A new frontier for Pharmaceuticals

What key trends will affect pharmaceutical companies’ operations and business success in 2016?

As we have already seen over the past years, there are a lot of changes in the pharmaceutical industry environment. We have various transitions and a very dynamic process behind this area, and important points that certainly affect operations and business in the pharma market are, for example: a) less launching of “blockbusters”, which represents less big or explosive revenues, b) the risks and dangers of the ‘patent cliff’, c) much more controlling strategies through payers (for example: drugs and medicines should be not only clinically effective, but also economically successful), d) more strength reimbursement policies, and also e) the continuously and quickly growing generic market.

Which strategies are most effective in managing supply chain for new innovative pharma products?

To face the coming problems and challenges, one of the key points to keep the pharmaceutical industry and advances in healthcare viable is, for example, the increase in the number and quality of innovative (truly innovative and not only “slightly different” or reformulations), economic – that is, cost-effective – new products. For example, for niche areas (such as orphan drugs), for areas with really no alternative up to now, smaller but more frequent launches, and with as low as possible marketing costs, in order to be able to invest more in RD costs, as RD must be ideal and optimized for real innovations. Minimizing marketing costs should occur through solid and emotionally empathetic relationships with the payers, prescribers and consumers. If these 3 “actors” from the healthcare systems work together, it would be possible to achieve the ideal development strategies for the right products. For example through partnerships between pharma and health insurance services aiming to achieve bilateral education; partnerships and cooperation between health insurance services and physicians and clinics or healthcare organizations, also to promote education and clarification and the development of common projects, as well as innovative projects, which aren’t so economically heavy or marketing-focused in order to comply with codes of conduct and regulations in different countries nowadays. Another alternative is the development of common projects with patient organizations – perhaps, for example, through a group of different pharma companies – but with a similar pipeline in some areas – and this would demonstrate to the population the true aim of “helping” and not only “making money” – as many people currently perceive the pharmaceutical industry. However, these are often ignored by the “big Pharma”- instead of joining all powers together, each sees the other as the enemy! This is not constructive.

What impact is the Patent Cliff set to have on the pharmaceutical industry in coming years?

The expiration of many patents during recent decades, the higher hurdles of reimbursement, the greater difficulties for new drug approval and continuously growing generic market makes the impact of the patent cliff ever more noticeable, and this will last into the coming years. So, small companies will most likely be bought or will merge with bigger ones, and there will come a time to rethink what to produce, in order to overcome this situation. There are still alternatives and possible strategies, as previously described, for a better interrelationship between pharma, patients and healthcare organizations – such as insurance providers, for example. The development of truly innovative medicines cannot occur without the help and support of the customers. However, the traditional kind of feasibility work that has been performed in pharmaceutical companies is very often completely beyond reality or far removed from “real life”. Even the development of clinical study documents, such as protocols and IBs, are sometimes extremely customer unfriendly. This occurs because there are a lot of people in the pharmaceutical industry – especially physicians – that have never worked with a real patient in a real medical or clinical environment. Many of these employees are involved solely in the theoretical aspects, and this can lead to serious mistakes during planning and performance of the drug development programs. However these issues are also often simply disregarded.

According to Andrew Ward writing for the Financial Times, dozens of big investors have backed a campaign by British activists for more transparency in the pharmaceutical industry. Helena Viñes Fiestas, head of sustainability research at BNP Paribas, stated that “open access to clinical data was as important for investors as for doctors and patients, because trial results heavily influenced the way that drug companies were valued.”

How will rising pressures for transparency impact the pharmaceutical industry?

Is the automobile industry transparent to such an extent? Are any other innovative industries? No one shows their plans before going onto the market – and neither should the pharmaceutical industry. There is also the issue of data safety, because during studies we work with human beings – individual people whose privacy must be protected. The pharmaceutical industry, together with patient organizations and healthcare organizations, have to work in cooperation to face this issue and only accept a level of transparency that would not be dangerous for all. The pressure will rise but must not be accepted in this way.



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Dr Gisele Borelli Montigny

About Dr Gisele Borelli Montigny

Dr. Gisele L. Borelli-Montigny is a Physician and healthcare expert with a successful career of over 15 years as a Staff Physician for Internal Medicine and Intensive Care. Additional professional experience includes working as Medical Consultant for health insurance companies, including Allianz and BMW, as well as Medical Manager and Medical Advisor for the Pharmaceutical industry (Daiichi Sankyo, Roche Pharma AG, Kendle). Dr. Borelli-Montigny owns TrialPlanet, a consulting office for Project Management and Medical Consulting, and ProCuore Medical Office, a very individualized and new concept of medical support and healthcare service on demand.