Regulatory Beat: Biotech Firms Collaborate on Third-World Drug Development - New research models plus public pressures prompt manufacturers to join partnerships to develop research treatments for negl

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Regulatory Beat: Biotech Firms Collaborate on Third-World Drug Development
New research models plus public pressures prompt manufacturers to join partnerships to develop research treatments for neglected diseases


BioPharm International
Volume 19, Issue 9

SCALING UP

Most collaborative projects rely on an industry partner to handle manufacturing and packaging of final drug products. Smaller biotech firms are likely to outsource manufacturing to a larger organization or developing-country partner. Those may include fairly sophisticated generics firms in India, China, and South Africa that have considerable expertise in formulation chemistry, low-cost scale up, and product distribution in Africa and Asia; some larger generic manufacturers are also gaining expertise in biotechnology formulation and production.

The search for effective disease treatments also may yield more-efficient and innovative formulations and manufacturing approaches. For example, iOWH is partnering with researchers at the University of California, Berkeley, and a spin-off company, Amyris Biotechnologies, to develop a large-scale, low-cost commercial microbial drug production process for artemisinin, the key ingredient in new antimalarials.

"Manufacturability" is an important consideration for identifying potentially successful products, says Jerald Sadoff, president of the AERAS Global Tuberculosis Vaccine Foundation (Rockville, MD, http://www.aeras.org/), formerly with Merck. Most projects fail because they can't be made at an acceptable cost or in a reliable way for millions and millions of doses. Based on expectations that its R&D portfolio will yield effective vaccines in the coming decade, AERAS has built a $10 million research and manufacturing facility in Maryland. This investment permits AERAS to produce candidate vaccines that meet good manufacturing practices standards for use in clinical trials. Sadoff acknowledges that a new vaccine may not be available for widespread use until 2012, but believes that these early efforts set the stage for scaling up to produce the 150 million doses or more needed every year for a successful product.

PUSH FOR FUNDING

The limiting factor on all these initiatives is inadequate funding from wealthy nations. The Moran report notes that more than half the nearly $255 million contributed to PPPs as of April 2005 came from the Gates Foundation; the US provided $16 million, much more than other governments, but still very little. Most of public funding for third-world health currently goes to treatment programs such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria and the President's Emergency Plan for AIDS Relief (PEPFAR). These programs can "pull" new drugs to market, but have not stimulated new research on less visible diseases.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,


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