Applied Clinical Trials
Industry news focusing on the people and organizations who work in the clinical trials profession.
Melynda Geurts
• Melynda Geurts, chief operating officer of D.L. Anderson (Dallas, TX), and Roy Fleischmann, MD, medical director of Metroplex Clinical Research Center (Dallas, TX), have both been elected as the newest members of D.L. Anderson's Board of Directors.
Roy Fleischmann
• After serving as head of preclinical development for Medigene AG (Munich, Germany) for the last nine years, Ulrich Moebius will now take on the position of head of preclinical development and project management at MorphoSys (Munich, Germany).
Ulrich Moebius
• The role of business development executive at Penn Pharma's (Wilmington, DE) North American location will be filled by James Knapp, who joins the company after a seven-year tenure at Almac (Craigavon, UK).
James Knapp
• Formerly holding senior positions in professional services and implementation management, William Broucek will now serve in the newly developed position of senior director, professional services, at Velos (Fremont, CA).
• With more than 20 years experience in virology drug development, Sharon Lynn Benoit will now serve as INC Research's (Raleigh, NC) principal strategist of Infectious Disease.
• Applied Clinical Trial's Editorial Advisory Board member and executive director of the Good Clinical Practice Alliance, Europe, Francis P. Crawley, has been selected as the chairman of ICR's (Bourne End, UK) annual spring conference and exhibition working party.
• Of the 12 nominees for this year's European Inventor of the Year award, four come from the pharmaceutical arena: Jurg Zimmermann of Switzerland, Brian Druker of the United States, Yiqing Zhou and his team from China, and Germany's Maria-Regina Kula.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
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.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.