Applied Clinical Trials
Industry news focusing on the people and organizations who work in the clinical trials profession.
•Pharmaceutical Product Development (PPD) (Wilmington, NC) has expanded its global product development department, adding drug development experience with the appointment of three new therapeutic area heads: Daniel J. Burch, MD, MBA, central nervous system; Puneet Mohan, MD, MBBS, PhD, cardiovascular/metabolism; and Alan M. Solinger, MD, FACP, FACR, rheumatology/immunology.
•Novella Clinical (Research Triangle Park, NC), a full service clinical research organization, announced Karen Kelso, PhD, has joined as Regulatory Affairs Director. Focused on cardiovascular medical devices, Kelso has regulatory experience in global markets for all medical device classifications (I, IIa, IIb, and III).
•Comprehensive Clinical Development (Comprehensive) (Miramar, FL), a strategic clinical research company, providing site services for Phase I through IV clinical trials, announced the promotion of Daniel Carpenter, PhD, and Elizabeth Harley. Carpenter is now Senior Vice President and General Manager, Clinical Operations, and Harley is Vice President, Strategic Relationships.
•ACM Global Central Laboratory's (Rochester, NY) Head of R&D, Andrew Botham, PhD, was a featured speaker at this year's New Dynamics of Biomarker Labs, Central Labs, and ECG & Imaging Labs conference. The meeting was held in London on February 27-28, 2013. Botham presented, "DILI to DIOT: The Early Detection of Drug-Induced Organ Toxicity. Is Your Trial Asking the Right Questions?"
•Accelovance (Rockville, MD) announced the addition of Ralph Boccia, MD, FACP, as the Oncology Medical Director. The addition of Boccia complements the oncology strength of the Maryland-based CRO that caters to biotech and small/mid pharma sponsors. In addition to his responsibilities at Accelovance, Boccia is a founder and the Medical Director of the Center for Cancer and Blood Disorders. He also is an active Clinical Associate Professor of Medicine at Georgetown University and consulting Medical Director of the International Oncology Network (ION) Clinical Research Program.
• Cenduit LLC (Durham, NC) appointed Chris Dailey as Global Head of Technology. In his role, Dailey will lead technology and service initiatives aimed at providing additional system functionality as well as improving the user experience for those interfacing with Cenduit interactive response technology to conduct clinical trials at sites across the globe.
• cr.appliance (Radolfzell, Germany) is hosting the International Marbach Castle DDI Workshop series, with the goal to improve and disseminate the scientific knowledge about drug-drug interactions (including food-drug and herb-drug interactions), to foster their proper preclinical and clinical investigation and communication, thereby improving the safe use of drugs in the light of ageing populations, complex patients with various co-morbidities, and increasing poly-pharmacotherapy. The event will take place May 26-28, 2013, at the Marbach Castle Conference Centre, Lake Constance, Germany. Visit www.cr-appliance.com/index.php?id=52 for more details.
• Exco InTouch (Sawbridgeworth, UK) announced that it formally received US-EU Safe Harbor Framework and US-Swiss Safe Harbor Framework Self Certification status by the US Department of Commerce's International Trade Administration. The designation certifies that Exco InTouch's practices meet or exceed the data privacy and security standards outlined by The European Commission's Directive on data protection.
• Theorem (King of Prussia, PA), a midsized provider of clinical research and development services, held the first Theorem Think Tank on drug development in Boston on March 7. The six sessions were divided into two tracks for attendees to choose from, and covered regulatory insight, electronic patient discovery, patient recruitment for oncology studies, CDISC, adaptive clinical trial designs, and medical device trials in the Asia-Pacific region. You can find the full speaker list at: bit.ly/Vz16S0.
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.
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
November 20th 2024Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.