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Prepared Witness Testimony The House Committee on Energy and Commerce
SARS: Assessment, Outlook, and Lessons Learned
Subcommittee on Oversight and Investigations
Dr. Paul H. Fischer Ph.D.
Introduction Chairman Greenwood and Members of the Subcommittee, thank you for having invited me here today to discuss the SARS outbreak and the potential for developing a vaccine to prevent this disease. My name is Paul Fischer, and I am the CEO of GenVec, Inc. GenVec is a publicly held biopharmaceutical company focused on the development and commercialization of novel therapies for severe diseases with inadequate therapy. We are currently in the clinic, testing product candidates that utilize our specialized technology to treat various forms of cancer, including pancreatic cancer, as well as advanced heart disease, and macular degeneration, which is a major cause of blindness. GenVec is also pleased to be collaborating with the U.S. Government for the development of new vaccines, including AIDS, malaria, dengue fever virus, and most recently, SARS. I'd like to take this opportunity to especially thank the NIH/NIAID's Vaccine Research Center. Only a few short weeks ago, I had a telephone conversation with Dr. Gary Nabel, Director of the Vaccine Research Center. In 30 minutes, we had agreed to expand our work to include a SARS vaccine, and within hours our teams were discussing strategy. Two weeks after our discussion, an amendment to a research contract being administered by SAIC of Frederick, MD giving GenVec the green light to initiate construction of vaccine vectors for testing against SARS by the NIH/NIAID was completed, and our researchers were able to get to work. I believe that this is precisely the type of leadership on the part of the government, facilitating rapid action by the private sector, which is needed to effectively rally resources and expertise to address SARS and other potential epidemics. GenVec is proud to be part of this effort, and we hope that SARS will one day be simply a page in the medical history books-but for now, there is much to be done. SARS: The Problem As any quick check on the news tells us, the SARS epidemic is a rapidly evolving story. It is unclear whether SARS will become a major recurrent health problem, or at what rate the coronavirus that induces SARS, triggering pneumonia-like symptoms in patients, mutates. What we do know is that as of May 5th, as reported in the Wall Street Journal, some 6,234 SARS infections have been reported, claiming some 435 lives in China, Hong Kong, Canada and elsewhere. We also know that the treatment of patients affected by SARS is time-consuming and costly, that the full-blown disease leaves people weakened for an extended period of time, and that the virus is capable of surviving for prolonged periods under a variety of conditions. While containment is certainly a worthwhile strategy, we also know that there are areas of the world where containment can become increasingly difficult. We have seen the alarming rate of infection in China. The disease could easily recur and spread to other sectors of the world. The isolation and treatment protocols required to contain it may not be widely available and the results could be traumatic. In seeking to counter the impact of SARS, time clearly is our enemy. SARS: The Solution In our quest to defeat SARS, or other new pathogens, several factors are key: · Speed is crucial. The SARS virus could become seasonal and return year after year, and will likely mutate. · Flexibility is critical. The approach should accommodate potential mutations, since viruses tend to mutate over time and become resistant to drugs or vaccines. · The safety of any contemplated preventative measures, such as a vaccine, is important. Avoiding the use of live viruses is a preferred strategy when feasible, so that the recipient populations-whether healthcare workers or the general public-are placed at the least possible risk. · Ease of manufacture is also a concern, as only a vaccine or other preventative that can be rapidly produced and distributed can be widely effective. GenVec's Approach GenVec's technology involves the use of an inactivated cold virus, known as an adenovector. The genes that the adenovirus needs to replicate are removed, and the resulting adenovector acts as a delivery vehicle for the gene of interest. In the case of a potential SARS vaccine, the adenovector will carry small pieces of the DNA from the SARS virus as its payload-not the entire genome for SARS, but only enough to position the body to generate an immune response to target all SARS proteins. This response will then be retriggered, on a greater scale, if the vaccine recipient is actually challenged by the disease.
The extensive experience that GenVec's researchers have accumulated during the course of our work is being placed at the disposal of the current project to rapidly construct test candidates. Our goal is to cooperate with the NIH/NIAID in preparing several vaccine candidates for evaluation, and then modifying the vaccine or vaccines that show the greatest degree of promise to be safe and effective as needed. We hope to have one or more vaccines result from our work that can be rapidly modified in response to future potential mutations. Vaccines of this type could be used to help contain an outbreak by protecting first responders and individuals at high risk, and could eventually be of potential use as a widely-delivered vaccine, such as the flu vaccine is today. Next Steps Synthetic SARS genes are already being made and within weeks the first adenovectors will be under construction at GenVec. New vaccine candidates should be ready for preclinical testing in animals by the NIH within months. Clinical grade production is possible this current year; and depending on the results of the preclinical studies, the first trials in human subjects could begin next year. Conclusion The investments that have been made over the last decade in core biology, genomics research, information technology and the biotech industry have made this rapid response to the SARS outbreak possible. GenVec has been able to put the same approach we have just outlined today to work in our collaborative research with the Navy for the production of agile vaccines against dengue fever and malaria. In the case of these and other biological threats, time is of essence and the lessons we learn in our laboratories now can and will be put to use to help defend against the health threats facing our nation and the world today, and potentially facing us tomorrow.
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