Author Archives: Paul Mirek

DURHAM, N.C., April 25, 2019 — Premier Research will moderate a panel on cell-based therapies on Tuesday, April 30, at the Clinical Operations in Oncology Trials West Coast meeting in Burlingame, Calif. Colin Hayward, the company’s chief medical officer, will lead a discussion about how researchers are overcoming the challenges inherent in creating cell-based cancerRead more

Dr. Krista Armstrong, Vice President, Neuro Business Unit and Strategic Development, discusses best practices for forging strategic Sponsor-CRO partnerships. As recorded at OCT New England.

Premier Research’s Chief Medical Officer discusses bridging the regulatory engagement gap from pre-clinical to first patient in at Outsourcing in Clinical Trials New England in Boston. Topics include: – Early regulatory engagement and creating a sound development strategy – Assessment and hiring of key staff members: which positions to fill immediately and which can waitRead more

The FDA has released a new draft guidance for sponsors of drug and biological products for the treatment of rare diseases in early development and in the planning of and participation in formal pre-investigational new drug application (pre-IND) meetings. Read the full guidance here or click the image to download.

The FDA has released a new draft guidance for sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for the treatment of specific hematologic malignancies. Read the full guidance here or clickRead more

DURHAM, N.C., October 30, 2018 — Angi Robinson, Executive Director for Rare Disease and Pediatrics at Premier Research, will discuss clinical development strategies for genetic rare disease research November 7 at the World Orphan Drug Congress in Barcelona. Ms. Robinson’s presentation, starting at 2:20 p.m., will examine management of confirmatory testing and specialty labs, theRead more

DURHAM, N.C., September 20, 2018 — Implementation of Europe’s new medical device regulations in 2017 started a transition that gives device companies up to five years to fully comply with strict new quality standards. But exactly what is changing, and why? And how will the new MDR and IVDR rules affect the players in thisRead more

DURHAM, N.C., September 19, 2018 — Premier Research, a leading provider of clinical development services to biotech and specialty pharma companies, has named Karen M. Brown Vice President of Marketing. She is responsible for developing strategic marketing plans to the company’s commercial objectives, brand, and position in the life sciences industry. Ms. Brown has spentRead more

DURHAM, N.C., JUNE 2, 2018 — Premier Research is sharing the viewpoints and insights of its clinical trial experts through a podcast that launches today. The inaugural edition of the Premier Voices podcast focuses on rare oncology drug development, and its introduction coincides with the American Society of Clinical Oncology’s annual meeting June 1-5 inRead more

DURHAM, N.C., APRIL 27, 2018 — Premier Research has been named a 2018 CRO Leadership Award winner by Life Science Leader magazine. The publication annually asks pharmaceutical and biopharma companies to rate the capability and performance of contract research organizations. Premier Research was recognized in five of six award categories: Capabilities — the company’s accessRead more

No more posts
Phone Us Now
Email Us Now