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    • All HBS Web  (1,457)
      • Faculty Publications  (88)

      Drug Development Remove Drug Development →

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      In a Landscape of 'Me Too' Drug Development, What Spurs Radical Innovation?
      ubingruo New research finds that large pharmaceutical companies, typically conservative in their pursuit of novel drug development, are more willing...
      Eli Lilly and Company: Drug Development Strategy (A)
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      • 2021
      • Working Paper

      Private and Social Returns to R&D: Drug Development and Demographics

      By: Efraim Benmelech, Janice Eberly, Dimitris Papanikolaou and Joshua Krieger
      Investment in intangible capital—in particular, research and development—increased dramatically since the 1990s. However, output and measured productivity growth remains sluggish in recent years. One potential reason is that a significant share of the increase in...  View Details
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      Benmelech, Efraim, Janice Eberly, Dimitris Papanikolaou, and Joshua Krieger. "Private and Social Returns to R&D: Drug Development and Demographics." Harvard Business School Working Paper, No. 21-083, January 2021.
      • December 2020
      • Technical Note

      Tales of Life-changing Innovations: Living Drugs | Note on the Development of CAR-T Therapies (through 2019)

      By: Amar Bhidé and Srikant M. Datar
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      Bhidé, Amar, and Srikant M. Datar. "Tales of Life-changing Innovations: Living Drugs | Note on the Development of CAR-T Therapies (through 2019)." Harvard Business School Technical Note 321-063, December 2020.
      • 2020
      • Working Paper

      Chimeric Antigen Receptor (CAR) T-Cell Therapy: Case Histories of Significant Medical Advances

      By: Amar Bhidé and Srikant M. Datar
      In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works; 2) the foundational advances and discoveries; 3)...  View Details
      Keywords: Immunotherapy; Health Care And Treatment; Innovation And Invention; Research And development; Governing Rules, Regulations, And Reforms
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      Bhidé, Amar, and Srikant M. Datar. "Chimeric Antigen Receptor (CAR) T-Cell Therapy: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-034, August 2020.
      • September 2020
      • Case

      Minerva 2004: Discovery

      By: John R. Wells and Benjamin Weinstock
      After nearly five years in operation, Doctor Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), was reflecting on the company’s next steps. In a few short years, she and her small team had managed to develop a nanoparticle process for...  View Details
      Keywords: Entrepreneurship; Financing And Loans; Strategy; Decision Choices And Conditions; Biotechnology Industry
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      Wells, John R., and Benjamin Weinstock. "Minerva 2004: Discovery." Harvard Business School Case 721-389, September 2020.
      • September 2020
      • Case

      Minerva 2010: Turbulent Times

      By: John R. Wells and Benjamin Weinstock
      In 2010, amid a flurry of new discoveries, Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), raised $6.6 million to test her new cancer drugs in mice. It had been more than 6 years since she had announced that she and her small team at...  View Details
      Keywords: Biotechnology; Research; Product development; Commercialization; Strategy
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      Wells, John R., and Benjamin Weinstock. "Minerva 2010: Turbulent Times." Harvard Business School Case 721-390, September 2020.
      • September 2020
      • Case

      Minerva 2020: Clinical Trials

      By: John R. Wells and Benjamin Weinstock
      In March 2020, Dr. Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Inc. (Minerva), was reviewing the first results of human clinical trials for the company’s novel CAR-T drug therapeutic, one of the first ever to target solid cancer tumors. The results...  View Details
      Keywords: Biotechnology; Strategic Decision Making; Entrepreneurship; Health Testing And Trials; Decision Choices And Conditions; Strategy
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      Wells, John R., and Benjamin Weinstock. "Minerva 2020: Clinical Trials." Harvard Business School Case 721-391, September 2020.
      • September–October 2020
      • Article

      The Past, Present, and (Near) Future of Gene Therapy and Gene Editing

      By: Julia Pian, Amitabh Chandra and Ariel Dora Stern
      Emerging gene therapy and gene-editing technologies will have a growing impact on patient lives and health-care delivery. We analyzed a decade of data on clinical trials and venture capital investments to understand the likely trajectory of genetically focused...  View Details
      Keywords: Gene Therapy; Gene Editing; Impact; Health Care And Treatment; Technological Innovation; Health Testing And Trials; Venture Capital; Change
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      Pian, Julia, Amitabh Chandra, and Ariel Dora Stern. "The Past, Present, and (Near) Future of Gene Therapy and Gene Editing." NEJM Catalyst Innovations in Care Delivery 1, no. 5 (September–October 2020).
      • 2020
      • Working Paper

      What Can Economics Say About Alzheimer's Disease?

      By: Amitabh Chandra, Courtney Coile and Corina Mommaerts
      Alzheimer’s Disease (AD) affects one in ten people aged 65 or older and is the most expensive disease in the United States. We describe the central economic questions raised by AD. While there is overlap with the economics of aging, the defining features of the...  View Details
      Keywords: Health Disorders; Health Care And Treatment; Economics
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      Chandra, Amitabh, Courtney Coile, and Corina Mommaerts. "What Can Economics Say About Alzheimer's Disease?" NBER Working Paper Series, No. 27760, August 2020.
      • Article

      Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study

      By: Noy Alon, Ariel Dora Stern and John Torous
      BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...  View Details
      Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care And Treatment; Mobile Technology; Software
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      Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
      • 2020
      • Working Paper

      Cephalosporins: Case Histories of Significant Medical Advances

      By: Amar Bhidé, Srikant Datar and Katherine Stebbins
      Our case history describes the development of three generations of cephalosporins – antibiotics that have significantly reduced hospital infections. Specifically, we chronicle how: 1) Early (pre-cephalosporin) antibiotics were developed in the first half of the 20th...  View Details
      Keywords: Health Care And Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation And Invention; Innovation And Invention; Governing Rules, Regulations, And Reforms
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      Bhidé, Amar, Srikant Datar, and Katherine Stebbins. "Cephalosporins: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-133, July 2020. (Revised August 2020.)
      • June 2020
      • Case

      Breakthroughs at Blueprint Medicines

      By: Richard G. Hamermesh, Kathy Giusti and Susie L. Ma
      Precision medicine company Blueprint Medicines was building a successful track record for bringing drug therapies to market 40% faster than average. The company had spent $40 million dollars and two years building a compound library that became its drug development...  View Details
      Keywords: Precision Medicine; Cancer; Biotechnology; Drug Development; Strategy; Expansion; Science; Genetics; Technology; Entrepreneurship; Organizational Culture; Management; Growth And development; Pharmaceutical Industry; United States; Cambridge; Massachusetts
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      Hamermesh, Richard G., Kathy Giusti, and Susie L. Ma. "Breakthroughs at Blueprint Medicines." Harvard Business School Case 820-001, June 2020.
      • May 6, 2020
      • Article

      We Shouldn't Wait for a Breakthrough in the Covid-19 Pandemic

      By: Gary P. Pisano
      The ultimate solutions to the Covid-19 crisis may be big breakthroughs in building massive test and trace capacity and developing vaccines and drug remedies. But in the meantime, we should not ignore the potential cumulative impact of the many small things we already...  View Details
      Keywords: Covid-19; Health Pandemics; Strategy; Leadership
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      Pisano, Gary P. "We Shouldn't Wait for a Breakthrough in the Covid-19 Pandemic." Harvard Business Review Digital Articles (May 6, 2020).
      • April 2020
      • Article

      Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning

      By: Ariel Dora Stern and W Nicholson Price, II
      In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...  View Details
      Keywords: Machine Learning; Causal Inference; Health Care And Treatment; Safety; Governing Rules, Regulations, And Reforms
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      Stern, Ariel Dora, and W Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
      • January 2020
      • Case

      Celata Bioinnovations

      By: John R. Wells and Benjamin Weinstock
      In December 2019, Jon Hu (HBS ‘19) and Dr. Samantha Dale Strasser, co-founders of Celata Bioinnovations, were raising $1 million to launch their company. They had founded Celata less than six months earlier with the aim of redefining the drug discovery process....  View Details
      Keywords: Drug Development; Drug Discovery; Drug Trials; Pharmaceutical Companies; Pharmaceutical Company; Pharmaceuticals; Therapeutics; Biologics; Biotech; Biotechnology; Biopharmacy Company; Biochemistry; Technology Commercialization; Technology Companies; Drug Testing; Startup; Start-up; Startups; Start-ups; Startup Financing; Strategic Decision Making; Strategic Decisions; Strategic Evolution; Fda; Food And Drug Administration; Clinical Trials; Disease Management; Market Attractiveness; Market Entry; Market Opportunities; Health Disorders; Technological Innovation; Technology; Commercialization; Business Startups; Finance; Decision Making; Strategy; Market Entry And Exit; Opportunities; Pharmaceutical Industry; Biotechnology Industry
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      Wells, John R., and Benjamin Weinstock. "Celata Bioinnovations." Harvard Business School Case 720-427, January 2020.
      • 2020
      • Working Paper

      Magnetic Resonance Imaging: Case Histories of Significant Medical Advances

      By: Srikant M. Datar, Amar Bhidé and Katherine Stebbins
      We describe how and why Magnetic Resource Imaging (MRI) came to complement—and partially replace—computed tomography (CT) imaging of soft tissue. Specifically we chronicle: 1) the development of foundational techniques and prototypes (through the 1970s); 2) how U.S....  View Details
      Keywords: Health Care And Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation And Invention; Innovation And Invention; Governing Rules, Regulations, And Reforms
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      Datar, Srikant M., Amar Bhidé, and Katherine Stebbins. "Magnetic Resonance Imaging: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-001, July 2019. (Revised July 2020.)
      • 2019
      • Chapter

      Characterizing the Drug Development Pipeline for Precision Medicines

      By: Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
      BOOK ABSTRACT: Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement...  View Details
      Keywords: Healthcare; Precision Medicine
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      Chandra, Amitabh, Craig Garthwaite, and Ariel Dora Stern. "Characterizing the Drug Development Pipeline for Precision Medicines." Chap. 5 in Economic Dimensions of Personalized and Precision Medicine, edited by Ernest R. Berndt, Dana P. Goldman, and John W. Rowe, 115–158. University of Chicago Press, 2019.
      • 2020
      • Working Paper

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

      By: Joshua 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; System Shocks; Research And development; Investment; Behavior; Pharmaceutical Industry
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      Krieger, Joshua, Xuelin Li, and Richard T. Thakor. "Find and Replace: R&D Investment Following the Erosion of Existing Products." Harvard Business School Working Paper, No. 19-058, December 2018. (Revised May 2020.)
      • 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.
      • 2018
      • Chapter

      The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century

      By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
      On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new...  View Details
      Keywords: Health Care And Treatment; Laws And Statutes; Research And development; Investment; Markets; Monopoly
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      Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.
      • June 2018
      • Teaching Note

      Sandra Brown Goes Digital

      By: Rosabeth Moss Kanter and Jonathan Cohen
      As a middle manager at a biotechnology company, Sandra Brown harnessed digital tools and social media to engage others and build campaigns for change in the company. This Teaching Note presents strategies for teaching the Sandra Brown case series, which follows Brown's...  View Details
      Keywords: Change Leadership; Change Management; Digital; Engagement; Stakeholder Engagement; Grassroots Movement; Organizational Change And Adaptation; Quality; Health Care Industry; Management; Career Path; Innovation; Leading Change; Management; Innovation And Management; Personal development And Career; Organizational Change And Adaptation; Quality
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      Kanter, Rosabeth Moss, and Jonathan Cohen. "Sandra Brown Goes Digital." Harvard Business School Teaching Note 318-156, June 2018.
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      Are you looking for?

      In a Landscape of 'Me Too' Drug Development, What Spurs Radical Innovation?
      ubingruo New research finds that large pharmaceutical companies, typically conservative in their pursuit of novel drug development, are more willing...
      Eli Lilly and Company: Drug Development Strategy (A)
      → Search All HBS Web
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