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.”

OCT Opens Office in New Markets

Clinical Trials Today reports that the Russian based contract research organization (OCT) Outsourcing Clinical Trials will expand its market by opening up a new office in Belarus.

Outside of Western Europe and North America, Central and Eastern Europe represent the largest number of global trial initiations. Ekaterina Mochalova, business development manager at OCT mentions, “Belarus is a very attractive region to conduct clinical trials, from our point of view.” What makes Belarus an attractive place for CROs is low competition among ongoing clinical trials, and a healthcare system that is still centralized which allows companies to enroll more patients at fewer investigative sites.

Clinical Testing Company Seeing Rise in Profits

Covance, a contract research organization, is one company that is proving the prediction that pharmaceutical companies are starting to rely on them more heavily. This article mentions that profits have risen for the Covance by 22.7%. The contract research organization industry is one of the few that is experiencing growth in an otherwise dismal economy. As mentioned in our previous blog post, much of this is because the cost of in house procedures is much more expensive than that of outsourcing to companies such as Covance. The company is also very optimistic in its outlook, which is inline with the trend, and predicts that they will be able to post a 20% growth in profit by the end of 2008.