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Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical
 

Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical

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Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical, a contract research organisation attending the marcus evans Evolution Summit 2013 in Europe and the Evolution Summit 2014 in ...

Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical, a contract research organisation attending the marcus evans Evolution Summit 2013 in Europe and the Evolution Summit 2014 in North America, on what is essential for a seamless clinical trial.

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    Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical Document Transcript

    • Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical Chief Medical Officers (CMOs) sometimes fail to acknowledge what is essential for seamless clinical operations, according to Dr Milen Vrabevski, Chief Executive Officer, Comac Medical. “Successful trials are primarily dependent on the physician’s devotion to the concept of a potential benefit to the patient and his or her willingness to commit time. These factors, in conjunction with a support staff of experienced coordinators and regulatory personnel, are essential for a seamless effort. The “nuts and bolts” of daily queries, Contract Research Organisation (CRO) monitoring visits and vigilance over accumulated data still require physician oversight. Nonetheless, the benefits outweigh the time required,” he details. Comac Medical is a CRO attending the marcus evans Evolution Summit 2013 in Europe and the Evolution Summit 2014 in North America. How is the landscape of clinical operations changing today? What challenges and opportunities is it presenting to CMOs? CMOs are operating in an environment that is constantly changing and with various regulatory requirements. Many companies conduct trials in developing or emerging markets to reduce costs and take advantage of their services. For example, the Balkan and Baltic regions are a highly attractive market for conducting trials. They are non- s a t u r a t e d , h a v e e x p e r i e n c e d investigators and flexible logistics. However, it is important to work with CROs that are experienced and able to manage in an unstable regulatory environment. What would help accelerate drug development and delivery/time to market? It is not surprising that as development costs have increased, the absolute number of newly approved drugs has constantly been decreasing for several years. Together with the greater scrutiny of the approval process, this has created a growing problem both for the drug industry and for patients who are desperately waiting for new drugs. It is therefore timely to consider how new technologies (namely functional genomics, proteomics and the related field of toxicogenomics) can help speed up drug development and make it more efficient. Ultimately, it will be market forces that decide whether the pharmaceutical industry will start using the large-scale “-omics” approaches. If it leads to cost savings, as we believe it will, pharmaceutical companies will inevitably adopt them. Secondly, by removing the considerable cost and delay of waiting for approval between stages, we can widen the pool of viable treatments and accelerate drug development. There is a desperate need for capital efficiency and reduction of risk in clinical development. We are watching the adaptive clinical trial design technologies that are available, as they give CMOs the opportunity to move forward and work faster. We see that as a good opportunity to tap into. What is unique about Comac Medical’s approach? We strongly believe that the time and effort spent in planning a product’s clinical development program directly correlates with the chance of success. Clinical Strategy Planning is the vital innovation needed to survive today’s challenges, includ ing financial constraints, the high cost of execution and competition. The right strategy improves the decision’s quality. Our personnel are highly experienced and trained, and clearly comprehend the cultural and professional peculiarities of sites and investigators. They are able to track and manage tools that encompass the entire clinical trial process, providing broad oversight capabilities. What is key to clinical trial success? What do Chief Medical Officers overlook? Better understanding the processes by which drug candidates affect the human body and identifying the cellular factors and processes with which these compounds interact will be the key to improved therapeutics. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. Working with experienced CROs that are able to manage a diversified regulatory environment and are committed to timely delivery of results is a key success factor Ensuring a Seamless Clinical Trial
    • The Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional t r e n d s a n d b r e a k t h r o u g h innovations. Please note that the Summit is a closed business event and the number of participants strictly limited. For more information please send an email to info@marcusevanscy.com or visit the event websites below: Evolution Summit (Europe): www.evolution-summit.com Evolution Summit (North America): www.evolutionsummit.com Contact Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division Tel: + 357 22 849 313 Email: press@marcusevanscy.com For more information please send an email to info@marcusevanscy.com All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.com About Comac Medical Comac Medical Ltd. founded in 1997 by Dr. Milen Vrabevski, CEO operates as a boutique full-service clinical research/site management organization via own network of offices with more than 250 full-time employees. 14 CEE countries / 100 million population incl. Romania, Poland, Bulgaria, Georgia, and others. Key achievements: Certificate of Recognition by USA NIH 3 FDA inspected Sites (NAI letters) EMA inspected Sites Certified by French Govmnt Hospital-based EU CA-inspected Clinical Research units ISO 9001:2008 DIA partner CDISC partner www.comac-medical.com About marcus evans Summits marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, case studies, roundtables and one-to-one business meetings. For more information, please visit: www.marcusevans.com Upcoming Events Discovery Summit (Europe) - www.discovery-summit.com To view the web version of this interview, please click here: www.pharmaceuticalseries.com/MilenVrabevski