In 1848, the most famous Gold Rush in American history began at Sutter's Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream.
Learn how one company sought support at multiple junctures—from manufacturing to biomarker evaluation to market access—to enable a faster and more effective launch of their new programmed death receptor-1 (PD-1)-blocking antibody.
Natural killer (NK) cells first earned their title as “killers” nearly 40 years ago when researchers observed the rapid immune response of these lymphocytes as they destroyed host cells infected with a virus or tumor cells. It seemed that NK cells could attach spontaneously without prior activation. Over time, researchers have learned more about the molecular mechanisms that regulate their activation and function.
“Patient centricity must be grounded in an engagement approach for the patients … ” Jonathan Zung, PhD, Covance. How do clinical research organizations (CROs) respond and support this increasing focus on patient-centric practices?
With pressures to fast-track clinical development, the pharmaceutical industry recognizes the value of improving internal clinical data management processes. Learn how using comprehensive analytical capabilities helps to advance clinical trial execution.
Biosimilars development in the U.S. is still rapidly growing and shifting. We discuss the key issues sponsors face today – from nonclinical testing to commercialization – along with considerations for a strategic regulatory approach.
Successful clinical trials require bringing together diverse data, drawing meaningful insights and acting on those quickly. Learn how one company did just that to avoid a costly trial that had a low probability of success.
Leading manufacturers increasingly employ stakeholder research early in development to better identify the needs of patients and providers. Learn how this strategy can build in compelling asset value during development, help avoid pitfalls and better inform go/no-go decisions earlier to avoid costly development delays or even dead-ends.
With its measurable impact on patient survival, there’s no denying that immunotherapy is already causing momentum in ways that cancer is treated. Learn more about how drug researchers and developers are identifying new candidates in their growing pipelines and exploring combinations of immunotherapies, while regulatory agencies are providing expedited review and approval of these therapies for new indications at an unprecedented rate.