July / August 2017

Advancing Innovative Technologies

Michael A. Arnold, RPh

Over the past several years, I’ve presented on various topics aligned with “emerging technology” in our industry. I routinely concluded those presentations stating, “He who has technology wins!” At that time, of course, I was referring to pharmaceutical manufacturing companies.

It’s now clear, however, that we are at the point where our patients are also well positioned to win. Few will argue that over the coming decade medicine will become more personalized as biotechnology evolves. In addition, patients will more routinely play a significant role throughout the supply chain, not only at its end.

While there is nothing more exhilarating than the prospect of affecting patients’ lives for the better, no challenge is more daunting. In addition to manufacturing technologies, for example, there are technologies that support the conduct of clinical trials that are integral to our success in serving patients. The challenges associated with emergence of these technologies include global regulatory standards for use and acceptance. We must overcome these and other challenges if we are to be successful.

ISPE recognizes that helping the industry advance involves more than training its people in the basics of facilities and equipment, production systems, and quality systems. We intend to strengthen our position as the go-to organization for knowledge regarding designing, building, and operating pharmaceutical plants across all technology platforms. We will continue to respond head-on to developing industry issues by fostering knowledge exchange and related professional development to achieve results. As always, through our efforts, we hope to improve patients’ access to quality medicines.

Key to our success is promoting member access to the regulatory agencies that help bring drugs and new technologies to market. At the ISPE/FDA/PQRI Quality Manufacturing Conference, held in Arlington, Virginia, from 5–7 June, more than 20 FDA representatives took time out of their week to interact with attendees, lead working sessions, and answer questions. The FDA regulatory panel held on the last day saw seven FDA staff answer questions on topics ranging from quality metrics to the mutual recognition agreement (MRA) and emerging technologies. The questions came from informed participants, and answers from the FDA were frank and straightforward. There are few associations that can offer such access to its members, and we feel privileged to be able to do so.

ISPE values its working relationship with regulators as we work to fulfill both regulatory and industry objectives. Our most recent decision—to rename the former ISPE Regulatory and Compliance Committee to Regulatory Quality Harmonization Committee (RQHC)—reflects our desire to partner with regulators in developing strategies that will promote global harmonization.


Regulators around the world continue to address the inevitable pipeline of new pharmaceutical manufacturing technologies. This is a space where industry and regulators need to partner frequently and effectively. The FDA’s Emerging Technology Team (ETT) in the Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) demonstrates the agency’s focus in this space. And the spirit of collaboration that surrounds it, in both intention and action, is one we should all share.

More than half the year may be behind us, but what lies ahead is very exciting: ISPE’s European and American biotechnology conferences, Process Validation and Process Validation Statistics Conferences, the 2017 Annual Meeting, the ISPE Biopharmaceutical Leadership Forum … and that’s just the conferences! Our roster of training courses in North America and Europe provides timely access to insights on data integrity, C&Q, biotechnology manufacturing facilities, and GAMP® GxP process control. I hope you will take advantage of these opportunities to enrich yourselves, learn, and collaborate with your peers.

To support these and other global initiatives, the ISPE International Board of Directors has approved the establishment of the ISPE Foundation to support education, training, and research for the advancement of innovative technologies. The foundation will also address global challenges in the development, manufacture, and supply of quality pharmaceutical products for the benefit of patients around the world, and provide a platform to support our Chapters and Affiliates. We look forward to working closely with them to identify global initiatives that will promote our industry and benefit ISPE members industry-wide, regionally, and locally.