Applied Clinical Trials
Industry news focusing on the people and organizations who work in the clinical trials profession.
Kevin K. Gordon
Michael J. Gallagher, MD
Judith Teall
Tita Jeter
• With over 25 years of experience, Kevin K. Gordon has been appointed Chief Financial Officer of Quintiles (Triangle Park, NC).
• Michael J. Gallagher, MD, has been named Vice President and Global Head, Medical Affairs, at Kendle (Cincinnati, OH) where he will provide global leadership for the company's medical affairs organization. Jeffrey M. Zucker has been appointed as Senior Director and Global Head, Patient Recruitment.
• Exco InTouch (Hertfordshire, UK) has hired Judith Teall to fill its newly-created position of Director of Patient Recruitment.
• Copernicus Group IRB (Raleigh, NC) has made four additions to its team including Bill Van Nostrand as Vice President and Chief Business Development Officer, Tim Schuckman and Marcie Goodale as Regional Directors of Business Development, and Tita Jeter as Manager of Quality Assurance and Regulatory Compliance.
• PPD (Wilmington, NC) has appointed Henrietta Ukwu, MD, as Senior Vice President of Global Regulatory Affairs.
• As Health Decisions' (Durham, NC) Chief Technology Officer, Bryan Minihan will strengthen the company's proprietary HD360° technology platform.
• Previously the Senior Therapeutic Director for Oncology at i3, Jane Bentley, PhD, has joined Novella Clinical (Research Triangle Park, NC) as Vice President, Clinical Operations.
• CRF Health (Plymouth Meeting, PA) has hired Bonnie Teschendorf, PhD, as Patient Reported Outcomes Scientific Advisor where she will lead CRF Health's PRO consulting initiative providing scientific insight and guidance to clients and internal staff, as well as to the global clinical trial sector.
• Anthony Maida, PhD, will lead PharmaNet Development Group's (Princeton, NJ) oncology team in his new role as Vice President, Clinical Research.
• Carlos Martínez Manchado has joined Ricerca Bioscience's (Concord, OH) Analytical Chemistry department.
• Leading sales, marketing, and business development strategies for late stage business, Evelyn Graham will use her previous drug development experience as Worldwide Clinical Trials' (King of Prussia, PA) Executive Vice President, Global Business Development.
• Biomedical Systems (St. Louis, MO) has promoted Shanin Hagene to the position of Director of Contracts and Budgets where she will supervise a team of contract specialists in the St. Louis and Brussels offices, and Steven De Hertefelt has been hired to the position of Business Development Director, Europe.
• Synexus (Manchester, UK) has made several changes to its executive management team with the appointment of Christophe Berthoux, MD, as Chief Executive.
• Bringing with her more than 20 years experience, Julie Heneghan has been appointed Vice President of Advanced Clinical (Bannockburn,IL).
• Stuart Mudge, PhD, has been appointed Global Regulatory and Clinical Affairs Manager by HalcyGen Pharmaceuticals (Melbourne, Australia).
• CTI Clinical Trial and Consulting Services (Blue Ash, OH) promoted Nick Schatzman to Business Development Associate. Timothy Bockerstette has joined as Director, Business Development Operations.
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.