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Founder and President, Pharmsource
Jim Miller is the founder and president of PharmSource Information Services. A preeminent expert in bio/pharmaceutical outsourcing, Jim established and presides over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing: PharmSource STRATEGIC ADVANTAGE. He is editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report. Jim serves as an editorial advisory board member for Advanstar Communication’s Pharmaceutical Technology and BioPharm magazines. He writes regular columns on outsourcing for Pharmaceutical Technology, Contract Services Europe and BioPharm magazines. In addition, Jim chairs the advisory committee of the Pharma & Biopharma Outsourcing Association (PBOA), and is a member of the board of directors of the American Type Culture Collection (ATCC), and serves on its technical committee.
Founder and Principal, Cerulean Associates
John Avellanet gives practical compliance solutions and streamlines quality systems for clients around the world. Winner of the 2009 & 2011 Best of Business Services award by the Small Business Commerce Association, John has earned international acclaim for his business-savvy and pragmatic FDA compliance advice. He co-authored the book, Pharmaceutical Regulatory Inspections (2014), with several current and former regulatory agency officers, and his industry classic, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (2010), was originally featured at BIO 2011 and garnered multiple five-star reviews from industry publications, blogs, Amazon.com readers, and former FDA officials. He has a breadth of experience designing, implementing, and being accountable for quality systems and compliance programs for FDA, DEA, ICH, GHTF/IMDRF, and ISO. For more than 15 years, John was directly accountable for regulatory compliance, records management, and information technology, most recently as a C-level executive for a Fortune 50 combination device firm. In 2006, Mr. Avellanet founded his independent lean compliance consulting and training firm, Cerulean Associates.