Ten years ago a cancer patient’s choice was pretty much limited to either systemic chemotherapy or local therapies such as surgery and/or radiation, and only two big pharmaceutical companies, Bristol-Myers Squibb and Astra Zeneca, focused on cancer drugs. “Now we know much more about the biology of cancer cells, yet cancer is still an area of significant unmet medical need, and all the major pharmaceutical companies and a host of biotechnology firms are trying to develop novel anticancer drugs,” says Hemanshu Shah, a former executive with Bristol-Myers Squibb, Johnson & Johnson, and GPC Biotech.

“We understand more about what goes wrong to what makes a normal cell grow into a cancer cell,” says Shah. “We use small molecules and monoclonal antibodies to target different aberrant processes that go on inside the cell — genes, enzymes, or proteins.”

The result: Many new and interesting drugs are under development, yet only five percent of cancer patients opt to participate in a formal trial. “That’s why companies are competing for the same limited pool of patients and are trying to do trials outside of the United States,” says Shah.

In addition, the cost of trials is increasing dramatically, because stiffer regulations require more information to be captured. Most biotechs and pharmaceutical firms farm out some or all of their clinical trial work. One pharma, Eli Lilly, has just sold that part of its business to one of the world’s largest development companies, the Carnegie Center based Covance.

Earlier this month Covance paid $50 million for Eli Lilly’s 260-person early drug development campus, in Indiana. The pharmaceutical industry hails this as a trend-setting outsourcing deal, and Covance’s CEO, Joe Herring, has said it is the most significant development at Covance since the company went public 11 years ago.

With revenues of more than $1.5 billion and more than 8,900 employees in more than 20 countries (800 at the Carnegie Center), Covance manages more than 15,000 clinical trial protocols in over 100 countries.

“We partner with biotech and pharmaceutical companies to write protocols, identify oncologists, manage the logistical aspects of trials, and manage regulatory aspects,” says Al Blunt, a senior medical director who focuses on oncology trials. With an M.D. from Washington University of St. Louis, he provides scientific and medical oversight for some of Covance’s oncology trials. “We provide safety oversight and medical oversight, analyze the data, and put together reports,” he says. “We work directly with the FDA.”

Blunt was attracted to the oncology field because cancer drug development is so scientifically driven. “Of all the therapeutic areas, oncology is the one that takes us to the point where we can dream of personalized medicine,” he says. “Because of discoveries in basic science and cancer, we can now begin to treat patients, knowing which patients will benefit from a particular therapy and which will not.

“In working with some of the leading companies in the United States and globally, we have helped bring a number of key molecules to market,” says Blunt. “We have certainly seen growth, over the years, in the oncology business. We are getting more and more knowledge about what drugs work or don’t work.”

Covance says it will keep the current Eli Lilly employees, who work in areas new to Covance, such as in vivo pharmacology, some toxicology services, and non-clinical imaging services. By doubling or tripling the workforce at the Indiana campus, called “Greenfields,” the company could use the site to serve non-Lilly clients next year. Lilly is promising to contract with Covance for services worth $1.6 billion over 10 years, more than double the previous Lilly business.

The need to conduct Phase 2 and 3 trials at many sites around the world, says Blunt, plays to the strength of Covance, which has one of the world’s largest central laboratories. located in Indianapolis, Indiana. “So all the lab specimens from a particular trial will be processed in the same way, at the same site,” says Blunt.

Citing the Lilly deal, Blunt predicts Covance will continue to lead the trend to outsourcing. “We will create strategies, global in scope, to increase outsourcing. It will be important to partner with companies that have a need for global development, and to find the most efficient way to collaborate.”

Covance Inc. (CVD), 206 Carnegie Center, Princeton 08540-6681; 609-452-8550; fax, 609-452-9375. Joe Herring, CEO. Home page: www.covance.com.

Siro Clinpharm

To enroll more patients and beef up participation in clinical trials, pharmas are moving outside the U.S. Siro Clinpharm, for instance, runs FDA clinical trials in India for more than 20 clients, ranging from large pharmaceutical companies to small biotechnology firms.

Headquartered in Mumbai, with more than 400 employees, it is the largest and oldest independent clinical research organization in India, according to Mark H. Bradshaw, president of the United States office, which is based at Alexander Road. The 12-year-old firm’s very first contract was for an oncology trial. In the intervening years it has brought more than 20 cancer drugs to market around the world. Recently it bought a 100-person CRO, Omega Mediation, which has significant experience conducting oncology clinical trials in Eastern Europe, Greece, and Israel.

Bradshaw grew up in Illinois and has a bachelor’s degree from Bradley University in Peoria and a Ph.D. from Johns Hopkins. He began at Glaxo in North Carolina and has also worked for Roche and other small pharmaceutical companies in the United Kingdom, Europe, and Asia. He then began to work for CROs. Most recently he was global vice president at Covance in the area of clinical research. In the United States his nine-person office does sales, marketing, and U.S.-based project management. For instance, it helps U.S.-based clients to overcome any time-zone issues and to understand the regulatory environment in India.

“Many of our trials are very complex, and many involve studies that were falling far behind their recruitment goals in the rest of world until Siro was brought on board to manage India recruitment,” says Bradshaw. “We often call these ‘rescue’ studies, and from the start we have done many of these.”

Siro has managed a number of Phase I oncology trials, though Indian laws can get in the way of a foreign company that wants to develop its drug in India. “Indian law prohibits first-in-human trials unless the pharmaceutical company developing the drug is an Indian company,” says Bradshaw.

The law’s intent is to prevent India from becoming a popular human testing ground for global pharma company studies in which the subjects can gain nothing from the study except financial remuneration. “This is usually the case in Phase I studies because so-called healthy, normal volunteers are used. However in the case of oncology drugs, the first studies normally use cancer patients because many oncology drugs have significant toxicities as well as therapeutic effects targeted at the cancer,” says Bradshaw. “There are cases where the new drug could have benefits for a cancer patient who has exhausted all conventional approved therapies.

“Even if the pharma company is not an Indian firm, the regulatory agency DCGI (the equivalent to the FDA) may then consider allowing an Indian study despite the fact that the first humans exposed to a particular dose of the new drug will be Indian,” says Bradshaw. “We have experience with these situations and understand the type of patient protections that must be put in place under these circumstances — as well as the obligations for possible continued treatment with the new drug — to which the pharma company must agree before presenting the situation to DCGI.”

Though Bradshaw’s company uses electronic data capture (EDC) systems in half of its trials, he thinks that good trial management trumps technology.

“Technology alone is not enough to make a meaningful difference in time or cost of clinical research,” he says, and adds that EDC systems are “vastly oversold.” Good doctors are not necessarily good typists. “The idea that investigators do most of this work themselves is naive at best,” says Bradshaw. “In many cases investigators actually resent being asked to do the pharma company’s online computer data entry for them. Some charge more in fees if the study uses EDC. Others hire specialists to do the electronic data entry, and pass those costs on to the sponsor.”

Siro Clinpharm USA, 743 Alexander Road, Suite 15, Princeton 08540; 609-924-4669; fax, 484-924-4660. Mark Bradshaw, president. Home page: www.siroclinpharm.com.

XenoBiotic Labs: Bioanalysis Central

One way for clinical trial managers to outsource is to send samples to an outside lab rather than to do the analysis in house. and many companies need to hire out that work. “In today’s world most big pharmaceutical firms don’t run their own clinics. They send samples to a bioanalytical laboratory with instrumentation that can get the reports,” says Neil J. Lewis, vice president of XenoBiotic Laboratories. Founded in 1987, XenoBiotic has 70 employees in 45,000 square feet at Morgan Lane, its only location. It offers contract research and regulatory consultation for pharmaceutical, biotech, and agrichemical firms.

“Samples come here from all over the world for bioanalysis — from a wide array of companies interested in a wide array of uses for drugs,” says Lewis, a City College of New York graduate (Class of 1966) with a Ph.D. from the University of Kansas.

By definition a “xenobiotic” chemical is one found in an organism but not produced by that organism. The firm using that name most frequently identifies substances using liquid chromatography mass spectrometry or high pressure liquid chromatography.

In a standard late phase study, Lewis says, the cost of analyzing the many thousands of samples could range from tens of dollars to hundreds of dollars per sample, depending on the complexity of the analysis or the complexity of the method. But that cost represents a miniscule amount, compared to the cost of developing a new drug. “It takes many years before a drug gets into the clinic, then to test it on people, to be sure it is safe and effective. Ultimately you have to build a plant to make the quantities that are needed,” says Lewis.

Lewis says that so many cancer drugs are under development that the trials are often conducted at many sites, which is expensive. He believes the E-patient movement, which can involve patients doing their own Web research to locate clinical trials, can be helpful.

“Ready access to information is a good thing as long as people are directed to something that does not put them in harm’s way,” says Lewis. “The Internet is a complex place and when you have a disorder desperately in need of some sort of treatment, people will look endlessly. But they need to look in mainstream channels, where they get reliable information, for trials done by reputable and reliable organizations, where all the safeguards can be built in. He recommends the National Institutes of Health website (www.clinicaltrials.gov).

XenoBiotic Laboratories Inc., 107 Morgan Lane, Plainsboro 08536; 609-799-2295; fax, 609-799-7497. Jinn Wu PHD, president. Home page: www.XBL.com.

More Cancer Fighters

Parexel/ClinPhone, 50 Millstone Road, Building 100, Suite 200, East Windsor 08520; 609-524-4100; fax, 609-524-4100. Howard Goldberg, president. Home page: www.clinphone.com.

ClinPhone, the clinical technology company headquartered in England with an office at Windsor Corporate Park, has interactive voice response systems for clinical trials. It was sold last week to Parexel, based near Boston (U.S. 1, August 20). Billed as the third largest clinical research organization in the world, Parexel has more than 8,800 employees in 69 locations in 52 countries. Traded on Nasdaq under the symbol PRXL, it provides knowledge-based contract research, medical communications, and consulting services to the pharmaceutical, biotechnology and medical device industries. Its technology division, Perceptive Informatics, has a medical imaging component.

“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 E-clinical platform,” said Josef Von Rickenback, CEO of Parexel International in a press release.

The $182 million deal is expected to close at the end of September. Only the name will change. Virtually all of the jobs will stay in West Windsor, according to a company spokesperson. Of the more than two dozen other Princeton companies operating in the clinical trial arena, many help to fight cancer. They are:

Radpharm, 100 Overlook Center, Third and Fourth Floors, Princeton 08540; 609-936-2600; fax, 609-936-2602. Ronald Berg, CEO. Home page: www.radpharm.com.

At Princeton Overlook Radpharm offers a central evaluation site for reading radiological images, and it has supported more than 300 clinical trials. It collects images from 5,000 sites in 60 countries. The central evaluation site provides consistent quality, says CEO Ronald Berg. To complete an evaluation of one image, two radiologists must agree. If they don’t, a third doctor is brought in for a tie-breaking opinion.

Radpharm played a part in 12 out of the 13 blockbuster oncology therapies submitted to the Food and Drug Administration from 1999 to 2007. Its evaluations of images can help pharmas determine whether their compounds are working or not working, saving time and money but also ensuring patient safety (U.S. 1, May 9, 2007).

The company was founded in 1998 by Robert R. Ford and Donald P. Rosen, two radiologists who used to be at Princeton Radiology Associates, the biggest radiology practice in the Princeton area. In 2006 it moved to Princeton Overlook, where it currently has 52,000 square feet. Having just passed the 300-employee mark, up from 250 only a year ago, it just signed a lease for 20,000 additional feet at the Carnegie Center.

MDS Pharma Services (MDZ), 219 Black Horse Lane, Suite 102, North Brunswick 08902; 732-951-3240; fax, 732-951-3834. Virginia Litwin, lab director. Home page: www.mdsps.com.

MDS Inc. is a publicly held, global life sciences company with 5,500 employees in 29 countries. More than 95 percent of its $1.1 billion in net revenues is generated from global markets. Contract research is the focus for the North Brunswick site (MDS Pharma Services).

Headquartered in King of Prussia, Pennsylvania, MDS Pharma Services brings in 43 percent of the firm’s total revenues. It has 39 sites globally and estimates that its market is worth $15 billion annually and is on a growth path of more than 10 percent annually. Oncology is one of its focus areas of clinical research activity, and it is donating $1 million over three years to the International Union Against Cancer.

PPD Inc. (PPDI), 3575 Quakerbridge Road, Neuman Building, Suite 201, Hamilton 08619; 609-528-8000; fax, 609-584-1802. Home page: www.ppdi.com.

Oncology is one of the top therapeutic areas for PPD Inc., which has 10,400 employees worldwide in 31 offices. On Quakerbridge Road, 40 PPD staffers manage clinical trials — doing clinical development and data management — for pharmaceutical firms, academic research institutions, and the government. “Companies engage us to do their data management and patient recruitment,” says Sue Ann Pentecost, a spokesperson at PPD’s headquarters in North Carolina.

Pharm-Olam International, 101 Morgan Lane, Princeton North Plaza, Suite 205, Plainsboro 08536; 609-297-8621; fax, 609-297-8622. Paresh Patel, data manager. Home page: www.pharm-olam.com.

Based in Houston, this CRO opened an office in the Princeton area last year (U.S. 1, November 8, 2007). Founded in 1995, the 500-person company specializes in conducting drug trials outside of the United States, and particularly in developing countries. Pharm-Olam has conducted trials in 40 countries spread around several continents. Its trial sites include Russia, Latin America, India, and Eastern Europe.

PharmaNet (PDGI), 504 Carnegie Center, Princeton 08540-6242; 609-951-6800; fax, 609-514-0390. Jeffrey McMullen, president www.pharmanet.com.

Last year oncology represented about 31 percent of PharmaNet’s late stage business or about $70 million of direct revenue. Founded in 1996, PharmaNet does consulting and contract clinical research. It currently has more than 1,200 employees in 25 global offices, with about 300 people in 60,000 square feet at the Carnegie Center.

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