Expanding Italy’s clinical trial capacities to the rest of the world

Opened in 2002, the park is now home to 3 companies and 9 research groups from Universities and centres working in: Stem cells, Oncology, leukaemia and Immunology; Molecular cardiology; Skeletal regeneration; Cell therapy and tissue engineering; Muscular dystrophies; Biomedical quality control; Neurological Disorders and Diabetes.

The infrastructure permits the development of concept to preclinical development based on the state-of-the-art facilities including a animal facility encompassing conventional and SPF small animals and a large animal surgery unit. The Fondazione has recently created a Lazio based pre-clinical to clinical trial platform with CRISC (http://w3.uniroma1.it/crisc/), and is also in an international biomedical portfolio management project (Transvac) involving the European Clinical Research Infrastructure Network (www.ecrin.org)

Recently PSB formed a mutual agreement with Datapharm Australia (www.datapharm.com.au). Datapharm Australia is established as the most experienced Australian Contract Research Organisation (CRO) (est. 1987). Locally based, internationally connected through ‘research point’ (www.researchpoint.com) , Datapharm Australia provides all or part clinical trial services to suit needs of Biotechnology and ‘Big Pharma’ companies Australia wide.

This global link aims primarily to:

•Increase overseas interest and awareness of each party’s capabilities (i.e. of Fondazione Parco Biomedico San Raffaele capabilities in Australia and Datapharm Australia’s capabilities in Italy).

•Enable a pipeline/‘support network’ for Australian and Italian/European biotechnology and pharmaceutical companies to utilise each party’s capacities where appropriate.

Although early days, the future advantages of this collaboration are numerous. Both parties will be able to add value for clients who wish to extend operations, research and/or clinical trial programs offshore in new markets. It will also allow a smooth passage for clients from both Europe and Australia to conduct clinical trials and access research opportunities in new markets. Collaboration and strong relations globally are essential to allow access to more patient numbers for global clinical trials whilst maintaining a high standard of quality.

Australia is one of the highest ranked countries for the biotech industry, home to over 420 companies and has many ongoing clinical trials, while Europe boasts over 1400 companies. Traditionally smaller companies have tended to stay close to home in product validation. This collaboration has been created to open the door to conduct more trials on both continents for companies to augment revenue and add value.

“This collaboration moves the Fondazione’s ongoing strategies to enable bench to bedside research into the global arena, and will offer Italian and European entities the possibility to penetrate one of the most dynamic biotech economies on the planet. The existence of the mutual recognition agreement between Europe and Australia for cGMP products will mean that the costs associated with this market penetrance should be significantly lower through the leveraging of the excellence of both partners.

Essentially it strengthens the efforts of both entities to generate a solid system of biomedical diagnostic and therapeutic validation through clinical trials and complements existing globalisation strategies thereby generating global opportunities for resident biotechnology companies.

Essentially it strengthens the efforts of both entities to generate a solid system of biomedical diagnostic and therapeutic validation through clinical trials and complements existing globalisation strategies thereby generating global opportunities for resident biotechnology companies.”

Marco Baccanti, Director General, Fondazione Parco Biomedico San Raffaele