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      • Article

      What Evolution Can Teach Us About Innovation

      By: Noubar Afeyan and Gary P. Pisano
      Many people believe that the process for achieving breakthrough innovations is chaotic, random, and unmanageable. But that view is flawed, the authors argue. Breakthroughs can be systematically generated using a process modeled on the principles that drive evolution in...  View Details
      Keywords: Breakthrough Innovation; Variance Generation; Selection Pressure; Emergent Discovery; Innovation and Invention; Value Creation; Innovation Leadership
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      Afeyan, Noubar, and Gary P. Pisano. "What Evolution Can Teach Us About Innovation." Harvard Business Review 99, no. 5 (September–October 2021): 62–72.
      • May 2021
      • Case

      The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease

      By: Amitabh Chandra, Spencer Lee-Rey and Caroline Marra
      This case explores incentives for rare disease drug development by chronicling the role of the Spinal Muscular Atrophy (SMA) Foundation in forming strategic partnerships with the scientific research community and pharmaceutical developers to transform the trajectory...  View Details
      Keywords: Innovation and Invention; Strategy; Business or Company Management; Society; Health; Public Administration Industry; Health Industry; United States
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      Chandra, Amitabh, Spencer Lee-Rey, and Caroline Marra. "The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease." Harvard Business School Case 621-112, May 2021.
      • February 2021
      • Case

      Digital Manufacturing at Amgen

      By: Shane Greenstein, Kyle R. Myers and Sarah Mehta
      This case discusses efforts made by biotechnology (biotech) company Amgen to introduce digital technologies into its manufacturing processes. Doing so is complicated by the fact that the process for manufacturing biologics—or therapeutics made from living cells—is...  View Details
      Keywords: Digital Technologies; Change; Change Management; Decision Making; Cost vs Benefits; Decisions; Information; Analytics and Data Science; Innovation and Invention; Innovation and Management; Innovation Leadership; Innovation Strategy; Technological Innovation; Jobs and Positions; Knowledge; Leadership; Organizational Culture; Science; Strategy; Information Technology; Technology Adoption; Biotechnology Industry; Pharmaceutical Industry; United States; California; Puerto Rico; Rhode Island
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      Greenstein, Shane, Kyle R. Myers, and Sarah Mehta. "Digital Manufacturing at Amgen." Harvard Business School Case 621-008, February 2021.
      • Article

      Sustainability, Business, and Health

      By: George Serafeim, Amanda M. Rischbieth and Howard K. Koh
      The coronavirus disease 2019 (COVID-19) pandemic has demonstrated that response demands involvement from every sector of society. As a major example, some businesses have stepped up in ways previously unimaginable. Garment companies have repurposed production to face...  View Details
      Keywords: COVID; COVID-19; Sustainability; Health And Wellness; Corporate Social Responsibility; Health Pandemics; Health; Corporate Social Responsibility and Impact; Corporate Accountability; Health Care and Treatment
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      Serafeim, George, Amanda M. Rischbieth, and Howard K. Koh. "Sustainability, Business, and Health." JAMA, the Journal of the American Medical Association 324, no. 2 (July 14, 2020): 147–148.
      • October 2019
      • Article

      Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations

      By: Derek C. Angus, Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen and Janet Woodcock
      Researchers, clinicians, policymakers, and patients are increasingly interested in questions about therapeutic interventions that are difficult or costly to answer with traditional, free-standing, parallel-group randomized controlled trials (RCTs). Examples include...  View Details
      Keywords: Adaptive Platform Trials; Health Testing and Trials
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      Angus, Derek C., Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen, and Janet Woodcock. "Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations." Nature Reviews: Drug Discovery 18, no. 10 (October 2019): 797–807.
      • September 2019
      • Case

      Nimbus Therapeutics

      By: Peter Barrett, Karim Lakhani and Julia Kelley
      This case focuses on Nimbus Therapeutics, a biotechnology startup based in Cambridge, Massachusetts, as its leadership team tries to determine the company’s long-term strategy. The startup’s founders structured Nimbus as a limited liability company, which has given it...  View Details
      Keywords: Business Startups; Organizational Structure; Strategy; Biotechnology Industry
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      Barrett, Peter, Karim Lakhani, and Julia Kelley. "Nimbus Therapeutics." Harvard Business School Case 620-016, September 2019.
      • Article

      Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures.

      By: Ariel Dora Stern
      The use of biomarkers holds great promise for the development of new therapeutics and the acceleration of clinical research. However, biomarkers must be validated—a complex and costly endeavor. Importantly, biomarker validation is meaningfully shaped by economic and...  View Details
      Keywords: Biomarkers; Information Management; Health Care and Treatment; Motivation and Incentives
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      Stern, Ariel Dora. "Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures." Journal of Law, Medicine & Ethics 47, no. 3 (September 2019): 396–397.
      • April 2019
      • Case

      Barber Cardiosystems

      By: Ranjay Gulati and Paul S. Myers
      Barber Cardiosystems, based in Melbourne, Australia, designs and manufactures therapeutic devices used for treatment of coronary conditions. Over four decades, it has grown to be among the top 200 medical device companies in the world. It competes against much larger...  View Details
      Keywords: Organizational Behavior; Strategic Alignment; Cost Management; Performance Productivity; Organizational Culture; Motivation and Incentives; Organizational Design; Strategy; Leadership; Medical Devices and Supplies Industry; Australia
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      Gulati, Ranjay, and Paul S. Myers. "Barber Cardiosystems." Harvard Business School Brief Case 919-505, April 2019.
      • February 2019 (Revised May 2019)
      • Case

      Hot Chicken Takeover

      By: William R. Kerr, Manjari Raman and Olivia Hull
      By December 2018, entrepreneur Joe DeLoss’s fried chicken company, Hot Chicken Takeover, has opened three restaurants in Columbus, Ohio, using an unconventional employment model that helps people with criminal records get back on their feet. DeLoss is proud of the...  View Details
      Keywords: Fair Chance Employment; Fair Chance Hiring; Open Hiring; Inclusive Hiring; Criminal Record; Homelessness; Therapeutic Employment; Corporate Culture; Managing The Future Of Work; Food; Entrepreneurship; Social Entrepreneurship; Values and Beliefs; Fairness; Human Resources; Compensation and Benefits; Recruitment; Employees; Retention; Selection and Staffing; Innovation Strategy; Job Offer; Job Interviews; Human Capital; Leadership; Growth Management; Corporate Social Responsibility and Impact; Mission and Purpose; Social Enterprise; Social Issues; Poverty; Welfare; Food and Beverage Industry; Ohio; United States
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      Kerr, William R., Manjari Raman, and Olivia Hull. "Hot Chicken Takeover." Harvard Business School Case 819-078, February 2019. (Revised May 2019.)
      • November 2018
      • Case

      David Hysong and SHEPHERD Therapeutics

      By: Ananth Raman, John Masko and Aldo Sesia
      In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his...  View Details
      Keywords: Cancer; Therapeutics; Drugs; Health Care and Treatment; Business Startups; Product Development; Financing and Loans; Growth and Development Strategy; Problems and Challenges
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      Raman, Ananth, John Masko, and Aldo Sesia. "David Hysong and SHEPHERD Therapeutics." Harvard Business School Case 619-012, November 2018.
      • May 2017
      • Other Article

      Stepwise Distributed Open Innovation Contests for Software Development: Acceleration of Genome-Wide Association Analysis

      By: Andrew Hill, Po-Ru Loh, Ragu B. Bharadwaj, Pascal Pons, Jingbo Shang, Eva C. Guinan, Karim R. Lakhani, Iain Kilty and Scott Jelinsky
      BACKGROUND: The association of differing genotypes with disease-related phenotypic traits offers great potential to both help identify new therapeutic targets and support stratification of patients who would gain the greatest benefit from specific drug classes....  View Details
      Keywords: Crowdsourcing; Genome-wide Association Study; Logistic Regression; Open Innovation; PLINK; Collaborative Innovation and Invention
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      Hill, Andrew, Po-Ru Loh, Ragu B. Bharadwaj, Pascal Pons, Jingbo Shang, Eva C. Guinan, Karim R. Lakhani, Iain Kilty, and Scott Jelinsky. "Stepwise Distributed Open Innovation Contests for Software Development: Acceleration of Genome-Wide Association Analysis." GigaScience 6, no. 5 (May 2017).
      • March 17, 2017
      • Article

      How Economics Can Shape Precision Medicines

      By: Ariel Dora Stern, Brian M. Alexander and Amitabh Chandra
      Many public and private efforts in coming years will focus on research in precision medicine, developing biomarkers to indicate which patients are likely to benefit from a certain treatment so that others can be spared the cost—financial and physical—of being treated...  View Details
      Keywords: Health Care and Treatment; Research; Economics; Motivation and Incentives
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      Stern, Ariel Dora, Brian M. Alexander, and Amitabh Chandra. "How Economics Can Shape Precision Medicines." Science 355, no. 6330 (March 17, 2017): 1131–1133.
      • November 2016
      • Case

      Anthony Starks at InSiL Therapeutics (A)

      By: Gary Pisano and Vicki Sato
      When Bruce Wayne hired Anthony Starks, he thought he had hit a home run by getting the most brilliant and passionate scientist-leader in the field to be his CSO. But a few months in, Wayne and Starks begin to clash over crucial forward-looking decisions about the...  View Details
      Keywords: Biotech; Silicon; Managing Innovation; Management Challenges; Managing People; Managing Organization; R&D; R&D Project Management; Platform; Venture Capital; Drug Discovery; management; Biotechnology Industry; California
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      Pisano, Gary, and Vicki Sato. "Anthony Starks at InSiL Therapeutics (A)." Harvard Business School Case 617-029, November 2016.
      • November 2016 (Revised December 2016)
      • Supplement

      Anthony Starks at InSiL Therapeutics (B)

      By: Vicki Sato and Gary Pisano
      This case accompanies the (A) case from Anthony Starks's perspective.  View Details
      Keywords: Biotech; Management Challenges; R&D; R&D Project Management; Management; Biotechnology Industry; California
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      Sato, Vicki, and Gary Pisano. "Anthony Starks at InSiL Therapeutics (B)." Harvard Business School Supplement 617-030, November 2016. (Revised December 2016.)
      • February 2016 (Revised September 2017)
      • Case

      Neurotrack and the Alzheimer's Puzzle

      By: Richard G. Hamermesh, Liz Kind and Carin-Isabel Knoop
      Elli Kaplan founded Neurotrack in 2012 with a breakthrough noninvasive cognitive diagnostics test that will detect Alzheimer's disease in its earliest pre-symptomatic stages. While the company has gained great traction in the three years since it was started, with no...  View Details
      Keywords: Alzheimer's Disease; Diagnostics; Healthcare; Entrepreneurship; Health Disorders; Science-Based Business; Business Model; Medical Devices and Supplies Industry; United States
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      Hamermesh, Richard G., Liz Kind, and Carin-Isabel Knoop. "Neurotrack and the Alzheimer's Puzzle." Harvard Business School Case 816-072, February 2016. (Revised September 2017.)
      • January 2016 (Revised January 2019)
      • Case

      The Allergan Board Under Fire (A)

      By: Lynn S. Paine, Suraj Srinivasan, John C. Coates and David Lane
      In 2014, the Allergan Inc. board of directors received a surprise takeover offer from Valeant Pharmaceuticals in alliance with hedge fund activist Bill Ackman's Pershing Square Capital Management. In the unprecedented arrangement between an acquirer and a hedge fund...  View Details
      Keywords: Allergan, Inc.; Valeant; Ackman; Pershing Square; Tender Offer; Activist Investors; Business Models; R&D; Board Of Directors; Securities Litigation; Acquisition Strategy; Takeover Defenses; Hedge Funds; Shareholder Rights; Proxy Contest; Shareholder Special Meetings; Legal Issues In Contested Takeovers; Governing and Advisory Boards; Mergers and Acquisitions; Corporate Governance; Management Teams; Business and Shareholder Relations; Pharmaceutical Industry
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      Paine, Lynn S., Suraj Srinivasan, John C. Coates, and David Lane. "The Allergan Board Under Fire (A)." Harvard Business School Case 316-010, January 2016. (Revised January 2019.)
      • January 2016 (Revised January 2019)
      • Supplement

      The Allergan Board Under Fire (B)

      By: Lynn S. Paine, Suraj Srinivasan, John C. Coates and David Lane
      In 2014, the Allergan Inc. board of directors received a surprise takeover offer from Valeant Pharmaceuticals in alliance with hedge fund activist Bill Ackman's Pershing Square Capital Management. In the unprecedented arrangement between an acquirer and a hedge fund...  View Details
      Keywords: Allergan, Inc.; Valeant; Ackman; Pershing Square; Tender Offer; Activist Investors; Business Models; R&D; Board Of Directors; Securities Litigation; Acquisition Strategy; Takeover Defenses; Hedge Funds; Shareholder Rights; Proxy Contest; Shareholder Special Meetings; Legal Issues In Contested Takeovers; Corporate Governance; Investment Activism; Business and Stakeholder Relations; Business Model; Business and Shareholder Relations; Valuation; Pharmaceutical Industry
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      Paine, Lynn S., Suraj Srinivasan, John C. Coates, and David Lane. "The Allergan Board Under Fire (B)." Harvard Business School Supplement 316-029, January 2016. (Revised January 2019.)
      • September 2014
      • Case

      Pfizer's Centers for Therapeutic Innovation (CTI)

      By: Gary Pisano, James Weber and Kait Szydlowski
      In 2010, Pfizer established four small research units in New York, Boston, San Francisco, and San Diego located close to several premier Academic Medical Centers (AMCs), or hospitals with adjoining medical schools. The goal of these units was to redesign collaboration...  View Details
      Keywords: Drug Development; Academic Collaboration; Research And Development; Innovation; Translational Research; Management; Operations; Problems and Challenges; Research; Science; Information Technology; Strategy; Biotechnology Industry; Pharmaceutical Industry; North and Central America; Europe; Asia
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      Pisano, Gary, James Weber, and Kait Szydlowski. "Pfizer's Centers for Therapeutic Innovation (CTI)." Harvard Business School Case 615-024, September 2014.
      • September 2013
      • Article

      Testimonials Do Not Convert Patients from Brand to Generic Medication

      By: John Beshears, James J. Choi, David Laibson, Brigitte C. Madrian and Gwendolyn Reynolds

      Objectives: To assess whether the addition of a peer testimonial to an informational mailing increases conversion rates from brand name prescription medications to lower-cost therapeutic equivalents, and whether the testimonial's efficacy increases when...  View Details

      Keywords: Testimonial; Peer Information; Social Proximity; Communication; Generic Medication; Familiarity; Marketing Communications; Decision Choices and Conditions; Identity; Health Care and Treatment; Marketing Reference Programs; Power and Influence; Brands and Branding; Health Industry
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      Beshears, John, James J. Choi, David Laibson, Brigitte C. Madrian, and Gwendolyn Reynolds. "Testimonials Do Not Convert Patients from Brand to Generic Medication." American Journal of Managed Care 19, no. 9 (September 2013): e314–e316.
      • November 2012 (Revised January 2013)
      • Case

      Companion Diagnostics: Uncertainties for Approval and Reimbursement

      By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
      The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory...  View Details
      Keywords: Models Of Reimbursement; Personalized Medicine; Regulation; Healthcare Reform; Health Care and Treatment; Health Industry; United States
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      Hamermesh, Richard G., Norman C. Selby, and Phillip Andrews. "Companion Diagnostics: Uncertainties for Approval and Reimbursement." Harvard Business School Case 813-037, November 2012. (Revised January 2013.)
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