Phase I-IIa Archives - Insights From Our Labs to Yours

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs.

by Mark Fletcher and Martin Knightupdated on Sunday, March 29, 2020Monday, February 17, 2020

Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …

Oren Cohen, MD, Recalls Life As an Infection Disease Physician During the HIV Epidemic of the 1980’s

by Joe Searlsupdated on Monday, February 17, 2020Monday, February 17, 2020

Sunday, December 1 is World AIDS Day, an international day dedicated to raising awareness of the AIDS pandemic caused by the spread of HIV infection, and a time to remember those who have died of the disease. It has been observed worldwide since 1988. Oren Cohen, MD, Covance Chief Medical …

Phase I cGMP Drug Manufacture at the CRU: 3 BIG Benefits

by Marcus Stavchansky, PharmDupdated on Sunday, March 29, 2020Friday, March 17, 2017

Using a cGMP pharmacy at your CRU for Phase I drug manufacturing yields benefits in quality and safety, timeline reduction and cost efficiency. The regulatory environment continues to move toward requiring drug manufacturing at current good manufacturing practice (cGMP)-compliant pharmacies. This trend and other factors make it increasingly attractive to …