The first draft of the book manuscript is currently being slashed and burned by my editor at Logos Press in D.C. The next few weeks promise an unhealthy mix of gift-wrapping and manuscript revisioning. The goal is to get the book to the printers by January so it's ready for publication to coincide with BIO 2010. The book is all about regulatory compliance and quality systems over the next decade, from 2010 - 2020, and is a blueprint, if you will, of what biopharmaceutical and device executives need to do in order get their new drugs and devices on the market as we increasingly face medicine personalization, reimbursement challenges, and globally harmonized regulations. It, as my editor has at least graciously allowed, "a blueprint for success."

Over the coming months, I'm building a special website dedicated to the book with downloads, mini-seminars, and chapter extracts.

In two weeks, just after Christmas holidays here in the States, the December issue of my newsletter will be released with all my various FDA forecasts and recommendations for 2010. So stay tuned!