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Yardley, PA, September 18, 2007- Axendia Inc., a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, today announced that its President and Founder, Daniel R. Matlis, will chair the “Product & Manufacturing Innovation Track” at the Advamed 2007 MedTech Conference.

Developed by industry, for industry, AdvaMed 2007 is the premier medical technology conference and exhibition for business leaders, policymakers, investors, news media, patient advocates, and industry stakeholders from around the world. The Conference is schedule from October 1st thought the 3rd at the Ronald Reagan Building & International Trade Center, in Washington DC.  

“Medical Device Executives are facing some of the most difficult challenges ever encountered in the industry,” commented Daniel R. Matlis, President and Founder of Axendia.  “To deal with increased market and competitive pressures, device manufacturers must innovate and reduce time to market while concurrently managing risk, increasing product quality and reducing costs,” Matlis added.

The Product & Manufacturing Innovation Track will include two session covering:
   - Innovative Strategies to Integrate Development, Manufacturing & Commercialization of Medical Devices
   - Quality by Design in Manufacturing: Best Practices & Case Studies from Innovators in the Medical Device Industry

The tack will be held on Tuesday, October 2nd from 9:00 AM till 12:15 PM at the Ronald Reagan Building & International Trade Center, in Washington DC.

For detailed information about the “Product & Manufacturing Innovation Track”, visit Advamed 2007

About Axendia
Axendia Inc. is a leading analysis firm focused on the Life-Sciences and Healthcare markets. The firm provides trusted advice to Life-Science Executives on Business, Regulatory and Technology issues. Axendia’s unique perspective is a result or our focus on the Life-Sciences and Healthcare markets and a unique blend of industry experience and strategic vision. This approach 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 Advamed
AdvaMed, the world’s largest association representing the medical technology industry, has more than 1,500 member companies, subsidiaries and divisions producing medical technology devices including, diagnostic products and medical information systems. AdvaMed members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world.  Leveraging its role as the voice of industry, AdvaMed has assembled the necessary expertise, mass of critical thinking, energy and people to create and organize its first medtech conference and exhibition. For more information about Advamed 2007, visit http://advamed2007.com/

By Daniel R. Matlis

Let’s face it; our industry is paranoid about sharing information. I often hear of the concern for disclosure of Intellectual Property, legal issues or trade secrets as justification for this behavior.

Of course our industry has a legitimate need to guard Intellectual Property, competitive data and trade secrets. If your notebook contained the compound that would cure for the common cold, you wouldn’t want your competitors to get their hands on it.

So why would Pfizer share their approach to securing the contents of their e-notebooks?

According to George Rathbun, Pfizer’s Director of Regulatory Compliance and a member of the Board of Directors of SAFE-BioPharma Association: “Pfizer developed this white paper to share with the rest of the industry our experience introducing electronic laboratory notebooks and SAFE digital signature technology. This is consistent with Pfizer’s role as a leader in the development of the SAFE technology within the pharmaceutical industry.” 

If you have ever been in a Life-Sciences R&D Lab, you have seen the traditional laboratory notebooks. They are numbered, paper-bound books used to document daily experiments and activities conducted by researchers. It is imperative that the books be dated, signed and witnessed on a daily basis. Once full, the paper notebooks are submitted to a Records Management organization for archiving. These steps are critical since information contained in these laboratory notebooks are often used to prosecute product patents.

The transition to electronic lab notebooks (eLN) has been a dream for many years.  The benefits of eLN are clear, a reduction of paper, savings in records management, easier access to stored information, and generally, less record-keeping time for scientists.

One key challenge to the adoption of eLN has been the implementation of legally binding electronic technology to sign and witness the content of the eLN. To address this issue, Pfizer relied on the use of the SAFE digital signature, an industry driven standard that allows scientists to apply an easy to use time-stamped electronic signature. The SAFE digital signature addresses the following issues:

1) Provides for the legally equivalent to a “wet” or ink-based signature
2) Meets regulatory guidelines such as 21 CFR Part 11 and HIPPA in the USA, as well as their international counterparts
3) Ensures security and data integrity
4) As a standard, it is designed to support global use.

The newly published Pfizer white paper entitled “Pfizer Implementation of SAFE Digital Signatures for Electronic Lab Notebooks,” chronicles the introduction, development and adaptation of digitally signed electronic Lab Notebooks. The system has more than 2200 users within Pfizer and averages more than 1000 signatures per day. 

Some in our industry might still be scratching their heads about Pfizer’s openness on this topic. I say Kudos to Pfizer for sharing their successful implementation of digitally signed electronic Lab Notebooks. As you know, I’m a big believer in learning from success.

To learn more about Pfizer’s implementation of eLN, I highly recommend reading the complete whitepaper. The Document can be can be downloaded from the SAFE-BioPharma Association’s website.

By Daniel R. Matlis

Early in my career, a mentor gave me these words of advice: “To succeed, you must learn from everything you do.”

Working to take that advice a step further, I began to learn from other people’s mistakes and more importantly from their success.
 
Earlier this year, I had the opportunity to meet three winners of the third annual Facility of the Year Awards (FOYA) competition, sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. Interviewing the leaders of these wining teams afforded me an opportunity to learn from their success, and share it with you in this three part series entitled “Learning from Success.”

Each article in the series will feature some of lessons learned from each of the winning projects. 

They are:
• Genentech located in Oceanside, California, USA, FOYA winner for Project Execution
• Shanghai Roche Pharmaceuticals, Ltd., Shanghai, China, FOYA winner for Project Execution Regional Excellence
• Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany, FOYA winner for Process Innovation

Lessons in Project Execution from Genentech
Genentech’s Oceanside Product Operations (NIMO) project, located in Oceanside, California, was built for the production of Avastin® (bevacizumab), a therapeutic antibody for the treatment of various forms of cancer.  This six-building, 500,000-square-foot, master-planned campus includes manufacturing, laboratory, office space, a warehouse, central utilities, and a “spine” inter-connecting space.  The facility designed to have a production capacity of 90,000 liters.

Genentech’s team consisted of the owner, engineering company, architect, and general contractor. The team formed and developed an innovative project delivery approach that is best described as “Design-Build Hybrid.”  This means that  civil, architectural, and structural work were executed using the traditional design-bid-build  approach , while mechanical, electrical, process, and instrumentation and controls (I&C) used a design-build strategy under the management of the general contractor.

In order to achieve consistency in project standards and quality, the owner, architect and general contractor all unanimously selected an engineering company to oversee all engineering performed by the design-build subcontractors in the mechanical, electrical, process, and I&C engineering disciplines.

 Johannes R. Roebers Ph. D. is the brains behind the “Design-Build Hybrid” methodology. At the time of our interview, Dr. Roebers was Sr. Director, Engineering, Facilities, and Validation at Genetech.

Today, he is Senior Vice President, Head of Biologic Strategy, Planning and Operations for Elan Corporation, plc. in Dublin, Ireland. 

During out interview Dr. Roebers shared these lessons from his award winning project:
1. Management must be willing to give you the freedom to do things differently.
  This lets you experiment with new approaches
2. The owner must be mature and know what they want.
  If you don’t know what you want, it will be expensive
3. Approach the project as a journey, and run it in a collaborative style.
  Use your plan as a guide, but be flexible to address the unexpected
4. Hand select sub-contractors based on their ability to get the job done, not lowest bid.
  Cheapest is not best
5. Develop a vision and rules for working together
  The team must get through the good and bad times, so build trust
6. Spend the time on a thorough vendor selection process
  You can only trust the trustworthy
7. Work with local people whenever possible
  It’s hard to run the other away, if your kids go to the same school
8. Develop preliminary specifications and work with the subcontractor to finalize them
  Builds of ownership and commitment
9. Be you contractor’s best customer
  They will be committed to getting things done for you
10. Once you developed a wining team, keep working together
  The team gets more efficient and effective

As a result of utilizing the “Design-Build Hybrid” approach and people-oriented execution focus, Johannes R. Roebers’ team delivered the base project on time and under budget.

Dr. Roebers concluded: “The results speak for them themselves: