Pairing Knowledge with Imagination

Albert Einstein’s statement captures the innovative spirit that underlies the drive of the 2017 recipients of ISPE’s Facility of the Year Awards (FOYA) Program, now in its fourteenth year. This annual program represents the heartbeat of our association, and the breath of its members.

This year’s winners, highlighted in the attached 2017 FOYA Supplement, have demonstrated their skill at pairing knowledge with imagination to achieve excellence. They will be honored at the upcoming FOYA Banquet, which will be held during the ISPE/FDA/PQRI Quality Manufacturing Conference, 5–7 June 2017 in Bethesda, Maryland, US.

You can’t really talk about manufacturing without invoking quality—that elusive attribute, equal parts quantitative and qualitative, whose whole is infinitely greater than the sum of its parts. It is both a goal and a fundamental characteristic of the medicines and devices we manufacture.

Quality manufacturing will keep drug shortages at bay and produce safe, effective medicines that are available and accessible to those who need them, wherever they are located. To achieve these lofty goals, industry must embrace a quality culture mindset, and adopt the tools needed to instill that mindset in employees and suppliers.

Inspiration Innovation Intelligence

In this issue, ISPE’s Chair Mike Arnold looks at Industry 4.0 and what it augurs for manufacturing. He likens the next wave of changes to the mobile revolution of the 1990s, and draws parallels with our collective effort to make drugs more accessible and affordable to patients.

Our special report looks at continuous manufacturing from the perspective of the organizers and key presenters of ISPE’s first Continuous Manufacturing conference in April 2016.

And our cover story pays tribute to an engineer’s engineer, who believed in the power of his vision not just for himself, but for the pharmaceutical industry as well.

Count On Ispe

We can’t manufacture imagination. Excellence, on the other hand, we can: by training our students and Young Professionals to value it, our middle managers to foster it, and our executives to recognize and reward it. By embracing change and planning for it.

It won’t be long before Industry 4.0 has reached beyond manufacturing to change the way patients access and use drugs, or for the pharmaceutical manufacturing industry to reimagine what it means to manufacture drugs and medical devices. And for the drugs themselves to be reinvented by the biopharmaceutical sector.

Industry professionals around the world are conceiving a new architecture of drug manufacturing. We at ISPE are here to support, reward, and recognize it.