New England Research Institutes Partners With Evidence

Watertown, Mass.-based CRO New England Research Institutes (NERI) established a strategic partnership with Evidence Clinical and Pharmaceutical Research Institute, a CRO which focuses on conducting trials in Russia and Eastern Europe. Evidence is headquartered in Saint-Petersburg, Russia, and has offices in Los Altos, Calif., and Swampscott, Mass. The companies stated that both Eastern Europe and Russia are becoming increasingly popular regions for conducting clinical trials, and sponsors are creating an ever larger presence there.

“In addition to our North American depth, we have established a consortium of strategic CRO partners in emerging locations. The Evidence team fits well within our mix of employees and partners because they offer excellent data quality, high recruitment rates, well-trained and experienced personnel, and advanced communication technologies,” stated Rebecca Li, Ph.D., NERI’s vice president of clinical research.

CWWeekly April 21st 2008 Issue

Top News
      
SpineMark CRO Creates Own Multi-Site Research Network

SpineMark CRO Management, a contract research organization (CRO) is creating a multi-site network of dedicated research centers, collaborating first with clinical investigators in Los Angeles and Denver. SpineMark CRO plans to have 20 such sites in place by the first quarter of 2009. Eventually, the company wants to have 35 centers across the U.S. and 10 outside the country.

AbCRO Opens Office in Ukraine

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened an office in Kiev, Ukraine. The opening comes just on the heels of the company’s two new offices in Russia—one in St. Petersburg and one in Moscow. The opening comes just on the heels of the company’s two new offices in Russia—one in St. Petersburg and one in Moscow.
    
Other breaking news...      

• Chiltern opens new office in Russia...
• eResearch Technology in partnership with nSpire Health...

Company Profile: An interview with James McDermott, corporate development director, Quanticate

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

 

Recent Industry Personnel Changes

Contract Research

Cincinnati-based CRO Kendle appointed Simon Higginbotham, formerly Kendle’s chief marketing officer, to president, replacing long time president and co-founder Chris Bergen.

Bergen helped start the company in 1981 with current chief executive officer, Candace Kendle.

“As we embark on the next stage of our corporate growth, it is imperative we have the dedicated leadership in place to support our needs as a larger global organization,” said Kendle. Bergen will remain in his role as chief operations officer.

In addition, the company appointed Alan Boyce to fill the position of chief marketing officer. Boyce held the position of vice president of Kendle’s clinical development in Europe and Africa from 2003 to 2007. He returns to Kendle after serving as chief operating officer at patient recruitment firm Synexus.

Wilmington, N.C.-based PPD appointed Mike Wilkinson, Ph.D, to the position of executive vice president of global clinical development. He will be responsible for all of the company’s phase II through IV trials in worldwide. Prior to PPD, Wilkinson was global head of internal medicine and vice president of project management at Quintiles. Before that, he served 27 years in the United States military, beginning with a career as a Navy Seal.

And after more than 16 years with the CRO, PPD’s Paul Covington, M.D. is retiring from his position of executive vice president and chief medical officer, effective June 30th. He will stay on in an advisory role for special projects through the end of the year and consult for the company thereafter. PPD stated it anticipates having a replacement in place by mid-2008.Covington, who is board certified in internal medicine, was in private practice in Clanton, Alabama from 1985 to 1990. He served as chief of staff and director of critical care and cardiopulmonary disease at a Clanton hospital. "Paul is one of the most talented physicians in our industry, and his leadership and unwavering commitment to excellence have played a significant role in the continued growth and success of our company," said Fred Eshelman, chief executive officer.

Wayne, Pa.-based CRO Encorium Group’s chief financial officer Lawrence Hoffman has resigned his post, effective May 2. Encorium stated Hoffman is leaving his post to pursue other interests. The company said it will begin the search for a new U.S.-based CFO immediately. "Larry has created a solid financial foundation that will support our ongoing global expansion and business development initiatives. On behalf  of the entire Encorium organization, we wish Larry good luck in his future endeavors and thank him for his  ole in the growth of the Company over the past four years,” said Kai Lindevall, M.D., Ph.D., chief executive officer, and Kenneth Borow, M.D., president and chief medical and strategic development officer,  in a joint statement.

Encorium also appointed Peter Asplund country manager of the company’s Swedish operations. He was formerly the director of marketing and business development at AstraZeneca. His previous posts also include director of business development at GlaxoSmithKline in the UK.

Laboratory Testing

St. Louis-based diagnostic testing company Biomedical Systems named Geert Dewulf, M.D. , managing director of the company's European operations, replacing Rita Jacobs who is set to retire following 27 years with the company. Dewulf will be based in Burssles, Biomedical System's European headquarters. Prior to joining Biomedical Systems, Dewulf held positions at Agfa Healthcare, where he served as Managing Director for Germany, Austria and Switzerland. Biomedical Systems provides centralized diagnostic testing (including cardiac safety and imaging) for clinical trials.

Technology

Ft. Lauderdale, Fla.-based eClinical provider OmniComm Systems promoted Stephen Johnson to chief operating officer. Prior to this position, Johnson was executive vice president of business development and professional services. He has been with OmniComm Systems since 2006, when he was appointed senior vice president of business development. "We have opened new offices in Bonn, Germany and Tula, Russia to support global clinical trials, we have built dedicated Professional Services and Clinical Services and Support divisions, built a bridge from Oracle Clinical to OmniComm through our OC Connect program and we have implemented our extremely successful CRO Preferred Partnership program. Steve has been the defining influence for all of these programs that were developed to provide quality deliverables to our customers. We look forward to benefiting from Steve's experience and dedication as he leads operations as our new COO," said OmniComm's chief executive officer Cornelis Wit.

Be sure to send Clinical Trials Today your organization's latest personnel news!

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...

CWWeekly April 14th 2008 Issue

Top News
      
Coast IRB Receives FDA Warning Letter

Coast IRB, an independent institutional review board (IRB) based in Colorado Springs, Colo., received a Warning Letter from the U.S. Food and Drug Administra-tion (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.

LabConnect Gains Centralized Pathology Testing with Bostwick Scientific Deal

LabConnect, a clinical trial–focused central laboratory provider based in Seattle, Wash., has inked an agreement with Bostwick Laboratories, adding one of the top anatomic pathology testing companies to its international list of networked labs.
      
Other breaking news...      

• Encorium inks third set of sponsor contracts in two weeks...
• OmniComm Systems lands contract with Criterium...

Company Profile: An interview with Paul Bishop, managing partner, and Lyle Camblos, managing partner, Atlantic Research Group

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

 

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.

CenterWatch Monthly April 2008 Issue

FDA Debarment Failures a Wake-Up Call for CROs, Drug Sponsors

After Congressional hearings on the antibiotic Ketek, a Congressional committee issued a scathing report on the FDA’s debarment process. The min-ority committee charged that debarment proceedings against individuals are inconsistent and haphazard. Staffers uncovered cases where individuals convicted of a felony related to the development or approval of a drug product were not debarred, while other individuals with similar circumstances or convictions were debarred. In response to Congressional concerns, sponsor companies and CROs should examine their processes and improve investigator selection and training methods to avoid potential debarment or disqualification proceedings.

CROs: The Promise of Biotech and Beyond

CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and others have been working hard to cater to biotech clients for several years. Those efforts should continue to pay off in 2008, which looks to be a good year for biotechs. With large pharmaceutical companies emphasizing biotech products more than ever, large CROs can leverage their expertise in biologics for additional work with existing customers. They can also take advantage of their global infrastructure in emerging markets. But there are some warning signs concerning sustained growth.

Innovative Medicines Initiative Gets Underway During DIA EuroMeeting

The afternoon session on the first day, March 3, of the DIA Euro-Meeting in Barcelona called “Innovative Medicines Initiative: The EU Commission/EFPIA Public-Private Initiative—Up and Running?” answered affirmatively the question it posed in its title.

Eye On: Osteoporosis

In osteoporosis, the density and quality of bone are reduced, with loss of bone mineral density (BMD) and changes to bone structure causing bones to become more porous, brittle and highly susceptible to fracture. Bones at the hip, spine and wrist are particularly vulnerable to osteoporotic fracture. CenterWatch has identified a pipeline of 15 drugs in various stages of development for osteoporosis. Many of these are novel formulations of PTH or target hormonal pathways in other ways, whereas others capitalize on recent advances in understanding of bone metabolism.

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

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.

CWWeekly April 7th 2008 Issue

Top News

Parexel Buys Larger Stake in India Venture and Expands Phase I Business in U.S., Europe

Waltham, Mass.-based contract research organization (CRO) Parexel has grown its early phase operations with an expansion of three clinical pharmacology units (CPUs), located in Baltimore, London and Berlin.

Progenitor Grows Organically in Latin America, India

The opening of Progenitor International Research’s new office in Buenos Aires, Argentina, a year ago signaled the beginning of a fundamental change to the company’s business model. Previously, Progenitor had worked exclusively as a CRO composed of teams in emerging markets who worked under a coordinated platform to deliver global development services. Progenitor’s office in Argentina represents the first organic growth of the company in an emerging market.

Other breaking news...

Averion’s 2007 net service revenue up...
Baylor College publishes plan for improving clinical trials...

Company Profile: An interview with Janice Sidorick, MPH, managing director, Janix, LLC

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

Suven Teams up With Chinese CRO VPSCRO

Asian Clinical Trials (ACT), the CRO of Hyderabad, India-based pharmaceutical company Suven Life Sciences, has entered into a pact with the Beijing -based company VPSCRO to conduct clinical trial services in India and China. VPSCRO claims it is the largest Chinese CRO in term of numbers of ongoing trials. The companies stated that the agreement will provide cost-effective services with faster patient recruitment speeds in the two regions.

“Given the fact that 50% of the global population is living in India and China and the global pharmaceutical industry’s ever increasing demand to reach out to diversified patient populations, the strategic collaboration...will provide a platform offering full-fledged clinical research solutions in the Asian region to global sponsors,” stated Venkatraman Sunder, vice president of operations for ACT.

Suven stock, trading on the Bombay Stock Exchange, jumped nearly 10% on the news.

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.

CWWeekly March 31st 2008 Issue

Top News     

Bio-Imaging Technologies Acquires Phoenix Data Systems

Newton, Pa.-based contract research organization (CRO) Bio-Imaging Technologies has opened up a new book of business with the acquisition of eClinical company Phoenix Data Systems. Bio-Imaging, which specializes in running trials that require medical imaging management, purchased the King of Prussia, Pa.-based company for $24 million, including $17 million in stock and $7 million in cash.      

inVentiv Clinical Moves into Latin America

inVentiv Clinical, the contract research organization (CRO) division of Somerset, N.J.-based marketing, communications and staffing firm inVentiv Health, has expanded its clinical services to Latin America with a new central hub in São Paulo, Brazil. The company stated it plans to bolster its operations in other countries throughout the region as well.

Other breaking news...      

Quintiles inks agreement with Medca Japan...
Encorium Group inks $2.5 million in new contracts...

Company Profile: An interview with Patrick Hughes, senior vice president, Exco InTouch

To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information. Past weekly article summaries for the year can be found in the CW Weekly Issue archives.

Parexel Buys Larger Stake in India Venture and Expands Phase I Business in U.S., Europe

By Stephen DeSantis

Waltham, Mass.-based contract research organization (CRO) Parexel has grown its early phase operations with an expansion of three clinical pharmacology units (CPUs), located in Baltimore, London and Berlin.

The expansion brings the company’s total worldwide phase I bed capacity to 550, one of the largest in the industry, the company stated. Parexel also has CPUs in San Diego and Los Angeles, and two facilities in South Africa. Each of its phase I facilities uses its clinical trial management and electronic data capture (EDC) technology, ClinBase. The company’s early phase services include bioanalytical services, data management, biostatistics, medical writing, pharmacokinetic services and consulting.

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.

NPS Pharmaceutical in Talks with FDA After More Positive Results with Gattex

By Tracy Trundle

NPS Pharmaceuticals issued positive results from a phase III extension study of Gattex (teduglutide), an injectable glucagon-like peptide-2 (GLP-2) analog, for the treatment of short bowel syndrome (SBS) in subjects who are dependent upon parenteral nutrition (PN).  PN is the practice of feeding a patient intravenously, the cost of which can exceed $100,000 a year.

SBS is a disabling syndrome that can arise after a resection of the small bowel. There are an estimated 10,000 to 15,000 SBS patients in North America who are PN-dependent.

Gattex was granted Orphan Drug status in the U.S. for SBS in August 2000.

This extension study enrolled 65 of the 71 subjects who had completed a 24-week randomized phase III study that evaluated low dose Gattex (0.05 mg/kg/day) and high-dose Gattex (0.10 mg/kg/day) versus placebo. The primary objective of the study was to assess the long-term safety and tolerability of daily Gattex dosing for up to 52 weeks.

Sixty-eight percent of the subjects who had received low-dose Gattex therapy and continued on low-dose Gattex, and 52% of the subjects who had received high-dose Gattex therapy and continued on high-dose Gattex achieved a 20% or greater reduction in PN after a total of 52 weeks of therapy.

Subjects treated with low-dose Gattex showed a mean 51% reduction in PN volume from pretreatment baseline to the end of 52 weeks (p< 0.001) and those treated with high-dose Gattex experienced a mean 24% reduction (p< 0.001).All of the subjects (100%) who had previously received placebo in the phase III study and were randomized to low-dose

Gattex therapy, and two out of seven subjects who had previously received placebo in the phase III study and were randomized to high-dose Gattex therapy, achieved a 20% or greater reduction in PN after a total of 28 weeks of therapy in the extension study.

Treatment was well tolerated in both dose groups with no statistical differences in the rate of adverse events compared with the placebo group.

Based on a series of positive phase III results, NPS is currently meeting with the FDA to discuss the path towards regulatory approval.

Tracy Trundle is a Research Analyst at CenterWatch.

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.”...