makes little sense since the GST is tasked by the company to identify, analyze, and mitigate a product's risks. The TPP, in essence, establishes boundaries for go-no-go decisions around a product or products in combination treatment. Involvement of the Oncology GST 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 the 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 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 for 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. The early development of a well-documented TPP will enhance chances of a successful product submission.

*The existing framework for most companies' TPP development does not include GST input for the safety section.

*GSTs have the required skill set to provide the product risk analysis necessary to produce an effective estimate of risks for the safety section of the TPP.

*This talk provides a new framework to include GSTs in the TPP development and methods for the GSTs to meet this new requirement.

Michael E. Kieffer

President

Focused Consulting, Staffing, & Drug Safety, LLC