Are you listening? Patients will tell you what a good drug looks like.

By Melanie Senior

Patients’ voices are no longer a nice-to-have in drug development. They are a critical determinant of commercial success. As more drugs reach budget-squeezed markets, showing clinical efficacy is no longer sufficient. Products need to be clearly differentiated – in terms of meeting real unmet needs in a cost-effective manner.

Regulators’ guidelines for including end-users’ views are multiplying fast as patient advocates become more vocal – and rightly so. Cost-watchdogs like the US Institute for Clinical and Economic Review (ICER) are formalizing patient engagement programs to help them properly measure true value.

But collecting and interpreting sufficient patient voices to draw meaningful conclusions around major unmet needs is tricky and time-consuming. Focus groups and patient fora – the traditional approaches – are fraught with bias. People do not always feel comfortable talking candidly about health issues in small, in-person gatherings. Their views may be impacted by how a question is asked, or by the experiences of others in the room. Patients able and willing to show up at such meetings represent only a very tiny minority of the overall population.

What’s needed is a systematic way of collecting and analyzing insights from as many patients as possible, in a rapid, efficient and non-intrusive fashion that overcomes many or all of the biases that hamper existing methods.

Semalytix’ artificial-intelligence powered Pharos platform offers just that. It captures hundreds of thousands of patient voices from across millions of relevant online sources, including disease-focused discussion groups and other social media sites. Nearly a quarter of people across the developed world discuss their healthcare needs and concerns on the internet, resulting in an unrivalled pool of patient insights.

These insights are not only high in number. They are also provided freely, at a time chosen by the patients, and through channels selected by the patients. They are unprompted, and communicated in patients’ own voices, using their own language. As a result, they offer drug developers a more accurate, timely understanding of disease burden than traditional methods.

Pharos can help pharmaceutical companies uncover key drivers of patients’ treatment decisions. It uses patient-listening studies to identify and detail:

  • Disease burden
  • Current treatment experience
  • Outcomes achieved using specific treatments

For example, Pharos might help identify how patients feel a particular disease influences their family life, sexual activity or their ability to work. It could elicit the needs which are met by current treatments, and, more importantly, those that are not. It may unpick the trade-offs that a majority of patients make in selecting one particular drug over another. Pharos might also highlight triggers – such as particular side-effects, or administration challenges - that lead to patients’ ceasing or switching treatment.

This information not only helps sponsors improve their existing products – for instance, with a new delivery route or formulation – but can also inform decision-making far earlier in the development cycle. “The danger for pharma is developing a drug that will not be perceived as valuable by patients. Understanding the target patient population and their needs is critical to developing a relevant target product profile, and to demonstrating that product’s value,” says Janik Jaskolski, co-founder and Chief Executive Officer (CEO) at Semalytix. Ideally, that understanding comes before key clinical trials are designed, so that appropriate endpoints and measures can be included.

Aggregating patient voices online is not a one-off process. Patients’ views evolve as new treatments become available and experience grows. Pharos offers a cost-effective way to elicit those voices at regular intervals to inform development, pre- and post-launch activities, and life-cycle management. The platform includes an interactive dashboard where patient-reported opinions and concerns are analyzed and clearly presented, and can be easily interrogated by commercial and HEOR teams.

Semalytix’s approach combines qualitative and quantitative observation-based methods, and is relevant across almost all therapy areas. Lifestyle and quality-of-life considerations have long been recognized in chronic, highly-prevalent conditions such as cardiovascular or inflammatory diseases, respiratory illnesses or diabetes, but are increasingly relevant too in oncology, as life-extending treatments multiply, and in other less widespread diseases. “Patients are interested in much more besides classical clinical endpoints such as survival. Our product allows drug-makers to drill down to particular segments of the population and understand what would really make their lives better,” says Philipp Cimiano, Chief Technology Officer (CTO) at Semalytix.

Pharos is used by multi-national pharma firms across several therapy areas including cardiovascular and inflammatory diseases, oncology, etc. It has generated multiple, actionable insights, including triggering a decision to develop a new route of administration for a given therapeutic. “It is exciting to see how we can help contribute to improved health outcomes but also better, happier lives,” says Jaskolski.

For drug developers, happier patients makes commercial sense, too. As patients’ voices become louder and more influential in drug development, it is all the more important that drug companies learn to listen – and have the tools to do so.






Tags: Semalytix, "patient listening", "Health"