The Australian Pharmaceutical Biostatistics Group are excited to announce our AGM and End of Year meeting will be held on 2nd December at The George Institute, The HUB, Level 5, 1 King St, Newtown from 1.30pm – 4.30pm.

Following the formal AGM, Dr William Reece, Director of Biostatistics at Labcorp will give an in-person presentation on Early Phase Oncology Trials. All members and guests are invited to join us in person for refreshments and networking. The event will also be available to join online. Please RSVP to apbgsteering@gmail.com for catering purposes and to receive the meeting link.

Date/Time
2nd December 2022, 1.30-4.30pm

Location
The George Institute, The HUB, Level 5, 1 King St, Newtown

Agenda
1.30pm Tea, coffee and networking
2pm APBG AGM
3pm Afternoon tea and networking
3.30pm Dr William Reece – Early Phase Oncology Trials
4.30pm Meeting Close

Early Phase Oncology Trials

Speaker: Dr William Reece (Labcorp)

Abstract: Despite its well-publicised shortcomings, the development of Oncology therapies has frequently relied on the 3+3 design to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for further development. To improve on this design, multiple alternative strategies have begun to find favor, being used globally, including the Continuous Reassessment Method (CRM), Bayesian Logistic Regression Method (BLRM), modified Toxicity Probability Interval, Bayesian Optimal Interval, i3+3, etc.. The performance of these model-based and rule-based designs depends much on arbitrary choices for target toxicity rates, maximum numbers of patients to be enrolled, and the uncontrollable effect of non-random patient selection. I’ll be presenting my perspective on choices of some of these parameters, the relative merits of some of these designs, considering their application in practice, and some considerations around how to optimally incorporate them into a development program. Furthermore, regulators are now beginning to require consideration of an Optimal Biological Dose, including randomization between doses, and an overview of efficacy, safety and PK/PD parameters. I’ll be presenting some proposals around how this might be addressed in the context of an oncology program where risk exposure of patients to a novel compound needs to be balanced against a requirement to give patients doses that can reasonably be expected to be therapeutic.

Biography: William is a Director of Biostatistics for Labcorp. He has a degree in Biochemistry, a PhD in Immunology and a Master’s in Biostatistics. He has held roles across academia and industry, including as a research immunologist, statistician for Eli Lilly, and heading up the Asia Pacific Statistics and Programming teams for Covance prior to taking on his current dual role of statistical consulting and director of commercial support for Data Management and Statistics. Throughout his statistical career, he has had a particular focus on oncology design, and regularly consults to biotech and pharmaceutical companies on the optimal design of early phase studies, assisting in protocol writing and NDA submissions.