Science is Beautiful Blog

Outsourced Manufacturing Partners Provide Expertise, Capacity, Speed

Posted by John Kouten, CEO

Jul 20, 2011 4:34:00 PM

John Kouten





Never before have the risks associated with drug development been higher.  According to PhRMA, the cost of bringing a new drug to market, approximately $1.3 billion, has increased 60% between 2000 and 2005. Further, according to recently published statistics, it can take up to 15 years for a new chemical entity (NCE) to progress from discovery to a marketed drug in the U.S.  And a study released by the Biotechnology Industry Organization (BIO) in February 2011 revealed that the country's overall success rates in bringing a new drug to market are now almost as low as one in ten. This figure applies to new medicines moving through clinical trials to US approval between late 2003 and the end of 2010.

So, as FDA drug approval rates go down and regulatory pressures increase, innovative drug companies must ensure flawless execution of their drug development processes.  Consequently, a practice that might have been considered heresy as little as five years ago has become one of the hottest trends in pharmaceutical development -- outsourced manufacturing partners.

When time is money (one day of delay in drug development can cost from $1 million to $4 million in lost downstream revenue), life sciences innovators are turning to formulation, manufacturing, packaging and supply chain solutions partners.  Ideal partners can accelerate development timelines, reduce cost, reduce waste and mistakes and ideally become a seamless member of the drug sponsor’s development team.

Strategic partnerships with solutions providers can offer life sciences companies:

  • Full service drug development, formulation, manufacturing, packaging and supply chain project management

  • Methodological and technical competencies

  • Best in class scientific expertise

  • A variety of standardized processes and protocols

  • A positive track record for working with regulatory agencies

  • Infrastructure and capacity to produce a variety of drugs and delivery methods

  • Highly trained technical personnel

  • Improved efficiency and productivity 

As drug development costs increase and regulatory requirements tighten, we expect to see pharma companies continue to move toward a more “virtual” model and increase the degree to which they partner and the openess of those partnerships. Keep an eye on the outsourced drug development and manufacturing industry to grow and expand its offerings from traditional services to include a variety of specialized niche technologies.

--John F. Kouten

Topics: US pharmaceutical market, drug development, pharmaceutical, FDA, contract manufacturing


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