The Bulgarian Drug Agency has announced reduced time periods for consideration of clinical trials on medicinal products for human use, pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. Both organizations will make efforts for the validation and assessment of the application in the Clinical Trials Information System – CTIS to be carried out within shorter time periods than those provided for in Chapter II of Regulation (EU) No 536/2014. In the event that no inconsistencies are found and no additional information is requested from the sponsor, the evaluation of the clinical trial may be completed within 35 days of the successful validation of the application.
The above approach may apply to mono-national and single-center clinical trials submitted to CTIS that are in later phases, as well as to substantial amendments to the above-mentioned clinical trials.
The change is expected to bring Bulgaria to the forefront of the European Union in the field of clinical trials.
Comac Medical has the pleasure to inform that we will be participating in this year’s ERS International Congress 2023 that will take place at MiCo in Milan, Italy from 9 – 13 September 2023.
Respiratory specialists will present the latest breakthroughs in respiratory medicine and scientific advancements.
Meet Comac Medical’s expert at the assembly! Vladimir Goranov, Comac Medical CFO, will be there and ready to discuss your upcoming clinical trial needs!
We look forward to meeting you in Milan and hope to start a dialogue with you or your company.
LONDON, June 9, 2023 /PRNewswire/ — Comac Medical (Comac or the Company) announced today that funds advised by EdgeCap Partners (EdgeCap) acquired a majority equity interest in the Company. Comac’s founder and CEO, Dr. Milen Vrabevski, as well as other shareholders, retain a significant minority stake and will continue in their current roles as executive managers, thereby providing continuity to all its clients and partners.
Headquartered in Sofia, Bulgaria, and established in 1997, Comac Medical is the leading full-service clinical research organisation (CRO) in Southern Eastern Europe, present in more than 30 countries and providing a comprehensive range of early to late-phase drug development services to the global pharmaceutical and biotech industries across a variety of therapeutic areas.
Christopher Backes, EdgeCap’s co-founder, said: “We are excited to invest in Comac Medical, which over the past 25 years has grown under Milen’s leadership into an outstanding business that customers overwhelmingly praise for its quality of service, deep medical expertise in early phase clinical development as well as its speed and agility, specifically with regards to patient recruitment across therapeutic areas and rare indications. We think Comac is uniquely positioned to capitalise on the CRO market’s favourable growth prospects and untapped potential.”
Kristjan Piilmann, EdgeCap’s co-founder, said: “Our investment in Comac reflects EdgeCap’s thematic focus on the healthcare & life sciences industry, as well as our commitment to partner with exceptional founders and management teams. We look forward to working alongside Milen and his team to accelerate the Company’s growth organically and to drive consolidation in the CRO space via a targeted buy-and-build strategy.”
Dr. Milen Vrabevski, Comac Medical’s founder, said: “This transaction is a significant milestone for Comac Medical and its over 350 employees who contribute to our success daily. To continue our strong growth trajectory in the years to come and to meet our customers’ needs, we are looking to significantly expand operations while preserving our unique culture that has served as the foundation of our success. EdgeCap supports this vision and is committed to investing significant resources to capitalise on an exciting opportunity ahead. I am thrilled to start this next chapter in our journey and partner with Kristjan and Chris as we work towards the growth and success of Comac Medical.”
The transaction has been completed in June 2023. Kristjan Piilmann, Christopher Backes, and Dr. Günter Schmid, Senior Operating Partner for EdgeCap, will join Comac’s Board of Directors.
Financial terms of the deal were not disclosed.
WOLF THEISS provided legal counsel to EdgeCap, and Kingsley Napley LLP provided legal counsel to Comac Medical and its shareholders in connection with the transaction. Deloitte LLP conducted financial and tax due diligence, and Health Advances LLC conducted commercial due diligence for EdgeCap.
About Comac Medical
Comac Medical, established in 1997 in Sofia, Bulgaria, is one of the largest full-service clinical research organisations (CRO) in South-Eastern Europe, present in more than 30 countries, providing a comprehensive range of early to late-phase drug development services to the global pharmaceutical and biotech industries across a variety of therapeutic areas with a differentiated expertise and track record for indications within oncology, dermatology, gastroenterology, and respiratory diseases.
The Company has a global customer base consisting of emerging biotech and established pharmaceutical companies, offering full outsourced clinical trial support across the entire clinical development timeline. Comac Medical’s FDA and EMA-inspected Clinical Research Unit (CRU) for Phase I, Bioavailability and Bioequivalence studies has 18 years of experience in early phase clinical research and counting over 260 completed clinical trials to date. The facility is the largest in the region and comprises 42 beds, an on-site pharmacy as well as a clinical and bioanalytical laboratory.
About EdgeCap Partners
EdgeCap is a London- and Tallinn-based private equity and growth capital firm focused on investing in high-quality European mid-market companies. Founded by Kristjan Piilmann and Christopher Backes, EdgeCap is backed by family capital and seeks to deploy between EUR 10-100 million per investment.
Contact: info@edgecap.eu
Some of the aspects which will be covered are:
- The changing spectrum of growth disorders – and the eternal 3rd percentile
- Updates on the best practices for conducting and publishing Real-World Evidence studies
- Introduction to benefit-risk assessment for medical writers
- Updates on the best practices for conducting and publishing Real-World Evidence studies
- Impact of CTIS on Medical Writing
- Safety Communication: Why it matters to patients and healthcare providers
- Getting into Medical Writing – Different types of medical writing: Targeting the right audience
- The CORE Reference Project – Value for the Global Regulatory MW Community
Some of the workshops and Expert Seminar Series which our team will attend are:
- Clinical Study Reports – Mastering the Essential Skills
- CORE Reference – Clarity and Openness in Reporting: E3-based
- Beyond Traditional Medical Devices
- Impact of CTIS on Medical Writing
EMWA is always a great opportunity to network among medical writers, communicators, and translators, and allows us to broaden our knowledge about our profession.
Comac Medical Scientific Team will join EUFEPS, the Open Forum Discussion on the ICH Draft Guideline on the Bioequivalence of Immediate Release Dosage Forms on Monday, May 15 in Frankfurt, Germany.
There are some modifications in bioequivalence requirements, relevant for European companies which should initiate comprehensive scientific discussion.
This event will give an opportunity to discuss the new regulations with European representatives of the ICH-Guideline’s drafting group and present our views and suggestions, based on our own experience, during the discussion.
Comac Medical Scientific Team will take part in 25th Pharmacokinetics/Pharmacodynamics (PK/PD) Expert Meeting, Nauen (Germany), April 20th -22nd, 2023.
Presentations and associated discussions will focus on the following topics:
- DDI – What is new 2023?
- Translation to & from patients – Concepts to address the translational challenge
- Drug development for brain diseases – New Approaches
Our team of experts is looking forward to be part of presentations and associated discussions covering PK/PD aspects of early to late stage drug development.
We are excited to share that our Head of Biostatistics, Prof. Krassimir Kalinov, has recently contributed as an author to several new publications, including:
• COVID-19 Infection in Chronic Kidney Disease Patients: Risk Factors for Death and Acute Kidney Injury – https://pubmed.ncbi.nlm.nih.gov/36294815/
• Serum and Urinary Biomarkers in COVID-19 Patients with or without Baseline Chronic Kidney Disease – https://pubmed.ncbi.nlm.nih.gov/36983566/
• Renin-angiotensin-aldosterone system blockers in COVID-19 patients with or without chronic kidney disease – https://pubmed.ncbi.nlm.nih.gov/36482641/
• Assessment of extrafine beclomethasone/formoterol for the treatment of chronic obstructive pulmonary disease: A non-interventional study in a Bulgarian population – https://pubmed.ncbi.nlm.nih.gov/36252915/
We are confident that Prof. Kalinov’s contributions will further enhance the scientific community’s understanding of different diseases and the application of Biostatistics in real-world settings.
As an organization committed to science, Comac Medical continues to support scientific activities through our daily activities and not only.
In 2022, Comac Medical celebrates its 25th anniversary. Established way back in 1997 by Dr. Milen Vrabevski in a small office in the city of Varna and having only a couple of employees, in the next 3-4 years the company has been able to turn into the largest research organization in South-Eastern Europe with over 400 employees and its own structures in over 30 countries.
Comac Medical in the beginning
Small part of Comac Medical now
Comac Medical has seriously expanded its activities for these 25 years with spinoffs and parallel businesses, and our team has earned more than 360 certificates for quality, participation, distinction and training.
The company reinvested 88% of its net sales revenue into R&D costs.
This was also stated by the Ministry of Education and Science: for the second time – in 2021, Comac Medical was awarded a Pythagoras Award in the category “A company invested the most in scientific research and development” for the period 2017-2019. According to the jury, after a tough competition, the company stepped ahead of the competition and responded decisively of the high criteria for a prize in this field. The Pythagoras Award went to Comac Medical for the second time – the company had won the award in the same category in 2016 as well. Compared to the results that led to the first Pythagoras Award, the investments on the basis of which the company was awarded for the second time more than doubled.
“I would like especially to thank my colleagues who carried this entire process of continuous investment and reinvestment in Bulgarian science on their shoulders. It is very important to emphasize the following: “Dear colleagues, this award is yours”, said Dr. Milen Vrabevski, owner of Comac Medical, at the award ceremony in 2021.
Awards and achievements
Comac Medical is the company that in 2016 put Bulgaria on the Horizon 2020 map (EU’s research and innovation funding programme) thanks to an innovative project for early diagnosis of inflammatory and degenerative processes in the lungs. The project received the Seal of Excellence from the European Commission, ranking the company also among the Growth Champions in Europe. The project director of the Executive Agency for Small and Medium-sized Enterprises established by the European Commission (EASME), Marco Rubinato, addressed Comac Medical with the following words:
“You are among the companies with the most innovative ideas in the world.”
For 25 years, Comac Medical has been facing significant changes in the regulatory environment as ICH GCP (R2), EMA Bioequivalence Guidance (2012), FDA Bioanalytical Method Validation Guideline (2018) and successfully implement them. We are again on the wave of significant updates (ICH M10, M11, M12, M13, EU legislation), but we believe that the “less is more” culture of our Managers will continue the successful implementation journey and the company mission to be a partner to our clients in the regulatory field.
For 25 years we have encountered many difficulties and dealt successfully therewith, but the last two years have been a real challenge for every single sphere of life. The emergence of Covid-19 imposed a new world order, we also had to comply with. In addition to being part of the team creating one of the world’s most recognized vaccines, Comac Medical found another way to be useful, relying on its strict and nationally known corporate social responsibility policy. The company turned one of its medical centers into a vaccination center and opened two additional mobile vaccination points at the border checkpoints with the Republic of North Macedonia – Zlatarevo and Stanke Lisichkovo. The points opened doors for vaccination of the Macedonian population at a time when this neighboring country still did not have the most desired and popular vaccines for its population. Over 5,000 vaccines have been administered there.
Vaccination centers
For 25 years, Comac Medical has become an integral part of the progress of our society not only through investments in people’s health, but also through its corporate social responsibility program. We are proud to effectively add value to the development of society and the fact that we are a factor in its growth.
The Bulgarian Memory Foundation, created by us, is an integral part of Comac Medical’s corporate social responsibility policy. Believing that there is still unrealized innovative potential in our country, for more than 16 years we have been investing in young people to believe in themselves and to find their way to a prosperous future.
The owner of Comac Medical and founder of the Bulgarian Memory Foundation, Dr. Milen Vrabevski, has been actively standing behind the cause of helping families with reproductive problems for years. Thanks to the financial support of Dr. Vrabevski, 41 children were born. The Bulgarian Memory Foundation is actively providing financial support to large families, to socially deprived and disadvantaged people; it also invests considerable funds in the Bulgarian historical diaspora in North Macedonia, Albania, Serbia, Ukraine and Moldova by organizing educational initiatives for integration, socialization and European perspective of young people by creating computer labs, purchase of ambulances, fire trucks, providing funds for important repairs, including construction of churches, as well as financial support for Bulgarian cultural centers in the countries where there is a Bulgarian diaspora. During the Covid-19 pandemic, protective equipment was provided for front line doctors from the Republic of North Macedonia.
Small part of the foundation’s donations
One of the main priorities of Dr. Vrabevski and the foundation is the education of young people, therefore every year they organize numerous educational seminars, where young people from Bulgaria, North Macedonia, Albania, Serbia, Moldova and Ukraine learn key competencies, meet successful entrepreneurs and university professors, create, have fun and make enduring friendships.
Through the “Path to the University” project of the Bulgarian Memory Foundation, entrance exam courses and career orientation meetings for young people from remote areas of Bulgaria have been financed on annual basis] in the private educational complex of Dr. Vrabevski – “Tsar Simeon the Great”, free admission for students from South-West Bulgaria and North Macedonia is also provided.
With regard to history, roots and homeland, Dr. Milen Vrabevski is the driving force and main ideologist of the successful implementation of the history school manual “My Bulgaria”. As from April this year, the second, expanded edition of the manual, implemented jointly between the Bulgarian Memory Foundation and the publishing group “Prosveta”, is a fact.
For his overall patriotic activity over the years, the owner of Comac Medical has received numerous important awards, some of them are “European Citizen’s Prize 2013”, “Enlightener of the Year 2014” and “Man of the Year 2019”.
This is just a small part of our 25-year history. A story that, thanks to all of you, we keep writing. We are proud of what we have achieved, we thank each and every employee for their contribution, and we believe that the best is yet to come!
We are happy to share that Comac Medical has been assigned with conducting Phase 2 randomized, placebo-controlled GULLIVER-2 trial. The results of the study were presented at AASLD The Liver Meeting on 4th-8th November.
Check the results in the following document.
Representatives of our Statistical and Medical Writing Team attended the “Slippery Slopes: Survival Analysis” workshop, which was part of EMWA Professional Development Programme at the 54th European Medical Writers Association (EMWA) Conference.
The workshop gave us an understanding of the analysis of survival in the context of clinical trials. We learned the basics of creating and interpreting Kaplan-Meier graphs and the different elements of reporting Kaplan-Meier analyses. The appropriate graphical and tabular presentation of these analyses was discussed, but the focus was on the interpretation.
This workshop gave us a basic understanding of Kaplan-Meier analyses and helped us to be able to interpret the resulting graphs.
