The strength of the Australian bio-economy

Lorraine Chiroiu | CEO | AusBiotech

Lorraine leads AusBiotech as its Chief Executive Officer and Managing Director and has worked as a dedicated advocate for the biotechnology sector since joining AusBiotech over a decade ago. In her role she works closely with public policy impacting the life sciences sector at state and Federal levels, including economic development, tax incentives, patent protection, medical research and its commercialisation. Lorraine works with the broad biotechnology community including AusBiotech’s 3,000+ members to inform and support industry development.

Opportunities in Australia’s healthcare sector

Benson Saulo | Consul-General to the US, based in Houston | Austrade

Benson brings insight, passion and experience that he has developed throughout his working life from across corporate, not-for-profit and government sectors.

Benson is a descendant of the Wemba Wemba and Gunditjmara Aboriginal nations of Western Victoria, and New Ireland Province in Papua New Guinea.  He was formally the Head of Partnerships - Investments at Australian Unity a Wealth and Capital Markets business. Benson’s focus was exploring private investing into Indigenous businesses to scale their impact through employment, financial empowerment and governance.

how the new south wales government is supporting clinical trials and advanced therapeutics

Anne O’Neill | Director Enterprise and International Partnerships | NSW Office for Health and Medical Research | Ministry of Health

Anne is a health and medical research professional with over 20 years’ experience in the health, medical research and policy sectors. She is responsible for leading the development and implementation of major policies and programs to enhance medical research capacity in NSW. She has particular responsibility for commercialisation initiatives including the NSW Medical Device Fund and NSW Health Commercialisation Training Program – both have been critical to accelerating the development of NSW intellectual property and the next generation of innovators and entrepreneurs in NSW. Anne is also responsible for developing international partnerships in medical research and commercialisation. Anne holds a Bachelor of Science (Physiology and Pharmacology) (Hons) and the Australia and New Zealand School of Government Executive Masters of Public Administration.

Australia as a destination for Clinical Trials – capabilities and infrastructure

Dr Megan Robertson | Group Chief Research Officer | St Vincents Health Australia and Chair, AusBiotech Clinical Trials Advisory Group

Dr Megan Robertson is the Chair of AusBiotech’s Clinical Trials Advisory Group; and is an alumna of the University of Melbourne where she completed a Bachelor of Medicine, Bachelor of Surgery (MBBS). She is the current Group Chief Research Officer at St Vincent’s Health Australia and Director of Research at St Vincent’s Hospital, Melbourne. She also works as a Senior Intensive Care Consultant at Epworth HealthCare (Richmond and Freemasons). She is on the boards of the Digital Health CRC, Opyl AI, St Vincent’s Institute of Medical Research, FearLess (PTSD-ANZ), and Queen’s College (Univ of Melbourne), and the Tuckwell Scholarship Selection Panel at ANU. She also works with national bodies including the Australian Commission on Safety and Quality in Healthcare, AusBiotech, and the National Health and Medical Research Council. Previously, she held positions as the Director of Professional Affairs, CICM, as the Executive Director of Research at Epworth HealthCare, and as the Co-Director of the Intensive Care Unit at Epworth Freemasons.

Conducting clinical trials in Australia – ethics, approvals and lead times

Kylie Sproston | CEO | Bellberry Limited

Kylie Sproston is 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 streamlined scientific and ethical review of Human Research projects across Australia. About one third of all TGA-registered clinical trials in Australia go through Bellberry Committees. 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. 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.

Why Australia should be a priority market for medical innovation

Luis Jimenez | VP of Business Development U.S. | PharmaLex Pty Ltd

Luis Jimenez serves as the Vice President of Business Development for PharmaLex, a global regulatory and quality consulting firm specializing in integrated strategic solutions for innovative technologies. PharmaLex Australia provides support from early-stage regulatory pathway analysis, to program management to registration submissions to the small and large medtech industry with FDA, TGA, EU and all major markets. Luis experience includes operations, quality control in cGMP manufacturing, regulatory affairs for manufacturing, design engineering, technology transfer and project management within a start-up and large corporations such as Johnson & Johnson and Express Scripts.

FAST-TRACK YOUR PHASE 1 CLINICAL TRIAL –UNDERSTANDING THE REGULATORY DIFFERENCES BETWEEN AUSTRALIA AND THE USA

Dr Graham Wood | Executive Vice President, USA | Nucleus Network

Dr. Graham Wood is a leader in the conduct and design of clinical pharmacology studies having held senior executive roles in a number of the top clinical research sites in the world. With over 22 years of experience, he has been involved with more than 200 first-in-human studies as well as over 2,000 studies across all areas of clinical pharmacology.

Dr. Graham Wood will speak about the regulatory path and associated costs for conducting first in human studies in Australia and the USA, and how you can benefit from Australia’s regulatory process and requirements to start your first-in-human trial in only 4-6 weeks.

Australia’s early phase sites: where the rubber hits the road

Jane Kelly | CEO | CMAX

With a background in nursing and business, Jane was one of the inaugural staff members at CMAX when it was established over two decades ago and has a long history of leadership within the early phase clinical trials sector. Jane is the CEO and a Director of CMAX, and has worked in many positions at CMAX over the years, including business development and project management, Jane has headed up the CMAX business since 2006 and has led the organisation through many transition periods, including the modernisation and expansion of the business to be one of Asia Pacific’s ‘go-to’ early phase units.

Strength of Australia’s IP framework for clinical trials

Dr Michael Christie | Principal | Spruson & Ferguson

Michael is a leading Australian patent attorney recognized for his legal acumen and his technical expertise in biotechnology, and is a member of Spruson & Ferguson’s life sciences team. Michael’s patent expertise spans all aspects of patent practice, from drafting and prosecution through to enforcement and portfolio management. Michael has also acted in several high-profile patent opposition and litigation matters concerning pharmaceuticals and genetic technologies. He is an expert in obtaining patent term extensions for patents covering pharmaceuticals. Michael represents Australia on the International Association for the Protection of Intellectual Property (AIPPI) Standing Committee for Pharma and Biotechnology.

Case study for international companies conducting clinical trials in Australia (lab services)

Catherine Osborne | CEO | Crux Biolabs

Catherine Osborne PhD GAICD is the CEO of Crux Biolabs, a specialist, accredited immunology service lab for clinical and pre-clinical studies. Since taking the helm of Crux Biolabs at the start of 2017, Catherine has led the contract research organization to NATA accreditation for clinical trial lab services, and expanded Crux’s range of contract research services as well as the size of the scientific team. After completing her PhD at the University of Melbourne, she had academic positions at CSIRO, University of California, Berkeley, and Monash University. Her previous commercial roles include Thermo Fisher Scientific and Jomar Life Research.

Australia’s advantages of utilising local labs to expedite data review and your Phase 1 clinical trial

Angela Luttick | Executive Vice President, Commercial | 360biolabs

Angela Luttick is a co-founder and EVP, Commercial at 360biolabs and leads growth and commercialisation strategies for the company. She is a virologist with more than 20 years’ experience in the discovery, development and commercialisation of novel drugs. Well accustomed to leading multidisciplinary teams and experienced in the generation and integrity of key discovery-stage biological data required for the preparation of IND packages used in filing numerous FDA submissions.

What you need to run your clinical trials in Australia

Dr Tina Soulis | Founder and Director | Alithia Life Sciences

Dr Tina Soulis has launched her own clinical consultancy company, Alithia Life Sciences, where her motivation and mission is to work with her clients to deliver efficient accomplishment of their project, add value to their programs and to ultimately enable improvement of human health and wellbeing. Tina has over 27 years of working in the healthcare (pharmaceuticals and devices), biotechnology, academic research, clinical research and management sectors in senior roles including: CEO of a Contract Research Organization, Director of a successful ASX200 company, VP of Clinical Strategy and Development with an innovative biotechnology company.