MedTech Forum: Clinical Trials Speaker Biographies

 

 

Falko Thiele 

Falko Thiele is a 20-year veteran of the medical device industry with experience in research and development, marketing, business development, regulatory affairs and clinical trials. He is the Director for Clinical and Regulatory Affairs at BIOTRONIK Australia, a German company that develops, manufactures and distributes implantable pacemakers, defibrillators, stents and cardiac catheters.

Under Falko’s leadership BIOTRONIK has successfully conducted a number of clinical trials in Australia and New Zealand ranging from small first-in-man trials involving only local sites to international multicentre landmark studies – and everything in between.

Falko is the chair of the Clinical Investigations Interest Group at the Medical Technology Association of Australia and takes an active interest in promoting Australia as a location for medical device trials.

In his spare time, Falko enjoys sailing and competes in triathlons.

 

 

Anne O'Neill

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, and position NSW as the leading location for research and development. Anne has particular responsibility for the development of commercialisation and philanthropy strategies for NSW.

Anne has a deep understanding of the sector, extensive networks and has particular strengths in engaging stakeholders and facilitating collaboration. She is passionate about the role of government in building the innovation workforce of the future and developing non-traditional career opportunities for early to mid-career researchers.

Anne holds a Bachelor of Science (Physiology and Pharmacology) and an Executive Masters of Public Administration.

 

Dr. Gordon McGurk

Dr McGurk is Director of NHMRC’s Clinical Trials Section. Along with his talented team, he has been working to improve the clinical trials environment in Australia. Some of the team’s achievements include the launch of the Human Research ethics application; launch of national scientific committees for complex genetic research and clinical trials involving medical devices, development of a streamlined process for research governance of clinical trials and the release of revised guidance for safety monitoring and reporting of clinical trials. He is currently Chair of Australian Standards Committee CH-026, which has just revised AS/NZS 2243.3 Safety in Laboratories (2010), is a Director of the Association of Biosafety for Australia and New Zealand (ABSANZ), and is also a graduate of the Australian Institute of Company Directors.

 

Prof. Gregg Jorgen Suaning

Gregg J. Suaning is Professor of Biomedical Engineering with the Graduate School of Biomedical Engineering at the University of New South Wales, and will soon become a Professor of Biomedical Engineering with the University of Sydney.

He has over a quarter century of experience in implantable neuroprosthesis in both industry and academia. He received his Bachelor and Master of Science degrees from the California State University in 1986 and 1988 respectively. His Ph.D. in visual prosthesis from the University of New South Wales (UNSW), Sydney, Australia was awarded in 2003.

Suaning is a prolific inventor with several patents in the medical device field – primarily in sensory bionics. He has authored over 150 book chapters, journal manuscripts and full-paper, refereed conference proceedings, and has raised more than $56M in competitive research funding during his academic career. He holds an Honorary Professorship with the Sydney Medical School at the University of Sydney and has been a Visiting Scientist at the University of Freiburg, Germany and Aalborg University, Denmark.

He is a recipient of the Bartimaeus Award from the Detroit Institute of Ophthalmology in recognition for his service to the blind community and in recognition of his collegiality in the advancement of the field of visual neuroprosthesis. Suaning is also a Senior Member of Institute of Electrical and Electronics Engineers (IEEE) and an Associate Editor of the Proceedings of the IEEE’s Engineering in Medicine and Biology Society (EMBS). He serves on the organising committees of the world’s largest biomedical engineering conferences to be held in 2017 and 2018. He was instrumental in securing this same conference for Sydney in 2023.

Suaning’s research includes robust collaborative research with industry to bring about the next generation of cochlear neuroprostheses for the deaf, and in leading-edge research to bring about neuroprosthetic therapies to restore vision to the blind.

 

Prof. Ian Kerridge

Ian Kerridge is the Director of PRAXIS Australia, Professor of Bioethics and Medicine at the Centre for Values, Ethics and the Law in Medicine (VELiM) at the University of Sydney and Staff Haematologist/Blood and Marrow Transplant (BMT) physician at Royal North Shore Hospital, Sydney. Ian is a founding Director of PRAXIS Australia.

He is an active clinical researcher, with a particular interest in the long-term effects of BMT and the treatment of multiple myeloma. He has taught bioethics and research ethics around the world for over 20 years and continues to conduct philosophical and empirical research in a range of important clinical, public policy and global health concerns including prescription drug policy, overdiagnosis, conflict of interest, end-of-life care, infectious diseases and infection control and organ donation and transplantation.

 

 

Hugo de Jong

Hugo is the group leader of PwC's recently formed Emerging Company team, having previously specialised in helping R&D entities obtain alternate sources of capital to fund their early stage activities. PwC's Emerging Company team specialise in identifying and engaging with earlier stage companies who have the ability to scale quickly, on a global scale. The team achieves this through a range of different services, including sourcing equity, raising alternate sources of debt, strategic advice on a retainer basis as well as being PwC's Australian conduit to the Global Accelerator programme. The Emerging Company team's main clients are technology companies who need to utilise PwC's networks and ecosystem to grow. 

 

Prof. Tony Weiss

Professor Weiss is a rare blend of successful Australian academic researcher, innovator and company founder. He is the McCaughey Chair in Biochemistry, Leader of the Charles Perkins Centre Tissue Engineering and Regenerative Medicine Node, and Professor of Biochemistry & Molecular Biotechnology at the University of Sydney. He is on nine Editorial Boards, and Fellow of seven Australian and international societies, including Fellow of the Royal Society of Chemistry and Fellow of the Australian Academy of Technological Sciences & Engineering. His discoveries on human tropoelastin and synthetic elastin have received many national and international awards. He is Scientific Founder of Elastagen Pty Ltd, a clinical stage medical company with an advanced pipeline of products based on the human protein tropoelastin as a pioneering medical biomaterial. Elastagen has successfully attracted capital from leading Australian and overseas life science venture capital groups. Elastagen’s operations have expanded from its Australian base to include production in Europe and clinical operations in the UK.

 

 

Sue MacLeman

Sue has more than 25 years experience as a pharmaceutical, biotechnology and medical technology executive with roles in corporate, medical, commercial and business development at Schering-Plough Corporation (now Merck), Amgen, Bristol-Myers Squibb and Mesoblast Ltd. She has also served as CEO and Board member of several ASX and NASDAQ listed companies in the sector and is currently a non-executive director at Reproductive Health Sciences Ltd and Oventus Medical Ltd.

 

 

 

Simon Windsor

Simon is from Bellberry Limited which is a national, private not-for-profit Australian company. Bellberry aims to support research and ethics in Australia and currently manages eight Human Research Ethics Committees (or HRECs). Bellberry HRECs are designed to provide independent ethics review, and where appropriate, approve and monitor human research projects, clinical trials and medical studies. Simon Windsor is a Medical Scientist and has previously worked as a Clinical Trial Coordinator based in the UK and Australia with sites in Singapore and New Zealand.

 

 

Ben Wright

Ben has a unique employment history that spans medical research, private industry, public companies and the defence industry. Currently the Chief Innovation Officer and Head of Investment Strategy at world leading deep technology incubator Cicada Innovations, his mandate is to grow technology startups into global businesses.  In 2016 the Cicada Innovations portfolio raised $81M and exited its 10th startup.  Ben is the Director of the NSW Health Medical Device Commercialisation Training Program (MDCTP).  MDCTP is open to clinicians, final year PhDs and post-docs who are commercialising medical technologies.  Graduates of the program have raised $15M over the past 2 years.  Ben is the architect and co-founder the GRIFFIN startup accelerator and delivers commercialisation mentoring and training internationally through programs in Singapore and UAE.  

 

Prof. Robyn Guymer

Robyn Guymer is a Professor of Ophthalmology at University of Melbourne and deputy director of the Centre for Eye Research Australia. She is also a senior retinal specialist at the Royal Victorian Eye and Ear Hospital. She is a clinician scientist who leads a team of 20 researchers primarily investigating Age-related Macular Degeneration (AMD). She has investigated genetic and environmental risk factors for AMD, predictors of response to treatments for late AMD, as well as being a principal investigator in many industry sponsored trials.

Professor Guymer is on several advisory boards, is the clinical program leader and on the scientific leadership team of Bionic Vision Australia and is part of the Mactel consortium and Beckman AMD initiative in the USA. She is currently investigating new strategies for treating early stage disease with a nanosecond laser and is working to identify novel imaging and functional biomarkers and surrogate endpoints to allow efficacy of interventions to be determined. She is a member of the Macular Society and a founding fellow of the Australian Academy of Health and Medical Sciences.

Professor Guymer was awarded the NHMRC’s 2016 Elizabeth Blackburn Fellowship for the top ranked female research fellowship in clinical medicine (Principal Research Fellowship).

 

 

Dr. John Gillespie

Dr Gillespie received his PhD from the University of Dundee, Scotland and continued his research on protein phosphorylation and metabolic control at the University of Edmonton, Canada. After moving to Sydney, he changed careers - moving into the field of healthcare economics. Dr Gillespie spent several years in consultancy where his main responsibility was conducting health technology assessments of new medical technologies and procedures for the Australian Department of Health and Ageing. At Medtronic he is responsible for health economics and reimbursement projects for neurovascular products. He is particularly interested in evidence requirements for funding decisions and is a regular contributor to industry commentary on Government policy regarding assessment of new technologies.