New Frontiers in Contraceptive Research A Blueprint for Action (2004) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-16
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According to a recent analysis by the Global Health Council, the world's 1.3 billion women between the ages of 15 and 45 experienced more than 1.2 billion pregnancies in the 6 years between 1995 and 2000 (Global Health Council, 2002~. Of these, more than 300 million or more than one1
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Over the next decade, 600 million girls are projected to reach adolescence, which will be the largest cohort of young women in human history. Although a number of reversible and nonreversible contraceptive methods are generally effective (barrier methods, hormonal methods, intrauterine devices, and contraceptive sterilization)
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A major goal of the present committee was to identify ways in which new information and new technologies can be rapidly and efficiently applied to contraceptive target identification, validation, and product development. Moreover, the committee found that there is still a great need to reenergize the field and to translate significant observations from the science of reproductive biology to practical applications in fertility regulation.
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4 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH FROM TARGET SELECTION TO PRODUCT DEVELOPMENT Identify and Validate Novel Contraceptive Targets In the course of genomics research, thousands of genes expressed in the reproductive cells and tissues of model organisms and humans have been identified, and many of these sequences appear to be unique to reproductive tissues and gametes. Remarkably, a recent study found that 4 percent of all genes may be uniquely and exclusively expressed in male
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Recent research in proteomics has also led to the discovery of proteins that are unique to reproductive cells and tissues. The identification of genes and proteins that are expressed specifically in the reproductive tract and, more importantly, that function specifically in the reproductive tract could lead to the development of new contraceptives that specifically affect the reproductive tract and thus produce minimal unwanted side effects.
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· Newly established genetic models should be rapidly distributed to the community of scientists involved in reproductive biology research for prompt and comprehensive phenotypic analysis. Accelerate the Discovery and Development of Compounds That Modulate Existing and Emerging Targets Several promising new targets for contraceptive development have already been identified, and many more will undoubtedly be discovered through efforts to implement Recommendations 1 to 3.
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Recommendation 5: Implement mechanisms to accelerate contraceptive product development and clinical testing once a lead molecule or concept prototype has been discovered in an academic laboratory by sharing multidisciplinary national and international resources. Specifically: · Create a special projects program in NIH, affiliated with the Contraceptive Clinical Trials network, to fund the development of novel contraceptive compounds that offer large potential benefits for the global community.
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This limits the ability of investigators in notfor-profit organizations to use these technologies in the development of their compounds. Recommendation 6: Develop mechanisms to access, apply, and enhance the technology of drug delivery and formulation science to contraceptive development.
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The choice of surrogate markers of sterility may be even more challenging for some of the future potential methods of contraception because they will likely target completely new pathways or steps in reproduction. Researchers can benefit from dialogue with regulatory bodies to address the unique aspects of contraceptive development and to design new approaches to clinical trials.
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Health benefits beyond pregnancy prevention offer significant added value to long-term users of a particular contraceptive method who tolerate the method solely for its contraceptive benefit. Benefits of current methods include alleviation of dysmenorrhea, acne, or premenstrual syndrome; improved endometrial bleeding patterns; or amenorrhea.
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Recommendation 10: Expand public-private partnerships that draw on the complementary strengths of the public-sector agencies, industry, foundations, consumer groups, and other organizations to expedite the translation of lead compounds into contraceptive products. Increase the Participation of Developing Countries Nongovernmental organizations, governmental public health agencies, universities, research institutions, medical research councils, and industry in developing countries can make valuable contributions to contraceptive development in several ways.
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The Global Health in Research Initiative provides competitive reentry grants to foreign scholars who have had postdoctoral training in the United States sponsored by Fogarty International Center training grants. Programs such as CONRAD, the Consortium for Industrial Collaboration in Contraceptive Research, the GMP, Family Health International, the Program for Appropriate Technology in Health, the Population Council, and the World Health Organization also have active collaborations with institutions worldwide, not just for clinical trials but also for preclinical activities and feasibility and proof-of-concept studies.
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Given the long period of time required in this field to make substantive contributions that may lead to new products, junior or midlevel faculty need the promise of adequate support. The academic community itself must also appreciate the unique features of contraceptive development research so as not to penalize those who pursue activities that may be viewed as being outside the traditional path (e.g., applied research or team-based research)
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Another strategy for improving communication among the many parties with an interest in this rapidly changing scientific field is a roundtable or forum. While an Alliance for Contraceptive Development would collect resource material and disseminate information, a Forum on Contraceptive Research would provide a mechanism to facilitate integration of the activities of different stakeholders.
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Governments and institutions worldwide can and do make valuable contributions to efforts aimed at developing and disseminating contraceptive technologies, but support from the United States, the largest single fonder of biomedical research, is important for meaningful progress in the field. Responding to both national and international unmet needs with respect to contraception is a matter of self-interest for the United States, and deploying the nation's intellectual and technical resources to address the problem of fertility control and family planning worldwide helps fulfill the humanitarian responsibility of the United States.
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REFERENCES Global Health Council.
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