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 year's BIO International Convention in Washington, DC, I'll be sitting down with some of the industry's top regulatory experts to look at current trends and strategies in the field. We'll hear from AstraZeneca, Biogen Idec, Human Genome Sciences, Sanofi and Acorda on what they did right, and what they plan to do differently in the future as they plot a path to a new drug or biologic application.
I'm particularly pleased to report that this breakfast is an affiliated event at BIO. And attendees will get a chance to ask the experts for some key feedback as we study the most important regulatory issues that face drug developers today. If you plan to be in Washington, DC, at the end of June, this is one event you won't want to miss. And let me know if you have any ideas for future events as we plan our schedule for the rest of this year.
Click here to see more about this breakfast. -- John Carroll
"The Best App in Town" is our third in a series of executive breakfasts around the country.