Key Personnel

John Avellanet, MCP, MS

Managing Director & Principal

John Avellanet is a co-founder of Cerulean, and an internationally acknowledged expert, speaker and syndicated author on lean compliance, preventing intellectual property theft, IT compliance and the FDA's Quality by Design.

He is a frequent guest on radio programs such as Tomorrow's Business and My Technology Lawyer, and is a regular columnist for the quarterly Journal of Commercial Biotechnology, discussing the practical aspects of compliance, quality systems and preventing intellectual property theft.

In 2007, Mr. Avellanet was a co-author for the book, Best Practices in Biotechnology Business Development, and began publication of his monthly newsletter, SMARTERCOMPLIANCE™.

Last year, he was awarded lifetime membership in the Who's Who of top executives in the pharmaceutical and life sciences industry, and was selected as one of the foremost experts on FDA compliance in new product development organizations by the 30,000-member Intota organization.

 

In addition to advising his corporate clients, Mr. Avellanet has served as a guest lecturer at the College of William & Mary's Mason School of Business, Virginia Commonwealth University's School of Business, and the Shenandoah University School of Pharmacy, and is a frequent speaker for the international FDA Expert Briefing series and ComplianceOnline.  Click to see a recent list of other speaking engagements.

 

Throughout his corporate career, including a stint as a C-level executive for a medical device and biotechnology Fortune 50 subsidiary, Mr. Avellanet has been personally accountable for regulatory compliance, records management, e-discovery litigation compliance and intellectual property security.

 

Today, Mr. Avellanet serves on the boards of the IT Compliance Institute, the Global Technology Transfer Organization and Independent Computer Consultants Association.

 

In addition to the prestigious Food and Drug Law Institute, Mr. Avellanet is a member of the Regulatory Affairs Professional Society, the Management Roundtable, the Institute of Management Consultants, the Society of Professional Consultants, the Institute of Validation Technology, the American Society for Quality, the Independent Computer Consultants Association, the BIO-IT Coalition, the Product Development & Management Association, the Society for Clinical Data Management, the Network of Experts and Alvin Toffler's World Future Society, an academic organization focused on future trend and technology analyses.  He serves on PC Magazine's Advisory Board, Inc. magazine's Inner Circle, and Microsoft's Internet Research Panel.  He has also been a regular beta-tester and advisor on new Microsoft software since 1995.

 

John grew up in the Washington, D.C. area and worked for several local and state government leaders in Alexandria and Richmond, Virginia.  He earned his Bachelor’s at the College of William & Mary in Virginia and his Master’s degree at the University of Kansas.

 

His consulting office is located in Williamsburg, Virginia near the College of William & Mary.

 

 

James H Koessler, MBA

Co-Founder

Member of Cerulean Associates LLC, James currently acts as the head of several investment and development companies in the western United States.

 

Since graduating from Harvard with a Finance MBA, his career has spanned executive positions as General Manager of a large agribusiness, senior Financial Consultant for Shearson, Lehman Brothers, and Audit Committee Chairman for an oil and gas company.  For five years, he was the President of Rocky Mountain Capital, a venture capital firm, and then served as the Country Director for the Peace Corps in Paraguay.

 

His office is in Billings, Montana.

 

 

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