| Combination products(CP) represent a new challenge | | | | market. |
| to the pharmaceutical industry in relation to how best | | | | Although there is little doubt that combination |
| to manage these exciting new biomechanical | | | | products may be an effective drug delivery system, |
| products. Combination drugs, known as CP, are | | | | it is not without its own challenges and hurdles. And |
| biologically engineered products that represent a | | | | one of the biggest challenges is the difficulty |
| mixture of drug, device and in some cases other | | | | between drug-device companies working together to |
| biological components, to form a single drug or | | | | offer the best product possible. This can be |
| product. Combination products represent a relatively | | | | challenging because companies need to work not only |
| new therapeutic treatment approach, which is | | | | through the potential cultural differences between |
| proving for some companies, to be a more effective | | | | their two countries, but also their industries, different |
| way of delivering their treatments.. Will combination | | | | practices and mind-sets, as well as different business |
| products change the whole pharmaceutical and | | | | strategies. |
| device industry as we know it, or are combination | | | | Another common challenge is appropriately |
| drug products just a pharmaceutical flash in the pan? | | | | recognizing target markets for which these |
| This is a key question many industry analysts are | | | | combination products will be sold. This can sometimes |
| asking. | | | | be difficult to assess some device companies prefer |
| Are CP really this effective treatment approach of | | | | to focus their marketing efforts on hospitals and |
| the future, as some pharmaceutical consultants and | | | | different health care environments, while others |
| advisors are saying? Some experts aren't yet so | | | | typically look to focus their efforts primarily on direct |
| sure, while others in the industry are already | | | | consumer use. |
| incorporating combination products into their primary | | | | Besides problems with business strategy, the biggest |
| marketing system. In many cases, drug companies | | | | challenge drug companies face are the obstacles |
| are finding combination products more appealing, for | | | | involved with passing FDA inspections. Regulations |
| the simple fact that marketing a single CP containing | | | | and FDA approval are probably the most daunting |
| both drug and device components together, and can | | | | obstacles because combination products require |
| be significantly more cost- effective than offering | | | | approval from more than one FDA agency. Also, it |
| either component on their own. | | | | can be difficult to determine how certain CP should |
| As collaboration between drug and device companies | | | | be classified, and regulated as well as who they |
| continues to grow, there would be no great surprise | | | | should primarily be marketed to, which can cause |
| to some in the pharmaceutical industry, to see | | | | more confusion and delay production. Regardless of |
| combination products as the primary drug delivery | | | | all the challenges drug manufacturers need to |
| system of the future. In fact, some combination | | | | overcome in the next few years regarding |
| products have already been in the market for years, | | | | combination drug products, there is little doubt, even |
| and have already proven to be profitable. And as | | | | among skeptics, that combination drugs are a |
| more drug companies in the future begin reaching out | | | | fascinating new trend in the pharmaceutical industry |
| to one another, the expectation is likely to bebetter | | | | that is here to stay. |
| and more cost-effective combination products on the | | | | |