Companies operating in the drug delivery sector need to fully take account of the “fourth domain” of patient centricity in addition to safety, efficacy and quality considerations.

This was the message at a recent keynote address on the Future of Drug Delivery at the CPhI Festival of Pharma virtual event, sponsored by Aptar Pharma.

Anne-Lise Ducournau Lichtenberg, pharmacist and contributor to the collaborative platform, Patient Focused Medicines Development (PFMD), told the event that it had identified more than 150 activities in which patients could be involved during drug delivery development.

“To the question, when is the right time to involve patients, the answer is there is no right time – it can be any time, at any step,” she said. “The goal for drug delivery is to ensure maximum health outcomes and benefits for the patient. Whereas in the past, the pharmaceutical industry has been mainly focused on developing drugs for widely spread chronic diseases touching large populations, nowadays we are going more and more into targeted personalisation and rare diseases.”

She said that there was now an increased complexity in the world of drug delivery and while the emphasis on safety, efficacy and quality remains, there was now a “fourth domain” of patient centricity.

Ducournau Lichtenberg estimated the financial cost per year of patient non-adherence to treatment at USD 100 million.

“It’s fundamental to develop a treatment that patients are eager to take,” she said.

In the area of drug packaging, she gave the example of a special syringe developed by one company which was co-created with patients with rheumatoid arthritis — who have difficulty self-injecting products – “so that the injection experience was totally enhanced and they have been able to do it themselves.”

“It’s all about finding that fine balance between what’s feasible from a product point of view and what’s desirable from a patient point of view, and how you combine together all those expectations into one final drug that will benefit patients,” she concluded.

Nicholas Brooke, executive director at PFMD and The Synergist, said that enhanced patient engagement was not only just an expectation on the part of drug regulators but was also becoming “a new norm” in the eyes of those in the industry, who are seeking to develop a competitive advantage.

“The issue is that there is no proper methodology – people have different perceptions of what patient engagement is, and even during the life-cycle of one molecule within one organisation, some of the teams in the different phases would sometimes do things that are in contradiction,” he told the event.

Tim McLeroy, Executive Director of Marketing and Patient Services at Noble, part of Aptar Pharma, said his company was expanding its services to “deepen its connection with the patient.”

“Human factors have been a place where we are now starting to do threshold analysis, summative and informative studies,” he said. “It gives us insights into how patients are interacting with devices and helps us to start to plan and pre-launch. We’re now expanding into patient onboarding services as well, and that comes from understanding the patient from the very beginning.”