Dr Maria Dynon has over thirty years experience in the biotechnology and pharmaceutical industry. This includes experience with emerging biotechnology companies, large international pharmaceutical companies, government and academia.
I have worked as an evaluator in Australia TGA, in marketing as an oncology Group Product Marketing Manager, in regulatory affairs as a senior consultant with a multinational consulting group, and also as a development and commercialisation manager.
Since setting up Dynon Consulting, I have continued my association with the biotechnology industry. My work has ranged from preclinical planning and project management to clinical review, trial development and reimbursement submissions. Other activities have included US regulatory submissions, preparation of non-confidential information packages and assistance with due diligence reviews. Some of these activities were undertaken as the Clinical and Regulatory Manager for Hatchtech Pty Ltd and as a Project Manager at BioDiem Ltd.
Some major successful projects include:
- Gap analysis and development plans
- Project management of clinical and nonclinical studies
- Formal meetings with FDA and TGA
- Successful IND and CTX submissions
- Ethics applications, responses to ethics queries
- Project management of a biological product from early laboratory work to Phase I and II clinical trials