By Hilary Thomas
The life sciences industry – and pharma in particular – is moving from a Business-to-Business to more of a Business-to-Consumer model for many medicines – where the patient and their family is the consumer. This reflects the shift toward more personalized medicines and greater autonomy for patients which has been further accelerated during the pandemic. More virtual appointments, the unmanageable pressure on healthcare systems, and demographics all mean that enabling patients to self-manage or be treated in or closer to home is key. But for this to happen at scale the life sciences industry needs to be part of the solution. In this article we discuss the healthcare changes brought about by the pandemic, and how life sciences organizations need to respond.
PATIENT EDUCATION AND INFORMATION
Over the past 2 years or so some key players in the industry have become household names, and their brands well known. Public awareness of these companies is unheralded and consequently their research, discoveries and products are now under greater public scrutiny than ever before. To respond to the pandemic, governments needed to create accessible material and set up distribution channels for information related to COVID-19 vaccines. Such accessible, yet detailed information has had to be presented in a more digestible way than what the industry is used to. A copy of the summary of characteristics is no longer enough. Access to this level and quality of information will be a new normal expected by regulators and it will need to be available in digital and interactive formats and be mindful of the target audience. As this shift occurs positive engagement with the public will be essential, with trust and transparency differentiating companies from their competitors.
PANDEMIC-FUELLED INNOVATION
Whilst innovation in response to COVID-19 has been exceptional to save lives and enable the world to return to normality, many projects deemed less critical were halted or deprioritized. So, sustaining the business-as-usual aspects of drug development has been challenging. The registration of published patent applications has plummeted; non-clinical and clinical trial submissions were deprioritized; recruitment has stagnated, and important data has been missed in the effort to get patients to investigational sites. Consequently, fewer products reached the market than intended. As a result, there has been a need for greater innovation in clinical trials – with a shift toward decentralisation and more management based at home. These are surely patient-centric improvements, and it will be important not to revert to pre pandemic practices but to sustain this level of innovation.
DECENTRALIZED TRIALS
The pandemic accelerated the need for and move toward decentralized clinical trials (DCTs) which have a lower impact on operations and also dependence on physical facilities and resources, making trials more accessible to diverse populations, given the need for less frequent visits. Life sciences organizations need to sustain the pace of DCTs and revert back to traditional models. By doing so they will become closer to their ultimate customers, take on a more significant role in shaping healthcare ecosystems and as a result help to address inequalities in the evidence base for new therapies.
TREATMENT AND DIAGNOSIS CLOSER TO HOME
During COVID-19, remote consultations were widely adopted – with the NHS reaching its 2023 target for virtual consultations in a matter of months in 2020. Virtual consultations are here to stay, and consequently home-based treatments will have to follow. This will require patients to be supported with more information and smart solutions to aid adoption and safety. Greater patient-centricity including more streamlined care and pathways are the holy grail and life sciences companies need work with healthcare organizations to deliver home-based solutions, so that the wider adoption of innovative medicines is possible.
Not only are treatments closer to, or in the home being facilitated, but the widespread use of COVID-19 diagnostics also has accelerated the use of the at home diagnostic. From lateral flow tests to a host of digitally enabled tests to monitor disease more conveniently. However, during the pandemic we saw a significant decrease in clinic-based diagnostic tests, including imaging, which has led to delays in diagnosis for many serious conditions. In this more patient-centric, agile future which is less dependent on the hospital and healthcare professionals, pharmaceutical companies will take a more holistic view of the total costs of care and barriers to uptake. As healthcare organizations continue along the digital transformation journey, and with a wider adoption of digital platforms, assets and devices, there will be a great focus on population health and outcomes far more than the current short-term approach. This will mean more seamless care pathways which are supported in real-time and not stochastically at hospital attendances, enabling the patient to be more pro-actively involved in their care. There is a role for Life Sciences companies in enabling the investment and evidence base for these changes to be adopted and become embedded in standards of care in the future.
SUPPLY CHAIN
The distribution of drugs, active pharmaceutical ingredients (APIs), medical devices and others, was severely undermined during the pandemic. In some countries there was not only a shortage of beds but also oxygen. Panic buying and lack of renewed prescriptions also led to a shortage of medication for long term conditions, and for vaccines, new supply chain routes had to be drawn, especially for items in the cold chain – which was not achievable in every country. While the peak of pandemic is behind many of us, a rethink of historical supply chains is needed, away from the just in time historical approach. Whether it’s the source of API and excipients, diversifying suppliers and geographies (avoiding the risk a specific country changes legislation/guidelines) to allow at home delivery from manufacturers, distributors or pharmacies/hospitals. An optimized factory to patient supply chain might be a reasonable solution for drugs requiring special transportation and storage conditions that cannot be met with local smaller offers.
In that context, a change in supply chain cannot ignore changes in consumer behaviour. With some patients preferring to keep a larger stock of medications at home requiring fewer visits to pharmacies or hospitals, doctors may need to consider prescription limitations to adjust this changing trend. This will impact how pharmaceutical companies measure demand and consumption and may require them to consider investing in smart tracking solutions such as blockchain. This could even require a revision of shelf lives or packaging sizes.
REGULATION
Such disruption also will require a change in the role and agility of regulators who will have to adapt to new ways of establishing a diagnosis, monitoring disease, undertaking clinical trials, drug supply, reimbursement and much more. Innovation will be the new way of working – accelerated by the wider uptake and innovation in digital, data and analytics. Many regulators recognise that they cannot go back to pre-pandemic levels of activity and are embracing this new world, and this creates an opportunity for life sciences companies to work with them in a more collaborative way – enabling them to stay one step ahead as more data led (including real world evidence) and digital approaches enable medicines to be expedited more effectively to market.
Working closely with regulators for innovative solutions, making them part of the process, will assure a better understanding not only of new products but also the reasoning behind their creation. On one hand, facilitating regulatory approval and, on the other hand, providing understanding to develop new guidelines and regulations.
CONCLUSION
The future will require more digitally connected, and this will facilitate more community and home-based healthcare systems with changing models of care which are ultimately more patient-centric. The pharmaceutical industry needs to be part of the solution and not a parallel challenge, taking a more holistic view of the care a patient needs with a particular condition rather than offering just a pill or infusion. From early engagement by providing patient groups information materials of new and established treatments to personalized practical tools to assure support is given whenever patients encounter a hurdle, every step must be considered on the drug journey, not just administration.
The role of clinicians is also changing – they too need to be more adaptable and take on the role of patient advocates, enabling patients to navigate this new order effectively. The prize for these seismic changes is that we can deliver sustainable, quality care, within our resources – both financial and human. The latter perhaps being the more crucial.
About the Author:
Hilary Thomas is a healthcare and life sciences expert at PA Consulting. A senior clinician and former academic with public, private, regulatory, and voluntary sector experience, has over 30 years’ experience working in and with healthcare systems and life sciences companies to improve the quality of patient care and outcomes
