Pacific Biomarkers Inc (PBI), a provider of biomarker laboratory services to the pharmaceutical, biotechnology and diagnostics industries, received an award of approximately $244,000 for its ongoing Organ Injury Biomarker Initiative. These funds will reimburse the company for prior and future expenditures through fiscal 2011 in this therapeutic area. The initiative was recognized as a "Qualifying Therapeutic Discovery Project" under a program created by Congress on May 21, 2010 under the Patient Protection and Affordable Care Act of 2010, the major United States federal health care reform legislation enacted earlier this year.
The federal program established criteria by which small businesses could apply to be certified for either a tax credit or a grant up to specified limits for tax years 2009 and 2010. The grant awarded to PBI is designed to offset up to 50% of qualifying research and development costs and provides $244,479.25 to the company. The total amount of grant money available nationwide was $1 billion.
Under the award guidelines, qualified therapeutic discovery projects had to show a reasonable potential to detect or treat chronic or acute diseases and conditions, reduce the long-term growth of health care costs in the United States, result in new therapies to treat areas of unmet medical need, or significantly advance the goal of curing cancer within 30 years. The projects also needed to show a reasonable potential to create or sustain high-quality jobs and to advance United States competitiveness in the fields of life, biological, and medical sciences.
The aim of this program at PBI is to diagnose organ injury occurring because of specific toxic effects of drugs that are in development and prevent their approval. Current costs related to the development of a drug, from discovery to the final approval, are estimated to be about $1 billion. Drug-induced toxicity accounts for 30% of all drug failures prior to reaching the market. This PBI program has the potential to diagnose toxic drug effects that currently are missed in clinical trials.
The key strategic goal for PBI is to provide pharmaceutical and biotech companies with services for testing robust novel biomarkers that have undergone thorough analytical validation and clinical qualification to diagnose early organ injury. This work is taking place in response to FDA-initiated recommendations for streamlining and improving drug development outcomes as outlined in the Critical Path Initiative through guidance from the Predictive Safety Testing Consortium (PSTC) and the Health and Environment Sciences Institute (HESI).
PBI submitted the application in July 2010 for reimbursement of Initiative expenses from 2009, 2010, and estimated future expenses through fiscal 2011. On November 1, 2010, the company received the award notice for the $244,479.25 grant.
Source: Pacific Biomarkers, Inc