Attendees exiting this year’s ISPE AM Keynote seemed energized and loquacious about the three speakers and their presentations:
Patrick Yang, Executive Vice President, Product Operations, Genentech, discussed Genentech’s perspective on the legacies of the biotech industry starting in 1976 with the development of insulin and growth hormone through today’s progress in the areas of cancer, immunology and age-related macular degeneration. He then engaged the audience to be introspective about the questions, “What will be our legacy? Could it be industrialization of what we do? Globalization? Technology advancement? Becoming an admired and respected industry once again? Beating a serious disease, like cancer?” Take-away message: We can leave a great legacy behind us if we do the right thing.
“What a character!” was a popular phrase referring to Hans Rosling, professor of International Health at the Karolinska Institute, Stockholm, Sweden. With his son and daughter-in-law he founded the Gapminder Foundation to promote a fact-based world view by developing Trendalyzer, software that converts international statistics into moving, interactive, and enjoyable graphics. He used the software (purchased by Google in 2007) to show the trends and links between health and the economy all over the world. Take-away message: Pharma can leave behind a legacy that is fair. The world can benefit from a bigger market from the pharmaceutical industry.
Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, US FDA, focused on pharmaceutical quality; its progress internationally in the last decade; an update of related intitiatives on the FDA front; and challenges for maintaining pharmaceutical quality. Take-away message (mantra I’m hearing from all the FDA folks here): Pharmaceutical manufacturers, importers, brokers and distributors must take primary responsibility for maintaining the quality of pharmaceuticals throughout the supply chain. FDA and other regulators cannot inspect quality into the global drug supply; inspection is only one important component.
What did you think about this year’s Keynote?
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