Industry news focusing on the people and organizations who work in the clinical trials profession.
People
CRF Health (Plymouth Meeting, PA ) announced two new additions to the company's executive leadership team. John Blakeley, with 25 years of direct commercial experience in the clinical research and pharmaceutical sectors has been appointed Chief Business Officer and a member of the executive team. Risto Enbuska joins CRF Health as Chief Technology Officer and brings a proven track record in R&D management and organizational leadership in a global environment.
BioClinica®, Inc. (Newtown, PA) announced that it has appointed John Hubbard, PhD, FCP, as Chief Executive Officer and a member of the board of directors.
Schulman Associates IRB, Inc., (Cincinnati, OH) announced the appointment of Rebecca Carson Rogers, MA, CIP, CHRC, as board chair. Rogers, previously of Dartmouth College's IRB, will join Schulman's board leadership and will guide the organization in expanding services for its more than 1800 institutional clients.
NeuroVive Pharmaceutical AB (publ) (Stockholm, Sweden) has recruited Gunilla Lindgren to the position as Clinical Trial Manager.
INC Research Holdings, Inc. (Raleigh, NC) announced the appointment of Richard N. Kender to the Company’s Board of Directors. Kender, who is an independent director for all SEC and Nasdaq purposes, will be a Class III director, serving for a term ending at the Company’s annual meeting in 2017. Kender will serve on the Company’s Audit Committee.
MMG (Rockville, MD) announced the appointment of Helen West to President, effective Jan. 1. She succeeds John Benbrook, who is departing MMG to become CEO of a Pennsylvania-based publishing company.
AMC Health (New York, NY) announced that Paul Argay has joined the company as Chief Marketing Officer. Argay comes to the company with over 25 years experience in marketing leadership positions and a consistent track record of launching and building businesses in product and service companies, large and small.
Health Decisions, INC (Durham, NC) announced the appointment of G. Stephen DeCherney, MD, MPH, as Interim CEO, effective immediately. DeCherney is Clinical Professor of Medicine at the University of North Carolina at Chapel Hill in the Division of Endocrinology, Adjunct Professor at UNC’s Kenan-Flagler Business School and a director of several corporations active in drug development and clinical research.
CTI Clinical Trial and Consulting Services (Cincinnati, OH), announced the following new hires: Lynn Amend joins as Assistant Study Manager; Amanda Coleman, joins as Administrative Assistant/Project Coordinator; Christine Eby, AuD joins as Assistant Study Manager; Karen Huber joins as Patient Recruiter; Maria Izzo joins as Associate Study Manger; Megan Kamm joins as Study Manager; Chris Laber joins as Assistant Manager, Business Development Operations; and Valerie Lander joins as Assistant Director, Clinical Trials. CTI also announced the following promotions: Renate Hochdorfer promoted to Senior Regulatory Specialist; Julia Höchst promoted to Senior Clinical Trial Assistant; Stephanie Makepeace promoted to Medical Writer; and Peter Mallow, PhD promoted to Associate Director, Health Economics.
New Facilities
Prolong Pharmaceuticals LLC (South Plainfield, NJ) announced the expansion of its South Plainfield manufacturing facility. A new long-term lease on the space adjoining its current facility is adding 24,000 square feet to the existing 24,000 square feet. In addition, the company this month secured 12,000 square feet of new executive and administrative space at One Cragwood Road, South Plainfield, which will serve as its new headquarters.
Awards
CluePoints (Cambridge, MA) announced that it has won a European Venture Contest award. The award program, which is part of the European Venture Summit, acknowledged CluePoints for its Central Statistical Monitoring (CSM) solution that employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data.
Medidata (New York, NY) announced that it has been named one of the 2015 Best Companies to Work for in New York State by the New York State Society for Human Resource Management (NYS-SHRM). Created in 2007, the Best Companies to Work for in New York State awards are part of a distinctive program designed to identify, recognize and honor the best places of employment in New York whose practices benefit the state’s businesses, economy and workforce.
***
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.