We spoke to Jessica Scott, Head of Takeda’s R&D Patient Engagement Office, about how patient engagement aligns with the company’s core values and how the PFMD Quality Guidance underpins its activity in this space

Tell us about Takeda’s key patient engagement activities?

Patient engagement (PE) is very much aligned with Takeda’s corporate priorities: starting first with the patient, then trust, reputation and business follows. The company is dedicating resources to this new function, resulting in implementing this strong vision and alignment across R&D. 

What this means for Takeda is we are moving forward with PE without needing to wait for evidence of return on investment: we have embedded patient engagement across R&D by incorporating it into our R&D KPIs (key performance indicators) such that every global programme team is required to include PE activity in their 2019 goals.

How has this translated into results?  

The informational need varies for each global program team, the disease area and where they are in development. PE activities are developed to meet those particular needs and thus are very context specific.

Some examples of the impact of PE on programme teams are:

  • Identifying a significant unmet need that had not previously been identified in the literature or by physicians.  
  • Understanding what trial participants would be willing to forgo in terms of symptom control in order to participate in a trial for a potential new medicine which might slow disease progression of a degenerative disorder. 
  • Learning that people living with Friedreich’s Ataxia would rather retain fine motor skills and coordination, like hand function, than the ability to walk. This resulted in a change of primary endpoint for a clinical trial.  

How does PFMD membership help you in working towards your PE goals? 

Takeda has helped to develop the PFMD Quality Guidance and the collaborative effort through PFMD has proven to be extremely valuable. We have incorporated the Guidance into our internal Takeda Guidance for how we conduct PE activities. It’s really the basis of how we engage with patients in R&D. Ensuring that our engagements are of high quality enabling us to gather deep insights through each engagement which then informs our decision-making, internal and/or external.

We have also worked with the Parkinson’s Foundation to apply the Guidance to a PE activity we conducted together. We provide feedback to PFMD on that experience. For 2020, we’re really looking forward to increased participation and collaboration with PFMD working groups. 

What are your future plans for PE projects in 2020 and beyond? 

In 2019, 30% of our global teams will have developed a PE plan – an overarching roadmap for how we’ll engage patients and the patient community over the course of the development of an asset. In 2020, that KPI will move to 100% of global programmes and our office will be driving and supporting those activities. 

We are developing a platform for returning individual data and results to study participants. This is a great example of PE insights that we’re acting on because we repeatedly hear that this is what patients need and want and it’s the right thing to do. 

We are also looking at the burden of clinical trial participation on patients. One of our recent patient advisory boards focused on reducing the burden of bio-sampling and imaging in trials. That has led us to the development of a set recommendations for teams across all therapy areas to develop clinical trials with the needs and interests of patients in mind. For example, we are looking to embed a process whereby teams work cross-functionally to minimize specimen sampling needs, review timing and consider less burdensome alternative tests. 

What is your message to other stakeholders on the value of patient engagement?

The key message is that although we may not be able to measure PE in the traditional sense to gauge return on investment – and that’s okay – we are progressing towards making patients true partners in drug development. For Takeda, we are taking action and changing the mindset from developing medicines for patients to developing medicines with patients. 

Do you think PE is finally becoming mainstream in medicines development? 

We are already seeing evidence of the value of R&D patient engagement and we communicate this internally through five-minute videos spotlighting specific PE activities. We’ve also shared some of these at conferences and in other external fora. 

We’ve defined PE in line with the DIA definition, as a two-way dialogue. Using this definition provides for engagements that enable a deeper understanding of patients’ perspectives as compared to other methodologies – such as surveys, for example, where we may limit the scope of patients’ responses by framing the questions. The two-way dialogue allows us to discover what we don’t know and would not have even realised without the input from our most important partners in developing new medicines and involving them early in the process allows us to translate these insights into action.

There is still a long way to go but as our teams experience PE their appreciation of the value of it grows. They also see it as the right thing to do for patients. The more experience our teams have, the more it will become mainstream.