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.