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, as well as Board appointments with ARCS Australia and the Association of Graduate Regulatory Educators (USA). Orin developed and delivers the Pharmaceutical and Therapeutics Specialisation course within the NSWHealth Commercialisation training program at CICADA Innovations. Orin received The Organisation for Professionals in Regulatory Affairs (TOPRA), UK award for excellence in regulatory education in 2017; became a Senior Fellow of the Higher Education Academy (UK) in 2018 and was elected a Fellow of the Regulatory Affairs Professionals Society (RAPS), USA in 2021. Her research focuses on regulatory science, workforce development and pharmaceutical policy. Orin is also a regulatory consultant and has been the regulatory responsible person for bringing several new medicines to the Australian and New Zealand markets.

Karen Scalzo-Inguanti has been with Novotech for the past 2 years as a Senior Therapeutic Strategy Manager. In this role she works with sponsors to create robust and feasible clinical strategies for their early phase studies in Australia, New Zealand, USA and Europe with focus in gastroenterology and dermatology. Prior to this role she worked at CSL Ltd as a Principal Clinical Scientist and Translational Researcher, where she was the scientific lead for clinical programs targeting inflammation. During her time at CSL she led cross-functional clinical development teams and biomarker strategy teams for Phase 1 and 2 studies. Karen has also spent time in academic research as a Post doc at the Department of Immunology, Monash University studying immune regulation in ovarian cancer and asthma/allergies. She has a Bachelor of Science (Honours) from Monash University and a PhD in Immunology from The University of Melbourne.

I’m a regulatory toxicologist with +35 years’ experience in the preclinical arena. My experience and training base comes from the 20+ years I worked for a UK-based global toxicology CRO. My final position being Toxicology Consultant. I have worked with a wide range of animal species, administration routes and study designs; attended numerous toxicology training courses and meetings; sat on National and International Working groups. My main focus areas are: regulatory preclinical study requirements, study design, animal ethics, toxicology data interpretation and knowledge sharing. To complement my preclinical research skills, from 2008-2018, I held risk assessment/management positions within Australian and New Zealand food, chemical and pharmaceutical regulators. I’ve facilitated many toxicology training sessions and presented posters at various toxicology meetings, including the US Society of Toxicology (SOT). I support ethical testing on animals, but I also have a keen interest in alternatives. In 2023, based on my preclinical experience I was appointed as a HREC member.

15+ years of CMC biologics regulatory experience Comprehensive & in-depth knowledge of regulatory requirements, cGMP, and scientific guidance applicable for biopharmaceuticals and complex biologics (ICH, FDA, EMA, MHRA, PEI, TGA, and WHO) Product categories: recombinant therapeutics (mAbs, ADCs, fusion proteins, enzymes, biosimilars, etc.) and complex biologics (cell & gene therapies, plasmid DNA therapeutic vaccines, mRNA therapies, vaccines, etc.) Education: MS, Applied Genetics

Jerneen Williams is the Director of Operations for Bellberry Limited, an independent not-for-profit organisation providing streamlined scientific and ethical review of Human research projects across Australia. As Director of Operations Jerneen supports the operations team to deliver excellence in scientific and ethical review and review services. She has an undergraduate degree in Genetics (Hons), a Master's degree in Clinical Trials Research, several publications and more than 20 years of clinical trials industry.

Professor Kevin Pfleger MA(Cambridge) PhD(Edinburgh) FBPhS is Director Biomedical and Health Innovation at The University of Western Australia (UWA) and the Western Australian Life Sciences Innovation Hub. He is also Immediate Past President of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, Head of Molecular Endocrinology and Pharmacology at the Harry Perkins Institute of Medical Research, Deputy Director of the Australian Research Council Industrial Transformation Training Centre for Personalised Therapeutics Technologies and Chief Scientific Advisor to Dimerix Limited. Professor Pfleger has developed globally-recognised expertise in molecular pharmacology over the last 20 years. He also has experience in research translation, being a named inventor on a number of patent families and being a spin-out company Chief Scientific Officer for over 6 years. This company, Dimerix, is now listed on the Australian stock exchange and is in Phase 3 clinical trials for chronic kidney disease. Professor Pfleger is also a scientific co-founder of RAGE Biotech and chairs the Advisory Board of VeinTech, in addition to advising and mentoring a number of other start-ups and entrepreneurs. Professor Pfleger supports innovation and entrepreneurship training as Chair of both Perth Biodesign and Biodesign Australia, as well as co-Director of the Australian Clinical Entrepreneur Program.