Business
investment, capital and otherwise, have been need- ed) will require the payment of a premium. This, in fact, is becoming a novel trend in the industry (see Table 1 for a list of recently-developed drugs with staggering prices). Since the actual cost of specific drugs is not disclosed by biopharmaceutical com- panies, nowadays it is difficult for the consumer to know which drugs required more investment than others, as drugs are being priced according to whatever the market can bear. Unfortunately, this strategy and all the marketing expenses involved in selling new drugs are unsustainable both for the pharmaceutical industry as well as for the health- care systems. Therefore, it is no wonder that we are facing a world’s healthcare crisis4. To compound the problem over the last few
years the bio-pharmaceutical industry has needed to deal with several important issues such as the massive patent expiration of some of its best-sell- ing drugs, lower productivity output, deficient pipelines, pressure from investors, litigation issues regarding the safety of drugs or related to intellec- tual property, more stringent regulatory require- ments, etc. Given this situation, the pharmaceutical industry has implemented a wide range of strate- gies to contain costs and maximise profits, such as massive layoffs, R&D cuts, divestitures, mergers and acquisitions (M&A), patent ever-greening, increment in the number of clinical trials, expan- sion of indications, pursue of niche markets, price increase, reorganisation, etc. Even biotech compa- nies have followed a similar pattern in order to sur- vive, as recently demonstrated by Celgene and its acquisition of Impact Biomedicines12. In fact, the sale of early stage biotech firms to big pharma right after proof-of-concept in humans or at the end of Phase II clinical trials has become both fash- ionable and profitable. In most of these cases biotech companies have become the R&D arm of big pharma, while big pharma have become pow- erhouses for clinical trials and marketing. The large size of most pharma companies, which has come as a result of the heavy M&A activity that we have experienced in the last decade, has created additional layers of management and dramatic changes in the dynamic of these organisations, which have made it more difficult for them to be managed, to be efficient and to be focused on pro- ductive R&D. From a scientific perspective, the information
provided by the sequencing of the human genome, higher sophistication of experimental models in animals and in humans, new genetic engineering techniques (such as CRISPR, among others), the advent of proteomics,
systems biology, Drug Discovery World Spring 2018
metabolomics, Big data, etc, have all represented a mine of information that will facilitate a better understanding of how the cell and living organisms work. This will eventually have a great positive impact in finding better treatments and cures for disease. However, handling all this information all at once today has made the biopharmaceutical industry situation even more complicated. So, there is not really clarity about which models, both at the R&D and business levels, the biopharmaceu- tical industry will pursue in the years to come. Thus, we are at a very crucial point in which,
more than ever, it is necessary to align pharmaceu- tical innovation with global healthcare policies for the benefit of patients and the survival of the world’s healthcare systems. But how do we deal with these challenges?
Benefits of the Core Model and its approaches today Understanding the Core Model – which brings to a convergence point all the elements necessary for successful drug discovery and development – and understanding the nature and contribution of each one of its constituents (see Table 2) could be of great assistance to the biopharmaceutical industry in the creation of better strategies to improve drug discovery development and serve as a guide to gov- ernments to formulate and implement better phar- maceutical, innovation and healthcare policies. It could help governments, investors and philan- thropic organisations/advocacy groups on how to allocate and deploy funding and economic resources in an optimal way. At present, the Periphery of the Core Model is
becoming more dynamic than ever. For instance, patient groups as well as health systems, which are partners of the pharmaceutical industry in clinical trials, are now playing an active role beyond advo- cacy, including actual financing of drug develop- ment, especially in rare diseases. This was the case, for instance, with the Cystic Fibrosis Foundation financing Kalydeco with Vertex, and thus bypass- ing big pharma. Patient opinion leaders and online communities are now collaborating in clinical tri- als and conducting their own observational stud- ies, as in the case of PatientsLikeMe and its 600,000 members. The importance of patient- reported outcomes in collecting real-world evi- dence is covered in several policy journals, such as Health Affairs and Value in Health. These initia- tives are becoming a novel and important model for improving drug development. Frustration with the biopharmaceutical compa- nies’ high pricing of drugs, sudden increase in
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