http://biotechbistro.com/forum/tags/personalized-medicine The Business of Biotechnology en-US Sat, 04 Sep 2010 20:43:39 +0000 bbpress 1.0-alpha-4 q http://biotechbistro.com/forum/search.php http://biotechbistro.com/forum/topic/personalized-medicine-and-fda-compliance-mix-in-new-book#post-49 Tue, 04 May 2010 08:40:57 +0000 javellan 49@http://biotechbistro.com/forum/ <p>Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine</p> <p>Published by Logos Press, and available nationwide through Barnes &#38; Noble, Amazon.com, Borders Books, and other booksellers, Get Market Now! (342 pages, ISBN: 978-1-934899-12-0, softcover) is designed for executives in the life sciences, from pharmaceutical and biotechnology firms, to medical device and diagnostic companies.</p> <p>Readers of advanced copies have also suggested the book will be “an excellent resource for investors and venture capitalists who need to accurately assess if a company has what it takes in its research &#38; development programs to succeed over the next ten years.”</p> <p>The book provides practical strategies to speed time to market and simply FDA compliance supported with analyses, advice and more than:</p> <p>• 25 figures, diagrams and tables<br /> • 15 different checklists and templates<br /> • 113 specific tactics<br /> • 16 case studies and real-world examples</p> <p>The book's readers also benefit from a dedicated book website - <a href="http://www.Get2MarketNow.com" rel="nofollow">http://www.Get2MarketNow.com</a> - full of downloadable templates, mini-tutorials, and more.</p> <p>Early reviews have cited the book for how well its writing and organization make complex, nuanced subjects easy to understand, from tackling the decline in new medicine innovation and R&#38;D productivity, through increasing business flexibility while still complying with regulations.</p> <p>Journalists who would like a review copy of Get to Market Now!, should contact the publisher Logos Press directly in Washington, D.C.: <a href="mailto:info@logos-press.com">info@logos-press.com</a> or 202-487-0089.</p> <p>Author John Avellanet is the founder and Managing Director of Cerulean Associates LLC, a private regulatory compliance consultancy based in Williamsburg, Virginia. Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for corporate clients and conference venues around the world. Enthusiastic testimonials from attendees cover his speaking page on his website. Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers.</p> <p>He serves on the boards of several industry associations, and is the FDA compliance columnist for several international industry journals. Every month, he publishes the regulatory intelligence and FDA quality systems advice newsletter for executives, SmarterCompliance™. Learn more about Mr. Avellanet on his award-winning blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> </p> <p>### </p> http://biotechbistro.com/forum/topic/upcoming-book-on-personalized-medicine-amp-fda-compliance#post-20 Fri, 05 Jun 2009 13:02:08 +0000 javellan 20@http://biotechbistro.com/forum/ <p>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.</p> <p>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.</p> <p>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:</p> <p>• Faster product innovation and development<br /> • Medicinal safety and efficacy by design<br /> • Cost-effective, lean quality systems<br /> • Flexible, regulatory compliance programs</p> <p>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.</p> <p>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.</p> <p>Publication is slated for May 2010.</p> <p>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, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>, or through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> </p> <p>### </p>