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August 28, 2002
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Background
Under normal circumstances, the incidence of naturally occurring infection caused by Category A, B, and C pathogens (as defined by the Centers for Disease Control and Prevention) is extremely low in the United States. For this reason, the number of investigators conducting research on these agents is small and the scope of this research limited. Since the September 11 terrorist attacks, public interest has grown in potential complementary and alternative medicine (CAM) remedies against these pathogens and the infections they cause. Citizens are interested in accessing additional options by which they might minimize their risk of infection and its consequences.
A second area of public health concern with regard to viral pathogens and CAM is the human immunodeficiency virus (HIV). There is widespread use of botanicals and other dietary supplements by persons with HIV infection, often without scientific evidence in support of that use.
In sum, there is a critical need to systematically and rigorously investigate CAM approaches to prevent or treat infections caused by the above pathogens.
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Purpose
The Preclinical Antiviral Testing Program for CAM (PATP-CAM) is a joint effort of the National Institute of Allergy and Infectious Diseases (NIAID) and the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH). The program also collaborates with the U.S. Army Medical Research Institute on Infectious Diseases. PATP-CAM offers an opportunity for testing of potential antiviral agents in vitro for their activity against numerous types of viruses (detailed below). Preclinical evaluations of antiviral therapies are also conducted in animal models of human viral infections.
The program considers as candidates natural and synthetic compounds that qualify as CAM (see NCCAM Web site for definition of CAM). We invite applications from scientists in the academic and business communities worldwide.
PATP-CAM also has the capability to collaborate with the United States Army Medical Research Institute on Infectious Diseases on the search for therapies for exotic viruses such as Ebola and poxviruses.
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Types of Testing
In Vitro Screens
- Herpesviruses (HSV-1, HSV-2, VZV, EBV, CMV, HHV-6, HHV-7, HHV-8)
- Respiratory viruses (Flu A & B, RSV, PIV, MV, HRV, Ad) Hepatitis B virus
- Orthopoxviruses (Vaccinia, Cowpox)
- Special Pathogens: VEE, Punta Toro, Pichinde, Yellow Fever, West Nile
- Human Immunodeficiency Virus (HIV)
Animal Models
- Herpesviruses (HSV-1, HSV-2, MCMV, GPCMV, HCMVSCID-hu)
- Respiratory viruses (Flu A & B, RSV, PIV-3, MV)
- Hepatitis viruses (WHV, HDV, HBV transgenic)
- Orthopoxviruses (Vaccinia, Cowpox, Rabbitpox, Ectromelia)
- Papillomaviruses (Shope, HPVSCID-hu)
- Human Immunodeficiency Virus (HIV)
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How to Nominate Substances
The Program Selection Panel is interested in selecting agents with the highest potential for positively impacting public health. Particular emphasis is placed on selecting and screening agents that may be used to prevent and/or treat infectious disease capable of being used as weapons of war or terror.
There are three submission dates per year: December 1, April 1, and July 1.
Programmatic questions may be directed to:
Richard Nahin, Ph.D., M.P.H.
Senior Advisor for Scientific Coordination and Outreach
National Center for Complementary and Alternative Medicine
31 Center Drive, MSC 2182
Bethesda, MD 20892-2182
Phone: 301-496-7801
Nominations should be submitted to:
Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd. Suite 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-451-6331
Types of Agents for Nomination
Nominations for PATP-CAM studies are allowed from the following categories:
- Biological or physical CAM agents that may not be adequately evaluated without Federal involvement;
- Commercial CAM products that generate too little revenue to support further evaluations;
- Potential CAM substitutes for existing chemicals or drugs that might not be developed without Federal involvement;
- CAM substances that occur as complex mixtures which may not be of interest to industry; and
- Emergencies or other events that warrant immediate Government evaluation of a CAM agent.
The selection process assumes that industry will evaluate those antiviral agents they have developed in-house. It is not the intent of the Federal government to replace or interfere with this process.
What to Submit with Nominations
Nominations should identify:
- The particular biological screens required
- The rationale for the nomination
- Any available background data on production and use
- The extent of available toxicological information.
The table/outline below can be used as a guideline for the type of information requested.
Note: It is recognized that not all potential nomination sources have the resources to obtain all the requested information. Therefore, all nominations will be considered, regardless of the extent of the information submitted.
- Physical and chemical properties
- Physical description
- Solubility
- Stability and reactivity
- Structure, if known
- Other relevant information
- References
- Production
- Production
- Source and synthesis
- Current production and pathway
- Commercial product(s) composition
- Use
- By age, gender, race, and socioeconomic status
- By disease/condition
- Prevention (primary, secondary, tertiary) or treatment
- Other relevant information (e.g., sales data)
- Toxicology
- Human data, case reports, and epidemiological studies
- Experimental animal information
- In vitro and other short-term tests
- Other relevant information
- References
- Disposition and structure-activity relationships
- Absorption, distribution, metabolism, and excretion
- Other relevant information
- References
- Ongoing studies in the government, industry, and academia
- Rationale for recommendation and suggested screening
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Selection and Evaluation Process
The PATP-CAM Panel, a panel of independent experts, will review and assess nomination information. The panel is composed of individuals involved with health research--including, but not limited to, botanists, ethnobotanists, immunologists, medicinal chemists, pharmacognocists, and virologists, as well as members of the lay public.
To determine selection priorities, the PATP-CAM Panel will assess the specific needs for studies, evaluate existing literature and testing data, assess ongoing evaluations in the government and private sector, and assess the overall plan for improving the public health armament for infectious disease.
The panel will make screening recommendations, which may include recommendations of screens beyond those requested by the nominator.
NCCAM and NIAID staff will review summaries of the panel recommendations to prioritize the products and finalize screening plans to address the most pressing research needs.
Evaluation Criteria
NCCAM and NIAID staff will use the following criteria to evaluate agents selected by the Panel:
- Technical feasibility of studying the nominated product(s)
- Availability of a research-grade product
- Existence of adequate outside testing
- Balance within the NIH research portfolio.
If screening is warranted, NIH staff will present the research plan to the Director of NCCAM for final review and approval.
Once a product is selected for screening, the nominator will have to supply approximately 2-3 mg of compound to NIH for each approved viral screen. Results will be available approximately 10 weeks after NIH receives the material.
During any of these steps the agent may be withdrawn if higher priority studies are found, or if the study proves to be impractical. Agents will be studied according to priority and allocation of resources; selection of an agent by the PATP-CAM Panel does not automatically commit the NIH to screen that agent.
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Confidentiality
Nominators must sign a confidentiality agreement with NIH before materials can be tested. The full agreement is available online at nccam.nih.gov/research/news/screening.pdf. In brief, the nominator must identify any information it deems to be proprietary and confidential information. To the extent permitted by law, this information will remain confidential for five (5) years from the date of disclosure, unless:
- The information is known by the public or becomes known by the public through no fault of NIH or its contractor(s);
- The information was obtained by NIH or its contractor(s) from a third party having no confidentiality obligation to the nominator;
- The information was made available to NIH or its contractor(s) by the nominator without a confidentiality obligation;
- The information has been independently developed by NIH or its
contractor(s) without reference to the nominator's information; or
- The information is required to be disclosed by law, regulation or court order, provided that NIH has notified the nominator, and NIH and/or its
contractor(s) have taken reasonable efforts to minimize the extent of the required disclosure.
NIH agrees that information or data about the product(s), including the evaluation results, will be kept in restricted-access files by NIH and/or the NIH contractor(s). Only employees of NIH or its contractor(s) will have access to the files containing information about the product(s), including the evaluation results.
The evaluation results are not confidential information and may be disclosed by NIH and/or its contractor(s) only in accordance with the signed confidentiality agreement.
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Intellectual Property
All rights, titles, and interest in and to all products and information provided by the nominator to NIH will remain with the nominator, as will all rights, titles and interest in and to any invention made during the evaluation that directly relates to the nominated product.
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