Cerulean's managing director, John Avellanet, has signed a contract with Logos Press to write a book covering the compliance and quality systems landscape over the next decade, including the compliance strategies required for new drug and device development and approval in the era of personalized medicines.
Based in part on Mr. Avellanet's April talk at the NIH on the future of the biopharmaceutical landscape, and his SmarterCompliance newsletter series on personalized medicine and the role of regulatory compliance, the book provides a strategic review of the compliance and quality systems best practices required for marketplace success over the next decade for biotechnology, pharmaceutical, and medical device firms.
The book is sub-divided into three parts: a review of today's landscape, an analyses of the key challenges likely to dominate over the next ten years, and then a step-by-step strategy covering:
• Faster product innovation and development
• Medicinal safety and efficacy by design
• Cost-effective, lean quality systems
• Flexible, regulatory compliance programs
As part of the book's practical, "how to" mindset, readers will be able to access bonus materials, downloads, and supplemental information online through a dedicated book website.
Subscribers to Mr. Avellanet's monthly newsletter, SmarterCompliance, will be able to access pre-publication materials and downloads as part of the lead-in to publication.
John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of the private compliance advisory firm, Cerulean Associates LLC, he publishes the monthly executive newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, http://www.ComplianceZen.com, or through his company's website: http://www.ceruleanllc.com