BioPharm International-02-01-2002

By Barara W. Unger, Don Hill Associates, Inc., pp. 14-18, 71. An effective, well-developed, and versatile preapproval inspection model focuses management and inspectors on conclusions, minimizes process reinvention, and tracks inspection readiness, especially when you are using a contract manufacturer.

By Tom Brody, DNAX Research Institute, pp. 38-42. Early sale or offers to sell an invention may result in the rejection of a patent application under 35 U.S.C. 102(b). Such a rejection is called "the on-sale bar," and it permanently prevents patenting of an invention.

By Heather B. Hayes and Jim Miller, PharmSource Information Services, Inc., pp. 60-62. Not just a quick fix, e-procurement requires a thoughtful and thorough approach to produce the most rewards.

By Fiona Adair and Daniel Ozanne,Biovation Ltd., pp. 30-36. Immunogenicity is often a barrier to further development of potentially therapeutic proteins. That barrier often remains unknown until late in the development chain. The authors explore various strategies for preventing immunogenicity and for predicting it earlier in the process.

By Jim Erickson, Blue Mountain Quality Resources, Inc., pp. 63-64. In the fast-paced biopharmaceutical manufacturing environment, "speed to market" is the hallmark catch phrase. Many companies are focusing only on the processes that add the most value and are outsourcing the rest. This focus on core competencies has some biotech companies reevaluating their calibration practices. Many are contracting more of that workload, from both laboratory and production facilities, to calibration service laboratories.

By Rajiv Nayar and Mark C. Manning, HTD Biosystms, Inc., pp. 20-28. Outsourcing is often considered a way to expedite drug development, but other options exist for companies that don't choose it yy} or that run up against the capacity shortage. The resources devoted to speeding up the drug discovery process led to combinatorial libraries, high-throughput screening, proteomics, and genomics. Now the same types of innovation can be applied to drug development to prevent valuable lead compounds from sitting idle on the shelf.

By Jill Wechsler, pp. 52-56. More curbs on reimbursement for expensive, cutting-edge therapies may shape R&D programs and industry growth

By Joseph F. Noferi, Esq., Ralph Dillon, and Daniel E. Worden, pp. 44-50. Implementing the ERES rule will do more than make your organization compliant with federal regulations. It will strengthen its intellectual property position for the information age.