India: Domestic clinical trials market booms

Thomas K. Thomas of The Hindu Business Line writes, the number of clinical trials being conducted in India has doubled from 170 in 2006 to 350 at the end of 2008, according to the Central Drug Standard Control Organisation.

And going by the indications in the first six months of 2009, the number of registered clinical trials in the country is likely to touch a new high.

Already between January and June this year, 130 trials have been registered with the drug regulator. Since the drug regulator has made it mandatory for clinical research organisations to register all drug trials from June onwards, a significant jump in the actual numbers is expected this year.

What's next for India? Now a global player in both clinical trails and cros--will India take the lead?

ACRO Reports that Clinical Research in Developing Worlds is Up to U.S. Standards

Pharmaceutical Online reports that the Association of Clinical Research Organizations (ACRO) has released a report that says clinical trials conducted in the developing world meet the same safety, ethical and quality standards as those conducted in the developed world. Based on the report's findings, ACRO, which represents the leading global Clinical Research Organizations (CROs), is urging several steps to ensure that a robust global research infrastructure continues to facilitate accelerated drug development.

With the changing landscape for CROs, the report has several key findings:

• Global trials speed drug development – The report concludes that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety. For example, phase III cancer trials are conducted three times as fast if both U.S. and global sites are used, compared to U.S.-only sites. What takes 5.8 years to enroll takes 1.9 when a global trial is implemented.
• Research quality standards must be met worldwide – The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe. CROs train research staff around the world in good clinical practice (GCP) principles and proof of compliance is required by drug regulators in every major pharmaceutical market.
• Clinical research improves local economies – Clinical research offers huge advantages for host countries, including an influx of advanced equipment, trained personnel and high-paying jobs. The presence of CROs also results in improvements in local health systems. Clinical trial sponsors in Poland, for example, fund 30 percent of hospital cancer therapy.
• Emerging market equals growth market – CRO activity in Central European countries, South Korea and Taiwan is very robust, medical infrastructures are advanced and capabilities are just about on par with Western Europe.

For more information about this report and about ACRO, please visit the article referenced here.

Clinical Research Safety And Ethical Standards In Developing World Up To U.S. Levels

Insourcing Is The New Outsourcing In Biopharma

Stephanie Wells of Life Science Leader writes, The growth of insourcing means that the future of contracted work is likely to be a blended approach. In some cases, the CRO would provide traditional external services, like general toxicology studies or Phase II clinical studies. In other cases, when a client is working in a new area and has not yet developed the necessary infrastructure, partnership with a broadly capable CRO means that many necessary services in the new field can be performed on an insourcing basis, including the help of an insourced “navigator” group of ex-FDA personnel who can guide the new compound through studies that ensure it has the best chance of proceeding efficiently through the regulatory process.

What do you think of insourcing? It is the new standard?

Insourcing Is The New Outsourcing In Biopharma

Sigma-Alpha Moves Differently from Classic CROs Offerings

Last week, Tony Fong of Genomeweb reported that, Sigma-Aldrich, hoping to grab a bigger slice of the biopharma industry's expanding appetite for outsourcing, (last) week expanded its services business to include mass spectrometry-based protein characterization, protein expression, and protein purification.

The idea is not for Sigma-Aldrich to collaborate with biopharmas on large-scale projects and manage them; "that's what a classic CRO does, and this is definitely not a classic CRO offering." Rather, what the company is offering is the chance for customers to choose individual services from a menu without fear of jeopardizing their intellectual property, she said.

In fact, the executive of one CRO said that because of the limited offering of services by Sigma-Aldrich, the two are not competing for the same business.

Sigma-Aldrich Debuts New Protein Services to Meet Biopharma's Growing Outsourcing Trend

CROs 2009 Workshop Video

For those who missed the workshop last month in Orlando, we are providing unlimited access to this timely workshop to all Partnerships attendees and their colleagues. And since we understand your training and travel budgets are limited at this time, this video workshop is completely free of charge.

Simply click the link below to watch the video at your leisure, and feel free to pass along to your CRO colleagues.

www.iirusa.com/cropartners/BDWorkshop.xml

If you are in business/corporate development, sales, marketing, client relations, account management, operations or project management at a CRO or other outsourcing provider, this video workshop will help you achieve your professional development goals including:

• Demonstrate value to Sponsors who are increasingly pushed to make decisions based solely on cost
• Understand how downsizing in pharma will make micro-managing a thing of the past as CROs take over as the ‘doer’
• Access the right people (decision makers) in an organization to approach for new business opportunities -- and getting them to return your call
• And much more....

As Sponsors increasingly look to CROs to provide expertise, what level of experience do CRO project managers need going forward?

Partnerships with CROs is providing unlimited, complimentary access to the video of our highly rated premier workshop for CRO Business Development professionals, CRO Strategies for Adapting to the Changing Tides in Pharma.

This in-depth workshop provides CRO BD Execs with the strategies necessary to approach, interact and work effectively with your current and prospective biopharma clients. And it's all FREE! Tell a friend:

http://www.iirusa.com/cropartners/BDWorkshop.xml

Recession, stimulus bill open new doors for CROs

Connie Johnson Hambley, principal, Steele Executive Search recently wrote an article on Massachusetts High Tech in which she discusses how CROs can benefit from the current economy and President Obama's economic stimulus plan. Here are a few excerpts from her article that we find are particularly relevant for our readership.

Legislators, practitioners and scientists are asking how to contain the soaring costs of health care while providing the best care. The $787 billion economic stimulus package provides for two prongs of inquiry — nearly $10 billion for academic research into new drugs, devices and surgeries for cancer and other illnesses and $1.1 billion to compare existing therapies to assess their effectiveness to treat specific conditions. These areas are subject to reporting and transparency standards as well as an increased focus on using funds efficiently.

CROs can be used strategically as well. They can perform additional directed research on a promising secondary direction while the sponsor company remains focused on its primary objective. Venture capital firms are using them to validate data before investing initial or secondary rounds.

Big pharmaceutical and device firms and biotechs are having layoffs and CROs are holding steady or growing, positioning themselves for winning in this down economy.

Based on your work, do you see CROs thriving in this environment? What do you think about Hambley's thoughts on using CROs strategically? We'd like to hear your thoughts.

For the complete article, please click here.

New CenterWatch Report Examines Japan’s Surging Clinical Trials Market

Healthplannews.com reports that Japan is participating in global drug development at historic levels; however, there is still work to be done there to sustain that growth. Japan's importance in the global drug development arena hasn't had near the impact of India's but could that change? We'd like to know your thoughts on this shift in leadership and in development, do you see more changes happening with Japan's CRO market?

A New Low in Drug Research: 21 Fabricated Studies

According to WSJ.com, Baystate Medical Center in Springfield, Mass., has asked several anesthesiology journals to retract the studies, which appeared between 1996 and 2008, the WSJ reports. The hospital says its former chief of acute pain, Scott S. Reuben, faked data used in the studies.

Some of the studies reported favorable results from use of Pfizer’s Bextra and Merck’s Vioxx, both painkillers that have since been pulled from the market. Others offered good news about Pfizer’s pain drugs Lyrica Celebrex and Wyeth’s antidepressant Effexor XR. Doctors said Reuben’s work was particularly influential in pain treatment and that they were shocked by the news.

Read more on the WSJ.com's health blog.

Raising alarms, study sees trials migrating abroad

John Carroll at FierceBiotech.com reports that the U.S. drug industry has shifted most of its clinical trials to overseas sites in a trend that experts warn raises serious ethical concerns. According to a study in the New England Journal of Medicine, 13,521 of 24,206 trial sites being sponsored by the top 20 U.S. drug companies in late 2007 were taking place beyond our borders, where data can be harvested cheaper and faster than the data gathered inside the U.S. And the study adds that the number of countries hosting trials has doubled in 10 years. Most of the countries hosting clinical trials may be using individuals who could never afford the medications and approval for these trials has been less than half. What are your thoughts?

India to Conduct 5% Global Clinical Trials by 2012

A few weeks ago we discussed the report released by RNCOs that discussed India's prominence in the global clinical trails arena. Today, another aspect of the report came in that claims India will be conducting 5% of global clinical trials by 2012. This claim is partly due to India's large patient pool, the recruitment of these patients is also among the fastest in the world. As most of the healthcare costs in India are paid “out of pocket”, a large patient population continues to have unmet medical needs. As a result, they readily volunteer to participate in clinical trials to get free treatment. So we ask you again, what do you think? Are other nations going to rise above India's prominence?

Indigo BioSystems Successfully Tests First Globally Accessible CRO Data Integration System

Three dimensional data can now be globally accessible thanks to the CRO Data Integration System that was just successfully implemented today from Indiana, USA to China. This will allow CROs across the world to access pertinent information and make quick decisions regarding the research of pharmaceuticals, etc. Before the implementation of this system, files were too big to send to other research labs, causing much delay for an industry whose survival is now based on being the first to find and release valuable information. How will this effect the world of CROs? We'd like to hear your thoughts.

From MSNBC

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.

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.

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.

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.