Elan and PPD Announce Global Business Relationship in Drug Development
Elan, plc and PPD, Inc. today announced they have formed a global business collaboration focused on the advancement, progression, and execution of Elan's development portfolio. The primary objective of this relationship is to deploy both companies' skills and expertise in a flexible, integrated manner to drive the execution of Elan's clinical programs in a parallel and expedited basis and on a global scale.
Under this business agreement, PPD will act as Elan's primary service provider for all development functions and activities. Elan will retain ownership of its assets and accountability for decision making with regard to strategy and progression of the individual molecules as well as the overall portfolio. This business construct will enable Elan to leverage the significant and high quality capabilities of PPD across project and data management, biostatistics, regulatory, clinical and medical monitoring, quality assurance, pharmacovigilance and other areas. Elan and PPD intend to work closely to build upon this initial relationship and continuously explore opportunities to leverage both companies' respective competencies and maximize the full opportunity of moving Elan's science into clinical development and advancing toward patients.
"Establishing this strategic collaboration with PPD will enable Elan to accelerate the progression of our science into the clinical development setting in a rapid and global fashion," said Eliseo Salinas, Chief Medical Officer, Executive Vice President and Head of Development for Elan. "The ability to fluidly access additional expertise and execution capability on a global scale will complement our internal talent and may enable us to move multiple programs forward in a parallel manner."
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
