Framework for a biopharmaceutical value chain

Medicilon is a Preclinical Research Outsourcing (CRO) company. With our more than 10 years experience on preclinical research services, we dedicated to provide our clients with customized preclinical services program in drug metabolism, pharmacokinetics, efficacy studies, and toxicology. We provide our clients a high-quality data and rapid turnaround time to support their drug development, preclinical studies and clinical research and to help them to select the most valuable drug candidates into clinical trials stage. Our preclinical research services consist in three major parts: pharmacokinetics, disease transplantation models and drug safety evaluation. Our services cover all of the aspects including design, in vivo studies, sample analysis, professional data analysis, IACUC review, and the preparation of application materials.Email:marketing@medicilon.com.cn WEB:www.medicilon.com.

An information management framework includes a network of connected processors, an application data server connected to the network, and an infrastructure for interfacing with the application data server. The framework includes a first client accessing the application data server through the infrastructure and making drug candidate data available on the application data server via the network, and a second client for conducting drug candidate research via the network against the drug candidate data.

1. Technical Field

The present invention relates to pharmaceutical development, and more particularly to a system and method for a discovery-to-Phase-2 framework for a biopharmaceutical value chain.

2. Discussion of Related Art

A problem facing the biopharmaceutical industry is the careful selection of drug candidates. It is estimated that the cost to develop a single, novel compound into a marketable drug is approximately $800M (Tufts Center for the Study of Drug Development) with up to a 15-year development timeline from discovery to U.S. Food and Drug Administration (FDA) approval (Ernst & Young, 2000). Furthermore, the FDA's drug approval process has been slowing. The number of new drugs approved by the FDA fell to 17 in 2002, compared with a 1996 peak of 53 (FDA, 2003).

Consolidation of the industry also plays a role in the selection process of new drug candidates. Large biopharmaceutical enterprises need a large return on investment (ROI) to cover high internal development expenses. This is one reason that the industry is growing more and more risk-averse. “De-risking” has become a term used in the pharmaceutical industry when referring to the concept of investing only in those drugs that have the best chance for FDA approval.

Smaller biotech companies and academic centers, which are an integral part of the drug discovery pipeline, function in the early stages of biopharmaceutical value chain (see FIG. 1). Academic research centers often lack the internal resources to efficiently develop and promote the results of novel, early preclinical research. Furthermore, the biotech companies, particularly start-ups, may lack the internal resources and technological infrastructure to move drug candidates into a position where the candidate would be attractive to larger biopharmaceutical companies for investment.

The declining research and development (R&D) productivity of the larger pharmaceutical companies, coupled with the failure of mergers to generate better drug development pipelines, has caused many pharmaceutical companies to look for collaborations with biotech and academia to fill these gaps. At the same time, a lack of internal start-up capital and low venture capital investment has caused drug candidates developed by smaller biotech companies and academic research centers to remain bottlenecked in the early stages of the biopharmaceutical value chain, prior to Phase 2, the point near which the interest of larges pharmaceutical companies is piqued.

Referring to FIG. 1, Phase 1 trials are clinical trials conducted to evaluate the safety of a drug or therapy; how a drug should be administered (e.g., oral, injection) and evaluation of dose levels. Phase 2 trials are conducted to further evaluate the safety of a drug or therapy and to evaluate drug efficacy. In addition, optimal dose levels are determined. Phase 3 trials are conducted to confirm the efficacy of a new drug or therapy.

Two recent examples that illustrate the willingness of large pharmaceutical companies to invest in drugs that have made it to early phase clinical trials are the relationships between Aventis and Regeneron, and Amgen and Biovitrum. Aventis, a large French pharmaceutical company, agreed to pay up $125 million up front, and possibly up to $510 million, to license a cancer drug candidate that is in Phase 1 of clinical trials from tiny Regeneron Pharmaceuticals located in Tarrytown, N.Y. Amgen, the world's largest biotechnology company, has agreed to pay Biovitrum, a small Swedish company, $86.5 million up front, followed by up to $400 million, for the rights to a novel diabetes drug candidate, which is in early Phase 2 of clinical trials.

Therefore, a need exists for a system and method for streamlining and efficiently/effectively moving drug candidates from the early phases of basic research and discovery to Phase 2 of the clinical trial cycle.