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      • 2023
      • Working Paper

      Evaluation and Learning in R&D Investment

      By: Alexander P. Frankel, Joshua L. Krieger, Danielle Li and Dimitris Papanikolaou
      We examine the role of spillover learning in shaping the value of exploratory versus incremental R&D. Using data from drug development, we show that novel drug candidates generate more knowledge spillovers than incremental ones. Despite being less likely to reach...  View Details
      Keywords: Research and Development; Forecasting and Prediction; Valuation; Pharmaceutical Industry
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      Frankel, Alexander P., Joshua L. Krieger, Danielle Li, and Dimitris Papanikolaou. "Evaluation and Learning in R&D Investment." Harvard Business School Working Paper, No. 23-074, May 2023. (NBER Working Paper Series, No. 31290, May 2023.)
      • April 2023
      • Background Note

      Note on Healthcare in Ghana

      By: Regina E. Herzlinger and Ben Creo
      This note accompanies case 323-033, “mPharma: Scaling Access to Affordable Primary Care in Africa” which discusses mPharma’s make-or-break strategic decisions. This note’s coverage of the Ghanaian healthcare system ranges from how care and drugs are delivered and...  View Details
      Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Health Industry; Pharmaceutical Industry; Ghana
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      Herzlinger, Regina E., and Ben Creo. "Note on Healthcare in Ghana." Harvard Business School Background Note 323-112, April 2023.
      • January 2023
      • Case

      Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery

      By: Regina Herzlinger and Brian Walker
      What should a successful executive (HBS Baker Scholar) assess as her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to successfully commercialize Cleave Therapeutics’ drug for a cancer with no current successful...  View Details
      Keywords: Product Development; Leadership; Health Testing and Trials; Research and Development; Risk and Uncertainty; Financial Condition; Partners and Partnerships; Pharmaceutical Industry
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      Herzlinger, Regina, and Brian Walker. "Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery." Harvard Business School Case 323-045, January 2023.
      • November 2022
      • Case

      The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales

      By: Regina E. Herzlinger and Tiffany Farrell
      Can an online, direct-to-consumer pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous...  View Details
      Keywords: DTC; Internet and the Web; Marketing Channels; Customer Value and Value Chain; Governing Rules, Regulations, and Reforms; Competitive Strategy; Service Delivery; Growth and Development Strategy; Pharmaceutical Industry; Health Industry; Retail Industry
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      Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
      • October 2022
      • Case

      Cost Plus Drugs

      By: Alexander MacKay and James Barnett
      In September 2022, Mark Cuban Cost Plus Drugs Company CEO Alex Oshmyansky considered the future of the company. Cost Plus Drugs was a retailer for more than 340 generic oral medications, selling their drugs at significantly lower prices than typical pharmacies....  View Details
      Keywords: Business Ventures; Decision Making; Entrepreneurship; Ethics; Health; Markets; Social Enterprise; Society; Strategy; Health Care and Treatment; Business Divisions; Factories, Labs, and Plants; Health Industry; Pharmaceutical Industry; United States; Texas
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      MacKay, Alexander, and James Barnett. "Cost Plus Drugs." Harvard Business School Case 723-362, October 2022.
      • 2022
      • Working Paper

      How Do Copayment Coupons Affect Branded Drug Prices and Quantities Purchased?

      By: Leemore S. Dafny, Kate Ho and Edward Kong
      Drug copayment coupons to reduce patient cost-sharing have become nearly ubiquitous for high-priced brand-name prescription drugs. Medicare bans such coupons on the grounds that they are kickbacks that induce utilization, but they are commonly used by...  View Details
      Keywords: Prescription Drugs; Coupons; Impact; Health Care and Treatment; Markets; Price; Spending; Pharmaceutical Industry; United States
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      Dafny, Leemore S., Kate Ho, and Edward Kong. "How Do Copayment Coupons Affect Branded Drug Prices and Quantities Purchased?" NBER Working Paper Series, No. 29735, February 2022.
      • Summer 2021
      • Article

      The Cost and Evolution of Quality at Cipla Ltd, 1935–2016

      By: Muhammad H. Zaman and Tarun Khanna
      This article examines the evolution of Indian pharmaceutical manufacturer Cipla towards producing drugs that met the quality standards of European and U.S. regulators. It employs new research in Cipla’s corporate archives, the Creating Emerging Markets database, and...  View Details
      Keywords: Cipla; Pharmaceuticals; Drug Quality; Generics; Quality; Standards; Information Technology; Cost; Organizational Culture; Business History; Pharmaceutical Industry; India
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      Zaman, Muhammad H., and Tarun Khanna. "The Cost and Evolution of Quality at Cipla Ltd, 1935–2016." Business History Review 95, no. 2 (Summer 2021): 249–274.
      • Article

      Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users

      By: Ariel Dora Stern, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup and Ernst R. Berndt
      Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the U.S. and worldwide. Against this backdrop, many look to the expanding market for biosimilars—follow-on products to biologic drugs—as a vehicle for controlling...  View Details
      Keywords: Pharmaceuticals; Drug Spending; Drug Pricing; Health Care and Treatment; Spending; Price; Markets; Cost Management; United States
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      Stern, Ariel Dora, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup, and Ernst R. Berndt. "Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users." Health Affairs 40, no. 6 (June 2021): 989–999.
      • 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.
      • 2021
      • 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. After providing an overview of antibiotic development and its challenges we describe how: 1) Early (pre-cephalosporin)...  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 May 2021.)
      • Working Paper

      Rebates in the Pharmaceutical Industry: Evidence from Medicines Sold in Retail Pharmacies in the U.S.

      By: Pragya Kakani, Michael Chernew and Amitabh Chandra
      Rising list prices are often used to illustrate the burden of prescription drug spending, but payers routinely negotiate rebates from manufacturers that generate differences between list and net prices. List prices are easily available and affect patient cost-sharing,...  View Details
      Keywords: Pharmaceuticals; Rebates; Health Care and Treatment; Markets; Price; Analysis; Pharmaceutical Industry
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      Kakani, Pragya, Michael Chernew, and Amitabh Chandra. "Rebates in the Pharmaceutical Industry: Evidence from Medicines Sold in Retail Pharmacies in the U.S." NBER Working Paper Series, No. 26846, March 2020.
      • October 2019
      • Case

      Impax Laboratories: Executing Accretive Acquisitions (A)

      By: Benjamin C. Esty and Daniel Fisher
      Impax Laboratories was a technology-based pharmaceutical company that used a “dual platform” strategy to sell both generic and branded treatments. While Impax had grown organically for most of its history, it was beginning to use major acquisitions for growth. In the...  View Details
      Keywords: Financial Reporting; Financial Statements; Mergers and Acquisitions; Capital Structure; Competition; Competitive Advantage; Corporate Strategy; Pharmaceutical Industry; United States
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      Esty, Benjamin C., and Daniel Fisher. "Impax Laboratories: Executing Accretive Acquisitions (A)." Harvard Business School Case 220-030, October 2019.
      • October 2019
      • Supplement

      Impax Laboratories: Executing Accretive Transactions (A)

      By: Benjamin C. Esty and Daniel Fisher
      Impax Laboratories was a technology-based pharmaceutical company that used a “dual platform” strategy to sell both generic and branded treatments. While Impax had grown organically for most of its history, it was beginning to use major acquisitions for growth. In the...  View Details
      Keywords: Financial Reporting; Financial Statements; Mergers and Acquisitions; Capital Structure; Financial Strategy; Competition; Competitive Advantage; Corporate Strategy; Pharmaceutical Industry; United States
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      Esty, Benjamin C., and Daniel Fisher. "Impax Laboratories: Executing Accretive Transactions (A)." Harvard Business School Spreadsheet Supplement 220-710, October 2019.
      • 2019
      • Article

      Pay-for-Monopoly?: An Assessment of Reverse Payment Deals by Pharmaceutical Companies

      By: Sana Rafiq and Max Bazerman
      Abstract Over the past eighteen years, pharmaceutical firms have developed a blueprint to impede competition in order to maintain their monopoly profits. This scheme, termed pay-for-delay, involves direct or indirect payment of money from a branded-drug manufacturer...  View Details
      Keywords: Monopoly; Policy; Competition; Agreements and Arrangements; Pharmaceutical Industry
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      Rafiq, Sana, and Max Bazerman. "Pay-for-Monopoly? An Assessment of Reverse Payment Deals by Pharmaceutical Companies." Journal of Behavioral Economics for Policy 3, no. 1 (2019): 37–43.
      • August 2018 (Revised February 2019)
      • Case

      Alvogen: Scaling Entrepreneurship

      By: Daniel Isenberg, William R. Kerr and Alexis Brownell
      Keywords: Pharmaceutical Companies; Scaling; Generic Drugs; Entrepreneurship; Leadership; Pharmaceutical Industry; Asia; Europe; United States; Iceland
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      Isenberg, Daniel, William R. Kerr, and Alexis Brownell. "Alvogen: Scaling Entrepreneurship." Harvard Business School Case 819-038, August 2018. (Revised February 2019.)
      • August 2018
      • Article

      The Impact of the Entry of Biosimilars: Evidence from Europe

      By: Fiona M. Scott Morton, Ariel Dora Stern and Scott Stern
      Biologics represent a substantial and growing share of the U.S. drug market. Traditional “small molecule” generics quickly erode the price and share of the branded product upon entry; however, only a few biosimilars have been approved in the U.S. since 2015, thereby...  View Details
      Keywords: Health Care; Biosimilars; Biologics; Pharmaceutical Competition; Healthcare Spending; Innovation; Health Care and Treatment; Spending; Market Entry and Exit; Competition; Innovation and Invention; Pharmaceutical Industry; United States; Europe
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      Scott Morton, Fiona M., Ariel Dora Stern, and Scott Stern. "The Impact of the Entry of Biosimilars: Evidence from Europe." Review of Industrial Organization 53, no. 1 (August 2018): 173–210.
      • November 2017
      • Case

      The 'Wonder Drug' That Killed Babies

      By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble
      In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children...  View Details
      Keywords: Regulation; Business and Government Relations; Business and Community Relations; Business and Stakeholder Relations; Product Marketing; Corporate Social Responsibility and Impact; Business History; Health; Government Legislation; Corporate Accountability; Ethics; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Public Administration Industry; United States; United Kingdom; Australia; Germany; Europe
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      Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
      • 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.)
      • May 2017
      • Article

      When Discounts Raise Costs: The Effect of Copay Coupons on Generic Utilization

      By: Leemore S. Dafny, Christopher Ody and Matt Schmitt
      Branded pharmaceutical manufacturers frequently offer “copay coupons” that insulate consumers from cost sharing, thereby undermining insurers’ ability to influence drug utilization. We study the impact of copay coupons on branded drugs first facing generic entry...  View Details
      Keywords: Brands and Branding; Insurance Industry; Pharmaceutical Industry
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      Dafny, Leemore S., Christopher Ody, and Matt Schmitt. "When Discounts Raise Costs: The Effect of Copay Coupons on Generic Utilization." American Economic Journal: Economic Policy 9, no. 2 (May 2017): 91–123.
      • February 2016 (Revised February 2017)
      • Case

      Alvogen

      By: Daniel Isenberg and William Kerr
      Alvogen is a young Icelandic generic pharmaceutical company, whose CEO believes that his global strategy will give them an edge in this competitive industry.
      Robert Wessman, Alvogen’s CEO, was also previously the CEO of Actavis, another Icelandic generics...  View Details
      Keywords: Pharmaceutical Companies; Generic Drugs; Entrepreneurship; Globalization; Risk and Uncertainty; Pharmaceutical Industry; Iceland
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      Isenberg, Daniel, and William Kerr. "Alvogen." Harvard Business School Case 816-064, February 2016. (Revised February 2017.)
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