Life Science Leader, April 2014
In January 2014, Senator Charles Schumer (D-NY) called on drug-makers, the FDA, and the Consumer Product Safety Commission to help reduce the number of emergency room visits among children who are accidentally given the wrong dosage.
He argues that implementing flow-restricting devices on liquid formulations could prevent approximately 10,000 emergency room visits each year and would cost only a matter of cents per bottle. While Schumer is pushing for legislature to mandate further measures to protect children, kids are not the only population that would benefit from improved delivery methods that are aimed at precise doses.
A recent survey among biopharmaceutical companies that engage CMO services showed that 73 percent of these businesses offer formulations for special needs patients, 53 percent offer pediatric formulations, and 50 percent offer geriatric formulations. Each of these populations are at risk for inaccurate dosing, and while a flow restrictor is a prospective means to reduce medicating inaccuracies, there are better technologies becoming available.
Packaging medications in a unit-dose format has been popular in Europe and Japan for some time, and has been widely embraced in the U.S. in the food and beverage market — just think of the little packets of flavoring one can add to their bottled water or the tubes of yogurt to take on the go. These convenient little packages are known as stick-packs and may be filled with powders or liquids. Not only are they premeasured to ensure accurate quantities — providing an advantage over the flow restrictor — the format reduces the likelihood of spilling the spoonful of medication while trying to gain a child’s compliance. Further, the packaging is travel friendly, and stick-packs can accommodate a wider variety of medications than liquids that would benefit from a flow restrictor, including powders and drugs that require sterile processing.
As pharmaceutical companies, especially those with OTC products, become more consumer focused — 44 percent of respondents to the same survey stated their company is very consumer focused, meaning they actively seek out information on the buyers of their products and use that information to shape product development — finding delivery and packaging methods that appeal directly to buyers helps to ensure brand loyalty. In fact, nearly two-thirds of respondents (62 percent) stated it is important for a CMO to provide proprietary technology to offer marketing differentiation. At present, there is some disconnect between showing strong consumer interest and understanding what strongly appeals to consumers. This presented itself in the research when interest levels in products specifically designed to be consumer-friendly lagged behind traditional pharmaceutical formats among the 42 percent who will outsource fill-finish projects in the coming year.
At present, there is some disconnect between showing strong consumer interest and understanding what strongly appeals to consumers.
When it comes to the product types of interest, there is a demand for advanced functionality, such as controlled or extended release, but survey respondents agreed their company’s product focus still leans toward tablets and capsules. This isn’t too surprising considering stick-pack technology is relatively new to the U.S. market, especially when it comes to prescription drugs. However, as outsourcing models evolve toward partnerships where biopharmaceutical companies expect CMOs to add value beyond reducing fixed costs, offering new technologies that are consumer friendly and ensure accurate dosing is a way for both brands (sponsor and CMO) to gain customer loyalty. Specialized delivery technology can cement biopharmaceutical customers into long-term relationships with their contract manufacturer, and user-friendly packaging that facilitates accurate dosing strongly appeals to consumers. These methods will aid in capturing market share as well as building brand loyalty among consumers.
The good news is that drug makers in North America will soon have wider access to manufacturers of medications in stick-pack format, which will in turn increase availability to consumers. An established European leader in unit-dose manufacturing, Unither, has plans to open the first liquid stick-pack line in the U.S. in the summer of 2014, which will join Ropack and PNP Pharmaceuticals (part of NSF), both based out of Canada to further serve the market.
Nice Insight CMO Strategy surveys are deployed on behalf of Nice Insight clients to a targeted group of outsourcing decision makers. The surveys are comprised of ~40 questions geared towards understanding current outsourcing practices, present and future expectations from outsourcing partners, which traits contribute to successful partnerships.[n=200]