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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...
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- 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),...
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- 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...
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- 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...
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- 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...
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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
- 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...
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- 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...
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- 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...
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- 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...
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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
- 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...
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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
- 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,...
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- 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
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
- 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...
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- 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...
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- 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...
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- 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...
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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
- 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...
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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
- 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...
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- 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...
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- 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...
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