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| Buckminsterfullerene C 60 has 60 carbon atoms in each molecule, arranged in a truncated icosahedron. (Photo credit: Wikipedia) |
The reasons behind are well known: less productivity in terms of approvals, we are at the end of the blockbuster drugs era, increased development costs and time, and increased regulatory hurdles.As a result, pharma industry is having problems in showing its double digit annual earnings. And pharma industry needs them because is a high risk investment. Development cost of a new drug are between 800 million [1] and more of 1 billion [2] (according to DiMassi in his interesting papers). DiMassi takes into account the failed programs that don't reach the market -1 out of 5 entering in clinical trials- and he capitalized costs. There are many discussions about the accuracy or this figures but after reading his papers I feel that he is right because he is reflecting the real costs that the pharma industry is paying. I even found another paper reviewing DiMassi's thesis that increased the costs...
Weather or not you agree with DiMassi's figures I'm sure that there is no doubt that the investment needed to move a molecule from bench to market is huge.
Biotechnology and nanotechnology role in drug development
Biotech and nanotech companies are part of the "ecosystem" of drug R&D for many years, specially biotech firms. They could help pharma companies to confront some of their problems, such as new molecules or new technologies for drug development.
Biotechnology brought a new class of drugs that didn't fit in what traditional pharma industry was betting. While biotech firms started developing biologic drugs, pharma was focused in small chemical compounds. I love small molecules because they are easy to synthesize, easy to formulate and they often allow oral delivery. However, their big counterparts are more specific and powerful, generally speaking. In any case, large molecules are a source of new drug candidates and have been able to tackle diseases with no alternative in the "traditional" small molecule drugs.
Life is not easy and while the new biotech leads where extremely powerful in vitro, they often have small or no activity in the alive organism. There are several reasons to explain the lack of activity, enzymatic degradation, impossibility to pass through biological barriers, immune response,... New delivery strategies were developed... some of them in the nanotech field.
Nanotechnology is not only impacting in drug delivery and formulation.Nanotech is the underpinning technology that is accelerating rapid advances in areas such as genomics, combinatorial chemistry, high-throughput robotic screening,drug discovery, high-throughput sequencing, and bioinformatics. The vision of nanobiotechnology is to build tiny, molecule-sized machines able to manipulate matter at the atomic level.
In the last few years,researchers have begun to construct primitive analogs of components that would be needed to build a functioning nanomachine. Examples include carbon structural frames, nano-scale grasping tools, molecule-sized motors, and logic gates that could serve as the basis for molecular-scale computers. Perhaps where nanotech has experience a bigger development is in pharmaceutical formulation field. There are three main ways in which innovative drug delivery systems improve pharmaceutical productivity:
- To combat patent loss for leading biotech drugs; innovative delivery systems may be employed by the leading players to manage product lifecycles by extending the patent protected period of a drug. Improved drug formulas, if launched prior to leading product patent expiration, will allow companies to capitalize on their existing patient population;
- The use of technology to enable pipeline drugs to be more effective; highly innovative products will, obviously, help set new market standards following their launch;
- To expand the number of drug candidates which may be brought into clinical R&D pipelines where pharmacokinetic profiles were not previously considered suitable, efficacious, or cost-effective.
[1] DiMasi JA, Hansen RW, Grabowski HG, 2003, “The price of innovation: new estimates of drug development costs”. J Health Econ.; 22(2) pág. 151–185
[2] DiMassi, JA; Graboswki, HG, 2007, “The Cost of Biopharmaceutical R&D: is Biotech different” Manage. Decis. Econ. 28: 469-479
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