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Monday, February 6, 2023
Home Pharma & Biotech Drug Discovery and Development Re-shaping the business model by placing the patient at the center

Re-shaping the business model by placing the patient at the center

By Nelio Drumond, Associate Director, Lead Process Scientist – Global Manufacturing Sciences, Drug Product, Takeda Pharmaceutical Company

The increasing prevalence of Patient Centric Drug Product Design within the Pharmaceutical Industry

Somebody wise once said: “You can’t deliver tomorrow’s innovation, if you’re still using yesterday’s business models”. Personally, I am a big fan of this statement and agree to the extent that I quote it in every life sciences event that I’ve been invited to speak at. Patient Centric Pharmaceutical Drug Product Design is my expertise and advocating on its behalf is my mission. You might be wondering, what is Patient Centric Pharmaceutical Drug Product Design? Don’t worry, this article will hopefully explain it for you.

Patient centric care is a term being used increasingly in clinical settings and research publications, however, it might still not be clear for many what it means. A basic assumption relates to the patient involvement within healthcare processes and its providers. This assumption is indeed correct, however, patient centricity is a much broader subject that integrates patients’ personal values, beliefs, and individual preferences into their therapeutic choices so that the most appropriate treatment for that specific patient, in that particular moment in time, can be provided by the healthcare professional. By doing that, patient centric care allows for patients to have an active voice in determining which healthcare provision is best for them. The word “centricity” is used to demonstrate that the patient is always at the center during healthcare provision (Fig. 1), while the involved stakeholders support the patient to navigate the decision-making process of identifying which therapy will bring the best benefit.

Fig. 1. The patient at the center during healthcare provision as basis for the patient-centric model.

Previous reports have suggested that patient nonadherence to prescribed treatments is estimated to cost around US$100 billion every year. Ensuring adequate patient adherence and therapy effectiveness is crucial to reduce the incidence of administration errors and potential adverse drug reactions, therefore lessening overall healthcare costs. One might ask oneself: how are we still experiencing this scenario in the 21st century, considering the recent developments in digital technology? There are several reasons. However, the main predicament, in my opinion, is in how the pharmaceutical business development model remains unchanged. The model should be matured to allow for quick adoption of new efficient methodologies, considering the current speed of tech innovation.

Patients themselves also evolve, and their preferences are likely different than what was being done 20 to 30 years ago. However, as the pharmaceutical industry lives and breathes within a heavily regulated environment, it is unfortunately required more time and effort to affect change. The model continues to prioritize compliance with regulatory requirements and return on investment, rather than gathering efforts on the development of pharmaceutical drug products that can meet the individual needs of the final consumer – the patient themself. Nevertheless, as we are currently facing an era of constant change and innovation, this creates, in my opinion, the perfect environment for challenging and bringing new critical thinking onto the table in order to extend the pharmaceutical business model, preferably to one in which the patient plays a central role.

Patient Centric Pharmaceutical Drug Product Design is a combination of the terms Patient Centricity and Pharmaceutical Drug Product Design. This research field addresses the specific needs of the target patient populations and how best they can be incorporated into the design of a drug product during clinical development. In an ideal scenario, the design should include non-complex elements that are intuitive and can support the patient to use it as intended, without the need for specific training or supervision. As such, by applying a patient-centric model, increased attention would be given not only to the dosage form design to ensure that the patient is able to administer it correctly, but also to the packaging design to confirm that the patient is able to easily access the medication.

Back in 2008, a revised ICH Q8 guideline has addressed the need for drug products to be designed according to the specific needs of the targeted patient population. Notwithstanding, current pharmaceutical pipelines still do not seem to be properly addressing the specific characteristics and needs of patients. For example, even though it is known which specific user group is expected to benefit from a certain drug product under development, it is usually the case that the targeted patient population is not properly represented in the conducted clinical trials. The implementation of patient-reported outcomes was a good start to promoting a patient centric approach during clinical trials, however, there is still more to be achieved. Another milestone is to ensure that the target patient population for a new investigational drug product is well established and appropriately represented in the clinical trials. Following that, clinical programs must be expected to assure that a proper environment is created for the patients to feel empowered to provide valuable feedback on how they perceive and intuitively use the investigational drug product. Lastly, it must be guaranteed that adequate clinical methodologies, with defined and clear endpoints, can be used by applying the subject of patient centric pharmaceutical drug product design to convert patient feedback into a drug product that is designed to meet the individual needs of the target patient population. Therefore, anticipating the characteristics of the targeted patient population during drug product design is more likely to generate an optimized pharmaceutical product that delivers the specific needs of patients in a real-world setting, something which the current business model is not considering during randomized clinical trials.

The recent multi-stakeholder framework conducted by the European Medicines Agency in September 2022 on patient experience data in medicines development and regulatory decision-making shows, without a doubt, huge progress towards the implementation of a patient centric model within the Pharmaceutical Industry. Slowly but steadily, we will get there.

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