Happy Holidays from CROs

We will be taking some much needed time off for the holidays. We'd like to thank you for your readership and we encourage you to check back with us next year for more innovative thought, perspective and news surrounding the world of contract research organizations.

We wish you a joyous holiday season!

Outsourcing to India

The St. Petersburg Times recently examined the outsourcing of clinical trials to India. With such a large population, the CROs appear to the population as a way to obtain health care, but with the numbers of companies flooding into India to conduct clinical trials, patients' best interests may be forgotten.

One concern brought up in the article is the difference between the patients of the clinical trial in India and the target patients of the drug in the United States.

"First of all the data must be applicable to the U.S., where the population may differ in clinically significant ways," he said. "And the FDA has to have the capacity to go over and inspect the data. If not, you're asking for trouble."

Another is the lack of oversight from the Indian government on the process of the clinical trials.

Government regulators on both sides of the globe are supposed to be the final backstop on the safety of clinical trials. But that hasn't happened in India. Despite being stung by controversies involving the testing behind drugs like Vioxx, Avandia and popular antidepressants, the FDA inspects fewer than 1 percent of all drug trials in the United States. Its record overseas is even worse.

Read the complete article here.

Partnerships with CROs: Best of 2008

As 2008 draws to a close, we'd like to share the most popular articles of the year.

Enjoy!

India, China, Latin America and CEE as Clinical Trial Destinations
CRO Industry Overview
Accenture has Big Plans For Outsourcing Services
CROs Under Fire
Indian government looking into regulation of Clinical Trials

CRO PharmaNet Development Group Explores Strategic Alternatives

ClinicalTrialsToday reports that PharmaNet Development Group, which is a troubled CRO, is working alongside UBS to explore alternatives, including the potential sale of the company.

The company’s share price has plunged from $39.19 in January to $1.01 in early morning trading Friday. The company has also received some letters of interest regarding the sale, but PharmaNet will not comment any further until a decision is made.

Keep Clinical Trial Participants in the Loop

This article on Outsourcing-pharma.com explains how not informing clinical trials participants of the study results may leave them confused and frustrated, and lacking information that might be important for their health. Currently, clinical researchers are not required to tell participants the results of the study, but they are required to tell them information that might affect their willingness to participate in the study.

When a group of people were informed of the research results via a site call, roughly 90 per cent of participants reported “high or complete satisfaction”, and when they informed of the results through the sponsor’s press release only 50 percent reported “high or complete satisfaction.”

Child Death Rate in Outsourced Clinical Trials in India

This post on InjuryBoard.com highlights how 49 children involved in clinical trials in India have died since 2006. Dr. Vinod K. Paul, the head of pediatrics the All India Institute of Medical Sciences, mentions that all these children have died from serious illnesses and not the nature of the clinical drug trials itself.

Still there is some concern that many illiterate, poor families who do not speak English sign contracts written by foreign lawyers without understanding the nature of the clinical drug trials. Other hazardous problems include the lack of inspections at the factories and fraudulent clinical trial data.

Most companies are turning to foreign countries because of fewer restrictions, and where patients don’t fully understand but sign consenting documents anyway. What are your thoughts?

Tigermed Consulting Announces OCT as a Partner in Russia

PMR reports that Tigermed Consulting, a Chinese CRO, has formed a strategic alliance with OCT, which is a Russian based CRO based in St. Petersburg. Tigermed is trying to create a global clinical trials network with this move. Read the full article here.

Thermal Fisher Opens up New Facility in India

From Clinical Trials Today:

Global laboratory supply giant Thermo Fisher opened a new $17 million clinical services facility in Ahmedabad, India, giving the Waltham, Mass.-based company the largest Indian presence of any company in its industry, according to a company release.

The new 150,000-square-foot facility will support growing demand for biopharma services in the region and serve as a hub for packaging, distribution and logistics management of clinical trial supplies.

“With the added capacity now available to us with this new facility, we can offer our customers a higher level of technology, quality and expertise to facilitate clinical trials that serve the needs of both local and multi-national pharmaceutical companies,” said Thermo Fisher president and CEO Marijn Dekkers at the opening of the new facility.

Read the rest of the article here.

Bilcare Boosts its Clinical Trial Business in India

This article on outsourcing-pharma.com reports that Bilcare has extended its clinical trials business with the opening of new packaging and storage capacity at its facilities in Pune, India.

Ajit Dubhashi, president of Bilcare GCS, Asia Pacific mentions:

"This will significantly enhance the capability of sponsors to conduct clinical trials across the world - inclusive of Asia- with desired alacrity.”

This deal has enhanced their global reach in Argentina, Brazil, Columbia, Chile, Mexico, Peru, Russia and Eastern Europe.

Regulatory Changes in India

Bio-IT World reports that in an attempt to broaden examination of the clinical research process within its borders, “India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS).”

The Indian Council of Medical Research has been regularly working towards establishment of a mandatory clinical trials registry to improve the reliability of data. The growth in clinical research in India continues, and so the importance of clinical monitors and research associates increases. India will have to play close mind to regulations over the next years since CRO growth is expected to increase in rapid numbers.

Clinical Trial Regulations Grow Tighter Overseas

John Carroll explains in this post on FieceBiotech that lately overseas regulators have been tightening their grasp of clinical trials around the world. Polish investigators want to know why two seniors died when they took two experimental bird flu vaccines developed by Novartis, and this is just one case of the tight regulations being put in place.

There is a growing concern that in the developing countries, the citizens are being used to test new drugs which will later be sold to more affluent markets. The Wall Street Journal estimates that roughly 40 percent of all clinical trials take place in lower-income countries.

Read the entire article in the Wall Street Journal

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.

India possibility for Australia's CROs Needs

Australia may need to turn to India for its future CROs needs. In this rocky climate, it proves to be the most cost-efficient way for Australians to develop new and innovative drugs. They are the number one location for biotechnology in the Pacific region and sixth in the world for developing drugs. Read more here.

Rashmi H. Barbhaiya, founder and CEO of Bangalore-based Advinus Therapeutics Pvt Ltd, had this to say about the possibilities:
"Australia has phenomenal strength in basic research in early drug discovery and identifying disease targets. My perception is to somehow translate this early drug discovery into identifying drug candidates for pre-clinical trials and clinical trials, wherein lies India’s strength."

CRO Stock Prices Going Down

This recent report, states that even though Contract Research Organizations have been reporting that their quarterly goals have been meet or exceeded, with the current market meltdown, this information is apparently not seen as relevant to investors. One reason cited for the stock prices of these corporations going down, despite company affirmations that they are fine, is the weakening dollar. Either way, it seems that short term investments are out of the questions.

CROs Open New Opportunities for Employment

The Financial Express reports that since CROs and the number of outsourced trials are multiplying in size, this is building many job opportunities in countries like India. Many analysts are estimating that total clinical research spending in India will increase to more than 30% annually through 2010.

This in turn will create a huge demand for experienced and qualified clinical research professionals. In terms of numbers, this will create more than $50,000 clinical research positions by the year 2010. The salary for clinical research professional range from $40,000 per year for a clinical research coordinator and $1,000,000 for a business development manager.

Clinical Outsourcing Spend is Going Down

We recently posted that companies have been spending less and less money in clinical outsourcing as many companies are realizing that outsourcing does not necessarily make everything cheaper.

I have come across this post form PharmaTimes and another post from Outsourcing-Pharma and am wondering if this is a growing trend within pharma and biotech companies? I’m curious as to how this sudden change will this affect the future of contract research organizations.

Reducing Costs and Time of Cancer Trials

Outsourcing-pharma.com reports that a non-profit group made up of CEOs of drugmakers working in oncology hopes to shorten the drug testing process by making a “common language” available for clinical trial contracts through a set of standardized templates.

It is speculated that this procedure can cut contract negotiation times from 300 days to 30 days. This is coming at a crucial time in the pharma industry since the number of oncology clinical trials rose by 13 percent last year. The templates were part of a 14-month project which was led by the CEO Roundtable on Cancer's Life Sciences Consortium (LSC), a task force of CEO Roundtable members in the oncology pharmaceutical/biotechnology industries in conjunction with the NCI.

Pharma Companies Are Outsourcing Less of Clinical Development Budget

Pharmaceutical Online reports that according to a study conducted by Cutting Edge Information, pharma companies across the industry are cutting back on outsourcing as a percentage of clinical development budgets. Compared to 2006, outsourcing as a percentage of the budget has reduced an average of 20% for every phase.

David Richardson, the lead author of the report mentions:

"Companies are now realizing that outsourcing does not necessarily make things easier, cheaper, or remove a burden from their plate. Research has appeared arguing against the cost-saving effects of outsourcing. Also, companies are being more frugal. Keeping things in-house grants easier oversight because of institutional proximity, ensuring efficient and competent work, instead of spending the same time managing a CRO."

Are companies budgeting less towards their outsourcing?

In an article at International Business Times, they say that companies have reduced their spending when it comes to outlays in outsourcing as a percentage of their clinical budget. In the study, the found that an average of 20% of the budget was reduced after each phase of the trial in research performed in 2006.

David Richardson, the lead author of the report, had this to say:
"Companies are now realizing that outsourcing does not necessarily make things easier, cheaper, or remove a burden from their plate. Research has appeared arguing against the cost-saving effects of outsourcing. Also, companies are being more frugal. Keeping things in-house grants easier oversight because of institutional proximity, ensuring efficient and competent work, instead of spending the same time managing a CRO."

Do you agree with his statement? Is this is what's happening with your clinical trial?

Averion expands in Eastern Europe

Averion, a clinical research outsourcer, recently announced that they'd be expanding operations and opening an office in Prague, Czech Republic. This is following a recent opening in Kiev, Ukraine, as well as Russia, Slovakia and Hungary.

According to this article:

The Czech Republic offers a strong clinical trial environment with large patient populations and well-qualified investigators in a broad range of indications, i.e. factors seen by its clients as top priorities and vital to the successful conduct of international trials.

New report focusing on outsourcing in central Europe

Centerwatch has published a new report focusing on outsourcing in Central and Eastern Europe. It focuses on the strategies that CROs and biotech companies need to focus on to succeed in these regions.

The author of the report, Sara Gambrill, had this to say about the report and the benefits of researching in Central and Eastern Europe:
“Industry experience and expertise in some countries, such as Poland and The Czech Republic, rival the West’s. Russia and Ukraine, with their very large populations and increasing experience, offer enormous growth potential.”

Find out more here.

ethica Clinical Research expands to South America

According to Pharma Times, The Canadian Clinical Research outsourcer, ethica, will be expanding operations to Buenos Aires, Argentina. They'll be partnering with Blanchard y Asociados, who is headquartered in Buenos Aires. They'll be expanding their human research protection program in to this section of the world.

Dr. Janice Parente, the founder and president of ethica has this to say about their expansion:

"While clinical research has globalised and nearly half of the world’s clinical trials are now being conducted outside of North America and Western Europe, there is a need to develop a global approach to the oversight of research on humans. We are proud to be playing a pivotal role toward achieving this goal.”

Clincal Trials in India

The Indian government recently has given the okay for phase I human clinical trials to be performed in India. This has led many to expect that the Contract Research Organization Industry, in India, will grow from being worth $200 million in 2007 to an estimated $600 million by 2010. There is one thing that could be preventing this estimate from coming true as remarked upon in this article. As Dr. S M Sapatnekar, dean and director of CREMA stated:

“The technology is constantly growing, and India is fast becoming a new hub for trials due to large patient population and strict compliance with the guidelines. However there is a serious dearth of researchers”

As an Ernst and Young report pointed out, 1000 students each year pass as researchers in India, however, by 2010 to keep up with demand, they will need 15,000 clinical researchers.

Clinical Trials Today: ethica Heads to South America

According to Clinical Trials Today,

ethica Clinical Research, a Montreal, Canada-based contract research organization (CRO), has partnered with Argentina-based Blanchard y Asociados to provide ethics review services for clinical trials in Latin America.

ethica founder and president, Janice Parente said,

“We’re already conducting trials in Latin America as a CRO. By opening our office in Buenos Aires,Veritas IRB becomes the first accredited IRB in Argentina ... and this provides us with the assurance that research participants’ rights and welfare will be protected in the studies that we and others participate in. We can now offer to investigators an IRB that is accredited and we can rest assured when we’re conducting the trials that risk management is being handled properly.”

Because South America is a traditionally different market in CRO, it’s going to be an interesting to gauge the success of ethica’s endeavor. Patient rights and responsibilities are key; but, how much will this cost and will the clinical research organizations be happy to foot the bill?

Bridge Laboratories to Support NIDA

The National Institute on Drug Abuse (NIDA), has awarded a 5 year base contract to Bridge Laboratories for the amount of $4.1 million. Bridge will be providing Toxicological Evaluation services on potential medicine for the treatment of drug abuse. Bridge Laboratories is a CRO that services globally, but is based out of the U.S. in Maryland with lab facilities in Beijing, China. As reported in this article, the CEO and President, Tom Oakley released this statement.

“We appreciate the confidence NIDA has shown in Bridge Laboratories over the past five years and look forward to collaborating with them to find ways to significantly improve prevention, treatment, and policy as it relates to drug abuse and addiction”

Changing Face of CRO's

As we remarked upon earlier on this blog post, Covance Inc. entered a deal with Eli Lilly and Co. to purchase Greenfield Laboratories in Indiana for $50 million, while also entering a contract research deal for $1.6 billion. This new business model for Contract Research Organization and Drug companies was recently discussed in this article from redOrbit. As the article quotes:

"The Covance deal represents the next phase," says Douglas Peddicord, executive director of the Association of Clinical Research Organizations in Washington, D.C. "It marks a move from a contract research organization providing outsourced, disintegrated services to one where it is in fact going to be a strategic partner in Eli Lilly's drug development work."

The article further quotes Peddicord as saying:

"Development projects that used a higher degree of clinical research outsourcing got to the finish line, as in submitting a new drug application to the FDA [Food and Drug Administration], 30 days faster than others without any diminishing in quality,"

It will be interesting to see if more and more companies will reach similar agreements if the Covance/Eli Lilly deal prove fruitfull.

Update to China’s Growing Lead in Clinical Outsourcing

Yesterday, we posted how China is slowly overtaking the lead for clinical outsourcing over India. This latest post on Pharmalot highlights three significant developments that are shaping Asian pharmaceutical outsourcing according to this report by PricewaterhouseCoopers. Here they are:

1 - The trend towards high-end innovation: Intellectual property concerns have previously inhibited this trend in pharma but, increasingly, such concerns are being overcome and major moves are being made by drugmakers to increase their drug discovery investment in Asia;

2 - Rapid expansion of clinical trials in Asia: The volume of clinical trials being conducted in countries outside of Europe, North America and Japan has been growing rapidly in recent years with Asian countries leading much of the growth. China has overtaken India as one of the fastest-growing locations. By June 2008, China had 428 clinical trials registered on the website Clinicaltrials.gov as under way and a cumulative total of 870 completed or ongoing trials compared with 737 in India. Cost has been a critical factor in this expansion. For example, clinical trials are estimated to be up to 50 percent cheaper in India compared to the US;

3 - A scaling up of manufacturing in Asia: With an increased commitment to international standards, Asian contract manufacturing organizations (CMOs) are securing more outsourcing orders from big pharmaceutical companies. In India, for example, there are more than 100 FDA-approved pharmaceutical facilities – the largest number in any country outside the US. Of course, Chinese officials say there are committed, but actions speak louder than words.

Read the full report here.

China is Ahead of India in Outsourced Trials

According to a new report conducted by PricewaterhouseCoopers (PwC), China continues to lead India in outsourcing of clinical trials to Asia. Pharmatimes.com reports that while India has lead in the past, now China has 870 trials registered or underway compared with 737 trials in India.

Findings from the PwC report proves indications that were made last autumn that China was pulling ahead of India as a preferred location for clinical trials. Read the full article here.

Clinical Trials in an Emerging Brazilian Market

China and India have taken advantage of the need for outsourced clinical trials through contract research organizations, but a new study published by Frost & Sullivan shows that the Brazilian market is emerging as the future of clinical trials.

Daniela Putti, Industry Analyst at Frost & Sullivan mentions

“Higher costs, competition from generics, and lack of productivity from R&D have been challenging pharmaceutical companies worldwide to better manage R&D costs and deadlines as well as improve quality of the whole drug discovery process. To responsibly address these issues, pharmaceutical and biotech companies are seeking for more accessible and efficient clinical trial locations such as emerging countries like Brazil. Here these companies and Contract Research Organizations (CROs) may likely find promising market features and growth opportunities for clinical trials.”

How will this affect current outsourced clinical trials in other countries?

inVentiv Clinical Solutions expands into Europe

In a recent news release by Globe Newswire, it was announced that Fernando Martinez, PhD, was appointed to be the director of clinical operations at inVentiv Clinical Solutions at their new office in Madrid. They plan to expand beyond Madrid into other regions of Europe including the emerging market countries of eastern Europe.

Kendle International

Earlier this week, Smart Cap Investor took a look at the CRO Kendle International. It's one of the leading CROs in the world. Based in Cincinnati, Ohio this CRO employs over 4,000 people in 48 locations in 28 countries. It has reached its $724.7 market cap by strategically placing itself where the future opportunities lie. Ithas locations in Australia, China, India, Singapore and Latin America and benefits from the current of outsourcing clinical trials. For more information, read Small Cap Investor's article here.

Some clinical trial results not published

In a recent article in the UK's The Guardian, they divulge that in a recent study involving 90 drugs from 1998 to 2000, 43% of the drugs never had a report published on the results of their clinical trials. Reports are typically published within five years of a drugs release date to give doctors and patients critical information so they can make the right decisions when it comes to prescribing and taking the drugs.

The study performed showed that results from 909 different clinical trials did not have their results published. Also noted was the fact that typically those trials with more statistically significant results were published more often than those with non-significant results.

What do you think about this? Those conducting and participating in clinical trials have the right to have their undertaking shared with those who are about to take the drugs they're testing. Do you think this will change anytime in the future?

Quintiles will become largest Asia-Pacific clinical development center

In 2009, Quintiles will relocate to a facility that is 80,000 square feet, which will double its size. The facility will open in Singapore, where since 1995, they have done more than 1,000 studies. Clinical Trials Today has the in depth story.

Anand Tharmaratnam, M.D., head of clinical development for Quintiles Asia Pacific, had this to say about the expansion:

“Firstly, a significant proportion of our customers are in Singapore and all of them are within a seven-hour direct flight from Singapore. Singapore is also connected by direct flights to a lot of our U.S. and European offices. Secondly, we are able to hire talent with multinational company experience in Singapore, and we are able to attract foreign talent to relocate to Singapore who find it a stable, secure and welcoming environment to live in as a foreigner. Thirdly, it is an attractive place from which to manage a business with very high ethical and transparent governance standards with an effective tax structure. Fourth, it is increasingly becoming a global hub for scientific excellence and innovation.”

Guidelines to choosing your CRO

In a recent article at ClinPage, Jodi Andrews goes over a few key factors that should go into choosing a CRO.

Experience -- Look at things such as: How many projects do they have at once? Average experience of staff members working on YOUR trial.

Flexibility -- What's the speed of communication with your CRO? Are staff members able to deviate from the company plan to modify the trial to your specific needs?

Cost considerations -- Do the company's CEOs have an eye on some of the projects? Is there enough oversight on the trial they'll perform? Is there a process for quality oversight? Is the big too low?

These are all things to consider when you're looking to outsource your clinical trial. From the amount of experience your CRO has to the involvement of their management, its important to find the right balance for your needs.

Do you have any other considerations not listed above that you look at when choosing a CRO?

Indian Share of the Clinical Trial Market

Contract Research Organizations, and the outsourcing of clinical trials, from markets outside the U.S. has proved to be a booming industry. India, especially has seen the effects of this increase in industry size. As reported here in in-Pharma Technologist.com, it is expected that by 2011 India will hold a 15% share of the market. In 2007 it was reported that the Indian CRO industry was valued at $200 million, however, by 2010 that value is expected to increase to $500 to $600 million. Data from KPMG indicates that the reason for this boom is that it is considered to be the cheapest market for clinical trials along side Russia.

No Need to Fear the EU Clinical Trial Directive

Many in the clinical trial industry were worried that the EU Directive would have a negative affect on the industry. In the latest study from the British Medical Journal as reported by Outsourcing-pharma.com, they reassure that so far there have been no negative repercussions, at least for Denmark. The main reason for the concern stemmed from worries that the amount of paper work that the Directive would require might result in public institutions being overwhelmed and unable to keep up. As the study reassures:

“academic researchers can match the demands for the good clinical practice quality standard that industry have adhered to for many years.”

Drug Approvals

Much has been said in the news regarding drug recalls such as this latest article from NY Times, where they discuss how certain drug imports from an Indian drug maker have been stopped. Also, as we mentioned yesterday, one tool CROs can use are LIMS to help with the authorization processes set in place by regulatory agencies. In relation to these news items, PharmaVoice mentions here, that there is a real need for technology to be updated in order to combat drug safety concerns. As of September 2007, the FDAA was updated to require certain sponsors to submit a “proposed REMS”. In addition, the EU is requiring a PSURs to be submitted every 6 months for the first 2 years. The PharmaVoice article summarizes:

“This will require companies to invest in more advanced pharmacovigilance technologies and to develop new processes for the analysis of adverse events both in the postmarketing environment and during development.”

Role of LIMS

This article from Bio-IT World reminds that it is important for CRO’s to use high-performance laboratory information management systems (LIMS). Sponsor companies and CRO’s who use LIMS, will see a lower “barrier entry” when dealing with regulatory agencies in respective countries. LIMS are helpful in gathering, analyzing and storing data for the CRO’s sponsors. It is especially important to be aware of regulations since on average bringing a new drug to market takes 15 years, and costs $2 billion.

NiKem is Accepted by the FMR

Contract Research Organizations, for the most part, are inherently global. NiKem Research Srl, is not an exception. As announced here, they recently received good news from the French Ministry of Research (FMR). The FMR has approved them to reach the status of “Crédit d’Impôt Recherche”. This allows the CRO, NiKem, to conduct Research and Development activities for private French companies. Guesseppe Giardina, CEO of NiKem, released this statement:

"The approval as a C.I.R. certified company by the French Ministry of Research is an important step forward for NiKem. We believe that our already significant business volume with French pharmaceutical and, most importantly, biotech companies will grow: in fact, our high quality standards are now combined with competitive prices and tax credit options. Thus, we expect to at least double our revenues in France in the next three years."

Phase I Trial Outsourcing in India by 2010?

Outsourcing-pharma reports that Phase I outsourcing of trials to India may be allowed in 2010. Currently Phase I trials are not allowed in India, but the Central Drugs Standard Control Organisation (CDSCO) is considering changes stances.

Allowing Phase I trials to be outsourced to India would boost India’s thriving clinical outsourcing industry as well as offer pharma companies a cost-cutting route. These are some of the areas that the CDSCO will be focusing in on: fixed timelines of 2-6 weeks for each application, internet based new drug application (NDA) status and the recruiting subject experts and reviewers.

Will the recent new of infant deaths in India change the progress of this proposal?

Indian government looking into regulation of Clinical Trials

According to this article at Sify Business, the Indian government is looking to allow CROs to conduct Phase 0 and Phase 1 clinical trials. This could begin occurring as soon as 2009 or 2010, after they've implemented an infrastructure to monitor the trials.

Presently, India only allows Phase I and Phase III trials if the company conducting the trial has gone to another country and conducted Phase O and Phase I trials there. But, new regulations could change this as well.

A recent gathering of Confederation of Indian Industry, those who are working with clinical trials took time to address current issues hindering the success of clinical trials in India. Some of these problems addressed were:
-Infrastructure
-Technical expertise
- Drug analysis
- Stringent clinical trial monitoring systems
- Mandatory regulations of CROs
- A way to keep track of patients so they don't participate in more than one clinical trial

Drug Industry's Rush to Outsource

India has now become the prime destination for drug companies looking to make a buck overseas with the plethora of brainpower and ability to save millions--maybe billions--of dollars for the company's research.

According to Business Week, "five Western companies have formed drug discovery partnerships with Jubilant, including Eli Lilly, Amgen, and Forest Laboratories. Lilly is also partnering with Piramal, as is Merck. Every month deals are signed with India's elite pharmaceutical companies. The goal is to take promising compounds discovered by the multinationals, run tests to weed out the weakest candidates, and develop some of the others into marketable drugs. Eventually the Indian partners also hope to rack up scientific breakthroughs that lead to entirely new medicines for diseases such as Alzheimer's, cancer, or diabetes."

So can this work? With American businesses happy to cut jobs in the USA for cheaper labor East; will there be another hit on the American economy? Alternatively, the positive effects of using cheap labor could build up the pharmaceutical industry allowing businesses to save money and, perhaps, expand their Western workforce.

Your thoughts?

Gryphon Investors Invests in CROs

PharmaTimes reports Gryphon Investors has announced an agreement with two US suppliers of clinical services to pharmaceutical and biotechnology industries.

Gryphon has invested funds in Synteract, which is a CRO with expertise in oncology and central nervous system drugs, and Vince Associates, which is a leading provider of services that specialize in sleep disorders research. Nick Orum, head of Gryphon’s Business Services Group mentions that the agreement has been a “year-long effort … to become an active participant in the dynamic, growing field of outsourced drug development services”.

Clinical trial for autoimmune drug halts

Recently, the Birmingham Business Journal reported that a clinical trial for BioCryst Pharmaceuticals found that tested drug BCX-4208 was shelved due to the trial showing that it had no effect on psoriasis. The test included 66 patients who suffered from severe psoriasis.

The drug did prove to meet this objective:
The study showed the drug met another objective by suppressing the number of immune T-cells which act as gatekeepers for the body in determining whether to accept transplanted organ.

Technology and Clinical Trials

Wall Street Journal posted this interesting article about firms that conduct clinical trials and their use of technology. Apparently many firms, including contract research organizations, are still are not using electronic means for documentation, and instead much of the information is still being recorded using the simple pen and paper method. As stated, IDC ran a report that concluded that only 45% of phase I-III clinical trails conducted last year used EDC. That is up somewhat 69

in comparison to only 20% in 2003. It should be noted however that the number of firms using EDC is expected to increase to 80% by 2011. As quoted in this article, Bob Weiler, CEO of Phase forward remarked that:

Clinical trials have taken so long to go electronic because “if you go back two or three years, many doctors did not have broadband connections,”

Tips to get to Clinic Faster

As this article informs, Medelis, an oncology CRO, is providing a free downloadable abstract titled Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster. The purpose of the abstract is to provide tips specifically for Chief Medical Officers to help them and their organization get to clinic faster. As the Medelis website reports, some of the topics covered include:

- Critical factors for a CMO to understand and evaluate during this step in the drug development process

- Regulatory assessments and how to avoid hitting a preclinical wall

- The nuances and complexities of rodent models, tumor selection, and other variables

- How to keep the preclinical, regulatory and clinical teams involved in feasibility dialogue

- The typical preclinical study process and the questions a CMO should be asking at each step

- Additional requirements unique to oncology preclinical trials

- What to look for in an outside preclinical team

Acurian expands patient model

Acurian, a patient recruitment solutions provider, has announced a change in their business model. This company is already widely known for their performance contracts based on the customers’ ability to leverage the Acurian database. Now their model will include advertising based strategies focusing on determining how sponsors buy patient recruitment advertising. They’ve already begun this model, and there are two large, centralized performance based contracts according to this post at Market Watch.

Update: Indian Institute and the death of babies in clinical trials

Last month, we informed you of the controversy including deaths of children in India that are though to be the result of drugs used in clinical trials.

The FDA News has updates to this story. The AIIMS (All India Institute of Medical Sciences) is claiming that the 49 infants who died were already ill when they came to the experiment. Daiich Sankyo and Novartis, two of the sponsors who were conducting studies, claimed none of their patients died as a result of the trial. The deaths occurred in the Institutes Department of Pediatrics beginning in 2006. There were 4142 subjects in the trials, and the children who died, as stated earlier, were already suffering from sever diseases. The foundation has not released how many children died in the treatment arms and control arms of the trial. The trial was for hypertension drugs.

Oncology accounts for most clinical trials

According to Clinical Trials Today, between October 2005 and September 2007, oncology accounted for the most clinical trials registered in a specific field. The research accounted for all trials ranging from Phase II through Phase IV. Aside from oncology, two thirds of all clinical trials registered included trials for central nervous system disorders, cardiology, endocrinology, infectious diseases, and respiratory diseases.

Chiltrem Early Phase has been fully integrated

Announced today in this Market Watch article, Chiltrem, a contract research organization, has been able to integrate their two early phase units into one cohesive unit: Chiltrem Early Phase. This was needed after the acquisition of Drug Development Solutions this past February.

Dr Brian Sanderson, Medical Director of Chiltern Early Phase had this to say:

"I am delighted to see the integration completed so thoroughly and ahead of schedule. We are now looking to build on our units' long histories of good science and medicine, both in the areas where we have traditionally been strong but also in new areas of specialization such as diabetes and cardiovascular medicine. We are also looking forward to forging academic links to provide specialist studies involving new biomarkers."

Covance Signs New Deal with Eli Lilly & CO

NJBIZ reports that the Princeton-based drug development company Covance Inc. entered into a $1.6 billion contract research deal with Eli Lilly & Co. of Indianapolis.

Covance will buy Eli Lilly’s 450 acre Greenfield Laboratories in Indiana for $50 million instead of just supplying outsourced clinical trials and testing work. Covance will take take complete responsibility for all testing and R&D support activities for Lilly at the site, and that is how this approach differs from typical practices states Wendel Barr, COO of Covance.

Covance will utilize over 260 Lilly staffers at the Greenfield campus. The COO expected work to start the day after the contract is signed, which is expected to be in October. Read the full article here.

Finding patients is the lengthy part of a clinical trial

According to a new report from Cutting Edge Information, detailed here at FDA Drug Daily Bulletin, it takes more time to recruit and enroll a patient for a clinical trial than it does to provide them medical care. There are a few things causing these problems, including competition for the same group of patients who are candidates for popular trials. The study cited the best way to find patients was through physician referrals, patient referrals, and newspaper and television ad.

AmeriStart to Promote Factory CRO

AmeriStart signed a contract yesterday to promote the contract research organization, Factory CRO, in the US as announced in this article. AmeriStart already represents many CRO’s, and with this latest addition, they will be promoting Factory CRO’s capabilities in the medical device market. Dirk Meijer, CEO of Factory CRO, released this statement:

“Our team of experienced physicians, clinicians, and medical device professionals has, over the past 20 years, conducted clinical studies for more than 50 American medical device manufacturers. Now, with a representative office and AmeriStart’s organizational support, we hope to expand and improve our standing in the USA marketplace.”

New Investigations in Deaths of Babies in Clinical Trials in India

India has become an attractive place for pharma companies to outsource their clinical trials to since on average it costs only 40 to 60 percent of what trials would cost in developed countries. AFP reports that India’s top medical facility will now investigate the deaths of 49 babies that occurred in clinical trials from the beginning of 2006 to the present.

A total of 4,142 babies were involved in clinical trials since January 1, 2006, and more than half of them were under the age of one. Shakti Kumar Gupta, head of administration for the state-run All-India Institute of Medical Sciences, mentions that he wants tougher and stricter regulations for clinical trials business in India, since it is now a 120 million a year industry growing at about 25 percent annually.

Health Minister Anbumani Ramadoss mentions:

"Earlier we had guidelines on how trials need to be conducted. Soon we will have a law."

A committee is expected to submit their findings later on next week. How will this affect partnerships with CROs in the future?

Acurian Invests in better patient recruitment techniques

Acurian, a patient recruitment service, has invested in data modeling in order to improve patient recruitment. This has increased the data modeling capabilities. According to this article at Clinical Trials Today, these tools will take analytical data expertise and technologies to help them recruit based on data they’ve collected. In addition, it will help them to develop and analyze patient recruitment campaigns.

CIO and Vice Presidnet of Operations, Roger Smith, had this to say about their new tools:

“So while we’ve made significant investments in analytical data expertise and technologies to help us run the only performance-based recruitment business in the industry, our customers are the true beneficiaries. Our data experts and tools help sponsors better understand the enrollment continuum from response to randomization so that there are no surprises in timelines or budget allocations.”

ACRO Accepts New Members

As reported in market watch, the Association of Clinical Research Organizations (ACRO), has accepted two more members, Clinilabs, and RPS. Clinilabs specializes in dealing with the central nervous system and cardiovascular therapeutics. RPS, provides global Phase I-IV clinical development solutions.

David Spaight, ACRO Chair and President, released this statement:

"I am extremely pleased to welcome Clinilabs and RPS as new members of ACRO. Their involvement will enhance the association's ability to represent the CRO industry broadly to government officials, research sponsors, patient groups, and others international stakeholders. We invite all CROs to consider membership in our industry's trade association."

Accenture has Big Plans For Outsourcing Services

The Financial Express reports that Accenture is planning to expand the scope of its life science centre in India and its capabilities of clinical trials.

Arjun Bedi, Global Lead of Accenture’s Health & Life Sciences R&D practice, mentions:

“There is a new wave in the outsourcing of the R&D model from in-house innovation engine to a virtual innovation network. A new dichotomy is being identified in the research process with virtual transformation in the front end and a development factory at the back end.’

Pharmaceutical growth is threathened by rising costs and decreasing budgets, and clinical trials are only becoming more complex and rigorous. Perhaps pharma R&D outsourcing might the solution, but pharma companies have been slow in adapting to R&D outsourcing because of concerns such as diverse portfolio applications, regulatory requirements, security and domain expertise.

BioMS Will Give $10m to MS Drug Testing

A clinical study for secondary progressive multiple scleroses will be being conducted by BioMS Medical Corp will receive $10 million from Eli Lilly and Co. BioMS Medical Corp is a leader in developing treatments for MS, and Eli Lilly will contribute their money towards the licensing and collaboration agreements. They signed on to the study after an independent drug safety company gave the treatment an OK. This was reported by FDA News.

Parexel and ClinPhone

We recently reported the deals that the Encorium Group, as well as Covance have made. In latest news as reported by PharmaLive, Parexel announced closure on the deal to acquire ClinPhone. This will help both companies become leaders for eClinical technologies. This is inline with the trend of growth within the contract research organization industry.

Josef von Rickenbach, Chairman and CEO of Parexel, released this statement regarding the acquisition:

"Biopharmaceutical companies require robust technology solutions to increase the efficiency and productivity of clinical research. This is especially important given the growing complexity and global nature of clinical studies today. We believe this acquisition further solidifies PAREXEL's leadership in providing integrated clinical and technology expertise. Combining the sophisticated, in-depth capabilities of Perceptive and ClinPhone represents a major step forward for PAREXEL in meeting increased industry demand for a truly comprehensive eClinical platform."

Encorium Group Announces $3.5 Million of New Contracts for Clinical Trials for Vaccines

MarketWatch reports that Encorium Group, Inc, which is a multi-national contract research organization, has announced the signing of $3.5 million of new business contracts with a global biopharmaceutical company.

This contract will cover clinical trials in the field of vaccines for infectious diseases in multiple European countries. Kenneth M. Borow, M.D., Encorium Group's President mentions:

"With the signing of these contracts, Encorium has announced approximately $13.5 million of new business during the past three weeks. In aggregate, these new contracts represent both repeat and new client business and cover a wide array of therapeutic areas for multiple small as well as large biopharmaceutical companies. Encorium will provide clinical trial services for these studies on three continents including North America, Europe, and South America. We are very encouraged about our company's ability to win new business, especially as we move forward with our globalization efforts."

New Reports proposed by the FDA to monitor safety

The FDA is now proposing a change to the way safety is reported on in respect to clinical trials. The FDA is proposing that clinical trial sponsors submit an annual Development Safety Update Report (DSuR), as reported by FDA News. This would replace current reports that deliver the status of the safety of drugs in clinical trials such as the IND Annual Report.

In this new DSUR, trial sponsors would be responsible for:

--updating the trial’s status

-- summarizing their understanding and management of identified and potential risks

--describing new safety concerns that could affect the protection of trial subjects

--examining whether the information collected during the previous year fits with knowledge about the product’s safety, the draft says.

Eli Lilly and Co. To Sell Greenfield Laboratories

In an update from a previous post, Eli Lilly, after deciding to cut costs as a result of the current economic climate, choose to sell their Greenfield Laboratories in Hancock County, Indiana. Covance, a contract research organization will be purchasing the lab for $50 million. While the lab was previously off limits for use by outside sources, with the change of hands, Covance will allow outsiders to come in and use the facilities for a fee. This article quotes Joe Herring, CEO and Chairman of Covance:

“Today's announcement represents an innovative approach to the R&D productivity challenges our pharmaceutical clients are facing,

Herring was also quoted as saying that it

"carves a new path to growth for both Covance and the CRO industry.”

The article continues by mentioning that Herring also was noted as stating that this marks a shift in dynamic where companies are changing from being a “fully-integrated pharmaceutical company” to a “fully-integrated pharmaceutical network”.

This new development is in line with what many of our previous posts have said about the changing environment for pharmaceutical companies who are starting to outsource more of their research and development to contract research organizations.

India’s Clinical Trials

India is known for their acceptance of outsourcing in their country. Due to the low costs of financing trials here, big Pharma has also started to look to India for outsourcing clinical trials. Time recently took a look at the business of CROs in India. Typically, it costs $1 billion to bring any particular drug to the market, and most of that money is devoted to the part of testing on humans. In India, not only is it cheaper to conduct the human trial, but there are also less strict regulations when testing the drugs. There are currently 400 clinical trials taking place in India. Although there are numerous doctors who are proficient in English to support the effort, few of those doctors have graduated from world class institutes, and even fewer of the people working on the clinical trials have been properly trained.

One of the allures of participating in clinical trials for Indian citizens is the healthcare that’s involved. Since India has no public health care system, the care given during a clinical trial is often better than not receiving any at all. Sadly, most of the citizens who sign up for the clinical trials are illiterate. And with Pharma pushing for trials to go faster, often times health standards are not the highest. The booming business will lead to medical breakthrough for India, but how will it affect their citizens in the long term?

Costs Are Too Much for a Drug Trial Center in Indianapolis

This article in the Indy Star reports that the Lilly Center for Medical Science will end clinical trials in Indianapolis later on this year. Many drugs that treat diabetes and depression grew out of research from the Lilly Center, but now early stage – Phase 1 trials in the United States are no longer cost-effective, and so most companies have begun to outsource their clinical trials.

Lilly is not getting out of early-stage drug trials altogether, but it has created a partnership with Covance in which they will conduct majority of the trials elsewhere. Covance already does preclinical toxicology testing for Lilly, but now it will conduct several more clinical trials. Working more closely with Covance will allow Lilly to get drugs out to the market faster and cheaper than before.

Days for patients in clinical trials increasing

In this article at ClinPage, they discuss a recent study that found clinical trial time periods had significantly increased between studies done ranging from 1999 to 2002 and from 2003 to 2006. The study found that the median number of days in clinical trials had doubled and stood now at 598 days, or 19 months. The article goes on to explain that the reason for the increase in time spent on clinical trials was the goal to achieve more accurate data recording throughout the clinical trail process. Medidata is trying to record all data collected in clinical trials, along with detailed efforts to integrate electronic data capture into the process. Better data collection will also allow for better comparison of data between similar trials.

Growth of CRO’s

We have posted some articles recently on the growth of the CRO industry. This article from The Motley Fool confirms what others have been saying and provides some more insight into this development. As can be seen by the chart featured, over the past year, CRO’s have seen their revenues increase. The article makes a point of stating that much of this growth is a result of the drug companies looking for ways to cut costs, with the current state of the economy, by outsourcing their research. Also, considering that their revenue is not tied to the success of a particular drug, their risk is minimal.

	1- Year Return	TTM Diluted EPS Growth
Covance (NYSE: CVD)	25.5%	24.1%
Paraxel International (Nasdaq: PRXL	39.2%	38.3%
ICON (Nasdaq: ICLR	73.8%	37.8%
Charles River Laboratories International (NYSE: CRL)	29.2%	22.1%
WuXI PharmaTech (NYSE: WX)	24.4%	N/A

Some important points the article makes are:

“It doesn't look like the growth that CROs have experienced over the last few years is likely to go away any time soon, either. A recent report by Turner Investment Partners estimates that in the next few years CROs will be involved in half of all drugs at some point during development.”

“What's interesting though is that the CROs may be shifting who their source of revenue . Many smaller biotech companies are now using CROs' expertise to get early drug development done. That same report estimates that biotech now accounts for 30% of CROs revenue globally, up from 21% five years ago.”