BioPharm International-05-01-2005

Cancer remains the primary indication (three products), again mirroring recent approval trends.

Saturated fractional factorial plans minimize the number of trials by one-half or better, which saves time and money.

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.

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.

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.

Once a necessary "magic ingredient" of media for mammalian cell culture, serum is rapidly being eliminated from media for biotherapeutic processes.

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.

$200 million and two years could be shaved off a drug's development time by using informatics effectively.

Geron rose 7% and StemCells 15% . . . when news of the New York capital funding effort hit the business pages.

FDA will allow nonprescription NSAIDs to share the market with products carrying black-box warnings.

Conversion of facilities from one use to another is a positive trend that keeps good paying jobs in local communities.