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      • Faculty Publications  (62)

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      • 2022
      • Working Paper

      The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives

      By: Ariel Dora Stern
      For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with...  View Details
      Keywords: AI and Machine Learning; Health Care and Treatment; Governing Rules, Regulations, and Reforms; Technological Innovation; Medical Devices and Supplies Industry
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      Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." NBER Working Paper Series, No. 30639, December 2022.
      • November 2022
      • Teaching Note

      Proximie: Using XR Technology to Create Borderless Operating Rooms

      By: Ariel D. Stern, Alpana Thapar and Menna Hassan
      Founded by Nadine Hachach-Haram in 2016, Proximie was a digital medicine platform that used mixed reality and a host of digital audio and visual tools to enable clinicians, proctors, and medical device company personnel to be virtually present in operating rooms (ORs),...  View Details
      Keywords: Technological Innovation; Business Growth and Maturation; Growth and Development Strategy; Corporate Social Responsibility and Impact; Decision Making; Health Industry; Medical Devices and Supplies Industry
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      Stern, Ariel D., Alpana Thapar, and Menna Hassan. "Proximie: Using XR Technology to Create Borderless Operating Rooms." Harvard Business School Teaching Note 623-034, November 2022.
      • Working Paper

      Representation and Extrapolation: Evidence from Clinical Trials

      By: Marcella Alsan, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein and Heidi L. Williams
      This article examines the consequences and causes of low enrollment of Black patients in clinical trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is more relevant for decision-making by physicians and patients when it...  View Details
      Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry
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      Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." NBER Working Paper Series, No. 30575, October 2022. (Revise and resubmit, Quarterly Journal of Economics.)
      • Article

      Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation

      By: Ariel Dora Stern, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann and Jennifer C Goldsack
      In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can...  View Details
      Keywords: Digital Health; Health Care and Treatment; Technological Innovation
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      Stern, Ariel Dora, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann, and Jennifer C Goldsack. "Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation." Lancet Digital Health 4, no. 3 (March 2022): e200–e206.
      • October 2021 (Revised January 2022)
      • Supplement

      Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)

      By: Linda A. Hill and Emily Tedards
      This case is the third installment in a series about the 10-year cultural and digital transformation of Pfizer’s Global Clinical Supply organization. In 2011, Michael Ku became Pfizer’s Vice President of Global Clinical Supply (GCS) after the company had undergone...  View Details
      Keywords: Clinical Supply Chain; COVID-19; Vaccine; Agile; Innovation and Invention; Change Management; Organizational Culture; Transformation; Leadership; Corporate Strategy; Health Pandemics; Crisis Management; Mission and Purpose; Health Care and Treatment; Supply Chain Management; Digital Transformation
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      Hill, Linda A., and Emily Tedards. "Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)." Harvard Business School Supplement 422-041, October 2021. (Revised January 2022.)
      • 2021
      • Book

      Lead and Disrupt: How to Solve the Innovator's Dilemma

      By: Charles A. O'Reilly III and Michael Tushman
      Why do successful firms find it so difficult to adapt in the face of change—to innovate? In the past ten years, the importance of this question has increased as more industries and firms confront disruptive change. The pandemic has accelerated this crisis, collapsing...  View Details
      Keywords: Organization Change And Adaptation; Organizational Change and Adaptation; Disruptive Innovation; Innovation and Management; Leading Change
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      O'Reilly, Charles A., III, and Michael Tushman. Lead and Disrupt: How to Solve the Innovator's Dilemma. Second ed. Stanford, CA: Stanford Business Books, 2021.
      • 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.
      • Article

      Ushering in Safe, Effective, Secure, and Ethical Medicine in the Digital Era

      By: William J. Gordon, Andrea Coravos and Ariel Dora Stern
      From clinical trials to care delivery, advanced, digitally enabled technologies and analytics offer new approaches to how we think about medicine, health, and biology. The COVID-19 pandemic has accelerated this conversation, and forced a roadmap, once measured in years...  View Details
      Keywords: Digital Medicine; Health Care and Treatment; Technological Innovation; Safety; Ethics
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      Gordon, William J., Andrea Coravos, and Ariel Dora Stern. "Ushering in Safe, Effective, Secure, and Ethical Medicine in the Digital Era." npj Digital Medicine 4, no. 56 (2021).
      • December 2020 (Revised January 2022)
      • Supplement

      Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (B)

      By: Linda A. Hill and Emily Tedards
      In 2011, Michael Ku became Pfizer’s Vice President of Global Clinical Supply (GCS) after the company had undergone three large-scale mergers and acquisitions. As Ku and his new leadership team set out to build a proactive, end-to-end, digital and physical clinical...  View Details
      Keywords: Digital Technology; Customer-centricity; Innovation; Customer Focus; Talent; Talent Management; Leadership; Innovation and Invention; Transformation; Organizational Culture; Customer Focus and Relationships; Change Management; Talent and Talent Management; Supply Chain; Mission and Purpose
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      Hill, Linda A., and Emily Tedards. "Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (B)." Harvard Business School Supplement 421-037, December 2020. (Revised January 2022.)
      • May 2020 (Revised January 2022)
      • Case

      Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (A)

      By: Linda A. Hill, Allison J. Wigen and Emily Tedards
      Michael Ku joined Pfizer in 2011, after the company had undergone three large-scale mergers and acquisitions. His mission was to drive the digital transformation of the company’s clinical supply chain, but he knew he had to start with the culture. Over the next eight...  View Details
      Keywords: Innovation; Digital; Change; Culture; Management; Talent; Pharmaceutical Companies; Customer-centricity; Collaboration; Cross-functional Management; Purpose; Leadership; Innovation and Invention; Transformation; Organizational Culture; Change Management; Talent and Talent Management; Customer Focus and Relationships; Supply Chain; Decision Making; Mission and Purpose
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      Hill, Linda A., Allison J. Wigen, and Emily Tedards. "Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (A)." Harvard Business School Case 420-108, May 2020. (Revised January 2022.)
      • 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.
      • Article

      Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

      By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
      Objectives:
      To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and...  View Details
      Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry
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      Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
      • October 2017 (Revised August 2020)
      • Case

      RB

      By: Joshua Margolis, Vincent Dessain and Jerome Lenhardt
      As 2016 was approaching its end, Rakesh Kapoor, CEO of RB, one of the world’s major fast moving consumer goods (FMCG) companies, envisioned the prospect of a major acquisition that would add a line of health-related products that promised growth in the developing...  View Details
      Keywords: Organization Behavior; Corporate Culture; Mergers & Acquisitions; Growth; Geographic Development; Mergers and Acquisitions; Organizational Change and Adaptation; Organizational Culture; Growth and Development Strategy; France
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      Margolis, Joshua, Vincent Dessain, and Jerome Lenhardt. "RB." Harvard Business School Case 418-033, October 2017. (Revised August 2020.)
      • September 2017 (Revised December 2017)
      • Case

      Intermountain Healthcare: Pursuing Precision Medicine

      By: Richard G. Hamermesh, Kathy E. Giusti, Robert S. Huckman and Julia Kelley
      Headquartered in Salt Lake City, Intermountain Healthcare operates 23 hospitals and hundreds of clinics in Utah and Idaho and provides insurance to approximately 850,000 patients through its insurance arm, SelectHealth. In 2013, Intermountain, known for its commitment...  View Details
      Keywords: Precision Medicine; Healthcare; Innovation; Cancer; Cancer Research; Health Care; Technology; Health Care and Treatment; Innovation Leadership; Disruptive Innovation; Entrepreneurship; Decision Choices and Conditions; Health Industry; Insurance Industry; Utah; United States; North America
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      Hamermesh, Richard G., Kathy E. Giusti, Robert S. Huckman, and Julia Kelley. "Intermountain Healthcare: Pursuing Precision Medicine." Harvard Business School Case 818-018, September 2017. (Revised December 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.
      • Article

      One Obstacle to Curing Cancer: Patient Data Isn't Shared

      By: Richard G. Hamermesh and Kathy Giusti
      Precision Medicine requires large datasets to identify the mutations that lead to various cancers. Currently, genomic information is hoarded in fragmented silos within numerous academic medical centers, pharmaceutical companies, and some disease-based foundations. For...  View Details
      Keywords: Healthcare; Technological And Scientific Innovation; Cancer Care In The U.S.; Cancer Treatment; Precision Medicine; Personalized Medicine; Data Sharing; Technological Innovation; Analytics and Data Science; Health Disorders; Medical Specialties; Research and Development; Customization and Personalization; Health Industry; United States
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      Hamermesh, Richard G., and Kathy Giusti. "One Obstacle to Curing Cancer: Patient Data Isn't Shared." Harvard Business Review (website) (November 28, 2016).
      • October 2016 (Revised November 2016)
      • Case

      Innovating Beyond Ochsner

      By: Richard G. Hamermesh and Olivia Hull
      The Ochsner Health System has developed a proprietary software tool designed to treat hypertension. Built into the system’s electronic medical records, the Hypertension Digital Medicine program allows patients to record their blood pressure at home and share readings...  View Details
      Keywords: Electronic Medical Records; Telemedicine; Hypertension; High Blood Pressure; Chronic Disease; Entrepreneurship; Health Disorders; Business Model; Business Startups; Innovation and Invention; Growth Management; Marketing Strategy; Product Launch; Product Positioning; Science-Based Business; Business Strategy; Health Industry; Technology Industry; New Orleans; Louisiana
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      Hamermesh, Richard G., and Olivia Hull. "Innovating Beyond Ochsner." Harvard Business School Case 817-028, October 2016. (Revised November 2016.)
      • June 2016
      • Article

      When Doctors Go to Business School: Career Choices of Physician-MBAs

      By: Damir Ljuboja, Brian W. Powers, Benjamin Robbins, Robert S. Huckman, Krishna Yeshwant and Sachin Jain
      There has been substantial growth in the number of physicians pursuing Master of Business Administration (MBA) degrees over the past decade, but there is continuing debate over the utility of these programs and the career outcomes of their graduates. The authors...  View Details
      Keywords: Medical Education; MD; MBA; Physicians; Executive Education; Training; Personal Development and Career; Health Care and Treatment; Health Industry; United States
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      Ljuboja, Damir, Brian W. Powers, Benjamin Robbins, Robert S. Huckman, Krishna Yeshwant, and Sachin Jain. "When Doctors Go to Business School: Career Choices of Physician-MBAs." American Journal of Managed Care 22, no. 6 (June 2016): e196–e198.
      • April 2015
      • Supplement

      Novartis Pharmaceuticals Corp: Redefining Success in the U.S. (B)

      By: Gautam Mukunda, Thomas DeLong and Aldo Sesia
      This (B) case describes the actions André Wyss, president of Novartis Pharmaceuticals Corporation, took in early 2012 to transform the company's General Medicines group and build its specialty medications, marketing the selling capabilities in the face of falling...  View Details
      Keywords: LEAD; Leadership And Change Management; Talent Management; Organizational Change and Adaptation; Leadership; Change Management; Talent and Talent Management; Pharmaceutical Industry; United States
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      Mukunda, Gautam, Thomas DeLong, and Aldo Sesia. "Novartis Pharmaceuticals Corp: Redefining Success in the U.S. (B)." Harvard Business School Supplement 415-049, April 2015.
      • October 2014 (Revised July 2022)
      • Case

      Gilead: Hepatitis C Access Strategy (A)

      By: V. Kasturi Rangan, Vikram Rangan and David E. Bloom
      Gilead had come up with an innovative drug for Hepatitis C, which affected 180 million people worldwide. The drug was priced at $1,000 a pill for the US market. Gilead had to decide how to price and market the pill in developing countries that bore the brunt of the...  View Details
      Keywords: Healthcare; Pharmaceuticals; Pricing; Access To Care; Emerging Markets; Health Care and Treatment; Price; Strategy; Ethics; Health Industry; Pharmaceutical Industry
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      Rangan, V. Kasturi, Vikram Rangan, and David E. Bloom. "Gilead: Hepatitis C Access Strategy (A)." Harvard Business School Case 515-025, October 2014. (Revised July 2022.)
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