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- May 2021
- Case
The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease
By: Amitabh Chandra, Spencer Lee-Rey and Caroline Marra
This case explores incentives for rare disease drug development by chronicling the role of the Spinal Muscular Atrophy (SMA) Foundation in forming strategic partnerships with the scientific research community and pharmaceutical developers to transform the trajectory...
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- May 2021
- Article
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 such as R&D has increased dramatically since the 1990s. However, productivity growth remains sluggish in recent years. One potential reason is that a significant share of the increase in intangible investment is geared toward consumer...
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- March 18, 2021
- Article
A Feasibility Study Using Time-driven Activity-based Costing as a Management Tool for Provider Cost Estimation: Lessons from the National TB Control Program in Zimbabwe in 2018
By: J. Chirenda, B. Nhlema Simwaka, C. Sandy, K. Bodnar, S. Corbin, P. Desai, T. Mapako, S. Shamu, C. Timire, E. Antonio, A. Makone, A. Birikorang, T. Mapuranga, M. Ngwenya, T. Masunda, M. Dube, E. Wandwalo, L. Morrison and R. S. Kaplan
Background: This study used process maps and time-driven activity-based costing to document TB service delivery processes. The analysis identified the resources required to sustain TB services in Zimbabwe, as well as several opportunities for more effective and...
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- December 2020 (Revised May 2021)
- Background 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
- 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...
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- 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...
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- 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...
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- 2021
- Working Paper
Development of CAR-T Therapies: 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)...
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- 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...
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- 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...
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- 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...
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- 2021
- Working Paper
SSRIs and Non-SSRIs (through 1999): Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
Our case history describes the development of Prozac, a blockbuster drug that transformed the treatment of depression – and became a cultural phenomenon in the United States. Specifically, we chronicle the: 1) prior treatments for depression and the research that...
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- 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)...
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- 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...
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- 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...
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- 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...
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- 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....
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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
- 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....
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- 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...
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- 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...
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