Innovation Theatre: New Approach Methodologies in First-in-Human Trials: Launch of Practical Guidance for Ethics Review and Decision-Making
| Tuesday, July 14, 2026 |
| 1:15 PM - 2:25 PM |
|
Sponsored By:
ASCEPT
Bellberry Limited
|
Details
New Approach Methodologies (NAMs) are increasingly being explored as part of the evidence package supporting first-in-human (FIH) clinical trials. These approaches, which may include human-relevant in vitro models, computational methods, organoids and other emerging tools, have the potential to strengthen how risk, mechanism and translational relevance are assessed. At the same time, their growing use raises practical questions for sponsors, regulators and Human Research Ethics Committees (HRECs): how should NAM data be presented, interpreted and weighed alongside traditional evidence sources?
This session will launch new practical guidance developed through the Bellberry/ASCEPT NAM thought leadership program to support the ethical review of NAM-informed FIH trials. The guidance has been informed by cross-sector consultation and a structured Delphi process involving experts from industry, academia, ethics review and regulatory settings.
Opening presentations will provide context on the global rise of NAMs, the rationale for the guidance, and the methodology used to develop it. A multidisciplinary panel will then discuss how NAMs are currently being used, where they may add most value, and what is needed to support credible and consistent adoption in trial decision-making.
Panellists will bring perspectives spanning research, regulation, ethics review, patient interests and industry implementation. Discussion will address practical issues including evidence quality, context of use, transparency, proportionality, and how Australia can position itself as a constructive and globally connected jurisdiction in this evolving field.
The session will be relevant to clinical pharmacologists, toxicologists, trial sponsors, regulators, HREC members and researchers seeking to understand how NAMs can responsibly support safer and better informed early-phase clinical development.
Speaker
Ms Kylie Sproston
CEO
Bellberry Limited
Session Chair
Biography
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's main area of technical specialisation is in the advanced manufacturing of sterile pharmaceutical and biological products and associated global supply chains.
Ms Sproston previously led and managed the Australasian operations of the global group BTG PLC (a specialist healthcare company based in London, UK), as General Manager and Company Director. Prior to that, she undertook a number of technical and management roles within AstraZeneca.
Ms Sproston is Chair of the Cooperative Research Centres Advisory Committee, with oversight of the Commonwealth Government $1.5Bn programme.
Ms Sproston received a MEng (Hons) in Mechanical Engineering from Loughborough University (UK) and an MSc in Pharmaceutical Engineering Advanced Training from University of Manchester (UK). She is a Graduate of the Australian Institute of Company Directors (AICD) Company Directors Course and a Fellow of the Australian Academy of Technology and Engineering (ATSE). Ms Sproston was awarded the 2021 ARCS Innovation Award.
Prof Carl Kirkpatrick
Monash University
Panellist
Biography
Carl Kirkpatrick is a Professor within the Monash Institute of Pharmaceutical Sciences, Monash University, where he is the Director of the Monash Moderna Quantitative Pharmacology Accelerator (MMQPA), a 5 year industry collaboration using systems pharmacology approaches to optimise mRNA therapeutics. Carl received his Doctor of Philosophy (Medicine) from the University of Otago (NZ). Since completing his PhD, he has worked extensively in the area of quantitative pharmacology and systems modelling as it applies to drug development and in the optimisation of existing pharmacotherapeutics. He is currently the Board Secretary and Board member of the Australasian Society Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), and Board Member of the Australian Medicines Handbook (AMH). Carl has a strong interest in the advancement of the pharmacy profession, including how to educate pharmacists optimally to undertake new roles within healthcare and pharmaceutical industry.
Dr Dan Tagle
Independent Expert on NAMsFormer Director, Office of Special Initiatives; Senior Scientific Advisor for Regulatory Scien
Panellist
Biography
Danilo Tagle is currently Senior Scientific Advisor on Regulatory and Translational Research at the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). He recently retired as Director, Office of Special Initiatives where he led efforts in developing innovative tools and technologies that can greatly accelerate development of diagnostics and therapeutics. These programs involve interdisciplinary collaborations between intramural and extramural components of NIH, and entail partnerships with other agencies, such as FDA, NASA, and DARPA, as well as with private sector. Some of the programs include tissue chips, 3D bioprinting, automated chemistry, electronic nose technology for disease diagnosis, quantum technologies, and the isolation and analyses of exosomes for biomarker and therapy development. He has served on numerous advisory and review committees, including the Biological and Physical Sciences Federal Advisory Committee, the White House OSTP Microgravity Science and Technology Interagency Working Group, and more recently on the LabCorp NAM Scientific Advisory Board. Dan obtained his PhD and MS in molecular biology and genetics from Wayne State University School of Medicine. He was an NIH National Research Service Award postdoctoral fellow in human genetics at the University of Michigan. Dan has authored many scientific publications and has garnered numerous awards, including several NIH Director’s Award, and more recently the Roscoe O. Brady Award for Innovation and Accomplishment; the Henry J. Heimlich Award for Innovative Medicine; the Department of Health and Human Services Secretary's Award for Distinguished Service: Rapid Acceleration of Diagnostics (RADx) Initiative, and the NASA Silver Group Achievement Award.
Prof Andrew McLachlan
University of Sydney
Panellist
Biography
Professor McLachlan is a pharmacist, academic and researcher with experience in clinical pharmacology and the quality use of medicines. He is Head of School and Dean at the Sydney Pharmacy School, The University of Sydney. Andrew is actively involved in clinical trials focused on generating evidence to better inform optimal pain management in musculoskeletal conditions. Andrew serves on committees related to human research ethics, medicines safety, medicines evaluation and international antidoping. He currently serves as chair of Bellberry HREC K.
Ms Ann Single
CEO, Patient Voice Initiative, President, HTAi
Patient Voice Initiative
Panellist
Biography
Ann is the CEO of a patient-led not for profit working to ensure patients are seen, heard and valued in healthcare decision-making, especially in health technology assessment (HTA). She’s worked in patient involvement in HTA for 25 years, first directing it within Scotland’s HTA agency and then sharing and developing good practice in HTAi’s Patient and Citizen Involvement Interest Group. From 2019-2023, she chaired this group of more than 300 multi-stakeholder members in 43 countries and is now its Outgoing Chair and HTAi’s first President from the patient community sector. She is a co-editor the book Patient Involvement in Health Technology Assessment (2017; 2nd edition in press), a faculty member of the International Patient Advocacy Management Masters Course at Rome’s Catholic University (Università Cattolica del Sacro Cuore) and a member of Rare Voices Australia’s Scientific and Medical Advisory Committee. She served as a Reference Committee member on the Australian Government’s HTA Policy and Methods Review (2022-2024).
Assoc Prof Orin Chisholm
Program Director, Pmdd Programs
University Of Sydney
Panellist
Biography
Orin is the program director for the postgraduate programs in Pharmaceutical and Medical Device Development at the University of Sydney. She has academic appointments with UNSW and Arizona State University, USA. Orin has a PhD in molecular oncology. She has many years of experience in the pharmaceutical industry and is a regulatory affairs consultant. Orin is a Senior Fellow of the Higher Education Academy (UK), was elected a Fellow of the Regulatory Affairs Professionals Society in 2021 and a Fellow, Medtech and Pharmaceutical Professionals (ARCS Australia) in 2025. Her research focuses on regulatory science, horizon scanning, workforce development and pharmaceutical policy.
Prof Andrew Wilson AO
University of Sydney
Panellist
Biography
Andrew is co-Director of the Leeder Centre for Health Policy, Economics and Data, University of Sydney. His research interests concern how research evidence can better inform decision making in clinical medicine, public health, and health service policy and planning especially in chronic disease prevention and management. He is the chair of the Board of the NSW Health Clinical Excellence Commission, a member of the Board of Bellberry and was chair of the PBAC from 2015-2024. He is chair of the Implementation Advisory Group for the response to the HTA policy and processes review.
Prof Michael Ward
Head of Pharmacy, Bellberry HREC Chair
University of South Australia
Panellist
Biography
Michael Ward is Head of Pharmacy, School of Pharmacy and Biomedical Science, Adelaide University and Chair of Bellberry Human Research Ethics Committees A and K. Michael continues to practice as a hospital pharmacist and has served on a number of TGA Advisory Committees including the Advisory Committee on the Safety of Medicines and the Advisory Committee on the Scheduling of Medicines.
Dr Michael Phelan
Principal Consultant
InnovApproach Consulting
Panellist
Biography
Michael Phelan, PhD, is the founder of InnovApproach Consulting, supporting clients in the development, qualification, and use of NAMs. He was the project lead for the first technology accepted into the US FDA’s ISTAND program (Integral Molecular’s Membrane Proteome Array) and contributed to shaping the program’s development. Dr. Phelan has extensive industry experience in regulatory affairs, quality assurance, and manufacturing. He earned his PhD in bioengineering as an intramural fellow at the US NIH, focusing on devices and materials for organoid culture.
