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Contact: Monica Malave
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Yardley, PA, October 24, 2006 — Axendia, a trusted advisor to Life-Science Executives on Business, Regulatory and Technology strategies, today announced that it has joined forces with Microsoft to strengthen the BioIT Alliance. 

Life science companies have unique technical challenges such as the need for more comprehensive data integration solutions, better technical collaboration and stronger knowledge management capabilities. The BioIT Alliance brings together science and technology leaders to consider innovative ways to address these challenges and use technology to reduce costs, streamline research and market their products more effectively. 

“We are pleased that Axendia, a leading advisory firm in the Life-Sciences Market, has joined the Alliance” said Don Rule, Microsoft’s Program Manager for the BioIT Alliance. “The Alliance unites the pharmaceutical, biotech, hardware, and software industries with leading advisory firms like Axendia, to explore new ways to share complex biomedical data and collaborate among multi-disciplinary teams to speed the pace of discovery in the Life Sciences” 

The Alliance will enable members to share information and to provide technical information about the solutions that they offer to the public. Alliance members will also collaborate on Proof of Concept applications that will address critical bottlenecks in discovery of new knowledge and application to our daily lives. 

“We are honored to join forces with Microsoft on the BioIT Alliance,” said Daniel R. Matlis, Founder and President at Axendia. “Through the Alliance, Axendia joins some of world’s top technology providers, to help the Life-Sciences industry move closer to making personalized medicine a reality”. 

About Axendia:

Axendia is the leading analysis firm focused strictly on the Life-Sciences and Healthcare markets. Our Mission is to be the most trusted advisor to Life-Science Executives on Business, Regulatory and Technology issues. With over 16 years experience in the Life-Sciences and Healthcare industries, Axendia provides a unique combination of hands on experience coupled with strategic vision. This enables us to successfully identify, create and execute strategies which provide lasting business value for our clients. Additional information on Axendia’s can be found at http://www.axendia.com/

About BioIT Alliance:

Formed in 2006, the BioIT Alliance is a cross-industry group working together to improve biomedical information technology on the Microsoft platform. Founding members include Affymetrix, Inc., Accelrys Software Inc., Amylin Pharmaceuticals, Inc., Applied Biosystems, The BioTeam Inc., Digipede Technologies LLC, Discovery Biosciences Corporation, Geospiza Inc., Hewlett-Packard Development Company, L.P., InterKnowlogy, Microsoft Corporation, Sun Microsystems Inc., VizX Labs LLC and other key companies in the pharmaceutical, biotech, hardware and software industries. Additional information about the BioIT Alliance can be found on the BioIT Alliance Web site at http://www.bioitalliance.org/

About Microsoft:

Founded in 1975, Microsoft (Nasdaq “MSFT”) is the worldwide leader in software, services and solutions that help people and businesses realize their full potential.
The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

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Source: Microsoft Corp.

Yesterday, at Microsoft’s biotechnology Executive Forum, Microsoft announced the initiation of the BioIT Alliance’s second proof of concept, called the Biomarkers Project, along with an update on the Alliance’s first proof of concept, the Collaborative Molecular Environment.

The BioIT Alliance is a cross-industry group working to integrate science and technology to accelerate the pace of drug discovery and realize the potential of personalized medicine. The early focus of the Alliance has been to address the data-capture and data-integration challenges that face the industry.

“The life sciences offer one of the best opportunities for information technology to accelerate the pace of drug discovery and development,” said Craig Mundie, chief research and strategy officer at Microsoft. “Our collaboration in the Alliance will help the life science industry move discoveries from the lab to the clinic much faster.”

The Biomarkers Project: Initiation of Second Proof of Concept 

“One of the most important fields of research today is in gaining an understanding of the relationship between genetic traits and clinical outcomes,” said Dr. Michael Hanley, vice president of Discovery Research at Amylin Pharmaceuticals Inc. “The research and pharmaceutical community is hindered by the lack of integration among the software tools that are used to gain this insight.”

To address these challenges of software integration, the BioIT Alliance is collaborating on its second proof of concept, the Biomarkers Project. This undertaking will simplify the process for identifying and validating genomic biomarkers — the characteristics that indicate the presence of a disease or the likely efficacy of a drug.

On February 26, 2004, the FDA published its final rule on “Bar Code Label Requirements for Human Drug Products and Biological Products”.  According to the Agency, “Bar Codes will allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.  This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings.” 

The Bar-Code rule requires linear bar codes on most prescription drugs and on over-the-counter drugs commonly used in hospitals and dispensed pursuant to an order. The bar code is required to contain, at minimum, the drug’s National Drug Code (NDC) number, which uniquely identifies the drug. The rule also requires the use of machine-readable information for blood and blood components intended for transfusion. The machine-readable information must include, at a minimum, the facility identifier, the lot number relating to the donor, the product code, and the donor’s ABO and Rh. 

During the same month, February 2004, the FDA’s Counterfeit Drug Task Force issued its report on “Combating Counterfeit Drugs”. This report called for the implementation of Radio Frequency Identification (RFID) technology to allow the tracking of pedigree and mass serialization for all drug products. The Agency set forth a phased approach to the implementation of RFID technology starting at the case and pallet level for products likely to be counterfeited and progressively including all products at the case, pallet, and package level by 2007. 

In February of 2006, the FDA conducted a Counterfeit Workshop in Bethesda, MD to get an update from stakeholders on the status of RFID implementations. Affected stakeholders, including manufacturers, distributors and pharmacists, presented progress made and concerns associated with RFID and e-Pedigree initiatives. During my remarks to the Task Force, I stated that RFID technology should be used as an enabler, not a silver bullet. I conveyed the agency’s role to set regulatory requirements, gathered in cooperation with all affected stakeholders. However, in my opinion, the FDA should not mandate specific technologies to be utilized to achieve compliance.  

In June 2006, the task force issued its update on the FDA Counterfeit Drug Task Force Report. The agency admitted that although in 2004 it was optimistic that widespread implementation of e-pedigree was feasible by 2007, unfortunately, this goal most likely will not be met. The report went on to say:

“…it is clear from our recent fact-finding efforts that the voluntary approach that we advocated in the 2004 Task Force Report did not provide industry with enough incentives to meet FDA’s deadline.
We continue to believe that RFID is the most promising technology for electronic track and trace across the drug supply chain. However, we recognize that the goals can also be achieved by using other technologies.
Based on what we have recently heard, we are optimistic that this hybrid environment of electronic/paper and the use of RFID/bar code is achievable in the very near future. We believe that efforts to ensure that hybrid pedigrees are secure and verifiable should be a priority consideration.” 

Is this a case of one step forward and two steps back? I don’t believe so. I see it as a net gain for all stakeholders, especially patients.  The FDA estimates that the bar code rule, once implemented, will result in more than 500,000 fewer adverse events over the next 20 years.

Hospitals have recently made major investments in Bar-Code systems to comply with these regulations and minimize medication errors. Asking them to now reinvest in RFID technology without realizing the benefit of Bar-Codes would be a mistake. 

By Daniel R. Matlis

In my “Final Word” column, published in Pharmaceutical Formulation and Quality, I discussed the need to deepen our industry’s gene pool. 

Johnson and Johnson has taken a huge leap to diversify the industries’ gene pool.  J&J recently announced the appointment of LaVerne H. Council to the position of vice president and chief information officer.

Council comes to J&J from Dell Inc.  She brings to the position a wealth of global experience in information technology, supply chain management and business operations. During her tenure at Dell, Council was responsible for infrastructure engineering, networking, security, and enterprise application interfaces and was the global supply chain technology leader for Dell’s core operations.

Skeptics might ask how her experience at a major computer maker qualifies her for the position at one of the most prestigious life-science companies? After all, what do PCs and healthcare have in common? Well, more than you think.

Read the complete column in Pharmaceutical Formulation and Quality.

By Daniel R. Matlis
 

According to a recent study by the Milken Institute the life sciences industry is an emerging powerhouse for U.S. global economic competitiveness in the 21st century. In the study, Philadelphia ranked as the 3rd most vibrant biosciences cluster in the nation.
Pennsylvania’s $2 billion Biosciences Enterprise commitment, coupled with Governor Edward G. Rendell’s $2.3 billion Economic Stimulus Package is fueling research and development, attracting venture capital, and supporting early-stage investment.
 

Recently, I had the opportunity to speak with Rebecca Bagley, Deputy Secretary for the Technology Investment Office of the Pennsylvania Department of Community and Economic Development (DCED), to learn about what the Commonwealth is doing to attract and retain life science companies.
 

What is PA’s vision around life sciences?
 

Life science is a major focus cluster for the Commonwealth since Governor Rendell took office. One of the reasons we focus in that sector is the continuum of assets the Commonwealth has to offer. The spectrum includes world class universities; eight of the United States’ largest pharmaceutical companies are located within a 50-mile radius of Philadelphia; and a strong venture capital climate.
 

How does the Commonwealth benefit?
 

We benefit through jobs, research and development expenditures, leveraging of capital into the state, as well as attracting entrepreneurs which benefit the state in the long run. There are more than 125 bio-pharma [biological-pharmaceutical] companies and more than 2,000 biosciences-related companies located in Pennsylvania.
 

How have trends such as outsourcing and the flat world impacted life science firms in PA?
 

The Commonwealth has a focus on innovation and early stage companies, funded not only through a venture capital network but also through our Life Science Greenhouses, a network and resource for early stage capital.
 

We also have the large pharmaceutical companies which provide potential for partnership opportunities.
 

In life sciences, it is less likely that the manufacturing will go overseas because of Food and Drug Administration (FDA) restrictions and the specialties that are necessary compared to a call center. Biotechnology manufacturing is much more complex and therefore more difficult to relocate overseas; we have not seen this trend with bio-pharma.
 

We have seen a significant shift to overseas life science manufacturing to countries like Mexico, Brazil and China. How has this impacted PA?
 

With our focus on innovation and heavy research and development, Pennsylvania offers a great advantage to bio-pharma companies. The Commonwealth is targeting high tech, complex manufacturing.
 

What initiative does the state have to attract foreign companies to establish headquarters in PA?
 

Within the Governor Rendell’s budget this year, we have a $ 15 million allocation for World Trade PA, which will help focus our international activities with both recruiting and attracting early stage companies to relocate here. For example, the Science Center in Philadelphia is recruiting early stage Japanese companies. Historically our goal has been to attract established companies to set up their U.S. headquarters in the Commonwealth.
 

How does your approach differ when dealing with early stage versus established companies?
 

The Technology Investment Office focuses on early stage innovation and technology.  There are other offices with in the department along with the Governor’s Action Team which focus on attracting or recruiting the established companies to PA.
 

We have a strong relationship with Pennsylvania Bio. This ensures that companies based in Pennsylvania stay in the state as they grow and require larger facilities. To that end, DCED Secretary Dennis Yablonsky and the president of PA-Bio meet with companies in Pennsylvania to make sure that growing companies are familiar with the range of incentives the state has to offer.
 

We offer packages that include loans, grants and tax credits that can accommodate relocation of large companies. We also can assist with site selection. The Governor’s Action Team works closely with local entities to ensure the process is smooth.
 

What is the state doing to attract service organization that support life sciences to ensure there is a complete ecosystem within the state?
 

That has been our approach from the beginning. We build clusters to include large pharmaceutical companies, service providers and early stage companies together in one area to have a complete market place.
 

So why should life science companies consider Pennsylvania?
 

The assets we have in the Commonwealth to develop life science clusters are very attractive to companies. From world class universities, which can provide research at their fingertips, to the supportive venture capital environment, and an extremely supportive and proactive state government, which provides both incentives and focused initiatives for the life science industry, we have created an environment which makes it very encouraging for companies to operate in the Commonwealth. Additionally, we offer great quality of life, great schools, inexpensive housing and thriving communities.

ã 2006 by Axendia