Lettie Kirk

3 mins 30/06/21
Author name: Dee Harper

Let’s Work Backwards: Patient centricity in OSD development

Lettie Kirk, Business Development Executive at Metrics Contract Services explores patient centric approaches in product development.

When Amazon develops a new product or service, it uses a working backward method. The approach starts with the product development team imagining that a product is ready to ship, and they must write a press release announcing its availability to the intended customer.

The release must focus on the customer problem, address how existing solutions fail, and detail the benefits of the new product and how it betters existing solutions. The release acts as a litmus test – if the benefits do not have the potential to interest customers, then they must be adapted and improved until they do, or the product will be shelved.

By applying the same rationale to drug development, beginning with the patient, and working backwards, innovative drug developers can create more successful therapies – both commercially and in terms of patient outcomes.

Patient-centric approaches

Pharma companies are already looking to get closer to patients and work with primary healthcare providers and other partners to create more holistic approaches to care. A key trend affecting the oral solid dose market is an increasing focus on useability and patient compliance from drug developers.

This increasingly patient-centric approach is driving a rise in demand for delayed (DR) and modified release (MR) oral solid dose products.

Release profiles

For formulators, MR/DR formulations enable drugs to be released in the optimal gastrointestinal (GI) locations to achieve desirable blood plasma concentrations for extended periods.  Strategic selection of excipients, coatings and delivery technologies can also yield MR formulations that fulfill very specific performance requirements such as gastro-retention and sustained-, pulsatile-, or delayed-release formats.

They can also be harnessed to create fixed dose combination products such as multilayer tablets, multiparticulates and mini-tabs. These have emerged in recent years as a highly effective and patient-friendly way of formulating new products, offering versatile release profiles and the ability to deliver multiple therapeutic payloads in a single dose.

The patient benefit

Through the lens of “working backwards from the patient,” these formulations provide the big-ticket benefits of greater convenience (fewer doses) and patient compliance, potentially greater efficacy and fewer side effects compared with immediate-release delivery counterparts.

From a commercial mindset, these patient-centric benefits can help OSD products maintain market share when compared with rival dosage forms.

Extending/renewing patent-life

Manufacturers are always exploring ways to extend the patents on their products and accelerate development. The relatively short development times and economic incentives mean that more new drug applications are following the FDA NDA 505(b)2 pathway. Products pursuing the pathway often include improvements to an existing product’s bioavailability. Typically, this is achieved with new fixed dose combinations and controlled release technologies which play a critical role in formulating an improved product for the pathway.

Metrics Contract Services

Helping clients realize this potential, Metrics Contract Services has the equipment and expertise to support our clients’ controlled-release drug product development and manufacture programs, from the clinical phase all the way to commercial production. Our one partner/one site approach ensures scientific continuity as well as a smooth tech transfer, saving our clients time and reducing cost while delivering a high-quality product.

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