Event the first Clinical Research Unit in Greece – Bioequivalence and vaccine studies in early 2023

Her first one and unique in Hellas , Clinical Research Unit of the AUTH located in the “Papageorgiou” hospital was inaugurated tonight by the Deputy Minister of Health Mina Gaga.

It is one of the four Units of the Special Biomedical Research and Education Unit (EMBIEE) of the AUTH, and its main objectives are to conduct phase I clinical studies, bioequivalence and/or therapeutic equivalence studies and pharmacovigilance – pharmacoepidemiology studies.

Contracts have already been signed for the first studies to start in early 2023. The first phase I study is funded by an Australian pharmaceutical company, the second is bioequivalence study and is sponsored by a Greek pharmaceutical industry and the third study is phase II and concerns the development of a vaccine for the respiratory syncytial virus (RSV) which is funded by a Chilean university.

Mrs. Gaga, who inaugurated the Clinical Research Unit, representing the prime minister said: “We are very interested in the new Clinical Research Unit.

The “Papageorgiou” hospital is, in principle, a pioneer in many things, as is the Aristotle University of Thessaloniki.

And of course it is also a personal wish of the prime minister who has started a group of scientists and the Greek diaspora abroad as well as foreign scientists for the advancement of biotechnology and for research, for young researchers and in universities and medical technology institutes, but also the attraction of investments in biotechnology which are very important for the country.

Thessaloniki is a big hub that has already started with Pfizer, the facilities we already know, Boehringer Ingelheim, Tripoli is also becoming now with our own companies which is also very important. Well, we have a very good future to look forward to for our young people, young researchers and for the country in general. We very much want to attract investment, but we also want the very important lifeblood of research to exist, which in Greece we are very good at.”

The Clinical Research Unit

The Clinical Research Unit of the Medical School of AUTH operates in a 500 square meter space on the 4th floor of the “Papageorgiou” hospital. It is a Clinic which has 18 beds dedicated exclusively to clinical studies and is staffed by a certified medical and nursing staff of 30 people.

“The studies we intend to carry out are early phase clinical studies, i.e. phase I studies which include studies conducted either in healthy volunteers since they concern the first phase of the development of a new drug, or for specific therapeutic preparations and in patients. These are the so-called first-in-human studies, i.e. for the first time a drug is used in humans. At the same time, within these clinical studies that we will do are bioequivalence studies.

They are studies done to prove the pharmacokinetic equivalence between original and generic drugs.

This Unit is innovative and unique throughout Greece.

There is no other such Unit officially with gazette to meet all the specifications required by law for phase I Units as it exists pan-European and this means that in addition to the one exclusively dedicated to clinical studies there must always be an Intensive Care bed immediately available, which in our case is downstairs and in agreement with the hospital is always available.

We also have a laboratory with a mass spectrograph where professor Nikos Raikos is responsible and where the pharmacokinetic studies required for the early phase studies will be carried out,” said the head of the Clinical Research Unit, associate professor of Pharmacology, George Papazisis.

To a question about the clinical studies that will start in 2023, Mr. Papazisis replied: “We have signed and at the beginning of 2023 the first two studies will start, a phase I study sponsored by an Australian company, a bioequivalence study sponsored by a Greek pharmaceutical company and we also agreed on a large phase II vaccine study concerning the respiratory syncytial virus (RSV). This study is not funded by a pharmaceutical company. It is funded by a Chilean University with which we collaborate. Importantly, studies can also be done that are not necessarily funded by pharmaceutical companies. There is still no vaccine for RSV so the study is important. This phase II study will be done only by us and the agreement with the University of Chile, where the director and professor of Greek origin Alexis Kallergis is responsible, is for us to run it on people over 60».

The Special Unit for Biomedical Research and Education

The president of the Department of Medicine, AUTH and chairman of the Board of the Special Unit for Biomedical Research and Education (EMBIEE), Kyriakos Anastasiadis, pointed out that the Clinical Research Unit is one of the four Units of EBIE, while the other three are the Basic and Translational Research Unit, Precision Medicine Unit and the Innovation & Research Unit in Medical Education.

EMBIEE, as mentioned by Mr. Anastasiadis, is an initiative of the Department of Medicine of the Aristotle University of Thessaloniki to support and promote biomedical research and education, based on interdisciplinary approaches, which mainly include medicine, biology, genetics, pharmacology and biomedical informatics.

The purpose of EMBIEE is to support and promote biomedical research and education, based on interdisciplinary approaches. In particular, it aims to:

1. In the two-way synergy between various medical, dental and pharmaceutical specialties, but also other thematic areas in health sciences, biomedical engineering, molecular medicine, pharmacogenetics and biotechnology.

2. In the development of biomedical research in the basic life sciences, in the field of translational research and in applied biomedicine, with the main goal of quality, safe and continuous provision of health services to the citizen, placing particular emphasis on the prevention and quality treatment of diseases.

3. In the creation, evaluation and standardization of innovative research and educational products, systems and services, as well as in the creation of spin-offs and start-up companies, to support and promote in the market innovative applications/products in biomedical practice.

4. In the creation of the field of meeting and cooperation of the university community with the companies active in the field of biomedical research, with the aim of solving the interdisciplinary and complex problems presented in the field of biomedical research.

RES-EMP

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