Our established record in development management
The following organisations have benefited from the development management expertise of Medicines Development. Activities have ranged from strategic input at an executive level through development plan compilation, and implementation to the preparation of successful funding applications.
Nexpep Pty Ltd transformed ground-breaking research on immune responses to gluten in coeliac disease into what could become a world-first coeliac disease vaccine, Nexvax2.
Medicines Development provided a full time Senior Development Manager and part time Project Leader to Nexpep to supplement Nexpep's own internal resources. The Development Manager was engaged with part funding under the Victorian Government's VicStart program which was a precursor to the current Victorian Government Smart SME ICP funding. Her role included strategic development planning, support for capital raising, development management and running a multi-centre, Phase I clinical trial of Nexvax2. The Nexvax2 technoogy has been acquired by ImmusanT Inc, a US-based biotechnology company.
Medicines Development is currently coordinating an international collaboration between Opal Therapeutics Inc. (Opal) and Massachusetts General Hospital (MGH) to develop a novel immunotherapy to treat HIV. The collaboration involves both the Ragon Institute of MGH, Harvard and MIT, Oxford University and the Chelsea and Westminster Hospital. Medicines Development provides a full time Development Manager and part time project leadership and coordinates operational activities. This includes candidate selection, manufacture under current Good Manufacturing Practice (cGMP), preclinical and toxicology testing and clinical development. The first in human clinical trial is currently being conducted in London Sponsored by Medicines Development. More information on the HIV immunotherapy clinical study can be found here
A Melbourne-based biological oncology company engaged a Senior Development Manager (part time) and Head of Development (part time) leading towards clinical development of their portfolio of products. Activities include manufacture, research, preclinical development and clinical development.
A mid-sized, Melbourne-based small molecule antiviral company engaged Medicines Development to undertake development support of its portfolio of products, and a review of the organisation's development processes.
A start-up biotechnology with novel therapeutic vaccine technology engaged Medicines Development to provide a full time Development Manager and part time Chief Operating Officer/Acting Chief Executive Officer. The team selected the lead candidate, developed the product through cGMP manufacture into preclinical testing. Successful capital raising was undertaken.
A Melbourne based research institute engaged Medicines Development to prepare a development plan and full grant application to a European granting body. The application detailed research, lead candidate selection, preclinical testing, manufacture and proposed clinical testing of candidates for an important developing world infectious diseases and immunology indication.
A Canberra based immunology company engaged Medicines Development to provide Development Management and clinical development advice for its oncology clinical program.
A Perth based biotechnology company developing bacterial vaccine vectors engaged Medicines Development to support product development planning and implementation.
Medicines Development provided clinical and development project leadership to a consortium including academic institutions and a Melbourne biotechnology company. The consortium was funded by the United States National Institutes of Health for the development of a novel prevention of HIV.
A full time development manager and part time Chief Operating Officer was provided to a Melbourne based biotechnology company developing a novel vaccine technology. In addition to development planning, a commercialisation package was prepared leading to the transition of the company to the United States where development continues.
