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INDUSTRY
Analysts suggest that, while pharmaceutical invoice spending will increase up to $650 billion by 2022, the net spending will remain substantially flat. This because while the demand for drugs and their prices are constantly increasing, the spending capacity of most healthcare systems remains flat.
Thus, companies will have to apply bigger discounts to stay in the market, and the profit margins will be eroded. The only solution to protect margins is to reduce the costs of development and regulatory testing, one of the main cost factors.
The methods usually used to test new drugs - in vitro, in vivo on animal, and then with phase I, II and III clinical trials - have not been changing substantially in a long time; while this process is reliable, it takes a very long time and it is very expensive, especially because the highest attrition rate is with phase II clinical trials, where already significant amount of money were spent on the New Medical Entity (NME).
The STriTuVaD project is exploring the reliability of a radically new approach, called in silico trials, which aims to replace at least part of animal and human experimentation with modelling & simulation. If we are successful, this will open up new opportunities for the pharma industry.
The opportunity of in silico for the pharma industry
According to SIRE life Science, the two most important trends for pharma industry are the contribution to innovation coming from emerging markets and from the issue of rising healthcare costs in established markets. The same source suggests that global healthcare spending was around $70 billion in 2014, up from $26 billion in 2012. In 2016, USA total medical costs hit $3.4 trillion, 18% of the country’s total GDP (Source: The Atlantic); but all developed countries are crossing the limit of 10% (see figure below).
Health care cost as percent of Gross Domestic Product (total economy of a nation)
(Source: Wiki WikiBasti - Own work)
According to a recent analysis, while invoice spending in the developed markets will reach over $650 billion by 2022, net spending will remain flat at $300-350 billion (Source: IQVIA Institute for Human Data Science).
In other words, the demand will raise, the label price will raise, but the spending capacity of the healthcare systems will not, and pharma companies will have to make bigger discounts to stay on the market. The only concrete opportunity for pharma companies to protect their profit margins in such markets is to reduce their operational costs. Almost every analysis endorsed by industries suggest that, by large, the most important operational cost is that research & development, if we include in it also the costs of R&D for all the compounds that failed to reach the market, especially those that fail late in the clinical evaluation process.
To give a sense of how bad this is, the highest attrition rate (75%) is reported to be in phase II, when massive amount of investments were done on that NME (Bunnage, 2011).
We offer that the only way for pharma industries to stay profitable in the next two decades is to revolutionize the way pharmaceutical products are developed and tested for safety and efficacy. The methods actually used are effective, but inefficient. There is a strong need to find new methods that are equally reliable but involve lower costs and shorter time to market.
The STriTuVaD project aims to demonstrate the credibility of a patient-specific in silico model of tuberculosis infection to predict the efficacy of new vaccines to be used as therapeutic adjuvants.
Combinatory therapies, where multiple NME, or even NME and biologicals are combined to achieve the optimal therapeutic effect, are very difficult to develop because of the combinatory nature of the clinical trials, which usually requires huge cohorts. But products that target primarily lower-income markets must be developed in a cost-conscious way, to ensure that selling prices are affordable. Thus, this application is a perfect test bed for in silico testing for efficacy of new treatments.
Under the advice of two major regulatory agencies, the European Medicine Agency and the US Food and Drug Administration, we plan to develop a general framework for the regulatory qualification of in silico methods to be used for the efficacy assessment of therapies. If this works, it should be relatively straightforward to extend such approach to the efficacy testing for a number of transmissible diseases.
Industrial partners
ETNA BIOTECH
Etna Biotech S.r.l. is a Research Center headquartered in Catania, Italy. Start-up of the former Swiss Serum and Vaccine Institute, later Berna Biotech, Etna Biotech is a company whose key competencies lie in researching and developing vaccines and immunotherapeutics for infectious diseases and other chronic illnesses.
Etna Biotech encourages relationships with the Academy, participating
in formative activities at the University of Catania (PhD programs & masters), in the follow-up of formed students and, ultimately, accompanying new professionals into the industrial world.
Etna Biotech has been acquired in 2008 by the Zydus International Ltd, a Zydus Cadila Company. Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The company is one of the top four pharma companies in India; the group has over 19.500 employees worldwide, world-class research and development centres dedicated to discovery research, and eight state-of-the-art manufacturing plants.
Etna Biotech is the coordinator of the STriTuVaD project. For more information on how our consortium can help your company in its development, please contact info@etnabiotech.it.
COMBINE GROUP
Strictly speaking the Computational Systems Biomedicine Research Group (COMBINE) is not a company… yet. The team, led by Prof Francesco Pappalardo, is the developer of the Universal Immune System Simulator (Pappalardo, 2010), the modelling technology at the heart of the STriTuVaD project. The group is very interested in exploring various possible industrial exploitation scenarios for our technology: if you
are interested please contact info@combine-group.org.
ARCHIVEL FARMA
ARCHIVEL FARMA is a Spanish private company specialized in the research and clinical development of new drugs of biological nature, currently focused in the field of tuberculosis. In collaboration with “Germans Trias i Pujol Health Science Research Institute” and “Germans Trias i Pujol University Hospital” (Barcelona, Spain), it has developed RUTI® (Cardona, 2006) a novel therapeutic vaccine for the
treatment of patients with latent TB infection, drug susceptible TB and Multi Drug Resistance TB. RUTI® is one of the three adjuvants we will test in the clinical trials run at the All India Institute for Medical Science in New Delhi, under the clinical guide of Prof DK (Salil) Mitra. For more information on RUTI contact archivel@archivelfarma.com.
IDRI
The Infectious Disease Research Institute (IDRI) takes a comprehensive approach to combat infectious diseases, combining the high-quality science of a research organization with the product development capabilities of a biotechnology company to create new diagnostics, drugs, and vaccines. IDRI’s mission is to apply innovative science to develop products to eliminate infectious diseases of global importance. They envision a world in which infectious diseases are either prevented or
rapidly diagnosed and treated using products that are available to all people, by transforming science into global health solutions. Dr. Steve G. Reed founded IDRI in 1993 with the key focus of fighting intractable infectious diseases by developing products that positively affect the world’s most underserved populations. IDRI currently has 125 employees, including 90 in R&D, experts in immunology, microbiology, adjuvant development and formulations, chemistry, and drug discovery. IDRI has developed a tuberculosis vaccine candidate designed to recognize both active TB and latent TB. The candidate, ID93 + GLA-SE, is composed of a recombinant fusion-protein antigen plus IDRI’s proprietary adjuvant, GLA-SE, and has been previously tested in humans. ID93 is another vaccine that will be tested in the STriTuVaD clinical trial at AIIMS. For more information on ID93 contact office@idri.org.
