jean.calleja-gius@um.edu.mt, Author at Gynocare

…And That's a Wrap!

jean.calleja-gius@um.edu.mt — Wed, 10 Apr 2024 07:25:19 +0000

Why was GYNOCARE COST Action timely?

The GYNOCARE COST Action has officially ended on the 9th September 2023.

GYNOCARE COST Action was timely because it was carried out in parallel with the following international initiatives:

The EU Mission for cancer, which is part of the Horizon Europe research and innovation programme for the years 2021-2027
Europe’s Beating Cancer Plan is a political commitment to turn the tide against cancer in the EU
European Reference Networks (ERNs): The first 24 ERNs launched in 2017
ORPHANET - the portal for rare diseases and orphan drugs; and ORPHAcode, supported via the RD Code project (2019-2021)
The legislation for medicines for rare diseases and for children was evaluated in 2020, and an impact assessment for revision of the legislation is currently ongoing
The Clinical Trials Directive has been repealed by the Clinical Trials Regulation which became applicable on 31 January 2022

What has GYNOCARE COST Action achieved?

40 open access scientific publications with multiple co-authors
Special Issue in the European Journal of Surgical Oncology
Contract to update of the international reference textbook on rare and uncommon gynae cancers (Springer)
4 book chapters, 1 patent on a surgical instrument
3 international conference (Malta, Italy, Bulgaria): over 250 attendees in total
2 Training Schools (North Macedonia, Bulgaria): over 200 attendees in total
Involvement of Policy Makers, including President of EU Parliament
Multiple press conferences and news items on national TV, radio and other media portals in different languages
Masters, PhDs, Career advancements, Promotions to Professorship
6 STSMs, 14 Virtual Mobilities, 3 dissemination grants, ITC conference grant
Achievement of outcomes beyond the agreed deliverables (eg collaboration with NASA space agency)
International Award for Professionalism in Medical Ethics and Research given to the Chair

Who were the stakeholders involved?

Clinicians: oncologist, gynaecologists, pathologists, paediatricians, surgeons, physicians, radiologists, etc
Nurses, Radiographers, Medical Physicists
Academics and Researchers, PhD and Masters students, medical students and students from allied health
Lawyers
Ethicists
Biomedical engineers
Biostatisticians and Epidemiologists
Public Health Experts
Policy Makers and Politicians
Pharmacists and the Pharma and Biotech Industry
Experts in the Clinical Trails Regulation
Patient Advocacy Groups – national and EU (eg EUROPADONNA, ESGO-ENGAGE)
Journalists and media experts

For more details, please refer to the following powerpoint presentation: Reflections of the Outcomes of GYNOCARE COST Action

We look foward to continue working together in the ongoing and future planned collaborations. Click here to read more.

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Early Career Stage Researchers in GYNOCARE

jean.calleja-gius@um.edu.mt — Wed, 17 Jan 2024 05:56:42 +0000

Promotion of Early Stage Career Researchers and Young Professionals

Mr Karl livori is a 3rd year MD student at the Faculty of Medicine and Surgery at the University of Malta who was awarded The Gedeon Richter Prize in Women’s Health for the academic year 2022-23. Mr Livori's second-year essay project entitled ‘Endometriosis-associated Ovarian Cancer’, carried out under supervision of Prof Jean Calleja-Agius, was considered the most meritorious submission.

Click here to read more.

PhD students benefitting from STSMs

Many PhD students and early career researchers, especially those hailing from ITC countries, have benefitted from STSM awarded through GYNOCARE COST Action.

Click here to read more:

STSM by Lithuanian PhD student in Italy;

STSM by Maltese PhD student in The Netherlands;

STSM by Italian PhD student in the UK

ITC Grants to ECIs

PhD students and ECIs benefitted from ITC grants to present their research work at international conferences.

Click here to read more.

PhDs obtained during GYNOCARE COST Action

Many of the MCs and participants in WGs obtained their PhD during the course of GYNOCARE COST Action.

Of note, Dr Irina Tripac from Moldova was awarded her 2nd PhD on her work on sentinel node status in patients with endometrial cancer.

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GYNOCARE in India

jean.calleja-gius@um.edu.mt — Sat, 16 Dec 2023 15:27:31 +0000

Invited lectures in Manipal and Mangalore

Dr. Yashwanth Subbannayya from the University of Surrey presented his work on the potential association of space flight with the development of gynecological cancers as part of two invited talks at the Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal India and the Centre for Integrative Omics Data Science, Yenepoya University, Mangalore, India

Dr. Yashwanth Subbannayya is an active MC member of the GYNOCARE COST Action.

At the Centre for Integrative Omics Data Science, Yenepoya University, Mangalore, India.

At the Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal India.

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GYNOCARE and Policy Makers

jean.calleja-gius@um.edu.mt — Fri, 15 Dec 2023 09:52:44 +0000

Meeting with the President of the European Parliament

Members of the GYNOCARE Consortium met Dr Roberta Metsola, President of the European Parliament, in her visit at the Biomedical Sciences Building at the University of Malta. The research being carried out especially in the field of cancer was showcased during this visit to the labs. Click here to read the details of the visit of the President of the European Parliament.

Cancer Symposium hosted by Her Excellency The President Emeritus of Malta

Prof Jean Calleja-Agius, Chair of the GYNOCARE COST Action was invited to deliver a keynote speech during the Cancer Symposium hosted by Her Excellency The President Emeritus of Malta, Dr Marie Louise Coleiro Preca. The title of this symposium was 'Cancer Research in Malta: From Biology to the Clinic'.

Click here in order to read the full speech delivered by Her Excellency, The President Emeritus on the occasion of this symposium.

Member of Parliament of the Bulgarian National Assembly addresses GYNOCARE conference

During the GYNOCARE Conference entitled 'Our Battle for Better Health Care is Eternal' which was held at the Sofia University in Bulgaria in 2023, policy makers, politicians, and small and medium enterprises (SMEs) in biotechnology, pharmaceuticals and computer science were invited. These need to be involved in bridging the gap between basic and clinical research and their application in the development of a cost-effective roadmap dedicated to the fight against cancer, especially when this is rare. The role of digital health as well as the importance of accurate electronic medical records were discussed in detail by Dr. Alexander Simidchiev, Member of the National Assembly of Bulgaria and Head of Department of the Medical Institute MVR.

9th edition of the Annual Rare Disease Colloquium

On the occasion of World Rare Disease Day, the University of Malta’s Rare Disease Medicine Study Group, together with the National Alliance for Rare Diseases Support—Malta, held the 9th edition of the Annual Rare Disease Colloquium, titled ‘Advanced Projects in Rare Disease Medicine’ on the 6th March 2024. The colloquium aimed to create awareness about the 6,000+ identified rare diseases and the reality of living with them.

Hosted by the President of Malta, His Excellency Dr George Vella at San Anton Palace, and in the presence of Malta’s Minister for Health and Active Ageing, Hon. Dr Jo Etienne Abela, a number of medical experts, researchers, patient advocates, policy makers and industry representatives convened to exchange their invaluable insights with the rare disease community.

In his opening remarks, Prof. Alex Felice, from the University’s Faculty of Medicine & Surgery, spoke about the fact that some rare diseases are disproportionately high in the Maltese population, and that through whole genome sequencing, these could be detected and diagnosed at birth and treated immediately to prevent severe disability.

Prof. Jean Calleja-Agius, from the Department of Anatomy, Faculty of Medicine and Surgery, briefed the audience about GYNOCARE, which aims to bridge the gap between research and cure in rare gynaecological cancers.

Dr James Clark, from the Office of the Medical Director at Mater Dei Hospital, said Malta joined the 24 European Reference Networks (ERNs) as a National Coordination Hub in 2019 and this affiliation has proved to be a significant asset for our healthcare providers and patients alike in addressing the challenges posed by rare diseases.

Dr Joanna Vella from UM’s Department of Pathology explained mitochondrial diseases and the ongoing research to identify their cause.

Dr Miriam Dalmas from the Department of Policy in Health, from the Ministry for Health and Active Ageing focused on the ‘1+ Million Genomes’; (1+MG) initiative which aspires to allow protected access to genomics and the related clinical data across Europe for the purposes of engendering better research resulting in more personalised healthcare and corresponding health policy-making.

Prof. Constantinos Deltas from the University of Cyprus delivered a talk called ‘The Biobank of Cyprus and Opportunities for Next Generation Research Projects’.

Click here to read more.

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Collaborations with other EU funded projects

jean.calleja-gius@um.edu.mt — Mon, 11 Dec 2023 09:14:05 +0000

GYNOCARE links up with other EU projects in the mission against cancer

The various members of the GYNOCARE COST Action have actively collaborated with other ongoing EU funded projects and has also paved the way for new joint collaborations in the mission against cancer.

Here are a few examples:

Dr Mariela Vasileva-Slaveva, MC member from Bulgaria is also MC member of the ongoing COST Action CA19138 - Lobular Breast Cancer: Discovery Science, Translational Goals, Clinical Impact (LOBSTERPOT). She organised a workshop dedicated to sentinel node biopsy especially in rare gynaecological cancer, during the GYNOCARE Training School held in Sofia University, Bulgaria in June 2023.

Prof Alex Felice and Prof Nikolai Pace, WG2 members from Malta are the focal points for BBMRI.mt, which is the European research infrastructure for biobanking and biomolecular resources in health and lifesciences.

Prof Alex Felice is the founder and custodian of the Malta Biobank. The Malta BioBank is the first national archive of biological samples. It houses a population bank and a clinical bank with specific collections. The population bank has a very large collection of random Maltese neonates, pooled neonatal samples, and samples from multiple births and senior citizens. The Malta BioBank is a founding member of ITHANET (thalassaemia network) Euro-BioBank and RDCONNECT as well as of BBMRI. It seeks to expand the scope of biobanking in Malta and the Euro-Mediterranean region.

Dr Olga Tzortzatou from Greece, WG3 lead and Dr Bridget Ellul WG3 member from Malta and Dr Sara Casati WG3 member from Italy, are representatives of the Ethical, Legal and Social Implications (ELSI) Research Program. The ELSI Research Program fosters basic and applied research on the ethical, legal and social implications of genetic and genomic research for individuals, families and communities.

Dr Vera Dimitrievska, Science Communication Officer for GYNOCARE is also the Vice-Working Group 3 Leader of another COST Action CA21123: Cancer- Understanding Prevention in Intellectual Disabilities (CUPID).

Prof Jean Calleja-Agius is a member of another COST Action CA21152: Implementation Network Europe for Cancer Survivorship Care (INE-CSC).

GYNOCARE MC members have collaborated closely with Prof Francisco Güell Pelayo, project leader B2-Inf. B2-InF is a H2020 Science with and for Society project which aims to give voice to citizens towards improving Assisted Reproduction Technologies (ART) for society. Other members of the B2-Inf consortium included Dr Vera Dimitrievska, Science Communication Officer for GYNOCARE.

Preserving fertility is the most frequently reported concern by young people diagnosed with cancer, yet it remains the least serviced across various health systems in Europe. Traditional cancer treatments are focused on disease cure, however, as cancer survivorship increases, there is increasing awareness and demand for life optimization treatments post cancer cure, such as fertility preservation. Coordinating fertility preservation activities across Europe is a multifaceted endeavour. There is an urgent need to revamp, optimise, and modernise care provision pathways to incorporate fertility preservation treatments into existing health systems. This is particularly relevant to deprived and underserved minority communities who often struggle to access such specialised treatments leading to significant longterm health inequality. Effective networking, knowledge sharing, and stakeholder education is therefore key to invoke a real change beyond the status quo of cancer care provision. In view of this, a number of MC members from the GYNOCARE COST Action have partnered up with clinicians and academics from the UK in order to submit a proposal new COST Action, focusing on fertility preservation in cancer patients.

Prof Jean Calleja Agius has been invited to be one of the role models who are challenging gender stereotypes and traditional roles, while strengthening the support system for girls who wish to pursue a career in the Science, Technology, Engineering or Mathematics fields. A significant step in Malta’s STEM pathways has been the island’s recent recognition as the first World Capital for Women and Girls in Science (Royal Academy of Science International Trust), an international achievement which was catalytic of the need for bigger spaces of dialogue about the potential of young females with an analytical mind and a vivid sense of curiosity. Click here to read more about the She Can project.

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Press Coverage and Public Dissemination

jean.calleja-gius@um.edu.mt — Sun, 15 Oct 2023 08:50:28 +0000

Media Coverage

The activities carried out by GYNOCARE covered on Newspoint, which is the official news portal of the University of Malta (UM), providing staff, students, alumni and the general public with information on news and activities at the University and beyond. It also includes notices that are of special interest to UM staff and students, as well as opportunities to participate in a wide range of events and research projects.

News items on Newspoint include:

Appointment of the Chair of the GYNOCARE COST Action - Click here to read more.
Launch of the GYNOCARE website - Click here to read more.
Publication of the first collaborative paper by the GYNOCARE Consortium - Click here to read more.
Participation in the 6th Annual Malta Rare Diseases Consortium - Click here to read more.
Role of GYNOCARE in World Gynae-oncology Day - Click here to read more.
Publication of collaborative scientific papers by members of the GYNOCARE consortium - Click here to read more.
Invited lecture during the final COST conference of another COST Action on rare diseases - Click here to read more.
Announcement of the first STSM - Click here to read more.
Announcement of the first in person GYNOCARE Conference, MC meeting and Core group meeting held in Malta - Click here to read more.
Proceedings of the first GYNOCARE Conference held in Malta - Click here to read more.
Announcement of more publications co-authored by members of the GYNOCARE consortium - Click here to read more.
Announcement of the webinar series on Biobanking in collaboration with ESSO - Click here to read more.
Announcement of the keynote speech by Action Chair at the AWG Symposium organised by NASA Genelab - Click here to read more.
Outcome of another STSM by a GYNOCARE participant - Click here to read more.
Proceedings of the first hybrid GYNOCARE Training School in North Macedonia - Click here to read more.
Announcement of the GYNOCARE Conference in Naples - Click here to read more.
Proceedings of the GYNOCARE Conference in Naples - Click here to read more.
Announcement of Award to GYNOCARE Chair - Click here to read more.
Announcement of the GYNOCARE Training School and Conference in Bulgaria - Click here to read more.
Proceedings of the GYNOCARE Training School and Conference in Bulgaria - Click here to read more.

In the United States, the activities carried out by GYNOCARE were disseminated via NEWSWISE, which is the official science communication portal of the Sbarro Health Research Organisation at the Temple University in Philadelphia, USA.

News items on Newswise include:

GYNOCARE COST Creates International Research Collab on Rare Cancers Affecting Millions of Women Annually. Click here to read more.
Researchers Target Commonly Mutated or Deleted Gene in Gynecological Cancers. Click here to read more.
International Research Collaboration to Address Delayed Diagnosis of Rare Gynecological Cancers. Click here to read more.

NEWSPAPERS

Here are the links for the newspaper articles related to GYNOCARE COST Action deliverables:

Maltese National News Agency:

Maltese professor involved in research to find cure for uterine cancer

Increase in women undergoing cancer tests after a decline during the pandemic

Oncology patients and Fertility Preservation:

https://www.illum.com.mt/ahbarijiet/socjali/66660/ftit_snin_ilu_lpriorit_kienet_li_nnisa_jfiqu_millkaner_illum_storja_differenti_irridu_li_jgixu_ajja_kuntenta__

Bulgarian National News Agency:

https://www.bta.bg/bg/news/bulgaria/oficial-messages/483898-balgarsko-druzhestvoto-za-borba-s-raka-na-gardata-rabotilnitsa-po-robotizirana-?fbclid=IwAR1rznIWYDkgZqqn7Uft1ftph7QwFZA75GdsZOFAuBP_7Yony1Sq_q27oW0

North Macedonian National News Agencies:

https://www.slobodenpecat.mk/od-ginekoloshkite-karcinomi-zaboluvaat-mladi-zheni-i-devojki-duri-i-pred-pubertet/

https://www.mkd.mk/makedonija/obrazovanie-i-zdravstvo/registracijata-na-karcionimi-e-na-nezadovolitelno-nivo

Регистерот на карционими во државата на незадоволително ниво

Во Македонија уште не постојат конкретни податоци за бројот на заболени со гинеколошки карциноми во државава

https://www.brif.mk/retkite-kartsinomi-i-ne-se-taka-retki-registerot-na-kartsionimi-vo-drzhavata-na-nezadovolitelno-nivo/

Во Македонија уште не постојат конкретни податоци за бројот на заболени со гинеколошки карциноми во државава

Ретките карциноми и не се така ретки, регистерот на карционими во државата на незадоволително ниво

https://makpress.mk/Home/PostDetails?PostId=501476

Ретките карциноми и не се така ретки, регистерот на карционими во државата на незадоволително ниво

https://www.fakulteti.mk/news/19092022/retkite-karcinomi-i-ne-se-taka-retki-registarot-na-karcinomi-vo-drzhavata-e-na-nezadovolitelno-nivo

Ретките карциноми и не се така ретки, регистерот на карционими во државата на незадоволително ниво

https://opserver.mk/makedonija/retkite-karcinomi-i-ne-se-taka-retki-registerot-na-karcionimi-vo-drzhavata-na-nezadovolitelno-nivo/

https://kurir.mk/makedonija/vesti/retkite-karcinomi-i-ne-se-taka-retki-registerot-na-karcionimi-vo-drzavata-na-nezadovolitelno-nivo/

https://makpress.mk/Home/PostDetails?PostId=501403

https://24.mk/details/mago-za-podignuvanje-na-svesta-za-vazhnosta-i-grizhata-za-reproduktivnoto-i-seksualnoto-zdravje-na-zhenata

https://opserver.mk/makedonija/mago-za-podignuvanje-na-svesta-za-vazhnosta-i-grizhata-za-reproduktivnoto-i-seksualnoto-zdravje-na-zhenata/

https://makpress.mk/Home/PostDetails?PostId=501791

Во Македонија уште не постојат конкретни податоци за бројот на заболени со гинеколошки карциноми во државава

https://24.mk/details/vo-shuto-orizari-ginekolog-ni-za-lek

https://24.mk/details/prof-tofovski-retkite-karcinomi-i-ne-se-taka-retki-kaj-nas-vo-makedonija

https://kanal5.com.mk/retkite-ginekoloshki-karcinomi-vo-porast/a547596

СЕКОИ 5 МИНУТИ УМИРА ОД ГИНЕКОЛОШКИ КАРЦИНОМ ПО ЕДНА ЖЕНА ВО СВЕТОТ Неопходно е подигнување на свеста за важноста на репродуктивното и сексуалното здравје

Од гинеколошките карциноми заболуваат млади жени и девојки дури и пред пубертет

https://www.facebook.com/watch/?v=1060624731430149

https://www.youtube.com/watch?app=desktop&v=bG5vS4kqA00&feature=youtu.be

TV interviews

The outcomes and deliverables of GYNOCARE COST Action have been disseminated during many TV interviews. Here are some examples:

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Special Issue in EJSO

jean.calleja-gius@um.edu.mt — Sat, 14 Oct 2023 08:51:06 +0000

Call for articles in Special Issue dedicated to GYNOCARE

Professors Jean Calleja-Agius, Gemma Gatta, and Sergio Sandrucci are guest editing a Special Issue entitled “Focus on Gynaecological Tumours” for EJSO - European Journal of Surgical Oncology.

Experts are invited to present a paper to the EJSO SI: Focus on Gynaecological Tumours.

The length of the article is a maximum of 3,000 words and 30 references (see the specific guidelines in the EJSO website).

The planned deadline is June 2024.

For more details, please contact Prof Jean Calleja-Agius.

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Collaborating Patient Advocacy Groups

jean.calleja-gius@um.edu.mt — Wed, 11 Oct 2023 22:02:36 +0000

Engagement with Oncology Patients and their Representatives

As part of the GYNOCARE COST Action, there was a very good collaboration with numerous patient advocacy groups involved in cancer, especially the rare gynaecological tumours.

MC members collaborated with the Fondazione ANT (Associazione di Tumori Onlus Italia) in Italy, thanks to Prof Francesco Pegreffi from the University of Bologna. This led to two important publications:

Paruto G and Pegreffi F (2022) La Telemedicina nell'Assistenza Terapeutica e in particolare Oncologica. Bologna University Press. This open access book was launched during a hybrid satellite meeting held in collaboration with GYNOCARE and the 'Fondazione Carlo Rizzoli per le Scienze Motorie', the 'Fondazione Assistenza Nazionale Tumori (ANT) Italia Onlus', and the 'Fondazione Cassa di Risparmio' in Bologna in September 2023. Click here to read the full text of the open access book.
Pazzaglia C and Pegreffi F (2021). La Salute del Caregiver. Bologna University Press. Click here to read the full text of the open access book.

Collaboration with the ALIVE Charity Foundation

Members of the GYNOCARE Consortium have been working closely with the ALIVE Charity Foundation, who in turn raise funds to support research in the field of cancer.

Together with the Research, Innovation and Development Trust (RIDT) in Malta, dissemination activities including symposia are held, aimed at patients, patient advocacy groups such as EUROPADONNA and all the relevant stakeholders. One example is the Cancer Symposium held under the patronage of Her Excellency The President Emeritus of the Republic of Malta.

Collaboration with the National Alliance for Rare Diseases Support

GYNOCARE COST members work in close collaboration with the National Alliance for Rare Diseases Support in Malta. The aims of this National Alliance are: to provide support and information to patients and relatives going through a crisis related to the mentioned illnesses and to other Alliances working in the field of rare diseases; to educate society in respecting, accepting, and helping as much as possible patients of rare diseases and their relatives; to form part of any national or international association whose aims are similar to that of the Alliance; to raise public and political awareness on rare diseases and conditions; and to encourage and promote research on rare diseases and conditions.

Among the numerous activities that GYNOCARE members are involved in, include the Annual Colloquium on Rare Diseases, which is held in collaboration with the National Alliance for Rare Diseases Support, the Office of the President of The Republic of Malta and the University of Malta.

Collaboration with ESGO-ENGAGE

Established in 2012, the European Network of Gynaecological Cancer Advocacy Groups is an ESGO network of European patient advocacy groups representing all gynaecological cancers (particularly ovary, endometrial, cervix, vulva and rare cancers).

ENGAGe objectives include:
- Facilitating the development of national gynaecological cancer patient groups in Europe and to facilitate networking and collaboration between them;
- Disseminating information and share best practices to empower patient groups and improve the quality of care across Europe;
- Increasing patient representation in ESGO activities by education on current research and health policy;
-Advocating patient care policies practices and access to appropriate care at both national and European levels; and
-Educating patient groups, health professionals, the public and health decision makers.

Dr Sharon O'Toole, leader of WG2 of GYNOCARE COST Action is very actively involved in ESGO-ENGAGE. During all the conferences and training schools organised by the GYNOCARE COST Action, she was always at the forefront in advocating for building patient partnerships.

Annually, members of GYNOCARE COST Action advocate for raising more awareness on rare gynaecological cancers on World Gynaeoncology Day and on World Ovarian Cancer Day.

Collaboration with the Bulgarian Breast Cancer Association (BBCA)

The MC member from Bulgaria, Dr Mariela Vasileva-Slaveva is the Director and Founding member of the Bulgarian Breast Cancer Association (BBCA). Together with her and the participants of the different working groups of the GYNOCARE COST Action, a successful 5 day event consisting of a training school and a conference were held at Sofia University in Bulgaria. This included a whole session dedicated to patient advocacy, with translators being available in order to ensure outreach. Among the speakers, there was Yulia Panayotova, who spoke about the role of women in inspiring other women to address inequalities in access to cervical cancer screening and Dr Margarita Tareyn, who stressed on the importance of effective doctor-patient communication.

Collaboration with IDIWAKA

Cervical cancer is the 3rd most common cancer worldwide among women. Uganda is the 7th country with the highest incidence of cervical cancer in the world and constitutes 40% of all cancers in the country, with high mortality among women aged 25-65 years. This is due to limited access to screening and preventive measures, which could reduce its incidence by up to 80-90%. Therefore, GYNOCARE has collaborated with Dr Cristina Clare Gallego de Largy, MC member from Spain, who is part of IDIWAKA. Together with her team from IDIWAKA, she has embarked on a mission on this new adventure with the aim of reducing mortality from cervical cancer in Ugandan women. It began at the Padre Pio Health Center III, Kamwenge (Uganda) , seeking to promote health and train the female population on the importance of HPV vaccination and carrying out free HPV tests. In addition, training will be carried out for local hospital staff so that in the long term they themselves will continue the project.

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Outcome of meetings with Pharma and Biotech SMEs

jean.calleja-gius@um.edu.mt — Wed, 11 Oct 2023 21:52:22 +0000

GYNOCARE building bridges with Pharma and Biotech

During the Training School organised in Sofia, Bulgaria in June 2023, one of the workshops was specifically dedicated to robotic surgery and its role in operating on patients with rare gynaecological cancer. This was organised by Dr Mariela Vasileva-Slaveva. The national media in Bulgaria covered this even in a press release. Click here to read more.

Dr Karina Belemezova from Sofia University gave a practical workshop on HPV testing in collaboration with a biotech company.

In addition, during the same meeting, there was a series of lectures dedicated to advances in robotic surgery in the field of gynae-oncology. Click here to read more.

Collaboration with Pharma Companies

Collaboration with pharma companies helped to support our early stage career researchers. One example is Gedeon Richter plc, which is a European innovation-driven specialty pharmaceutical company with products distributed in more than 100 countries worldwide. The Gedeon Richter prize includes a monetary prize and a book token for the medical student whose women’s health related essay submission is deemed to be the most meritorious by a board of assessors representing the departments of obstetrics and gynaecology and of the pre-clinical studies. Mr Karl Livori was awarded this prize in 2023, following his essay on ‘Endometriosis-associated Ovarian Cancer’ , done in collaboration with GYNOCARE members.

There was an exhibition area set up specifically organized by pharma companies at GYNOCARE conferences, and conferences organized by GYNOCARE members.

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Dissemination to Pharma & Biotech industries

jean.calleja-gius@um.edu.mt — Wed, 11 Oct 2023 21:40:41 +0000

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.

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