Collaboration with Pharma and Biotech
The Strategy for Scientific Dissemination of the GYNOCARE COST Action included the outreach and collaboration with the pharmaceutical industry and biotech companies.
Working Group 4 led by Prof Antonio Giordano, was specifically focused on bridging the gap between research and the pharma industry.
In February 2023, a two day conference was held by GYNOCARE in Naples and the theme was 'Bridging the Gap between Research and Cure in Rare Gynaecological Cancer'. The proceedings of this conference can be accessed here.
During the three-day Training School held at Sofia University in Bulgaria in June 2023, there were workshops and lectures held in collaboration with the pharma industry and biotech companies. Click here to read more.
An informative scientific paper was published by Prof Klejda Harasani, leader of WG5, outlining clinical trials on pharmacological therapies for rare gynecological cancers.
The Clinical Trials Directive and the interpretation of clinical trials have been outlined on several occasions during dissemination events organised by GYNOCARE. These include the keynote lecture delivered by Prof Neville Calleja, Director of Health Information and Research within the Ministry for Health in Malta and Head of Department of Public Health at the University of Malta.
Round Table Discussion with Stakeholders from Pharma and Biotech
During the last day of the GYNOCARE Conference in Naples, a Round Table discussion was held with key stakeholders from the pharma and biotech industries. While randomised control trials (RCTs) are the gold standard in novel therapy development, in rare diseases the low patient numbers as well as the cost involved in interventional clinical trials represent a significant barrier. As such, a more efficient research approach through real world evidence (RWE) and pragmatic (combining interventional and real-world arms) studies would leverage the abundant historical patient data in patient journals and databases and bypass the need for large numbers of real-time patients and high financial burden.
Dr Stephanie Darmanin, working for private pharma companies in Sweden, Dr Danica Cujic from Serbia, Prof Klejda Harasani from Albania and Dr Mariela Vasileva-Slaveva from Bulgaria, were among the speakers who gave their perspective from the industry experience. Identifying relevant key opinion leaders, establishing relationships at a local, national, and global level and engaging in international collaborations around RWE to create bigger data collections is critical. When approaching pharmaceutical company medical affairs teams and patient organizations for industry-sponsored research grants and joint projects, researchers should have a clear, clinically relevant idea, with a connection to patient data/samples, a correlation to parameters of disease/clinical phenotypes, and outcomes that can eventually be applied in the clinic, or at least be of clear relevance to clinicians and patients. The opportunity presented by investigator-sponsored studies (ISS), where the investigator is the instigator of the study proposal as well as the principal owner of the data, but resources are provided by a partner within the pharmaceutical industry, should be further explored.
A collaborative approach involving clinicians is preferable in order to gain company interest and create a platform for future investment in the disease area. Innovative protocols for personalized one-patient clinical trials, designed around the individual patient’s genomic, proteomic and histological profile are an appealing option, which will however require consideration of regulatory and ethical implications.
