Tutorial- Tuesday at 9:00 AM EDT
Title: Combination Complexities, Contribution of Components Considerations in Cancer: Gleanings from Interactions with Health Authorities at Various Stages of Development
Presenters: Brent McHenry, BeiGene

Abstract:

Combination therapies have been widely used in medicine. Various challenges in drug development are posed when designing and executing clinical trials. In this presentation, we will discuss various interactions with health authorities in the context of combination therapies used in oncology. Combinations can target multiple mechanisms of action to improve treatment response, minimize development of resistance, et al. However, various strategic implications for many therapeutic areas, available treatments and regulatory landscapes, differing practices in multiple regions of the world and many other factors introduce complexities in this space. Some successful approaches used in demonstrating the contribution of components for the evaluation of efficacy and safety will be discussed at multiple stages of drug development (e.g. at the design and analysis stages). Benefits and complexities in designing 2-arm compared to 3 or more arm designs as well as experience based recommendations will be considered.
Combination therapies have been widely used in medicine. Various challenges in drug development are posed when designing and executing clinical trials. In this presentation, we will discuss various interactions with health authorities in the context of combination therapies used in oncology. Combinations can target multiple mechanisms of action to improve treatment response, minimize development of resistance, et al. However, various strategic implications for many therapeutic areas, available treatments and regulatory landscapes, differing practices in multiple regions of the world and many other factors introduce complexities in this space. Some successful approaches used in demonstrating the contribution of components for the evaluation of efficacy and safety will be discussed at multiple stages of drug development (e.g. at the design and analysis stages). Benefits and complexities in designing 2-arm compared to 3 or more arm designs as well as experience based recommendations will be considered.



Bios:
Brent McHenry " is a Director of Biostatistics at BeiGene. Brent received his PhD in Biostatistics from the University of Pittsburgh in 2003. He started his career with an academic tenure-track appointment as an assistant professor at MUSC, where he supported Type-1 Diabetes DCCT/EDIC research that justified the value and initiated the regular use of HbA1c monitoring. He taught courses in regression, applied statistics, sampling theory, et al., working specifically on methodologies for time-to-event data.

In 2005, Brent shifted to industry joining BMS, where he worked for nearly 17 years leading the development of oncology medicines such as Opdivo (nivolumab) and Yervoy (ipilimumab) in multiple indications including RCC, Prostate, Gastric, Esophageal, CRC, Lung, Melanoma, et al.

Brent joined BeiGene in 2021 with vast experience in statistical designs and analysis leading to many successful regulatory submissions across the globe. At BeiGene he leads development of multiple promising compounds in various therapeutic areas.
Brent resides in Deep Creek, Maryland. In his spare time, he enjoys exercise, reading, spending time with his family and training his German Shepherds."