The Strategic Commercialization of Biotechnology Innovation Professor Scott Stern Kellogg School of Management, May 2009 The Gale of Creative Destruction Capitalism, then, is by nature a form or method of economic change and not only never is but never can be stationary... The fundamental impulse that sets and keeps the capitalist engine in motion comes from the new consumers’ goods, the new methods of production or transportation, the new markets, the new forms of industrial organization that capitalist enterprise creates... This process of Creative Destruction is the essential fact about capitalism. J. Schumpeter, 1942 Many industries are marked by the “gale of Creative Destruction”… The “S-Curve” Pattern: Initially increasing then declining R&D productivity within each physical “architecture” Old Physical limits The Framework: Early R&D is filled with failures, dead ends, and competing versions. Once key choices are made, R&D Productivity improves -- focused and with few physical barriers. However, market leaders resist “shift” to new S-curve… Technical Metric R&D Effort Assumes that profiting from innovation requires competing in the Product Market In the disk drive industry, changes in technological leadership equals changes in market leadership Christensen, 1997, p.23 Indeed, biopharmaceuticals is currently undergoing a significant shift in the underlying S-Curve Performance Maturity/diminishing returns “Biology-based” drug development Take-off “Chemistry-based” drug development 1970s 1990s Time/effort And, the life sciences revolution will likely usher in key S-curve transitions for the forseeable future Are established firms in the pharmaceutical industry fated to the gale of creative destruction? Should biotechnology firms premise their competitive advantage on competition with established pharmaceutical firms? An alternative is contracting as a start-up commercialization strategy R&D Investment Production & Marketing Alliance Licensing Revenues Acquisition Profiting from Innovation Through Contracting with more established product market competitors Biotechnology! Radical Innovations New Organizational Forms – – – Entrepreneurial Start-Ups Smaller Firms High-Powered R&D Incentives University Involvement YET…. – – Commercialization Achieved through Cooperative Development and Marketing btw Entrepreneurial Start-Ups and More Established Pharma Firms Despite 30 years of radical innovation, biotechnology firms, by and large, continue to commercialize through cooperation with established pharmaceutical, agricultural products, or medical device companies Biotech – Big Pharma Collaborations Remains a Central Commercialization Approach for Biotechnology Firms! For biotechnology entrepreneurs, commercialization strategy is becoming an ever more important strategic choice... Compete in the Product Market Versus Cooperate via the Market for Ideas? The Benefits of Commercialization via the “Market for Ideas”… Avoiding Duplicative Investments – Costly Marketing & Manufacturing Assets – Imitative R&D Programs Taking advantage of “High-Powered” Research Incentives in Small Firms – Product Market Assets v. Entrepreneurship Softening product market competition – Extending product market franchises Effective commercialization depends on translating a technology into a value proposition which is dependent on key complementary assets… MANUFACTURING MARKETING CORE TECHNOLOGY & INNOVATIVE KNOW-HOW DISTRIBUTION COMPLEMENTARY TECHNOLOGIES Why is trading in an ideas market so hard? The Disclosure Problem – Figuring out the “price” for an idea requires information which intrinsically reduces its value The Contingency Problem – Value of Ideas depends on factors such as market demand, existence of other technologies The Perception Problem – Different individuals perceive the value of an idea differently prior to product market experience When does the “disclosure problem” matter? Innovation Bob Kearn’s Intermittent Windshield Wiper DeCode Genetic’s Gene Markers for Heart Disease Critical “Secret” Knowledge Was the secret protected? The concepts of variablespeed windshield wiper Yes, but enforcement was incredibly costly Overproduction of FLAP protein (which is predicted by gene markers) dramatically increaseses heart disease risk Yes, but rights actually belonged to Bayer AG, rather than DeCode The Product Market Versus the Market for Ideas…. Effective Strategy Depends on the Choosing a Route which Maximizes Profits, Given the StartUp Commercialization Environment The Drivers of Commercialization Strategy To maximize both the Size and Share of the Innovation “Pie,” technology entrepreneurs must consider two key features of the commercialization environment… – The Degree of Excludability – The Degree to Which Established Firms Possess Control over Specialized Complementary Assets The Degree of Excludability is the Ability of Forestall Imitators from Copying your Technology Formal Intellectual property protection – Patents – Copyrights – 20 year length The right to prohibit “producing” The right to prohibit “copying” Trademarks Ability to Forestall Reverse Engineering – – The ability to forestall competitive development More than simply trade secrecy There has been a dramatic rise in the rate of patenting in the US and around the world! What are complementary assets? Those assets necessary to translate an innovation into commercial returns Competitive manufacturing Distribution Core technological know-how Complementary technology Services Suppliers Established firms often control the specialized Complementary Assets necessary to translate new technology into commercial returns MANUFACTURING MARKETING CORE TECHNOLOGY & INNOVATIVE KNOW-HOW DISTRIBUTION COMPLEMENTARY TECHNOLOGIES Complementary assets can only be a source of strength if they are tightly held Innovation Genentech’s Synthetic Insulin iPod / iTunes Complementary Assets How tightly held? Manufacturing, Tightly held by Eli Lilly. Lilly Regulatory Expertise, exploited power in initial MD Relationships deal, but ongoing disagreements led to costly litigation Artistic Content, including historical catalogues Medium, since there are many record companies. Jobs plays them off against the other, while leaving enough on the table to achieve a comprehensive arrangement The inability of biotechnology academic entrepreneurs to capture the majority of the value associated with their innovations is a consequence of the strong and specialized complementary asset portfolios held by downstream players in the pharmaceutical, medical device and agricultural technologies sectors How do Biotech Entrepreneurs Choose a Commercialization Strategy Effective Commercialization Strategy Depends on Assessing Two Key Questions Do incumbent’s “complementary assets” contribute to value proposition from new technology? No Yes Can invention by the startup preclude effective development by the incumbent? No Yes Industry Dynamics Are A Consequence of the Commercialization Environment Do incumbent’s complementary assets contribute to value proposition from new technology? No Yes Can invention by the startup preclude effective development by the incumbent? No The Attacker’s Advantage Reputation-based ideas trading Yes Greenfield Competition Ideas Factories Differences in Commercialization Strategy Across Industry Result from Differences in the Commercialization Environment Do incumbent’s complementary assets contribute to value proposition from new technology? No Yes Can invention by the startup preclude effective development by the incumbent? No Disk Drive Industry Cisco Yes Video Games Biotechnology Some Evidence: The MIT Commercialization Strategies Survey Figures represent the rate of Do incumbent’s complementary cooperation within each assets contribute to value “cell” proposition from new technology? No Yes Can invention by the startup preclude effective development by the incumbent? No Yes 14% 30% 34% 56% But... When does a “Cooperation Strategy” Make Sense for a biotechnology entrepreneur? How do I implement a cooperation strategy? Too early? Embryonic technology is often too speculative to allow for an effective bargaining position Moreover, start-up innovator cannot threaten to be an effective and nearterm product market competitor Too Late? Investing too far into the value chain likely leads to ineffective product development and incurring sunk investments that are duplicative with the resources of potential partners – ImClone’s Erbitux drug actually was quite promising but led to significant shareholder losses due to ImClone’s insistence of managing late-stage drug development So, when to cooperate? Returns to Cooperation Concept Exploration / Prototyping Commercialization Ideas Generation TIME At each stage, consider the two key questions: Do incumbent’s “complementary assets” contribute to value proposition from new technology? No Yes Can invention by the startup preclude effective development by the incumbent? No Yes The timing of cooperation is closely tied to the excludability environment – the pace of licensing deals increases dramatically after patent rights are granted (resolving uncertainty over scope, etc) 2.5 2 Hazard ratio 1.5 1 0.5 0 -30 -20 -10 0 10 20 30 Month window to/from patent allowance Gans, Hsu and Stern, 2008 Final Thoughts The promise of the life sciences and biopharmaceutical innovation offers the promise (but not a certainty) of dramatic opportunities for improvement in our treatment of disease and the human welfare. – Not simply a matter of exploiting “technological opportunity,” the economic, social and health benefits from biopharmaceutical innovation depends crucially on effective institutions and law – How can we ensure that we realize the “life sciences” century? Shaping both the incentives to innovate and the ability to maximize the social value arising from scientific discoveries and technological innovation But, in part because the underlying science and technology are advancing so rapidly, many key challenges and controversies reflect the need for institutions and the law to “catch up” with the life sciences revolution Thank You!
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