FDA - Publications - Faculty & Research

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... View Details

Keywords: by Sean Silverthorne; Biotechnology; Health; Pharmaceutical; Technology

13 Nov 2020
News

Student Startups Help Fight COVID-19

Labs. “A crisis like this illuminates the importance of innovation.” One example is Umbulizer, which offers a reliable, portable ventilator at 10 percent of the cost of a $40,000 hospital-grade machine. The device recently gained emergency View Details

04 Sep 2019
News

Accelerating Scientific Discovery

have, and how can we support their development?” Chandra explains that because “science is long and hard”—running the gamut from basic research and drug discovery, to clinical trials, to FDA review and approval, to post-approval... View Details

Keywords: Jennifer Gillespie

01 Dec 2022
News

Road to Recovery

contracting with some more innovative commercial and Medicaid programs while advocating for federal change in billing codes and seeking FDA approval for the company’s offerings. DynamiCare’s biggest victory came in March 2022, when the... View Details

Keywords: April White; Ambulatory Health Care Services; Health, Social Assistance

06 Oct 2020
Blog Post

2+2 Where Are They Now Spotlight: Curtis Wu (MBA 2018)

generating drug substance to confirm the candidate’s efficacy through clinical trials, and submitting data to the FDA for regulatory approvals. My team’s primary responsibility is to generate data and manufacture drug substance to meet... View Details

06 Dec 2021
News

Vision: Sound Science

It was a milestone to celebrate: Earlier this year, designations from FDA and European Union regulators moved researchers at the Boston-based startup Akouos, Inc., a step closer to producing the first-ever therapy for gene-mediated... View Details

Keywords: Deb Blagg

15 Dec 2024
News

After Ozempic

Back before Ozempic, when Kate Mulroney (MBA 1984) spoke at technical conferences about her work at Novo Nordisk, people often assumed she was talking about Novartis. “I’d have to explain that’s a Swiss company; we’re Danish,” says Mulroney, now head of advanced... View Details

Keywords: Jen McFarland Flint; Illustrations by Pete Ryan; Ambulatory Health Care Services; Health, Social Assistance

15 Jun 2016
Research & Ideas

These VC Partners May Make Your Firm Less Innovative

same VCs. Finally, they determined how “innovative” each company was, based on the number of new products they introduced that were approved by the FDA (averaging one product every two years). The data showed that companies tied to a... View Details

Keywords: by Michael Blanding; Financial Services; Banking

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... View Details

Keywords: Martha Lagace

07 Aug 2000
Research & Ideas

The Business of Biotech

are fundamental to biotech's success.—Gail Maderis Time—a precious asset in any industry—has special value in biotech, particularly since the multiphase FDA approval process can add years to a drug's development. "My biggest source... View Details

Keywords: by Julia Hanna; Biotechnology; Health; Technology

01 Dec 2019
News

The Race Against Resistance

people die as a result. And yet, there are only 42 antibiotics currently in clinical development, and typically only 20 percent of infectious disease drugs that enter phase 1 clinical trials will receive FDA approval. Eric Kimble (MBA... View Details

Keywords: Lisa Scanlon Mogolov

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

Keywords: 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... View Details

Keywords: Re: Andi Wang

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... View Details

Keywords: by Judith A. Ross

04 Sep 2019
News

Advancing Diagnostics that Can Save Lives

should humans do and what should algorithms do?’” she notes. As she seeks to tackle tasks such as securing FDA approvals and raising venture funding, Kelley has already found her affiliation with the Life Lab and her access to other... View Details

Keywords: Susan Young

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... View Details

Keywords: 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... View Details

Keywords: by Martha Lagace

11 May 2017
News

Going with the Flow

Hoxworth Blood Center, where it was processed and stored. Parents paid an initial processing fee at the time of delivery and an annual storage fee in the month of the child’s birthday. At the time, most organizations dealing in blood were nonprofits, such as the Red... View Details

Keywords: Robert S. Benchley

09 Feb 2010
First Look

First Look: Feb. 9

human patients. Doyle believes NovoCure has the potential to become an important company with a major new cancer therapy platform but must complete pivotal (Phase III) clinical trials and receive FDA approval. Doyle's venture capital... View Details