Business and People Update March 2010

March 1, 2010

Applied Clinical Trials

Volume 0, Issue 0

Industry news focusing on the people and organizations who work in the clinical trials profession.

People

Sam Ricchezza

• With 14 years of business development and marketing experience in the pharmaceutical contract development and manufacturing industry, Sam Ricchezza was chosen as DiTEBA Research Laboratories' (Mississauga, Ontario) new Senior Vice President of Business Development.

Alison Bond, PhD

• Leading Quanticate's (Cambridge, MA) new Pharmacovigilance Services team, Alison Bond, PhD, will use her past experience as an Independent Pharmacovigilance Consultant.

Robert Sammis

• Industry veteran Robert Sammis will serve as Vice President of Finance for eClinical (Newtown, PA), a division of BioClinica, where he will oversee the development of budgets, forecasts, and financial results to help guide management decisions.

Nick Randazzo

• A PHT (Boston, MA) employee since 2000, Nick Randazzo has a new role as Vice President of Sales after previously serving as an account executive and leader within the PHT sales organization.

• Using her 20 years experience in both the CRO and pharmaceutical industries, Kimberly New will take on the role of Project Director at StatWorks (Research Triangle Park, NC) where she will manage global projects and key sponsor relationships.

Petr Arenberger, MD, PhD, will continue to fill the position of Chief Executive Officer of restructured FGK Clinical Research s.r.o. (Munich, Germany), in Prague, previously known as Avemedica s.r.o., and Cherry Lucas will serve as Director of FGK Clinical Research in London.

• Assuming the highest-ranking role at ACRP (Alexandria, VA), Heike Schön will serve as the Chair of the Association Board of Trustees with Valerie Willetts serving as Vice Chair.

• As the new Senior Vice President, Portfolio Management, at Synexus (Manchester, England), Jeremy Hicklin will utilize his 11 years of experience in the pharmaceutical industry.

• Working as the head of information technology, Bob Kaplan will use his 16 years of experience in health care technology as the Chief Information Officer at Clinical Trials and Surveys (Towson, MD).

• Former Senior Director at Wyeth, Steve E. Unger, PhD, has joined CEDRA (Austin, TX) as Vice President and Laboratory Director.

• Bringing with her over 20 years of experience, Gretchen Dieck, PhD, will take on the role of Vice President, Safety, Epidemiology, and Risk Management for United BioSource (Bethesda, MD).

• With an extensive background in health care and clinical research organizations, Robert Patton was chosen as Vice President, Business Development, for Clinical Trial and Consulting Services (Cincinnati, Ohio).

• Joining REMS Group (Paramus, NJ) as Chief Operating Officer, Gerard P. Maher will develop risk evaluation and mitigation strategy programs.

Accelovance (Rockville, MD) has made two new additions to its team with the appointments of Joseph W. Angie, Jr., as Chief Financial Officer and Lisa Beth Ferstenberg, MD, as Chief Medical Officer.

• Formally Vice President of Clinical Development and Chief Medical Officer at Camargo Pharmaceutical Services, Samer E. Kaba, MD, will now become the Medical Director at Medpace (Cincinnati, OH) where he will formulate clinical development plans and strategies with clients.

Alliances

• An alliance with Centerphase Solutions (Upper River Saddle, NJ) allows Mayo Clinic (Rochester, MN) to use its Enterprise Data Trust of 7 million patient records to provide Centerphase perform protocol review, and help identify Mayo patients that qualify for enrollment in clinical trials.

Synomics Pharma (Wareham, MA) and BioScience Laboratories (Bozeman, MT) are partnering to provide fully integrated topical clinical Phase I study services.

• A three year, multi-million agreement between BioClinica (Newtown, PA) and Cephalon (Frazer, PA) will enable the latter to use BioClinica's clinical data management services.

• To complete studies in patients with renal impairment, Clinilabs (New York, NY) has formed an alliance with Spectra Clinical Research (Rockleigh, NJ), a division of Spectra Laboratories.

• Researching the continued development of unacylated ghrelin agonists for the treatment of type II diabetes, Alizé Pharma (Lyon, France) and Eli Lilly (Indianapolis, IN) are partnering on Alizé's AZP-01 project under a research collaboration and license option agreement.

Quintiles (Research Triangle Park, NC) has chosen invivodata (Pittsburgh, PA) as its primary partner for ePRO solutions.

• Expanding on a previous agreement, Novella Clinical (Research Triangle Park, NC) will provide clinical research services to OSI Pharmaceuticals (Melville, NY) for two years.

Company News

MS2 (West Lebanon, NH) doubled its clinical trials business from December 2008 to December 2009 by increasing operational efficiency and reducing total costs for sponsors.

• Expanding its staff in the United States, India, and South Africa, Criterium (Saratoga Springs, NY) is adding staff to its monitoring services, business development, and regulatory departments.

• Introducing a new ePRO System, Vitalograph (Buckingham, England) has developed the In2itive eDiary that combines an integrated spirometer and features a removable flow head.

• Originally certified in 2001, Beardsworth (Flemington, NJ) was certified for the ninth year in a row as a Certified Women Business Enterprise by the Women's Business Enterprise National Council.

• ClinicalRSVP, a subject registry developed by Independent Data Integrator (Ft. Lauderdale, FL) to prevent dual enrollment in clinical trials, has registered over 1500 subjects.

• A recent advancement in The Cognition Group's (Newark, NE) Signal Enhancement System will allow patient interviews to be recorded and viewed in a more precise format to improve international clinical trials.

• After careful inspection of the facility, staff, and laboratory equipment, PPD's (Wilmington, NC) global central lab operations in Singapore became the fourth lab in the company to earn accreditation by the College of American Pathologists.

• Originally founded as a one-person consulting firm, PPD (Wilmington, NC) is celebrating 25 years of advancing drug development.

• Utilizing PharmaVigilant's (Westborough, MA) new imaging functionality technology, TissueGene (Rockville, MD) has chosen PharmaVigilant to support a three year Phase II study to test the efficacy and safety of a new drug aimed at treating patients with a degenerative joint disease of the knee.

• With a recent infusion of $15 million in financing, Virtify (Cambridge, MA) plans to accelerate its enterprise content compliance software suite into the life sciences markets in the United States, Europe, and other markets.

• Moving toward a fully electronic business environment, MWB Consulting (Northamptonshire, UK) has joined with Safe-BioPharma Association (Fort Lee, NJ).

BioStorage Technologies (Indianapolis, IN) has launched a new mobile biorepository, OSIRIS, that is capable of transporting and storing temperature sensitive biological samples and materials.

Training Magazine has ranked Quintiles (Research Triangle Park, NC) #47 on its "Training Top 125" list.

Mergers/Acquisitions

• Two Institutional Review Boards, Independent Review Consulting (San Anselmo, CA) and Ethical Review Committee (Independence, MO), announced they have entered a preliminary agreement to enter a merger starting with the formation of Ethical and Independent Review Services, a new Limited Liability Corporation to provide management services for both companies.

• Joining two core labs, RadPharm (Princeton, NJ), an Imaging Core Laboratory and Medifacts International (Rockville, MD), a Cardiovascular Core Laboratory, announced their merger into CoreLab Partners (Princeton, NJ).

• Helping to strengthen their presence in Europe and Asia, Ricerca (Concord, OH) plans to acquire the Discovery and Preclinical business of MDS Pharma Services located in Bothell, Washington; Lyon, France; and Taipei, Taiwan.

• Enabling Watson Pharmaceuticals (Corona, CA) with biopharmaceutical developments and manufacturing capabilities is its $15 million acquisition of Eden Biodesign (Liverpool, UK).

New Facilities

• Adding to its offices in London, Boston, Osaka, and Prague, BBK Worldwide (Newton, MA) opened an office in Los Angeles in order to meet increasing demands for worldwide coverage.

• Researching the physiological effects of medical interventions and biological causes of diseases, the Duke Clinical Research Unit opened at Duke University Medical Center (Durham, NC).

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