Table 1 PDP work on determinants of innovation
From: Product Development Partnerships: Case studies of a new mechanism for health technology innovation
Case Study | R&D | National Markets | International Markets | Manufacture | Regulatory Systems | IP management |
|---|---|---|---|---|---|---|
MMV and Coartem Dispersible | Sponsored clinical trials | Supports training of local health workers and expansion of use of product by new community health worker programs. Engages national policymakers to encourage policy shift in favor of improved child treatment and survival. | Ensure alignment of product with Global Fund, UNICEF and PMI requirements for international procurement. Collaborated with Novartis in international launch and communication activities around product introduction. | Worked with Novartis to plan for production volume | Helped back regulatory pathway for eventual approval in 24 countries. Facilitate country specific regulatory review in key countries in sub-Saharan Africa. | Obtained access commitments from Novartis which have ensured accessible/affordable pricing of product for public sector uptake. |
PATH and JE vaccine | Sponsored surveillance research. Helped set up monitoring and evaluation plan. | Helped establish state-level distribution programs | Arranged international supply of vaccine from China | Obtained agreement for continued manufacture in China | Facilitated review by Indian authorities to obtain approval | Respected China producers rights and obtained agreement for supply at low price |
IVI and cholera vaccine | Undertook clinical trials to evaluate safety and efficacy | Establishing an investment case for cholera vaccine | In progress | Developed new production and quality control methodologies and transferred to Vietnam and India | Obtained licensure in India and Vietnam | Developed know how which was protected to ensure control of product |
IVI and dengue vaccine | Helped two biotech move product from lab to Phase 1 study | Undertook study of potential markets in most endemic countries | Initiated work with international agencies to raise awareness of dengue | Worked with developing country manufacture to establish production | Worked with WHO and national regulatory authorities to develop pathway | Undertook detailed freedom to operate study showing no serious constraints |