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.