Designed with the Patient in Mind

Patient-centric drug development is becoming more prominent in the bio/pharma space thanks to increasingly informed patients, a rise in drug development targeting niche disease areas, and the evolution of the regulatory space to reflect the importance of patient experiences. Not only can drugs designed with the patient in mind be more effective at lower doses, have fewer side effects, and be less invasive, they may also improve adherence rates, which ultimately provides a significant economic incentive for all involved (1).

Pharmaceutical Technology discussed the topic of patient-centric drug development in more detail with Joy Mendez, head of Global Marketing and Commercial Strategy at Bavarian Nordic, an international biotechnology company based in Denmark.

PharmTech: Why is patient-centricity an important consideration for drug manufacturers during the development/formulation stages?

Mendez (Bavarian Nordic): It is important to consider the patient’s point of view to be sure that any given product is suitable, understandable, and does not pose barriers for use. If a dosage form is inconvenient, difficult to take, or overly complicated to use, it can raise barriers for patients and affect compliance. Compliance is critical to ensure the most benefit is obtained from the medication. 

Additionally, any drug development must consider special patient populations and if supplementary clinical data or formulation work needs to be done to support them. The special populations will be specific to the therapeutic area and the disease that is targeted with the medication.

PharmTech: Has the industry move away from the ‘blockbuster’ increased the need for patient-centricity when developing and formulating a drug product?

Mendez (Bavarian Nordic): The fact that not all patients have the same needs and expectations even when they have the same diagnosis is important to consider. Understanding those differences among patients allows for better informed development when it comes to formulation, presentation, and packaging in addition to ensuring the medication addresses clinical unmet needs that are meaningful to patients.

PharmTech: What kind of delivery issues can companies face when developing and formulating drugs, and how can drug delivery be used to improve patient-centricity?

Mendez (Bavarian Nordic): There is a wide range of challenges that can present when it comes to drug delivery. It can often take quite some effort to find a solution that also results in a well-accepted presentation for patients. However, already understanding what patients need and are willing to accept will narrow the options to be considered when addressing delivery challenges.

PharmTech: Are there other technologies that can help to improve the patient-centricity of a drug formulation?

Mendez (Bavarian Nordic): Certainly, there are options for improving patient-centricity. As a vaccine company, we tend to deal with intravenous, intramuscular, and subcutaneous modes of administration where we want to ensure the duration and frequency are easy for patients to manage and cause minimal to no side effects. 

However, other modes of administration are often needed, for example for certain age groups or for those who are particularly afraid of needles. Inhaled, sublingual, or oral formulation technologies are options for non-injectable formulations. 

Also, important to consider are storage conditions that allow the vaccines to be stored for longer at a variety of temperatures. All these options make it easier for patients, particularly in case they need to take the vaccines home for self-administration.

For vaccines specifically, there are numerous formulations and presentations available, and various options can also be considered to address bioavailability issues. Furthermore, patients are becoming more flexible in the formulations they are willing to take and new methods of delivery are no longer a barrier, as long as they are convenient and understandable.

PharmTech: Have you noticed any specific trends over the past few years regarding patient-centric drug development?

Mendez (Bavarian Nordic): Certainly, there is more patient-centric work being done in different therapeutic areas, but the most changes would likely be in oncology. Understanding a patient’s specific genetic profile and tumor characteristics has led to more specifically targeted treatments being developed and even treatments being personalized to each single patient. Patient centricity will certainly continue to improve as the differences and commonalities across patients and barriers they face become better understood.

PharmTech: How can drugs be designed for affordability?

Mendez (Bavarian Nordic): Of course, it depends on the technology being employed. When in initial stages of availability, new, highly personal treatments tend to be costlier, but as time goes by, processes will improve that will allow prices to go down.

Reference

1. A. Siew, “Patient Centricity Takes Center Stage,” Pharm. Tech. 41 (11) 16–23 (2017).