New PDF release: Biotechnology Entrepreneurship. Starting, Managing, and

By Craig Shimasaki

ISBN-10: 0124047300

ISBN-13: 9780124047303

As an authoritative consultant to biotechnology company and entrepreneurship, Biotechnology Entrepreneurship and Management supports the overseas group in education the biotechnology leaders of the next day.

Outlining basic innovations important to graduate scholars and practitioners getting into the biotech in administration or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides demonstrated techniques and hard-won classes from a number one board of educators and practitioners.

It presents a 'how-to' for people education at any point for the biotech undefined, from macro to micro. insurance levels from the preliminary problem of translating a know-how notion right into a operating enterprise case, via securing angel funding, and in handling all points of the outcome: company valuation, enterprise improvement, partnering, organic production, FDA approvals and regulatory requirements.

An attractive and easy type is complemented through diversified diagrams, pics and company movement charts with choice bushes to aid powerful administration and selection making.

  • Provides proven options and classes in an attractive and straightforward variety supplemented by way of adapted pedagogy, education information and evaluation sidebars
  • Case reviews are interspersed all through each one bankruptcy to help key strategies and most sensible practices.
  • Enhanced via use of diverse specified photographs, tables and circulate charts

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Additional info for Biotechnology Entrepreneurship. Starting, Managing, and Leading Biotech Companies

Sample text

The old model was based on hierarchical organizations with discovery and development conducted within the walls of the pharmaceutical company. The goal was to bring to market drugs for broad populations and heavily market them with a large salesforce. A “blockbuster drug” is considered to be one that has in excess of $1 billion in annual sales. 11 Lipitor chemical structure. 30 and metastasize. The two, though, ran into difficulty getting support for their work at Genentech. Bazell reports that by 1988, the company disbanded its oncology staff after its unsuccessful interferon-alfa trials and was no longer focusing on developing cancer therapies.

As the technology emerged and the first companies seeking to commercialize biotechnology products were placing their stakes in the ground, there were high-profile debates over the safety and ethics of the new technology, questions about whether new laws were needed to restrict and control its use, fights over what could and could not be patented, and regulatory concerns about how to review and evaluate these new products. For the industry to take hold, there were several critical policy developments during the early years of the industry that set the stage for its subsequent growth and development.

Pfizer’s Xalkori was approved in 2011 to treat certain patients with late-stage, nonsmall cell lung cancers who express a mutated anaplastic lymphoma kinase, or ALK, gene. About 5 percent of patients with non small cell lung cancer, or about 9000 people a year with the disease, have the mutation. The drug costs $9600 a month or $115,000 for patients who use it for a year, according to Forbes. Xalkori was approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit.

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Biotechnology Entrepreneurship. Starting, Managing, and Leading Biotech Companies by Craig Shimasaki

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