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    • All HBS Web  (239)
      • Faculty Publications  (58)

      Clinical TrialsRemove Clinical Trials →

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      • March 2015
      • Case

      Twine Health

      By: Robert S. Huckman, Ariel D. Stern and Matthew G. Preble
      In late 2014, Dr. John Moore (CEO), Frank Moss (chairman), and Scott Gilroy (CTO) of Twine Health (Twine) had to resolve several challenges that threatened to restrict the widespread dissemination of its sole product, Twine. Twine was a cloud-based platform that... View Details
      Keywords: Health Care; Chronic Disease; Technology Adoption; Digital Health; Health Acceleration Challenge; Strategy; Disease Management; Health; Health Care and Treatment; Information Technology; Mobile and Wireless Technology; Health Industry; United States; Massachusetts
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      Huckman, Robert S., Ariel D. Stern, and Matthew G. Preble. "Twine Health." Harvard Business School Case 615-068, March 2015.
      • June 2014 (Revised February 2017)
      • Case

      Kathy Giusti and the Multiple Myeloma Research Foundation

      By: Richard G. Hamermesh, Joshua D. Margolis and Matthew G. Preble
      What do you do when your rising professional career is cut short by an unexpected cancer diagnosis? Kathy Giusti shifted careers, built a new organization that transformed how cancer research is done, and now faces the challenge of sustaining the organization and its... View Details
      Keywords: Philanthropy; Philanthropy Funding; Entrepreneurship; Health Care; Management Styles; Personalized Medicine; Health Care Outcomes; Cancer; Cancer Care In The U.S.; Personal Care; Leadership; Leading Change; Social Entrepreneurship; Philanthropy and Charitable Giving; Health Care and Treatment; Leadership Style; Management Style; Management Skills; Growth and Development Strategy; Business Strategy; Health; Health Industry; United States; Canada; Spain
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      Hamermesh, Richard G., Joshua D. Margolis, and Matthew G. Preble. "Kathy Giusti and the Multiple Myeloma Research Foundation." Harvard Business School Case 814-026, June 2014. (Revised February 2017.)
      • October 2013
      • Case

      FasterCures: Removing Barriers to Treatments

      By: Richard G. Hamermesh and James Weber

      In mid-2013, as FasterCures celebrated its 10th anniversary as a center of the Milken Institute, Executive Director Margaret Anderson thought about what the organization should do to ensure it had even more impact in its next 10 years. FasterCures was a non-profit... View Details

      Keywords: Health Care; Health Care Industry; Health Care Policy; Health Services; Healthcare; Healthcare Reform; Healthcare Ventures; Nonprofit; Non-profit Management; Not-for-profit; Incubator; Accelerator; Venture Philanthropy; Medical Services; Medical Solutions; Medical Research; Medical Treatment; Clinical Trials; Drug Reimbursement; Early Stage; Early Stage Research Funding; Early Stage Funding; Milken Institute; Michael Milken; David Baltimore; Partnering For Cures; National Institutes Of Health; Cancer Care In The U.S.; Cancer Care Services; Policy-making; Health Care and Treatment; Health; Health Testing and Trials; Entrepreneurship; Social Entrepreneurship; Nonprofit Organizations; Policy; Health Industry; United States; District of Columbia
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      Hamermesh, Richard G., and James Weber. "FasterCures: Removing Barriers to Treatments." Harvard Business School Case 814-003, October 2013.
      • September 2012 (Revised November 2014)
      • Case

      Cialis Lifecycle Management: Lilly's BPH Dilemma

      By: Elie Ofek and Natalie Kindred
      How should Eli Lilly further develop and market a new indication of its highly successful erectile-dysfunction (ED) drug, Cialis, without confusing Cialis's hard-won brand equity with physicians and patients? With the final stages of clinical trials for the new... View Details
      Keywords: Product Positioning; Attitudes; Brands and Branding; Pharmaceutical Industry; United States
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      Ofek, Elie, and Natalie Kindred. "Cialis Lifecycle Management: Lilly's BPH Dilemma." Harvard Business School Case 513-005, September 2012. (Revised November 2014.)
      • July 2011 (Revised September 2012)
      • Case

      Intraoperative Radiotherapy for Breast Cancer (A)

      By: Willy Shih
      "This trial is going to take longer." Those were words that Michael Kaschke, CEO of Carl Zeiss AG, was not surprised to hear as he nurtured the intraoperative radiotherapy business inside his company's microsurgery unit. But he also didn't expect it to take 13 years to... View Details
      Keywords: Finance; Business History; Disruptive Innovation; Emerging Markets; Organizational Change and Adaptation; Research and Development; Safety
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      Shih, Willy. "Intraoperative Radiotherapy for Breast Cancer (A)." Harvard Business School Case 612-003, July 2011. (Revised September 2012.)
      • November 2009 (Revised August 2010)
      • Case

      NovoCure Ltd.

      By: William A. Sahlman and Sarah Flaherty
      Venture capitalist William Doyle must raise $35 million for a portfolio company with a promising, novel cancer therapy, just as global capital markets are imploding in the fall of 2008. NovoCure, Ltd., has developed an electrical-field-based therapy, called Tumor... View Details
      Keywords: Financial Crisis; Entrepreneurship; Venture Capital; Investment; Health Care and Treatment; Health Testing and Trials; Technological Innovation; Financial Services Industry
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      Sahlman, William A., and Sarah Flaherty. "NovoCure Ltd." Harvard Business School Case 810-045, November 2009. (Revised August 2010.)
      • Article

      Czech Mate: Expropriation and Investor Protection in a Converging World

      By: Mihir A. Desai and Alberto Moel
      This paper examines the expropriation of a foreign investor by a local partner and the subsequent resolution of that case through international arbitration in favor of the investor. Despite the investor's 99% interest in joint venture, the local partner managed to... View Details
      Keywords: Joint Ventures; Capital Markets; Foreign Direct Investment; Geographic Location; Multinational Firms and Management; Governance Controls; Courts and Trials; Rights; Czech Republic; United States
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      Desai, Mihir A., and Alberto Moel. "Czech Mate: Expropriation and Investor Protection in a Converging World." Review of Finance 12, no. 1 (2008): 221–251. (This paper is a revised version of ECGI Working Paper No. 62/2004.)
      • February 2008
      • Article

      Does Focus Improve Operational Performance? Lessons from the Management of Clinical Trials

      By: Robert S. Huckman and Darren Zinner
      Keywords: Performance; Operations; Learning; Management; Health
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      Huckman, Robert S., and Darren Zinner. "Does Focus Improve Operational Performance? Lessons from the Management of Clinical Trials." Strategic Management Journal 29, no. 2 (February 2008): 173–193.
      • January 2006 (Revised July 2006)
      • Case

      Drug Testing in Nigeria (A)

      By: Debora L. Spar
      In 1996, a meningitis epidemic swept across Nigeria. Thousands of children were struck and, lacking appropriate medicine, were liable to die from the disease. Doctors at Pfizer had an antibiotic that could probably save most of these children's lives. The drug was new,... View Details
      Keywords: Risk and Uncertainty; Health Pandemics; Health Testing and Trials; Developing Countries and Economies; Pharmaceutical Industry; Nigeria
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      Spar, Debora L., and Adam Day. "Drug Testing in Nigeria (A)." Harvard Business School Case 706-033, January 2006. (Revised July 2006.)
      • August 2005 (Revised December 2006)
      • Case

      Procter & Gamble: Electronic Data Capture and Clinical Trial Management

      By: Robert S. Huckman and Mark J. Cotteleer
      Considers whether the management of Procter & Gamble (P&G) Pharmaceuticals should adopt Web-based electronic data capture (EDC) as the default standard for the management of its clinical drug trials. Provides a detailed description of the existing paper-based process... View Details
      Keywords: Health Testing and Trials; Internet and the Web; Information Technology; Adoption; Business Processes; Industry Structures; Technological Innovation; Service Operations; Pharmaceutical Industry; United States
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      Huckman, Robert S., and Mark J. Cotteleer. "Procter & Gamble: Electronic Data Capture and Clinical Trial Management." Harvard Business School Case 606-033, August 2005. (Revised December 2006.)
      • 2005
      • Working Paper

      Does Focus Improve Operational Performance? Lessons from the Management of Clinical Trials

      By: Robert S. Huckman and Darren E. Zinner
      Citation
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      Huckman, Robert S., and Darren E. Zinner. "Does Focus Improve Operational Performance? Lessons from the Management of Clinical Trials." Harvard Business School Working Paper, No. 05-073, May 2005.
      • November 2003 (Revised September 2008)
      • Case

      Circle Gastroenterology Products (A)

      By: Regina E. Herzlinger and James Weber
      A new, minimally invasive medical device has achieved only one-third of its budget. Was the problem one of marketing strategy, sales, reimbursement, and/or clinical trials? View Details
      Keywords: Health Testing and Trials; Marketing Strategy; Product Marketing; Sales; Medical Devices and Supplies Industry
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      Herzlinger, Regina E., and James Weber. "Circle Gastroenterology Products (A)." Harvard Business School Case 304-052, November 2003. (Revised September 2008.)
      • August 2003 (Revised August 2024)
      • Case

      Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment

      By: Regina E. Herzlinger and John McDonough
      Many health care innovations appear successful; but fail. This is the first case in the Innovating Health Care course that investigates how to create successful health care innovations. It is part of the first module in the course. This module focuses on how to... View Details
      Keywords: Three Pillars; Industry Analysis; Health Care and Treatment; Innovation and Invention; Innovation and Management; Medical Specialties; Health Industry
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      Herzlinger, Regina E., and John McDonough. "Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment." Harvard Business School Case 304-009, August 2003. (Revised August 2024.)
      • April 2003 (Revised October 2004)
      • Case

      Novartis: The Challenge of Success (A)

      By: Sandra J. Sucher and Stacy McManus
      Preliminary results from Phase 1 clinical trials of a newly developed compound, STI571, showed that 31 out of 31 patients with chronic myelogenous leukemia (CML) had their blood counts return to normal. In the world of oncology, this was unheard of. This was the... View Details
      Keywords: Decision Making; Health Testing and Trials; Innovation and Invention; Markets; Distribution; Product Development; Production; Problems and Challenges; Research; Research and Development; Complexity; Biotechnology Industry; Pharmaceutical Industry
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      Sucher, Sandra J., and Stacy McManus. "Novartis: The Challenge of Success (A)." Harvard Business School Case 603-043, April 2003. (Revised October 2004.)
      • February 2000 (Revised October 2000)
      • Case

      Kendle International Inc.

      By: Dwight B. Crane, Paul W. Marshall and Indra Reinbergs
      Candace Kendle and Christopher Bergen, the CEO and COO of Kendle International, Inc., are reviewing ways to finance the growth of their privately-owned company. Kendle is a contract research organization that conducts clinical drug trials for pharmaceutical and... View Details
      Keywords: Acquisition; Financing and Loans; Venture Capital; Stock Options; Banks and Banking; Debt Securities; International Finance; Financial Strategy; Management Skills; Private Ownership; Initial Public Offering; Biotechnology Industry; Pharmaceutical Industry
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      Crane, Dwight B., Paul W. Marshall, and Indra Reinbergs. "Kendle International Inc." Harvard Business School Case 200-033, February 2000. (Revised October 2000.)
      • November 1994 (Revised December 1995)
      • Case

      Scripps Research Institute, The: November 1993 (Abridged)

      By: Josh Lerner
      In November 1993, Dr. Richard Lerner, president of the Scripps Research Institute, faces the challenge of maintaining his organization's financial and scientific vitality. A proposed cooperative venture with Sandoz has attracted considerable criticism. Meanwhile, a new... View Details
      Keywords: Joint Ventures; Financing and Loans; Policy; Management; Organizational Change and Adaptation; Problems and Challenges; Research; Nonprofit Organizations
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      Lerner, Josh. "Scripps Research Institute, The: November 1993 (Abridged)." Harvard Business School Case 295-068, November 1994. (Revised December 1995.)
      • November 1991 (Revised April 1994)
      • Case

      Nucleon, Inc.

      By: Gary P. Pisano
      Nucleon is a small biotechnology company whose first potential product is about to enter clinical testing. Before Nucleon can begin clinical trials, however, its management must decide how and where to manufacture the product. Three options are being contemplated: 1)... View Details
      Keywords: Factories, Labs, and Plants; Entrepreneurship; Health Testing and Trials; Rights; Product Development; Production; Partners and Partnerships; Research and Development; Biotechnology Industry
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      Pisano, Gary P. "Nucleon, Inc." Harvard Business School Case 692-041, November 1991. (Revised April 1994.)
      • Forthcoming
      • Article

      Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

      By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern
      Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to... View Details
      Keywords: Innovation and Invention; Governing Rules, Regulations, and Reforms; Government Administration; Research and Development; Pharmaceutical Industry
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      Chandra, Amitabh, Jennifer Kao, Kathleen L. Miller, and Ariel Dora Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." Review of Economics and Statistics (forthcoming). (Pre-published online March 18, 2024.)
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