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LUNCH WORKSHOP: Bellberry–ASCEPT Partnership on New Approach Methodologies (NAMs)

Tracks
Track 2
Thursday, December 11, 2025
1:00 PM - 2:00 PM
Hall E2
Sponsored By:
ASCEPT
Bellberry Limited

Overview

Delivered by: ASCEPT & Bellberry


Details

In 2024, Bellberry and ASCEPT joined forces with the intention to develop guidance on regulatory expectations for New Approach Methodologies (NAMs), ensuring our sector is prepared for their growing role in preclinical safety and efficacy assessment. This workshop will update members on the evolving global landscape for NAMs in drug discovery, preclinical testing, first-in-human trials, and regulatory approval (including HREC and TGA). It will also outline how the Bellberry–ASCEPT partnership is working to ensure the safe and effective adoption of NAMs in Australia. We will share key outcomes from the second workshop in the series, “Practical Application of NAMs to Support First-In-Human Clinical Trials: Strategies, Challenges, and Regulatory Perspectives”, which brought together stakeholders across research, industry, and regulatory domains. Panellists will discuss how NAMs have and could be used to support HREC approvals for first-in-human studies, followed by an interactive Q&A session.


Speaker

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Prof Dominic Geraghty
Professor Emeritus
University of Tasmania

Chair

Biography

Emeritus Professor Dom Geraghty was the University of Tasmania’s inaugural Pro Vice-Chancellor -Launceston (2019-2024). Previously, he was a teaching and research academic for 30+ years. He has published ~100 papers, mostly focussing on vanilloid (capsaicin) receptor pharmacology in animals and humans using a combination of tissue-, whole animal- and cell-based techniques. Dom held a number of senior academic roles, including Acting/Head of the Schools of Human Life Sciences (2012), Health Sciences (2016) and Creative Arts and Media (2018-19 😊), Dean/Deputy Dean of Graduate Research (2014-19) and Chair/Deputy Chair of the Academic Senate (2017-18). Dom has been a member of ASCEPT for 40 years and is a past Director (2011-20), President and Chair of the Board (2016-17).
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Ms Kylie Sproston
CEO
Bellberry Limited

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
The 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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A/Prof Michael Ward
University of South Australia

Presenter

Biography

Associate Professor Ward is Dean of Programs: Pharmacy and Medical Science. Michael's overarching philosophy is one of a connection between the foundational sciences and clinical practice. The expression of this is evident in all areas of his contribution to teaching, research, knowledge application and commitment to maintained clinical practice. His research interests are broadly focussed upon the determinants of drug response including pharmacogenetics, drug metabolism and drug interactions. Michael's background highlights the elements that underpin his philosophical approach to teaching and learning and to research. Namely, to engage with the emerging medicines and therapeutic modalities through research-acquired expertise; to remain contemporary in a complex and dynamic area of professional practice; and to accept responsibility for challenging teaching endeavours which he believes are critical for safe and effective professional practice. These three elements allow him to model explicitly the interactions between research, science-based evidence and contemporary professional practice in my teaching.
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A/Prof Nicola Smith
Head of Department of Pharmacology
UNSW Sydney

Presenter

Biography

Associate Professor Nicola J Smith is an expert in molecular pharmacology with a track record in exploring GPCR structure-function relationships in the context of cardiovascular disease and metabolic disorders, and more recently lung cancer. She is the Head of the Department of Pharmacology at UNSW Sydney, Australia, where her team works on a class of G protein-coupled receptors called ‘orphan GPCRs’. Recently, her career focus has been interrogating receptor deorphanisation claims and calling for more stringent standards of evidence. Smith is the current President-elect of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT).
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