INSIDE YOU’LL FIND
> Determining the Best Phase 1 Clinical Trial Design
> Accessing a Large and Diverse Pool of Healthy Volunteers
> Considerations of Drug Delivery and Biological Sample Collection Methods
> Questions around Trial Assay’s
> Navigating Regulatory Approval Processes
> and Much More!
About The e-Book
An increasing number of drug developers are creating more novel compounds across a growing range of indications and rare diseases than ever before. In 2020, the FDA’s Center for Drug Evaluation and Research (CDER) approved 53 new molecular entities (NMEs), including new drugs and new therapeutic biologics, in line with the previous three-year average and despite the COVID-19 pandemic. This trend held through the first half of, 2021 with 27 NMEs approved.
In this high-stakes sector, small and medium biotech companies with novel compounds must move quickly into Phase 1 clinical research. It is essential to design studies that collect the right data from the right participants using state-of-the-art, cost-effective methods. Small and medium biotech firms greatly benefit when placing trials with a Phase I CRO with a “can-do” attitude and a shared entrepreneurial spirit.
“A CRO with a skilled pharmacy team
will be able to manipulate a compound
to ensure consistent drug delivery when
a different format is required.”
– Dr. John Oldenhof
Executive Vice President,
Scientific Affairs at BioPharma Services
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