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European Biopharmaceutical Review

Global Environments: Navigating the Perfect Storm

Today’s pharmaceutical and biotech industry sectors are largely a product of the late 20th century. In the post-industrial era, manufacture and provision of pharmaceutical drugs have been organised and have prospered as fully integrated business units. One of the trends of today is the formation of new enterprises on a geographically dispersed virtual business model. Historically, there have been the chemistry-based pharmaceutical companies and the biology-intensive biotech companies. The distinction between pharma and biotech businesses is becoming increasingly blurred, as the pharmas build out biotech-focused business units, either organically, or by mergers and acquisitions (M&A). In fact, all the major pharmaceutical manufacturers are pursuing biotech products.

The global reach of the pharma and biotech companies of today – both large and small enterprises – is enabled by general advancements in commerce, technology, and government. Globalisation of the industry is a double edged sword, presenting the obvious opportunities for markets and suppliers, but also placing increasingly stringent demands on recognising and exploiting the sources of competitive advantage.

For the past two decades, the industry buzz has been about ‘pipeline productivity’. The well-known graphic showing exponentially increasing drug R&D expenditures by the pharmaceutical industry, in parallel with level or declining new drug approvals, year-by-year, has been a popular talking point at industry meetings and conferences.

With many current drugs going off-patent, competition from generics manufacturers is increasing. The observation of a pipeline drought is a harbinger of industry profitability and competitiveness of the major players. This recognition has stimulated the search for new tactical approaches to discovery and development: outsourcing, new technology, revision of regulatory approaches, and appeals to government protection.

Lagging R&D pipeline productivity is a legitimate cause for concern because it reflects an imminent drop in value creation and return on investment from the largest industry players. That said, it is only one indicator of the perfect storm in which the pharmaceutical and biotechnology industries are struggling to navigate in order to continue to prosper and expand in relation to global healthcare needs.


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Dr Emile Bellott is a private consultant in drug development, based in the Boston area. In more than 25 years of industry experience, his pharmaceutical activities have focused on drug discovery and development, synthesis and design of small molecule therapeutics, and informatics and structural biology. Emile served as VP of Operations, and co-founder of two development-stage biotech companies and founder of a lifescience software company. His operational experience spans medical devices, pharmaceutical development and chemistry outsourcing. He earned a PhD in Physical Organic Chemistry from Harvard and a MBA from the Harvard Business School.
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Dr Emile Bellott
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