Business
within a major, logical framework or paradigm rooted in basic economic principles. As a result, collaborations are underexploited and the entire process of drug discovery and development, the business of science, and the public policies that reg- ulate and fund basic, applied and translational sci- ence remain sub-optimal or deficient, bringing severe penalties on the economy and the global sys- tems of healthcare. Furthermore, in spite of the realisation that col-
laboration is essential for the progress of science, there is still a great deal of secrecy, misunderstand- ing, and misuse of intellectual property, hindering collaborative efforts. Of course, secrecy and pro- tection of intellectual property are necessary in the business of science (or are they?), but the attitude toward it has become obsessive and paranoiac resulting in many useless patents that do nothing but block scientific progress in related areas. All of this adds to the economic burden of developing new drugs.
‘Old-school pharma’ and the Core Model In examining the Core Model further and the his- tory of the biopharmaceutical industry, it becomes clear that this model is not only a paradigm for the development of present-day biotechnology drugs (it also solves the ‘Paradox of the Anticommons’), but actually a universal model that has been in use to great effect in the development of drugs since the beginning of the pharmaceutical industry. Though it is impossible to discuss here in detail the abundant specific cases of drugs that were suc- cessfully-developed in this fashion (see references 1-3 for the history of drug discovery and develop- ment), several examples of drugs and companies that benefited from this approach need to be noted. For instance, the success of the German chemical and pharmaceutical company Hoechst lay in its ability to secure strong ties with academia and academic scientists, such as Robert Koch (and later with Clemens von Pirquet and Koch’s student Arnold von Libbertz) for the devel- opment of tuberculin as a testing agent for tuber- culosis; with Emil von Behring, who discovered the diphtheria antitoxin and developed a serum therapy against diphtheria (together with Emile Roux) and tetanus; and, among many others, with Paul Ehrlich, who postulated the theory of recep- tors, coined the term chemotherapy, found a cure for syphilis (Salvarsan), and carried out impressive studies on autoimmunity. The development of these agents in a commercial manner was the direct result of close collaboration between the
Drug Discovery World Spring 2018
‘Core’” (in this case academic inventors and Hoechst), the ‘Bridge’ (other academic scientists working in related problems), and the ‘Periphery’ (public hospitals, the German government and other not-for profit organisations). Other German firms (such as Merck & Co, Afga and Bayer), the major Swiss firms (Ciba, Hoffmann-La Roche, Sandoz) and European and American firms fol- lowed a similar pattern in the second half of the 19th century, cementing the great success of the pharmaceutical industry ever since. In the 20th century, medicines such as penicillin (first pro- duced in a mass-scale by Merck & Co in the United States), insulin (commercially released by Eli Lilly), the first sulphonamide, Prontosil (Bayer) and antibiotics, in general, were also developed in the same fashion. Late in the 20th century, the birth of the biotechnology industry and the devel- opment of the first biotechnology drugs can be explained by the Core Model, with a close and systematic collaboration between academia, industry, investors, government agencies and phi- lanthropic organisations/advocacy groups, via knowledge transfer, integration and translation.
The bio-pharmaceutical industry challenges today One of the greatest challenges that the bio-pharma- ceutical industry has to face today is the high cost of research and development (R&D)1. According to recent estimates by the Tufts Center for the Study of Drug Discovery and Development (TCSDD), it takes, on average, more than $2.558 billion (pre-tax, 2013 dollars) and 10-15 years to develop a new drug9. Although these exact figures are controversial – and we should bear in mind that the actual expenditure depends on the drug and whether it is developed by a pharmaceutical or a biotech company – it is a fact that drug discovery and development is a very complex, difficult, unpredictable, risky and capital/labour-intensive endeavour. Furthermore, over the last years the amount of money invested in this field has dramat- ically increased while the number of new chemical entities (NCEs) brought to the market has lagged behind. This situation calls for a careful examina- tion of the reasons accounting for the increase of overall R&D cost as well as for novel ways to opti- mise the process. Pharmaceutical drugs form an essential compo-
nent of the global healthcare system. They are needed even for preventive-prophylactic pro- grammes. But the high price of innovative drugs and the lack of drugs in some important and spe- cific disease areas is perhaps the greatest challenge
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