Global Health Technologies
Creating new health interventions that address unmet needs in the developing world is critical for improving global health. We provide an enabling infrastructure to help our clients design and implement product development programs for drugs and medical devices. We work closely with multidisciplinary teams drawn from both the public and private sector to help clients achieve their development goals. Our experience includes:
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Managing drug/medical device development
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Regulatory strategy (domestic and international)
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Technology assessment and commercialization
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Market/demand assessment
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Research ethics and informed consent
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Strategic and operational planning
Managing Drug/Device Development
We provide demonstrated expertise and achievement in the rapid development of new products for global health. Key elements of our approach to product development include:
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Capacity—staff and facilities with extensive capacity to deliver comprehensive development services
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Regulatory support—creative solutions for working effectively with domestic and international regulatory agencies
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Scientific excellence and quality—unwavering commitment to the scientific and regulatory integrity of the work performed, including quality assurance of work conducted by third-party vendors
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Comprehensive view—thorough analysis of each study's data and consideration of the implications with respect to the larger project and regulatory requirements
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Flexibility—experience to guide effective product strategy in response to unexpected study results
We are supporting the Global Alliance for TB Drug Development (TB Alliance) for development of PA-824, the TB Alliance's first drug candidate for improved treatment of TB. We are assisting the TB Alliance in the integrated planning, implementation, and contract monitoring of studies to advance the compound through preclinical and clinical studies required for regulatory approval. We prepared a successful Investigational New Drug application for PA-824 and serves as the TB Alliance's regulatory contact with the U.S. Food and Drug Administration for the drug.
We are working with the International Partnership for Microbicides (IPM) to investigate the safety and acceptability of innovative vaginal delivery systems that provide HIV prevention drugs to women for weeks or even months. We are investigating the acceptability of other topical microbicides for HIV prevention at clinical trial sites in Malawi and Zimbabwe. The findings will be used for problem-solving of emergent adherence, retention, acceptability, and ethics issues in larger clinical trials. Our staff are also providing broader support for clinical trials, including the following activities:
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Ethnographic studies
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Protocol development
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Ethics review and training
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Clinical trial management
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Data collection and analysis
Read more about our institutional experience and capacity for microbicides research.
Technology Assessment and Commercialization
Technology transfer is the process of developing practical applications from the results of scientific research. For more than 30 years, we have conducted technology and market assessments for government and industry. We coordinated and authored major sections of the 2001 TB Alliance report "Economics of Tuberculosis Drug Development," providing a basis for the public and private sectors to make informed decisions regarding investments in new TB therapeutics.
As part of the National Institute of Allergy and Infectious Diseases' (NIAID) TB Drug Development Program, we are actively facilitating partnerships between biotechnology companies, research labs, foundations, and international organizations to cooperatively develop, test, and introduce new TB therapies. We provide
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Market and pharmacoeconomic data on drugs and medical devices
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Resources and opportunities to find partners to establish public and private collaborations for the development of promising global health products
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Technology evaluation and transfer support
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Regulatory strategy for domestic and international approvals
Ethics and Informed Consent
Clinical research in low and middle-income populations requires additional efforts to ensure trial subjects' ability to freely and effectively decide upon participation in research. Our staff are actively involved in ethics consultation and generation of innovative informed consent approaches for clinical studies in the developing world. We have
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Led the development of an array of materials supporting a comprehensive informed consent process for multiple international studies
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Consulted on development of video materials for international clinical trials
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Contributed to ethics training curricula and conducted ethics training for staff at multiple levels, including researchers, community leaders, and peer recruiters
We have also collaboratively authored six Codes of Practice for DuBiotech, a biotech research park effort in Dubai. We helped establish a set of foundational regulations that will facilitate and regulate biotechnology research at DuBiotech. The Codes of Practice focus on Good Clinical Practices (GCP) and bioethics, including informed consent for human research, formation, and function of independent ethics committees, and responsibilities of investigators and sponsors engaged in clinical research. We are now assisting DuBiotech's implementation of these codes.
