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January 2018
Case

Spark Therapeutics: Pioneering Gene Therapy

By: Robert F. Higgins and Tina Liu

Spark Therapeutics is a pioneering gene therapy startup. It was spun out of The Children’s Hospital of Philadelphia (CHOP). The company had taken with it much of the intellectual property and talent that CHOP had developed. The company is considering an initial public... View Details

Keywords: Health Care and Treatment; Innovation and Invention; Business Startups; Opportunities; Problems and Challenges; Strategy

February 2010 (Revised April 2010)
Case

Organization and Strategy at Millennium (A)

By: Julie M. Wulf and Scott Waggoner

This case examines Millennium's strategic and organizational responses to the rapid evolution of the biopharmaceutical industry. In the early 2000s, as Millennium's competitive advantage in early-stage research slipped away and its losses mounted, founder and CEO Mark... View Details

Keywords: Transformation; Leading Change; Management Succession; Organizational Change and Adaptation; Competitive Strategy; Competitive Advantage; Biotechnology Industry; Pharmaceutical Industry

October 2022
Case

Lyra Health: Transforming Mental Health

By: Rembrand Koning and Nicole Keller

In January 2022, Lyra Health was deciding between several different alternatives to grow the business. Founded in 2015, Lyra Health, was a digital mental health platform that combined technology with human therapists and coaches to deliver high quality mental health... View Details

Keywords: Mental Health; Health Care and Treatment; Corporate Entrepreneurship; Customer Value and Value Chain; Growth and Development Strategy; Expansion; Health Industry; Technology Industry; San Francisco

26 Jul 2016
Working Paper Summaries

The Impact of the Entry of Biosimilars: Evidence from Europe

Keywords: by Fiona Scott Morton, Ariel Dora Stern, and Scott Stern; Health; Biotechnology; Pharmaceutical

March 2010 (Revised May 2012)
Case

Myelin Repair Foundation: Accelerating Drug Discovery Through Collaboration

By: Karim R. Lakhani and Paul R. Carlile

This case presents the Myelin Repair Foundation's accelerated research collaboration model for drug discovery. It highlights the challenges of building a multi-disciplinary and multi-institutional research collaboration that is attempting to create a treatment for... View Details

Keywords: Research and Development; Intellectual Property; Risk and Uncertainty; Strategic Planning; Collaborative Innovation and Invention; Health Disorders; Pharmaceutical Industry; Biotechnology Industry; Health Industry

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

Keywords: Models Of Reimbursement; Personalized Medicine; Regulation; Healthcare Reform; Health Care and Treatment; Health Industry; United States

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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February 2010
Supplement

Organization and Strategy at Millennium (B)

By: Julie M. Wulf and Scott Waggoner

This case examines Millennium's strategic and organizational responses to the rapid evolution of the biopharmaceutical industry. In the early 2000s, as Millennium's competitive advantage in early-stage research slipped away and its losses mounted, founder CEO Mark... View Details

Keywords: Leading Change; Transformation; Decision Choices and Conditions; Crisis Management; Competitive Advantage; Commercialization; Selection and Staffing; Product Development; Organizational Change and Adaptation; Pharmaceutical Industry

Article

Affording to Wait: Medicare Initiation and the Use of Health Care

By: Guy David, Philip Saynisch, Victoria Acevado-Perez and Mark D. Neuman

Delays in receipt of necessary diagnostic and therapeutic medical procedures related to the timing of Medicare initiation at age 65 years have potentially broad welfare implications. We use 2005–2007 data from Florida and North Carolina to estimate the effect of... View Details

Keywords: Medicare; Behavior; Insurance; Health Care and Treatment; Insurance Industry; Public Administration Industry; Health Industry; North Carolina; Florida

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July 2023 (Revised July 2024)
Case

Miracle Therapeutics: Negotiating an IP License (A)

By: Satish Tadikonda, Michael Singer, William Marks and Wendi Yajnik

(General Experience Case) Beth Sharp and Jennifer Brilliant founded Miracle Therapeutics based on intellectual property developed by Brilliant and her post-doctoral student, John Supreme, in Brilliant’s lab at Elite University (EU). Miracle will have to obtain a... View Details

Keywords: Business Startups; Entrepreneurship; Patents; Negotiation Process

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.... View Details

31 May 2023
Video

Martine Rothblatt: Making Implausible Dreams Reality

19 Apr 2023
Video

How Martine Rothblatt Started a Company to Save Her Daughter

26 Apr 2023
Cold Call Podcast

How Martine Rothblatt Started a Company to Save Her Daughter

Keywords: Re: Debora L. Spar; Pharmaceutical; Medical Devices & Supplies; Health

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

Keywords: R＆D Investments; Drug Development; Product Shocks; M＆A; Biopharmaceutical Industry; FDA; System Shocks; Research and Development; Investment; Decision Making; Pharmaceutical Industry

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Case: The Allergan Board Under Fire (A)

In 2014, the Allergan Inc. board of directors received a surprise takeover offer from Valeant Pharmaceuticals in alliance with hedge fund activist Bill Ackman's Pershing Square Capital Management. In the unprecedented arrangement between an acquirer and a hedge... View Details

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... View Details

Keywords: Entrepreneurship; Financing and Loans; Strategy; Decision Choices and Conditions; Biotechnology Industry

January 2016 (Revised January 2019)
Supplement

The Allergan Board Under Fire (B)

By: Lynn S. Paine, Suraj Srinivasan, John C. Coates and David Lane

In 2014, the Allergan Inc. board of directors received a surprise takeover offer from Valeant Pharmaceuticals in alliance with hedge fund activist Bill Ackman's Pershing Square Capital Management. In the unprecedented arrangement between an acquirer and a hedge fund... View Details

January 2001 (Revised July 2003)
Case

Pharmacyclics: Financing Research & Development

By: Malcolm P. Baker, Richard S. Ruback and Aldo Sesia

Pharmacyclics (NASDAQ: PCYC), a pharmaceutical company that manufactures products that will improve existing therapeutic treatments for cancer, arteriosclerosis, and retinal disease, was considering a $60 million private placement in February 2000. The company had more... View Details

Keywords: Valuation; Cash Flow; Financing and Loans; Business Startups; Financial Strategy; Medical Devices and Supplies Industry; Pharmaceutical Industry; Health Industry

February 2021
Case

Digital Manufacturing at Amgen

By: Shane Greenstein, Kyle R. Myers and Sarah Mehta

This case discusses efforts made by biotechnology (biotech) company Amgen to introduce digital technologies into its manufacturing processes. Doing so is complicated by the fact that the process for manufacturing biologics—or therapeutics made from living cells—is... View Details

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