Publications

August 2023 (Revised May 2024)
Case

Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations

By: Satish Tadikonda and Amanda McEwen

The success or failure of Dicerna Pharmaceuticals (Dicerna) as an emerging pharmaceutical company would likely hinge on its lead drug candidate Nedosiran and the company’s ability to see it successfully through clinical development. Ralf Rosskamp, Chief Medical... View Details

Keywords: Business Strategy; Health Testing and Trials; Product Development; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry

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... View Details

Keywords: Gene Therapy; Gene Editing; Impact; Health Care and Treatment; Technological Innovation; Health Testing and Trials; Venture Capital; Change

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December 2002
Teaching Note

Abgenix and the XenoMouse (TN)

By: John T. Gourville

Teaching Note for (501-061). View Details

Keywords: Health Testing and Trials; Decision Choices and Conditions; Sales; Product Development; Joint Ventures; Health Industry; Pharmaceutical Industry

18 Feb 2016
News

Challenge Aims to Speed Drug Trials Process

The HBS Health Care Initiative is seeking innovative ideas from the science, patient, business, and medical communities on how to transform trials for precision medicine. Through the HBS Precision Trials Challenge, it aims to bring diagnostics and therapies to market... View Details

24 Mar 2020
Research & Ideas

These Coronavirus Heroes Show Us How Crisis Leadership Works

Schinecker, CEO of Roche Diagnostics, leads a company that received the FDA’s first emergency use authorization for a commercially developed COVID-19 test on March 13. Roche now believes it can ship up to 400,000 View Details

Keywords: by Bill George; Health

January 2007
Article

A Randomized Clinical Trial of EMDR, Fluoxetine and Pill Placebo in the Treatment of PTSD: Treatment Effects and Long-term Maintenance

By: Bessel A. van der Kolk, Joseph Spinazzola, Margaret E. Blaustein, James Hopper, Elizabeth Hopper, Deborah Korn and William B. Simpson

Keywords: Health Testing and Trials; Health Care and Treatment; Health Disorders

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11 Nov 2015
Working Paper Summaries

Public R&D Investments and Private-sector Patenting: Evidence from NIH Funding Rules

Keywords: by Danielle Li; Health; Biotechnology; Pharmaceutical; Medical Devices & Supplies

12 Aug 2019
Working Paper Summaries

Case Histories of Significant Medical Advances

Keywords: by Amar Bhidé, Srikant M. Datar, and Katherine Stebbins

Article

Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials

By: Caroline Marra, William J. Gordon and Ariel Dora Stern

Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of... View Details

Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology

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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

December 2023 (Revised March 2024)
Case

Manufacturing Moderna's Future

By: Satish Tadikonda and William Marks

In 2019, Moderna faced long odds of survival having failed to develop a successful clinical program out of the vast platform technology they had built around mRNA. Nearly overnight, the company skyrocketed to success with a vaccine for COVID-19, leading to an extremely... View Details

Keywords: Health Pandemics; Health Testing and Trials; Technological Innovation; Product Development; Production; Science-Based Business; Biotechnology Industry

01 Jun 1996
News

GMAT Added to Admissions Criteria

In April, Dean Kim B. Clark announced that Harvard Business School will add the Graduate Management Admissions Test (GMAT) to the portfolio of criteria used to evaluate a candidate's application to the MBA Program, effective for... View Details

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... View Details

Keywords: Biotechnology; Strategic Decision Making; Entrepreneurship; Health Testing and Trials; Decision Choices and Conditions; Strategy

31 Jan 2016
News

Studios Back App, Hoping to Fill Cinema Seats

to keep testing it,” said Mr. Bakal, adding that variable pricing won't be among the company’s offerings when it launches nationwide. Atom Tickets has been operating in three test markets since April, where... View Details

23 Jan 2019
News

The Promise of Personalized Medicine

be able to do computational prediction for creating a top 20 list of antisense oligos. With those, we can test them against his cell line. So as part of the biopsy, in phase one, we establish a cell line. What that is, is it’s taking... View Details

March 2015 (Revised February 2022)
Supplement

CV Ingenuity (B): Epilogue

By: Regina E. Herzlinger and Andrew Otazo

Duke Rohlen used a lea-nfunding, iconoclastic strategy for his start up for a drug eluding balloon for peripheral artery disease. His giant competitors were first movers. Did Duke obtain the funding he sought? How did his DEB fare versus that of his competitors? The... View Details