BioPharm International, May 2005 - BioPharm International

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BioPharm International, May 2005
Columns and Departments
Regulatory Beat: FDA Ambitiously Encourages Innovation While Ensuring Safe Therapies
By Jill Wechsler
FDA will allow nonprescription NSAIDs to share the market with products carrying black-box warnings.
Site Expansion: Adaptive Reuse of Facilities
By Stephen Rothrock
Conversion of facilities from one use to another is a positive trend that keeps good paying jobs in local communities.
StreetTalk: Stem-Cell Revolution: Big Opportunity for Investors
By Brian O'Connell
Geron rose 7% and StemCells 15% . . . when news of the New York capital funding effort hit the business pages.
Final Word: The National Academies' Guidelines for Human Embryonic Stem-Cell Research
By Jonathan D. Moreno, Ph.D.
On April 26 the National Academies of Sciences and the Institute of Medicine released guidelines for human embryonic stem (hES) cell research, the result of eight months of deliberations by a human research ethics committee I co-chaired with MIT's Richard O. Hynes. Composed of scientists, physicians, lawyers, ethicists, a social scientist, and a private citizen, the committee held a two-day public workshop and numerous meetings. We also reviewed international guidelines, policies, and procedures in this field.
Operations Excellence: Process Analytical Technology (PAT) to Play Key Role in Advancing Operations Excellence
By Amir London
Three meetings of the BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, were held recently. The east coast meeting was hosted by Genzyme at its headquarters in Cambridge, MA; the west coast Chapter met at the Genentech campus in South San Francisco, CA; and the European forum held its meeting in Frankfurt, hosted by Aventis.
From the Editor in Chief—Quality Leadership
By Carol L. Fisher
Despite the ringing of two stray cell phones disrupting the quiet, all eyes and ears were glued, almost reverently, on New York City's former Mayor Rudy Guiliani at INTERPHEX when he presented the day's keynote address. First, he thanked the audience for providing the therapeutic options that allowed him to successfully defeat prostate cancer awhile back. Next came his imitation of James Gandolfini in the hit TV show "The Sopranos," as he reminisced about his duties as NYC's former chief prosecutor. Once he had our full attention, close to 1,000 of us, he shared what he felt are the most valuable leadership attributes and how they will successfully get you through challenging and uncertain times.
Articles
Knowledge Management Strategies for Biologics Research
By Christopher Larsen, Ph.D.
$200 million and two years could be shaved off a drug's development time by using informatics effectively.
Biopharmaceuticals: Approvals and Approval Trends in 2004
By Gary Walsh, PhD
Cancer remains the primary indication (three products), again mirroring recent approval trends.
Discovering Value in Outsourcing Facilities Management
By Timothy Maechling , Jeffrey Bredeson
Your company's job is to make biopharmaceutical products. Managing facilities is a function supporting the main task. General manufacturing companies discovered this long ago, but pharmaceutical producers have been lagging. Once you consider the outsouring of non-core activities like facility management (FM), office services, space planning, and utilities management, you can focus on core business functions that make profits.
Using Design of Experiments in Validation
By George R. Bandurek, PhD
Saturated fractional factorial plans minimize the number of trials by one-half or better, which saves time and money.
Special Section
Media Development for Mammalian Cell Culture
By Geoffrey Hodge
Once a necessary "magic ingredient" of media for mammalian cell culture, serum is rapidly being eliminated from media for biotherapeutic processes.

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