The Journey from Biologic to Biosimilar—A Clinical Perspective

Clinical Researcher—January 2021 (Volume 35, Issue 1) PEER REVIEWED Wasi Akhtar, BPharm, MBA   Biosimilars, even though they are newer versions of existing, trade-name biological products whose patents have expired and share identical amino acid sequences with those earlier products, are not identical to the reference product. Biosimilars do not utilize the same living cell […]

Clinical Goes Digital to Bring Medicines to Patients Faster

Clinical Researcher—January 2021 (Volume 35, Issue 1) DATA-TECH CONNECT Henry Levy   In response to COVID-19, the clinical research enterprise has made Herculean efforts to minimize disruption and accelerate clinical development in the past year. From simpler trial designs and faster protocol development to decentralized trials that digitize specific trial processes, there have been countless […]

Clinical Trials Have Put Patients at the Center—But What About Caregivers?

Clinical Researcher—January 2021 (Volume 35, Issue 1) RECRUITMENT & RETENTION Jennifer Price   Patient centricity is now a key focus area for clinical trial sponsors and clinical research organizations (CROs) eager to develop better protocols, support more inclusive study designs, and increase participant engagement from recruitment to study close-out. Whether it’s patient-centered study design, focus […]

Now Performing in the Biotech Big Top: The Chief Medical Officer

Clinical Researcher—January 2021 (Volume 35, Issue 1) CAREERS & CULTURES Rosalie Harrison   It often seems that, when talking with chief medical officers (CMOs) about their work, circus metaphors abound. “It is like this,” one CMO told me, “I am trying to balance many plates, but none of them are spinning.” Another confided, “I feel […]