Janssen’s Catherine Taylor, Vice-President, EMEA Medical Affairs, Therapy Area Strategy, discusses the importance of systemic innovation across the healthcare system to realise the full value of medicines.

Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world. As an oncology trained medical doctor who practiced in the UK NHS for 10 years, I have seen the benefits first-hand, as patients live longer lives, free from symptoms, and are able to return to work.

Beyond that, there are positive impacts for wider society, healthcare systems and economies.^[1] It is essential, therefore, that we continue to streamline the development, regulatory and access process, so that patients have faster access to better and safer medicines.

Cultivating a pro-innovation environment

To achieve this, it will be critical to maintain a pro-innovation environment. Systemic innovation isn’t limited to discovering new molecules, it’s a mindset we must continue to apply across the board. We need to be able to think outside the box and find new interventions and new delivery methods that lead to better and more sustainable standards of medical care.

Because, despite the great improvements made across the industry in recent years to accelerate innovative development, we still face many challenges. Innovative ‘next-generation’ medicines are met with a series of hurdles such as increased cost of development, regulatory challenges and delays, and longer and more complex clinical trials. And it all fuels the debate: are medicines a cost or an investment?

The answer to this question comes back to our definition of value. Value-based healthcare is a delivery model in which providers are rewarded based on the value and difference they bring to patients’ lives, rather than volume of treatments provided.^[2][3]

A few months ago, I spoke with Professor Joaquin Mateo, Chair of the ESMO Translational Research and Precision Medicine Working Group. We agreed that one of the key future foci of innovation in medicines lay in the treatment of patients with medicines targeted specifically towards the molecular signature of their disease. The ideal state is that one day patients only receive (and the healthcare system only provides) medicines that will improve their condition. While we have made great progress with some diseases, we are not there yet, and we need to ensure that focused investment into research continues to bring the value that patients truly deserve.

The role of innovation in value-based healthcare

Delivering value for patients doesn’t start and end in our R&D labs; actions can be implemented across all stages of the drug development lifecycle to encourage and embrace a pro-innovation environment.^[4]

For example, alongside stable, transparent and long-term policies or research plans, incentives can encourage innovation from those willing to take risks and tackle areas of unmet patient need. Effective intellectual property systems are also essential in stimulating research and sustainable innovation for the future.

And strong collaboration from all involved in health research is another key component of a value-based healthcare approach. From patients, patient bodies, pharmaceutical companies, and academia, to regulatory bodies, public institutions, and small and medium-sized enterprises (SMEs), all key stakeholders must come together to help the patients who most need new medicines to access them as quickly as possible.

The European Commission’s Pharmaceutical Strategy for Europe, adopted in November 2020, outlines a series of concrete actions to ensure accessibility, availability, and affordability of medicines. ^[5]The Strategy also highlights the importance of drawing lessons from the COVID-19 pandemic to enhance crisis preparedness and response mechanisms, and so help make the healthcare industry more prepared and resilient.

How can innovation within Medical Affairs drive value?^[6]

Medical Affairs is at the forefront of driving innovation across our industry, making it an exciting and ever-evolving area to work in. From innovative evidence generation to accelerating medical treatment adoption and transforming medical engagement, our teams play a huge role in helping to deliver much-needed treatments to patients across the world.

According to EFPIA, there are over 7,000 medicines currently in development globally. As part of this, innovative treatments such as CAR-T therapy and retinal gene therapy are emerging as ways to target rare diseases, multiple indications and underserved populations. Such therapies present significant challenges to our current regulatory and access processes, but these are challenges we must overcome if patients are to benefit.

The key, of course, is to always start with the end goal in mind – what change do we want to bring to patients? So, alongside developing and providing the treatment itself, it’s also important to provide comprehensive medical education, and to explore new patient pathways and delivery systems. That way, everyone understands the value of the treatment, and the route to getting it to the right patients at the right time is clear.

Data will always be central to everything we do, as it has the power to communicate the potential of a new treatment to change a person’s life. If we are to move towards a value-based healthcare system, then we must utilise the power of both clinical trials data and real-world evidence, to produce the best possible data package for regulatory submissions. Effective data analysis can lead to accelerated access and improved outcomes for patients. And building the voice of the patient into our business innovation is crucial – we need patients’ unique perspectives and experience to keep us focused on solutions that will have the largest impact on their lives.

At Janssen, we strive to improve access to our innovative medicines and vaccines and achieve the best possible outcomes for patients across the world. Where I feel Medical Affairs can move the needle is as the scientific bridge, engaging with key stakeholders like clinicians, researchers, payers, policymakers, and regulators. Our role is to help translate the data and impactfully articulate the demonstrated medical value of a medicine; and to collaboratively explore how the value of that medicine could be improved. Ultimately, we want to ensure that those patients who could benefit most from our treatments are able to receive them – that’s what drives our Medical Affairs purpose.

This blog first appeared on Pharmaphorum on 11 April 2022

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