U.S. HOUSE OF REPRESENTATIVES COMMITTEE ON OVERSIGHT & GOVERNMENT REFORM SUBCOMMITTEE ON ENERGY POLICY, HEALTH CARE & ENTITLEMENTS
DECEMBER 12, 2013
“FDA CHECK-UP: DRUG DEVELOPMENT AND MANUFACTURING CHALLENGES”
Chairman Lankford and Ranking Member Speier, Members of the Committee, my name is Paul Hastings, Chairman and Chief Executive Officer of OncoMed Pharmaceuticals headquartered in Redwood City, CA. I also serve as Chairman of the Biotechnology Industry Organization (BIO) Emerging Companies Section Governing Board, which represents the smaller, emerging biotechnology companies that often do not yet have a product on the market.
BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations – the majority of which are small and emerging companies, with 90% having fewer than 100 employees. BIO members are involved in the research and development of innovative health care, agricultural, industrial, and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better health care, enhanced agriculture, and a cleaner and safer environment.
I have over 27 years of experience in the biotechnology and pharmaceutical industry. My current company, OncoMed Pharmaceuticals, is working at the cutting edge of oncology research, focusing on a specific set of cells within tumors: tumor initiating cells, which drive the growth of the tumor and can morph into various cell types within the tumor. We have developed the ability to isolate and monitor these tumor initiating cells using specific surface markers and technologies. Our studies have shown that tumor initiating cells are more resistant to standard chemotherapy agents and radiotherapy. So, some current treatments may succeed at initially decreasing the size of a cancer, but leave behind an increased proportion of these most malignant cells. We have developed a portfolio of antibodies and have tested them within xenograft models derived from freshly resected human cancers. These antibodies target biologic pathways critical for the survival of tumor initiating cells. We believe these models are more representative of the effects of these treatments in cancer patients than traditional models using cancer cell lines, which may no longer accurately reflect the properties of the original tumor. We currently have five products in clinical development in 13 completed or ongoing clinical trials, with hundreds of patients having received our experimental therapies, and we are pursuing the discovery of additional novel anti-tumor initiating product candidates.
I would like to thank the Committee for holding this timely and important Congressional hearing. The U.S. biotechnology industry is working on treatments and therapies that have the potential to deliver new solutions to our most pressing health care needs and is a key element of an innovation-driven economy.
I. UNLEASHING THE PROMISE OF BIOTECHNOLOGY TO IMPROVE HUMAN HEALTH
Currently, there are nearly 1,000 biotech drugs and vaccines under development for more than 100 diseases.1 By harnessing the power of molecular biology and genomics, we have come a long way in turning incurable diseases into treatable diseases, increasing the ability of patients to maintain independent lives, and generally improving the quality of life for many patients suffering from chronic and life-threatening diseases. Improving quality of life, decreasing hospitalizations, and allowing patients to live longer and more independent lives is not only a public health goal – it is a national imperative.
Approximately 60% of individuals between the ages of 50 and 64 have at least one chronic disease and the Baby Boomer population is projected to double the number of individuals that are 65 or older to 71.5 million by 2030.2 In fact, chronic medical conditions account for more than 75% of total health care spending.3 If we consider that the projected cost to care for a single chronic disease, Alzheimer’s, is projected to increase from $203 billion in 2013 to $1.2 trillion per year in 2050, and that developing a treatment that would delay the onset of Alzheimer’s by just five years would reduce that projected increase in cost by $447 billion – it is clear that we need to promote and implement policies that enable the effective development and approval of innovative treatments and therapies.4, 5
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