01 December 2006
Key Points:
Dr Teresa Baker has extensive experience in pharmaceutical regulatory and medical affairs in Australia and New Zealand, both at senior management level and in a consultancy capacity. She recently completed a law degree and joined the product liability group in June 2006 to provide in-house scientific expertise to the pharmaceutical and medical devices practice.
Teresa is a scientist by training and obtained a Bachelor of Science degree with first class honours in chemistry in 1988. She then conducted post-graduate research in synthetic organic chemistry at the University of Western Australia and Oxford University and was awarded a PhD in 1993. Teresa entered the pharmaceutical industry in 1993 and has acquired valuable experience during her 13 years in the industry. Her roles in the pharmaceutical industry also included serving on the peak industry body's Regulatory and Scientific Committee, the Code of Conduct Committee, the Code of Conduct Appeals Committee and the Monitoring Committee.
In the management roles Teresa held in the pharmaceutical industry, her responsibilities covered oversight of regulatory affairs, clinical research, health outcomes, medical information and pharmacovigilance activities. As a result, she has a very broad understanding of how pharmaceutical businesses operate. She also completed formal qualifications in pharmacoeconomics, with distinction, from Monash University in 2001, which she has been able to apply in pharmaceutical pricing strategies and submissions to the Pharmaceutical Benefits Advisory Committee.
In 2001 Teresa founded Pharmedica Consulting Pty Ltd, a company providing consultancy services to the pharmaceutical industry in regulatory affairs, clinical research, medical information, pharmacovigilance and health outcomes. She has provided advice to many of the major pharmaceutical companies in Australia across most therapeutic areas. She has considerable experience in drug registration and variations, reviewing the adequacy of data packages submitted to the Therapeutic Goods Administration ("TGA") and Medsafe, clinical trial applications, compiling expert overviews and appealing TGA decisions.
Teresa also has considerable experience as a front-line negotiator with the TGA in matters involving labelling, drug safety, the acceptability of data packages, recalls and critical supply. She recently provided advice to a major pharmaceutical company in establishing their Regulatory Operations division and streamlining their Regulatory business, and has also advised international entities wishing to establish businesses in Australia or conduct clinical research in Australia.
In August 2006, Teresa was appointed to the Administrative Appeals Tribunal as a part-time member, and is working towards certification as a mediator. This appointment will provide her with an in-depth understanding of administrative law and will add value to her current experience in TGA appeals.
Teresa has written extensively for Life Sciences Insights since joining Clayton Utz and in this edition comments on the recent recommendations given by the Expert Scientific group in the UK following the TGN14112 trial.
