axendia

Please Do The Right Thing Even When No One is Looking

axendia — Thu, 11 Sep 2008 22:11:00 GMT

On September 15 2008, FDA’s final rule on “Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials” will become effective.

The Rule makes “early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (cGMP) statutes and FDA investigational requirements.” Additional detail is available in the FDA’s Companion Guidance Document.

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Interview on Closed-Loop Quality Execution and Continuous Innovation

axendia — Fri, 05 Sep 2008 00:00:00 GMT

During a recent interview, the folks at Camstar asked that I share my thoughts on the impact that Closed-Loop Quality Execution on Life Sciences Manufacturing in the “Age of Continuous Innovation”.

Visit Axendia's Life-Science Panorama to see the full interview.

Regulatory Compliance - Nature or Nurture?

axendia — Sat, 09 Aug 2008 03:09:00 GMT

Individual and organizational responses to regulatory compliance fall into one of four categories.

The great philosopher “GI Joe” said “knowing is half the battle.” Understanding an individual’s tendency toward regulatory compliance can help you choose the best approach to presenting and addressing compliance issues.

So, are you a Contrarian, a Zealot, a Rationalist or Illusionned?

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Axendia’s President to Chair 3rd Annual MES for Life Sciences Congress

axendia — Wed, 09 Jul 2008 20:25:00 GMT

YARDLEY, Pa. and WOBURN, Mass., July 9, 2008 -- Axendia Inc., a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, and CBI Research Inc., a provider of live and electronic conferences for senior-level executives in the pharmaceutical and biotech industries, today announced that Daniel R. Matlis President and Founder of Axendia, will chair CBI's "3rd Annual Manufacturing Execution Systems for Life Sciences Congress" to be held on August 5 - 6, 2008 in Philadelphia, PA.

Over 500 pharmaceutical, biotech and medical device executives have benefited from the Manufacturing Execution Systems (MES) Conference. The 3rd Annual meeting convenes manufacturing decision-makers from the pharmaceutical, biotech and medical device communities.

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Color and Glass Brighten a Sterile Facility, Lessons from IDT Biologika

axendia — Tue, 17 Jun 2008 02:46:00 GMT

Sterile Manufacturing facilities are often, well sterile. They are typically comprised of drab clean-rooms where the color palette is limited to stainless steel and shades of grey.

For this installment of our “2008 Learning from Success” series, I had the privilege of speaking with Dr. Ralf Pfirmann, Managing Director of IDT Biologika’s site in Dessau-Rosslau, Germany. IDT’s new vaccine manufacturing site received the 2008 Facility of the Year Award for Operational Excellence.

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First Standardized Branded, Pharmaceutical Grade Placebo

axendia — Wed, 28 May 2008 17:11:00 GMT

For years I have been joking about some company marketing a sugar pill based on clinical trial data supporting the “placebo effect”.

I never thought I would see the day when this prediction would come true.

Well, today is the day. Efficacy Brands LLC has begun selling Obecalp “…the First Standardized Branded and Pharmaceutical Grade Placebo…”

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Building a Winning Facility with Sweat Equity, Lessons from Bristol-Myers Squibb

axendia — Thu, 22 May 2008 15:10:00 GMT

For this installment of our “2008 Learning from Success” series, I had the privilege of speaking with Mark Wagner, Vice President Worldwide Clinical Supply Operations and Sarah K. Doshna Associate Director, Parenteral Manufacturing Pharmaceutical Research Institute. They represented Bristol-Myers Squibb (BMS), the winner of the 2008 Facility of the Year Award for Equipment Innovation.

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Shifting from CACA to PACA

axendia — Thu, 08 May 2008 23:15:00 GMT

No, it is not a typo; I mean to spell it C-A-C-A.

Last week, I had the opportunity to present at Camstar’s 2008 “Vision to Value” Manufacturing 360 Customer Conference. One of my sessions was entitled “Shifting from CAPA to PACA”. The takeaway message was simple: Our industry must move from the current Reactive “Corrective and Preventive Action” (CAPA) to a proactive “Preventive and Corrective Action” (PACA) approach of Quality management.

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The Age of Continuous Innovation

axendia — Wed, 23 Apr 2008 02:00:00 GMT

Last week, I was asked me to provide my thoughts before the release of their new eBook entitled “Winning Profit in the Age of Continuous Innovation”

As I read the eBook I kept thinking about Heraclitus’ famous refrain: “The only constant is change.”

In this century, with the increasing rate of scientific knowledge, information has become ubiquitous. Innovation has taken its place as the fuel for the growth engine.

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Learning from Success – 2008 Pharmaceutical FOYA Winners

axendia — Wed, 09 Apr 2008 23:04:00 GMT

During Interphex 2008, I had the opportunity to interview the winners of the Forth annual Facility of the Year Awards (FOYA) competition, sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.

The wining companies were:

Boehringer Ingelheim Pharma GmbH & Co.KG,
Bristol-Myers Squibb,
IDT Biologika GmbH,
F. Hoffmann La Roche AG,

I was very encouraged to hear many of the same themes as I spoke with representatives from the winning teams...

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A Broken Pipeline

axendia — Thu, 13 Mar 2008 00:42:00 GMT

Yesterday, a group of seven leading academic research institutions issued a report entitled “A Broken Pipeline? Flat Funding of the NIH Puts a Generation of Science at Risk.”

The report was co-authored by Brown University, Duke University, Harvard University, The Ohio State University, Partners Healthcare, the University of California Los Angeles, and Vanderbilt University.

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Robots Building People

axendia — Thu, 06 Mar 2008 20:27:00 GMT

No it is not the title of the latest sci-fi blockbuster film, but one of the lessons I learned from FIRST.

Last week I had the opportunity; no the privilege, of being a judge at the “2008 New Jersey Regional FIRST Robotics Competition (FRC).”

FIRST (For Inspiration and Recognition of Science and Technology) was founded in 1989 by Dean Kamen to inspire young people’s interest and participation in science and technology.

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Managing Documents and Records, The Never-ending Process

axendia — Wed, 27 Feb 2008 19:55:00 GMT

That was the theme of the 21st annual DIA Conference for Electronic Document Management (EDM) hosted in Philadelphia on February 5 through 8. The goal of this year’s conference was to focus on grass roots; getting back to basics and best practices. While the intent was not specifically about the transformation to an electronic ‘state’ and the associated evolving standards, it was evident many attendees still want to know how to get there. The overarching theme for the conference was the “Never-ending Process”.

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Supreme Court Shields Medical-Device Makers

axendia — Fri, 22 Feb 2008 15:15:00 GMT

In its February 20, 2008, decision in Riegel v Medtronic, Inc., the U.S. Supreme Court ruled that The Medical Devices Act of 1976 (“MDA”) was sufficient to preempt any State law that purported to “establish or continue … any requirement … which is different from, or in addition to, any requirement” under relevant federal law.

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The State of Outsourcing in Life-Sciences

axendia — Wed, 20 Feb 2008 00:02:00 GMT

Lately, I have been getting a lot of questions regarding the state of Outsourcing in Life-Sciences.

When I started working in Life-Sciences, nearly two decades ago, going offshore meant moving operations to a company owned facility in Puerto Rico. This was the heyday of Section 936. Established in 1976, Section 936 of the Internal Revenue Code provided U.S. firms operating in Puerto Rico with tax-free income. Lower wages and the security of being home (Puerto Rico is a free associated state of the US) made the island a hub of Life-Science activities.

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