New Victorian manufacturing facility at CSIRO Clayton

BioMedVic members interested in the production of biological products such as vaccines, antibodies and stem cells for clinical trials will be delighted to know that a new Advanced Biotechnology Manufacturing Platform will be built at the CSIRO Clayton Central precinct.

The facility will allow the development of state of the art, early-stage biological and pharmaceutical products in Australia, and will ease the process of manufacturing for a wide range of companies, including those smaller ones that can’t afford to manufacture their candidates overseas.

The new manufacturing facility will be owned and run by CSIRO. It has received substantial funding from several institutions, including the Victorian Government, MTPConnect, SIEF and NCRIS/TIA , as well as companies including Telix Pharmaceutical and Sementis P/L. This investment is expected to boost the translational capabilities of the biotech sector in Australia, help to increase the number of Victorian institutions doing clinical trials while supporting local jobs and attract more investments from Australian biotech companies.

For more information see the CSIRO Blog or the Victoria Government page.

St Vincent’s Hospital and ShareRoot collaborate to improve ethical compliance in clinical trials

St. Vincent’s Hospital and the company ShareRoot have started a collaboration to apply the MediaConsent platform, a tool specifically designed to improve the compliance with human research ethics during clinical trials and enhance patient engagement.

More information is available here

Report: Trends in Australian Clinical Trials

BioMedVic welcomes a new report released by the Australian New Zealand Clinical Trial Registry that reveals insights into the landscape of clinical trials in Australia.

The report draws on data from over 10,000 Australian clinical trials registered between 2006 and 2015 and identifies national trends in clinical trial activity.

Over 5 million people participated in Australian clinical trials during the reported period, with 18, 19 and 7 percent participating in cancer, cardiovascular disease and mental health disorders trials, respectively.

The report identifies a moderate growth in the total number of trials registered each year, reflecting increases in non-industry-sponsored smaller-scale trials and non-drug interventions. In fact, non-drug trials grew from 43 percent in 2006 to 58 percent in 2015.

Industry-funded trials remain the largest investment source – estimated at $930 million of the total $1.1 billion spent on clinical trials in Australia each year. Government provides over $164 million for clinical trials through the NHMRC and other sources, with growth in investment anticipated through the MRFF.

The report calls for further assessment of the reduction in trial size over 2006-2015 (median of 167 participants down to 97) and proposes this change could be due either to appropriate changes for more targeted therapies, or inappropriate reductions in sample size.

The report stresses the need for a publicly-accessible national database of all clinical trials conducted in Australia, to help reduce unnecessary overlap, facilitate the promotion of research collaboration and a reduction in publication bias, as well as highlight research gaps.

“Given their demonstrable value, clinical trials in Australia appear to have a bright future, particularly if ongoing investment is made,” writes ANZCTR Manager Prof Lisa Askie and Director Prof John Simes. “The optimisation of such investment will require multiple strategies, including making full use of the data available through the ANZCTR, now and into the future.”

Updated editions of The Clinical Trials Landscape in Australia are planned for every two years.

Workshop | Clinical Trials Essentials

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BioMedVic is pleased to partner with PRAXIS Australia to deliver the Clinical Trials Essentials workshop suite to the Australian clinical trials sector over the next six months. Topics include Privacy in Research, Research Integrity and Clinical Trials, ICH E6 Addendum and Social Media in Research.

BioMedVic Members are eligible for discounts for group bookings of 15 or more – ask PRAXIS for details.

More details here.

Research at the Heart of Health

MEMBER FEATURE

THE ROYAL WOMEN’S HOSPITAL MELBOURNE

The Royal Women’s Hospital does more than support the health of Melbourne locals – it is a hub of active research aimed at improving health outcomes for women and children in Victoria and globally.

Over 3,000 patients are currently participating in 62 clinical trials throughout the hospital’s services in nine research centres. The hospital’s recently released 2015 Research Report “Discoveries improving care for women and babies” showcases this research leadership. The Report includes details of the hospital’s clinical trials and translational research in newborn and cancer research, as well as in gynaecology, pregnancy, mental health, infectious diseases, midwifery and maternity, anaesthetics and allied health. Continue reading