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LUNCH WORKSHOP: New Approach Methodologies (NAMs) in Drug Development

Tracks
Track 2
Thursday, December 11, 2025
1:00 PM - 2:00 PM

Details

Where NAM evidence meets current regulatory requirements and how it informs first in human decisions. Includes a short readout from ASCEP/Bellberry NAM Meeting #2 and one case example, with time for questions.


Speaker

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Ms Kylie Sproston
CEO
Bellberry

Presenter

Biography

Ms Kylie Sproston is the CEO of Bellberry, a not-for-profit organisation with the dual aims of protecting the welfare of human research participants, and improving the quality, efficiency and effectiveness of research. Bellberry provides scientific and ethical reviews for more than 40% of the TGA-registered clinical trials in Australia. Bellberry’s achievements were recognised recently, winning the Telstra Best of Business Award for Championing Health. A Chartered Engineer, Ms Sproston has expertise across the full pharmaceutical product lifecycle, and has held key positions in both technical and management disciplines in the global Pharmaceutical and Biotech industries from research to global manufacturing and supply. Ms Sproston has recently completed three terms as a ministerial appointment on the Cooperative Research Centres Advisory Committee, two of which as chair, with oversight of the $1.5 billion Commonwealth Government programme. She is a Fellow and Director of the Academy of Technological Sciences and Engineering.
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Prof Carl Kirkpatrick
Director, Centre for Medicine Use and Safety
Monash University

Presenter

Biography

Carl is Professor of Pharmacy Practice, Medicine Use and Safety. He has a significant portfolio of research in optimising pharmacotherapy via pharmacokinetic/pharmacodynamic modelling techniques to improve patient outcomes. His research interests include population pharmacokinetic and pharmacodynamic modelling, monitoring and bayesian optimisation of dosing of antibacterial agents (especially aminoglycosides), optimisation of dosing in renal dysfunction, pharmacokinetics and dosing in obesity, drugs in breast milk and quality use of medicines.
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Prof Andrew McLachlan AM
Head of School and Dean
University of Sydney

Presenter

Biography

Professor Andrew McLachlan is the Head of School and Dean of Pharmacy in the Sydney Pharmacy School and a Member of the Order of Australia. He is the former Program Director of the NHMRC Centre for Research Excellence in Medicines and Ageing and previously Professor of Pharmacy (Aged Care) (2006-2018) in the then Faculty of Pharmacy and at Concord Hospital’s Centre for Education and Research on Ageing. He is a pharmacist, academic and researcher experienced in clinical pharmacology and research on the quality use of medicines. His research focuses on understanding the variability in response to medicines and how this can be managed to optimise patient care, particularly in special patient populations such as older people, the very young and the critically ill. He is interested in translating clinical pharmacology research and high quality clinical trial evidence into real-world practice.
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Leanne Weekes
Director of Research & Policy
Bellberry Limited

Presenter

Biography

Leanne Weekes is the Director of Research and Policy at Bellberry Limited. Her work focuses on advancing ethics, policy, and sector-wide initiatives, including thought leadership, aimed at strengthening Australia’s clinical trials sector. Prior to joining Bellberry, Leanne established and led Clinical Trials: Impact & Quality (CT:IQ), an MTPConnect-funded initiative that brought together the clinical trials sector to develop and implement recommendations to improve impact, quality, and efficiency. She has over 12 years of experience in biopharma research and development, managing clinical trials and programs for pharmaceutical companies and CRO's across Australia, New Zealand, the UK, and Europe. Earlier in her career, Leanne worked in pre-clinical drug and diagnostic development for Australian and US biotechnology start-ups, having begun her career in bench research.
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