Event photos: Opening Ceremonies

Callistus Ikwunze Ewelike/News Agency of Nigeria (NAN)

Callistus Ikwunze Ewelike/News Agency of Nigeria (NAN)
Report of the break out session. During the plenary session, the rapporteurs of the respective break our session groups, presented their summary reports on the assigned topics for discussion. The main points are summarized below:
Session 1: Is ANDI needed? Will it fill a gap? What are the challenges? What is needed to make it successful?
Is ANDI Needed?
Yes. Presently we are suffering from a Poverty of knowledge and an inability to utilize what we already know to benefit our own people. There is an overreliance on the West and a need to harness our use traditional systems for our benefit. ANDI offers such an opportunity. Yes. Because we need to depart from creating a divide between herbal/traditional medicine and western medicine. ANDI has the potential to provide great public health benefit in Africa by all available means. May or may not be needed depending on the approach we take. Many other networks already exist, even for very specific diseases, however the impact they have made remains to be seen/validated. ANDI will make itself needed or not depending on the way we choose to operate. Some were concerned that ANDI is another WHO initiative owned and controlled by WHO, in which case it would not be needed. This was clarified and the focus placed on the fact that ANDI is being created by Africans for Africans only with support (not necessarily financial) from WHO. ANDI will only become useful/needed when we see ourselves in the right perspective and do not underrate ourselves. We will need to adopt a visionary mentality.
Will ANDI fill a gap?
Gaps do exist but we need to only focus on particular ones and move towards them. Are we going to be funders, virtual organizations etc. Training is a major gap, including the redistribution of expertise. There is a gap in identifying already existing centres in country. A gap in material development. A management gap that ANDI can fill. Many scientists sometimes work on the same things and do not even know, thus wasting already limited resources. Stand-alone work is becoming outmoded and is not encouraged. ANDI can fill the gap in the development of both “herbal compounds” and “pure compounds” possibly simultaneously but at least synergistically.
What are the challenges?
The need to structure ANDI and the choice we will make. Funders, virtual and lean etc, and getting past the friction that might develop from the choice we make. Creation of a system that can make an impact on the global market and health system. Niprisan stood on the shelf for a very long time before an Indian company came by to purchase and market and has now filed with the USA FDA for orphan drug status. Developing the spirit of entrepreneurship and being willing to take calculated risks. Having an up to date database which will be updated regularly in order to facilitate networking and discourage duplication and unhealthy competition. Getting government support for ANDI employing advocacy tools. Standardization of methods across Africa such that there can be effective exchange of ideas and global
recognition.Conflicts of interest between individuals and institutions. Institutional and political commitment.
What do we need to do?
Create an interactive website and database where information and messages can be posted so communication can continue remotely and networking can continue. Secure funding from African governments and other appropriate sources. We might have to rely on goodwill funds to start with. Seeking for good legislative policies in Africa as well as health information policies that will promote ANDI’s objectives. Make use of in-country and expatriate experts, as well as African scientists and other experts in the diasporas to move ANDI forward. We have already started doing this. Make truth in every form; including honesty and integrity our sunum bonum.
Session 2: What should be the scope (diseases and products)? Is capacity available to initiate and implement agreed activities? What are the low-hanging fruits?
What should be the scope (disease and products)?
ANDI activities should be centered on the development of Traditional, natural, synthetic medicines and diagnostics for the management of communicable and non-communicable diseases in Africa, giving priority attention to prevalent and neglected disease.
Is capacity available to initiate and implement agreed activities?
Some levels of capacity is in certain areas of product development, but there is need for a scientific audit to determine precisely the levels adequacy.
What are the low hanging fruits (examples)?
Drugs:
Diagnostics
Session 3: Who are the key stakeholders? Who will fund? What are the important organizational and funding issues and options that need to be addressed?
Key stakeholders:
African-wide groups
Existing/related initiatives
Government Ministries/advocates for policy making/funding
Organizational Structure
Who will fund ANDI?
Plenary session on Next Steps (Chaired by Amb. Dr. Tom Mboya)
Best Poster Awards. The following were given the Best Poster Awards:
Panel discussions. Plenary panel discussions were held to address questions on the following topics:
A. Can products be discovered , developed and registered in Africa? Are there examples?
B. What are the needs and opportunities for ANDI? What are the challenges (including IP management)?
C. How can Africans in Diaspora support ANDI
D. How can other African institutions and governments support ANDI?
E. How can ANDI synergize with other product R&D initiatives?
Break Out Sessions. Participants engaged in lively discussions, debates and brainstorming on several topics (see below) during the break out sessions. The topics discussed by the three groups were as follows:
Questions/Comments:
Responses To Questions/Comments
Issues on Funding: Drug discovery may cost $800m in the US, which is more expensive to invest due to the cost of doing business: It is expected to be much cheaper in Africa as a result of lower wages or cost of labour and maybe the raw materials. Also the ANDI concept of networking and taking advantage of synergies among member states or organizations may help in lowering the cost of innovation. The funding has to start from Africans themselves
Many stakeholders are looking at
Current financing New financing options Sustainable financing for R&D IGWG targets for 2010
Dr. Renganathan
Issues on strategy: The WHO is working on a global strategy and there is no specific document known as an African strategy. But ANDI is the contribution from the African region towards the global strategy on better health through R&D and innovation.
Dr. Renganathan
Issues on intellectual property management (IPR): There are a lot of issues and it must be approached at the technical level which also covers biodiversity. You cannot achieve good management by just talking about it. You have to be involved in it through developing innovation and acquiring your own IPR. The issue is not just IPR itself but in doing the deal — the IPR deal.
Dr. Ridley
Traditional approach to innovation: The traditional approach is also scientific and no one is condemning the traditional approach. There has to be dialogue between the traditional approach and the scientific approach to find a common ground or a mid-point.
One of the challenges of the traditional approaches is in dealing with the micro and macro environmental issues in R&D such as the issues of safety and efficacy, quality and standards.
Dr. Ridley
Issues on cost and viability: The Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV) have developed 5 different portfolios of drug development costing about US $50million a year. Hence drug discovery is not a cheap venture. But through network and synergies, Africans could develop innovation at lower costs — for instance, using a workforce of high skill at a lower cost.
But the question is not just about cost, but whether you can achieve what you said you were going to achieve. If the big pharmaceutical manufacturers are sure about you achieving your goals they will most likely put their money down, but if not, they just do not want to waste their time, not just their money. Hence you have to be very honest on what you can deliver.
Dr. Ridley
Ingredient for successful R&D/innovation: It takes a good and experienced researcher to know the ingredient as itemized by the speaker. A good innovation drive requires transparency, healthy competition, drive for openness, etc.
Dr. Ridley
Building capacity: The issues raised on building R&D capacity in genetic issues, etc, clearly shows that there are capacity gaps in the continent. The South African government recently started to develop a diagnostic facility on a particular disease but soon discovered that there were no adequate samples for it. In other words, the centre has excess capacity and the challenges soon became getting enough capacity for the center to be sustainable. Hence the network of ANDI is expected to bring together areas of limited capacity and merge with areas of excess capacity in order to forge ahead.
Dr. Ridley
Rapporteurs
6th October 2008
(By Dr. E. Renganathan, Executive Secretary on Public Health, Innovation and Intellectual Property (IGWG); WHO, Geneva)
Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)
Background
WHO Commission on Intellectual Property Rights, Innovation and Public Health established 2004. WHO Commission’s report was published in April, 2006. The World Health Assembly (WHA) in May 2006 adopted resolution WHA59.24 requesting the DG to establish an Intergovernmental Working Group (IGWG). IGWG to draw up a global strategy and plan of action that aims at inter-alia, securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries
IGWG Process
First session of the IGWG held in December, 2006. Second session of the IGWG held in November, 2007 and resumed in April, 2008. Follow-up drafting group to finalize strategy at the WHA 61 in May 2008.
Other Related Activities
Member States had additional opportunities to provide further inputs to the negotiating text during the process. Web-based public-hearings held in November, 2006 and August to September, 2007. Regional Consultations held in all regions from August to October, 2007.
Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property
The global strategy is designed to promote innovation, build capacity, improve access and mobilize resources.
Eight elements of the plan of action:
Prioritizing research and development needs Promoting research and development Building and improving innovative capacity Transfer of technology Application and management of intellectual property (IP) Improving delivery and access Ensuring sustainable financing mechanisms Establishing monitoring and reporting systems.
At the 61st World Health Assembly
Member States adopted the global strategy and the agreed parts of the plan of action on public health, innovation and intellectual property (Resolution WHA 61.21) The strategy proposes that WHO play a strategic and central role in the relationship between public health and innovation and IP within its mandates, capacities and constitutional objectives. Member States were urged to adopt and support actively the wider implementation of the global strategy, in particular through providing adequate resources to enhance and implement the specific actions recommended in the global strategy on public health, innovation and intellectual property. Relevant international organizations and other relevant stakeholders were called upon to give priority within their respective mandates and programmes to implementing the global strategy and plan of action on public health, innovation and intellectual property.
Recommended expected outcomes for ANDI
Equitable access to good quality, affordable medicines. Commitment and engagement of governments and other stakeholders. Promotion and sustainability of African led R&D innovation through discovery, development and delivery of affordable new tools, as well as supporting capacity and infrastructure development. Leverage and building of existing activities in Africa. Leadership by African scientists and institutions with clear political support, ownership and involvement of African countries and regional networks.
(By Dr. R. Ridley, Director, Special Programme for Research and Training in Tropical Diseases (TDR); Geneva)
Innovation is the act of bringing about an improvement by introducing something new, such as an idea, product or process. It is applicable to business and technology as well as all areas of life.
Distinction between invention and innovation.
Invention is the first occurrence of an idea for a new product or process Innovation includes carrying it out into practice
Diffusion of innovations is in two folds which include:
Cultural diffusion more like geographical diffusion Process of adaptation and improvement
Innovation for health — can occur at any stage along the value chain of capacity building and knowledge management which may include the following:
New knowledge/discoveries New and improved tools New and improved interventions New and improved strategies
Although ANDI focuses on technological innovation, the whole value chain remains important.
Some examples of innovation for health
Fleming’s discovery of penicillin and its development, production and widespread distribution as a drug. Discovery of the value of oral rehydration therapy and its scaled-up production and availability in endemic and epidemic situations. Concept of community-directed interventions for delivery of ivermectin for river blindness and its validation by experimentation and scaled up implementation.
The new TDR Vision is to foster an effective global research effort on infectious diseases of poverty in which disease endemic countries play a pivotal role. However, for disease endemic countries to play a pivotal role, they must be involved in generating innovation of their own as well as testing the innovations of others.
Countries engaging and succeeding in innovation-driven development include South Korea and Singapore while India, China, Brazil, South Africa and the Gulf states are also making progress. Brazil in the 1990s invested only in R&D with no economic growth. It has recently adopted the two pronged approach of R&D and innovation, and they are beginning to experience some measure of economic growth.
For health, it has to be shown that R&D is not just for discovery but for wealth creation. Innovation has to take into account the different fields of human endeavour and not just any singular discipline in order to succeed. The countries of the north see the cost of innovation as not just a cost but an investment for economic growth.
Some activities and behaviours associated with innovation include:
Experimentation Research and development – The EU Lisbon Strategy has set as a goal that their average expenditure on R&D should be 3 % of GNP
Entrepreneurship Risk taking Persistence
Managing innovation is often complex and reasons for innovation failure are:
External causes
Idea proven invalid or unworkable Change (reduction) in demand and need for the innovation and/or inability to obtain resources for development Superior (competing) innovation developed
Internal causes include poor
Organisation and leadership Goal definition Participation in teams Monitoring of results Knowledge management
Common to both — poor communication
Some observations
Organisation and management can be as important as the idea
Organisational structures can in themselves be innovative
Borrow from others what works well and adapt it to your needs
ANDI concept can lead to innovation ‘potentially’
Some strategic considerations or questions for ANDI are:
Why ANDI now?
What ‘cost-effective’ practices can be used?
Are there opportunities for African innovation to be competitive?
Why ANDI now? Environmental considerations.
There is a new international movement for the initiative through frequent meetings on R&D and innovation. Hence there is a growing international and governmental interest e.g.
There is a growing recognition that capacity for innovation is a pre-requisite for sustainable economic development
The capacity and critical mass for R & D is now present in many countries to provide a platform for innovation to move forward.
Cost consideration: some proven practices with low start-up costs are
Public-private partnerships Virtual product discovery and development Venture capital support for biotech start-ups Technology transfer Networks — through network, you can access ’scarce’ expertise and build capacities as well as utilise new information technologies. Hence there is no need for reinventing the will.
Opportunities –- There are opportunities that could help drive innovation in Africa and make African R&D and innovation competitive. For example:
New technologies allow for innovative organizations and networking, e.g. mobile phones; internet. The fact that there are different regional disease burdens and needs of users of innovations. Africans are better placed to develop appropriate tools for African innovation. Markets that are small in the context of developed countries could be meaningful in developing countries. Indigenous knowledge is available and may be useful.
NOTES
– Address regional poverty — associated health issues through innovation
– Build regional capabilities critical for economic development through network
Abuja, Nigeria — African-based researchers and institutions have the capacity to develop new drugs and diagnostic tools for diseases affecting Africans, but are hampered by a lack of coordination and funding to the continent. At the conclusion of the first meeting of the new African Network for Drugs and Diagnostics Innovation (ANDI) in Abuja, Nigeria, participants from 21 countries committed to a network approach to increase the ability of African countries to bring forward new medicines and diagnostics.
The Vice-President of Nigeria, Dr. Goodluck Jonathan, stated that “Nigeria is in full support for ANDI. We understand the pivotal role of R&D to national development”. Nigeria’s minister of health, the chair of the Nigerian senate committee for health, and the minister of state for the federal capital territory of Nigeria, attended.
Communicable diseases such as tuberculosis, HIV and malaria account for about 60% of the mortality and morbidity in Africa. There are pockets of product discovery and development activities in Africa, but no one African country or institution has demonstrated the capacity to move from basic research to the commercialization of a new drug.
His Excellency Tom Mboya-Okeyo, Ambassador of Kenya in Geneva, who led the concluding session, said, “ANDI is a valuable niche in the global strategy”. He was referring to the efforts by the World Health Organization to develop a plan to increase R&D and intellectual property management across the globe.
A new study mapping the R&D capacity and gaps was released at the meeting. Conducted by the Special Programme for Research and Training in Tropical Diseases (TDR), in collaboration with African institutions, it concluded that there is enough capacity on the continent to build from, with significant potential for increasing the number and quality of new tools developed, as well as providing economic development to the countries. It also highlighted the need for a systematic evaluation and validation of the biological activities of traditional medicines.
This initial report of the 4 UN organizations sponsoring TDR (UNICEF, UNDP, the World Bank and WHO), along with the commitment from the African countries, will be used to build support and collaboration with health experts, high level national officials, business leaders, international organizations, donors and policy makers. The goal is to develop locally sustainable health research and development, coordinated through an African-based and led organization. TDR Director Robert Ridley said, “ANDI will help connect people and give African scientists the opportunities to lead and manage this research and development. We believe that this approach will lead to long-term sustainability and success”.
The full report and more detailed coverage on the meeting is available online at www.who.int/tdr/svc/research/lead-discovery-drugs.
Day 1
Opening Ceremony
The meeting was opened by the Vice-President of Nigeria, Dr. Goodluck Jonathan, the chairperson for this launch, and who was represented by the Minister of State for the Federal Capital Territory of Nigeria, Senator J.J. Akpan Uduodehe. The Vice President, on-behalf of the Federal Republic of Nigeria, pledged to host and provide infrastructure for ANDI in Abuja Nigeria. The meeting was attended by over 200 participants - scientists, policy makers, donors and business leaders - from 21 countries (14 countries from the African continent).
Dr. Mohammed Hassan Lawal, who is the Minister of Health and also the Minister of Labour and Productivity of Nigeria and Mrs. Grace Ekpiwhre, the Minister of Science and Technology, also graced the occasion. Other dignitaries who attended the opening ceremonies included the Senate Committee Chairperson for Health Dr. Iyabo Obasanjo Bello, the WHO representative in Nigeria Dr. Peter Eriki, and the Chairman of the Independent National Electoral Commission of Nigeria, Prof. Maurice Iwu who attended the meeting in his personal capacity. Dr Uford Inyang, Director General of the National Institute for Pharmaceutical Research and Development (NIPRD) and also chair of the local organizing committee, welcomed the participants and other invitees to Nigeria, and presented a goodwill message to set the tone for the meeting. Dr. Alicia Greenidge, Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, lauded African’s involvement in the IGWG (Intergovernmental Working Group on Public Health, Innovation and Intellectual Property) process, and lent its support for ANDI, expressing a willingness of the IFPMA to work with ANDI to develop high quality drugs.
To demonstrate WHO’s high level support for the creation of the ANDI, the following were present: Dr. Robert Ridley, WHO/TDR Director, Dr. Elil Renganathan; Executive Secretary of WHO’s Secretariat on Public Health, Innovation and Intellectual Property; Dr. Peter Eriki, WHO Country Representative in Nigeria; and Dr. Solomon Nwaka, Manager of Drug Discovery at WHO/TDR, Geneva.
Dr. Nwaka presented the concept and rationale for the African Network for Drugs and Diagnostics Innovation (ANDI) with the goal to promote and sustain an Africa-led innovation through the discovery, development and delivery of affordable new tools to fight diseases in Africa, including those based on natural products and traditional medicines. This concept was welcomed and recognized by the meeting participants which will support capacity and infrastructural development, leverage existing activities in Africa to establish and manage a robust product R&D portfolio, will have elements of public-private partnerships, will manage IP and explore creative ways to stimulate product innovation in Africa. The product R&D landscape that was developed to support ANDI was presented and applauded as an excellent initial outcome of ANDI. Dr. Ridley talked about TDR’s work and the relevance of ANDI to this. Dr. Renganathan drew the link between the Global Strategy developed by the Intergovernmental working group and the creation of ANDI.
Plenary Session: Short presentations and case studies relevant to the R&D landscape in Africa.
The plenary session started with short presentations made by Dr Robert Ridley, Dr Elil Renganathan and Dr Solomon Nwaka (see Presentations 1-3). These were followed by presentations on several case studies based on going activities in Africa (see Presentations 4-13). The case studies included drug discovery based on synthetic compounds, ongoing projects based on traditional medicines and natural products, and diagnostics registered in Africa. The ensuing discussions centered on funding mechanisms for ANDI, concerns about cost of drug development and its implications, and the molecular/western approach to drug development versus the traditional/holistic approach. Intellectual property management including issues relevant to natural products and traditional medicine were also discussed. The case presentations demonstrated that capacity in Africa for product R&D does exist and that ANDI may help provide the necessary framework that will link stakeholders for a unified agenda on product R&D innovation in the continent. From the discussions, several suggestions/recommendations on how ANDI can contribute arose. They are summarized in the following:
Provide a framework for coordination among African scientists for an integrated and unified R&D agenda Establish a searchable interactive database of scientists, centres and services to facilitate information sharing and communications among partners Identify centres with capacities to scale up available resources, exchange expertise Mobilize African academia/scientists with complementary disciplines to work together in priority R&D areas; may also attract better funding opportunities through ANDI Establish SOPs and accredit laboratories/centres of excellence Establish links with commercial arm to facilitate transition from research to product Evaluation of Traditional Medicine compounds should be limited to accredited laboratories and subject to WHO/ANDI audit Promote and facilitate sustainable investments through governments and other funding institutions ANDI can help with funding advice and the development of local human resources and facilities Develop All-African Clinical NCE candidates Take African Traditional based herbal medicines and remedies to international market Build an effective pre-clinical development platform in the context of an African initiative Facilitate contacts with regional and Western pharmaceutical industries Provide the platform for funding and investment in product R&D in Africa ANDI can be the focal point for funding and investment for R&D in Africa Encourage African governments to invest/support R&D Seek recognition of diagnostics/drugs registration licenses among member states in Africa Promote establishment of venture capitalists that focus on health innovations Promote establishment of centres of excellence and encourage formal and informal networks among African scientists Use convening power of ANDI to link investors to entrepreneurs, provide expertise in entrepreneurship, set up African-based investment fund and guide companies through regulatory acceptance ANDI can provide the opportunity for bringing together African scientists and traditional health practitioners to work for a common goal Can promote a balance in the management of multiple relationships and fair dealings in conflicts Can set the stage for financial sustainability of product R&D activities in Africa
Poster Session
There were 93 posters submitted for presentation to the meeting. The poster session complemented the Case Studies earlier presented during the Plenary Session with specific examples of product R&D capacity in Africa. Areas covered by the posters included natural products, early phase discovery, medicinal chemistry, strategic issues for research and networking, diagnostics and modern drug discovery. The poster session was conducted throughout the meeting with participants vying for the recognition of Best in Poster Award which was announced on the last day of the meeting.
A new initiative – the African Network for Drugs and Diagnostics Innovation (ANDi) – has been launched to promote and sustain African-led research and development in the treatment of diseases, including those based on traditional medicines and natural products. The first meeting of ANDi will be held in Abuja, Nigeria 6-8th October 2008.
The network’s launch follows numerous calls for increased investment in health R&D in Africa. It is envisaged that ANDi will have a secretariat in Africa with a strong element of public-private partnerships. ANDi will also support capacity and infrastructural development.
Many reports from international bodies have stressed the need to promote R&D and economic development in developing countries and for commitment from African governments in support of health research. Many international and philanthropic agencies do support research and capacity building in Africa. However, Africa’s own capacity has not been systematically harnessed. There is also a need for better understanding of the research needed to support informed decision making. This is especially important in the area of health product discovery, development, evaluation and delivery A mapping exercise was therefore been initiated to support and inform an R&D strategy for ANDi to better understand available human and infrastructural capacity. The exercise has involved consultation with many African researchers and scientists, interviews and discussions with scientists and policy makers, as well as literature and internet searches.
Initial data from the mapping exercise suggest that significant gaps in capacity, financing and infrastructure remain. In the area of traditional medicines, a systematic research evaluation and validation of the biological activities of traditional medicines is a gap that needs to be filled. Also needed is coordination of fragmented R&D in Africa activities. Mechanisms to support the management of intellectual property need to be put place.
The first ANDi meeting has the following objectives:
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