Outsourcing Articles

MOs and CROs face a future defined by an explosion of international competition and a growing stormcloud of increased attention to the more comprehensive areas of facility and expertise demanded by domestic outsourcing clients.

the past, contract manufacturing in life sciences has been largely confined to small pharma and biotech companies. Large organizations typically have only used contract manufacturing organizations (CMOs) to meet excess demand beyond their own manufacturing capacities or for packaging needs in particular geographic locations.

s industry observers report, the contract research market is growing. Indeed, the Tufts Center for the Study of Drug Development predicts this market will continue expanding 16% per year for the next five years.1 Despite this growth, however, there are clues that segments of this market will mature in the near- to mid-term.

a intensely competitive environment, pharmaceutical companies from small to large are continuously seeking creative ways of accelerating their development process. Timelines to commence clinical trials are becoming shorter as companies seek definitive results that would prove or disprove their product's potential.

ime when it's commonplace for companies to outsource many aspects of their manufacturing tasks overseas to Asia or India, a recent move buy an overseas outsourcer has put an interesting twist on the current trend. Headquartered in Shanghai, WuXi Pharmatec is a leading China-based pharmaceutical and biotechnology R&D outsourcing company.

ilio A. Emini, Ph.D., joined Wyeth as executive vice president for Vaccine R&D in November 2005, following a stint at the International AIDS Vaccine Initiative and a 20-year career at Merck, where he last served as senior vice president of vaccine and biologics research. We spoke recently about Wyeth's commitment to vaccines and the expanding role of vaccines among major pharma companies.

2007 was a year of milestones in the world of pharmaceutical cold chain management practices, setting the stage for additional guidance, and regulatory updates with respect to temperature control during storage and distribution.

pportunities Beyond Cost Savings

Maximizing the Strategic Value of Global R&D Outsourcing

Reviewing 2007's transactions and the trends they portend

If there really can be "too much of a good thing," providers of contract development services may be experiencing it. Contractors are having to admit that the robust demand for services arising from the surging new drug pipeline may be pushing them to the limits of their ability to deliver.

That's a key insight gleaned from the 2007 survey of market conditions conducted by PharmSource in conjunction with BioPharm International and its sister publications Pharmaceutical Technology and Pharmaceutical Technology Europe. The survey was conducted in May and received 544 responses, including 432 from biopharmaceutical companies and 112 from service providers. All respondents were involved in buying or providing chemistry, manufacturing, and controls (CMC) services, including analytical chemistry and microbiology, formulation, process development, packaging, and API and dose manufacturing