Putting Malta on the map for clinical trial work

Coryse Borg speaks to Robert Smith, Director of Smiro Qualitas Ltd, an independent pharmaceutical consultancy firm, about the strategic reasons behind establishing a presence in Malta, the gaps in the country’s clinical-trial landscape, and how targeted investment could unlock long-term value for patients, companies and the wider economy.

What inspired Smiro Qualitas to establish a dedicated presence in Malta, and how does the country’s current healthcare landscape influence your long-term vision?

When looking to set up an overseas business in the EU, I was looking for three key factors. A European country where English was widely spoken. A regulatory agency that had a broadly similar approach to the UK regulator. A country where there was the long-term potential to develop and grow the business.

Malta was the only country where all three of these criteria were met.

Currently, there is very little clinical trial work performed on the island and much of the pharmaceutical landscape is occupied by generic companies, rather than innovator companies.

What is the most significant gap as regards clinical trials in Malta today and how is Smiro Qualitas uniquely positioned to help bridge it?

When doing the research into where to locate the company, it was clear in our conversations with a number of individuals in this sector that there was no real infrastructure to support clinical trials in Malta, mainly because the likely volume of work was not worth the investment for the clinical research organisations who work in the clinical trials arena.

Smiro Qualitas’ model of operation is different.  Firstly, within the company, we have a group of professionals with a great deal of experience of supporting clinical trials.

We can support companies and individuals wanting to establish and run clinical trials through our extensive network of contacts. If an individual wants to set up and run a clinical trial, we can guide them through the process and work with them from inception of the trial to close out and reporting of results.

Rather than selecting a single CRO to run the clinical trial from start to finish, Smiro Qualitas will partner with small independent companies to bring the level of expertise required to run a successful clinical trial.

As many of these companies are small individual owner owned, they do not have to answer to shareholders and will often make the decision as to whether to participate in a project based on their interest in the project, rather than how much revenue and profit it will generate.

This is ideal for small startup companies that spin out of hospitals and universities, as this tends to be a cheaper option to get the product in early phase clinical trials.

How do you envision Malta’s clinical-trial landscape evolving with the right investment and support, and what role do you see Smiro Qualitas playing in making the country a recognised hub for advanced, patient-centric research?

The pharmaceutical landscape is changing. More and more of the new therapies are biologically based.

Though we have seen many companies cut back their cell and gene therapy programmes with a loss of jobs, all the recent break through therapy announcements for hard-to-treat diseases have come from the gene therapy or cell therapy space.

As scientific knowledge grows, with respect to the genetic basis of disease and the tools develop to edit the human genome in cells, many more rare and incurable diseases will be able to be treated.

Currently, what is difficult to predict is the cost of these new therapies, which are very expensive. I would hope that as the technology develops, many more of the solutions` will be platformed based, which would bring down the cost of goods.

Malta is well placed to take advantage of this with an excellent university and health care system.

With a long background working in cell and gene-based therapies, Smiro Qualitas has the expertise to help Malta take advantage of this evolving landscape, by focusing its efforts in these niche high value products. For biologicals, once a manufacturing process is established, it rarely moves from its initial site of manufacture due to the huge costs involved in moving the manufacture.

As many of these products will be small batches, this makes the investment case to move a production site harder to make.

What kinds of investigational treatments do you foresee becoming available locally- (as opposed to having to travel abroad - through strengthened clinical-trial capability?

My hope is that we can attract the clinical trials for rare and orphan diseases where Maltese patients currently must travel to EU centres currently, especially where patients are going to be on long-term treatment.

Smiro Qualitas has the expertise with respect to storage, handling, and shipping of product, especially, the biological, biotech, cell and gene therapy drugs of the future. These are the products that have challenges with storage, distribution, and handling.

One of the support activities we can offer to Maltese clinical sites is the clinical pharmacy aspect of the trials.

As a pharmacist, I can and have supported clinical sites in the preparation and administration of these medicines, by training the medical, nursing and pharmacy teams in the correct handling of these products.

What practical steps are you taking to help Malta participate in advanced research involving biologics, gene therapies, and other next-generation therapeutics?

One of the practical steps we have undertaken is to build a Maltese facility capable of storing biological, biotech, gene therapy, and cell therapy products of the future.

In addition, Smiro Qualitas is experienced in the logistics required to ensure clinical trials in these areas.

A big part of the challenge for advanced products is the time required to get the product from manufacture to the patient, when the product shelf-life is short.

Understanding these logistics and ensuring the appropriate resources are in place to ensure the logistics pieces are in place, are key for trial success.

Smiro Qualitas with its facility has put in the practical pieces to solve the problem. However, this is only part of the solution. In addition, we have built the logistical infrastructure.

With your operations spanning both the EU and the UK, how does Smiro Qualitas help companies navigate the regulatory fragmentation that has intensified post-Brexit?

There has always been regulatory fragmentation. because member states have chosen to implement EU Directive and regulations according to their own national traditions.

A perfect example of this is how different countries chose to implement the role of the QP in their own National Law. In reality, while there is some divergence between UK and EU regulations, the regulations between the EU and UK are broadly the same.

The major change is that the EU no longer accepts the activities performed in the UK as being equivalent to those performed in the EU.

Therefore, Smiro Qualitas role is to explain all this to client and walk them through the best and most cost-effective solutions that will stand up to regulatory scrutiny in both the EU and the UK.

In addition, our role is also to work with the client and to use the regulations constructively to resolve problems the clients have come across

Malta’s life-sciences sector is evolving rapidly. How do you see Smiro Qualitas contributing to this momentum, and what impact could this have for Maltese patients over the next decade?

Having a facility that can support clinical trials in Malta for Maltese patients changes the dynamics for the clinical trials arena in Malta.

Previously, where was no dedicated expertise for clinical trials, Malta has a company with that expertise. It also has a company that has won an award in this space.

Malta also has a company with strong links into the clinical trials arena in the major markets, so when talking to clients it can start asking the questions about considering Maltese patients for their clinical trials.

What is your ultimate ambition for Smiro Qualitas’ role in reshaping Malta’s pharmaceutical research ecosystem?

Smiro Qualitas’ ambition is not just about reshaping the pharmaceutical research landscape. Smiro Qualitas want to reshape the Maltese pharmaceutical landscape as a whole.

I would like to think Smiro Qualitas can act as a catalyst with the right support to bring into Malta the high value future biologic, biotech, gene and cell therapy products that will drive the future growth of the pharmaceutical industry.

This will bring highly skilled and well-paid jobs that will drive future prosperity for Malta.