The APBG welcomes you to join this webinar on Working in at Team – Statistician – Data Manager – Medical Writer presented by Statistician Belinda Butcher, Medical Writer Sophie Gibb and Clinical Data Manager Leanne Stootman, all from WriteSource Medical.
Date/Time: Tuesday 22nd October 2 to 3pm (Sydney time)
Location: Online (please contact us at apbgsteering@gmail.com for virtual meeting details)
Abstract
The production of high-quality clinical trial research requires the cooperation of various functional groups. Biostatisticians, data managers and medical writers are key people responsible for ensuring the research is cohesive through the design, implementation, analysis and reporting phases. Effective collaboration between these groups of people is critical to streamline the production process and ensure consistency within the research itself and of documentation produced through a trial.
The various documents and systems required for a trial are highly related with a given study design, objectives, endpoints and other elements flowing from these. The medical writer, statistician and data manager, should be introduced at the start of a project and be supported in working collaboratively together throughout the trial to ensure high quality, consistent documentation and research outcomes. We share some of our experiences of working as a multidisciplinary team – what is effective, and case studies illustrating some potential pitfalls of insufficient communication and where cross-functional responsibilities are not clearly understood.
Speakers
Belinda Butcher is the director of WriteSourceMedical Pty Ltd, a medical writing, data management and biostatistics consultancy. She has dual expertise in pharmacology and statistics. Sophie Gibb is the medical writing manager at WriteSource Medical Pty Ltd, she has extensive experience in regulatory writing and medical communications for drugs and devices in a diverse range of therapy areas. Leanne Stootman is the manager of clinical data management at WriteSource Medical Pty Ltd, she has a broad experience including data management, clinical operations and quality.
2024 APBG Mid Year Meeting
Please join us for our mid year meeting to be held at IQVIA’s North Sydney Office and online. We will be treated to three presentations: an introduction to the SSA’s mentoring program by Lizzie Korevaar, an introduction to ACTA STInG’s DSMB mentoring program by Sabine Braat, and a presentation on PK/PD Modelling and Simulation: How they can support drug development by Zheng Liu.
Date/Time: Wednesday 21st August 1.30 to 4pm
Location: IQVIA, 141 Walker St North Sydney and online (please contact us for virtual meeting details)
Agenda
1.30 pm Arrival and networking
2 pm Introduction to Statistical Society of Australia’s Mentoring Program – presented by Lizzie Korevaar
2.20 pm Introduction to ACTA Statistics in Trials Interest Group (STInG) Data and Safety Monitoring Board (DSMB) mentoring program – presented by Sabine Braat
2.40 pm Afternoon tea and networking
3 pm PK/PD Modelling and Simulation: How they can support drug development – presented by Zheng Liu
4 pm Meeting close
Introduction to Statistical Society of Australia’s Mentoring Program
Speaker: Lizzie Korevaar
Abstract: Recognising a need to build better connections between early-career and more established statisticians in Australia, Karen Lamb created a mentoring program through the Biostatistics & Bioinformatics Section of the Statistical Society of Australia (SSA) in 2020. The program involved 10 mentor-mentee pairs from around Australia and ran for 12 months. The program has since expanded broadly across the SSA and is run by the Mentoring Program Committee, co-chaired by Karen and Lizzie Korevaar. The broader program is now in its 4th year, pairing between 20 and 30 mentees and mentors each year. In this talk, Lizzie will provide an overview of the program and its benefits to participants.
Introduction to ACTA Statistics in Trials Interest Group (STInG) Data and Safety Monitoring Board (DSMB) Mentoring Program
Speaker: Sabine Braat
Abstract: The ACTA Statistics in Trials Interest Group (STInG) Data and Safety Monitoring Board (DSMB) mentoring program was established to facilitate and support training for statisticians in the role of a DSMB statistician. Statisticians are essential members of DSMBs but the number of statisticians in Australia with expertise and experience to fulfill the role of a DSMB statistician does not meet the growing demand. This mentoring program aims to address this shortage by providing ‘on-the-job’ training for statisticians and revolves around meetings for one or more DSMBs on which the mentor is the DSMB statistician and the mentee acts as a silent observer of the DSMB process. A total of 6 mentor-mentee pairs were solicited in 2020 and started the mentoring program in 2021. An additional group of 9 mentors and mentees have commenced in 2022. The presentation will provide an overview of the ACTA STInG DSMB mentoring program.
PK/PD Modelling and Simulation: How they can support drug development.
Speaker: Zheng Liu
Abstract: Pharmacokinetics (PK) plus pharmacodynamics (PD) equal to pharmacology, which plays an essential role in drug development. PK is the study of how our body treats the drug and PD is the study of how the drug treats our body. PK exposure is a key factor connecting dose to PD, efficacy and safety of the studied drug in question. PK/PD modelling and simulation has become a powerful approach to support drug development and regulatory review, which is often referred as Model-informed drug development (MIDD). This presentation will provide an introduction about the concepts of PK, PD, and seven case studies about how PK/PD modelling and simulation can support drug development.
Biography: Zheng Liu is the Director of Quantitative Clinical Pharmacology in IQVIA, a CRO providing clinical trial services to the drug development industry. Zheng has been leading IQVIA’s PK/PD modelling & simulation team since 2022, and also a member of IQVIA’s Early Phase Oncology Centre of Excellence team. He has over 10 years’ experience in PK/PD modelling & simulation as well as in clinical research fields, both in industry and academic settings. Zheng has over 10 first-authored publications related to modelling and simulation, demonstrating his contribution to the field. He has been also supervising post-graduate research students in academics.
Australian Pharmaceutical Biostatistics Group 