President

Katrina Campion
GlaxoSmithKline

My involvement in Clinical Research began more than 20 years ago. Prior to joining the Therapeutics Industry 15 years ago, I worked for 5 years as a Research Assistant/Study co-ordinator in epidemiology and preventive medicine at Monash University. Like many others I did not have a career plan in mind on leaving school. It was luck rather than good planning that allowed me to combine my undergraduate qualifications in Sociology and History (BA) and an accelerated registered nursing qualification! During this period I also completed a Graduate Diploma and Master of Arts Degree during this time and went on to also study in areas of computing and public health. In 1993 I joined Glaxo as a Clinical Research Associate. During my years at GSK, I have worked primarily as Clinical Research Manager across therapy areas and been responsible for trials through all phases. During 1998, I spent time working in our global head office in London as a Medical Communications Scientist and on my return to Australia in 1999 had the privilege of hosting the FDA whilst they audited a key registration trial which I had driven from inception to publication. Over the last few years I have also had the opportunity to be involved in activities in Japan and India which have enabled me to develop a hands on appreciation of the challenges of conducting global registration trials outside of ANZ.

Vice President

James Bryden
Abbott Australasia

James has been a member of the Pharmaceutical industry since 1994, joining as a CRA within a Contract Research Organisation (Pharmaco::LSR). He has since gained experience as CRA, Senior CRA, and Clinical Research Manager with both Pharma company (3M Pharmaceuticals) and a CRO (Trident Clinical Research). Working in both CRO and Pharma company environments, has given James a broad experience in many therapeutic and speciality areas such as pharmaceutical products, biopharmaceuticals, devices, and nutritional studies. James’ particular interest is in project and personnel management.

Director

Adrian Bootes
Roche Products

Adrian holds graduate and post-graduate qualifications in pharmacy, and an MBA. He has extensive experience in the industry in both regulatory affairs and clinical research. He has held a number of positions with ARCS including membership of the Regulatory Education Subcommittee and later Regulatory convenor, was subsequently elected to ARCS Council for four years (1996 – 1999) and held Council positions as Education Convenor for two years during which time the educational programme was substantially broadened, and subsequently established the ARCS' web site whilst Internet Site Convenor. Upon re-election to Council in November 2004 he has worked for the last two years within the Member Services, Internal Audit and Finance subcommittees. Adrian has completed the Essential Directors Course, Modules 1 and 2, run by the AICD, and has been a keen contributor to ensure the continued growth and financial stability of the organisation.

Director

Amanda Jubb
Consultant

Amanda has 15 years experience of clinical research roles within the pharmaceutical industry. With a core foundation as a CRA Amanda has worked predominantly in line management roles coordinating teams and projects locally and across the Asia Pacific region. Amanda has been exposed to various business set-ups and styles including global and local organisations, manufacturing companies and CROs. Amanda has represented her functional area on internal management teams and has benefited from completion of four of the AICD training courses.

Director

Trevor Schoerie
PharmOut

Trevor currently has full responsibility for a small consultancy, including business development, marketing and sales and financial control of the company. This includes corporate compliance, staff selection, motivation and retention. Trevor has 20 years of diverse experience in the pharmaceutical, biotech, medical device & veterinary drugs industries. Experience that includes; research and development, production and regulatory compliance for the manufacture and sale of life science products in international markets. Trevor operated at an executive level in an overseas multinational company, manufacturing Pharmaceuticals. More recently he was the CEO of an Australian / Singaporean boutique life science engineering consultancy offering turn-key solutions to the life science industry. Trevor believes strongly in sensible compliance that delivers business results, not just audit success. Trevor has excellent local and international industry networks and currently serves on the ISPE board of directors and is a director of three companies. Trevor can bring this experience to bear on ARCS activities. His contribution to ARCS will be good corporate governance, risk exposure reduction and promotion of ARCS on a national level.

Director

Ailsa Surman
Eli Lilly Australia

Ailsa holds degrees in biochemistry and pharmacology from the University of Auckland. She worked as an evaluator at Medsafe’s predecessor in the New Zealand Ministry of Health and for PHARMAC, before joining the pharmaceutical industry in New Zealand. She subsequently held global regulatory affairs and pharmacovigilance roles for 6 years in GSK’s UK headquarters. Since returning from the UK in 2005 Ailsa has been in the regulatory affairs team at Eli Lilly Australia, with responsibility for all aspects of regulatory support for a portfolio of products in both Australia and New Zealand. During this time Ailsa spent 18 months leading the regulatory team, managing personnel from the regulatory affairs, pharmacovigilance and product quality areas. Ailsa has been involved in the ARCS Regulatory Education Subcommittee since arriving in Australia, and has been co-convenor of the ESC for the past three years. During that time, working with a team of other enthusiastic volunteers, the ESC has delivered a wide range of educational events for regulatory professionals, including increasing numbers of opportunities for interaction with officials from the TGA and other regulatory bodies. Ailsa looks forward to bringing her understanding of the needs of ARCS’s regulatory members to the Board in order to work with other Directors to develop strategy that reflects the needs of all ARCS members.

Director

Teresa Schafer
Piper Alderman

Dr Teresa Schafer is a partner in Piper Alderman's Corporate Group. She is both a lawyer and scientist, and has extensive experience in the regulation of therapeutic goods in Australia and New Zealand. She provides broad advice to clients in the pharmaceutical and medical device industry on regulatory and reimbursement issues; generic defence strategy; patent protection and infringement; clinical research issues; promotion and advertising; and product safety and recalls. In addition to her role at Piper Alderman, Teresa is a part-time member of the Administrative Appeals Tribunal, and hears matters in the General and Veterans Appeals Divisions, which includes reviewing decisions of the TGA.

Director

Sarahann Simpson
Pfizer Australia

Sarahann Simpson is Country Safety Lead for Pfizer Australia. Sarahann has a Bachelor of Pharmacy degree from the University of Sydney and a Master of Science (Hons)(Ecotox.) from the University of Technology, Sydney. Sarahann joined the pharmaceutical industry originally in a medical Information role with Reckitt & Colman and from there she went on to work in regulatory affairs. In 1997, Sarahann began working in pharmacovigilance with 3M Pharmaceuticals before moving on to Merck Sharp and Dohme. Since 2004 Sarahann has worked in Drug Safety for Pfizer where her team handles spontaneous adverse event reports as well as serious adverse events from clinical trials and safety reporting to investigators. Sarahann has been a member of ARCS since 1984. She has been an active member of the ARCS Pharmacovigilance Education Subcommittee since its inception as well as serving for three years as Convenor. Sarahann is also a member of the Medicines Australia Pharmacovigilance Expert Advisory Group.