Anna Formosa, Country Manager,

Pharm-Olam

"The core of our business is represented by international trials, as we are recognized as leaders in diseases like warm autoimmune hemolytic anemia (WAHA)."

Pharm-Olam is a mid-sized CRO with a global presence. Could you introduce its activity in Italy? Pharm-Olam Italy was established in 2004 close to Milan, and in 2009 we moved the office to the Milan city-center. We are a niche player in the CRO panoramic, having established ourselves as key players in oncology, infectious diseases, rare diseases and immunology. The core of our business is represented by international trials, as we are recognized as leaders in diseases like warm autoimmune hemolytic anemia (WAHA). In the past 10 years, we began offering more local studies, important for marketing registration and for players who want to be present in the country but lack the capabilities. Pharm-Olam Italy has doubled its size since 2004, and we have supported over 50 clinical trials in both pharma and medical devices through these years. What has the pandemic meant for clinical studies providers like Pharm-Olam? During the lockdown, hospitals were fully engrossed in helping Covid patients, so enrolment for all but oncological trials were put on hold. The timelines agreed with our clients were delayed, nevertheless, we stayed connected with study coordinators and Principal Investigators (PIs), who, in turn, stayed in touch with patients, monitoring treatment compliance or side effects. At this time the sharing of data via remote visits was not possible due to the new GDPR guidelines on data protection therefore we had to follow the study progression via direct communication with site staff. As the pandemic continued and when there was no immediate sign of the sites opening, we then worked with the EC’s to agree on a platform for remote visits whilst maintaining data privacy. However, despite this, some sites did not approve this practice until 12 months later. In May 2020 hospitals re-opened and our CRAs were able to resume on site monitoring activities. We now also have an approved remote visit process in place with sites as a backup solution should there be another lockdown. What are some recent demand drivers? The pandemic has clearly intensified the focus on vaccines, and many companies run vaccine trials in Italy. We support our UK colleagues who are partners in the Phase 3 development of the Valneva Covid vaccine. In Italy, we see higher interest in research, particularly biotech research, offering small companies with one or two molecules the opportunity to enter the market. This is a very lively market, with many ongoing trials and high competition, which drives a high level of quality. What opportunities does Italy offer as a CRO outsourcing destination? Between 2014 and 2018, investments in clinical research averaged €750 million per year, with hospitals representing 50% of the beneficiaries. Italy is a very innovative country and its history proves so: Italians were the first to use stem cells, the first genetic therapy was done here, and the first somatic therapy too. Italy also ranks 6th in terms of clinical publications globally, and we have very well-respected opinion leaders. Many clinical trials involve Italy, especially now that the timeline for clearing the regulatory framework is similar to the rest of EU. With many solutions for endocrinological or cardiological pathologies, biotech companies are focusing more on rare diseases with no existing therapies. Orphan drugs also have a faster access to funds and a wider, less competitive market promise. How do you manage patient recruitment for rare diseases? Clinical studies for orphan drugs involve multiple sites with fewer patients, so it is challenging in terms of resources and cost implications. Study design on rare diseases has a huge influence on patient recruitment and mapping the patient landscape is crucial. However, given the potential positive impact that new drugs could have on rare conditions – in some situations, leading to cure – patients are very willing to take part in clinical trials. How are digital solutions playing a part in clinical research? More companies, including Pharm-Olam, offer home-services for patients, but it is yet to see how the market will react, depending on each country. The idea is to offer greater comfort to the patient, but also minimize data entry mistakes and improve reporting. However, while the world is becoming more digital, some patients are not as digitally-savvy. Also, regulations do not always keep up with technology. Another emerging trend is that of digital therapies, through which a patient can be monitored remotely by implanting a device that delivers the therapy while the patient is doing normal activities.

image