Approaches to Address the Impact of Increasingly Complex Clinical Trials

Pam Atwell, Director, Operational Strategy & Planning, Clinical Development Services, COVANCE INC .
William D. O’Riordan, MD, Medical Director, eSTUDYSITE

Ensure patients safety is the most important part of the trial. The current state of affairs in clinical trials is that an overwhelming 92% behind enrollment timelines. Trial delays have impact on the registrations of the products. What have we seen over the past few years? We’re looking for patients in nontraditional countries, we’re chasing patients where they haven’t been tapped into in the past. Even though they exist, we’re waiting for investigators to catch up to the demand to give us access to the patients. With out and investigator site, we can’t get patients enrolled in our clinical trials. In India, 2% of the global investigator pool in 2007. China didn’t approach 1% of the pool. Investigators are small percentage at the moment, top 20 growth rates are all in emerging markets: China, Estonia, Russia, Peru. We have not only more complex studies, but we also have more of them, with few investigators for find patients.

What does this mean for the emerging markets? Investigator sites aren’t in place and the protocols are very complex. Will we see the same churn rate as we see in the western countries? Research for a year and then dropping off?

FMEA – Processes Failure Mode & Effects Analysis (FMEA) Systemized group of activities to identify the mission failures and their impacts. It was developed by the US government. Covance has applied this to clinical trial management. The steps that have been identified for potential failures or places that failures could occur on a clinical trial. We can identify possible places to identify failure at a site. Pick up on the places for protocol deviation and violations that occur. You can then rank your failures. Risk score for all potential failures.

What are the barriers to success? Lack of fundamental understanding of the nature of risk management, Up-front planning requires initially more time and cost, ongoing review processes also require additional resources, appears to add complexity, and cultural change in how many clinical trials are currently conducted.

William – Proactive method of addressing as far as the concerns of the research sides. Average increase of CRF pages went from 55 in 1999 to 180 in 2006. Compensation per procedure has decrease 7.9%. Pharma must plan ahead better and better to proactively manage trials.

Covance has two committees:
Protocol review committee to examine proposed protocol, each member of panel has specific task to overlook. The committee reconvenes in one week and reports on the areas they were designed. They then decide whether or not to take the protocol. This must be done very early on.

Fast Start Committee is in charge of coordinating and implementing and protocol and addressing and solving complex issues contained in the new protocol.

Updated:

Here is a short clip from this track session

Key Findings on CRO Industry

Over at FierceBiotech they've recently summarized some key findings from the Top 10 Contract Research Organizations, which is a report published by Business Insights that examines the competitive landscape of the global CRO industry. Here are some of the issues they've uncovered:

• The CRO market will grow at an annual rate of about 14% over the course of the next 3 years.
• Quintiles leads the CRO market this past year, but the 10 major CROs accounts for 56.1% of the market. There are over 1,100 players in the industry.
• In an attempt to expand services and offerings, it has led to increased alliances, joint-ventures, and other partnership deals.
• Covance is the 2nd largest CRO only trailing Quintiles
• Biomarkers will become an important part of clinical research after the FDA has recommended their usage
  

PPD Extends its Reach to Eastern and Central Europe

We recently posted that Covance was planning on opening up several offices across Eastern Europe, and now according to this article in novinite.com PPD is set to buy AbCRO, which is Bulgarian based CRO, in order to expand its drug testing businesses in Eastern and Central Europe.

The purchase which is expected to be completed in March will add Romania, Bulgaria, Serbia and Croatia to PPD’s operations in Europe and also help bolster its already existing operations in Poland, Russia and the Ukraine. What other clinical trials companies are investing heavily in Eastern and Central Europe?

Covance Opens Offices in Ukraine, Slovakia and Israel

Earlier today I came across this post on the Future of Biopharma blog that highlighted an article on ClinicalTrialsToday that details the recent expansion of three new clinical development offices Covance has opened in Central and Eastern Europe and the Middle East.

The purpose of the new offices is to speed clinical trials and develop strategic relationships in those areas. The new offices will be located in Kiev, Ukraine; Bratislava, Slovakia; and Tel Aviv, Israel. Covance has been providing services already in these parts for quite some time, but now these locations will support staff and the CRO’s regional network of field-based clinical research associates.

Covance expands into Eastern Europe and Middle East

Covance has opened up new offices in Kiev, Ukraine; Bratislava, Slovakia; and Tel Aviv, Israel. The Ukraine and Slovakia offices will be in support of the CROs regional network and field based CRAs. The new office located in Tel Aviv will be a center to support staff for operations in Greece, Turkey and the Middle East.

For more information, read here.

Merck and PPD Partner in Outsourcing Deal

Clinical Trials Today reports that CRO PPD has entered into a strategic collaboration with Merck to expand its global laboratory business. Under the agreement, PPD will have access to Merck’s 130,000 square foot facility in Wayne, PA as well as 80 employees who will operate there.

In return, PPD will provide Merck with range of assay development and immunogenicity testing services as well as traditional central laboratory and sample storage services over the next five years. This is the beginning of a trend of strategic agreements we have seen between CROs and big pharma. We have seen this in August 2008 when Covance partnered with Eli Lilly in a $1.6 billion contract research deal.

Will we see this trend continue between CROs and big pharma in 2009?

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.

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.

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."

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.

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.

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.

Outsourced Drug Trials Are Expected to Grow

About 25 percent of all preclinical drug testing is already outsourced to CROs, but according to this latest article in the International Herald Tribune, it is expected to grow to 50 percent in three years. Over the next five years, larger CROs are expected to absorb many specialized companies to boost their diversity. This expectation has already lift shares of CROs such as Covance and Parexel International, which were in stock market trouble this year.

Drug companies save millions of dollars each year by outsourcing clinical trials to CROs since it eliminates the need to build its own laboratories and researchers are not needed. David Windley, an analyst with Jefferies mentions as long as drug makers "keep trying to develop new drugs, then you have to do a lot of work. What they're then doing, they're turning to outsourcing in a more cost-efficient way."