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- July 2021
- Teaching Note
The Carlyle Group: Carving Out Atotech
Teaching Note for HBS Case No. 321-153. On January 31, 2017, The Carlyle Group ("Carlyle") closed its $3.2 billion acquisition of Atotech, an international Specialty Chemicals and Equipment company. In Carlyle's Washington, DC headquarters, the US-based deal...
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- 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...
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- April 2021 (Revised December 2021)
- Case
The Carlyle Group: Carving Out Atotech
On January 31, 2017, The Carlyle Group ("Carlyle") closed its $3.2 billion acquisition of Atotech, an international Specialty Chemicals and Equipment company. In Carlyle's Washington, DC headquarters, the US-based deal team—Martin Sumner, Greg Nikodem, Tanaka Maswoswe...
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- January 2021 (Revised October 2021)
- Case
eToro: Building the World's Largest Social Trading Network
By: Elie Ofek and Danielle Golan
Social trading platform eToro was preparing for the launch of its expanded offering in the U.S. The company faced critical decisions regarding product-market fit, go-to-market strategy, positioning and monetization. Moreover, it faced the challenge of how best to make...
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- Fall 2020
- Article
Christo and Jeanne‐Claude: The Negotiation of Art and Vice Versa
Over the past two decades the Program on Negotiation at Harvard Law School (PON) has named thirteen people as Great Negotiators. The project, directed by my colleague Jim Sebenius, has given us the opportunity to commend our honorees’ outstanding work and to learn from...
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- December 2019
- Technical Note
Technical Note on Bayesian Statistics and Frequentist Power Calculations
By: Amitabh Chandra and Ariel Dora Stern
This Technical Note provides an introduction to Bayes’ Rule and the statistical intuition that stems from it. In this note, we review the concepts that underlie Bayesian statistics, and we offer several simple mathematical examples to illustrate applications of Bayes’...
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- November 2019
- Teaching Note
Actera Group: Investing in Mars Cinema Group (A) and (B)
By: Victoria Ivashina and Jeffrey Boyar
In summer of 2010, Murat Çavuşoğlu (HBS MBA 1994) led private equity firm Actera Group’s investment in Mars Cinema Group (Mars), the leading movie exhibitor in Turkey. Immediately after acquiring Mars and merging it with the second larger player in the market, AFM,...
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- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel Dora Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of...
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- September 2017
- Supplement
Actera Group: Investing in Mars Cinema Group (A)
By: Victoria Ivashina and Eren Kuzucu
In summer of 2010, Murat Çavuşoğlu (HBS MBA 1994) led private equity firm Actera Group’s investment in Mars Cinema Group (Mars), the leading movie exhibitor in Turkey. Immediately after acquiring Mars and merging it with the second larger player in the market, AFM,...
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- September 2017
- Supplement
Actera Group: Investing in Mars Cinema Group (B)
By: Victoria Ivashina and Eren Kuzucu
In summer of 2010, Murat Çavuşoğlu (HBS MBA 1994) led private equity firm Actera Group’s investment in Mars Cinema Group (Mars), the leading movie exhibitor in Turkey. Immediately after acquiring Mars and merging it with the second larger player in the market, AFM,...
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- September 2017 (Revised July 2019)
- Case
Actera Group: Investing in Mars Cinema Group (A)
By: Victoria Ivashina and Eren Kuzucu
In summer of 2010, Murat Çavuşoğlu (HBS MBA 1994) led private equity firm Actera Group’s investment in Mars Cinema Group (Mars), the leading movie exhibitor in Turkey. Immediately after acquiring Mars and merging it with the second largest player in the market, AFM,...
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- January 2017
- Article
Innovation Under Regulatory Uncertainty: Evidence from Medical Technology
By: Ariel Dora Stern
This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34% (7.2 months)...
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- March 2015 (Revised February 2022)
- 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...
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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
- 5 Feb 2013
- Conference Presentation
Financing Entrepreneurial Growth
By: Tom Alberg, Andrew A. Bogan, Harold Bradley, Robert D. Cooter, Monika Gruter Cheney, Oliver R. Goodenough, William R. Hambrecht, Frank Hatheway, Thomas F. Hellmann, Marianne Hudson, Jared Konczal, Josh Lerner, Robert E. Litan, Diane Mulcahy, Ramana Nanda, Frank Partnoy, Joe Ratterman, Nava Ravikant, Jay R. Ritter, Alicia Robb, David T. Robinson, Allison Schrager, Barry Silbert, E. R. Sirri, Daniel Stangler and Sharon Vosmek
Despite recent innovations in entrepreneurial finance, particularly at the early stage of business creation, many new and young companies continue to face hurdles to acquire capital.
The Kauffman Foundation addressed current challenges and opportunities in... 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...
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- December 2008 (Revised October 2013)
- Case
Amylin Pharmaceuticals: Diabetes and Beyond (A)
By: Richard G. Hamermesh and Rachel Gordon
Ginger Graham, CEO of Amylin Pharmaceuticals, joined the company with the expectation of taking the company's signature drug, Symlin, to market. However, unforeseen regulatory challenges have put the approval process in jeopardy. At the same time, the company has a...
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- December 2003
- Case
Antitrust Regulations in a Global Setting: The EU Investigation of the GE/Honeywell Merger
By: Mihir A. Desai, Belen Villalonga and Mark Veblen
Helps students understand the principles underlying competition and antitrust policy in the context of the proposed GE-Honeywell merger. The U.S. Department of Justice has already approved the transaction and it is being considered by the European Commission. The...
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- September 1991 (Revised February 1993)
- Case
Burroughs Wellcome and AZT (A)
Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S....
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- April 6, 2022
- Article
A Radical Treatment for Insulin Pricing
By: Leemore S. Dafny
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a...
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