From pharmaceutical research to development

Malta's pharmaceutical industry has reached a stage of development where it is wise to consider making a paradigm shift from the production of generic products to fill a void in the chain of research needed to launch new products on the market. The industry particularly needs scientists with strong backgrounds in various areas to push forward the development and formulation of existing as well as new products.

Malta is a perfect candidate for this job and could serve as the bridge between research and development. This job would entail development scientists taking initial findings and turning them into something practical.

This area is suitable for Malta to tackle because it only requires, as a start, a handful of scientists and a few of their postgraduate students. We also need to train trouble-shooters who can solve technical problems for the industry as a whole, especially problems that cannot be solved internally.

The project would entail offering a service whereby a chemical entity is turned into a product, prepared for the clinical tests and followed up by clinical trials. To be successful in such a project a management team is required consisting of clinicians, toxicologists, biologists, chemists, pharmacists, bulk production experts, and marketing people.

The first job would be to get the product to the clinic. This would involve studies that could include toxicology, formulation, stability and metabolism. The studies' results would be included in a package sent to the Medicines Authority which would be asked to authorise the next research step, namely to run safety studies on humans. Malta has the advantage that in a short period of time it established its own Medicines Authority, which is respected for its scientific and ethical integrity not only in Europe but also by other international bodies such as the US Food and Drug Administration.

With our outstanding clinicians, Malta is able to take up clinical studies of any dimension. Phase I clinical trials study the effects of the drugs on humans, in particular, the drugs' bio-availability and pharmaco-kinetic characteristics. We also have the right people to carry out Phase II and Phase III studies both in terms of medical and regulatory personnel. We could design Phase II and III trials to be able to reach a pre-determined registration date and even establish how long the trials would take.

For such a project to be successful, suitable premises are required. True to their medical tradition the St Luke's Hospital buildings may serve as a pharmaceutical research city. With the participation of private enterprise, this could grow to the strength of the ICT Smart City. In this way one would not be putting all our eggs in one basket. In fact, co-operation between these two projects would be desirable and possible.

As with Smart City, the key to success lies in the training of personnel. In this case we are in an even better stage than in ICT since we have professors and academic staff whose experience in the field ranges from 10 to over 30 years, with strong international contacts. We are lucky that in 2010, hundreds of international pharmaceutical scientists will be gathering in Malta for an informal meeting and they have already expressed their interest to assist in the development of pharmaceutical research in Malta. It would be a once-in-a-lifetime occasion lost if we do not grasp this unique opportunity.

The University's departments of Pharmacy and Chemistry have both recognised the need for appropriate multidisciplinary research training in the pharmaceutical field. The departments have adopted the first steps to involve undergraduate and graduate students in projects related to pharmaceutical development and research with the industry's participation.

The success of these endeavours could be seen in the student presentations during the latest annual pharmacy symposium held earlier this month at the state-of-the-art Mater Dei Hospital auditorium.

The Pharmacy department has established a scheme to provide a trained research workforce and infrastructure within the profession capable of providing a robust and scientifically sound body of knowledge on which to develop and improve pharmaceutical services and professional practice as well as meet the requirements of the pharmaceutical industry. Other departments in the faculties of Medicine and Science have laid out similar schemes.

To complement the work carried out by the Malta Council for Science and Technology (MCST) a research resource centre now needs to be funded to sustain these schemes and establish research training awards for the pharmacists, doctors and scientists undertaking formal taught courses involving teaching in methods relevant to research. Project development grants are also needed.