January / February 2018

A New Year, A New Dawn

Anna Maria Di Giorgio

One year ago, I wrote about the industry’s collective pathway to hope, lit by the desire to alleviate human suffering. One year on, extraordinary forms of hope became reality with the approval of CAR T-cell therapy, emergence of CRISPR technology, and advent of digital tracking devices that make life easier for patients. One year from now, I am certain even more along that pathway will have been revealed. And it will likely be tied to virtual or artificial intelligence.

In this issue we shine a light on people who bring hope, and the companies that deliver it. Our cover story features the recipient of ISPE’s 2017 Max Seales Yonkers Award, François Sallans, Vice President and Chief Quality Officer for Johnson & Johnson. Among his many virtues, François works tirelessly to elucidate the drug shortages problem, champion the benefits of a quality culture, and enrich the library of ISPE tools on both topics.

Our feature story celebrates the 2017 Facility of the Year (FOYA) Overall Winner: Eli Lilly and Company. You’ll recall that Lilly received Category Awards in Process Innovation and Facility of the Future for its continuous direct manufacturing kits 2 and 3 in Indiana and Puerto Rico. When accepting the award on Lilly’s behalf, David Sternasty, Vice President, Director of Production Site, said “The most important thing a leader can do is find someone who’s doing something well and say, ‘Do more of that.’ That’s what the FOYA awards do: They advance pharmaceutical engineering and say, ‘Do more of that.’”

This issue debuts two new ISPE columns. Sharing news and musings on the regulatory front is “Regulatory Update,” by Carol Winfield, ISPE’s Director of Regulatory Operations, Regulatory Affairs. From our knowledge networks is “Building Community,” by Konyika Nealy, Senior Director of Guidance Documents and Knowledge Networks, Publications. We also welcome Caroline Rocks, the new International YP Chair, and her first column.

Our profiles take us to Europe to meet Belgian YP Lise Heyninck and the leaders of the UK Affiliate. And our “Back Page” infographic (a new feature) depicts Italy’s role in the pharmaceutical industry.

We launched ISPE’s biotechnology conferences in 2016 to bring together dreamers, thinkers, and strategists—those that can imagine and create therapies that have the widest reach, easiest access, and greatest impact on patients. We didn’t know we’d attract so many of you! The 2017 edition, held in Dublin last fall and profiled in this issue, was a “standing room only” event. And mark your calendars for the 2018 event, which will be held next September in Lyon, France.

I hope you have registered for the European Annual Conference, to be held in Rome 19–21 March. It will be tough to beat the 2016 conference in Barcelona, but I think the Romans are up for it.