We think that drug delivery and drug development will become increasingly synonymous. Indeed, we’ve blogged in the past about some of the areas where traditional drug delivery techniques can be used to create valuable products. Others have noted that pharma companies should be paying more attention to drug delivery during drug development.
But why the marriage between “development” and “delivery”? And why now? Here are a few reasons:
1. As we have said before, delivery technologies can be used to solve pharmacokinetic challenges which NCEs can bring. It’s true that NCE innovators will have to give up fees and Royalties to access delivery technologies, but this will be increasingly preferable to shelving imperfect NCEs in an era of significant patent expirations.
2. Competitive segments such as pain management can use delivery technologies to create products that are safer, easier to use, and that can increase compliance. The development of oral thin films containing insulin is a fascinating example of what can be done with “old” molecules. A good summary of the use of delivery techniques with biopharmaceuticals may be found here (online magazine).
3. A common concern with drug delivery-based products is that insurance companies are reticent to reimburse these products in the presence of a non-drug delivery option. This is generally the case, but it presumes that the drug delivery version confers no clinical advantage. Thus, some companies developing drug-delivery based products need to run head-to-head studies, sometimes against a generic product. But this is not only expensive, but fraught with risk. Thus, the needs of the patient, the physician, and the insurer must be taken into account early and often. If this three-way conversation takes place early enough, then the proper clinical trials can be planned and executed in order to mitigate some of these risks.
These factors have organizational implications as well. Drug development will have to incorporate earlier input from formulators, engineers, insurers, IP attorneys,and other experts who may not normally be intimately involved in the early development process.
So the name change makes a lot of sense to us. We believe development and delivery will slowly come together both scientifically and organizationally. We look forward to reading Drug Development and Delivery in 2011 and beyond as these exciting changes take place in our industry.