Applied Clinical Trials
Industry news focusing on the people and organizations who work in the clinical trials profession
People
• Formerly holding a quality management position at Patheon (Research Triangle Park, NC), Karl Fry is now the director of quality for Penn Pharma (South Wales, UK) where he will manage a 22-person quality management team.
Karl Fry
• With 17 years of clinical research experience, Dr. Rer Nat Wilfried Dierkes will work in the medical and clinical development division of Diapharm (Oldenburg, Germany) where he will perform clinical studies and prepare clinical reports for the pharmaceutical service provider.
Dr. Wilfried Dierkes
• After serving 22 years at Catalent Pharma Solutions (Somerset, NJ), Tony Engel will now join Penn Pharma (South Wales, UK) as the head of analytical services, in which he will manage 45 analytical chemists.
Tony Engel
• Filling the role of associate director of business development for Japan at ERT (Philadelphia, PA), Miki Stevens will work with the company's Japanese partner, Site Support Institute (SSI), to facilitate sales activities and improve domestic support of Japanese sponsors and sites.
Miki Stevens
• Jeffrey Davidson, PhD, has become the senior director of clinical statistics for Octagon ResearchSolutions (Wayne, PA), where he will oversee all statistical activities and staff.
• Harald von Eick has joined CTI (Cincinnati, OH) as its new managing director of Europe and Michael Meisner will become the director of clinical operations. Both men will be located in the company's Germany office.
• With more than nine years experience in the central laboratory industry, Theresa Thackray will become the new head of business development in Europe for ACM Global Central Laboratory (York, England).
• To accommodate Health Decision's (Durham, NC) increased productivity goals, the company has hired Craig Hurt to fill the position of Controller.
• The new clinical pharmacology unit of ICON (Dublin, Ireland), located in Omaha Nebraska, will become Alan Marion's, MD, PhD, new place of work as he has been appointed the company's vice president and medical director.
• Joining Oncodesign Biotechnology (Dijon, France) as the Vice President of Drug Discovery, Jan Hoflack, PhD, will be responsible for establishing and directing integrated drug discovery activities.
Alliances
• The Korean-based CRO, Dream CIS (Seoul, South Korea) has chosen to implement Oracle's (Redwood Shores, CA) Health Sciences applications, which includes the use of Oracle Remote Data Capture 4.5.3 and Oracle Clinical.
• To support the research and development for AVI BioPharma's (Corvallis, OR) exon skipping candidate drugs for treating Duchenne Muscular Dystrophy, Action Duchenne (London, England) has collaborated with the company.
• A $145 million, five-year contract with Covance (Princeton, NJ), will commit Merck (Whitehouse Station, NJ) to purchasing genomic analysis services from the company.
• The signing of a license agreement between OmniComm Systems (Fort Lauderdale, FL) and a West coast clinical research organization will allow the CRO to use the company's TrialMaster solution in a technology transfer model.
• Being selected as the preferred provider for a top 10 pharmaceutical company, Cardiocore (Washington, DC) has been awarded with several cardiac safety service contracts.
Awards
• Ranking 20th among America's fastest-growing small public companies, Phase Forward (Waltham, MA) has moved up from 38 on last year's Fortune's Small Business 100 list.
• At the SAS Professionals Convention held this past July, SAS Institute (Cary, NC) acknowledged a group of six from Satellite (Middlesex, UK)—a niche CRO providing innovative clinical outsourced solutions—for their success in BASE SAS certification. Each person was awarded a certificate as well as £5000 worth of SAS training.
Company News
• Experiencing growth across the UK, Central and Eastern Europe, India, and South Africa, has led Synexus (Manchester, England) to double its head office capacity.
• The Scott Partnership (Cheshire, UK) has been selected by ERT (Philadelphia, PA) to lead its global PR campaign.
• Quorum Review IRB (Seattle, WA) has recently launched a newly redesigned version of its Web site.
• BSI (Reston, VA) has recently launched CE-Dedicated FastTrack, a CE marking program intended to conduct reviews at an accelerated pace.
• With the anticipation of future growth at its Craigavon headquarters, Almac (Craigavon, Northern Ireland) has the potential to create over 500 jobs during the next five years and has also acquired a 5.4 acre site.
• After changing its name from Cardinal Health to CareFusion (San Diego, CA), the company has taken part in a string of marketing activities, including being added to the New York Stock Exchange and ringing the bell on Wall Street.
Care Fusion's truck parked outside the NYSE.
Mergers/Acquisitions
• The Web-based ePRO and late phase solutions company Maaguzi has recently been acquired by Phase Forward (Waltham, MA) for $11 million.
• Upon a five-year service agreement, Covance (Princeton, NJ) will also be acquiring Merck's (Whitehouse Station, NJ) Seattle-based Gene Expression Laboratory.
New Facilities
• After opening new offices in Belgium, Hungary, and Brazil, a new office in Edinburgh, Scotland, marks Chiltern's (London, UK) fourth new office opening since the New Year.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Obe-Cel Achieves High Response Rates, Durable Outcomes in r/r B-Cell Acute Lymphoblastic Leukemia
December 3rd 2024CAR T-cell therapy obecabtagene autoleucel produced high response rates, durable outcomes, and low toxicity in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, especially benefiting those with low-to-intermediate bone marrow burden.