Dec 31, 2019:
Dr Ayaaz Hussain Khan, Global Head Generics, Navitas Life Sciences (a TAKE Solutions Enterprise) emphasises that patient centricity should form the crux of pharma drug design and development
The advances in technology has empowered patients, making them more knowledgeable, with better access to information than ever before. Patients interact with their peer groups and other patients online and exchange experiences, taking part in support groups and, thereby, contribute to real-time data generation. This empowerment has improved patient visibility, with an expectation to be heard during drug design and development.
The pharma industry too is recognising patients as important stakeholders in their healthcare dialogue. Food and Drug Administration (FDA) and European Medicines Agency (EMA), which are authority regulatory bodies, are incorporating patient input into their decision making.
It’s not just the authorities but publishing houses as well that are catering to the shift in perspective. An interesting initiative launched by The British Medical Journal in 2014 required clinical trials publications to incorporate insights from patients by including them as peer reviewers, authors, editors and even guest contributors. Such strategies help in showcasing patient perspectives.
A step in the right direction
The change in the social landscape where patients are becoming increasingly aware has laid additional stress on health care. There is a strategic balance between the need to act in the best interests of patients while managing costs of the pharma industry. Earlier, pharma companies were focused on making profits, getting involved in the cycle of investing in new drugs, recovering the costs of R&D and making a profit. Though it is important and understood that pharma companies need to make profits, a shift in focus on patients will help their products do well in the market and benefit the patient as well.
How will a patient centric design help develop better drugs?
Patient centricity during drug design will help in addressing key requirements of a target population, like the needs of people with impairments or certain co-morbidities. There could be factors that may affect usage of certain drugs, making it imperative to develop drugs that are appropriate for use. A case in point is the use of child lock in medication packages which may not be user friendly for people with arthritis. Another example would be the inability to read information booklets provided with drugs due to poor vision or poor literacy standards.
The development of solid oral dosages is another important focus point of patient mediated customisation. Pediatric or geriatric patient populations have an inability to swallow tablets or capsules. Pediatric patients are often faced with a fear of chocking while consuming oral dosages, while mentally challenged patients are known to skip taking medications by hiding the pills in their cheeks.
A startling study conducted in India showed that 90 per cent of patients who discontinued their epilepsy treatment did so because they could not afford it. If the target population is unable to afford the medication, then the drug will not be as commercially viable, even if it was a highly effective formulation. A sniff of patient centricity in India is evident with the government hinting at the design and development confidential of generic drugs to combat the high costs of branded drugs. As a sort of checkpoint, the Government has made it mandatory to carry out bioequivalence studies to understand the efficacy of the generic drugs against the branded drugs.
An understanding of the needs of the target population will, therefore, help in designing mechanisms that promote the use of the drug among the targeted population. Identifying specific requirements of the patient population during product design has a higher likelihood of being relevant to patient needs in a real-world setting. Such considerations are not widespread in the current clinical trials scenario.
Promoting better usage in the market
Quantifying initiation, implementation and discontinuation of medications help in measuring the correct and incorrect dosing practices. Such data can be used by drug developers in developing formulations with market outcomes that are closer to those predicted during clinical trials. This could make the product commercially viable, while failure to do so may be commercially disastrous. A study conducted in the US showed that more than 50 per cent of medicines that were prescribed were not taken correctly or not consumed at all. One of the factors associated with non-compliance in India is lack of education about the prescribed medicine. This reduces the efficacy of the treatment, while increasing the risk of negative health outcomes and a failure of the drug to do well in the market.
Using AI to get more data points in clinical trials
Many pharma companies and healthcare providers understand the need to get patient specific data, collected either from patients’ diaries or sensor technology. Such data collection may be carried out even during the clinical trial process. The Apple watch heart study is a case in point, where real time data of over 400,000 participants was collected to understand heart health, taking experimental studies out of the confines of closed doors.
Another essential use of technology in understanding patient behaviour is in the use of synthetic control arms which removes the need of patient population on placebos or under standard care. This also increases the number of patients who will receive the potential therapy, impacting the progress of their disease condition.
Pharma companies are now working on collecting multiple data points like a patient’s genomic, phenotypic, molecular and clinical data. The multiple variables that are collected could be used to simulate clinical trials, improving clinical trial outcomes and reducing the time taken to complete trials.
Healthcare and pharmaceutical companies guide and engage patients through social media based on the services that they may need. There has been a steep increase in the number of patient communities, which are great for crowd sourced information. The use of analytics on such patient chatter will throw better insights and real time data that can be used to tailor pharmaceutical services. Such online communities also provide one of the early warning signs of diseases like flu.
Patients now not only have their own health records in hand, but they also decide who to share it with. Moreover, wearables help such patients monitor their health and connect with their doctor, while the devices also act as alarms alerting doctors about an impending health outcome. This information will not only be used to help the patient concerned but will also be used to develop better treatments that could help many more.
Driving factor for innovation
Patient centricity, therefore, should form the crux of pharma drug design and development. Affordability has been one of the key driving factors for generic medicines, and with patents of some top branded drugs getting over soon, there are a lot of new drugs that are expected to enter the market. Flexibility and ease of use have promoted the spread of wearables that monitor fitness and health. Medicines for children are no longer bitter and difficult to swallow formulations but pleasant tasting wonder drugs that support the interests and needs of the patient. A closer to home example is that a mother is more likely to prefer fruit flavored and sweet tasting syrups that a child is more likely to swallow rather than a hard to swallow tablet. Patient centricity is the driving factor for innovation in pharma, a pulse on the needs of the target population could go miles in terms of market acceptability.
|Dr Ayaaz Hussain Khan
Global Head, Generics,
Navitas Life Sciences