Assessing decision inputs in drug development between small, early stage companies and big pharma : is there is a difference?

The pipeline productivity challenge facing large, publicly traded pharmaceutical companies, collectively referred to as "Big Pharma," is well known. The unprecedented success Big Pharma achieved over the past few decades in commercializing blockbuster products means that it is now faced with near-term patent expirations on such products, representing billions of dollars in lost sales and profits. In order to maintain its economic momentum, Big Pharma is increasingly relying on the universe of smaller, early stage biotechnology and pharmaceutical companies as a source of new products. Early stage companies may offer Big Pharma something beyond simply more product bets. Several recent consulting studies have shown that economic returns to Big Pharma of products sourced externally are greater than those developed internally, which raises the question: What, if anything, are early stage companies doing differently from Big Pharma in their product development programs? The goal of this thesis is to evaluate product development programs ("projects") and compare qualitatively and quantitatively the decisions for projects at key decision points between early stage pharmaceutical and biotechnology companies and Big Pharma. Given that much of the critical discovery and R&D work on pharmaceutical products happens both before and during a product's entry into human clinical trials, this thesis focuses on those areas of the development continuum where R&D plays a central role. The key decision points are therefore: lead candidate selection/optimization, moving a project from pre-clinical trials into Phase I human clinical trials, and moving a project from Phase I to Phase II clinical trials in humans.

Department dc:contributor.department

Harvard University--MIT Division of Health Sciences and Technology.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2007

Author dc:creator

• Rippy, Daniel S. (Daniel Spensley)

Advisor dc:contributor.advisor

• Fiona Murray and Kimberly M. Thompson.

• Harvard University--MIT Division of Health Sciences and Technology.

Statement dc:rights

• M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/42209

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/42209