Newsletter View

Newsletter February 2010


Dr. Angelos M. Stergiou (photo left), MD, President & Chief Operating Officer, Genesis BioPharma Group, discusses the plans BioPharma has to open a clinical trial facility in Athens. The clinic will be fully dedicated to clinical research drugs developed by Biopharmaceutical companies and Genesis' own developed drugs. Dr. Steve R. Arikian (photo right), MD, is Chief Executive Officer of Genesis BioPharma Group.

Please provide us with an overview of Genesis BioPharma Group and your distinctive features.

The Genesis BioPharma Group is an integrated group of specialty companies that offer an innovative, state-of-the-art approach to Product Development to accelerate product approval timelines and maximize the value of a pharmaceutical, biologic or medical device.

Our Phase I-IV studies incorporate the full range of services from clinical study design to bioanalytics to peri-approval and post-marketing services. We optimize and enhance our clinical research capabilities globally in single and multi-center clinical trials, physician initiated studies, registry and observational studies, PROs, prospective and retrospective studies.

In addition to providing a full suite of development services to our clients, Genesis also utilizes this core expertise to develop our own products, through all stages of clinical development.

Genesis provides a novel approach to clinical trial conduct through our dedicated Clinical Research Clinics (CRCs), which focus exclusively on clinical trial patients.

What do you plan on doing in Greece?

Genesis BioPharma is pleased to announce the opening of its flagship dedicated clinical trials facility, Genesis Medical, by summer 2010. Genesis Medical will provide patients who are seeking treatment in critical diseases access to the most innovative research drugs. 

The flagship facility will open its doors in New York City, with parallel expansion within Europe, beginning with Athens as we have already identified a site in central Athens. The Facility in Athens will provide patient access from the Balkans, mid-East and Russia.

Additional facilities will be located in Zurich, Switzerland (access to central Europe), and London, UK (access to Northern Europe and major hub due to central location).

What will be the role of this clinic?

Genesis Medical will conduct Phase I-IV outpatient clinical trials and will deliver its services through its highly trained staff that includes physicians, nurses, dedicated clinical research personnel.

The clinic will be fully dedicated to clinical research drugs developed by Biopharmaceutical companies and Genesis' own developed drugs with the objective of providing gold-standard diagnostic work and therapies to patients participating in a particular protocol and allowing them to be treated with novel drugs, giving patients access to those treatments in development, and providing hope, many times in diseases which seem incurable.

Genesis will provide access to tomorrow's BioPharmaceuticals today, in advance of FDA or EMEA or other health authority approval, through clinical trials in a nurturing atmosphere that maximizes outcomes.

We at Genesis believe that such a clinic will embrace many patients in the US and Europe as we put the patients’ well-being as our top priority and individually assessing which protocol they may be candidates for via our sophisticated patient management system and triage.

In summary, we want to help and treat as many patients in need who desire enrolling in a clinical trial.

Are you looking for investors and partners?

We are currently seeking investors to accelerate the development of our global clinics.

The global market has high levels of demand for research and a shortage of supply. To illustrate, according to a 2002 Wall Street Journal article, approximately 6,000 new drugs, procedures and treatments were being tested in 80,000 different locations in the US alone, and 80% of clinical research trials were being delayed because of participant shortages. And this appears to be a trend that has continued into more recent years.

New drug development is very costly and increasing for drug companies and the need to minimize the development timeline is great. The environment for dedicated research sites is strong with many organic growth opportunities, even in the face of the current financial crisis.

Why should one invest in the Genesis BioPharma Group?

We believe that Genesis Medical presents a unique investment opportunity as it serves a growing market that is in need of a faster vehicle to secure drug approval. The Genesis Medical clinical trials clinics will do just that.

The principals of Genesis have conducted numerous clinical trials in a wide range of medical indications. Our comprehensive experience allows us to pursue a wide range of trials with limited sales and marketing effort. Because of our proven experience, the majority of trials we will contract for are from drug companies and CROs.

The Management Team is also known for meeting or exceeding its enrollment targets in past clinical trials, having run studies and enrolled patients for a total of more than 2,000 patients, typically enrolling 5-50 patients for a trial, depending on its requirements.

The population of the New York Tri-State area from which we will initially draw its patients in the US, is approximately 20M providing an ample population base in which to increase patient enrollment in trials. The other locations include Athens, Greece, Zurich, Switzerland and London, UK with a combined total population of more than 20M. The Company has developed its own database of 6,000 prospective patients, including medical data, that it uses to identify patients likely to meet the criteria of a specific clinical trial.

The expansion of the worldwide pharmaceutical market has expanded from U.S. $390 billion in 2001 to an $708 billion in 2008 and the demand for more efficient methods of bringing products to market provides an excellent atmosphere for the growth of Genesis Medical.