Applied Clinical Trials
Industry news focusing on the people and organizations who work in the clinical trials profession.
• Profil Institute for Clinical Research (San Diego, CA) has appointed of John Amatruda, MD, a Pharmaceutical Research Executive, and Jerrold Olefsky, MD, Professor of Medicine at the University of California, San Diego, to its Board of Directors.
John Amatruda, MD
• With more than 20 years of experience in the pharma industry, George Köllner has joined contract research provider Syntagon's (Södertälje, Sweden) quality assurance and regulatory team where he will oversee GMP projects.
• Chiltern International (London, UK) announced that Marcelo Piccirillo, MD, and Carlo Lanza, MD, have joined the company, bringing their expertise in the areas of gastroenterology, oncology, and pediatrics to serve clients' needs.
Carlo Lanza, MD
• Clinipace Worldwide (Zurich, Switzerland) has appointed Jürgen Frisch, MD, to Chief Medical Officer of European Operations.
Jürgen Frisch, MD
• Clinical Site Services (Glen Burnie, MD) has made several new additions including Peter Zalewski as Director of Visual Communications, Nicole Giles as Site Support Specialist, and Kristina Astle as Marketing Associate.
Peter Zalewski
• RadSite (Houston, TX) has named three new members to its advisory board including Anthony Defrance, MD, Clinical Associate Professor, Stanford University, Director of Cardiology, HealthHelp, Medical Director for the CVCTA Education Center, and Director of Cardiovascular Imaging at Nevada Imaging Centers; David Levin, MD, former Chair of Radiology at Thomas Jefferson University Hospital, faculty appointments and leadership roles at the New York Hospital-Cornell Medical Center, Downstate Medical Center, Harvard Medical School, and Brigham and Women's Hospital; and Jon Shanser, MD, Diagnostic Radiologist at Reno Diagnostic Center; former Chairman of the ACR Coding & Nomenclature Committee and its Regulatory Compliance Task Force, former President of the CRS, and current Executive Committee Member.
• CTI Clinical Trial and Consulting Services (Cincinnati, OH) has made several new hires and promotions including Therese Swaisgood as a Clinical Coding Specialist, and Katelyn Westerkamp and Michel Conner both as Research Associates. Recently promoted are Stephanie Makepeace to Senior Project Manager and Medical Writer, Mike Montani to Senior Project Manager, and Robert McRae to Study Coordinator.
• Premier Research Group (Philadelphia, PA) has hired Sean Russell to the position of Vice President, Marketing, where he will have global responsibility for leading and developing global marketing.
• Following a career with increasing levels of responsibility in finance for several successful, global public companies, Stuart Grant has been appointed Patheon's (Toronto, CA) Executive Vice President, Chief Financial Officer.
• Y-Prime Technologies (Malvern, PA), a provider of clinical trial management consulting services and software solutions, has named Dave Espenshade Vice President of Sales and Marketing.
•Bringing with him over 28 years of leadership experience in oncology R&D, Preclinical Oncology Services (Nottingham, UK) has appointed Martin Page, PhD, as Scientific Consultant.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.