This brief discusses the Council\u27s health technologies development and the product development path from conceptualization to market. It defines the steps in the Critical Path Framework, and examines activities at the preclinical and clinical stage

Brady, Martha

Population Council: Knowledge Commons

Masthead LogoPopulation CouncilKnowledge CommonsHIV and AIDS Social and Behavioral Science Research (SBSR)2011Constructing a critical path for productdevelopment, commercialization, and accessMartha BradyPopulation CouncilFollow this and additional works at: https://knowledgecommons.popcouncil.org/departments_sbsr-hivPart of the Health Services Research Commons, Immune System Diseases Commons,International Public Health Commons, Medicine and Health Commons, Pharmaceutics and DrugDesign Commons, Pharmacy Administration, Policy and Regulation Commons, Virus DiseasesCommons, and the Women's Health CommonsThis Brief is brought to you for free and open access by The Population Council.Recommended CitationBrady, Martha. 2011. "Constructing a critical path for product development, commercialization, and access," brief. New York:Population Council.The critical pathThe focus of the FDA’s Critical Path initiative includes: Assessing safety.•	Demonstrating medical and/or public health utility. •	Industrialization.•	Equally important elements in delivering the product to the user include:Ensuring regulatory approval.•	Establishing licensing and distribution channels.•	Seeding and developing markets.•	Negotiating financing and procurement mechanisms.•	Generating demand among potential users, providers, •	and policymakers.Developing service delivery guidelines and training.•	Creating an enabling policy environment.•	Planning for scaling up.•	The Population Council is an international nonprofit, nongovernmental organization that conducts bio-medical, social science, and public health research on HIV and AIDS; poverty, gender and youth; and reproductive health (RH). Our work cuts across disci-plines, geographies, and the public and private sec-tors. The Population Council develops and tests the effectiveness and acceptability of new and improved health technologies, including contraceptives and microbicides, which are designed to benefit women and men in developing countries. Our work includes user’s perspectives throughout the development and introduction process. In addition, we encourage licensing, registration, manufacturing, and distribution of contraceptive and other RH technologies devel-oped by the Council.Council’s work on product developmentThe Population Council has developed and licensed some of the most widely used long-acting, reversible contraceptives in the world. Our work includes basic research directed toward fundamental understanding of biology and disease processes, providing the foundation for product development, as well as translational research which employs novel techniques and tools in the lab, and innovative approaches in field programs to ensure that our scientific discoveries translate into improving the lives of women and men around the globe.As a product developer we know what is required to take an innovation to a viable product. Product developers must negotiate scientific and technical dimensions along the critical path from innovation to commercial product. Whether work-ing with drugs, devices, or biologics—or some combination thereof—our experience suggests that this pathway encompass-es scientific, technical, programmatic and policy dimensions. Population Council    One Dag Hammerskjold Plaza     New York, New York     10017www.popcouncil.org   ©The Population Council, Inc.   June 2011for more InformATIon, VISIT www.PoPCounCIl.org or ConTACT mArTHA BrADy, mBrADy@PoPCounCIl.orgConSTruCTIng A CrITICAl PATH for ProDuCT DeVeloPmenT, CommerCIAlIZATIon, AnD ACCeSSmartha Brady, Senior AssociateAssessing safety Demonstrating medical and/or public health utilityIndustrialization/manufacturingEnsuring regulatory approval Licensing/distribution,  market    development      Procurement/financingDemandgeneration EnablingpoliciesScalingupBrady, M., Critical Path Framework, ©2011 Population Council.Scientific, technical, Programmatic, and Policy dimenSionS of a critical Pathdimension Definition  Illustrative Activities Assessing safety* Show that the product is adequately safe for each stage of developmentPre-clinical•	Show that product is safe enough for human testing Eliminate products with safety problems  Clinical •	Show that product is safe enough for use in humans  Identify potential issues with labeling Demonstrating  medical and/or  public health utility*Show that the product benefits	people	who	will	eventually use itPre-clinical: Select appropriate design (devices) or •	candidate (drugs) with high probability of effectiveness Clinical•	Show effectiveness in people Evaluate acceptability among users Industrialization/manufacturing*From lab concept or prototype to a reliably manufactured productDesign a high-quality product: physical design, •	characterization,	specificationsDevelop production capacity for:•	Manufacturing scale-up Quality control Transfer of technology Ensuring regulatory approval Approval of product by regulatory authorities (e.g., FDA, EMA, SRAs)Determine regulatory pathway; engage regulatory bodies •	Work with manufacturer to submit dossiers•	Licensing/distribution, market development Establish licensing arrangements Identify suitable licensing and distribution entities •	Conduct market seeding activities•	Strengthen supply chain•	Procurement/ financingMechanism for bulk  purchasing	and	financing	Establish	public	sector	pricing	and	financing	arrangements•	Engage donors around procurement•	Conduct strategic demand forecasting•	Demand generation Transform unmet need into user demandCreate awareness among users, providers, and •	policymakersEngage advocacy, civil society, and women’s groups•	Identify market segments, advertising and pricing strategies•	Document user perspective•	Fostering an enabling policy environmentIncorporate into  international guidelines and national norms Issue WHO guidelines•	Develop country service delivery protocols •	Identify and train providers and key opinion leaders•	Conduct implementation research to identify best ways to •	expand access and improve qualityScaling up Take product to mainstreamPrepare introduction strategy with local stakeholders•	Assess acceptability under routine service conditions•	Conduct implementation research and measure and •	evaluation   

Constructing a critical path for product development, commercialization, and access

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Constructing a critical path for product development, commercialization, and access

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