Dr Charlotte Lemech Medical Director, Scientia Clinical Research

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Presentation transcript:

Dr Charlotte Lemech Medical Director, Scientia Clinical Research SCR Dr Charlotte Lemech Medical Director, Scientia Clinical Research

Overview The first purpose built, publicly funded early phase clinical trials facility in NSW Controlled entity owned by UNSW and funded by UNSW, NSW and commonwealth government Located within the Bright Alliance Building with the Nelune Comprehensive Cancer Centre and the Sydney Children’s Hospital The Bright Alliance aims to accelerate world class research in cancer prevention, treatment and care and provide access for more patients to this research

Creating a research hub to: Co-located in a major research precinct with Prince of Wales Hospital, Royal Hospital for Women, Sydney Children’s Hospital, UNSW and the Lowy Cancer Research Centre Creating a research hub to: Provide more opportunities for patients to be included in clinical trials Enhance the skills and knowledge of clinical researchers and ancillary staff Create career opportunities for staff wanting to specialise in clinical research Establish a support network for researchers to increase trial activity and share ideas

The SCR Team Lisa Nelson, CEO Charlotte Lemech, Medical Director Extensive phase I and clinical trial operational expertise, both local and international including the established phase I centres, Nucleus Network in Melbourne and Linear in Perth. Charlotte Lemech, Medical Director Medical Oncologist and investigator in over 30 oncology and haematology studies including first-in-patient studies in the UK and Australia. Franziska Loehrer, Quality Systems Manager Extensive phase I experience, including as General Manager of the phase I GSK unit previously located at Prince of Wales Hospital, Sydney Justin Nash, Lab Manager PhD (Organic Chemistry) with a particular interest in PD markers, Nuclear Magnetic Resonance, Liquid Chromatography-Mass Spectrometry and quantitation of peptides and small molecules.

The Facility First-in-human, first-in-patient clinical trials in patient groups and healthy volunteers Ability to perform and support later phase trials in patient groups across therapeutic disciplines Level 5 17 consult rooms 2 procedure rooms Board room and offices IP dispensing suite

Ambulatory telemetry, blood pressure and holter monitoring, spirometry Level 6 30 inpatient beds 2- and 4- bed private rooms 24-bed open ward Laboratory and freezer room IP suite Ambulatory telemetry, blood pressure and holter monitoring, spirometry

Laboratory capabilities Pharmacy services Temperature monitored IP storage area Grade B manufacturing suite Laboratory capabilities Receipt, distribution of samples Freezer room LCMS assay development and processing Biomarker development

What makes Scientia? The View!

Trial One Automates clinic operations to manage recruitment, data management and sample tracking Real-time study data collection to reduce errors and improve timelines Integrates with bedside patient monitoring, telemetry, ECGs Supports open-label, single and double blinding Generates schedules and provides appointment reminder notifications Allows remote monitoring Tablet-compatible

The People The Collaborations at SCR, POWH and UNSW The Bright Alliance NECTA Australian sites International