Tips to Quell “Firefighting” in Clinical Research

Clinical Project Managers (CPMs) can spend a considerable amount of time “firefighting”. Recently, Dalfoni Banerjee was invited by the Society of Clinical Research Associates (SOCRA), New York State Chapter, to discuss best practices that CPMs can immediately implement to prevent firefighting – and make their working lives easier and more productive. During the virtual presentation,[…]

Now Playing on ACRPtv!

Dalfoni Banerjee was recently invited by Michael Causey, Editor-in-Chief at ACRP, for a segment called, “Project Management for Non-Project Managers.” During the chat, Dalfoni provides a few thoughts on how clinical research professionals who don’t have formal project management training can leverage skills they already have to succeed. It’s a short episode, but packed with[…]

Biosimilar switching: new evidence against interchangeability

Biosimilar Switching Not Suitable For All Patients 100% of patients?who developed antibodies to?innovator anti-TNF-? exhibited antibody reactivity against the biosimilar. ?Study results cast?doubt on interchangeability. 8 June 2016 According to a report from European League Against Rheumatism Annual Congress (EULAR) 2016, patients with antibodies to biological infliximab are less likely to benefit from infliximab biosimilar[…]

GI-targeted oral JAK inhibitor shows promise in Phase I Study: TD-1473

Theravance Biopharma Reports Positive Results From Phase 1 Clinical Trial of a GI-Targeted Pan-Janus Kinase (JAK) Inhibitor TD-1473 showed a reduction in plasma exposure compared to?currently-approved JAK inhibitor. On June 9, 2016, Theravance Biopharma released positive results from a completed Phase I clinical trial of TD-1473, its oral GI-targeted pan-Janus kinase (JAK) inhibitor. TD-1473 is[…]

Pipeline biosimilar for asthma meets primary endpoint in P2/3 study

In Brief Biosimilar News reports that Sorrento’s experimental anti-IgE biosimilar, STI-004, met it’s primary endpoint in a 32-week, Phase 2/3 study conducted in China. ?Patients who received?STI-004 experienced?asthma exacerbation at a lower rate than those who received placebo: ?21% vs?55%. According to the Sorrento press release, the patient population included both?adult and adolescents suffering from[…]