eClinical Technology News

• New York, N.Y.-based Medidata Solutions electronic data capture (EDC) won an agreement with Boston, Mass.-based CRO Parexel through the Medidata’s non-exclusive service provider model, ASPire to win. Medidata stated the CRO was attracted to Rave’s broad user acceptance, ease of deployment and real-time access to clinical data. Medidata Solutions also landed a contract with Dublin-based Elan Pharmaceuticals for the technology company’s Medidata Rave solution. Medidata stated that much of Elan’s data management operations is outsourced so it needed a product that could be easily adopted by any CRO regardless of past experience with the technology. Elan will use the solution for mid-to-late stage trials in North America.

• Cambridge, Mass.-based Akaza Research launched OpenClinica 2.2, a new version of the company’s open source clinical trial software. The updated version offers enhancements such as improved case report forms (CRFs), international language capability, full study audit reports and improved support for multi-site trials.

• Cleveland, OH-based eClinical company Datatrak has signed a five-year contract with Japanese telecommunications group NTT Data Corp. The enterprise-wide subscription license agreement that calls for NTT Data to standardized its systems on Datatrak platform, allowing NTT Data new Life Science group. The deal is worth $2.4 million with $2.1 million in upfront cash. Any optional services for the platform would be contracted separately. The agreement also gives NTT Data the ability to sublicense the eClinical platform to Japanese contract research organizations (CROs).

• Ft. Lauderdale, Fla-based OmniComm Systems has partnered with the City of Hope, a renowned research and treatment center for life-threatening diseases have entered into a new collaboration. The partnership is an effort to standardize the center’s case report forms and reporting tools to be aligned with the National Cancer Institute (NCI) requirements. City of Hope uses OmniComm’s EDC system TrialMaster.

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.

CenterWatch Monthly December 2007 Issue

Asia-Pacific Countries Set for Global Clinical Project Leadership

With more than 30% of the world's population, Asia-Pacific is becoming an integral part of global drug development, and in the future will take a leadership position on some global projects. After 50% growth between 2005 and 2006 in the Asia-Pacific region's new global clinical trials initiated by pharma and biotech, intense competition for talent has resulted. As sites conduct more clinical trials, 38% or more of sites in the top four respondent countries to CenterWatch's survey of the Asia-Pacific region believed that EDC would best prevent future delays.

Avandia Warning Spurs More Drug Safety Services

In the wake of reports questioning the safety of popular diabetes drug Avandia, contract research organizations were already seeing increased demand for work involving drug safety even before the FDA revised the black box warning on the drug's label last month. In September, the FDA Amendments Act of 2007 was passed. It gives the FDA new authority to improve drug safety. The legislation marks a significant change in the FDA's authority to monitor safety concerns post-approval.

CROs Still Expanding Eastward in Europe

The clinical research market in Central and Eastern Europe (CEE) has been growing steadily in the past five years, and contract research organizations are continuing to expand their presence there. CEE is still the emerging region with the greatest number of new global trial initiations, according to CenterWatch analysis. In fact, the number more than doubled between 2002 and 2006.

Eye On: Hypertension

Hypertension, or chronic elevation in blood pressure, is defined as a systolic blood pressure (SBP) above 140 mmHg and/or a diastolic blood pressure (DBP) above 90 mmHg. For patients with diabetes and chronic renal disease, treatment goals are more rigorous, namely to reduce SBP below 130 mmHg and DBP below 80 mmHg.

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

Recent Industry Personnel Changes

Contract Research

• U.S. and India-based site management company, Excel Life Sciences, appointed Dan McDonald as vice president of business development and has added Wayne Pines to the company’s board of directors. Prior to joining Excel Life Sciences, McDonald was senior vice president of strategic development at D. Anderson & Company and held various senior positions at CenterWatch, most recently as the company’s general manager. Pines is a consultant on regulatory issues, advertising and promotion, media strategies and crisis management involving biological products, pharmaceuticals and medical devices. He is currently president of regulatory services and healthcare at Washington, D.C.-based APCO Worldwide. He also spent seven years as associate commissioner for public affairs at the FDA.

• Parexel is expanding its late phase research services and has appointed Dr. Victor Kiri, formerly with GlaxoSmithKline, as director of pharmacoepidemiology within the company's Clinical Research Services business. Kiri's responsibilities include advising clients on the design and conduct of comparative observational studies, offering epidemiological analysis for compounds in development, and guiding strategic decisions regarding future areas of research and product development.

• Wayne, Pa.-based Encorium Group appointed Linda Nardone, Ph.D. as chief operating officer and executive vice president, reporting to chief executive officer Kenneth Barow, M.D. Nardone joined Encorium from Zila Biotechnology as general manager. She also held positions at Pharmacia, Sterling Winthrop, Immunomedics and Elusys Therapeutics.

Technology

• London-based clinical software company, InferMed appointed Martin Rouen as director of product development. Rouen joined InferMed from Alphameric Solutions as program and development manager. He will report directly to the company’s chief executive officer Duane Lawrence.

• Morrisville, N.C.,-based eClinical provider etrials appointed Michael Mickens vice president of sales and client services and Chuck Piccirillo to vice president of product development. Mickens will be responsible for leading the sales organization, creating and implementing a customer-focused, team-oriented sales strategy. Mickens joined etrials from Cerner Corp., as vice president of worldwide sales and business development. Prior to Cerner, he was vice president of worldwide sales and business development at QED Solutions. He has also held sales and business development positions Fiserv and Oracle. Prior to etrials, Chuck Piccirillo was at Hill-Rom's HealthCare IT Solutions business, Kodak, Carestream Health, and Nova MicroSonics.

Patient Recruitment

• Dallas-based patient recruitment firm D. Anderson & Company appointed Teddie Garrigan to the position of executive vice president, charged with leading the company’s project operations department. Garrigan was previously vice president and chief strategic officer for The Herman Group of Companies. She was also president and chief executive officer of strategic advisory company Seaborn Communications.

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

CWWeekly December 10th 2007 Issue

Top News

Global Clinical Trials Opens Office in Romania

Princeton, N.J.-based Global Clinical Trials (GCT), a contract research organization (CRO) with operations in Central and Eastern Europe, has opened a regional office in Bucharest, Romania.

PRA Winds Down Busy Year with Phase I Acquisition

Raleigh, N.C.-based contract research organization (CRO) PRA International will be ending a year of transformation with an early management shakeup, an equity buyout, a relocation of its headquarters out of state, and finally an acquisition in the European phase I market.

Other breaking news...      

• Quintiles and IntraLinks ink deal...
• Private equity closes Synexus deal...

Company Profile: An interview with John Farinacci, chief executive officer, ResearchPoint

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.

PRA International Completes Buyout

Genstar Capital, a private equity group based in San Francisco, has completed its acquisition of PRA International, paying $797 million for the Raleigh, N.C.-based contract research organization (CRO).

During a conference call in July, PRA executives said that Genstar will invest in the company to accelerate plans for expanding the firm’s service offerings and broaden its geographic footprint.

In response to an analyst’s question during the call, Terrance Bieker, chief executive officer of PRA, stated its board of directors came to the conclusion that the right course of action was to provide its shareholders with an immediate premium on their investment.

“This decision is driven by value and reward, and it was determined that this is a right price for the shareholders. So, the decision for doing this is not so the company can perform better in a different venue, it was done because it is a very good return to the shareholders,” Bierker said.

Shareholders will receive a cash buyout of $30.50 per common share. That would be a 24% premium over PRA’s average closing price for three months prior to the July announcement.

Genstar was an early investor in PRA and already owned 12.8% of the company. In June 2001, PRA’s executive management team completed a buyout of the company, partly with financial backing from Genstar. The company went public in November 2004.

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.

ClinTech Relocates To Scotland

ClinTec International, a CRO based in the UK, is moving it global headquarters to Scotland from its current offices in Windsor. The office will be in Glasgow, Scotland.

The headquarters will house all of the company’s corporate functions including sales, human resources, IT, finance and marketing as well as clinical operations. The move is being assisted by a $2.7 million Regional Selective Assistance Grant from the Scottish Enterprise—an economic development agency funded by the Scottish government.

ClinTec has pledged to create 240 new jobs over the next three years. The company stated one of the incentives to relocate to the region is its highly skilled talent pool available due to the many universities and academic research institutes. More than a dozen CROs maintain operations in Scotland, including Quintiles, Aptuit, Charles River Laboratories and BioReliance.

In August, PPD obtained a $9.1 million RSA grant to the construction of a 34,000-square-foot office in Lanarkshire, Scotland to support its late-stage services.

CWWeekly December 3rd 2007 Issue

Top News

MJFF Signals Increasing Investment in Clinical Research

The Michael 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.

eResearch Technology Buys Covance's ECG Unit

In a deal potentially worth $50 million, eResearchTechnology (eRT), a Philadelphia-based eClinical company made a major purchase with the acquisition of the cardiac safety business unit of Princeton, N.J.-based contract research organization (CRO) Covance.

Other breaking news...

• etrials to pay Datasci LLC to settle patent infringement suit...
• FDA and Duke University Medical Center collaborate on improving trials...      

Company Profile: An interview with Toru Mimura, Ph.D., president and chief executive officer,IBERICA USA, Inc.

Platelet Growth Factor Hits Endpoints in Phase II

By Tracy Trundle

GlaxoSmithKline reported positive results from two phase II trials of Promacta -- a non-peptide thrombopoietin receptor agonist (platelet growth factor) which can stimulate the growth and differentiation of bone marrow cells that priduce blood platelets -- for the treatment of chronic hepatitis C-associated thrombocytopenia and chronic Idiopathic thrombocytopenic purpura (ITP). The first study was an international, multicenter, double-blind, randomized, placebo-controlled, dose-ranging study. A total of seventy-four HCV-infected subjects with platelet counts between 20,000 and 70,000/mL were enrolled. The subjects received Promacta (30mg, 50mg, or 75mg daily) or placebo for four weeks (pre-antiviral phase).

The primary endpoint was platelet count increase to greater than or equal to 100,000/mL at week four. The subjects could then initiate antiviral therapy and continue Promacta or placebo for 12 additional weeks (antiviral phase).

The primary endpoint was reached by 75%, 79% and 95% of subjects in the Promacta 30mg, 50mg and 75 mg groups respectively, compared to no platelet elevations in the placebo group (p<0.001). Treatment was generally well tolerated, with all adverse events mild to moderate in nature. The second trial was a multicenter, randomized, double-blind, placebo-controlled study.

A total of 118 subjects with chronic ITP and platelet counts <30,000/mL and who had relapsed or were refractory to at least one ITP treatment were enrolled. The subjects received once-daily oral Promacta (30mg, 50mg, or 75 mg) or placebo. The primary endpoint was the proportion of subjects with a platelet count greater than or equal to 50,000 per cubic millimeter after up to six weeks of therapy.

The primary endpoint was achieved in 28%, 70% and 81% of subjects who received Promacta (30mg, 50mg and 75mg, respectively) compared to 11% of the  placebo group <0.001). Platelet counts rose to greater than 200,000/µL in 4% of the placebo-treated subjects and in 14%, 37% and 50% of the Promacta 30mg, 50mg and 75mg-treated subjects, respectively. Treatment was generally well tolerated.

Phase III trials of Promacta are currently underway.   

Tracy Trundle is a Research Analyst at CenterWatch.

Encorium Group Reports Mixed Results in Third Quarter

Pennsylvania-based CRO Encorium Group reported mixed results for its third quarter of 2007. The company’s net revenue more than doubled from $3.7 million in 2007 to $7.2 million during its third quarter.European operations constituted the bulk of the CRO’s revenue at $4.8 million with its North American business generating $2.3 million.

Encorium attributed the growth to the addition of Espoo, Finland-based CRO Remedium, acquired in November 2006.

The company's backlog increased to $36.8 million at September 30, 2007 versus approximately $29.1 million as of September 30, 2006.

However, the company reported a net loss of $1.28 million, double last year’s $643,000 for the comparable quarter. The company expects full year revenues of approximately $31 million compared with $15.3 million for the year ended Dec. 31, 2006. Depreciation and amortization expense increased to $623,000 due to $500,000 of non-cash amortization expense related to the business combination with Remedium.

"At the present time, Encorium’s pipeline of potential new business opportunities is in excess of $40 million. This is fairly evenly distributed between opportunities in North America and Europe. There have been a significant number of proposals carried over from our third quarter in which we are hopeful that final decisions will be made by the end of 2007," Stated Kenneth Borow, M.D., president and chief executive officer. We continue to evaluate a variety of acquisition possibilities and are focusing on companies and areas that would enhance Encorium’s existing geographic footprint and therapeutic area capabilities.

Barrow said Encorium is evaluation at specifc acquisitions that would expand its current "geographic footprint".

"This can come through our expansion into emerging clinical trial markets (for example China, South America and/or India) as well as broadening of our capabilities within targeted sectors such as oncology, endocrinology, and medical devices. We hope to provide an update on our expansion plans in the coming months," he added.

Encorium also appointed Linda Nardone, Ph.D. chief operating officer, a newly created position for the company. Prior to Encorium, Nardone was general manager for Zila Biotechnology where she oversaw a phase III drug product for oral cancer.