Gadi Saarony, Parexel Consulting

Nov 03, 2008
By Pharmaceutical Executive Editors

With the financial markets in turmoil, every decision point is being scrutinized by stakeholders of biopharmaceutical companies. Less room exists for error, and finite capital investments need to be used wisely. Biopharmaceutical industry executives must consider the impact of decisions not only on specific products, but on the entire company.

Exercising Judgment
Now more than ever, a primary focus should be on reaping the greatest return from R&D investment. This includes making the right—and timely—go/no-go decisions, and gaining the most efficiency from the product development process.

The R&D environment is increasingly complex, and biopharmaceutical companies must maximize the value of their products at every stage of the product lifecycle. Crucial decisions must be made about which products should be developed, and how to bring safe and effective products to market efficiently. Along with scientific decisions, decisions regarding the most efficient paths to regulatory approval—especially to achieve first cycle approval—and on which markets to pursue all need to be made early in development planning.

Strategic Outsourcing
Overall, biopharmaceutical companies need to think beyond their usual approaches to outsourcing. Typically, companies have outsourced back-office operations or routine activities. Now they should be thinking about partnering to obtain strategic capabilities. For instance, our clients are increasingly turning to us to provide regulatory affairs support for entire product classes and geographies.

The biopharmaceutical industry is moving from a fixed to more of a variable cost structure—one based on eking the most productivity out of the fewest possible internal resources. That means leveraging the resources of partners and vendors in a targeted way, linking directly to the volume of work that needs to be done. This factor, combined with the industry’s greater focus on discovery, demands the increased leverage and strategic skills of outsourced partners.

With the growing globalization of biopharmaceutical development, companies need partners that can provide gateways to key international markets. The smallest to the largest companies can take advantage of this global opportunity by working with outsourced global partners that have local operations in numerous countries. Small and emerging biopharmaceutical companies with limited infrastructure and expertise can especially benefit from the breadth and depth of expertise, capabilities, and access that global organizations provide. A biopharmaceutical company should be able to obtain the same high quality global standards from any of its partners’ locations worldwide. It is vital that partners have well-established local capabilities and expert resources, including experience working with regional regulatory authorities in a wide array of geographies.

It is far faster and less expensive for a company to gain access to global markets and a worldwide team through outsourcing than by building its own locations and teams. Speed to market, especially in emerging regions for biopharmaceutical development, will continue to be a growing, critical competitive differentiator.

Gadi Saarony is Corporate Vice President and Worldwide Head of Parexel Consulting and can be reached at [email protected]

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