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Published Articles

A summary of many of our published articles.  Some recent articles require registration to download a reprint.

 

2008 | 2007 | 2006

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2008 Articles

Lean Outsourcing  (no registration required)  Outsourcing in the biopharmaceutical and medical device industries continues to grow.  For executives grappling with how to get the biggest bang for their money, Cerulean's managing director provides five of the key insights he's provided to his clients over the years as part of his Lean Compliance strategy.  (167kb)

From Contract Pharma, June 2008

Six Pitfalls to Avoid in Supplier Management  (no registration required)  Managing suppliers is fraught with challenges.  Rare is the executive who has not made a mistake.  In this article, Cerulean's managing director, John Avellanet, looks at some of the most common mistakes - most of which he's personally made - and offers lessons learned on how to avoid making your own mistakes. Adapted from an article published in Cerulean's SmarterCompliance™ newsletter.  (428kb)

As republished on the Biotech Blog, June 2008

Intellectual Property Protection  (registration required)  Joint Development Agreements (JDA) can protect outsourced IP. This article lays out the three critical components of a functional, enforceable JDA. Adapted from an article published last year in Cerulean's executive newsletter and Mr. Avellanet's chapter on preventing intellectual property theft in the book Best Practices in Biotechnology Business Development.

From Contract Pharma, April 2008

Export Compliance for Life Sciences  (reprint available in Summer 2008)  U.S.-based pharmaceutical, biotechnology and medical device companies that work with offshore partners, ship equipment out of the U.S. or that re-export combination products with internal technology need to have a defined and well-tended export compliance program covering both tangibles and intangibles.  This article highlights eight steps to building a good export compliance program.

From Journal of Commercial Biotechnology, April 2008

Getting the Results You Expect from Consultants  (no registration required)  Based on our managing director's experience as a biopharmaceutical executive, and honed with the help of CEO clients, this article presents seven straightforward steps to take to find and qualify the right consultant or professional service for you.  (369kb)

From BioPharm International, April 2008

Chapter: Securing Intellectual Property from the Inside Out  (available for purchase Spring 2008)  Intellectual property is the greatest asset of any company; it must be thoroughly protected and secured.  This chapter, from the new book Best Practices in Biotechnology Business Development, reveals a real-world strategy of eight tactics to safeguard intellectual property from employees, contract personnel and partners intent on theft.  24 pages ($9 USD)

From Best Practices in Biotechnology Business Development, March 2008

Shared Risk:  A Regulatory Compliance Strategy  (registration required)  For regulators, biopharmaceutical and medical device risk seems so straightforward.  For pharmaceutical, biotechnology and medical device executives, however, risk is hardly clear-cut, particularly when global supply chains and vendors are involved.  This article expands upon a radio interview given in 2007 by Cerulean's managing director to chart a practical pathway to sharing risks and burdens of compliance with vendors and suppliers.

From BioProcess International, March 2008

Lean Compliance for Midsized Companies  (registration required)  Turf battles, redundancies, and inefficiencies in handling compliance efforts cost companies millions each year.  The five themes of lean compliance - simplicity, rapid prototyping, agile risk, grow knowledge, and proof - are reviewed.

From Journal of GXP Compliance, January 2008

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2007 Articles

Part 11 Compliance and Quality by Design  (registration required)  Provides case studies with a strategy for implementing Quality by Design combined with aspects of 21 CFR Part 11 (electronic records) to improve a pharmaceutical, biotechnology or medical device company's new product pipeline, speed time to market and increase compliance and business flexibility.

From Pharmaceutical Manufacturing, October 2007

Quality by Design:  Defining Your Preclinical Package  (registration required)  Presents a real-world strategy for biopharmaceutical companies that need to develop a faster, less expensive, easier preclinical package for a new product.  The article is based on published FDA insights, discussions with FDA officials and other scientific experts, plus recent client experiences.

From European Biopharmaceutical Review, Autumn 2007

Pharmaceutical Manufacturing's Interview with John Avellanet  (registration required)  Following the filing of the data management lawsuit against Novartis, Pharmaceutical Manufacturing interviewed Mr. Avellanet about two of the allegations brought up in the legal compliant.  The interview discusses the issues brought up in the lawsuit in the context of what other pharmaceutical, biotechnology and medical device companies experience.

From Pharmaceutical Manufacturing, August 2007

Putting the Biotech Puzzle Pieces Together  (registration required)  Presents a community coalition-based strategy for states interested in growing their biotechnology economies can adopt; draws upon lessons learned from Massachusetts, North Carolina and Florida.

From Virginia Business Magazine, September 2007

When Business Grows, Consider Renting a CIO  (registration required)  Reviews a growing trend among small and mid-sized businesses to hire interim or virtual Chief Information Officers instead of full-time executives.  Includes interviews with previous customers of Cerulean's Virtual CIO service and other service providers.

From TechJournal South, August 2007

How to Prepare for an Inspection of Information Integrity  (registration required)  Last year, 95% of all regulatory enforcement focused on one topic:  the integrity - or lack thereof - of a company's information.  This article presents four steps to prepare for an inspection of your company's information integrity.

From SMARTERCOMPLIANCE™, July 2007 and Pharmaceutical Manufacturing, August 2007

Cost-Effective IT Outsourcing  (registration required)  Presents three proven tactics to identify and implement strong information technology (IT) outsourcing arrangement that will improve a company's bottom line.  Examples are provided along with typical costly mistakes (and their warning signs) to avoid.

From Journal of IT Financial Management, Summer 2007

Why CIOs Should Commoditize IT  (registration required)  This case study reviews the development efforts of a medical device company and the role its information technology organization played to speed both product innovation and time to market.  The company is identified only by the initials of its name at the time of this work.

From BIO-IT World Magazine, June 2007

Adapting to Global Competition  (registration required)  Trying to lure top employees, investors and low-risk startups has become increasingly difficult; particularly as each region pushes for biotechnology growth as the panacea for economic development.  This article provides three brief strategies - with examples - to consider to help you adapt and flourish in a "flat world."

From The Independent, May/June 2007

Elucidation:  Lessons from the Auto Industry  (registration required)  The FDA's Quality by Design (QbD) initiative is set to change how biopharmaceutical, biotechnology, pharmaceutical and medical device firms design, develop and test new products.  This article offers a strategy to leverage the lessons learned by Toyota back in the 1970s when implementing "lean design."

From BioProcess International, June 2007

SMB Validation:  Four Ways to Do More For Less  (registration required)  Small to mid-sized businesses, start-ups and pre-clinical development stage companies have it tough when it comes to regulatory compliance.  This "how-to" article presents four real-world tactics and examples to improve your compliance and achieve computer validation  without busting your budget or working overtime.

From Journal of Validation Technology, May 2007

Positive Enforcement:  Seven Principles  (registration required)  Learn how to end compliance struggles without bringing in your HR department or breaking your budget.  This article presents an overview of Cerulean's innovative Positive Enforcement strategy, with seven practical steps you can take today.

From Regulatory Affairs Focus Magazine, May 2007

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2006 Articles

 

Note:  registration not required; you will need a PDF reader to access these articles.

Protecting Intellectual Property & Regulatory Compliance during Development Collaborations  New product development collaborations in the biopharmaceutical industry are a dual-edged sword, fostering innovation and speeding time to market while risking intellectual property loss and compromising regulatory compliance.  Use the six simple tactics in this strategy article to increase your intellectual property protection and improve your compliance capacity. Originally published in the Winter 2006 edition of the European Biopharmaceutical Review. (851kb)

Six Rules for Great IT Project Success Between cost overruns, project delays, unfulfilled expectations and quality control issues, less than 30% of IT projects are successful. This is unfortunate because - conducted and delivered well - projects are one of the most powerful ways IT contributes to a company's bottom-line. Use these six rules to get your project back on track today.  Published in The Independent and the Journal of Projects & Profits. (724kb)

Simple Computer Maintenance for Small Businesses & Nonprofits The average computer lasts approximately 3-4 years before it's replaced. For small businesses and nonprofits, that cost could be better allocated toward improving their bottom-line than speeding word processing. Use the five plain English recommendations in this article to increase your computer's usable life and focus your monies on improving your livelihood.  Published IT Hot News. (655kb)

The Rule of Salt: 100 Days to Increased Innovation through IT & Compliance Innovation is the key to competitiveness. Yet in 2005, 6 out of 10 companies admitted being unable to produce a single innovation that added to their financial results. At the same time, 73% of CEOs today don't believe they are getting their money's worth from their company's compliance and IT security and controls efforts. This article provides six steps you can take over 100 days or less to increase your innovation without compromising compliance or IT security.  Published on the Ziff-Davis Web Guide. (704kb)

Empowered Compliance: A Five Stage Strategy to Support Your Company's Bottom Line One-in-five CEO's and other top executives are rated as too risk averse due to compliance worries to effectively compete in a global marketplace. This strategy provides Compliance executives and organizations the ability to impact their company's financial results with a sustainable competitive advantage. Supporting tactics and real-world examples for each of the five phases of the strategy allow immediate and practical usage.  Published in the Journal of Projects & Profits. (678kb)

Five Steps to Extend Your Computer's Life Written specifically for nonprofits, this article is a revised version of the "Simple Computer Maintenance for Small Businesses & Nonprofits" article (above), and incorporates elements from Cerulean's workshop for nonprofits on cost-effective IT strategies. Originally published on TechSoup in November 2006. (843kb)

15 Seconds on the Web: Ten Writing Tips to Improve Sales The average visitor to your website makes a decision to buy or move on in 15 seconds or less. Based on research from behavioral scientists, web consultants and academia, this article provides ten practical techniques that you can apply today to make the most of those 15 seconds and improve your sales. Originally published on SiteReference in early August 2006, the article was ranked as one of the 5 best-rated articles on the web. (545kb)

Hardball Learning: Six Hard-Hitting Strategies for Capturing Your Listeners' Hearts and Minds Do you have the backbone to engage your audience in a conversation? Long after the presentation, hardball presenters and their material remain memorable. Use these six simple strategies to shift your position from podium-presenter to focused facilitator. Originally published on Ezine Articles. (545kb)

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