Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

Informed Strategy Key to Drug Development Innovation, Premier Research Says in Naming Regulatory Chief

DURHAM, N.C., June 27, 2016 — Small biotechnology companies taking new biopharmaceutical products from benchtop to bedside need an informed regulatory strategy and a close working knowledge of the Food and Drug Administration and other regulatory agencies. So when it sought a new head of regulatory affairs, clinical development service provider Premier Research found its ideal...

Clinical Research: Phase 1 - Phase 4

Premier Insight 265: Complete Response: Lymphoma Trial A Surprising Success For Five Patients

A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma is still almost three years from completing patient follow-up, but already it has succeeded beyond expectations in the form of five patients declared disease-free a year and counting. The Phase 2 trial involved a CD19 antibody that was tested at 26 sites...

Clinical Research: Phase 1 - Phase 4

Premier Insight 258: Glioblastoma Drug Study Yields ‘Unexpectedly Huge’ Advance

A three-nation study of a treatment for recurring glioblastoma showed the therapy more than five times as effective as the typical protocol, an unexpectedly large advance in fighting these aggressive brain tumors. But it was a long road, and the drug’s efficacy was a big factor in extending the trial to five years — nearly...

Clinical Research: Phase 1 - Phase 4

Premier Insight 256: A Talent for Resolving Unusually Complex Issues

A customer came to us with a seven-year project to develop a novel human antibody from scratch, to treat multiple myeloma. There were no benchmarks, no relevant data on similar compounds because there were no similar compounds. The first challenge: engage key opinion leaders This project was never going to be easy or “by the...

Clinical Research: Phase 1 - Phase 4

Rare Oncology Research in the 21st Century

Speakers: Sachin KulkarniExecutive Director, Strategic Development, Oncology & General MedicinePremier Research Juliet M. MoritzExecutive Director, Strategic Development, Rare DiseasesPremier Research Study of rare cancers tends to look more like rare disease research than standard oncology research. This webinar will highlight some of the challenges in designing and conducting trials for rare cancers and explore positions...

Clinical Research: Phase 1 - Phase 4

Rare Disease Trials: The Beginning, the Middle and the End

Speaker: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research This session includes a regulatory overview of rare diseases and orphan drug status as well as practical considerations for varying stages of the development process. Viewers will learn more about conducting successful Natural History studies and the presenters will review how to avoid common...

Clinical Research: Phase 1 - Phase 4

Measuring How Well Subjects Know and Do in CNS Trials

Central nervous system (CNS) disorders represent a major medical challenge and a significant opportunity for therapeutic innovation. Sponsors who have a clear understanding of the regulatory landscape and neuropsychological testing modalities available are poised to address critical unmet needs for the millions of people living with CNS conditions. Central nervous system (CNS) conditions, including psychiatric,...

Clinical Research: Phase 1 - Phase 4

Premier Research Names Etienne Drouet Executive Director, Oncology Europe

Premier Research Group announces the appointment of Etienne Drouet to the position of Executive Director, Oncology Europe. In this position, Mr. Drouet will play a leading role in the operations, strategic planning and corporate development of Premier Research’s growing portfolio of oncology business.

Clinical Research: Phase 1 - Phase 4

Premier Research Names Susan Stansfield, Ph.D. Executive VP, Clinical Development, Strengthens Premier’s Operational Delivery on Worldwide Projects

Premier Research Group announces the appointment of Susan C. Stansfield, Ph.D. to the position of Executive Vice President, Clinical Development. In this position, Dr. Stansfield will have global responsibility for leading and developing the company’s clinical trial management services provided to the biopharmaceutical industry.