There May Be Dragons: Mapping 7 New & Emerging Pharma Development Risks

You’ve made incredible strides in forming a viable pharma or biopharma company with a mission to help transform the lives of patients. But as you move deeper into development, complexity will arise that involves much more than just your molecule.

You have to think about things like technology transfers, shipping and logistics, not to mention comparator drugs and ancillaries such as needles, glucometers and IV sets. Then there are also increasingly complicated regulatory expectations across countries.

Large pharma companies often have the staff and experience to manage and move drug products and ancillaries within and across borders, but new and emerging companies tend to run lean and be scientifically focused. As a result, you may not have the resources or expertise to coordinate development programs across multiple sites, geographies or vendors.

On paper, it’s easy to draw a streamlined process leading to clinical development success—but with complex modern molecules you’re likely to encounter unexpected risks and challenges along the way that may threaten the resilience of your plan.

This eBook is designed to help you map seven key risk areas in drug development and clinical services—and build a plan to overcome them.