Northwell Health

Diversity in clinical trials critical to refining medicines and therapies

Tuesday, November 14, 2017

Leaders from Northwell Health’s Feinstein Institute for Medical Research, the FDA and Boehringer Ingelheim recently led a symposium on the barriers and opportunities to increase patient diversity in clinical trials. Because medicines may affect people differently based on age, sex and race, the diversity of clinical trial participants is important to better anticipate differences in treatment effects once the medicines are on the market.

[Read More]

Preparing for the ICH E6 Revisions

Monday, May 1, 2017

In November 2016, the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued Step 4 of the new Good Clinical Practice (GCP) E6 (R2) guideline. A core principle of E6 (R2) is the integration of quality management (QM) and risk-based approaches to span the entire clinical trial process. The addendum embodies the concept of proactive planning for quality, oversight, preventive action and documentation.

[Read More]

Northwell Health, GE Ventures partner on bioelectronic medicine

Thursday, February 23, 2017

Northwell Health‘s Feinstein Institute for Medical Research has announced a strategic alliance with GE Ventures to support the Feinstein’s Center for Bioelectronic Medicine (CBEM). With this investment, the Feinstein Institute will continue its work in discovering, developing and commercializing new diagnostic and therapeutic solutions in bioelectronic medicine for a wide range of acute and chronic diseases and injuries, including neurodegenerative diseases, cancer, diabetes and hypertension.      

[Read More]