BioSpectrum Magazine features Dr. Vijai Kumar of Excel Life Sciences

Excel Life Sciences (ELS) President and Chief Medical Officer was recently interviewed for a feature article in BioSpectrum Magazine. The wide ranging article includes updates from Dr. Kumar on the performance and growth plans of ELS, as well as his insights on the state of the clinical research industy in India and beyond. ELS is a leading provider of comprehensive clinical trial and site management services in India and is regularly featured in industry trade publications and journals. Please click on the link below to read the full article:

http://biospectrumindia.ciol.com/content/BioServices/11004081.asp

First Survey Made Public on the Understanding and Experiences of Clinical Research Volunteers in India

It is well known that India is a region of the world where clinical research is on the rise. There are many incentives for conducting research in India, including its huge population of treatment-naïve patients and lower cost of conducting trials. It’s estimated that by 2010, the clinical research market in India will reach $500-600 million (1) .

That growth has also brought a tremendous amount of regulatory oversight and safety measures to protect the rights of patients. But that growth has also attracted a tremendous amount of scrutiny and negative media coverage. However, not much information has been publicized regarding Indian patient’s knowledge and understanding of clinical research and their experiences, especially with the Informed Consent process.

Excel Life Sciences has recently conducted a survey of over 500 study participants. This Excel Life Sciences research brief analyzes the important findings of that study and includes comparisons to a study of U.S. patients conducted by CenterWatch.


Key Findings:

• 56% of patients in India were not aware of clinical research prior to participating in a study
• 97% of patients understood the informed consent form (70% very well, 27% well)
• 97% of patients first found out about the clinical study through a physician, vs just 23% in the United States
• Only 8% of patients in India made the decision to participate on their own, vs 38% in the United States
  

Method: This research brief is comprised of proprietary data collected from the 2008 Informed Consent survey of Indian study volunteers by Excel Life Sciences and public data from a 2005/2006 U.S. patient survey conducted by CenterWatch and publicized at the 2006 DIA Annual Meeting. Excel Life Sciences collected the survey data through clinical research coordinators supporting studies at active clinical research sites. Data was collected from July 2008 and the survey is ongoing.

Observations and Conclusions:

Better than Expected Understanding

Considering that India is still an nascent market for clinical research, Excel Life Sciences was surprised to find that over 40% of patients had some understanding about clinical research trials prior to participating. Most patients though, lacked more than surface level awareness and understanding. Overall, patients seemed to have a strong understanding of what was required of them in a study and the risks of participating. In general, the vast majority of patients, some 97%, understood the informed consent document (70% very well, 27% somewhat well). Specifically, patients had a strong understanding of the following:

• 98% understood the number of times that they would have to visit the study site
• 93% understood that the study would carry risks and discomforts
  

Traditional Health Information Sources Used by Volunteers

The advent and expansion of the Internet, along with the litigious healthcare environment in the United States has caused many patients to pursue a variety of information sources to make educated healthcare decisions. In fact, U.S. surveys have found that more than 60% of volunteers go outside of their managed-care setting to self-refer into clinical trials. The Excel Life Sciences survey has found that there is a much more traditional information system in place in India, where patients still turn to their physicians for information about their health. In total 97% of patients in the Excel Life Sciences survey, first learned about the study through a physician, including primary care (76%) or another physician (21%).

Patients: Decision Support System is Strong

According to survey findings, there is both a cultural and operational support system in place in India assisting patients with making an informed decision:

• Culturally, the role of the family and trust in their primary care physician play a very important part in a patient’s decision to participate. Most patients travel with loved ones to doctor visits and the same is true for their clinical trial visits. Only 8% of volunteers made the decision to participate in the trial by themselves vs. 38% in the United States.
• Operationally, the sites involved in the survey had a dedicated highly trained clinical research coordinator working at the study site, assisting busy physicians with running the trial and helping to answer questions patients or their loved ones have about the study and informed consent form.
  

When considering this support system in India, it is interesting to note that Excel Life Sciences has found that average study retention rates are in the low to mid 90th percentile. In comparison, the United States and Western Europe historically see an average of 25% of trial volunteers drops out of trials before completion. Higher retention rates allow studies to finish sooner and help reduce study costs and speed the development of new compounds.

Authors:
Dr. Vijai Kumar, President and Chief Medical Officer - Excel Life Sciences,
Dr. Saurendra Das, Executive Director of Operations, India – Excel Life Sciences
Dan McDonald, Vice President-Business Strategy - Excel Life Sciences.

The study was last updated October 2008.

(1) Pricewaterhouse Coopers September 2008 Forecasting Report

About Excel Life Sciences

Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, Washington DC, Hyderabad, Mumbai, New Delhi and 21 other locations across India, ELS is one of the most experienced and fastest growing trial management and site support organizations in India, offering customized clinical trial solutions including: regulatory consulting, preparations, submissions and query resolution; site identification and selection; patient recruitment and retention; training of all clinical research stakeholders; technology transfer; product licensing and more.

ELS has one of the most experienced and respected clinical operations teams in India with over 125 years of collective experience in conducting more than 350 global and domestic trials at hundreds of sites and with thousands of patients. ELS has also trained over 1,500 clinical research personnel in India. For more information visit: www.excellifesciences.com

Competitive Technologies Announces Sales Order From ELS for Pain Management Devices

Fairfield, CT - (January 12, 2009) - Competitive Technologies, Inc. (NYSE Alternext US: CTT) announced today that it has received a sales order from Excel Life Sciences, Inc. (ELS) for pain management therapy devices. The device is a non-invasive method for rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs. ELS, CTT's country-exclusive distributor in India, recognizing the benefits of the innovative device, was the first announced healthcare services provider to sign a distribution agreement for the device. Subsequent distribution agreements granted country-exclusive distribution rights to GEOMC Co., Ltd. for Korea, to AG Healthcare for Malaysia, and to Biogene Pharma Limited for Bangladesh.

The order from ELS has an approximate retail value of up to $1 million. Shipment of the devices to ELS is scheduled to begin immediately.

ELS is a U.S.-based, India-focused provider of clinical research and healthcare services. They have a special focus on improving patient care in the markets in which they operate. ELS has a fully-owned Indian subsidiary with its main office in New Delhi, and 21 operational locations serving a network of over 700 hospitals across India.

The CTT device has Medical Device CE certification from the European Union allowing sales of the device throughout Europe and several other countries, including India. Approval of CTT's pending FDA 510(k) medical device application will authorize U.S. sales of the device. The review and selection process for distributors in Europe, Asia, the U.S. and Latin America is continuing. CTT has exclusive worldwide rights to this patented device.

Dr. Vijai Kumar, ELS's President and Chief Medical Officer, said, "We have seen this device in action, and have witnessed its pain relieving capabilities. ELS is starting formal clinical studies using this new pain management device at four leading healthcare facilities in India within the month. The protocol for these studies will follow U.S. FDA guidelines and treat a total of 160 patients divided into four specific neuropathies. We expect this new device to initiate a paradigm shift in the perception and treatment of pain in India. There are over four million people in the country suffering from severe cancer, neuropathic pain and other forms of chronic disabling pain."

Mohit Mehrotra, ELS's Founder and Chief Operating Officer, commented, "We are proud to work with CTT to bring this progressive medical technology to India. We are focusing considerable resources on this technology and our relationship with CTT. We will be launching the device at the All India Institute of Medical Sciences' (AIIMS) International Conference of Indian Association of Palliative Care in February, where we expect it to generate a high level of activity and interest among the participants. ELS is a sponsor of the New Delhi-based conference, the largest of its type. Our extensive knowledge about healthcare in India, along with a large network of research hospitals and clinics, helps us understand the needs and expectations of both patients and healthcare providers. We believe this device will revolutionize pain management for both constituents."

"ELS is a key element in our strategy for building a strong distribution base across the Indian continent through Southeast Asia," said Aris D. Despo, CTT's Executive VP, Business Development. "They are an effective and strategic partner for CTT in the important Indian market. India's $1.75 billion medical device market, supported by its growing middle and upper classes of over 150 million people, represents a significant opportunity for sales of our innovative pain management technology."

"We believe that revenue and profits from the pain management technology will dramatically exceed those produced by any other technology in our 40-year history and reach approximately $200 million per year in distributor sales to hospitals and clinics as the device attains mature market levels," said John B. Nano, CTT's Chairman, President and CEO. "We expect financial results generated by this medical device to have the potential to significantly increase CTT market capitalization. This medical device is a prime example of our strategy to connect clinical science to patient care, improving healthcare for mankind."

Developed in Italy by CTT's client, Prof. Giuseppe Marineo, the technology was brought to CTT through the efforts of Prof. Giancarlo Elia Valori of the Italian business development group, Sviluppo Lazio S.p.A., and assistance from the Zangani Investor Community™. The technology, with a biophysical rather than a biochemical approach, uses a multi-processor able to simultaneously treat multiple pain areas by applying surface electrodes to the skin. CTT partner, GEOMC Co., Ltd. of Korea, is manufacturing the device commercially for worldwide distribution. For more information on the device, visit www.CalmareTT.com.

The device has been used on over 3,000 patients in Europe, including at the Pain Management Center at Tor-Vergata University Medical Center in Rome (http://www.ptvonline.it/uo_ter_ant_ing.asp)., and at Fondazione Parco Biomedico San Raffaele in Rome (www.scienceparkrome.eu).

About Excel Life Sciences, Inc.

ELS is a U.S.-based, India-focused provider of comprehensive clinical research and healthcare services, helping to advance science and improve patient care. ELS is a privately owned Delaware corporation, with 21 operational locations across India and a network of approximately 1,000 physicians serving over 700 hospitals. ELS has U.S. offices in Boston, Chicago, and Durham, N.C. Its success is built around passionate and experienced individuals working alongside clients to accelerate clinical research and deliver new drugs and medical devices to the markets, while maintaining the highest standards of quality. ELS is committed to improving and expanding the clinical research enterprise in India. Visit ELS's website: www.ExcelLifeSciences.com

About Competitive Technologies

Competitive Technologies, established in 1968, is a full service technology transfer and licensing provider focused on the technology needs of its customers and transforming those requirements into commercially viable solutions. CTT is a global leader in identifying, developing and commercializing innovative technologies in life, electronic, nano, and physical sciences developed by universities, companies and inventors. CTT maximizes the value of intellectual assets for the benefit of its customers, clients and shareholders. Visit CTT's website: www.competitivetech.net

Statements made about our future expectations are forward-looking statements and subject to risks and uncertainties as described in our most recent Annual Report on Form 10-K for the year ended July 31, 2008, filed with the SEC on October 28, 2008, and other filings with the SEC, and are subject to change at any time. Our actual results could differ materially from these forward-looking statements. We undertake no obligation to update publicly any forward-looking statement.

Clinical Research India Primer

Up until 2005, India was probably best known in the world of pharmaceuticals as a generic powerhouse. Due to poor laws around intellectual property, most multi-national biopharmaceutical companies did not seriously consider India as a destination for clinical trials. Numerous other challenges and roadblocks existed as well. But as the Industry began to globalize rapidly throughout the 90’s and early part of this decade, regulators, entrepreneurs and businesses began to recognize the significant economic opportunity that they were facing, as well as the opportunity to gain new credibility in the world of medicine, science and the international business community. The response was a profound and rapid change in the regulatory landscape related to research and intellectual property that has created an inviting market which is realizing true and sustained growth.

So what is the regulatory environment today and where does it need to go?

The regulatory environment has improved dramatically in a short time period, with development of a standardized and predictable regulatory review and approval process. There are a growing number of FDA compliant IRBs. To some degree the process can be even better than other parts of the world in that conditional IRB approval can precede Ministry of Health approval. Regulatory approval timelines are also very reasonable and because sites are largely new to clinical research or don’t have established business practices related to clinical research, PI and site contracts can take as little as 3-5 weeks. A Regulatory Affairs CRO India can assist global biopharmaceutical companies with effectively planning and placing their clinical trials in India.

A look at 1572 filings – the form an investigator needs to submit in order to participate in a US IND study – shows that a rapidly growing number of investigators are from India, far outnumber growth rates seen in other Asia-pacific regions such as China, Japan and Australia. Sponsors are finding that the regulatory timelines, data quality, costs and abundance of patients make India one of the most attractive countries in the Eastern world to run their studies.

The attractive aspects of the market are translating to a growth spurt in the number of studies taking place in India. An analysis conducted by Excel Life Sciences has identified a minimum of nearly 900 clinical trials taking place in India today, a number that is growing by double digits annually. This figure doesn’t take into account non US IND studies, investigator initiated studies and other studies taking place.

The well known consulting firm AT Kearney ranked the attractiveness of markets across the world using the US market as the benchmark. India ranks second only to China on that scale and other than population size ranks very closely to or better than China in a number of categories, including perhaps most importantly to many companies, the regulatory environment and timelines.

Epidemiology

Like many diseases in India, given the size of the patient population and lack of standardized healthcare, disease prevalence is often much higher than other regions of the world and many of the patients are treatment naïve. These factors typically result in shortened enrollment timelines and naturally reduced costs.

If you look at the breakout, it reflects those therapeutic areas made up of conditions that are most prevalent in India. These conditions to some degree represent the evolving and improving socioeconomic status of India – essentially lifestyle diseases, e.g. Cardiovascular conditions, Diabetes and other endocrinology conditions, as well as many types of cancer. For example:

Oncology/Cancer

Today there are an estimated 2.5M people in India suffering from cancer and that number is expected to grow significantly in the months and years ahead driven by strong growth in tobacco related cancers, as well as those that are environmentally driven as India continues to develop rapidly from an economic and lifestyle perspective. An Oncology CRO India can assist sponsors with finding and screening these patients for their clinical trials.

Cardiovascular Diseases

The overall incidence of heart disease has doubled in India during the last 20 years and this trend is expected to continue. The World Health Organization (WHO) estimates that 60% of the world's cardiac patients will be Indian by 2010. Our statistics show that between the years 2003 and 2006, top sites in India saw over 100,000 patients. A Cardiology CRO India may be used by a global biopharmaceutical company to identify and enroll these patients in a clinical trial.

Endocrine and Metabolic Disorders

An estimated 108 million people in India suffer from endocrine and metabolic disorders. Diabetes is the most prevalent disease in this therapeutic area with approximately 35.5 million cases. Our clinical investigators have experience conducting global trials and have access to a large and diverse treatment naive patient pool. In fact, these investigators see 400 - 500 new cases per month and provide treatment for approximately 2,000 ongoing cases per month. An Endocrinology CRO India and Diabetes CRO India like Excel Life Sciences can assist global biopharmaceutical companies with identifying and enrolling the right patients for their clinical trials.

Neurology

India has a high prevalence for neurological and psychiatric diseases and disorders. Our statistics show that between the years 2003 to 2006 some of the leading sites in India saw over 30,000 psychiatry and over 40,000 neurology patients respectively. Although many people are already being treated, the majority are not. The World Health Organization (WHO) estimates that at minimum, an additional 25 million people in India are in need of mental health services. A Neurology CRO India or Neuropsychiatry CRO India like Excel Life Sciences can assist global biotech and pharmaceutical companies with identifying the right Neurology patients for their clinical trials.

Contract Research Organization India / CRO India Support:

There are several different models and configurations that exist today in terms of who sponsors might partner with to place and conduct studies in India. The least common way is through Sponsors identifying and hiring their own sites. You really don’t see much of this and sites haven’t built up the confidence and business know-how to be soliciting business with Sponsors on their own.

Instead there are 2-3 common models that exist. What makes Model #1 interesting from a US perspective is that it involves the use of a Trial or Site Management Organization – terms and concepts that have a slightly negative connotation in the US and Western Europe as a promise largely gone unfulfilled. In the US the SMO concept peaked during the 1990’s and early part of this decade, but many of the SMOs found that sites didn’t need or appreciate the support and that sponsors weren’t willing to award them more than a handful of sites in many cases. In India though, the concept is thriving. Largely due to the vast network of inexperienced sites, who:

1. Don’t have the know-how or means to market and contract their own business – so the SMO acts as the lead generator.

2. Need the support of a full-time CRC from the SMO for day-to-day study conduct, which due to large patient loads, the investigator does not have the time to manage.

So, this model is being used more often, where Sponsors looking to place a study in India work with an TMO/SMO to handle all aspects of regulatory, site selection, patient enrollment and so on and then the SMO contracts with a CRO to handle the monitoring aspect of the study, therefore avoiding a conflict of interest. This is why these companies are now being referred to as Trial Management Organizations, because they handle most of the activities that traditional SMOs and CROs handle without conducting the monitoring.

Sponsors are finding that day-to-day site management is critical in India since there are often first time investigators involved in a study and more importantly, the patient loads and activity level at each site, warrant the placement of and support from a full-time CRC. In general, sponsors are finding that patients are enrolled faster, retained better and that there is higher quality data coming from the site when a SMO is involved. In profiling more than 900 sites across India, Excel Life Sciences found that less than 15% of all sites have a full-time CRC on staff. When a CRC is present, they are typically spread across multiple studies.

The Trial Management Organization in India is a hub of activity for a clinical study. This multi-faceted approach requires superior upfront and ongoing training as well as vigilant project management and site support.

A comprehensive site support model involves placement of a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-today study conduct activities. Coordinators must be trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site. CRC study conduct support activities can include, but are not limited to the following:

Prestudy:

• Regulatory Submissions
• Select PI
• PI Training Programs
• Patient data base
• IRB submission
• Pre screening
• Source Document (SD) templates
• Referrals

Study conduct:

• Identify patients, SIV
• Assist ICD
• Ensure SD
• Transcribe CRF
• Send lab samples
• Scrutinize results
• Maintain Trial Master File
• Prepare for monitoring & audit
• Track enrollment
• Ensure 100% follow up
• Timely payment of patient expenses

Post study:

• Query resolution
• Study close out