BioPharm International-01-01-2004

There are pressures on biopharma to grow up — and to grow up fast. Although we still hear references to its "infancy," I think we're well past that stage and already confronting the awkward — and sometimes painful — experience of adolescence.

By implementing a comprehensive improvement program for its organizational and operational functions, one company increased capacity by more than 100% and 50% for two of its biopharmaceutical products.

Quality assurance units are interwoven throughout the biopharmaceutical enterprise and provide support to sustain operations. Most importantly, they must have the capacity and leadership to adapt to change.

In September 2003, Sweden's biotechnology sector recorded a striking achievement. Amgen, the world's largest biotechnology company, announced plans to acquire exclusive rights to Biovitrum's small-molecule enzyme inhibitors for the treatment of metabolic diseases.

Molecular mimicry is a common, but undesirable, property of disease proteins. Sequence similarities between cancer proteins and self-proteins allow tumor cells to hide, thereby avoiding attack from the immune system. HIV uses the same evasive tactic.

Training programs do not have to be complex to be successful. There are basic elements, however, that all must have to meet FDA requirements and ensure that employees have the knowledge and skills to maintain high quality standards.

Biopharmaceutical companies can access their suppliers? resources to reduce validation and compliance efforts.

New policies revise payment formulas and open the door to increased scrutiny of prices and effectiveness.

Competition from generic drugs is rising. How should investors react when a blockbuster drug goes off patent?