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- All HBS Web (176)
- Faculty Publications (65)
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- 22 Aug 2005
- Research & Ideas
Balancing the Future Against Today’s Needs
remote monitoring service for cardiac device patients, which hit the market well before 2010 (the FDA approved it in January 2002). It was only by thinking in terms of "reinvention," says George, that this could have been...
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by Paul Michelman
- 08 Dec 2003
- Research & Ideas
Why Europe Lags in Pharmaceuticals and Biotech
healthcare allows you to do something that means a great deal to the consumer. In a September speech, FDA Commissioner Mark McClellan said that low drug prices charged elsewhere in the world results in U.S. consumers paying more. He urged...
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- 15 Feb 2000
- Research & Ideas
The Right Connections
connections can be a source of information about the FDA approval process and offer insights as to how to market and sell the young firm's products. They can also provide resources and contacts to facilitate these tasks. Another...
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by Judith A. Ross
- 06 Jun 2017
- First Look
First Look at New Research and Ideas: June 6, 2017
Pharmacyclics is a biotechnology company that had received FDA approval in late 2013 for its flagship asset Imbrivica (ibrutinib), a biologic treatment for chronic lymphocytic leukemia and two other even rarer blood malignancies. Entering...
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Sean Silverthorne
- 13 Feb 2018
- First Look
New Research and Ideas, February 13, 2018
improve the care of patients with diabetes by contracting an app. They go through a rigorous evaluation of the FDA regulations, the existing market, and potential commercial competitors to try and identify a market opportunity. Since...
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Sean Silverthorne
- 07 Aug 2007
- First Look
First Look: August 7, 2007
and issues around current practices. Purchase this note: http://www.hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=807124 U.S. Food and Drug Administration Harvard Business School Note 807-050 Describes the U.S. FDA with particular...
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Martha Lagace
- 06 Feb 2007
- First Look
First Look: February 6, 2007
2003, the firm has been waiting for the FDA to declare that meat and milk from cloned animals are no different from non-clones. During that period the company has worked to educate regulators, consumers, and members of the livestock chain...
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Martha Lagace
- 29 Aug 2017
- First Look
First Look at New Research and Ideas, August 29
loomed large. Purchase this case: https://cb.hbsp.harvard.edu/cbmp/product/215036-PDF-ENG Harvard Business School Case 910-403 GTC Biotherapeutics: Developing Medicines in the Milk of Goats GTC is the first company in the animal world to receive View Details
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Sean Silverthorne
- 04 Apr 2019
- Cold Call Podcast
Can Mark Zuckerberg Rebuild Trust in Facebook?
they're getting great results because of leadership. I think it's time for Mark Zuckerberg and Sheryl Sandberg to step up to leadership. Industries do not do a good job of self-regulation, so we have regulatory bodies. We don’t let pharma regulate itself. They have to...
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Re: Gerardine A. Doyle
- 28 Apr 2009
- First Look
First Look: April 28, 2009
funds in reserve in the event that the FDA requests further data. Purchase this case: http://hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=709002 VOSS Artesian Water from Norway Harvard Business School Case 509-040 VOSS is a...
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Martha Lagace
- 05 Mar 2019
- First Look
New Research and Ideas, March 5, 2019
to minors—an allegation JUUL Labs’s executives strongly denied. The company now faced an FDA probe and investigations by at least two state attorney generals. It needed a strategy to deal with its mounting regulatory and public relations...
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Dina Gerdeman
- 31 Jul 2007
- First Look
First Look: July 31, 2007
would mean navigating the FDA approval process, as well as raising the capital necessary to finance the endeavor. It was up to Bollinger to decide on a strategy for Vascugel's clinical trials. In addition, he would have to decide how much...
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Martha Lagace
- 01 Feb 2011
- First Look
First Look: Feb. 1
Medical Richard G. Hamermesh and Lauren BarleyHarvard Business School Case 810-027 Novasys has developed a new medical device and procedure for the treatment of female stress urinary incontinence that is cheaper and can be performed in doctors' offices. In spite of...
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- 15 Apr 2014
- First Look
First Look: April 15
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 marketed as a diagnostic and preventative tool and that it was subject to...
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Sean Silverthorne
- 16 Apr 2001
- Research & Ideas
Brand Power from Wedgwood to Dell: Part One
was a time of diluted, distorted foods. There was no FDA or FTC. His brand was created on quality, tastiness, pure manufacturing techniques, and on convenience. Convenience was not part of Wedgwood's equation. But convenience needed to be...
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by Martha Lagace
- 10 Oct 2017
- First Look
First Look at New Research and Ideas, October 10, 2017
https://pubwww.hbs.edu/faculty/Pages/item.aspx?num=53307 Harvard Business School Case 518-031 MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work In June 2014, MannKind Corporation announced that after years of development and billions of dollars in...
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Sean Silverthorne
- 08 Jan 2008
- First Look
First Look: January 8, 2008
challenges arise against the backdrop of the accelerated approval process, uncertainty about what the FDA will ultimately decide, and whether the company should indeed pursue early approval. Purchase this case:...
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Martha Lagace
- 18 Dec 2018
- First Look
New Research and Ideas, December 18, 2018
R&D-intensive firms react to negative shocks to their existing products? We explore this question using detailed project-level data from drug development firms. Using FDA Public Health Advisories as an exogenous and idiosyncratic...
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Dina Gerdeman
- 19 Sep 2017
- First Look
First Look at New Research and Ideas, September 19
time, Imprimis was in the process of seeking FDA approval for a branded drug called Impracor. This process, already difficult, was further complicated by recent manufacturing issues. Meanwhile, the opportunity arose for Imprimis to...
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Sean Silverthorne
- 07 Apr 2003
- Research & Ideas
XTV: Xerox’s Attempted Recovery From “Fumbling the Future”
with researchers at PARC. Much of that time was occupied with interviewing prospective customers who had significant problems with document management. For example, a pharmaceutical company that was applying for FDA approval had to manage...
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by Henry Chesbrough