Bio's National Investor Conference Plays Matchmaker

By Stephen DeSantis

CenterWatch ‘watched’ as more than 60 emerging biotech companies and 125 venture capitalists from across the U.S. converged at the 1st annual BIO National Venture Conference in Boston this week.

The event was hosted by the Biotechnology Industry Organization (BIO), the National Venture Capital Association (NVCA) and the Massachusetts Biotechnology Council (MBC). Boston will now become the Conference’s permanent home.

The conference was designed to bring young, early-stage, startups together with potential investors to fill the coffers of the next wave of biotech hopefuls. These firms often are on the cutting-edge of developing new treatments involving innovative antibiotics, RNA-based therapies, and stem cell and regenerative medicines. The mating game was especially poignant given what many perceive as a severe funding drought in the life science industry.

“This conference is aimed squarely at the seed stage companies of today. We want to help get their footing and grow to become the industry leaders of tomorrow,” said Jim Greenwood, president and chief executive officer of BIO, during his opening remarks.

A recent report by the NVCA found that first quarter 2008 funding for seed and early stage enterprises – especially essential for young biotechs –fell 17% in to $1.7 billion compared with the first quarter of 2007. Overall, venture funding in all sectors was down 5% to $7.1 billion compared with the same period in 2007.

The software industry led the pack with the most venture funding; however, the news wasn’t all bad for life sciences. The biotechnology and medical device sector had the largest number of deals (234) of any industry during this year’s quarter.

Recently, large pharma has been on a biotech buying spree of sorts, paying well for promising companies. Such recent deals include GlaxoSmithKline purchase of Sirtris Pharmaceuticals  for $720 million and last month Takeda Pharmaceutical announced it will pay $8.8 billion for Millennium Pharmaceuticals...

Magic Johnson—Celebrity Spokesperson for Minority Patient Recruitment?

By Sara Gambrill

Earvin “Magic” Johnson, NBA champion and chairman and chief executive officer of the Johnson Development Corp., came to IIR’s 17th Annual Partnerships with CROs in Las Vegas, Nevada, with a mission—to urge pharma to increase minority participation in clinical trials. But, he left, quite possibly, with an even bigger mission—to become a celebrity spokesperson for minority patient recruitment.

Johnson began a talk that touched on the personal and professional and made people laugh as well as reflect by pointing out some important statistics.

“Half of America will be minorities in 40 years. We must get them involved. We must do a better job to educate them. They have to take part in what’s going on in medicine,” said Johnson. “I’m going to do my part. I know the reason I’m standing here 16 years [after being diagnosed with HIV] is because someone participated in a clinical trial.”

During his talk, Johnson discussed the anguish of having to tell his wife about his HIV diagnosis and his fears at that time for both her health and their baby’s health. (His wife was pregnant at the time and both his wife and child were healthy.) He discussed the physical and emotional difficulties of receiving an HIV diagnosis in those days.

“When I first announced [in 1991] that I had HIV, we only had one drug—AZT. My doctor started off having me take it 15 times a day because I’m big. It’s the only time I wished I wasn’t tall,” he joked. “Now there are 26 drugs,” Johnson said in gratitude to the hundreds of clinical researchers present at his talk.

Coast IRB Receives FDA Warning Letter

By Stephen DeSantis

Coast IRB, an independent institutional review board (IRB) based in Colorado Springs, Colo., received a Warning Letter (to see document click here ) from the U.S. Food and Drug Administration (FDA) concerning the company’s improper expedited review of a phase I study being conducted in northern California. In an unusual move, the agency has temporarily suspended the IRB’s ability to do expedited reviews.

Text from the warning letter:

An FDA Warning Letter is quite rare among independent or central IRBs with perhaps one or two issued in a single year. Warning letters to institutional review boards in hospitals or academic settings are more numerous, with the FDA issuing six per year on average.

Coast’s warning letter stemmed from an FDA audit conducted between July 10 and 18, 2007. IRBs are subject to such standard audits every five years. The FDA subsequently reported its inspection findings to the company in a standard Form FDA 483.

“We were surprised to get it. We thought we had adequately responded to the FDA. Obviously the FDA had a different view on that,” said Gary King, general counsel for Coast.

Although Coast stated it has taken steps to minimize any disruption in its business, by adding review boards and holding more frequent meetings, not having the ability to do expedited reviews will no doubt put stress on the company.

“That is going to be a tremendous burden because there is a huge amount of work that is done via expedited review. And these can be as minor as a change of a comma to a semicolon on a consent form,” said David Vulcano, vice-chairman, board of trustees of the Association of Clinical Research Professionals (ACRP). Vulcano has researched IRB issues extensively, including warning letters.

Coast’s responses to that inspection letter were submitted in August and November 2007; however, they have not been made publicly available. According to the FDA, the company failed to address its concerns in their responses, prompting the agency’s action.

Parexel's Josef von Rickenbach On Phase I Activity

Parexel recently expanded its early phase operations in three of its phase I facilities. The move brings the company’s global phase I bed capacity to one of the largest in the industry, at 550.

Parexel also has phase I services in India through a partially owned venture with Synchron Clinical Research’s Ahmedabad-based facility, which has 86 beds. Last month, Parexel increased its ownership stake in that venture from 19.5% to 31% at a cost of $5 million. At the same time, Parexel sold its France-based bioanalytical and biomarker testing laboratory facility—owned since 1999—to a subsidiary of Synchron for approximately $6.7 million. The unit will now be called Synexel Research International and will stay within Synchron’s operational network.

ClinicalTrialsToday recently asked Josef von Rickenbach, Parexel's chairman and chief executive officer, to provide some additional insight into the CRO's recent moves within the burgeoning  phase I market.

U.S. Disease Foundation Investment in Biopharmaceutical Industry Continues to Rise

U.S. disease foundations invested about $75 million last year in biopharmaceutical companies to fund discovery and development of new drugs and therapies for their corresponding diseases, according to CenterWatch estimates published in the August 2007 issue of The CenterWatch Monthly.

The 2007 figure represents a 10-fold increase since 2000, and foundations’ investment continues to rise.

The Boston Globe picked up the story about this kind of investment, called “venture philanthropy” when it wrote about the Cystic Fibrosis Foundation’s latest investment in Lexington, Mass.-based Epix Pharmaceutical.

Read today’s Globe article for more.

To read the full article from this issue or for more information on these and other breaking stories, please click here.

EDICT Report Provides Road Map To Comprehensive Patient Enrollment

A much anticipated report published by Baylor College’s Eliminating Disparities in Clinical Trials [EDICT] project has provided a nine-step action plan for improving the policies surrounding the conduct of clinical trials. The EDICT project set out to create a series of policy proposals designed to help patient recruitment and retention in clinical trials. The four-year project is supported by an unrestricted grant from Genentech.

Among the issues the policies meant to address are minority participation, patient insurance, informed consent, and standards and accreditation.

“Although disparities in clinical trials has been discussed and debated extensively, this problem has generally been under-addressed and, as a result, has received little direct, systematic, or sustained intervention,” said Armin Weinberg, Ph.D., director of Baylor College of Medicine’s Chronic Disease Prevention and Control Research Center and EDICT’s principal investigator.

Averion Sees Fruits of Acquisition

Southborough, Mass.-based contract research organization (CRO) Averion showed signs that its recent acquisitions and operational changes are paying off. Averion reported that 2007 net service revenue was up an impressive 163% to $34.8 million, due primarily to its acquisition of Swiss-based CRO Hesperion. Averion paid $36.2 million for the company in November. That acquisition doubled the size of Averion’s staff to 400 and expanded its operations into 14 countries.

“With our broader geographic base, expanded client relationships, and added capabilities for managing full-service, large global clinical trials, we are well-positioned to capitalize on the growing trend favoring clinical trial outsourcing,” said Averion’s chief executive officer, Markus Weissbach, M.D., PhD.

And Although Averion’s income from continuing operations was still in the red with a loss from of $3.9 million, it is inching closer to profitability. Its loss is down from $4.6 million in the year prior. The company is getting more efficient as well. Direct expenses during 2007 increased to $20.7 million versus $8.2 million during the prior year; however, those expenses as a percentage of revenues decreased to 59% in 2007 from 62% the year prior.

The company reported a research backlog of $74.7 million last year compared to $35.6 million in 2006. Again, its backlog of business was due to Hesperion’s strong contribution. In October 2007, the company sold its staffing services business to members of that division’s management. That move resulted in a loss from discontinued services of $1.4 million during 2007 compared with $500,000 during the prior year.

Averion went public in July 2006 in a reverse merger with San Diego-based company IT&E International, a regulatory compliance and validation services firm.

MHRA’s New Phase I Accreditation Scheme in Effect Today

By Sara Gambrill

The Medicines and Healthcare products Regulatory Agency’s (MHRA) voluntary Phase I Accreditation Scheme went into effect today with the stated goal of formalizing routine inspections and increasing the scope and depth of inspections. Most importantly, the aim of the MHRA’s new scheme is to avoid harm to trial subjects and for handling medical emergencies during first-in-human trials should they arise.

In the wake of the international media attention that TeGenero received in March 2006 after administering TGN1412 to six healthy volunteers who suffered a nearly fatal “cytokine storm,” the UK in particular has intensely scrutinized how first-in-human phase I trials are conducted and how their conduct could be improved. 

In response to the Duff Report, the European Medicines Agency (EMEA) released a new guidance document on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. The guideline went into effect September 2007.

Out of the 22 recommendations made by the Duff Report, three fell under the category of “the clinical environment for first-in-man studies” and two under “developing expertise” on the part of clinical research personnel conducting first-in-human clinical trials.

The final recommendation reads, “The development of a national inspection and accreditation system for clinical centres that undertake first-in-man studies of higher risk agents should be encouraged. The accreditation should be open to all centres that fulfill defined criteria, in both the public and private sectors.”...

Japan’s New Regulatory Attitude Evident at DIA EuroMeeting

By Sara Gambrill

One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who  was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.

What he went on to say was both surprising and refreshing, coming from a representative of PMDA. He said that he had wondered what he would wear if he didn’t get his luggage in time for the session. In the end, even though he had been reunited with his clothing in time, he decided to wear the PMDA T-shirt to foster an informal atmosphere for the session, which he hoped the audience would find acceptable. This last sentiment was met with an enthusiastic round of applause from the hundreds in attendance, many from big pharma.

Clearly the message PMDA wanted to send during its session was that the agency is striving for openness, cooperation and timeliness to promote Japan’s role in global drug development.

Both Uyama and Satoshi Toyoshima, Ph.D., executive director and director, Center for Products Evaluation at PMDA, discussed many objectives and initiatives to accelerate the drug process in Japan, but the initiative that will have the most immediate impact will launch in April. With the new Investigational New Drug Application (IND) Consultation Process, PMDA wants to increase the number of face-to-face meetings with sponsor companies and also meet with them in a more timely manner.

Uyama noted that in 2006 there were 473 sponsor applications for IND consultations with PMDA, with only 295 actually granted. PMDA wants to increase the percentage of consultations granted to those sponsors that apply and has a tentative plan that Uyama shared with the DIA EuroMeeting audience. From April forward, the new IND consultation process should have a predictable schedule of about five months, during which sponsors are able to submit an expression of intention, apply and submit documents to PMDA.

Five weeks prior to the face-to-face meeting, there will be an inquiry and response period between sponsors and PMDA. Four days prior to the face-to-face meeting, PMDA will give its opinion, which will be discussed at the meeting. Draft minutes will be drawn up and then finalized one month after the meeting.

EDICT Project Opens Policy Recommendations For Public Comment

The EDICT project, short for Eliminating Disparities in Clinical Trials, has invited the public to comment on a series of policy proposals design to help patient recruitment and retention in clinical trials. The period open to public comment runs until March 21.

Shortly after, the final policy recommendations will be brought before the Congress, the National Institutes of Health and the Food and Drug Administration.

Among the issues the policies address are minority participation, patient insurance, informed consent, and standards and accreditation. EDICT is a collaborative alliance between Baylor College of Medicine’s Chronic Disease Prevention and Control Research Center and the Intercultural Cancer Council (ICI). It consists of researchers, public health officials, patient advocates and other various stakeholders.

The four-year project is supported by an unrestricted grant from Genentech.

AbCRO Opens Two Offices in Russia

By Sara Gambrill

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened two offices in Russia.

The St. Petersburg office has three employees and will be in charge of operations, while the Moscow office has one person and runs regulatory affairs. AbCRO has one active oncology clinical trial in Russia now and is bidding on others.

“Russia is the biggest country in our region. We had an existing client base that was interested in working with us if we had operations in Russia, so we decided that it was time that we did,” Dana Leff, chief executive officer of AbCRO, told CWWeekly at the DIA EuroMeeting in Barcelona. 

AbCRO was founded in 1999 and had two employees with an office in Sofia, Bulgaria, and a marketing office in Stamford, Conn. From 2001 to 2006, the company grew strongly, nearly doubling its employees between 2005 and 2006. “Between 2006 and 2007, our revenues more than doubled and our staff increased by about 60%. Our projections for revenue growth this year are about 60%,” said Leff.

AbCRO currently has 170 employees. AbCRO also has offices in Bucharest and Cluj, Romania; Zagreb, Croatia; and Belgrade, Serbia. In addition, the company opened an office in Warsaw, Poland, last year.

The company also has a clinical research associate in Kiev, Ukraine, with plans to open an office there soon. AbCRO has always had a business model that required clinical research associates to be full-time employees, which differentiates the company from some other CROs in the region.

Leff added that the company is planning to conduct feasibility studies in Azerbaijan. That country´s capital city, Baku, has a population of about 4 million and has good infrastructure. Azerbaijan’s average income levels are also a bit higher than those of neighboring countries.

Sara Gambrill, senior editor at CenterWatch and author of The Emerging Markets of Clinical Research.

Parexel Courts ClinPhone with Takeover Bid

UK-based eClinical company ClinPhone rejected a preliminary takeover offer from Parexel International,  a contract research organization (CRO) based in Waltham, Mass.

Although financial details were not disclosed, ClinPhone said it considered the offer too low.

“The board believes the indicated value materially undervalues the company and its prospects and the board therefore rejected this approach,” ClinPhone said in a statement.

Shares of the eClinical company’s stock, listed on the London Stock Exchange, shot up 16% to $1.93 immediately on the news. Parexel’s shares closed up 3.7% on Feb. 19 at $57.88.

In a statement, Parexel confirmed that it had made the initial offer for all of the shares issued by ClinPhone to be paid in cash. With its initial offer rejected, the company must now decide its next move. 

“Parexel is currently evaluating its options in relation to ClinPhone. A further announcement will be made in due course. However, there can be no certainty that an offer for ClinPhone will be forthcoming,” Parexel's statement said.

ClinPhone has about 730 employees. The company is valued at about $127 million. Parexel had 2007 revenues of more than $900 million.

In an interview with Reuter’s John Bowker, ClinPhone chief executive Steve Kent stated: "We are extremely confident about it (rejecting the bid),” adding that the firm had not consulted shareholders about the approach. We have very substantial plans (for growth). We have a clear business plan," he said. According to Kent, ClinPhone’s directors have not yet consulted with shareholders regarding the offer.

In September 2007, UK-based clinical trials technology company ClinPhone was forced to reduce its estimated 2007 revenue by roughly $20 million and its earnings by $1.98 million. The company blamed the drop in estimated financials to an increase in sales of its electronic data capture (EDC ) software at the expense of licensing the product, telephone outages and a weak U.S. dollar.

ClinPhone said it had an “exceptionally high rate” of contract cancellations during June and July, primarily due to “operational” issues.

Ketek Hearing Winners and Losers

By Steve Zisson

After listening to the Feb. 12th hearing by the House Energy and Commerce’s Subcommittee on Oversight and Investigations probing study fraud and the antibiotic Ketek, one thing is clear: PPD, which monitored the study in question sponsored by Aventis (now Sanofi-Aventis), took the least hits from Congress. And it is also quite clear that many in Congress, including committee staff, don’t seem to understand much about the research process.

Outside of the FDA—which the committee would like to hold in contempt of Congress for failing to respond to a subpoena— taking the toughest criticism from the committee was Sharon Hill Price, founder and chief executive officer of Copernicus Group, the institutional review board (IRB) which oversaw the study.

Price, who admitted to being a bit nervous, was hammered by Michigan Democratic Rep. Bart Stupak, chairman of the oversight and investigations subcommittee, and House Energy and Commerce Committee Chairman John Dingell.

Stupak was upset that Copernicus didn’t provide in a timely fashion a call log of a phone call from Ann Marie Cisnernos, the former PPD study monitor and whistleblower, who reported the fraud that led to the conviction of Anne Kirkman-Campbell, a clinical investigator on Study 3014. Price told committee members she doesn’t recall talking to Cisneros.

Visibly frustrated with Price’s answers, Stupak at one point asked Price, “Why do you exist?” Presumably Stupak was referring to the IRB and not Price herself. Many of Stupak’s and Dingell’s questions showed a clear lack of understanding of clinical research. At one point Stupak was baffled at what “GCP” stood for. He was told Good Clinical Practices, the research standard. Ouch.  Dingell seemed lost when trying to figure out where in the research process an IRB figured in.

Revolutionary Public-Private Partnership for Early Phase Trials Established in France

By Sara Gambrill

The Centre Hospitalier Universitaire (CHU) de Caen, a university teaching hospital and the largest hospital in the West of France, and Therapharm, a large, private contract research organization founded in 1980, have joined forces to form the first public-private partnership to conduct early phase clinical research in France. The clinical research center is called Centre de Recherche Clinique-Basse Normandie (CRC-BN). The center conducts phase I and II clinical trials that are industry-sponsored, investigator-initiated and government-sponsored.

Antoine Cournot, who is president of Therapharm and spearheaded the partnership, said, “The objective of the clinical research center is to be able to perform early phases, phase I and II, with a high level of international quality but with a professional approach.”

The impetus for the unique partnership was to attract more industry-sponsored clinical research to France. Creating a public-private partnership clinical research center in a large hospital has been a dream of Cournot’s for 20 years, when he first attempted to establish one in Paris, where Therapharm’s headquarters are. Ten years ago, when Therapharm moved its phase I unit from Paris to Caen—in close proximity to CHU de Caen—Cournot approached the hospital about his idea.

But, it wasn’t until 18 months ago that the hospital and Therapharm met for a serious discussion about plans for building CRC-BN...

Veritas Medicine Restructures Business, Drops Trial Listing Service

By Stephen DeSantis

Cambridge, Mass.-based Veritas Medicine, a clinical trial services company, has discontinued its patient recruitment services and laid off a number of employees.

According to Veritas, it is restructuring the company to focus solely on its clinical trial disclosure business. The company’s clinical trial listing service and patient screening business will be terminated.

Veritas stated it ceased providing patient recruitment services on Feb. 8.

The company’s clinical trial listings service had been a major part of its business since its inception. One of its main patient recruitment services asked for potential subjects looking to enroll in trials to fill out medical and geographic information, which could then be matched with studies posted by sponsors. That service also contained a trial notification message to be sent to potential subjects via email.

“There have been reductions of staff who were directly related to the patient recruitment business, but the clinical data disclosure team is intact,” said Andrew O’Brien, Veritas’ president and chief executive officer, in a statement to CWWeekly.

The company is responding to the evolving landscape of the industry’s transparency requirements. That business consists of Veritas’ clinical trial registry system, its sponsor registry web site development and its patient response service.

“Historically, this has been a smaller part of our business, but it certainly is where we see the best growth prospects today,” said O’Brien.

The company’s web-based platform allows clients to post trial listings and results to different registries. Veritas’ web site development service helps its clients develop their own corporate registry sites in a branded environment.

“We’re focusing Veritas Medicine on the clinical data disclosure business because there is a terrific market opportunity and we are very well positioned there...the disclosure requirements for our biopharmaceutical customers are growing more complex,” said O’Brien.

In the last year, Veritas has been through some significant changes. After seven years as Veritas’ chief executive officer, Joe Avellone, M.D., left. In May 2007, Parexel, a Waltham, Mass.-based contract research organization, named Avellone to the position of corporate vice president of clinical research operations for both North and Latin America. Avellone remains on the company’s board of directors. He previously served as chief operating officer for BlueCross BlueShield of Massachusetts.

Veritas was founded in 1999 with an initial investment of $8 million from Burrill & Company, BioAsia’s Biotechnology Development Fund II, Cambridge Incubator and Seaflower Ventures. Three years after launch, Veritas had raised a total of $16 million in funding. Its current list of investors includes Burrill & Company, Vivo Cambridge Innovations, Seaflower Ventures and MDS Capital.

Stephen DeSantis is the Senior Associate Editor at CenterWatch.

Rapid Growth of Asia-Pacific Clinical Trials Market Focus of New CenterWatch Report

BOSTON, Feb. 6 -- CenterWatch, a publishing and information services company focused on market research about clinical trials, finds in a new report that the Asia-Pacific region is grabbing an increasing share of the global clinical trial market, and with new regulatory changes across the region, has already been growing at more than 50% in recent years.

According to the new 160-plus page report from CenterWatch entitled, Asia- Pacific's Growing Role in Global Clinical Trials, Asia Pacific countries are tapping into their power as a bloc to boost their role in the expanding global clinical trials market.

An important part of the report contains the results from CenterWatch's first-ever survey of clinical researchers in the region. CenterWatch surveyed more than 156 investigative sites from more than a dozen countries in Asia Pacific. The survey revealed, among other results, the key role of electronic data capture (EDC) of clinical trial information in this region.

Phase Forward Delivers Strong 4Q, 2007

Waltham, Mass.-based eClinical company Phase Forward reported strong fourth quarter and full 2007 annual results on Jan. 31. Revenues for the full year 2007 were $134.3 million, a 26% increase from $106.6 million in the previous year. More than 70%, or $96.9 million, of its total revenue stemmed from its electronic data capture product (EDC) product InForm.

"We believe Phase Forward's proven track record of delivering highly scalable and complex deployments for companies of all sizes serves as a strong motivating factor that influences customers to adopt Phase Forward and has made us a strategic partner of choice for many of our customers. Our strong business momentum and solid industry fundamentals make us optimistic about our outlook heading into 2008," said Bob Weiler, chief executive officer and president of Phase Forward.

Phase Forward’s operating income was $19.7 million for the year, an increase of 50% from 2006. Its full year operating margin of 14.7%. Revenue was up 25% for the fourth quarter of 2007 at $37.8 million compared with $30.2 million during the same period last year 2006. Net income nearly tripled to $15.7 million or 36 cents a share, from $5.48 million.

During the year, Phase Forward acquired the Montpelier, Vt.-based phase I software management company Green Mountain Logic for $5.2 million in cash.

"During 2007, we added over 50 new direct customers. These included clients spanning the global pharmaceutical, biotech, medical devices, CROs and academic sectors and range from the smallest to some of the largest life science companies in the world," said Weiler.

For 2008, the company stated it expects revenues to be between $165 and $169 million.

Clinical Data, Affymetrix in Marketing Deal

Newton, Mass.-based analytical services company Clinical Data signed a service and marketing agreement with Affymetrix, a diagnostic technology company based in Santa Clara, Calif. The agreement allows Clinical Data’s two subsidiaries, Cogenics and Epidauros Biotechnologies AG, to sell Affymetrix’s drug metabolizing enzymes and transporter (DMET) solution. DMET is a method for analyzing the genetics of drug metabolism. It allows sponsors to gain valuable data on pharmacokinetics compared to a patient’s genetic profile.

“We believe that Cogenics’ and Epidauros’ expertise in genetic biomarker discovery and history with ADME studies will greatly enhance the DMET offering by making it more attractive, comprehensive and valuable to pharmaceutical customers seeking to address drug metabolism issues that arise in drug development,” said Pratima Rao, senior director of product marketing at Affymetrix.

Cogenics and Affymetrix collaborated on the development of DMET, which just became available in January.

Parexel Builds Momentum, Boosts 2008 Outlook

Parexel, a global contract research organization (CRO), continues on a nice roll with its shares up another 1.7% yesterday to $57—just off its 52-week high.

Last week when Parexel reported strong earnings, its shares got a hefty pop. That good news came after Mad Money host Jim Cramer gave the contract research sector a thumbs up on Jan. 14, noting Parexel’s strength in late phase work.

In its second quarter reported Jan. 23, Parexel said net income jumped 27% to $11.5 million, or 40 cents a share, from $9.08 million, or 32 cents a share, in the year ago period. Revenue increased 29% to $284.3 million.

Josef H. von Rickenbach, Parexel’s chairman and chief executive officer, noted, "During the second quarter, very strong revenue growth was driven by increases across all business and geographic reporting segments. The quarter's operating performance further validates our strategy and tangibly demonstrates that the initiatives we have been focusing on over the past few years are bearing fruit. In combination with the current favorable outsourcing market, our proven capabilities to compete for and win significant levels of new business leaves us well-positioned to further improve operating margins and drive profitable growth.”

For its third quarter, the company expects earnings of 42 cents to 44 cents a share on  revenue of $240 million to $250 million.

For  fiscal 2008, Parexel boosted guidance to $1.78 to $1.83 a share from $1.75 to $1.81 a share. Parexel also adjusted upward its revenue range to $935 million to $955 million, from $890 million to $920 million.

Parexel’s backlog rose 41% year-over-year to $1.778 billion as of Dec. 31, 2007.

LabCorp to Acquire Tandem Labs

Burlington, N.C.-based LabCorp has signed an agreement to acquire the bioanalytical services company Tandem Labs for an undisclosed amount. Tandem performs analytical lab work for drugs in all stages of development including discovery, preclinical, and clinical. Founded in 1981 as Northwest Toxicology Consultants, the company initially operated as a clinical toxicology reference laboratory.

LabCorp is the second largest reference laboratory testing company in the U.S., but its client base is primarily hospitals, clinics and government agencies. It offers tests ranging from routine blood analyses to HIV and genomic testing. Tandem Labs will join the Esoterix clinical trials group at LabCorp and maintain both its name and management.

LabCorp has revenues of $3.5 billion and 23,500 employees. The company has a network of 36 laboratories and 1,300 service sites.

The bulk of LabCorp’s testing business involves performing quick routine tests on more than 360,000 patient specimens daily, serving hospitals, clinics, doctor’s offices, law enforcement agencies and medical testing centers. As with most reference labs, its most frequently requested tests include blood chemistry analyses, urinalyses, blood cell counts, Pap, HIV, and substance-abuse tests.

LabCorp’s central laboratory business generates 2% of its revenue. The company has a 4% share of the central labs market, holding steady since 2003. Its clinical testing headquarters is located in Raritan, N.J., and its European headquarters, in Belgium.

The deal is expected to close in the first quarter of 2008.

Pharm-Olam Growth at Record Pace in 2007

Houston-based contract research organization (CRO) Pharm-Olam International reported record revenue growth in 2007, signing $100 million in new contracts signed in the 12 months.

According to Iain Gordon, vice president of global business development at Pharm-Olam, the company saw increased demand for its data management and biostatistics services. He attributed much of company’s revenue growth to that demand.

The company also reported record geographic coverage and services additions. It established regional offices in Princeton, N.J. and Novosibirsk, Russia in 2007.

“Our global coverage continues to grow, however, our decentralized business model remains the same, allowing us to start studies quickly and manage them efficiently”, said Gordon.

In the past three years, the company has been expanding its international presence at a rapid pace. It has more than 20 offices in 40 countries across North America, Western Europe, Central and Eastern Europe, Latin America, Asia, and Africa. In June, Pharm-Olam announced plans to expand its Latin American presence by opening offices in São Paulo, Brazil and Buenos Aires, Argentina. The company also has a presence in Mexico City.

In August 2006, the company expanded its India operations and tripled its staff there. In late 2006, it opened a new office in Pretoria, South Africa.

Type I Diabetes Drug See Positive Results in Phase II

By Tracy Trundle

Diamyd Medical (formerly issued positive long-term results from a phase IIb trial of Diamyd, GAD-65), recombinant glutamic acid decarboxylase (GAD) delivered with alum for injection, for the treatment of type I diabetes. This randomized study enrolled seventy pediatric and adolescent subjects in Sweden.

The subjects received two single injections of Diamyd or placebo. The primary endpoint for the trial was the preservation of beta cell function as measured by C-peptide.

Thirty months after the first injection, preservation of insulin was significantly higher in subjects receiving Diamyd, both in the fasting state and after meal stimulation, compared with placebo-treated subjects.

Diamyd also increased GAD antibody levels at fifteen and twenty one months post-injection. Based on the data, phase III trials are planned.

The GAD gene technology was originally developed by the University of California, Los Angeles (UCLA). In 1997, BioSyn was granted an exclusive worldwide license to UCLA's GAD technology.

Tracy Trundle is a Research Analyst at CenterWatch.

Recent Industry Personnel Changes

Contract Research

Philadelphia, Pa.-based CRO Premier Research Group appointed Patrick Melvin to senior director, Clinical Trial Management, where he will specialize in Premier’s oncology business. Melvin – who started out in the industry as a CRA for a large CRO – has experience working on early phase trial designs and large late stage global projects.

Texas-based CRO ResearchPoint appointed Matthew Walker to the position of executive vice president, of business development & marketing. He will have responsibilities in sales, marking and leading the strategic growth of the company. Walker joined the CRO from Hart InterCivic, a provider of election services, geospatial system integration, and print solutions. Most recently he was senior vice president and general manager of the company. Walker also has experience in healthcare through Deloitte Consulting.

Cambridge, Mass.-based Outcome Sciences hired Francis Campion, M.D. to medical director or Provider Programs. He will work with hospitals and medical societies to develop outcomes programs. Campion works at Harvard Vanguard Medical Associates (HVMA) as the director of complex chronic care in its disease management program. Campion also practices internal medicine at HVMA’s Kenmore center. Formerly he served as the director of clinical information systems for the Atrius Healthcare System.

Research Triangle Park, N.C.-based Quintiles promoted Dipti Amin to senior vice president of its Strategic Research and Safety Services (SRS) and Medical and Regulatory Services divisions. Prior to the new role, Amin was senior vice president, Global Medical Services, Regulatory Affairs and Medical Writing, and Strategic Drug Development Unit.

Associations

The Association of Clinical Research Organizations (ACRO) elected David Spaight and Stephen DeCherney, M.D. as new officers for 2008. Spaight, current president of MDS Pharma Services, was elected Chair of the organization. DeCherney is the chief innovation officer for Quintiles and will serve as chair-elect for ACRO.

Consulting

Cambridge, Mass.-based clinical consulting company Cytel appointed Irving Dark as vice president of Cytel Clinical Research Services. Dark brings 15-years of experience in the drug development industry.  Prior to Cytel, Dark was vice president, Business Development and Operations for Veristat where we was involved with the company’s compliance activities to ensure adherence with regulatory and GCP guidelines. Dark also held several key positions at Parexel.

Kendle Looking to Grow Phase I Business

Cincinnati-based CRO Kendle is expanding its phase I business with the appointment of Phillip Davies, a 20-year industry veteran in early stage research, and made another key hire to grow its Asia-Pacific operations.

The company stated that Davies will provide the leadership needed to grow its phase I units, which include a clinical pharmacology unit in The Netherlands and a bioequivalence facility in West Virginia. Kendle said Davies will focus on expanding its capabilities worldwide.

Prior to the appointment, Davies had roles within Kendle’s pharmacology business in Germany and the UK. Before joining Kendle, he spent six years with Eli Lilly in its pharmacology operations. Most recently, Davies was director of global exploratory and program phase medical operations. Davies, as vice-president of phase I, will report directly to Kendle’s chief executive officer, Candace Kendle, PharmD.

“Phase I is a rapidly growing area of opportunity and is an integral part of Kendle’s business plan, with the market to grow between 13.4 and 16% annually through 2010,” said Kendle.

Kendle also hired Ross Horsburgh, M.D. as vice president of global clinical development for the Asia Pacific region. Prior to joining Kendle, Horsburg was regional medical director for AstraZeneca’s Asia Pacific region. He will be based in Singapore and report to Martha Feller, senior vice president of global clinical development for phase I through III operations.

Negative or Positive Trial Results?

By Steve Zisson

There’s some great quotes in the Wall Street Journal’s story about the New England Journal of Medicine’s assertion that effectiveness of antidepressants has been exaggerated by selective publication of positive clinical trial results.

The NEJM study reviewed unpublished trial data submitted to the U.S. Food and Drug Administration (FDA).

The NEJM research was led by Erick Turner, a psychiatrist at Oregon Health and Science University. Turner previously worked at the FDA where he reviewed psychotropic drugs.

Here’s the best quote in the article from Turner about what he believes are doctor’s attitudes toward prescribing antidepressants.

"There is a view that these drugs are effective all the time," he said. "I would say they only work 40% to 50% of the time," based on his reviews of the research at the FDA, "and they would say, 'What are you talking about? I have never seen a negative study.'"

Who’s view? Do doctors believe that these antidepressants, or any drugs, work 100% of the time? Isn’t 40% to 50% effectiveness considered a successful drug?

You can check out the WSJ story here.

Steve Zisson is editorial director of CenterWatch.

Going Mad for CROs

By Steve Zisson

Public, global contract research organizations (CROs) are having a great run with stock prices soaring and their global growth story intact. The sector got additional validation Jan. 14 when “Mad Money” host Jim Cramer featured the niche. In general, star stock picker Cramer got the story straight on CROs, even though a few times he mispronounced company names. That happens, but at least he got the stock symbols right. And that is what counts. You can watch a replay of the episode here.

Here’s the story that CenterWatch has been covering since the beginning of time, or sometime around 1994:

Pharmaceutical companies are continuing to outsource their clinical trials in a greater percentage to CROs. And now many of those trials are going overseas. The handful of global CROs, including the largest (private, but formerly public Quintiles)  have the infrastructure in place worldwide to handle those large trials. It isn’t an easy thing to build quickly so there is a barrier to entry.

Cramer said the sector is a good defensive play in a tough overall stock market. CROs, he said, would continue to grow because pharmaceutical companies desperately need to bring more drugs to market. And CROs can do the job much more cheaply than pharma companies that develop drugs in-house. We have always said that clinical research is hard work and Cramer made a good point that CROs do it better than pharma and biotech companies because they are doing it every day. Hard work done every day creates expertise.

Cramer’s picks? His favorite is Covance (CVD for you home gamers) because of its strength at opposite ends of the pipeline—in both preclinical and late phase. He also gave a thumbs up to Parexel with its expertise in late phase. Charles River got the Cramer nod as a pure-play preclinical company.

There’s always a bull market somewhere…

Steve Zisson, managing editor of CenterWatch.

U.S. Supreme Court Will Not Hear Abigail Alliance v. Eschenbach

By Sara Gambrill

The Abigail Alliance’s petition for a writ of certiorari in The Supreme Court of the United States was denied on January 14. A writ of certiorari is a document which a losing party files with the Supreme Court asking it to review the decision of a lower court.  It includes a list of the parties, a statement of the facts of the case, the legal questions presented for review, and arguments as to why the Court should grant the writ.

The question presented was “whether terminally ill patients who lack alternative treatment options have a constitutional right to purchase unapproved investigational drugs that have not been shown to be safe or effective and that have not been authorized for treatment uses by the Food and Drug Administration.”

Industry insiders as well as many terminally ill patients believed that if Abigail Alliance had won its suit that it would wreak havoc on the drug development process and how it is regulated.

In August 2004, Judge Ricardo Urbina of the U.S. District Court for the District of Columbia granted the government’s motion to Abigail Alliance’s original lawsuit, which was filed on July 28, 2003, on the ground that the FDA policies do not violate the rights of patients. Abigail then won its suit on appeal in a 2-1 decision handed down by a three-judge appellate panel in the U.S. District Court for the District of Columbia in May 2006.

FDA then appealed in July 2006 for a re-hearing before all the judges of that court on the grounds that the May 2006 decision presented a serious threat to FDA’s ability to ensure the safety and effectiveness of prescription drugs sold in the U.S. The re-hearing was granted in November 2006 and the case was argued in March 2007 and decided in August 2007...

Quintiles Expands Central Lab in China; Consolidates Services

Quintiles has consolidated its China-based Global Central Laboratories and Clinical Development Services (CDS) businesses into a new, 17,000-square-foot facility in Sun Dong Ann Plaza in Beijing. The new site is larger than the CRO’s original laboratory located at the Peking Union Medical College Hospital (PUMCH). The CDS plans to grow to a staff of more than 60 in the next year.

The company stated that by consolidating these businesses its could improve coordination and efficiency for Quintiles’ customers

“The globalization of clinical research is continuing to increase, and China is just beginning to see the rapid growth we have experienced in India, Australia and throughout Asia Pacific,” said Lai Lee Tan, head of the Quintiles’ Clinical Operations and general manager in China.

Quintiles’ laboratories in China are certified by the College of American Pathologists (CAP) and the National Glycohemoglobin Standardization Program (NGSP).

Jobson Medical Information LLC Acquires CenterWatch and New England IRB From Thomson Healthcare

NEW YORK, Jan. 8 /PRNewswire/ -- Jobson Medical Information LLC ("JMI"), a leading healthcare information and marketing services provider, announced that they had acquired the assets of CenterWatch and The New England Institutional Review Board ("NEIRB") from Thomson Healthcare Inc., a subsidiary of the Thomson Corporation.  Terms of the transaction were not disclosed.

CenterWatch and NEIRB provide information and services that support the efficient execution of clinical trials.  Founded in 1994, CenterWatch is a publishing and information services company supplying critical data to the clinical trials industry.  Key customers include pharmaceutical companies, biotechnology and medical device companies, CRO's and patients involved in clinical trials.  The CenterWatch website lists over 5,000 clinical trials and details of over 30,000 clinical trial sites.  The website attracts over 200,000 visitors per month.

NEIRB provides FDA mandated services to pharmaceutical companies and CRO's.  Founded in 1988, NEIRB was one of the first central institutional review boards established to meet the ethical review needs of a burgeoning drug development market.

"Both CenterWatch and NEIRB expand our presence in the development stage of the pharmaceutical product pipeline.  Allied with our Medical Intelligence Solutions business we are developing significant scale in clinical trial information services," said Mike Tansey, CEO of JMI.  "We are extremely pleased to welcome the talented and  experienced staff of these two businesses to the JMI team."

Thomson was advised by Berkery, Noyes & Co., LLC.

About Jobson Medical Information LLC: JMI is a premier integrated healthcare information and marketing services provider.  Through its diversified, multi-media portfolio of marketing services, information databases, trade publications, medical education programs, events, websites and other digital and traditional media services, JMI is uniquely positioned to reach, educate and influence a highly targeted network of approximately one million healthcare professionals across more than 20 specialties.  A description of JMI's products can be found online at www.jobson.com.

JMI is an affiliate of The Wicks Group of Companies, L.L.C. (www.wicksgroup.com), a New York-based private equity firm that invests in selected segments of the communications, information and media industries.

SOURCE:  Jobson Medical Information LLC

Michael J. Tansey, CEO of Jobson Medical Information LLC, +1-212-274-7000; or Matthew Gormly, Managing Partner of The Wicks Group of Companies, L.L.C., +1-212-838-2100

PPD Completes New Leadership Appointments in Global Move

By Stephen DeSantis

Wilmington, N.C.-based contract research organization (CRO) PPD continues revamping its global operations with the appointment of Sebastian Pacios, M.D., hired to lead—as a senior vice president—the CRO’s European, Middle East and Africa operations.

Pacios has experience running trials in those regions, having served at PRA International as vice president of the company’s clinical research and project management in Europe, Africa and Asia-Pacific.

Last year, PPD set out to break its phase II-IV operations into four separate territories: North America; Latin America; Europe, Middle East and Africa; and Asia. PPD has been steadily appointing new leaders to these regions since then.

PPD’s move is more evidence of the emphasis CROs are now putting on global expansion, as more sponsors push for overseas trials. 2007 saw significant CRO expansions into emerging markets as companies worked hard to keep up with pharma and biotech.

PPD had been criticized by analysts in July, including Jefferies & Company’s David Windley, for not capitalizing enough on trials outside the U.S. Windley changed his rating from “Buy” to “Hold” at that time.

“At this point, we are cautious about PPD’s disproportionately small percentage of revenue outside North America,” Windley had said in an analyst note last summer.

According to PPD, about one-third of its revenue is generated outside of the U.S.

The criticism apparently resonated. The CRO’s global restructuring began in October 2007 when PPD appointed Paul Colvin as senior vice president of clinical operations for North America and Simon Britton as vice president of operations for Asia. Colvin joined PPD after 14 years with Eli Lilly, most recently he oversaw clinical operations and global patient enrollment optimization. Britton served seven years at GlaxoSmithKline. For a time he was head of international clinical operations, managing the company’s global clinical operations group across 25 countries.

One month later, Jose Luis Viramontes, M.D., was hired to head the company’s drug development services in Mexico, Central America and the Caribbean. Viramontes came to PPD after 14 years with Merck Sharp & Dohme Mexico. He was most recently clinical research associate director at the company.

In December, Philip Mathew, M.D., was hired to lead all operations and expansions in India. The company has also launched a second office in Mumbai, located in the Dynasty Business Park in the Northern part of the city. Prior to PPD, Mathew was associate medical director at Covance and had served as a principal investigator with MDS Pharma Services...

Dissuasion in Recruitment Research

By Jennifer Higgins, Ph.D.
Springfield Neurology Associates, LLC

Of all the techniques considered for affecting the behavior of patients and encouraging their clinical trial participation, nary a single researcher has considered the benefits of dissuasion. It is true on its face the concept seems a bit counterintuitive. After all, typical recruitment approaches involve persuasion, enticement, inducement and have, during less proud times, inched closer toward undue influence. What has not yet been explored is the benefit of dissuasion, or discouraging participants from refusing to participate in voluntary clinical research.

Critics contend that this approach is likely to be misconstrued and experienced as undue influence, coercion and exploitation. The industry regularly points to the horrifying medical experiments conducted by Nazis during WWII and the Tuskegee syphilis experiments as evidence for all that is wrong with more aggressive recruitment tactics. They maintain that there is an inherent human tendency toward abuse of power among researchers and others who are not kept under tight regulatory control and who may be permitted to more actively market their clinical trials.

More optimistic recruiters maintain a different view. They believe that with proper counterbalancing of education and training, enhanced and more aggressive recruitment may be benefits to all involved. Drawing primarily from social psychology and marketing literatures, several key components of a successful dissuasive recruitment campaign begin to surface. Perhaps most important is what may be gleaned from research on the use of negative affect for persuasion (Huang, 1997). This research provides powerful evidence of the potential negatively affecting ads have for predicting persuasiveness. Three sets of affective responses toward three graphic and unpleasant Benetton ads were measured to test distress attitudes toward ads and fear/jitteriness factors experienced by respondents.

Results indicate that in predicting persuasiveness of negatively affective ads, it is important to take the concurrent nature of the types of negative affect and their directions of persuasiveness into account. Perhaps an even more significant finding of this research is that the practice of advertising unpleasant feelings per se generated by negatively affective ads may not be sufficient for consumer persuasion.

It is the attention generated by these unpleasant feelings that gives rise to the persuasiveness of negatively affective ads. Simply put, by using negatively affective ads, marketers successfully create an enormous level of brand awareness which commonly translates into an increase in sales. Based on the findings outlined here, recruiters are urged in the short-term to consider beginning experimentation with placement of negatively affective advertisements.

It seems the timing could not be better for such experimentation. Given the near daily accounts of negative effects of sundry medications, both within and without clinical research, there seems ample opportunity for placement of negatively affective ads. An example of the kinds of ads the author is proposing may be described using the recent Avandia crisis involving Glaxo-Smith Kline...

AAHRPP Accredits Final Batch of Organizations for 2007

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredited its final 11 organizations for the year.

In 2007, the association has accredited a total of 47 institutions, independent review boards (IRBs), contract research organizations (CROs), universities and hospitals. Accreditations are valid for three years.

The following have received full accreditation:

• University of Alabama at Birmingham, Birmingham, AL

• University of Illinois at Urbana-Champaign, Champaign, IL

• Wayne State University, Detroit, MI

• Department of Veteran Affairs Northern California Health Care System, Mather, CA

• John D. Dingell VA Medical Center, Detroit, CA

• North Florida/South Georgia Veterans Health System, Gainesville, FL

• Sioux Falls Veterans Administration Medical Center, Sioux Falls, SD

• VA Boston Healthcare System, Boston, MA

• VA Central California Healthcare System, Fresno, CA

• VA Iowa City Health Care System, Iowa City, IA

The Carl T. Hayden Veterans Affairs Medical Center, Phoenix, AZ received AAHRPP’s “Qualified Accreditation status”. Qualified Accreditation status means that the organization meets most of the full standards. Any deficiencies are minor, few in number, and purely administrative. These deficiencies would not cause direct harm to patients.

“AAHRPP accredits organizations that can demonstrate they provide participant safeguards that surpass the threshold of state and federal requirements,” the association states.

Premier Consolidates Expertise into One Consulting Unit

Philadelphia, Pa.-based Premier Research Group has consolidated its experts, including therapeutic leadership, medical device development, adaptive clinical trials design, and clinical trial informatics, into a single consulting group called Strategic Product Development (SPD) that will be led by Samer Kaba,M.D., vice president of SPD and global medical affairs.

Premier's operations group structure has not changed and continues to be led by Philip Butler, President, Global Operations.

MJFF Appoints Senior Medical Advisor

By Sara Gambrill

The Michel J. Fox Foundation for Parkinson’s Research (MJFF) has appointed Irene Hegeman Richard, M.D., to the newly created position of Senior Medical Advisor, a sign that MJFF’s investment in clinical research will continue to increase.

MJFF participates in venture philanthropy, a term coined to describe the funding that disease foundations provide to biopharmaceutical companies to research potential drugs and therapies in their respective diseases. U.S. disease foundations’ investment in the biopharmaceutical industry in 2007 will be about $75 million—10 times as much as their investment in 2000, according to CenterWatch. The figure should continue to rise.

MJFF launched its industry program, called Therapeutics Development Initiative, in 2006 to expand its industry investment. Last year, 10 industry research teams were awarded $4.6 million, though other funding commitments often have an industry component. The foundation has committed $5 million to industry in 2007 to 2008. Since its founding in 2000, MJFF has funded more than $98 million in research, either directly or through partnerships.

etrials Becomes Sixth EDC Company to Settle Datasci Patent Dispute

By Stephen DeSantis

Morrisville, N.C., based-etrials has agreed to pay $1.75 million to Maryland-based technology firm Datasci LLC to settle a long running EDC technology patent infringement suit. The settlement includes an upfront licensing fee  for three of Datasci’s eClinical legacy products. By licensing the original technologies, Datasci has agreed to dismiss its claim against etrials, giving up any future royalty rights.

“Obviously we are eager to see more companies in this whole marketplace obtain licenses and start to use this technology. We hope there will be many more,” Marc Kozam, Co-founder of Datasci told CenterWatch.

He stated that the majority of companies from the original lawsuit have either settled with or are close to doing so.

The products in the agreement include ASFlash–offered by etrials in 2002 through 2003–and QSCapture and Webcapture, which aren’t current offerings.

“The settlement limits any future exposure and allows us to focus all of our attention on improving etrials' core operations and expanding our market share within the rapidly growing market for eClinical technologies and services," stated Chip Jennings, etrials’ chief executive officer.

Datasci filed similar lawsuits against eClinical companies Phase Forward, Datatrak, DSG and DataLabs. Phase Forward settled for $8.5 million. In August 2006, DataLabs, which was acquired by ClinPhone in October 2006, settled its suit for an undisclosed amount and a nonexclusive licensing arrangement.

DataLabs cited the primary reason for its settlement agreement was because of the possibility of its customers getting sued, which Datasci was exploring. DataTrak settled their case this year for undisclosed amount. DSG's suit was dismissed in March 2007. The terms of the agreement between Datasci and DSG were confidential.

According to Kozam, Datasci is an ongoing venture that is presently developing new innovations to address some of the challenges in the eClinical Marketplace.

“We don’t have end user products at this point, but there are several areas of development that are occurring," he stated.

In 2002, the U.S. Federal Patent and Trade Mark Office awarded Mark L. Kozam, founder of Maryland-based MLK Software a patent— 6,496,827—for the “methods and apparatus for the centralized collection and validation of geographically distributed clinical study data with verification of input data to the distributed system.” The patent was filed in January 2000 and patent office records show the company began the process of obtaining the patent by filing a Patent Cooperation Treaty (PCT) in May 1998.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Nevada Doctor Reports Cherie Thibodeau to Attorney General’s Office

By Sara Gambrill

Cherie Thibodeau, a fraudulent study broker, may not be working her scam much longer.

For the past few months, she has been trying to solicit Las Vegas area doctors for business, using a business card that says, “Cherie Thibodeau, M.D., PhD., Chief Medical Officer/Clinical Operations.” As far as can be determined, Cherie Thibodeau does not have a license to practice medicine, and posing as someone with a medical license is an offense that is under the jurisdiction of the Attorney General’s Office in Nevada.

One Nevada doctor, whose confidence Thibodeau gained, reported her to the Attorney General’s office last week.

Off and on between stints in California State Prison, Thibodeau has operated under several aliases, including Cherie Casio and Cherie Rivard, and last year, started claiming to have a medical degree. During the six years that CenterWatch has been reporting on her activities, Thibodeau has bilked numerous investigative sites across the U.S. out of potentially hundreds of thousands of dollars.

CenterWatch obtained a copy of a solicitation letter from an alert reader who recognized Thibodeau’s name from previous articles in CWWeekly and The CenterWatch Monthly. That letter was sent by “Cherie Thibodeau, M.D.” and “Dr. X” to Las Vegas area doctors on Oct. 3, 2007. The letter states that “Doctor X” has been selected to participate as a principal investigator in a phase IIa post-herpetic neuralgia clinical trial and is looking for “consulting physicians who are interested in referring patients who meet criteria for the study and enroll as possible participants.” Thibodeau promises compensation to doctors for patient referrals, which is unethical according to Good Clinical Practice.

Dr. X became suspicious of Thibodeau during the site review when she gave the monitor a different name  than the doctor knew her by—Cherie Casio. When Dr. X asked her about it, Thibodeau claimed that Casio was her maiden name and that she preferred to use it.

Thibodeau’s typical scam is to promise doctors that she will get them studies and handle administrative tasks for a percentage of the study budget. All payments go through her. Thibodeau starts off paying sites their fair share or enough of it for the first one or two studies and then pays them nothing and can’t be reached. Lately, she’s paid sites nothing at all, defrauding them of funds due them. Most recently, she bilked a site in Ohio out of $5,000.

Sara Gambrill, Senior Editor at Thomson CenterWatch and author of The Emerging Markets of Clinical Research.

Michael J. Fox Foundation Gets It and Gets It Done

By Steve Zisson

The Michael J. Fox Foundation (MJFF) for Parkinson's Research gets it. They have figured out just how many bottlenecks there are for getting good research out of academia and to the patient. And Michael J. Fox is willing to put its money where it is needed to move along the drug development process.

It is no small task, but MJFF is headed in the right direction. The foundation has awarded $95 million for Parkinson’s disease (PD) research since its founding in 2000. Last week, MJFF kicked off its 2008 Target Validation effort. Under this annual program, the foundation will award up to $2 million for projects designed to “validate the therapeutic potential of scientific discoveries, pushing them one step closer to possible pharmaceutical industry investment and clinical trials.”

Maybe the most interesting step the foundation took this year is to enlist contract research organizations (CROs) in its efforts for the first time. The foundation and many observers understand that discoveries will be a long time in coming to clinical trials if everything is left up to academics.

MJFF has identified several CROs to help applicants gather critical information essential for ensuring studies are appropriately designed to validate or invalidate targets, such as dosing amounts and brain bioavailability.

Grant submissions must include the necessary pharmacokinetic and toxicology studies required to fully validate their targets, and the Request for Applications (RFA) includes a list of CROs equipped to perform these studies.

For investigators who are not able to carry out the required test in their own labs, MJFF has identified several CROs to help applicants gather this critical information. The expertise and resources provided by the CROs will allow awardees to obtain information critical to fully validating the proposed targets.

"Target Validation is emblematic of our Foundation's aggressive, 'get-it done' approach to driving PD drug development and speeding delivery of treatments that can improve patients' quality of life," said Katie Hood, interim chief executive officer of MJFF.

"Target Validation has a single purpose: to definitively assess the importance of promising targets by proving or disproving their druggability. This is a vital component of the Foundation's strategy to accelerate the pace of drug development by reducing industry's risk around investing in potential PD treatments."

Target Validation 2008 specifically seeks investigator-initiated applications to demonstrate that modulation of a specific cellular target (such as a gene or protein) results in a PD-relevant therapeutic response in an appropriate whole-animal mammalian model of PD. Of particular interest are targets whose manipulation holds the potential to treat the symptoms of PD, including both 'motor' and 'non-motor' symptoms such as cognitive dysfunction, autonomic dysfunction, sleep disorders and depression.

Also of interest are targets that could be used to protect or restore degenerating neurons, as well as those that can treat complications of current PD treatments (e.g., dyskinesias).

Target Validation pre-proposals are due by Dec. 18, 2007 and funding is anticipated by spring 2008.

A conference call with MJFF Research Programs staff to further clarify the aims and goals of this initiative will be held Nov. 27 at noon U.S. Eastern Time. Researchers wishing to participate in the call must RSVP to conferencecalls@michaeljfox.org and will receive an e-mail reply with call-in details.

Steve Zisson, managing editor of Thomson CenterWatch.

Finally Out with the Old at PharmaNet?

By Steve Zisson

Some equity analysts remained on edge about PharmaNet Development Group’s recent personnel changes during its third quarter conference call on Nov. 1. But should they be?

Some wondered if it was a case of the remaining higher ups from the former SFBC finally leaving or was if there were more to it and another shoe was going to drop. Late last week, PharmaNet Chairman Jack Levine and Director David Lucking resigned from the board.  And Chief Accounting Officer David Natan and the company agreed to a mutual separation, the company said.

The resignations were announced on Thursday, Oct. 22 and Jefferies & Company analyst David Windley followed up with a downgrade of PharmaNet to “Hold” from “Buy,” citing unexpected risk from the surprise announcement. In the conference call, analysts pressed PharmaNet president Jeffrey McMullen for more, but he was about as forthcoming as he could be given the nature of the personnel moves. The three who left were part of the old regime, the former SFBC.

After the downgrade, on Monday, Oct. 26, shares of PharmaNet fell $1.82, or 5.3%, to close at $32.42.

But shares were back up big time Thursday, jumping 13% to $35.95 after PharmaNet beat analysts’ expectations with earnings of $10 million, or 52 cents a share, more than double last year’s 20 cents a share, excluding items. The company also raised 2007 guidance to between $1.22 and $1.29 a share from the prior $1.12 to $1.24 a share.

For the quarter, overall revenue rose 20% to $124.4 million with direct revenue at nearly $100 million. The company also boosted 2007 guidance for direct revenue to $361 million to $365 million compared with its previous forecast of $342 million to $352 million.

It’s been a good year for PharmaNet and its investors with the stock up more than 60%, and with the old SFBC finally behind it, 2008 looks promising.

Steve Zisson, managing editor of Thomson CenterWatch.

NEJM Takes Shots at CROs

By Stephen DeSantis

A recent New England Journal of Medicine (NEJM) Perspective piece criticized the clinical trials industry for its reliance on contract research organizations (CROs). The piece describes the rapid growth in the CRO industry, questions the quality of research data it generates and cites various clinical trials that have shed some negative light on CRO-run studies.

The article “Commercializing Clinical Trial–Risks and Benefits of the CRO Boom” was written by Miriam Shuchman, M.D., a NEJM national correspondent.

“Given the steady dominance of CROs in the clinical trials domain, the current flaws in the model will need to be remedied. This will require some shift in focus–less single-minded attention to ‘deliverables’ and ‘billable hours’ and greater concern with the discovery of new knowledge,” concluded Shuchman.

Shuchman was unable to be reached for comment at the time of publication.

In the article, Shuchman references two now well-known examples involving CROs: the TeGenero monoclonal antibody study conducted by Parexel in England and the Aventis (now Sanofi-Aventis) trial for the antibiotic Ketek performed by PPD. In both cases, the CROs were found to have acted appropriately and well within regulatory requirements.

Another major point of contention with Shuchman is the industry’s apparent focus on speed and cost-efficiency as opposed to quality data. She notes that CROs have gradually taken over much of the role formerly done by academic institutions.

Doug Peddicord, director of the Association of Clinical Research Organizations (ACRO), strongly disagreed with Shuchman’s criticism of CROs compared with academic centers.

“There is certainly no research that we are aware of that suggest that the number of 483s [FDA Form 483–Notices of Inspectional Findings] or other indicators of difficulties with GCP [Good Clinical Practice] compliance are any different between those two settings,” said Peddciord.

She cites a Tufts Center for the Study of Drug Development report that found CRO-managed projects showed fewer delays than projects that did not use CROs. The 2006 Tufts report also found that those studies did not show a decrease in research quality.

Schuchman went on to question that premise. ACRO’s Peddicord found her argument puzzling.

“To cite a sourced article that says that CROs usage improves the speed of the development process without diminishing the quality of the research and then to go on, in essentially the same sentence, with an unsubstantiated statements from anonymous ‘others’ doesn’t follow basic standards of evidence and is problematic,” he said.

Among myriad of other issues she cites in the piece is that CROs have a high staff turn-over rate during clinical projects, causing the their workforce to be “younger, less skilled, less experienced and less educated” than at pharma companies or within academia.

“Actually, pharmaceutical, biotechnology and CRO employees are drawn essentially from the same personnel pool. And we’re seen a high degree of cross-sector movement all around in recent years,” stated Peddicord. He said the personnel turnover is due to a severe shortage of clinical professionals in both industry and academic institutions, putting experienced workers in high demand.

“There are fewer skilled investigators, skilled monitors and skilled research coordinators than the whole drug development enterprise needs,” he said.

Shuchman suggested that although an alternative model, academic research organizations (AROs), “avoid some of the workforce and qualification problems,” they must compete with CROs for contracts which add pressure to the institutions to conform to sponsor study designs.

According to CenterWatch data, there are few AROs of any size and only one, Duke, that has some ability to conduct the kind of large global clinical trials that are required today. While there are more than 1,000 CROs worldwide, only about a dozen of the largest can conduct trials globally.

“One of the things that we certainly reacted to, in terms of the perspective piece, is the assertion that this kind of specialized expertise has begun to ‘kill clinical research.’ It was absolutely unwarranted and there is no empirical data provided within the article to support that claim,” said Peddicord.

Averion Sells Clinical Staffing Services Unit

Massachusetts-based contract research organization (CRO) Averion International has sold its clinical staffing services unit to members of the company’s management. The new owners are Harvey Greenawalt and Philip Clark.

The company will be called IT&E Inc.The unit sold for $2.3 million, which includes some contingencies based on the buyer’s ability to generate certain revenue goals from the unit. Averion is due an upfront cash payment of $455,000, deferred payments totaling $250,000 and unsecured promissory notes of $1.6 million. Averion stated the decision was made so that the company could focus on its core CRO business. Averion’s chief executive officer Phillip Lavin called that segment“a financial burden on our operations.”

For the first half of 2007, staffing services’ net service revenues decreased $3.2 million from the same period in 2006. Averion reported a net loss of $2.6 million for the first six months of 2007.

“Our strategy is to enhance our ability to capitalize on the trend toward increased clinical trial outsourcing that is driving industry growth, while taking measures to reach sustainable profitability,” said Lavin.

The clinical staffing unit became part of Averion when the CRO was acquired by IT&E International last August. To complete the reverse merger, IT&E changed its name to Averion International shortly after.

In August, Averion inked a deal with Brazil-based SMO and research center BIOCANCER. The non-exclusive agreement called for the companies to sub-contract and jointly market in their respective markets.

Averion stated the agreement provided it with an expanded patient population, leading investigative sites and access to the South American trial arena. A

verion also announced it has signed a deal with Albuquerque, N.M.-based Biomoda, a cancer diagnostic technology company. The agreement calls on Averion to provide clinical services such as protocol design and study management for Biomoda.