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.
Duality role of chief executive officer (ceo) in corporate governance and per...Alexander Decker
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An Interactive Roundtable Discussion with Jean M. Gatewood, Vice President, Clinical Research Strategy, Fox Chase Cancer Center – Temple Health at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
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Duality role of chief executive officer (ceo) in corporate governance and per...Alexander Decker
This document summarizes a research journal article that examines the practice of CEO duality in Nigerian companies and its implications for corporate governance and performance. The study uses financial data from 30 Nigerian companies over 5 years to compare the return on equity (ROE) of companies with dual CEO/chairman roles versus those without. The findings show a statistically significant difference between the two groups, with companies having CEO duality performing lower on average. The authors recommend minimizing CEO duality to strengthen governance and enhance corporate performance.
Ahead of the marcus evans Evolution Summit 2023, read here an interview with Erwin De beuckelaer discussing how utilising and harmonising digital measures in clinical trials will transform the pharma industry.
Ahead of the marcus evans Evolution Summit 2023 and the Evolution Europe Summit 2023, read here an interview with Alexander Fetkovsky discussing the gaps in the clinical trial supply chain.
Ahead of the marcus evans Evolution Summit 2022, read here an interview with Kristine Koontz discussing what it takes for sponsors and vendors to have a mutually beneficial relationship.
An Interactive Roundtable Discussion with Jean M. Gatewood, Vice President, Clinical Research Strategy, Fox Chase Cancer Center – Temple Health at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
Presentation delivered by Sonia Sethi, Vice President, Clinical Operations & Client Engagement, Veristat and Jacqueline Mardell, Vice President, Clinical Operations, Ascendis Pharma at the marcus evans Evolution Summit Fall 2019 in San Diego CA
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2) Setting up clinical trials in the UK and Europe to test the drug nitisinone through a national research center and consortium.
3) Recruiting and retaining over 140 patients from around the world for the trials over 9 months through online outreach and regular communication.
4) Working directly with patient advocacy groups in Europe, Asia, the Middle East, and North America to support patients.
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Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Presentation delivered by Johan Luthman, Vice President, Neuroscience Clinical Development, Eisai Pharmaceuticals at the marcus evans Evolution Summit Fall 2015 in Las Vegas
1) A clinical trial was designed to evaluate the efficacy and safety of clobazam for the orphan pediatric indication of Dravet syndrome.
2) Challenges included a lack of dosing data in young children, capturing baseline seizure frequency variability, and conducting a placebo-controlled trial when clobazam was already available.
3) Pharmacokinetic modeling was used to determine appropriate dosing and sample sizes to supplement limited data, and regulatory and external input helped address challenges.
For more information contact: Slideshare@marcusevans.com.
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Ahead of the marcus evans Evolution Summit November 2019, read here an interview with Dunya Botetzayas discussing how risk-based monitoring can have a positive effect on a study site
This document discusses efforts to find a cure for a rare genetic disease called Black Bone Disease or Alkaptonuria (AKU) through several steps:
1) Understanding the disease through studies of patient symptoms, mouse models, and metabolic pathways.
2) Setting up clinical trials in the UK and Europe to test the drug nitisinone through a national research center and consortium.
3) Recruiting and retaining over 140 patients from around the world for the trials over 9 months through online outreach and regular communication.
4) Working directly with patient advocacy groups in Europe, Asia, the Middle East, and North America to support patients.
Presentation delivered by Dr Steven M. Fruchtman, Chief Medical Officer, Onconova Therapeutics at the marcus evans Evolution Summit Spring 2017 held at the Ritz-Carlton Coconut Grove, FL, May 8-10.
Presentation delivered by Dr Laura Esserman, MD, MBA, Director, UCSF Carol Franc Buck Breast Care Center, Professor of Surgery and Radiology, UCSF at the marcus evans Evolution Summit Fall 2015 held in Las Vegas, NV
This document discusses opportunities for collaboration between academia and industry to drive efficiency in research. It notes that while academia traditionally focused on pure research and industry on profit, drug discovery now requires a mixed model with contributions from both. Effective collaborations could help address challenges like rising costs and project attrition. However, differences in culture and goals can hamper partnerships. The document recommends developing focused projects and consortia, addressing intellectual property and conflicts of interest upfront, and managing collaborations strategically like an investment portfolio to maximize their potential for innovation.
Presentation by Andreas Grauer, MD, Executive Medical Director, Global Development Leader, Amgen at the marcus evans Evolution Summit Fall 2015 in Las Vegas
This document summarizes a presentation on strategies for boosting pharmaceutical innovation given by Kenneth Kaitin. It discusses the current challenging environment for drug development, including expiring patents, competitive markets, and high costs. Drug development times are long with low success rates, driving costs upwards. Oncology has become a major focus of R&D investment. The presentation proposes ways to stimulate innovation in areas of high medical need but low commercial appeal, such as through regulatory and legislative incentives.
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Presentation delivered by Johan Luthman, Vice President, Neuroscience Clinical Development, Eisai Pharmaceuticals at the marcus evans Evolution Summit Fall 2015 in Las Vegas
1) A clinical trial was designed to evaluate the efficacy and safety of clobazam for the orphan pediatric indication of Dravet syndrome.
2) Challenges included a lack of dosing data in young children, capturing baseline seizure frequency variability, and conducting a placebo-controlled trial when clobazam was already available.
3) Pharmacokinetic modeling was used to determine appropriate dosing and sample sizes to supplement limited data, and regulatory and external input helped address challenges.
For more information contact: Slideshare@marcusevans.com.
Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Each Stakeholder and Unravel Disease Mechanisms
Eric Low
Cascais, 16 March 2015
For more information contact: Slideshare@marcusevans.com.
Roy Pettipher
CRTH2 Antagonists for the Treatment of Asthma and Allergic Rhinoconjunctivitis
Drug Discovery Summit Lisbon March 16-18 2015
This very short document contains only three words: experience, marcus evans, and summits. It does not provide enough contextual information to generate a multi-sentence summary. The document consists of three terms but their meaning and relationship are unclear from the limited information provided.
Dr Nicolas Sireau, Chairman and CEO, AKU Society, Chairman and Co-founder, Findacure, a speaker at the Evolution Summit 2014, discusses 10 steps from Black Bone Disease
The Importance of Biomarkers in Hematology/Oncology Drug Development - Presentation by Steven Fruchtman, Former Chief Medical Officer, Syndax Pharmaceuticals, at the marcus evans Evolution Summit 2014 held in Palm Beach, FL May 7-9
Achieving Realistic Project Timelines through Strategic Partnerships and Alliances - Presentation by Nancy Widener, Speaker at the 2014 Evolution Summit held in Palm Beach FL May 7-9.
Achieving Realistic Project Timelines through Strategic Partnerships and Alli...
Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical
1. 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
2. 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
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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
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To view the web version of this interview, please click here: www.pharmaceuticalseries.com/MilenVrabevski