11Sep/07

Pfizer Shares Successful Implementation of Electronic Lab Notebooks

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.

05Sep/07

Learning from Success – Building with Trust at Genentech

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.

jr.jpg

 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:

  • Zero Observation during the FDA pre-approval inspection earlier this year
  • Very low injury rates in construction
  • Tremendous pride and ownership by everybody who was involved. 
  • I still have craftsman come to me saying: “this was the best project of my life!” 
  • Current smooth, successful operations producing Avastin”
  • 28Aug/07

    Life, Liberty and the Access to Promising Investigational Drugs

    By Ronald L. Trowbridge, Ph. D.
    Volunteer Adjunct Scholar
    Abigail Alliance for Better Access to Developmental Drugs

    In August, we (Abigail Alliance) lost our case in the D. C. Circuit Court of Appeals.  We are appealing this decision to the Supreme Court.  We argue that terminal patients with no options left but death have a constitutional right to promising investigational drugs already proven safe enough for further testing on people, in the care of a qualified physician.

    Recently my partner Steve Walker and I conducted painstaking research that disclosed appalling findings.  We collected data from the FDA, the American Cancer Society, and from a number of research oncologists expert in their respective fields of cancer indication and corresponding drug response.  We focused on the 12 promising investigational drugs that the Alliance had pushed for early access over the past five years, all of which were subsequently approved by the FDA.

    In sum, these 12 drugs—had they been available to people denied entry to clinical trials—would have helped well over one million people live extended lives, anywhere from a few months to many years.

    Generally, our critics cite four lines of opposition:

    1. Our proposal would open a floodgate to quack drugs on the market.  Not true for two reasons:  one, the promising drugs we promote must clear at least Phase I of FDA testing and control; two, a qualified physician must officially prescribe these drugs for individual patients.

    2. Our proposal would cause a maelstrom of confusion in record-keeping, given responses to limited patients in clinical trials and responses of unknown thousands of terminal patients to investigational drugs.  But if we can get a man to the moon, we can design software systems that will separately track clinical-trial patients as well as terminal patients getting investigational drugs.  Establishing such dual systems will take diligence, especially at the outset, but it’s doable and worth the effort: extending human lives.

    3. Our proposal will harm some terminal patients.  This argument is incredulous, because it says to the terminal patient:  “This drug might not be safe for you, so we won’t let you take it.  You can go ahead and die, but you’ll be safe from the drug.”  As Orwell said in 1984 on doublespeak, war is peace, hate is love, and terminal death is safety.  Let the decision to take a promising investigational drug be between the qualified physician and patient, informed of the risk.

    4. Our proposal will discourage patients from entering clinical trials.  Three responses here:  one, our proposal speaks only of terminal patients denied access to clinical trials.  Two, patients will seek the best odds for survival, and why not? Three, the FDA acknowledged in its own legal brief:  “the number of persons who are accepted for participation in clinical trials is relatively small . . . . The number of qualified would-be participants may exceed the number of spaces in the trials.”

    This fall the ACCESS Act will be introduced in the House and Senate legislating our proposal.  The Act will permit promising investigational drugs, still regulated by the FDA, to be prescribed to terminal patients.

    Dr. Trowbridge was Chief-of-Staff to Chief Justice Warren Burger and the Commission on the Bicentennial of the U. S. Constitution.  Before that, he was appointed by President Reagan, with unanimous confirmation by the U. S. Senate, to a top-level administrative position at the United States Information Agency.  He holds a Ph. D. in English from the University of Michigan.

    20Aug/07

    HHS Secretary Mike Leavitt Joins the Blogosphere, For Now…

    By Daniel R. Matlis

    On August 13th, Secretary of the Department Of Health And Human Services Health And Human Services Mike Leavitt started writing his very own blog. The stated purpose of the Secretary’s blog, aptly named Secretary Mike Leavitt’s Blog, is to foster public discussion, and demonstrate “the Secretary’s continuing desire to engage Americans in the exchange of ideas on health care and the provision of human services. It provides an opportunity for the Secretary to share his observations as well as a means for him to have an open conversation about health and the related challenges that face the nation.”Mr. Leavitt has not yet decided if blogging is a permanent thing for him. He has committed to write for the next month or so. After this trial period “I’m going to see how I feel after that time period. I may continue; I may not”, the secretary wrote.

    Responses and comments posted on the blog will be managed by staff following a detailed Comment Policy.

    So for the next month, you have the opportunity to communicate directly with the head of HHS with the following caveat:

    “We recognize that the Web is a 24/7 medium, and your comments are welcome at any time.  However, given the need to manage federal resources, moderating and posting of comments will occur during regular business hours Monday through Friday.  Comments submitted after hours or on weekends will be read and posted as early as possible the next business day.”

    For your convenience, I have added a link to the Secretary’s Blog on Life-Science Panorama’s Blogroll (see the left hand column of the page under Blogroll).

    17Aug/07

    SAFE-CRIX Partnership to Enable Fully Electronic Life-Science Transactions

    By Daniel R. Matlis

    This week, SAFE-BioPharma Association and CRIX International announced a formal collaboration aimed at architecting the CRIX e-platform. The e-platform would handle the exchange of clinical research data (i.e., the data normally collected during the course of a clinical trial), as well as the submission, receipt, and management of regulatory product information. Both SAFE-BioPharma Association and CRIX International are not-for-profits funded by Life-Science companies. 

    CRIX International is dedicated to leveraging technology to accelerate and streamline the interaction between sponsors of new drug products, their business partners, research institutions, academia, and health authorities involved in bringing new therapies to patients throughout the world.

    CRIX’s North American Advisory Council includes members representing standard organizations including:

    • Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization with a mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
    • Health Level 7(HL7), an international community of healthcare subject matter experts and information scientists collaborating to create standards for the exchange, management and integration of electronic healthcare information. HL7 promotes the use of such standards within and among healthcare organizations to increase the effectiveness and efficiency of healthcare delivery for the benefit of all.

    SAFE-BioPharma Association manages the SAFE™ standard, which provides a secure and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions. The standard also facilitates fully electronic processes by creating a system of trusted identities and legally enforceable digital signatures.

    SAFE-BioPharma Association’s members include Amgen, AstraZeneca, Bristol-Myers Squibb, Genzyme, GlaxoSmithKline, Johnson & Johnson, Merck, Organon, Pfizer, Procter & Gamble, Roche and Sanofi-Aventis.

    I’m encouraged to see industry organizations, like CRIX, SAFE, CDISC and HL7, coalescing to develop open yet structured approaches to advance the use of information technology in Life-Sciences. These industry standards will yield more efficient processes for the development of healthcare therapies.

    I would much rather see our industry developing and implementing consistent standards than government agencies imposing regulatory requirements on Information Technology.