“A pioneering opportunity”: piloting the first How-To Guide

by | 26 Jan 2021

Danielle Barron speaks to Schiffon Wong, Executive Director, Global Evidence & Value Development at EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, about how piloting the new “How-To Guide for Patient Engagement in the Early Discovery and Preclinical phases will help shape their future patient engagement practices
 The PFMD How-to Guides are designed to be a valuable and useful resource for organisations involved in all aspects of patient engagement. But for organisations at the very beginning of their patient engagement journey, they will be indispensable.
Wong explains that Merck KGaA, Darmstadt, Germany, historically did not receive any direct input from patients during the preclinical phase. A review of the How-to Guide by those involved in the Translational Innovation Platforms organization, which works on discovery stage projects, was initiated by Wong. She was impressed by the co-creation involved in the development of the How-to Guides and suggested this was the tool that could kick start their patient-focused drug development efforts at this early discovery stage.
“The How-to Guide helped our discovery scientists understand; wow, these are the things we could be doing to include the patient perspective, so for us, this is a very pioneering opportunity,” Wong says.
“The How-to Guide is helping us pull patient-focused drug development forward into discovery in a way that has been informed by PFMD’s broad co-creation approach. And we know that we’re already anchoring this in best practice.”
Merck KGaA, Darmstadt, Germany will now become the very first biopharmaceutical company to implement the How-to Guide to Involving Patients in the Early Discovery and Preclinical Phases. It’s no wonder Wong says the discovery team are “very excited” about the pilot and the potential of patient engagement. Having begun in September 2020, it is due to run until at least the first quarter of 2022; “and by the time the pilot concludes, we plan to have a target product value profile that has been informed by this entire process,” she explains.
The experiential perspective of Merck KGaA, Darmstadt, Germany will be an invaluable aspect of the pilot process. Using the guide in practice has already highlighted potential opportunities for further refinement of the guide; for example, the How-to Guide assumes one disease condition is in focus at the time, however, in the circumstances of the discovery team, nine possible disease conditions are currently under consideration. “We are now incorporating patient experience data into the decision-making that determines which possible indications will be prioritized to advance to development.”
While they are at an early stage in the pilot, Wong already believes the How-to Guide could become an integral component of their initial preclinical analyses going forward.
“The discovery teams may say, yes, in addition to mechanistic, medical, and scientific analysis, we need the patient perspective. And if we get that buy-in, I definitely believe we’ll be in a position to recommend that this How-to Guidance be considered for all our discovery teams.”
“This pilot is one way we are driving our evolution towards a more patient-oriented organization. While the near-term impacts of the pilot are integrating patient insights prior to first-in-human and in the target product value profile, the ultimate goal is to develop a drug that will make a meaningful impact on patient lives.”
That’s why Wong says the patient should be at the forefront of their minds from day one. “At the end, we’re going to be able to deliver an innovative medicine that really fits into the context of a patients’ lives, and ultimately, improved health outcomes[FB1] .”
Getting patient input early on sets the direction for an array of subsequent activities, Wong points out. “Understanding this, we are excited about our recently announced commitment to patient-focused drug development. Patients and caregivers are the experts and we must involve them throughout research and development. We strongly believe that our approach to patient-focused drug development will have benefits for individual patients, for patient communities, and for improved public health around the world.”

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