Stuart Hazell PhD MASM GAICD
Managing Director
Dr Hazell has more than 35 years experience in life science and biotechnology. This includes research, consulting and senior management roles in industry and academia.
Recent activities and experience:
• Case Manager with Commercialisation Austrailia since 2010.• Prior position as COO and CEO of Panbio Ltd responsible for:
- Restructuring of manufacturing operations to achieve greater efficiency
- Development and setting of strategic objectives
- Restoration of company to profitable growth• Due diligence and sale of the company through a Scheme of Arrangement to Inverness Medical Innovations Inc. for $42 million (85% premium over volume weighted average share price for the 90 days trading prior to offer announcement)
• Pepfactants Pty Ltd (University of Queensland spin-out) - contract CEO (10 days per month)
- Development and setting of strategic objectives
- Development of business plan and marketing materials
- Technology marketing to global industry players in oil and gas exploration, industrial fluids and agrochemicals
- Capital raising• Australian Red Cross Blood Service - strategic review of research activities to achieve more effective use of resources
• Pfizer Animal Health - technical review of intellectual property option to facilitate decision making process with respect to exercising the option
• Queensland Dept of Tourism, Regional Development and Industry - Industry wide survey and review of biotechnology sector in Queensland to assist policy development and resource allocation.
• Review of the Office of Health and Medical Research for Queensland Health.
• Point of care medical device market research for large international medical diagnostics company.
------------------------------------------------------------------------------------------------------
Gail Hazell
Administration ManagerGail has almost forty years experience as an office or administrative professional in a variety of fields. Her positions have covered the banking, medical and political sectors, all of which required a level of discretion, attention to detail, and an ability to relate to people. Gail brings all these qualities into play in her role as Administration Manager in this dynamic business.
------------------------------------------------------------------------------------------------------
Myriam Battistutta BAppSc RAC
Senior Consultant Quality and RegulatoryMyriam has over 30 years experience in the area of medical science, including medical laboratory science, research & development, and in various senior management roles in industry. Myriam has been engaged in senior positions in Quality and Regulatory Affairs in the in vitro diagnostic devices industry for the last 10 years. Her most recent role was as Asia Pacific Vice President Quality and Regulatory for a significant multi-national diagnostics company. She brings to Fusidium broad and deep experience in regulatory strategy development for worldwide markets. Myriam's 20 years prior experience in clinical laboratories, in both the public and private sectors, has given her invaluable end user and patient perspectives when addressing issues of Quality Management.
Myriam has broad and deep experience in regulatory strategy development for worldwide markets.
One of Myriam's key accomplishments since joining Fusidium has been to provide Quality Management System compliance advice and services to a multinational company. Her direct involvement led to the lifting of a World Health Organisation (WHO) Notice of Concern and therefore resulted in multi-million dollar markets re-opening for the company.
Whilst working in senior roles within the IVD industry Myriam has contributed to numerous industry committees including the following:
• MTAA Code of Practice Strategic Action Committee (2007 – 2009)
• IVDA Technical & Regulatory Standing Committee (2009)
• TGA/IVD Working Party member (2011)
• AusMedtech Expert Regulatory Panel (by invitation, 2012)
A demonstrated capability in analysing and preparing regulatory packages for the TGA.Myriam's senior regulatory roles within the IVD industry required her to be either directly involved with, and/or manage regulatory affairs professionals preparing regulatory submissions for the TGA for a wide variety of IVDs ranging from Class 2 up to the higher risk Class 4.
In addition to achieving successful regulatory submissions within Australia, Myriam has vast experience in interpreting registration requirements for worldwide markets including the USA, Canada, the EU, various countries within Latin America and Asia. In some cases this has been for products quite novel to the market. For example, in answering a call made by the FDA to manufacturers world-wide for a need for a WNV diagnostic for the US population she contributed to the successful development of, and to the regulatory submission of, the first West Nile Virus IVD to be granted U.S. FDA clearance. This required regular collaborative interaction with the USFDA to ensure a product was cleared in the shortest timeframe possible without compromising the safety and efficacy of the product.
------------------------------------------------------------------------------------------------------
Lorna O'Kane
Research AssistantLorna has worked as a library professional and an office administrator in a number of different industries for more than thirty-five years. Her positions have included working as a Library Technician in a specialized management library, a law library and a researcher for a real estate agency. Good people skills, a fine eye for detail and an enquiring mind were a necessity in all these appointments. Lorna brings these attributes, and more, to her role as Fusidium’s Research Assistant.
------------------------------------------------------------------------------------------------------
Kyle Murphy
Kyle E. Murphy is the Managing Director and Founder of KMG Japan. Kyle has lived in Japan for a significant portion of his adult life. His business has involved working with Japanese and Asian Life Science and healthcare businesses for over 30 years.
Kyle speaks Japanese fluently and built a strong network of contacts in both the healthcare industry and government administration. He has represented over 100 clients and successfully structured numerous alliances between Japanese, Asian and foreign companies. Prior to founding KMG Japan, Kyle served as the First Commercial Secretary in the US Embassy in Tokyo where he managed all trade negotiations and activities related to bringing US companies into the Japanese healthcare market. Kyle began his career in the healthcare industry with business development and marketing positions at Schering-Plough in Osaka, Japan and SmithKline in the US.