Dear APBG Members and Guests,
Please join us for our end of year meeting and AGM to be held online and at Parexel’s office in Macquarie Park. Details of speaker and topic to follow once confirmed.
Agenda
1st December 2025 10am – 12.30 pm
After the AGM, there will be an optional lunch (self-paid) at a nearby café. Separate invitation will follow for this.
We are excited to invite members and friends to an upcoming APBG Webinar featuring Dr Felicity Flack, Senior Manager, Strategy and Services at the Population Health Research Network (PHRN). She will speak on “Unlocking the Power of Linked Data: Opportunities for Australia’s Pharmaceutical Sector. Please RSVP to apbgsteering@gmail.com for the Zoom link.
Date: Wednesday, 6 August
Time: 9:00-10:00 am (Perth) | 11:00 am-12:00 pm (Sydney)
Format: Online
Biography:
Dr Felicity Flack is the Senior Manager, Strategy and Services at the Population Health Research Network (PHRN), Australia’s national data linkage infrastructure. In this role, she provides high-level strategic support to the Chief Executive and Board, leads the development of national policies, and coordinates the national strategic planning process. She also oversees communications for the network and negotiates strategic partnerships with external collaborators who share PHRN’s vision for linking life data to improve the wellbeing of all Australians. Felicity is a national expert in research data infrastructure, research ethics, and data governance. She has worked extensively in the field of linked data, helping to shape Australia’s approach to the ethical and secure sharing of health data for research. She has published widely on decision-making in sharing health data and is a respected voice on the ethical, legal, and practical dimensions of data use in the health sector.
The Australian Pharmaceutical Biostatistics Group’s 2024 AGM and End of Year meeting will be held on 3rd December at The Macquarie Business School CBD Campus, level 24/123 Pitt St, Sydney from 9am-11.30am as well as online.
Prior to the formal AGM, former FDA employee, Ken Quinto, who will provide an FDA Real World Evidence update. Following morning tea, the formal AGM proceedings will begin. After the meeting, members are invited to join the steering committee for lunch. Please RSVP to apbgsteering@gmail.com for catering purposes and to receive the meeting link.
Date/Time
3rd December, 9-11.30am
Location
The Macquarie Business School CBD Campus, level 24/123 Pitt St, Sydney, and online
Agenda
9am – 10 am FDA RWE Update
10-10.30 am Morning Tea
10.30-11.30 am AGM
12pm Lunch – optional and at own cost, The Rook Rooftop Bar Sydney
FDA Real World Evidence Update
Speaker: Ken Quinto M.D., M.P.H. Executive Director focused on RWE for regulatory use at Lilly’s Center of Innovation within Value, Evidence, and Outcomes
Abstract: In this talk, I will give an overview of FDA’s Real World Evidence program including a background of the program, demonstration projects, guidances, and FDA’s Advancing RWE program.
Biography:
Currently, I serve as Executive Director focused on RWE for regulatory use at Lilly’s Center of Innovation within Value, Evidence, and Outcomes. Prior to joining Lilly in October 2023, I served as a senior medical advisor in the Real-World Evidence Analytics Staff in the Office of Medical Policy at FDA’s Center for Drug Evaluation and Research from 2018 to 2023. My main duties included leading demonstration projects intended to support the agency’s evaluation of real-world evidence, evaluating real-world evidence sponsor submissions across all therapeutic areas, and contributing to medical policy development mandated by the 21st Century Cures Act. Key focus areas included pragmatic trials and replication of clinical trial results with non-interventional study designs. Also during my 11-year career in the U.S. government, I served as a medical officer at FDA’s Office of Pediatric Therapeutics reviewing post-market safety and adverse event reporting of drugs, biologics, vaccines, and medical devices used in children, as an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention’s National Center for Health Statistics, and as a medical officer/claims analyst at the Centers for Medicare and Medicaid Services.
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.
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.
The APBG is delighted to invite members and guests to join this webinar on Implementing the estimand framework in global drug development: Application of causal inference approaches.
Date/Time:
Thursday 1st February 7.30-11pm (Sydney time)
Location:
Virtual – please contact apbgsteering@gmail.com for meeting link
Instructors:
Details:
This evening short course introduces how causal inference approaches are relevant and used in the implementation of estimands framework in drug development. It includes 4 lectures:
Lecture 1 – Introduction to Estimands and Causal Inference:
Lecture 2 – Estimation Methods of Causal Effects Targeting at Hypothetical Estimands:
Lecture 3 – Principal Stratum:
Lecture 4 – Conditional and Marginal Treatment Effects:
The Australian Pharmaceutical Biostatistics Group are excited to announce our AGM and End of Year meeting will be held on 8th December at The Macquarie Business School CBD Campus, level 24/123 Pitt St, Sydney from 2.15pm – 5.00pm as well as online.
Following the formal AGM, Michael Fitzgerald, Director of Biostatistics at Phastar will give an in-person presentation on Missing Data and Multiple Imputation, sharing insights and strategies through a case study with a recurrent event endpoint. Please RSVP to apbgsteering@gmail.com for catering purposes and to receive the meeting link.
Date/Time
8th December, 2.15-5.00pm
Location
The Macquarie Business School CBD Campus, level 24/123 Pitt St, Sydney, and online
Agenda
2.15pm Arrival tea and coffee
2.30pm AGM including vote on new constitution
3.30pm Afternoon tea
4.00pm Michael Fitzgerald – Missing Data and Multiple Imputation
5.00pm Meeting close
5.45pm Dinner – optional, details to be provided later
Missing Data and Multiple Imputation
Speaker: Michael Fitzgerald, Director of Biostatistics, Phastar
Abstract: This presentation will share a case using simulated data based on a real study where the primary endpoint was recurrent event data. We will describe the missing data strategy for the primary analysis and sensitivity analyses that were planned, plus a bonus method using multiple imputation and pattern mixture models for a tipping-point analysis which we recommend is used for future studies.
Biography:
Michael Fitzgerald is a Director of Statistics at Phastar, primarily working in clinical trials across a diverse range of therapeutic areas with pharma, biotech, and MedTech, while building a team of statisticians for Phastar across the Asia-Pacific region. Michael learned his trade as a statistician working on investigator-led studies while working at the University of Newcastle’s Centre for Clinical Epidemiology & Biostatistics and in the Hunter Medical Research Institute.
Michael has been honing his skills in the application of advanced missing data techniques over the past 12 years while working on late-phase trials, this has become particularly important with the rise of the estimands framework and expectations of more robust sensitivity analysis from regulators and sponsors.
This year we will delve into the fascinating realm where Statistics and Pharmacokinetics intersect, with an exclusive presentation from renowned statistician and pharmacokineticist Glynn Morrish, Owner and Director of Remedy Research.
All members are warmly invited to join us in person for refreshments and networking. For added convenience, the event will also be accessible online. Please RSVP to apbgsteering@gmail.com for address and the online link. We look forward to seeing you there!
Agenda
2pm Tea, coffee and networking
2.30pm Presentation by Glynn Morrish – Pharmacokinetics and Statistics: When two become one (an untold love story?)
4pm Afternoon tea and networking
4.30pm Meeting Close
Abstract for Pharmacokinetics and Statistics: When two become one (an untold love story?)
A key objective throughout the drug development process is to understand exposure of the investigational product, how exposure relates to efficacy and safety, and how exposure may change with different populations and administration regimens. Pharmacokinetics is the study of how the body interacts with administered products and determines exposure. In the analysis of pharmacokinetic data, rigorous and robust statistical methodology must be applied to ensure appropriate outcomes and accurate reporting are achieved. Further to this, the recent and future advancement of the pharmacometrics domain heavily relies on the application of advanced statistical concepts. This presentation will provide an introduction to clinical pharmacokinetics, describe non-compartmental and model-based pharmacokinetic analysis methods, and discuss the statistical methodology and techniques that are applied to various drug development objectives.
Biography of Speaker Glynn Morrish
Glynn Morrish is the Director of Remedy Research, a consultancy organization providing pharmacokinetic and statistical analysis services to the drug/device development industry. Glynn has over 20 years’ experience in clinical research and data analysis, both in industry and academic settings. He has a deep passion for biostatistical and pharmacometric analysis and its application to the drug/device development process; demonstrated by his contribution to the development of over 100 pharmaceutical products, authoring of peer-reviewed publications, conduct of non-for-profit and commercial courses in clinical data modelling and simulation, and the supervision of post-graduate research students.
Australian Pharmaceutical Biostatistics Group 