Publications
Publications
Show Results For
- All HBS Web
(174)
- Faculty Publications (38)
FDA
→
Page 1 of 38
Results →
- October 2024
- Case
Allurion: Competing in the Age of GLP-1
By: Satish Tadikonda, Rajiv Lal, David Lane and Sarah Sasso
Shantanu Gaur had built Allurion into a formidable business internationally, providing obesity patients with a less invasive option long before GLP-1 drugs became the latest craze. Selling Allurion's medical device across 60+ countries, he awaited FDA approval to bring... View Details
- February 2024
- Case
Compass Pathways: Pioneering Psychedelic Treatment
By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu
This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no... View Details
- June 2023 (Revised July 2024)
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This... View Details
This... View Details
- December 2022 (Revised September 2024)
- Case
Sword Health
By: Regina E. Herzlinger, Annelena Lobb and Carin-Isabel Knoop
Virgilio “V” Bento, CEO of Sword Health—a startup that provided virtual physical therapy to patients in self-insured firms via AI and sensor technology with supervision by a physical therapist with a doctorate—considered how to increase its U.S. market share. To do so,... View Details
- September 2022
- Article
Find and Replace: R&D Investment Following the Erosion of Existing Products
By: Joshua L. 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
- 2022
- Article
Missing Novelty in Drug Development
By: Joshua Krieger, Danielle Li and Dimitris Papanikolaou
We provide evidence that risk aversion leads pharmaceutical firms to underinvest in radical innovation. We introduce a new measure of drug novelty based on chemical similarity and show that firms face a risk-reward trade-off: novel drug candidates are less likely to... View Details
- 2024
- Working Paper
Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances
By: Amar Bhide and Srikant M. Datar
By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the... View Details
- 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
- May 2021 (Revised May 2022)
- Case
Headspace vs. Calm: A Mindful Competition
By: Ayelet Israeli and Anne Wilson
By 2021, the mindfulness app wars reached their apex. Over 2,000 meditation apps were available to consumers, but two apps, Headspace and Calm, dominated the space, jointly holding about 70% of the total market. Headspace had established itself as the approachable... View Details
Keywords: Marketing Communication; Integrated Strategy; Brand; Brand ＆ Product Management; Brand Communication; Brand Differentiation; Brand Building; Brand Management; E-Commerce Strategy; Ecommerce; App; App Development; Applications; COVID; COVID-19; Pandemic; Pricing; Pricing Strategy; Subscription Model; Subscription; Partnerships; Strategic Partnerships; B2B Vs. B2C; B2B; Health ＆ Wellness; Wellbeing; Digitization; Commoditization; Mobile App; Mobile App Industry; Mobile Healthcare; Mobile Marketing; Digital Brand; Digital Health; Consumer Health; Apps; Online Business; Online Competition; Online Community; Online Entertainment; Entertainment And Leisure; Meditation; Marketing; Marketing Communications; Brands and Branding; Price; Strategy; Competition; Competitive Strategy; Competitive Advantage; Partners and Partnerships; Health; Well-being; Mobile and Wireless Technology; Communication; Communication Strategy; Disruption; Consumer Behavior; Digital Marketing; E-commerce; Applications and Software; Health Industry; Technology Industry; Communications Industry; United States; North America; United Kingdom
- June 2019
- Teaching Note
Zebra Medical Vision
By: Shane Greenstein and Sarah Gulick
Teaching note is meant to accompany Zebra Medical Vision case, which offers a look at a company’s decisions as a small startup competing with other startups and major technology companies. It also demonstrates the challenges faced by a machine learning company working... View Details
- February 2019 (Revised September 2019)
- Case
Theranos: The Unicorn That Wasn't
By: Joseph B. Fuller and John Masko
In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains... View Details
Keywords: Theranos; Blood; Lab Testing; Fraud; Holmes; Balwani; Shultz; Carreyrou; Securities And Exchange Commission; Food And Drug Administration; FDA; SEC; Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Medical Devices and Supplies Industry
- 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
- September 2018 (Revised December 2019)
- Case
Zebra Medical Vision
By: Shane Greenstein and Sarah Gulick
An Israeli startup founded in 2014, Zebra Medical Vision developed algorithms that produced diagnoses from X-rays, mammograms, and CT-scans. The algorithms used deep learning and digitized radiology scans to create software that could assist doctors in making... View Details
Keywords: Radiology; Machine Learning; X-ray; CT Scan; Medical Technology; Probability; FDA 510(k); Diagnosis; Business Startups; Health Care and Treatment; Information Technology; Applications and Software; Competitive Strategy; Product Development; Commercialization; Decision Choices and Conditions; Health Industry; Medical Devices and Supplies Industry; Technology Industry; Israel
- 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
- April 2017
- Case
Imprimis (A)
By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
This case examines the strategic choices and evolving business model of Imprimis Pharmaceuticals from the perspective of CEO Mark Baum. The (A) case provides a brief history of the company and of the compounding business, outlining the challenges faced by Imprimis in... View Details
- March 2015 (Revised January 2024)
- Case
CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details
Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Health Industry; Medical Devices and Supplies Industry; United States; Europe
- December 2014 (Revised August 2015)
- Case
Improving Melanoma Screening: MELA Sciences
By: Regina E. Herzlinger, Kevin Schulman and Frédéric Dijols
MELA is a start-up medical device company looking to develop a novel technology to help physicians diagnose a deadly skin cancer, melanoma. The case reviews the FDA medical device development process, the development path pursued by MELA, and the regulatory and... View Details
- January 2014 (Revised June 2014)
- Case
23andMe: Genetic Testing for Consumers (A)
By: John A. Quelch and Margaret L. Rodriguez
On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was... View Details
- January 2014
- Supplement
Fred Khosravi and AccessClosure (C)
By: Richard Hamermesh and Lauren Barley
On September 11, 2013, the three-judge panel of the U.S. Court of Appeals for the Federal Circuit denied St. Jude's request to rehear an appeal on the "double patenting" ruling for the '439 patent. Further, it removed the injunction threat that was hanging over the... View Details
- November 2012 (Revised January 2013)
- Case
Companion Diagnostics: Uncertainties for Approval and Reimbursement
By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory... View Details