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      • Faculty Publications  (39)

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      • February 2025
      • Case

      Abiomed: A Change of Heart

      By: Satish Tadikonda, Faith Robertson and William Marks
      After acquiring Impella CardioSystems AG in May 2005, Abiomed Inc., a company focused on cardiac care, ran into a dilemma. Its Impella 2.5 device was approved for use in the European Union, but CEO Michael Minogue had seemingly bet the company's future on the ability... View Details
      Keywords: Mergers and Acquisitions; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; European Union; United States
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      Tadikonda, Satish, Faith Robertson, and William Marks. "Abiomed: A Change of Heart." Harvard Business School Case 825-011, February 2025.
      • October 2024
      • Case

      Allurion: Competing in the Age of GLP-1

      By: Satish Tadikonda, Rajiv Lal, David Lane and Sarah Sasso
      Shantanu Gaur had built Allurion into a formidable business internationally, providing obesity patients with a less invasive option long before GLP-1 drugs became the latest craze. Selling Allurion's medical device across 60+ countries, he awaited FDA approval to bring... View Details
      Keywords: Corporate Entrepreneurship; Health Care and Treatment; Global Strategy; Competitive Strategy; Medical Devices and Supplies Industry; Health Industry; United States; United Kingdom; France; India; Brazil; Middle East
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      Tadikonda, Satish, Rajiv Lal, David Lane, and Sarah Sasso. "Allurion: Competing in the Age of GLP-1." Harvard Business School Case 525-011, October 2024.
      • February 2024
      • Case

      Compass Pathways: Pioneering Psychedelic Treatment

      By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu
      This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no... View Details
      Keywords: Commercialization; Corporate Strategy; Competitive Strategy; Product Launch; Health Testing and Trials; Research and Development; Laws and Statutes; Pharmaceutical Industry; Europe; United States; United Kingdom
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      Zuzul, Tiona, Kisha Lashley, and Gamze Yucaoglu. "Compass Pathways: Pioneering Psychedelic Treatment." Harvard Business School Case 724-412, February 2024.
      • June 2023 (Revised July 2024)
      • Case

      Biogen and the Aduhelm Melee

      By: Amitabh Chandra and Lauren Gunasti
      Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.

      This... View Details
      Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry
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      Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 2024.)
      • December 2022 (Revised September 2024)
      • Case

      Sword Health

      By: Regina E. Herzlinger, Annelena Lobb and Carin-Isabel Knoop
      Virgilio “V” Bento, CEO of Sword Health—a startup that provided virtual physical therapy to patients in self-insured firms via AI and sensor technology with supervision by a physical therapist with a doctorate—considered how to increase its U.S. market share. To do so,... View Details
      Keywords: Business Growth and Maturation; Competitive Strategy; Health Industry; Technology Industry
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      Herzlinger, Regina E., Annelena Lobb, and Carin-Isabel Knoop. "Sword Health." Harvard Business School Case 323-022, December 2022. (Revised September 2024.)
      • September 2022
      • Article

      Find and Replace: R&D Investment Following the Erosion of Existing Products

      By: Joshua L. Krieger, Xuelin Li and Richard T. Thakor
      How do innovative firms react when existing products experience negative shocks? We explore this question with detailed project-level data from drug development firms. Using FDA Public Health Advisories as idiosyncratic negative shocks to approved drugs, we first... View Details
      Keywords: R&D Investments; Drug Development; Product Shocks; M&A; Biopharmaceutical Industry; FDA; System Shocks; Research and Development; Investment; Decision Making; Pharmaceutical Industry
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      Krieger, Joshua L., Xuelin Li, and Richard T. Thakor. "Find and Replace: R&D Investment Following the Erosion of Existing Products." Management Science 68, no. 9 (September 2022): 6552–6571.
      • 2022
      • Article

      Missing Novelty in Drug Development

      By: Joshua Krieger, Danielle Li and Dimitris Papanikolaou
      We provide evidence that risk aversion leads pharmaceutical firms to underinvest in radical innovation. We introduce a new measure of drug novelty based on chemical similarity and show that firms face a risk-reward trade-off: novel drug candidates are less likely to... View Details
      Keywords: Drug Development; Risk Aversion; Research and Development; Innovation and Invention; Investment; Pharmaceutical Industry
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      Krieger, Joshua, Danielle Li, and Dimitris Papanikolaou. "Missing Novelty in Drug Development." Review of Financial Studies 35, no. 2 (February 2022): 636–679.
      • 2024
      • Working Paper

      Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances

      By: Amar Bhide and Srikant M. Datar
      By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the... View Details
      Keywords: Health Care and Treatment; Innovation and Invention; Governing Rules, Regulations, and Reforms
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      Bhide, Amar, and Srikant M. Datar. "Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 21-132, June 2021. (Revised May 2024.)
      • 2021
      • Working Paper

      Regulatory Approval and Expanded Market Size

      By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
      Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details
      Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry
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      Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
      • May 2021 (Revised May 2022)
      • Case

      Headspace vs. Calm: A Mindful Competition

      By: Ayelet Israeli and Anne Wilson
      By 2021, the mindfulness app wars reached their apex. Over 2,000 meditation apps were available to consumers, but two apps, Headspace and Calm, dominated the space, jointly holding about 70% of the total market. Headspace had established itself as the approachable... View Details
      Keywords: Marketing Communication; Integrated Strategy; Brand; Brand & Product Management; Brand Communication; Brand Differentiation; Brand Building; Brand Management; E-Commerce Strategy; Ecommerce; App; App Development; Applications; COVID; COVID-19; Pandemic; Pricing; Pricing Strategy; Subscription Model; Subscription; Partnerships; Strategic Partnerships; B2B Vs. B2C; B2B; Health & Wellness; Wellbeing; Digitization; Commoditization; Mobile App; Mobile App Industry; Mobile Healthcare; Mobile Marketing; Digital Brand; Digital Health; Consumer Health; Apps; Online Business; Online Competition; Online Community; Online Entertainment; Entertainment And Leisure; Meditation; Marketing; Marketing Communications; Brands and Branding; Price; Strategy; Competition; Competitive Strategy; Competitive Advantage; Partners and Partnerships; Health; Well-being; Mobile and Wireless Technology; Communication; Communication Strategy; Disruption; Consumer Behavior; Digital Marketing; E-commerce; Applications and Software; Health Industry; Technology Industry; Communications Industry; United States; North America; United Kingdom
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      Israeli, Ayelet, and Anne Wilson. "Headspace vs. Calm: A Mindful Competition." Harvard Business School Case 521-102, May 2021. (Revised May 2022.)
      • June 2019
      • Teaching Note

      Zebra Medical Vision

      By: Shane Greenstein and Sarah Gulick
      Teaching note is meant to accompany Zebra Medical Vision case, which offers a look at a company’s decisions as a small startup competing with other startups and major technology companies. It also demonstrates the challenges faced by a machine learning company working... View Details
      Keywords: Business Startups; Science-Based Business; Applications and Software; Patents; Cross-Cultural and Cross-Border Issues; Health Care and Treatment; Health Industry; Medical Devices and Supplies Industry; Technology Industry; Israel
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      Greenstein, Shane, and Sarah Gulick. "Zebra Medical Vision." Harvard Business School Teaching Note 619-053, June 2019.
      • February 2019 (Revised September 2019)
      • Case

      Theranos: The Unicorn That Wasn't

      By: Joseph B. Fuller and John Masko
      In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains... View Details
      Keywords: Theranos; Blood; Lab Testing; Fraud; Holmes; Balwani; Shultz; Carreyrou; Securities And Exchange Commission; Food And Drug Administration; FDA; SEC; Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Medical Devices and Supplies Industry
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      Fuller, Joseph B., and John Masko. "Theranos: The Unicorn That Wasn't." Harvard Business School Case 319-068, February 2019. (Revised September 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.
      • September 2018 (Revised December 2019)
      • Case

      Zebra Medical Vision

      By: Shane Greenstein and Sarah Gulick
      An Israeli startup founded in 2014, Zebra Medical Vision developed algorithms that produced diagnoses from X-rays, mammograms, and CT-scans. The algorithms used deep learning and digitized radiology scans to create software that could assist doctors in making... View Details
      Keywords: Radiology; Machine Learning; X-ray; CT Scan; Medical Technology; Probability; FDA 510(k); Diagnosis; Business Startups; Health Care and Treatment; Information Technology; Applications and Software; Competitive Strategy; Product Development; Commercialization; Decision Choices and Conditions; Health Industry; Medical Devices and Supplies Industry; Technology Industry; Israel
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      Greenstein, Shane, and Sarah Gulick. "Zebra Medical Vision." Harvard Business School Case 619-014, September 2018. (Revised December 2019.)
      • August 2017 (Revised July 2018)
      • Case

      MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work

      By: Elie Ofek and Amanda Dai
      In June 2014, MannKind Corporation announced that after years of development and billions of dollars in expenses, the FDA had finally approved its drug, Afrezza. MannKind would thus be the only company with an inhalable insulin on the market. As an alternative to... View Details
      Keywords: Health Care and Treatment; Product Launch; Product Positioning; Marketing Strategy; Adoption; Pharmaceutical Industry
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      Ofek, Elie, and Amanda Dai. "MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work." Harvard Business School Case 518-031, August 2017. (Revised July 2018.)
      • April 2017
      • Case

      Imprimis (A)

      By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
      This case examines the strategic choices and evolving business model of Imprimis Pharmaceuticals from the perspective of CEO Mark Baum. The (A) case provides a brief history of the company and of the compounding business, outlining the challenges faced by Imprimis in... View Details
      Keywords: Strategy; Healthcare; Drug Compounding; Pharmaceuticals; Compounding; Drug Development; Decision-making; Mark Baum; Imprimis; Small Business; Decisions; Cost vs Benefits; Business Strategy; Business Model; Decision Choices and Conditions; Pharmaceutical Industry; United States
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      Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (A)." Harvard Business School Case 717-426, April 2017.
      • March 2015 (Revised January 2024)
      • Case

      CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies

      By: Regina E. Herzlinger and Andrew Otazo
      Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details
      Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Health Industry; Medical Devices and Supplies Industry; United States; Europe
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      Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies." Harvard Business School Case 315-045, March 2015. (Revised January 2024.)
      • December 2014 (Revised August 2015)
      • Case

      Improving Melanoma Screening: MELA Sciences

      By: Regina E. Herzlinger, Kevin Schulman and Frédéric Dijols
      MELA is a start-up medical device company looking to develop a novel technology to help physicians diagnose a deadly skin cancer, melanoma. The case reviews the FDA medical device development process, the development path pursued by MELA, and the regulatory and... View Details
      Keywords: Healthcare Industry; Health Care; Health; Health Care and Treatment; Health Testing and Trials; Health Industry; United States
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      Herzlinger, Regina E., Kevin Schulman, and Frédéric Dijols. "Improving Melanoma Screening: MELA Sciences." Harvard Business School Case 315-042, December 2014. (Revised August 2015.)
      • January 2014 (Revised June 2014)
      • Case

      23andMe: Genetic Testing for Consumers (A)

      By: John A. Quelch and Margaret L. Rodriguez
      On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was... View Details
      Keywords: Public Health; Genome Testing; Health Care; Ancestry; 23andMe; Marketing; Product Launch; Health; Health Care and Treatment; Health Testing and Trials; Genetics; Strategy; Health Industry; United States
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      Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised June 2014.)
      • January 2014
      • Supplement

      Fred Khosravi and AccessClosure (C)

      By: Richard Hamermesh and Lauren Barley
      On September 11, 2013, the three-judge panel of the U.S. Court of Appeals for the Federal Circuit denied St. Jude's request to rehear an appeal on the "double patenting" ruling for the '439 patent. Further, it removed the injunction threat that was hanging over the... View Details
      Keywords: Medical Devices; Vascular Closure Device; Patent Litigation; Patenting; Biomedical Research; Biotechnology; Biotech; Technological Innovation; Patents; Health Care and Treatment; Biotechnology Industry; United States
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      Hamermesh, Richard, and Lauren Barley. "Fred Khosravi and AccessClosure (C)." Harvard Business School Supplement 814-074, January 2014.
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