Vitaly Proutski, head of the R&D information of AstraZeneсa Russia, one of the leading pharmaceutical companies and key partner of the Skolkovo Foundation talks about key trends in the industry disclaimers of AstraZeneca: · Expert opinion on key trends in contemporary biopharmaceutical industry · The following text isn’t an official opinion of the company Vitaly Proutsky: Larger health problems: - Generally speaking I think the trend to focus on larger health problems will continue. However there will be at least some shift towards smaller and niche indications, driven by the quest for higher margins/profitability, easier registration paths and faster market acceptance/access. Basically, “small is good” or at least OK. So, there will be more drugs worked on that treat complications of big diseases, rather than big diseases themselves, or even complications of complication, or complications of treating big diseases. Personalization of treaments: I believe the trend towards personalization of treatments will continue with yet higher proportion of drugs being developed along with biomarkers. This however does not mean that all those will be brought to market with companion diagnostics. The regulatory and logistical landscapes are still very diverse in different countries and while in some companion diagnostics path will be the necessity or a choice, in others pharma will not want or be in a position to insist on the use of specific co-approved tests and will be happy for the local approaches to testing to be applied. this and all photos below were granted by AstraZeneca Targeted delivery: Another obvious trend is further development of targeted delivery approaches with “directable” nano-particles and antibody-drug-conjugates (ADCs) being the most widely tried approaches. This will apply to new compounds in pharma pipelines and those that have been abandoned in the past due to the low therapeutic index and systemic safety/toxicity issues. I personally favor nano-particles because of their broader applications in terms of disease areas (ADCs are really only applicable in oncology), types of molecules and higher “payloads”. There will be of course some areas where ADCs have an advantage. None of these approaches will of course be a “silver bullet” though. Cancer vaccines: I think there will first practical advances in cancer vaccines. In a way this could be described as ultimate personalisaton of cancer treatment, when individual’s immune cells are “trained” against that very individual’s tumor cells and then injected in the body to fight the tumor. I doubt however this approach will be soon used as a stand-alone treatment. Immuno-oncology: Immuno-oncology is another powerful trend when the dugs actually mobilize the immune system to fight the cancer. This approach, which focuses on the development and delivery of therapies that improve the body's intrinsic potential for generating an effective immune response against cancer, has been talked about for a long time. However it seems to be finally making its way it to the clinic and some of the results are quite encouraging. Once again, it is unlikely to become a “silver bullet” and will be used alongside the more established approaches such as surgery, chemo and radio therapy. Vitaly Proutsky Regenerative medicine: Regenerative medicine and disease reversion will be strong trends in particular in cardiovascular (CV) and metabolic disease (MD) areas. In particular, while until recently the focus of many CV drug programmes was on the reduction of cholesterol levels or prevention of atherosclerotic plaque raptures (the actual frequent cause of MI and CV death), the focus may be shifting towards the reduction of plaques and thus not only maintaining but actually improving the quality of life of patients. Similarly, in diabetes, the trend will be to induce regeneration of Islets of Langerhans in pancreas rather than addressing the consequences of their destruction. Biosimilars: Perhaps unrelated to the above, I believe the next few years will see a continuous rise of biosimlars. With about $70Bn a year worth of biologics coming of patent in the next few years, it is definitely an opportunity not to be missed by younger biopharma, who may not be ready yet (financially and scientifically) to tackle original drug discovery and development, but may be able to realize this enormous financial potential and learn how to do pharama R&D by actually doing it, yet in a relatively lower risk area - developing a biosimilar is a complex process but at least we know that their original prototypes do work. Hepatitis C Finally, watch the hepatitis C virus space. At the moment patients with this important disease have fairly few treatment options and these ones are rather poorly tolerated by a large proportion of patients. In the next couple of years I expect an explosion of new drug launches, which hopefully will improve this situation.
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