Industry news focusing on the people and organizations who work in the clinical trials profession.
Packaging Coordinators Inc. (PCI) (Philadelphia, PA) announced the addition of Jamie Houghton to the North American Clinical Services team. Houghton will be based out of PCI’s North American Clinical packaging and distribution site located in Rockford, IL.
SAFE-BioPharma Association, (Ft. Lee, NJ) the non-profit collaboration that developed and manages the global SAFE-BioPharma digital identity and digital signature standard, has elected Greg Koski, PhD, MD, to its board of Directors. Kosky is a co-founder and President/CEO, Alliance for Clinical Research Excellence and Safety, in Boston, MA.
WIRB-Copernicus Group (WCG) (Princeton, NJ) announced the recent appointment of Shai Feinsod as Regional Executive for Israel.
Celerion (Lincoln, NE) announced the appointment of Clayton Dehn as Executive Director, Metabolic Diseases. Dehn will lead the expansion of Celerion’s current capabilities that support early Proof-of-Concept in the development of diabetes, obesity, metabolic and cardio-metabolic interventions.
Comprehend (Palo Alto, CA) has named life sciences and technology veterans Lee Black and Ben McGraw to its executive team to support growth in adoption of its cloud-based clinical data insights software.
CSSi (Glen Burnie, MD) announced the hire of Rose Hunsicker, who joins the CSSi team as Director of Business Development. Hunsicker will be focused on cultivating long-term business relationships with sponsor and CRO clients throughout the United States as well as European markets.
ICON plc, (Dublin, Ireland) named Manuel Ploch as General Manager, Japan. In this role, Ploch will lead all of ICON’s operations in the region, which include offices in Tokyo and Osaka.
CTI Clinical Trial and Consulting Services (Cincinnati, OH) announced the following new hires: Louis Minham, Senior Director, Information Technology; Kelly Kelso, Study Manager; Rachel Gilbert, Biostatistician I; Traci Bechtel, Senior Regulatory Specialist; Catherine Van Gilder, Clinical Monitoring Coordinator; Andrew Schildknecht, Research Associate; Sandra Wöhr, Clinical Trial Assistant, Germany. CTI also announced the following promotions: Brad Spiers to Senior Accounting Manager; Michelle Clifford to Study Coordinator; Katie Westerkamp to Project Manager; and Kyra Graham to Senior Research Associate.
TrialNetworks (Needham, MA) co-founder and chairman Vivek Murphy, MD, MBA, has been nominated to serve as the 19th Surgeon General of the United States of America by President Barack Obama. Dr. Murthy is currently an attending physician at Brigham and Women’s Hospital and an instructor at Harvard Medical School.
Rho (Chapel Hill, NC) announced the addition of Gail Fowler as Vice President of Operations. In this position, Ms. Fowler will lead a growing team of research professionals, including project managers, clinical research associates, data managers, biostatisticians, statistical programmers and program managers.
Camargo Pharmaceutical Services (Cincinnati, OH) named Jim Beach, a veteran healthcare executive with broad experience in operations, R&D, marketing, and sales, to Chief Operating Officer.
PRA (Raleigh, NC) announced its intent to acquire privately-held CRI Lifetree, a specialized research organization. CRI Lifetree focuses on the conduct and design of early stage, patient population studies, and is therapeutically focused in Human Abuse Liability, addiction, pain, psychiatry, neurology, pediatric, and infectious disease services.
Algorithme Pharma (Laval, Québec, Canada) announced the signing of a strategic alliance with the University of Montreal Hospital Research Centre (CRCHUM), allowing for access to an extensive pool of patients and the new 520,000 square foot research complex for conducting complex early-stage clinical trials. The partnership will also provide access to CRCHUM’s diverse research groups with extensive clinical research experience in therapeutic areas including oncology, neuroscience, cardio-metabolic diseases and respiratory disorders.
CRF Health (Plymouth Meeting, PA) was named in the 2013 edition of Deloitte’s Technology Fast 500. This is the second year in a row that CRF Health has been ranked as one of the fastest growing companies.
Theorem Clinical Research (King of Prussia, PA) announced that “Smart Thinking,” a book that brings together theories and insight into the future of the industry, is now available online as a free download on the company’s website.
Pharmaceutical Product Development, LLC (Wilmington, NC) announced that the company clinical research associates (CRAs) earned recognition as top CRAs at the annual PharmaTimes US Clinical Researcher of the Year competition. Rebecca York, a senior CRA based in Austin, Texas, won the gold award in the New Clinical Research Associate category, which recognizes researchers with up to four years of experience. PD’s Kelly Little, a CRA based in San Diego, won the bronze award in the new CRA category.
Catalent Pharma Solutions (Somerset, NJ) announced that the construction and validation of its clinical supply facility in Shanghai, China has been completed. It is the first clinical supply facility in China to provide end-to-end clinical supply solutions from clinical supply management, comparator sourcing and primary packaging to storage and distribution. The facility is also validated to support biologics requiring refrigerated and frozen supply chain management.
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.
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.
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.
Opdivo plus Yervoy Significantly Outperforms Chemotherapy in MSI-H/dMMR Metastatic Colorectal Cancer
December 2nd 2024Phase III CheckMate 8HW trial results demonstrated that the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improves progression-free survival and has a better safety profile compared to chemotherapy in the first-line treatment of MSI-H or dMMR metastatic colorectal cancer.