Clinical Trials Market Expected to Grow in India Despite Economic Crisis

Outsourcing-pharma discusses in this post that even though the country is going through a rough economic crisis, the Indian clinical trial market is predicted to continue its growth. This information comes from a partner at Ernst & Young, and he also states that biotechs increasingly turning to India will help drive growth from its current $200m a year to $600m a year in 2010, which is what KPMG predicted.

Parexel Completes Chinese Bridging Study

According to this article in Clinical Trials Today, the contract research organization Parexel has completed a Chinese bridging study to be conducted outside of China at their Los Angeles facility. Parexel recently acquired California Clinical Trials (CCT), which does a number of ethnobridging studies.

Michelle Middle, corporate vice president and worldwide head of Clinical Pharmacology at Parexel mentions:

“The goal of Parexel clinical pharmacology is to help sponsors to get as much information as soon as possible in drug development.”

Briding studies have grown increasingly important to clinical research, as more and more companies are looking to cut back on costs.

CROs Under Fire

This article on Bio Health Investor discusses how although CROs experienced rapid growth up until August this year, it seems as if the trend is coming to a crashing halt. Apparently CROs are not immune to the global economic crisis; Charles River Laboratories have even reported that it is cutting its guidance for 2008.

Now there is even a concern for the amount of jobs that will be available in the CRO sector. CRO stocks have been performing horrible as of lately. Time will only tell what the future lies in store for the medical industry.

CRO BioReliance Enters Tech-Development

From Proteo Monitor:

Contract research organization BioReliance this month launched a new array service for the screening of non-human antigens in animal serum, the first fruit of a new technology-development strategy the company embarked upon after being sold by Invitrogen last year

The array platform, called ReliArray, currently in beta testing and available only to select customers, will formally debut in January, replacing the ELISA technology currently being used by BioReliance for serological testing.

Read the rest of this article here.

India's clinical trials not affected by the recession

Last week, we wrote about the opportunity that the global recession is presenting to India and their clinical trials.

While the cost of clinical trials vary on the basis of complexity and disease segment, a simple trial in India can cost 15-20% of the US price, while a more sophisticated trial—involving imaging systems—may be 50-60% of the US price. Studies suggest that R&D expenditure is increasing by 15% per year, making global biopharmaceutical companies look for cheaper options. India scores high due to faster enrollments, speed of completion, large and diverse patient pool as well as increasing private healthcare network.

The Economic Times takes a deeper look into this belief. Read more here.

MarketWatch: Quintiles, SAS Announce Development of First-Ever Clinical Trials Statistical Programming Certification

Quintiles, SAS Announce Development of First-Ever Clinical Trials Statistical Programming Certification

From MarketWatch:

Quintiles, the world's No. 1 pharmaceutical services company, and SAS are developing a unique program to produce certified specialists in the use of SAS programming to evaluate clinical trials results, the companies announced today.
The Quintiles-SAS Clinical Trials Statistical Programming Certification will certify that the successful candidate has shown that he or she has the expertise necessary to organize, analyze, and report clinical trials results. Incorporating industry-specific data, language and concepts, SAS and Quintiles will develop an exam and related training materials that emphasize the SAS skills statistical programmers need in the pharmaceutical and biotechnology industries.
"We're responding to a customer need through this collaboration with Quintiles," said Herbert Kirk, Vice President, SAS Education Division. "The pharma and biotech industries have statistical requirements that our standard certification exams don't measure. With this new certification, our pharma customers can hire people with confidence."

For more information, please click here.

Biotrial, Full-Service CRO and European Leader in Drug Evaluation and Pharmacology Research, Appoints New Head to Manage its Growing Data Management

From PRWEB:

Biotrial, a leading CRO for early phase clinical trials, today announced that Monique Duguépéroux-Klocke has joined the company as its new Head of Data Management.
Rennes, France (PRWEB) November 15, 2008 -- Since 1989 Biotrial has provided consistent and reliable clinical data management for in-house clinical trials, as well as complex global clinical studies. From CRF design, data entry, database design, data validation, statistics and consulting, to name a few, Biotrial's experience includes a wide range of therapeutic areas.
Monique Duguépéroux-Klocke brings over 15 years of experience in the field of clinical research. After leaving a well-known CRO (PAREXEL in Berlin) she worked for over 10 years at one of the top French pharmaceutical companies: Servier Laboratories, as head of the Data Management, Outsourcing Department.
"We are really excited about these new changes in Biotrial's Data Management department," said Isabelle Cimarosti, Director of Biometrics Department. "Monique Duguépéroux-Klocke's arrival attests to our growth and reinforces our position as a global service provider."

To read the rest of this article, click here.

Economic Crisis Presents an Opportunity for the Indian Pharma Outsourced Industry

This latest article on BioPharmaLife discusses how even though clinical trials in the US are going through a rough patch the Indian pharma outsourced industry is expected to thrive due to the economic crisis.

With many companies pulling back on investments, drug-makers are turning to India for cheaper resources for manufacturing and research. By the year 2011, the US is expected to have outsourced 65% of all its clinical trials to India.

Mayo Clinic Pulls Out of Clinical Services

Outsourcing-pharma.com has recently reported that the world-renowned Mayo Clinic has shut its doors on clinical services due to increased competition from other companies driving outsourcing of clinical trials to emerging countries such as Latin America, Asia, and Eastern Europe.

Mayo Clinic has mentioned in their statement that they will no longer accept contracts and that 30 employees would lose their job straight away. The statement reads:

“This decision will allow Mayo to focus its efforts on its successful and growing clinical reference laboratory business, Mayo Medical Laboratories, which provides ... laboratory testing services to clients throughout the world.”

MarketWatch: EyeGate Pharma Enrolls First Dry Eye Patient in Phase II Clinical Trial of Lead Product EGP-437

WALTHAM, MA, Nov 10, 2008 (MARKET WIRE via COMTEX) -- EyeGate Pharma, the leader in ocular drug delivery, a specialty pharmaceutical company using iontophoresis technology to safely and non-invasively deliver therapeutics to treat serious ocular diseases, today announced that it has enrolled the first dry eye patient in a Phase II safety and efficacy clinical study of EGP-437 (a combination drug/device). This patient enrollment marks the Company's second clinical trial initiated in the second half of 2008. In July, the Company initiated a landmark Phase II clinical study in severe uveitis, which represented the first U.S. study under an open IND to employ iontophoresis technology to deliver an active compound into the eye.

Read more here.

Outsourced Clinical Trials Going Through a Rough Patch

This latest post on BioPharmaLife discusses how the multi-million dollar outsourced clinical trials industry in India is currently going through rough times, as CROs are facing difficulties in recruiting patients and keeping them for the entire period of the trial. There are serious worries since it is estimated that $1 billion will be invested in outsourced clinical trials in India by 2011.

The large volume of people available in India and China make these locations ideal for clinical trials. D Anderson has joined with Clinical Research Education and Management Academy to focus on patient recruitment in the future. The CEO of D Anderson mentions:

"Earlier, we used to recruit patients and retain them till the trial is over but currently the number seemed dwindling. Therefore, in this conference, we are planning a strategised approach."

Kendle sees revenue increase

As reported by Clinical Trials Today, Kendle saw a 25% jump in third quarter revenues, with a net revenue of $124.8 million. New business increased 21% to $212 million. Share prices increased 20% this morning to $25.68.

Nurse dismissed for error in clinical trials

Nicola Gibson, a nurse at James Cook University Hospital, South Teeside, England, was dismissed of her duties after she did not perform her duties properly for the Study of Heart and Renal Protection (SHARP) between July 2004 and January 2006 being performed from Oxford.

According to Medical News Today, Ms. Gibson failed to document informed consent of patients to participate and contribute blood samples in the study, did not interview patients for as long as required and thus denied them full consultation in the study, failed to take and/or record blood tests, did not administer medication to groups of patients as allocated and then tried to cover her mistakes by recording the medication as provided.

Nigeria Opens Clinical Trial Center

Announced recently at AllAfrica.com, Nigeria has opened their first clinical trial center at Lagos State University College of Medicine, Lasucom. The center was donated by GlaxoSmithKline.

Professor Clement Adebamowo, Chairman, National Health Research Ethics Committee of Nigeria (NHREC) had this to say about the new center:
"We lost our direction because we started to pay more attention to things that are not based on science and to things that are not based on reasoning. Research is a systematic investigation designed to make generalisable knowledge. We need to put in place a programme that guarantees, in a transparent manner, that any research done in Nigeria is credible. We need to invite a lot of research into the country. Research generates employment, new drugs and new discovery. There are many diseases we wish we can find cure for... Research yields exceedingly profitable results."

India, China, Latin America and CEE as Clinical Trial Destinations

As part of our Partnerships with CROs LinkedIn group, we often share discussions regarding various aspects of the clinical outsourcing industry. I recently posted a specific question regarding new markets and their rise as destinations for outsourcing clinical trials. The question:
What are your thoughts on India, China, Latin America and CEE as clinical trial destinations in terms of capacity, resources and facilities? Received several excellent responses. I thought it would be great to share some of the responses with our readers:

Guy Bafort, Director Regional Clinical Operations CEET at Bristol-Myers Squibb:

R&D activities in the CEE region for example have been ongoing for more then a decade. What we do see over the last couple of years is a substantial uptake of R&D activities in all those countries. In CEET alone, this translates into an annual increase in the number of clinical trials with 25% to more then 50% on an annual basis over the last 3 years (data based on http://www.clinicaltrials.gov . The outcome is increased competition, not only for sites, investigators and patients, but also for resources. It is becoming increasingly more of a challenge to find experienced staff. In terms of facilities in CEET, it really depends, but the majority of sites fit the standards we need for our studies. Now that the competition for sites and investigators is increasing, companies and CROs are reaching however out to less experienced sites in more remote regions of the larger countries within the region.

Mahalingam Vasudevan, President , Roxanne Research:
Human Resource: India has substantial capacity to meet the rapidly growing demand for clinical trials. India has 300 universities, over 750 graduate and post-graduate programs, and about 50 million college graduates. There are over 700,000 medical professionals and over 600 ICH/GCP compliant sites. Large pool of specialist clinical investigators who are GCP-trained and compliant, and who have participated in numerous international clinical trials

Patients Resource : India has the largest pool of patients suffering from cancer, diabetes and other maladies is leading the country to an altogether different destination: the global hub of outsourcing of clinical trials. Almost all the top names in the pharmaceutical world have zeroed-in on India, setting up clinical trail facilities in major cities ( Eli Lilly / Pfizer / Roche /.. ). The overall impression is that the data quality is usually excellent with Genuine CROs.

Advantage of India : Patient diversity / Patient heterogeneity/ World class medical infrastructure/ Familiarity with western medical facilities/ English competency / Cost competency ( patient recruitment, shorter timelines,manpower etc.,) / ICH / GCP guidelines implementation / Project management competencies / Central lab facilities ( Internationally, nationally accredited)/ Regulatory guidelines and government policies – helping clinical research in India ( MOH, DCGI, ICMR, DBT etc.,) / and also
* “Western” disease distribution
* High patient numbers available
* Many tertiary care and specialty hospitals
* Large number of medical specialists
* Patients generally “therapy naïve”
* Low cost
* No language barriers
* IT-based advantages

Quality in Trials : Although the US FDA has yet to inspect any clinical trials in India, most sponsors and CROs carry out their own audits of clinical trials. Numerous audits in India are a testimony to the level of quality. Data from clinical studies in India have been successfully filed with international regulatory quality is the hallmark of global acceptance, most sponsors and CROs invest heavily in monitoring, quality control and investigator training.

Srirupa Pal, Vice President, Roxaane Research:

The outsourcing of drug discovery research to India is on the rise. According to research firm Frost & Sullivan, the Pharma outsourcing business in India will grow to around $7 billion by 2013. In 2006, they had estimated value of the Indian Contract Research and Manufacturing Services (CRAMS) market as $895 million.This above mentioned statistical analysis reflects the extent of growth the CRO industry is currently experiencing and its bright future prospects.

Another report by Pune-based research firm Value Notes, forecasts a growth of 23.6 percent annually for the industry up to 2010. Presently, India conducts about 1.5 percent of the Global Clinical Trials. This could rise to 5 percent by 2008 and 15 percent by 2011. And that is the percentage of a global trial that itself is increasing by 10 percent every year.


All of these and several more on LinkedIn raise some excellent insights into the state of these markets as destinations for CROs. I invite anyone else with their own perspectives to please add them here as a comment or on our LinkedIn group.