Introducing Products

Successfully introducing a product and achieving widespread adoption requires engagement and action from a variety of stakeholders.

Case Study: Launch of New Pediatric Treatments

TB Alliance has developed accurately-dosed, child-friendly forms of TB drugs. Here's some of the work we are doing to ensure they reach the million children around the world in need.

Policy and Guidelines

Challenge

Before patients can access new regimens, policy-makers at the global and country levels will need to assess the suitability of the products for their constituents and adapt treatment recommendations to integrate new products.

Response

TB Alliance has worked side-by-side with the WHO to accelerate countries’ adoption of recommended guidelines for the treatment of pediatric TB, organizing a series of regional consultations and country workshops to drive policy uptake and guideline change. In addition, we have invested in clinical research to strengthen the evidence base on appropriate dosing for vulnerable pediatric populations, including children under 5 kilograms and children with resistant forms of the disease.

Registration / Post-Approval Studies

Challenge

A key step in making a drug available is product approval by stringent and national regulatory agencies.

Response

TB Alliance has performed research to clarify regulatory pathways and worked to support commercial partners in filing for national drug registration throughout the TB endemic world. In addition, we have worked with WHO’s Essential Medicines program to ensure timely submission for WHO prequalification and for inclusion in WHO’s Essential Medicines List, which will facilitate registration in the high TB burden countries.

Product Presentation / Manufacturing

Challenge

The presentation of new TB treatments needs to be carefully considered to maximize acceptability, simplicity (for logistics and dispensing), and cost effectiveness.

Response

TB Alliance has partnered with manufacturers to catalyze the development of new pediatric TB treatments that are appropriately dosed, quality assured, and affordable. The new products come in fixed dose combination form, requiring less pills and fewer variations in pill burden based on weight, making therapy as simple as possible. Products are also easier for children to take – quickly dispersible in a small amount of water and fruit-flavored.

Procurement / Distribution

Challenge

Procurement and distribution supply chains must be well established to ensure a smooth transition from existing to new regimens with an uninterrupted supply of product available to patients.

Response

TB Alliance has worked with suppliers and procurers of pediatric TB treatments, including the Stop TB Partnership’s Global Drug Facility, to ensure timely availability of the new treatments for purchase. In addition, we have performed research to understand procurement requirements in the high TB burden countries in order to help navigate potential bottlenecks and accelerate availability. In collaboration with Management Sciences for Health, we are currently supporting countries in planning for the phase out of older products and phase in of new treatments.