Evidence & Performance Blog

We had the pleasure to meet Doctor Pierre Le Sourd, former President of Bristol Myers Squibb France and most recently President of the Leem (The French Pharmaceutical Companies Association).

Mr Le Sourd brings us 30 years of pharmaceutical experience to help us understand current challenges and perspectives in this industry.

[ADS] According to you, what are the major challenges that the pharmaceutical industry has to face?

PLS:

Over the past decade, pharmaceutical and life sciences companies have entered a difficult period where shareholders, the market and regulators have all created significant pressures for change within the industry. From thinning pipelines and skyrocketing operating costs to calls for lower prices and a greater regulatory burden, the industry is confronting unprecedented challenges that are expected to radically transform the business.

[ADS] Are these challenges confined to the European market?

PLS:

According to my experience, the challenge is worldwide. The European pharmaceutical sector’s growth and strong performance seem to contradict the industry’s concerns over competitiveness and innovation of Europe. One good example of this dynamism is the Innovative Medicines Initiative (IMI) created by The European Commission. This joined collaboration between public and private biopharmaceutical stakeholders reach the major goal to overcome the research bottlenecks in the drug development process by pooling competencies and resources together.

[ADS] How important is it for pharmaceutical companies to improve R&D business models?

PLS:

The industry’s current business model is both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets. Its core problem is basically the huge complexity in demonstrating safety and performance of a new drug or a new device, especially because of lack of productivity in R&D processes.

Many Pharma companies are currently engaged in wide-scale R&D restructuring, adopting a biotechnological approach to drug development by establishing disease-focused R&D units, R&D spin-offs, strategic partnerships and joint ventures.

[ADS] How has the pharmaceutical R&D market changed in recent times?

PLS:

Refocusing and Restructuring and are the main changes that occurred in Pharma R&Ds.

During Q2 and Q3 2008, we saw the biggest Pharma companies restructuring their departments, although R&D was the most impacted.

Refocusing was the first objective. In an innovating, rapidly changing and challenging environment, the companies must invest in key areas of future growth and evolve their business to compete. “Emerging market” such as Brazil, Russia, India, China and the Middle East are seen as significant growth drivers of the future. They are already contributing close to 25% of today’s market growth and are forecasted to grow even faster in the future. It is essential that we have an operating structure that is dynamic and responsive to the opportunities in these markets, in which generic drugs are becoming competitive.

The second objective was restructuring. Of course, once the focus is shifted you need to readapt your company. Thus R&D was the main department that suffered from this. A lot of jobs have been cut so that smaller, more efficient teams were dedicated to specific tasks. This had also a huge impact on productivity, efficiency. We have less people, but we need to be more productive. That the reason why R&D processes have to be reviewed.

[ADS] As far as clinical research is concerned, what should be the best strategies to speed up the marketing approval on a worldwide basis?

PLS:

You don’t decide to reduce the cycle time over night. The best approach is first to analyze where you spent most time & cost. Which part of your processes could be improved? I think that effective management control tools and methods could be used on top of any organizational transformation efforts.

You absolutely need to define different performance metrics that you will follow and measure to define first, where you are now, basically how you work today. Then you define where you want to be and by when. This transformation effort in place, you can then follow the evolution of your improvement by continuously looking at your first identified metrics. Performance management becomes a mean to formulate milestones and measures success or failure.

[ADS] What major benefits the technology brings and what do you see as the biggest benefits to integrating and operating new technologies?

PLS:

There are a strong industry demands for solutions that enable the time- and cost saving automation within the drug discovery value chain and the Clinical Development process.

There are also strong demands for collecting post marketing data, country by country, once the product is on the market. It‘s a key aspect of continued safety and performance considerations.

With the advent of the new enabling technologies (internet for example), the potential for these solutions is enormous, but their implementation and acceptance will be never easy because of the number and disparity of solutions already in place and the extreme complexity of the processes

Integrated tool sets that enable cost-effective performance of the product development is, for me, necessary, and, I’m sure, the vendors able to deliver and support those tools in a near future will be valued.