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5,100 vaccines received at two North Macedonian border checkpoints at Comac Medical’s vaccination centers

The Bulgarian clinical research company Comac Medical officially closed its two vaccination centres on the border with the Republic of Northern Macedonia. The initiative started in May with the financial support of the owner of the company – Bulgarian philanthropist and entrepreneur Dr. Milen Vrabevski. For three months the medical centres at Zlatarevo and Stanke Lisichkovo border checkpoints, together with another one at the hearth of Sofia, delivered over 5,100 COVID-19 vaccines. People could choose between the products of Pfizer and Johnson & Johnson.

Both Bulgarians and Macedonians with a permanent or temporary Bulgarian citizenship took advantage of the opportunity to get vaccinated at the border centers. Whole groups of police officers, firefighters and kindergarten staff organized visits to the vaccination points. Dr. Milen Vrabevski explains that the motivation for the initiative was simple – people in RN Macedonia did not have access to the most popular vaccines against COVID-19 for far too long. That is why he decided to act:

„There are over 120,000 citizens with Bulgarian passports in our Western neighbor, we were obliged to think about these people. We have permanent and temporary residents whose families and ancestors are connected with Bulgaria. We follow the European Union’s policy for the integration of the Western Balkans, which includes assistance and care in the pandemic situation. We always think of our brothers and sisters in the Republic of Northern Macedonia”, said Dr. Vrabevski.

On 10 June 2021, Reuters Events Pharma partnered with leading industry minds from organizations like Mallinckrodt Pharmaceuticals, Amsterdam UMC, Peachtree and Julius Clinical to discuss the future of outsourcing regional and global trials. More than 500 participants subscribed for the webinar and took part in the organized polls. According to the Reuters’ webinar personalization is the new king of global outsourcing. Patients are crying out for more flexible, more diverse and less burdensome trial designs, while the ever larger CROs become less versatile with every merger. Therefore, it’s no surprise that pharma is beginning to ask questions about how to receive the one-to-one attention we need to build innovative global trials.

The exclusive discussion covered topics such as how to improve efficiency and streamline solutions with more personalised approach to clinical. The participants also shared strategies that drive value for patients and shine a light on pharma excellence. In relation to clinical trial outsourcing, Mrs Tsvtelina Ivanova, CCO of Comac Medical commented on how to reach a more personalized future, providing a better experience and operating with more efficiency, and improving timelines. She also shared Comac Medical’s experience on the positives and negatives associated with working with small CROs, risk factors and debunking some of the myths.

Sharing their expertise also were:

  • Anne Marie Inglis, PhD, Senior Director, Clinical Operations, Mallinckrodt Pharmaceuticals
  • Prof. Philip Scheltens, Professor of Cognitive Neurology and Director of the Alzheimer Center, Amsterdam University Medical Centers
  • Tsvetelina Ivanova, CCO, Comac Medical
  • Dr. Keith Coffee, SVP Medical and Scientific Affairs, Peachtree
  • Hans van Dijk, Chief Operating Officer, Julius Clinical

The event is part of the Reuters Pharma events and is free to access through the link: https://youtu.be/SIsFI0sgTEU

 

Yesterday 10 June 2021, at an official ceremony in the Balkan Hotel, the 18th consecutive edition of the “Annual Responsible Business Awards” was held – the most authoritative national competition for corporate social responsibility and sustainable development, which is held under the motto “Give a good example” and is organized by Bulgarian Business Leaders Forum.

At the event, Comac Medical received two awards for the program “Road to the University” a joint project of Comac Medical and the Bulgarian Memory Foundation. The aim of the initiative is to support young people living in small remote settlements in Bulgaria, with limited opportunities for development, as well as young people from families with low social status and different ethno-religious background, to gain access to free courses in school subjects they can use to apply to the desired higher education institutions, and then to develop in the professions of their dreams.

The first award was presented to Comac Medical by the Minister of Education and Science Prof. Nikolay Denkov – second place in the category “Investor in Knowledge” among 27 nominations in it. At the award ceremony, Minister Denkov humorously reminded the attendees that Comac Medical was about to become a serial recipient of awards, after the company was recently granted with the Pythagoras award in the category “Company with the biggest investment in research and development in Bulgaria”.

The second award that Comac Medical received for the evening was the special “Engage” award of the British Embassy in Sofia for the employees’ contribution to a responsible project of the company. The award was presented by Tim Buceret, Head of the International Trade Department at the British Embassy. Comac has been chosen among all 78 companies and a total of 111 projects that took part in this year’s edition of the Annual Responsible Business Awards.

Comac Medical’s CCO (Chief Compliance Officer) Mrs. Tsvetelina Ivanova along with other clinical leaders from organisations like Mallinckrodt Pharmaceuticals, Amsterdam UMC, Peachtree and Julius Clinical will explore the emerging future of outsourcing regional and global trials and discuss overcoming concerns around perceived risks and inefficiencies when building tailor-made trial solutions.

This exclusive discussion covers other topics such as:

  • How to build an outsourcing strategy that will deliver greater design flexibility and closer working with industry expert KOL’s
  • Where to find the right partners who can deliver personalized access to local sites, patient populations and scientific support
  • Why developing a peer-to-peer approach with local experts results in patient-preferred trial designs, outcomes and deliverables

Sharing their expertise are:

  • Anne Marie Inglis, PhD, Senior Director, Clinical Operations, Mallinckrodt Pharmaceuticals
  • Prof. Dr. Philip Scheltens, Professor of Cognitive Neurology and Director of the Alzheimer Center, Amsterdam UMC
  • Tsvetelina Ivanova, Chief Compliance Officer, Comac Medical
  • Dr. Keith Coffee, SVPMedical and Scientific Affairs, Peachtree
  • Hans van Dijk, Chief Operating Officer, Julius Clinical

The event is part of the Reuters Pharma events and is free to access through the link: https://bit.ly/3eFGOVV

On May 24, in an official ceremony in Sofia, for another year the Ministry of Education and Science granted the awards for significant contributions and achievements in scientific development – “Pythagoras”.

Pythagoras Award 2021 in the category “Company with the biggest investments in scientific research and development” for the period 2017-2019 was awarded to Comac Medical Ltd. According to the jury, after a rivalled competition, the company has distinguished itself and met the high criteria for a prize in this area.

The award was received by the owner and CEO of Comac Medical, Dr. Milen Vrabevski.

“This is the second time I receive this award and I am extremely grateful that you all give me the opportunity and motivation to continue in this direction. Most of my gratitude goes to my colleagues who carried on their shoulders the whole process of continuous investment and reinvestment in Bulgarian science. It is very important to emphasize the following: “Dear colleagues, this award is yours”, said Dr. Vrabevski during the award ceremony and noted that by constant investment in innovative thinking, he and his team achieved some extraordinary results, and an example of this is the vaccination of the citizens of the Republic of Northern Macedonia that started on his  initiative.

The Pythagoras Award goes to Comac Medical for second time after the company won the prize in the same category in 2016. The company demonstrates an accelerated rate of increase in its investments in scientific activities, and as a result of this favorable dynamics, the funds invested in scientific R&D by 2020, compared to 2016, have doubled.

Comac Medical was established in 1997 by Dr. Milen Vrabevski, owner and CEO of the company. Over the years, Comac Medical has proven itself as the largest company for research and development investments in Southeast Europe, conducting both traditional and highly innovative clinical studies in various therapeutic areas and in projects for  improving patients’ quality of life.

In 2021, Comac Medical operates in 30 countries. The company reinvests 88% of its net sales revenue in scientific R&D investments. The company’s costs for the cumulative three-year period (2018-2020) amount to BGN 62,324,000 – significant funds with absolute value for the scale of the country.

Over the last five years, the company has placed a specific focus on finding innovative solutions of health and social challenges, including through Horizon 2020 program, on forward thinking towards personalized medicine and on creating specialized knowledge about lung diseases that are as equally important as the oncological and cardiovascular diseases.

After having started the vaccination process in the medical center of Comac Medical in the yard of Alexandrovska Hospital in Sofia, on 17th May 2021, with the kind assistance of the Ministry of Health, Ministry of Interior, Ministry of Foreign Affairs, Ministry of Defense and Customs Agency, we are beginning the vaccination of citizens at the border checkpoints St. Lisichkovo and Zlatarevo.

Those wishing to be vaccinated will be able to do so only after sending a preliminary request to +359 (0) 886 800 264 (Viber), +359 (0) 882 516 981 (Viber). After stating their wish on the phone numbers stated above, our team will contact them for specifying the date and time for vaccination.

We call for strict adherence to vaccination dates and times in order to avoid crowding!

On the Health Worker’s Day, 7 April, the Medical Center which is part of the largest Contract Research Organization in Southeastern Europe, Comac Medical, owned by Dr. Milen Vrabevski, was approved by the Ministry of Health to perform the functions of a vaccination center.

As part of Dr. Vrabevski’s initiative, the Medical Center will also focus on covering the vaccination of the citizens of the Republic of North Macedonia.

“We hope that the state will support us in this journey. Discussions with Minister Karakachanov are underway, and their outcome aims to provide additional support using military vans as vaccination centers at the border crossings, which will facilitate the vaccination of all citizens of the Republic of North Macedonia – whether they have a Bulgarian passport or not,” commented Dr. Milen Vrabevski.

CÚRAM, the Science Foundation Ireland (SFI) Research Centre for Medical Devices, hosted a webinar on 16 February 2021.

The organizers welcomed the Chief Compliance Officer of Comac Medical – Tsvetelina Ivanova, who took part in this event along with representatives of the European Commission, business organizations and EU Member States.

The webinar introduced key recent developments in the next generation medical device technologies and their potential to impact health outcomes and improve the quality of life of patients. The webinar also covered the regulatory environment necessary to sustain the competitiveness of this highly innovative European sector.

Bulgaria was represented by Ms Tsvetelina Ivanova (CCO Comac Medical ltd.) and by Ms Karina Angelieva Vice Minister of Education and Science of Bulgaria.  Ms Tsvetelina Ivanova presented the innovative project of Comac Medical part of the Horizon 2020 programme concerning a medical device for diagnosing respiratory diseases.

Comac Medical is one of the few SMEs in Bulgaria that have benefited from the EU’s largest research and innovation framework programme in history which goal is to lead to more breakthroughs and discoveries by taking great ideas from the lab to the market focusing on three key areas: excellent science, industrial leadership and societal challenges.

In 2015 Comac Medical positioned Bulgaria on the map of the Horizon 2020 programme with an innovative approach for early diagnostics and monitoring of inflammatory and degenerative processes in the lungs including but not limited to asthma, chronic obstructive pulmonary diseases (COPD), tuberculosis and lung cancer.

After successfully completing the Phase I of Horizon 2020, Comac Medical’s team submitted a final report, containing the details and the outcomes of the feasibility study which had proved the commercial potential and the significant innovativeness of the project idea. Currently, Comac Medical is in a process of obtaining an IP protection at international level.

“According to the latest statistical data in Horizon 2020, the participation of the Central and Eastern European countries is less than 5% in the health topics. This leads to concentration of innovations and excellent research in some countries while we are losing the unique opportunities to build innovation ecosystem chain across the whole EU. There is still unused potential in Central and Eastern Europe. We believe that together we can reword problems in a different way, generate innovative solutions and strategic vision in order to find new creative approaches in the future”, commented Ms Tsvetelina Ivanova.

The owner and CEO of Comac Medical Dr. Milen Vrabevski was awarded an honorable certificate by the prestigious medical edition “The doctors we trust”, which once again brought together the most authoritative and respected physicians and managers of medical institutions in Bulgaria.

“I want to thank all the doctors. The importance of the medical profession was recognized by the society. There is more positive attitude towards Bulgaria now and in hard times people remember the state that can lend them a hand,” said during the event Dr. Milen Vrabevski.

“Instead of being judges of the state, we should at certain moments replace it and make sure that Bulgaria is acknowledged,” he recommended. “Bulgarians from abroad should be in the focus of our attention and as a civilized European country we should think about them. In this regard I am crossing the borders of Bulgaria and in addition to my personal example, I made several key donations to the Republic of Northern Macedonia for the colleagues fighting the Coronavirus pandemic from the first line ensuring the most necessary protective equipment is available – these are the cities St. Nicholas, Delchevo and Strumica. Then I moved on to Albania, Prespa region, where I bought an ambulance, a car for social care and a fire truck, “said Dr. Vrabevski.

This year the ceremony held a minute’s silence in memory of the doctors who lost their lives in the fight against Covid-19. Due to the pandemic, the event was held in a different format, and thousands of people watched the online discussion of experts on the topic “The day after tomorrow”.

We would like to remind you that Dr. Vrabevski was included in the prestigious medical edition:” The doctors we trust”, issued yearly in Bulgaria. A total number of 600 Bulgarian doctors, medical centers and hospitals were included as nominees. Nominations were done directly by the patients based on certain criteria like health care, competence, empathy.

On 09 November, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. The issuance of an EUA is different from FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. As part of the evaluation of the EUA, the agency imposed several quality measures to protect patients. The company owning the proprietary rights is required to implement these quality measures to manufacture this drug under the EUA.

Bamlanivimab is authorized for patients with positive results from direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

Based on its review of the scientific evidence available, the FDA determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate COVID-19.

You can access the whole article here

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