Latest Business and People News
People News
Amy McKee,MD, former Deputy Director of the FDA’s Oncology Center of Excellence, has joined PAREXEL as Vice President, Regulatory Consulting Services. The company also announced Matthew M. Cooney, MD, as Senior Medical Director, Global Therapeutic Area Lead, Oncology/Hematology within PAREXEL’s Global Medical Services team.
Avomeen Analytical Services announced Carla Totton as its new leader of its Quality Assurance Unit and will be responsible for all of Avomeen’s DEA, FDA and ISO 17025 compliant operations and facility.
Premier Research has made the following appointments: Juliet Moritz has been appointed as its Vice President, Patient and Stakeholder Engagement (PASE); Vicki Gashwiler as executive director of clinical development services, medical device and diagnostics; and Sundeep Shrivastava as executive director of clinical development services, medical device and diagnostics; and John Pappan has been named director of regulatory affairs, medical device, and business strategy.
SHYFT Analytics, a Medidata company, announced Bruno Lempernesse is the company’s new vice president and general manager for the SHYFT RWE solutions team. Additionally, Aaron Galaznik, MD has been named as head of research.
Susie Robinson
CRF Bracket announced that Susie Robinson will join the company as Chief People Officer.
uMotif has appointed Rachel Lowrey as Head of Marketing, bringing over a decade of eClinical technology marketing experience to the role.
LINK Medical has announced that Marie Moores, MSc, is now the Executive Vice President of Clinical Operations, based in their UK office.
Business News
To kick off Rare Disease Day on February 28 and March as Rare Disease Month, Premier Research announced a new scholarship for rare disease patient advocates in partnership with Professional Patient Advocates in Life Sciences (PPALS).
Recognition
Rho announced one of its Clinical Research Scientist Meagan Vaughn was recently honored by the Triangle Business Journal as a 2019 Health Care Hero. Vaughn was honored in the Volunteer category for her personal and professional dedication to advancing a cure for Cystic Fibrosis.
Milestones
Veeva Systems announced four of the world’s top seven largest CROs are standardizing on Veeva Vault eTMF. Vault eTMF enables CROs to maintain an always up-to-date TMF and gives sponsors greater control of standard operating procedures for TMF management.
Pharm-Olam, a global, midsized CRO, marked its 25th anniversary with several announcements, including enhancing its rare disease services and elevating it to their Center of Excellence (COE) tier, thus joining oncology-hematology and infectious disease and vaccines in this category.
CRF Bracket recently closed its first full quarter as a combined business--after CRF Health and Bracket merged in September 2018--with a 20%-plus increase in new clinical trial business.
SGS, a life sciences clinical and bioanalytical contract solutions provider, announced positive preliminary data from a controlled human infection trial with FluGen Inc.’s investigational M2SR vaccine that aimed to assess whether the vaccine could induce broadly protective immune responses and protect against the substantially mismatched SGS challenge strain. The study was carried out at the human challenge unit within SGS’s clinical pharmacology unit in Antwerp, Belgium.
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.
