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A Revolution in R&D

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Chapter 3: Managerial Challenges<br />

Preface: Look<strong>in</strong>g Back and Look<strong>in</strong>g Forward<br />

The Story So Far<br />

The genomics revolution is poised to sweep aside<br />

the old economics of pharmaceutical R&D. The<br />

biotechnology and pharmaceutical <strong>in</strong>dustries—and<br />

perhaps health care delivery <strong>in</strong> general—are on the<br />

br<strong>in</strong>k of transformation, and companies that<br />

embrace the revolution <strong>in</strong> the right way stand to<br />

reap enormous benefits. Develop<strong>in</strong>g a new drug<br />

should become considerably less unpredictable and<br />

much less expensive. Companies will record<br />

improvements both <strong>in</strong> efficiency and <strong>in</strong> success<br />

rates all along the value cha<strong>in</strong>, and the average cost<br />

and time needed to br<strong>in</strong>g a new drug to market will<br />

fall correspond<strong>in</strong>gly. (See sidebar, “Potential<br />

Sav<strong>in</strong>gs—From Theoretical to Practical.”)<br />

But this benign prospect is clouded by some warn<strong>in</strong>gs:<br />

great rewards will require comparably great<br />

efforts; a new paradigm <strong>in</strong> R&D economics may<br />

necessitate paradigm shifts <strong>in</strong> R&D management;<br />

above all, the great promise is offset by great risks—<br />

though, as <strong>in</strong> any revolution, the risks of stand<strong>in</strong>g<br />

aside may be greater than those of gett<strong>in</strong>g <strong>in</strong>volved.<br />

Ensur<strong>in</strong>g Your Future<br />

All biopharmaceutical companies are, or should be,<br />

actively decid<strong>in</strong>g how best to engage <strong>in</strong> the revolution.<br />

Mak<strong>in</strong>g such decisions is no easy matter. The<br />

familiar bear<strong>in</strong>gs are no longer there, s<strong>in</strong>ce the<br />

competitive and regulatory landscapes have<br />

changed so much—and cont<strong>in</strong>ue to change—<strong>in</strong> response<br />

to the promise that genomics offers. Compa-<br />

nies have been rush<strong>in</strong>g to claim <strong>in</strong>tellectual property<br />

rights (<strong>in</strong> the so-called IP land grab), now that<br />

the sequenc<strong>in</strong>g of the human genome has been<br />

completed. Statutes and court decisions regulat<strong>in</strong>g<br />

those IP rights keep emerg<strong>in</strong>g and modify<strong>in</strong>g the<br />

picture. (See sidebar, “Intellectual Property—Lost<br />

and Found.”) And the corporate map is be<strong>in</strong>g redrawn:<br />

the major mergers of recent years have created<br />

<strong>in</strong>dustry superpowers, and the pace of acquisitions<br />

and alliances is set to quicken, if anyth<strong>in</strong>g.<br />

(See sidebar, “Industry Changes.”)<br />

With so much change occurr<strong>in</strong>g, there are bound<br />

to be w<strong>in</strong>ners and losers. Although the decisions<br />

will be unfamiliar and difficult, success will <strong>in</strong> the<br />

end be determ<strong>in</strong>ed by traditional criteria. The w<strong>in</strong>ners<br />

will be those who make optimal strategic<br />

choices and then implement them <strong>in</strong> an optimal<br />

way. The two components of the w<strong>in</strong>n<strong>in</strong>g comb<strong>in</strong>ation<br />

will differ from company to company, accord<strong>in</strong>g<br />

to each company’s size, aspirations, f<strong>in</strong>ancial<br />

power, capabilities, and so on. In this f<strong>in</strong>al chapter<br />

of our report, we identify the strategic and operational<br />

issues and exam<strong>in</strong>e the various options that<br />

different companies might exercise.<br />

To beg<strong>in</strong> with the strategic issues, then—specifically,<br />

the challenge of def<strong>in</strong><strong>in</strong>g a strategy <strong>in</strong> the<br />

genomics era.<br />

Strategy—Search<strong>in</strong>g for Genomic<br />

Competitive Advantage<br />

Before genomics, biopharmaceutical companies<br />

used two basic tools—chemistry and molecular biol-<br />

41

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