These days, getting a dialogue started with regulators at a very early stage of development is one of the most important tasks for any biotech company. Their feedback on trial design, special protocol assessments, fast track versus priority review and so on can make a huge difference in a program's long-term value, helping to shape the foundation of business pacts and offering a chance to shave costs and time--with an added bonus of increased marketing time.
On June 29, during this...