Tina Soulis

Neuroscience Trials Australia

Dr Tina Soulis drives the strategic direction of the organisation as well as the clinical development of all projects for academic and commercial sponsors. Prior to her role with Neuroscience Trials Australia, Tina was the director of clinical development at Acrux Pharma Pty Ltd, a successful Australian biotechnology company. She managed the strategic direction, development, co-ordination and reporting of the company’s clinical programs. Tina had pivotal involvement in taking a product (Axiron), right through all stages of clinical development and in submission of the product dossier for regulatory approval.

Tina is an experienced driver of clinical drug development, particularly in the design, management and implementation of clinical trials and has worked as a clinical researcher and in senior roles within the pharmaceutical and biotechnology industry for over 25 years. Her experience encompasses all stages of drug development in many therapeutic areas and geographical regions.

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Strategies in CNS Drug and Device Development: The Australian Advantage

Neuroscience Trials Australia is an Australian-based, niche contract research organization (CRO) specializing in all aspects and phases of neuroscience clinical research. Therapeutic areas of expertise include epilepsy, stroke and stroke-related conditions, motor neurone disease/ALS, multiple sclerosis (MS), Alzheimer’s disease (AD)/cognitive disease studies, Parkinson’s disease and movement disorders, spinal cord injuries, concussion/TBI, Huntington’s disease, neurosurgery, pain, neuromuscular disease, mitochondrial disease and migraine. Case studies will be presented to demonstrate the advantageous environment in Australia allowing a successful project. Pivotal points of difference include a centralised system for fast ethics/Institutional Review Board approval, Centralised Clinical Trial Agreement templates, a fair and simple R&D tax incentive allowing a refund of 43.5% of spend, a regulatory system requiring NO review as well as access to multiple clinical trial networks with direct access to sites and patients.

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