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Good Practices Key to Pharma

By Kevin Davies

Aug 15, 2005 | Prior to the Best Practices award presentations, guests at the National Press Club dinner in Washington, D.C., on June 28 heard from two powerful figures in the biopharma industry.

H. Thomas Watkins succeeded Bill Haseltine as CEO of Human Genome Sciences (HGS) last November, following two decades at Abbott Laboratories. Watkins checked off HGS’s drug discovery organization, patent estate, balance sheet, and manufacturing base as key assets in the company’s evolution from genomics powerhouse to major pharma focusing on therapeutic proteins and antibodies. He noted that, “The process has been a much more challenging journey than anyone thought.”

Watkins professed to being “very excited” about the potential for a number of therapeutic drugs and targets, including the TRAIL superfamily of “death” receptors for cancer treatment, albuferon for hepatitis C, and Lymphostat-B for rheumatoid arthritis and lupus. Watkins pledged to “maintain our base as a gene discovery organization.” Meanwhile, HGS has reorganized its research group by creating a new division, CoGenesys.

Howard Asher, founder and chairman of Life Sciences Information Technology Global Institute, offered a preview of results of his organization’s online survey among senior life and health science professionals to identify good informatics practices. His goal, he said, was “to look at IT like no other industrial sector has before.”

Almost 9 of 10 respondents agreed that consistent IT practices would expedite regulatory approval and similarly agreed on the need for a global, centralized reference base for bio-IT professionals. Three-quarters of respondents stressed the need for definitive best practices in the industry.

“Only six [FDA employees] are IT-trained professionals. And they’re going to come in and determine best practice? We need a playbook, we need a rulebook,” Asher said.

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