A niche Contract Research Organisation. Dr Tina Soulis, CEO

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1 A niche Contract Research Organisation A niche Contract Research Organisation Dr Tina Soulis, CEO 1

2 Introducing The Florey (Institute of Neuroscience and Mental Health) The largest Brain research capability in the Southern Hemisphere and one of the world s top 10 Brain Research Centres Our teams work on a range of serious diseases including stroke, epilepsy, Alzheimer s disease, Parkinson s disease, Multiple Sclerosis, Motor Neurone Disease/ALS, Huntington s disease, traumatic brain and spinal cord injury, depression, schizophrenia, mental illness and addiction. We are world leaders in imaging technology, stroke rehabilitation and epidemiological studies. 2

3 NTA: Our place in the world Neuroscience Trials Australia (NTA), is a business within The Florey Institute of Neurosciences and Mental Health ( A niche, not-for-profit CRO A team of clinical research professionals with an average of 12 years experience (Pharma, Biotech and CRO experience across local and Global companies) Operating within markets and on projects that are both local and global ~75% of projects are Commercial ~70% from overseas Clients 3

4 Our services 4

5 Clinical Trials in Australia: the economic profile and competitive position of the sector, June 2017 The first comprehensive overview of the entire clinical trials landscape in Australia 5

6 Reducing costs by paying less tax R&D Tax Incentive encourages industry to conduct research and development activities via two ways 43.5% refundable R&D tax offset Available to eligible companies with an aggregated turnover of less than $20 million Refundable for companies in tax loss (providing an upfront cash refund) 40% non-refundable R&D tax offset Available to all other eligible companies Companies can carry forward unused credit amounts for use in future years Eligible activities: Pre-Clinical Manufacturing Clinical Research/Regulatory Not all work needs to be undertaken in Australia Legislation implementing the new program passed the Australian Parliament on 24 August 2011 and received Royal Assent on 8 Sep

7 Ease of approval Centralised Clinical Trial Agreement templates: Medicines Australia template reduces timelines associated with individual legal review Regulatory: majority of studies require Clinical Trial Notification (CTN). This is an acknowledgement by the TGA within 10 days of ethics approval so no regulatory submissions No regulatory review in 99% of cases No GMP product required for Phase I studies No IND required in order to undertake your project in Australia 5 Phase I units 7

8 Q U A L I T Y Cerebral Therapeutics example World first drug and device trial Therapy is the combination of a complex precise medication delivery pump which administers a reformulation pharmaceutical implanted and delivered through a catheter implanted directly into the fluid around the brain Project team includes Project Manager, Clinical Research Associate and Clinical Field Engineer,, Neurosurgeons, Neurologists, Blinded raters 8

9 Q U A L I T Y What NTA provides Oversight and Support Interaction with ethics and sites Interaction with regulators, device manufacturers Overall timeline and budget management Protocol and associated document development Project Manager Overall project management, main point of Client contact, sign-off reports, oversight of CRA Clinical Research Associate (CRA) and Clinical Field Engineer (CFE) site management, main point of contact with sites, site recruitment, monitoring, authorship of reports, device management and site training Data Management Set up and maintenance of edc/electronic Case Report Form, biostatistics 9

10 Q U A L I T Y Recruitment via Neuroscience Clinical Trial Networks Stroke: Australasian Stroke Trials Network (ASTN) Dementia: AC4R MS: MS Research Australia Parkinson s Disease: Movement Disorders Society of Australia Epilepsy: Australian Epilepsy Clinical Trial Network Surgery: Neurosurgical Society of Australia Neuromuscular: Australian Neuromuscular Network Pain: Australian Pain Society Headache: Headache Australia Spinal Cord Injury: Spinal Research Institute Motor Neurone Disease: FightMND 10

11 Q U A L I T Y Parliament passes medicinal cannabis laws February 2016: Schedule 8 becomes Schedule sites across Australia Access to epilepsy patients through Australian Epilepsy Clinical Trial Network AECTN Highly engaged and motivated patient population and sites Access to specialised patient populations: Lennox Gaustaut, Dravet, pediatric PK unit capabilities, tuberous sclerosis Proven track record of over recruitment Multiple successful FDA audit outcomes 11

12 Q U A L I T Y Eye offers a unique opportunity for novel interventions Ophthalmology often lead the way: Gene replacement therapy Stem cells trials Encapsulated technology-cntf Bionics Advantages: Small organ, relatively isolated Less drug needs to be made and purified Less risk of systemic side effects Can see what is going on directly: can directly see pathology, blood vessels, nerves Imaging the retina has become extraordinary