Chair: Ambassador Tom Mboya

The Chair welcomed invitees (TF members, ministers and international organisations) to the breakfast meeting and allowed participants to introduce themselves. He again stressed the importance of ministers to help implement the ANDI board/governance and raise awareness for ANDI. He also made a call for increase of in-country budget allocation to biomedical R&D. Funding can only commence once legal status is finalized and hosting arrangements concluded. A project development team for the AfDB proposal has been identified and these efforts will commence following the 2^nd Stakeholders meeting. The plan will be that this proposal will be presented to the ANDI board once it is constituted.

Presentation on ANDI governance, financials and implementation - Solomon Nwaka.

• Governance (Board)
• Budget expectations
• Nature of Innovation Fund
• Relationship with AfDB

Comments from AfDB representative (Tshinko Ilunga) - AfDB have been looking at two ways to support ANDI 1) help TDR establish ANDI through funds to initiate projects but this is a small funding window (technical assistance funds from country contributions as trust funds to WHO/TDR to help in establishing ANDI). This is available to member states. 2) African Development Fund is a window that is provided directly to countries allocated every 2-3 years. Also a portion allocated to “multinational” funds that could finance specific ANDI projects e.g. infrastructure building, equipment, training etc. Discussion:

• Uganda - ANDI Task Force could be tasked to collect funds directly from countries -this may be the best method of raising initial funds.
• Zambia - Positions on the board and executive director important
• TF member - Need to make clear what benefits are drawn from countries that contribute to the capitation funds => important to articulate value proposition to countries so they can make case to their governments
• TF member - How can interim funding start ahead of capitation fund? Potential to tap existing pools like EDCTP, TDR, etc. and then eventually fees put on all countries for running/capitation
• EDCTP - How will ANDI’s regional hubs link up with the recently proposed regional centers of excellence discussed at the recent WHO Health Ministers meeting Centers of excellence will be encouraged and supported by WHO but not actively created by WHO. ANDI will have overlaps but can also harmonise/synergise with these centers given the focus on drugs and diagnostics - e.g. reinforce, leverage or complement activities in this area. Currently there is no organization with the ability to translate R&D to products in Africa so really no competition with any existing organization.
• Egypt - Can EU take a role in coordinating calls on ANDI? (EU response - no specific calls on ANDI or role in leading coordination but do have regular calls on Africa and can certainly raise discussions pertaining to ANDI)
• EU - EU support of R&D in Africa has calls that are open to all researchers on Africa but cannot be made specific to ANDI or preferential to those supported by ANDI - rules of the call for proposals and evaluation cannot be changed - we are looking at other possibilities of providing support to ANDI
• Egypt - maybe use these EU calls as a way to identify promising projects that are closer to a product
• TF member - think it needs to start with a call for proposals to galvanize and begin operations such that in 18 months ANDI is operational and can sign contracts with investigators. To do so there needs to have a good prospect for several million that could be leveraged with other funders. Believe that initial money should come from Africa. Two approaches - can ask for running funds or overall endowment (10-15 M per country for 5 yrs but not contribute again or several hundreds of thousands per country every year)

“Bright Ideas” Parallel session A: Moderator: Ivan Addae-Mensah

Development, Validation and Application of a New Rapid Semi-Quantitative TLC Assay Method for Antimalarial Drugs Currently in use in Africa Ivan Addae-Mensah, Ghana (addae-mensah.pdf)

Discussions points:

• Automation of the process is in view with the expectation of more funding. At the moment communities are encouraged to use the developed kits.
• What control was used to compare the TLC data? Were TLC and HPLC run simultaneously? Bioequivalence study could be done before reporting to the drug regulatory authority. TLC was to get the possible range, and those that were seemingly complying subjected to the HPLC. Standards from the WHO collaborating centers in Sweden were used. No bioequivalence studies yet.
• What was responsible for the variation in the results from the TLC and HPLC? The ranges for the TLC facilitated a good selection for the range to be used for the HPLC. There was not very much variation.
• The spray reagents used was anisaldehyde in methanol and WHO protocol was used for the HPLC. The method used was not subjective, rather, it is a simplified method to detect fake drugs.

Discovery of specific plasmodium enoyl-ACP reductase and dihydrofolate reductase inhibitors from Sudanese medicinal plants and antimalarial candidates: Asaad Khalid, Sudan (asaad.pdf)

Discussions points:

• What percentage of the work was done in Sudan and in the USA? Enzyme is not commercially available; enzyme is received from the USA. The screening is done in Pakistan. Production of the enzyme is envisaged in Sudan.
• Was the toxicity of these compounds measured? Toxicity could be eliminated by emerging techniques so the toxicity would be done but it is not a priority.
• The currently available active components should be developed to finished products instead of continuous screening of more plants. Further studies will continue as well as screening for more active plants.
• Database of the plants have been established in other centres and should not be a priority.
• How good did some of structures presented work? About 70 % activity.
• What was the methodology used to discover the inhibitors? Spectrophotometry.
• What are the genetic differences between the parasite and the host enoyl-ACP reductase? Plasmodium has a different fatty acid synthesis pathway and is not available in the host. Most enzymes are shared with the host pathway but a few specific enzymes are the most potential targest.
• What are the functional groups at the binding site? To be explored.

Recombinant Viral Vectors as Suitable Surrogates for Pilot Antiviral Screening Studies of Medicinal Plants Esimone Charles Okechukwu, Nigeria (esimone.pdf)

Discussion Points:

• Results within days - how is this possible? Cytotoxicity? The assay takes about 36 hours for results to start showing up. The MTT method as well as the stable cell lines expressing luciferase were used for toxicity assay.
• Possible effects transferring these products into oral compounds? The method of formulating these compounds is currently been explored.
• Did you use a microscope to follow gene expression? Human cytomegalovirus (CMV) promoters were used and fluorescence microscopes was used to count GFP positive cells.

Pharmacognostic Standardization of some Herbal Medicines used in Nigeria, Towards Monograph Development Adeola Jegede, Nigeria (jegede.pdf)

Discussion Points:

• Names of plant used to be indicated on the boxes, how do you detect non compliance with the law? All raw samples provided were labeled, but there is no guarantee that these were correct.
• Standardization of raw material and the products, what are the components involved? Enlightenment seminars with traditional healers is envisaged to help the standardization process.
• Endangered species of plants - it is possible to mass propagate plants and so collaboration with NABDA (National Biotechnology Development Agency) Abuja should be sought to develop and mass produce such plants. Regulation at country level is needed and should be enforced. NIPRD is helping to facilitate the development of the products and a clearly transparent procedure is followed to involve the traditional healers.

Antimicrobial and Wound Healing Activities of the Extract of Dissotis Theifolia (Melastomataceae) Stem Formulated in Topical Pharmaceutical Vehicle Damian Chukwu Odimegwu, Nigeria (odimegwu.pdf)

Discussion Points:

• What was the control? Gentamycine cream was used as positive control.
• Was the antifungal activity tested? Were the rats used in the experiments matched for age, sex? Weight, age and sex were standardized.
• Were there any toxicity studies done? This will be done in the near future.
• Negative control was required as well as the positive control. Broth sensitivity testing was required.
• What was the range of bacteria as well as the standardization used? Wide range, the wounds were of particular size about 22 sq mm for all the animals.
• Why the choice of the rare species instead of the common plant in the region? The choice is based on previous work done by the group and the plant is also quite common in the area and generally consumed extensively.

“Bright Ideas” Parallel session B: Moderator: Barthelemy Nyasse

Anticancer antifolates for the treatment of malaria: examples of methothrexate and trimetrexate Alexis Nzila, Kenya (nzila.pdf)

Discussion points

• Were the Phase I studies conducted on children to establish toxicity?

The study sample consisted of 25 adults, Methothrexate (MTX) has been used for a long for the treatment of arthritis in adults and children and its safety has been established.

• Have you reviewed the chemistry of MTX to establish whether there are problems of resistance?

A lot has been done to on the chemistry of MTX, the drug is active against Fansidar resistant strains of P falciparum and it remains active.

Miracidial assay as a simple, inexpensive biological test for sensitivity to Praziquantel (PZQ) using field and laboratory PZQ - susceptible Schistosoma mansoni isolates Abdel Nasser Sabra, Egypt (sabra.pdf)

Discussion points

• What method have you used to assess reversal of resistance to PZQ?

An in vivo model was used to assess resistance at doses 11.5 mg - 200 mg/kg for 5 consecutive days and then sacrificed to establish susceptibility.

Molecular basis of human infectivity of Trypanosoma brucei gambiense: Potential for antisleeping sickness drug discovery Emmanuel Olofu Ogbadoyi, Nigeria (ogbadoyi.pdf)

Discussion points

• Have you compared the sequence of the Serum Resistance associated (SRA) genes available on the Database to see if there are any similarities with respect to Trypanosoma brucei gambiense? There is no need to repeat what has been done already

From the laboratory to a patent to a product: A success story from KEMRI Sophia Matu, Kenya (matu.pdf)

Discussion points

• Have you established toxicity of Tbcide?

Tbcide is used as disinfectant for use by laboratory workers to curb the risk of infection with Tuberculosis, appropriate concentrations and exposure time were confirmed to ensure effectiveness as well as establish side effects.

Industrial preclinical drug absorption, distribution, metabolism & excretion (ADME) and Pharmacokinetics (PK) for lead discovery and lead optimization Collen Masimirembwa, Zimbabwe (masimirembwa.pdf)

Discussion points

• You mentioned testing plant compounds at your facility, what are the costs?

You can send a few compounds and the facility can test them for free. However, providing for research supplies such as recombinant enzymes and reagents can be very costly. Therefore, testing of compounds will depend on the availability of funds

• The risk associated with unsafe products has been clearly reflected in one of your slides. There have been studies conducted, which involved a number of withdrawn products from the market, most of these were cold preparations, slimming agents, etc. From this study it is clear that there has been one key enzyme identified, Cytochrome P450 (CYP450) which has contributed significantly to major drug safety problem. The work you are doing is important as it will lead to safer products. Other similar offending enzymes should be identified. There are other related initiatives targeting genes, pharmacogenetics as well as pharmacogenomics that will also contribute to safety

CYP450 is the basis for selection of compounds that are tested at the facility. I also have a poster that looks at tools to support drug/ diagnostic discovery, development and optimal use of medicines with the hope to address the influence of genetics on the response to therapeutics.

Aptamer and nanotechnology based approaches for active targeted drug delivery of anti-TB drugs Boitumelo Semete, South Africa (semete.pdf)

Discussion points

• Have you considered assessing acute toxicity of the nano particles?

To establish toxicity of the nano material, histopathology assays were carried out. There are reference points available for industrial nano particles such as silica but none available for nano particles we are currently using

• It would be interesting to see interaction of nano particles with the cells in the brain since you have established that the nano particles do cross the blood - brain barrier

Post session, the judges suggested that for the next meeting, consideration be given to having two categories for the contests, namely Junior and Senior Scientist level to motivate younger scientists. Winners of best oral (Bright Ideas) and poster presentations are listed below.

Plenary Sessions 4 & 5: Moderators: Sanaa Botros and Alex Ochem

Public-Private Partnerships, Regional Industry Focused Presentations – R&D Case Studies

Strengthening Capacity, Collaboration and Quality of Clinical Research in Africa: EDCTP Networks of Excellence - Michael Makanga (1_makanga.pdf)

Contributions and questions from participants:

1. Nigeria: How EDCTP can promote ANDI by making participation in ANDI a requirement/advantage for support from EDCTP. The major beneficiary of EDCTP is African scientists; 63% of EDCTP projects are by African PIs.
2. http://www.edctp.org/ is the website where all information on EDCTP is available.
3. Unequal distribution of projects with most in East Africa and only 10 in Central Africa. Calls are made and scientists respond. More coming from East Africa and of higher quality. EDCTP is engaging in capacity building to enable more competitive bidding.
4. University of Nairobi, Kenya: Need for skills in ethics and proposal writing or else IRBs will be burdened with low quality proposals. EDCTP has a multidisciplinary approach to clinical trials and so addresses all aspects. They leave applicants to identify where their gaps are to include various training components as deemed necessary. EDCTP currently running a project in collaboration with COHRED on mapping IRB capacity on a country-by-country basis in Africa utilizing a Wikipedia approach. Information will be freely available on the EDCTP website.

South African industry overview from Department of Trade and Industry - Anthony Mbewu (on behalf of Andre Kudlinski - 2_kudlinski_mbewu.pdf)

Contributions and questions from participants:

1. Diaspora: Wanted to know why Fansidar imports were significantly large. The response to this was not available since Dr. Mbewu was presenting for the director and so had no further details available on this.
2. Nigeria: Increase in pharmaceutical imports into South Africa over the past 15 years is worrisome. Also wanted to know how many APIs are produced in South Africa. The number of pharmaceutical companies closed down in South Africa each year is an issue of concern. Not many APIs are produced in SA; the specific number is not known. About 37 companies close down in South Africa not on account of GMP issues but based on decisions by multinationals to consolidate their operations.
3. Nigeria: How examples from India and China can be replicated in South Africa and the rest of Africa by ANDI. India and China were not signatories to the WTO agreements and so were not bound by them. Brazil is a large economy and so was able to flout WTO agreements and not get into trade wars that would severely damage their economies unlike South Africa. Brain re-gain was recommended as a means to achieve the status of India and China by making incentives available to Africans in the diaspora who wish to return to build capacity in Africa.

Prioritization of Drug Targets – The TDR Targets Database - Fernan Aguero (3-aguero.pdf)

Contributions and questions from participants:

1. Does the TDR targets database integrate other sources of information relevant to drug discovery? This TDR database does integrate other sources of information relevant to drug discovery and TDR targets makes it possible for users to ask questions and make more refined searches online.
2. Support to ANDI for docking studies. This is not offered by the TDR targets database but others in Argentina can offer this support.
3. Suggestion of a possible upgrade to an “ANDIpedia” kind of database which users can edit and include comments. TDR targets receive user information in a moderated fashion in order to avoid scams. A survey is also available for users to provide new information which will be published online.

Coordination Rationalization and integration of antimalarial drug discovery & development Initiatives (CRIMALDDI) – Steve Ward (4_crimalddi.pdf)

Contributions and questions from participants:

1. Website is up and active

http://www.crimalddi.org/. Concern about any overlap in work being done regarding antimalarials. Issues regarding various stages of work on potential antimalarials is best addressed by MMV.

2. How CRIMALDDI can help scientists. CRIMALDDI will not necessarily be funding projects but will only be coordinating existing efforts; expected to last for 24 months.

An introduction to the ICGEB - Iqbal Parker

• 75 member countries
• 3 components worldwide: Trieste, Italy; New Delhi, India; Cape-Town, South Africa
• 3-year funded projects available to researchers in member countries by competitive bid
• Doctoral and post doctoral training with returnees grants
• Organizing of meetings and training courses
• Technology transfer such as e-poetin, interferons etc available to any company and industry in member countries/li>
• ICGEB can collaborate with ANDI by training of scientists, capacity building activities and pursuing of projects in collaboration with ANDI

Plenary Session 6: Meeting Summary. Moderator: Rob Ridley

Presentation of meeting summary and conclusions was provided by Dr Tshinko Ilunga, who described the meeting as fruitful with exciting contributions throughout (meeting_summary.pdf).

Day 1: Ministers of Health, Science & Technology and other agencies pledge their support towards ANDI. The Minister for Science & Technology, Ms Naledi Pandor gave a keynote address.

Day 2: Presentation of the Strategic Business Plan and discussion on issues related to the ANDI stakeholders. Most notably the Plan was formally adopted and the draft resolution passed. This was followed by a high level roundtable discussion with the ministers who wholeheartedly gave support to ANDI and suggested broader engagement with other African ministers.

Day 3: on the concluding day, discussions continued at the Funders Forum and technical presentations were given during the parallel sessions (Bright Ideas) to demonstrate the level of capacity on the continent. Additional presentations were provided by representatives from Public private partnerships and regional industry.

CSIR, South Africa: When will ANDI project funds be available? Depending on availability, this could be possible by early 2010.

U Ghana, Ghana: A full list of representative countries should be included in the final report, to reflect the strength of ANDI.

National Centre of Research, Sudan: What will TDR do after ANDI is established? TDR will continue to give full support to ANDI.

Olabisi Onabanjo U, Nigeria: What will happened at country level in advocacy for ANDI? The establishment of hubs will be quick and they will be responsible for providing a structural framework in which the country level advocacy will be done.

The moderator thanked the ministers that attended the program and also other invitees for their invaluable contributions.

Prof. Mbewu concluded the meeting by stating that ANDI is part of a rebirth in Africa for medical research. Being the birthplace of medicine and medical sciences, the continent must not be left behind in the new wave of biorevolution.

Rapporteurs: Ahmed Adedeji, John H. Amuasi, Raymond De Vre, Foluke Fakorede, Noluntu Funani, Doan Hackley, Palmer Netongo and Bernadette Ramirez.

Presentation of the Strategic Business Plan

Anthony Mbewu welcomed Zimbabwe deputy Minister for health Tendai Mombeshora who acknowledged the partnership with WHO to accomplish quite a lot in health related issues such as HIV care, appreciated ANDI as an initiative and pledged financial and political support of his government to ANDI.

Dr Pascal Mocumbi, EDCTP high representative heralded the role of the EDCTP, with its four regional Networks of excellence ready to work with the capacity that ANDI will be developing.

Ambassador Tom Mboya, Chair of the ANDI Task Force made an introductory presentation of the Strategic and Business Plan (SBP) to ANDI Stakeholders and called on the members of the ANDI task force that helped to develop the ANDI SBP to do self introductions. The objectives of the second ANDI meeting were presented and the active participation of all participants was sought to critically review the SBP and bring up any concerns before the SBP is adopted - paving the way for its implementation. Regional mobilization plans to get all the political leaders involved in the ANDI agenda, based on the adopted SBP was announced. He elaborated on the wide nature of the consultations that were involved in the elaboration of this SBP with emphasis on the IPR mechanism laid down by ANDI in this SBP. The issue of advocacy was highlighted to ensure proper transfer of ownership of ANDI and recommended that the SBP be widely distributed to the whole African family interested in addressing the health inequalities that exist in Africa. He brought up issues like the high infant mortality rates and reduced life expectancy in Africa to elaborate on the cases of inequalities in Africa (mboya_andi-meeting-objectives.pdf).

Dr. Tshinko Ilunga, Vice-Chair, ANDI Task Force, presented an update of the ANDI Task Force activities (Post-Abuja), summarized the TOR of the Task Force and potential areas of focus from the activities carried out so far since the creation of this ANDI Task force in Dec 2008 (tshinko_task-force-report_cape-town.pdf).

Dr. Precious Matsoso, WHO/PHI presented the Global Strategy and Plan of Action and the potential engagements with ANDI. A background of the task of the global strategy and plan of action in WHO was presented, and links with the ANDI roadmap was established. Four questions that brought about the creation of the global strategy and plan of action on public health innovation and intellectual property were put up as well as the eight key elements of the May 2008 resolution WHA 61.21 that highlighted the important role of ANDI as another landmark. The ANDI family was called upon not to limit funding mobilization to government but to expand to seek social contract with the private sector, trying to tap from their corporate social responsibilities (matsoso_phi.pdf).

Dr. Solomon Nwaka, WHO/TDR provided an overview of the ANDI SBP (which included the following points) nwaka_sbp.pdf:

• Presentation of the ANDI Strategy
• Presentation of the Business Plan (SBP)
• Scope of work
• Organizational Structure
• Implementation Plan

Q&A for Clarification

Diaspora (USA): In view of the estimated $1 billion required to bring a drug to market what mechanisms will ANDI put in place to make interventions affordable?

ANDI is clearly aware of this high cost and will engage in cost effective emerging and innovative mechanisms to identify leads so that the cost of the final interventions are affordable for the low income people of Africa.

ISHReCA: Endowment funds could pose particular problems to African governments, the majority of which have a record for failing to maintain contributions.

How will the ANDI fund be any different?

The Task Force will continually remind governments to honour their engagements concerning ANDI and their pledged support.

University of Jos, Nigeria: Can the Task Force assist in identifying country specific plans so that researchers take these priority areas to policy makers. In relation to fundraising - how do we ensure development partners earmark a percentage of their budgets for funds to R&D.

Proper coordination of the regional hubs would be essential and central to understand specific regional needs and potential engagement strategy with countries. However, projects will be highly competitive and specific interest projects will be followed very closely.

CSIR: We have the knowledge, the scientific competence and good will, when will ANDI project funding be available?

After adoption of the SBP the implementation will begin immediately.

Roundtable Discussion Focusing on Technical Aspects and how to Implement the Strategic Business Plan

Introduction: Ambassador Tom Mboya made reference to the draft resolution as capturing the spirit of the ANDI strategy and business plan and encouraged participants to study it. Ambassador Mboya also encouraged participants to study the Global Strategy and Plan of Action and its links with ANDI.

Contributions and questions from Participants:

1. The need to ensure that diagnostics are not relegated in favour of drugs during the project selection process was highlighted by participants from Nigeria and Sudan. Dr. Ridley suggested two possible ways of selecting projects; being disease specific or being open and flexible. It is likely that ANDI will pursue an open approach at present so the quality of projects proposed will determine the research that is conducted. However ANDI will ensure that projects that focus on diagnostics are not neglected. Dr. Ochem reminded the gathering that although in the name ANDI drugs are mentioned before diagnostics, it should not in any way be misconstrued to suggest diagnostics were secondary to drugs.
2. A participant from the diaspora was concerned about how the STAC would be formed and how the review process was going to be handled. Dr. Nwaka made reference to page 34 of the SBP. He intimated that measures had been put in place to ensure the transparency of the review process and that well established processes and procedures would be adopted by the board.
3. The issue of already existing strong networks in Africa attracting partnerships from the North and increasing capacity but having financial problems, was raised by a participant from the National Institute of Medical Research in Tanzania. It was suggested that ANDI consider the integration/involvement of already existing networks into the structure of the proposed regional hubs. Dr. Inyang reminded participants that ANDI was not going to compete with already existing networks. The mapping exercise conducted by ANDI last year demonstrated existing capacity but very little coordination or inter-country collaboration. ANDI will synergize existing efforts to create health products.
4. Prof. Addae-Mensah from Ghana cautioned participants not to allow “this unstoppable Tsunami” to turn around and destroy us. He mentioned the existing poor record that African governments have in making promises and failing and encouraged all participants to be advocates for ANDI in their respective countries. Dr. Ilunga of the African Development Bank reinforced the need for all to serve as ambassadors of ANDI in their countries.
5. A participant from the Kenya Medical Research Institute encouraged ANDI to address potential challenges that might result regarding intellectual property and to ensure that Africa does not lose out. Dr. Nwaka indicated that the second mapping which is incorporated into the SBP, took IP issues into consideration and involved WIPO and the WTO (who will also be providing funding). Reference was made to pages 35 and 36 of the SBP which discuss IP issues.
6. A participant from Sudan suggested that an action plan model of operation developed by experts on specific diseases (such as is done by the European COST initiative) could be adopted by ANDI. Dr. Ridley agreed that this was a good idea which could be implemented later in the life of ANDI. This is also dependent on the funds that will be available for research into specific diseases.
7. Concerns about the potential for neglect of basic research and focusing on compound screening were raised by a participant from NIPRD.  An enquiry was also made into how ANDI would create opportunities for PhDs and Post Docs. Prof. Mbewu made reference to page 25 of the SBP in response and said ANDI would leverage local knowledge on the use of Africa’s rich biodiversity with traditional medicines being a particular strength. Capacity building will be in 3 forms. In specific projects; specific platforms; and mapping and interaction with already existing capacity building projects in order to avoid duplication of efforts. Africans in the diaspora will also be able to contribute to the building of capacity.
8. A participant from the diaspora based in Florida, USA inquired on the criteria for success with which ANDI will be measured and also mentioned the need to address the building of skills and human resource. Dr. Bostros indicated that capacity building will be an integral part of ANDI. Dr. Nwaka made reference to page 54 of the SBP which makes mention of the process of transitioning from one point to another including the termination of projects that might not carry much future value which would in itself be an indication of good work. Other indicators for success suggested by participants included an ANDI peer reviewed journal, publications and patents, and eventual improvement in morbidity and mortality from both communicable and non communicable diseases in Africa. A contributor from the TB Alliance mentioned ANDI’s ability to create a detailed portfolio of drugs and diagnostics as a measure of success.
9. Concerns were raised by a participant from Nigeria about how much the African Union has been brought in to the picture regarding ANDI; considering they have a crucial role to play. Dr. Ochem mentioned that the AU is involved in ANDI by default and re-emphasised the crucial role they have to play. He also reiterated the need to keep pressing home requests for support from African governments.
10. A representative from the European Union stressed the need to identify bottle necks in the entire process running from identification of projects to the development and marketing of drugs and diagnostics. He also mentioned the importance of identifying the innovative aspects of projects that are to be funded given that ANDI is to support innovation. ANDI’s ability to utilize already existing funding mechanisms will also be very important.
11. A representative from the African Development Bank noted ANDI’s heavy reliance on the proposed 600 million dollar endowment fund for success. He stressed the need for more detail on how the creation of this endowment fund will be achieved. Dr. Ridley mentioned the existence of potential one-time donors and annual/periodic donors and emphasized the creation of the endowment fund as being critical to the sustainability of ANDI.
12. The need to address safety of bio-resources in Africa (including genetic) was raised by a participant from Nigeria in addition to the need for harmonization of efforts and not to limit work on a particular project to a particular country.
13. Participants from Nigeria reminded the gathering of the desire of the African people to see the products we claim to be developing on the shelves as well as the need for ANDI to collaborate with NGOs. The need for ANDI to support participants in approaching their governments for support was also raised. Drs. Ochem and Ilunga supported the call for ANDI to focus on putting products on the shelf and indicated that NGOs have been considered and have a place on the ANDI board since they can be instrumental in making the products that are developed available to the people.
14. A participant from Cameroon inquired on how good projects with poor proposals could be identified and helped. Drs. Nwaka and Ridley indicated that best practice would be followed and support offered for good ideas to be presented in good proposals.

Conclusion: Ambassador Tom Mboya proposed the adoption or otherwise of the SBP by the participants of the 2^nd ANDI stakeholders meeting by popular assent, to which a resounding “aye” was heard in response.

Plenary Session 2: Moderator: Dr. Tshinko Ilunga

Institutional Presentations – R&D Case Studies

Health Product R&D in South Africa and at the MRC: Prof. Anthony Mbewu

Presented an introduction of the health research landscape of the Republic of South Africa with the involvement of about 0.95% of the national GDP spent in research with about half of the actual research spending coming from international funding agencies like the NIH and the Wellcome Trust. An overview of the MRC was presented with key performance indicators like a novel vaccine candidate under phase I trial in the USA and Republic of South Africa and an anti TB drug under development in collaboration with Johnson and Johnson (mbewu.pdf).

Questions:

WHO-AFRO: There is currently a lot of capacity in the Republic of South Africa, how is the Republic of South Africa engaging with other countries in the sub region to develop national priorities?

ICGEB: How would ANDI guarantee continental mobilization of personnel? ANDI intends to engage regional hubs to transform “brain drain” to become “brain gain” within the regions. Databases of human resources personnel would be developed to facilitate networking and build science culture within scientists geared towards improving the quality of life of our people.

Walter Sisulu University RSA: Could ANDI benefit for the MRC’s strategy of engaging weaker institutions with stronger ones within the MRC? Research units within post conflict regions are engaged into programs to bring them up to speed. The EU model could be copied by the AU to fund research.

U Buea: With all the money involved in RSA health research funding, that there are no products on the shelves is quite frightening and discouraging to other African countries, what are the spin off companies marketing? Products have not come to the market because of the general lag in health research due to lack of interest at the later stages of the chain. References will be provide to show how much funding has been provided by the private sector. PPP should be an active part in the implementation of the ANDI SBP to get these private partners to come on board.

Product R&D in East Africa, Kenya and KEMRI: Dr. Jennifer Orwa

Presented the mandate of the KEMRI and main research areas. Though no lead compounds have been developed, traditional medicines for malaria are under development. No patent developed but researchers are called to collaborate more while their IP rights are protected. A herbal preparation for Herpes simplex virus is under development. There are quite a lot of challenges for which the KEMRI is looking up to ANDI for strengthening to further develop the unique opportunities the KEMRI offers.

Such as provision of funds for traditional medicine product development, and support for the different stages of the development of products within the KEMRI and establish synergy with the rest of Kenya (mpoke.pdf).

Questions:

Promising herbal preparation for HSP with whole extract, what is the normal way to proceed to the use of this extract in humans?

KEMRI does separations and follows the standardization process. Studies are just to confirm the merits of the traditional medicines. Compounds are developed to be used as markers for laboratory testing.

Addis Ababa University, Ethiopia: in collaboration with DNDI what challenges for leishmaniasis trial in KEMRI. Based on the request from ANDI these questions have been raised not because of much expectation from ANDI but as sign of a home work well done.

NIPRD: How will the existence of ANDI guarantee success of an initiative such as KAVI?

Social scientists and marketers should be in research institutes to be more aggressive.

Collaboration is very difficult within researchers and ANDI should help to forge much collaboration so that ANDI does not fall short of expectations.

How are standards in KEMRI formulated? How can ANDI incorporate standards?

ANDI will engage in best quality standards and practices. Work with WHO and NEPAD to harmonize and set up regulatory agencies for drugs together with partners such as DNDI, NEPAD and the Gates foundation.

R&D Case studies Egypt and North Africa: Prof Maged Al-Sherbiny

With the belief that science and technology is important, harmonizing with the different groups and ministries involved is important.

A newly created Higher Council for Science and Technology composed of 9 ministries chaired by the Prime minister coordinates all research in Egypt. Sets the priorities and structures that are needed for the country’s research as well as remove the barriers for researchers to have their job to be done. A science and development fund ensures that there is funding for research. The Higher Council coordinates the over 360 research centers in Egypt.

With all the technology in Egypt, the country is willing to work carefully with ANDI. Hepatitis C, identified as a priority in Egypt brought about the call from the EU specifically for Hepatitis C. SESAME success was presented as a potential model for ANDI. Challenges include lack of sustained funding, coordination trust in own capacity, module, unorganized access to traditional medicine products. Proposals for how these challenges could be addressed were made and key future directions were provided based on specific country needs (al_sherbiny.pdf).

Questions:

What is the level of resistance to praziquantel . No evidence of praziquantel and Ivermectin resistance, however there is potential for resistance to both drugs.

Hepasa developed in Cameroon and another product developed in Tanzania could be explored by Egypt in collaboration since the burden of hepatitis C is huge and Egypt is very willing to do so.

Drug Discovery in West Africa: The NIPRD Experience: Prof Uford Inyang

Reiterated the poor coordination of R&D within West Africa and poor advocacy for research results. Potential development of home made artemisinin based drugs utilizing extracts from plants grown in Nigeria. Main challenge is power supply and finite resources in R&D with heavy dependency on external funding (inyang.pdf).

Questions: 

National Biotechnology agency, Nigeria: Diagnostics were left out in the presentation and called on ANDI to engage in diagnostics, prevention and drugs.

ISHReCA: Publications in local journals should be encouraged and evaluation of scientist who engage in networking instead of knowledge generation should be encouraged so that more researchers would be willing to engage in this part of science. Mechanisms to position pharmaceutical products and the improvement of the  poor participation of industry in phyto products that will result from ANDI efforts would be enhanced.

NIPRD is collaborating with agronomists to find the most appropriate area in Nigeria to cultivate Artemisia annua. Intellectual Property should be paid attention to when dealing with external collaborators.

Biotechnology in South Africa (Department of Science & Technology). Dr. Theresa Smit:

The National biotechnology strategy was presented with the various institutions involved.

Genetic DNA technology to test phytocompounds is available in RSA. RSA is using genetically modified plants.

Training is needed in areas where capacity is needed. Researchers in RSA are in most parts of Africa and more interaction and engagement is going on with other countries. Biosafety and benefit sharing act is under development (smit.pdf).

Plenary Session 3: Moderator: Prof. Anthony Mbewu

Presentation of the strategic and business plan to African Ministers and Round table discussion focusing on political aspects and how to implement the SBP

Introduction: Dr. Solomon Nwaka presented a brief summary of the SBP to the four ministers gathered.

Short Comments from the Ministers gathered:

Assistant Deputy Minister for Science and Higher Education, Egypt:

• All must work with the vision of ANDI being established in the next year. AMCOST can provide political coverage for ANDI activities.
• ANDI needs to attract the interest of the relevant ministries in African countries.
• The issues surrounding ANDI’s legal status should be looked at closely and addressed.
• Financing: Proposed starting with small fees/levies from countries and later soliciting for monies from donor agencies before moving to the endowment fund.

Minister for Science and Technology, Zambia:

• ANDI is ambitions and needs to be followed expeditiously.
• Need to engage political leadership.
• Science and research is often neglected because of its inherent inability to produce short term results that generate popular support translating into votes.
• Regional blocks e.g. SADEC, ECOWAS, COMESA, OCEAC to appreciate what ANDI is trying to do. Also include the AU in all discussions.
• Appreciated problems of research and science when he was moved to Science and technology ministry.

Minister of State for Health, Uganda:

• Very impressed and will take story of ANDI to Uganda.
• Gave example of the Ugandan President having supported research and innovation by funding a local scientist to extract a molluscicide from a local plant.
• Many resolutions have been signed in the past but little follow-up.
• Africa must adopt a do-it-yourself attitude to certain problems that are unique to the continent.
• Encouraged “any politician worth his name” to take up the mantle and push ANDI.
• Encouraged African governments to take the lead in financing ANDI.
• Suggested ministers of health, technology and finance to meet and discuss these issues especially to harmonize thinking and allow for the release of funds.

Deputy Minister of Health, Zimbabwe:

• Pointed out that every country seems to have some R&D going on, this underlines a fundamental appreciation of the importance of research in Africa.
• Decisions are normally taken by cabinet and thus role of ANDI must be clearly defined to them.
• Advocated for greater inter-ministry communication in country to foster support for ANDI.
• Need to convince universities, NGOs etc so they are aware of the ANDI SBP.
• ANDI to be adopted at the regional level (SADEC, ECOWAS, COMESA) and to be adopted at country level by parliament.
• Need to improve links between researchers and traditional medicine practitioners and ensure that IP is protected.

Comments from participants:

• CSIR, South Africa: More than just money required, but need for peaceful and stable environments to work.
• Olabisi Onabanjo University, Nigeria: ANDI to serve as an annual forum for scientists to voice their concerns and to share ideas.
• WHO representative, South Africa: Need for people in-country to appreciate the importance of research and so be empowered to demand R&D for health just as they do roads etc.
• University of Nigeria: Need for ANDI to acquire political clout through the AU in order to mandate the politicians to act in support of ANDI and health R&D in general.
• NIPRD, Nigeria: Need to have pressure groups to influence politicians such as the American Association for the Advancement of Science.
• TBRI, Egypt: The need to work ANDI into the already existing meetings for ministers of health/science.
• NIPRD, Nigeria: Need to have African governments making contributions to enhance a sense of African ownership.
• TBRI, Egypt: To have the ministers present to serve as advocates in their various regions by providing them with advocacy letters to be written by the Task Force.
• Diaspora: To get the ministers and politicians to view the issues to be addressed by ANDI as national security issues.

Conclusion: Prof. Mbewu closed the day’s session and commended the gathering on their enthusiasm and contribution to the discussions

Rapporteurs: Foluke Fakorede, Palmer Netongo and John Amuasi

A warm welcome to the opening ceremony of the 2^nd Stakeholders Meeting of the African Network for Drugs and Diagnostics Innovation (ANDI), was led by the host Professor Anthony Mbewu of the Medical Research Council, South Africa and also in his capacity as co-chair of the local organizing committee. The following is a summary of the goodwill messages delivered by various invited dignitaries:

Dr Anthony Mbewu – President MRC, South Africa (Co-chair of the local organizing committee)

The need for innovation in African R&D is greater than ever. We cannot depend on the developed countries to provide solutions to diseases that disproportionately affect Africa. There is great optimism for the success of ANDI in addressing these needs.

Ambassador Tom Mboya – Kenya Mission to the UN, Switzerland (Chair ANDI Task Force)

Firstly commended the South African government for the financial support and hosting the 2^nd Stakeholders meeting. ANDI is a movement that brings researchers together to work as a team to develop drugs for neglected tropical diseases killing people in Africa. 40% of Millennium Development Goals target health and ANDI is part of the movement to address these health issues without competing or undermining other efforts. ANDI is complimentary. If ANDI is to succeed, African governments need to support the initiative financially and otherwise. We hope that the Strategic Business Plan developed by the Task Force will be adopted as a road map towards the successful implementation of ANDI.

Dr Stella Anyangwe – WHO representative, South Africa

The beauty of ANDI is that the capacity for R&D will be built in Africa, for Africans and largely by Africans. The 46 country offices of WHO in Africa pledge their support to make ANDI a success.

Ms Precious Matsoso – Director PHI/WHO, Switzerland

ANDI is a step towards the implementation of the Global Strategy and Plan of Action for Public Health, Innovation and Intellectual Property of the World Health Organization. ANDI will create access to medical interventions but there are a few prerequisites to making it work: 1) Responsive regulatory environment, 2) Innovative supportive structures, 3) Social contracts between private and public sectors, and 4) Recognition of constraints in overcoming the financial crisis. ANDI must be at the cutting edge of prevention, but most importantly reduce mortality and morbidity rates in Africa.

Dr Rob Ridley – Director TDR/WHO, Switzerland

This meeting is a follow up to the commitment to the ANDI concept, made in Abuja. ANDI is moving from the technical phase into becoming an organization. The ministerial representation here today shows the commitment from the sectors (Health and Science & Technology) to which ANDI responds. He further solicited for the implementation of the pledge for 1% of the continents GDP to be spent on science and technology and 2% of health budgets on health research which will surely improve the continents health indices.

Dr Peter Atadja – Representative of Africans in the Diaspora

ANDI is a dream come true. If successful, Africans in diaspora who are the initiators of ANDI will have the opportunity to contribute skills acquired elsewhere towards the development of their continent. Innovation in Africa is a matter of national security, and should be treated as such - else the continent will soon be wiped out by the various disease epidemics plaguing us. Africa is said to generate about a trillion dollars GDP, thus a passionate appeal to governments to commit as little as 0.1% to research and development in Africa was made.

Dr Albrecht Jahn - European Union

The European Union shares the global ambition to address neglected tropical diseases in Africa, hence the union is willing to support the success of ANDI.

Dr Tom Hurley – African Development Bank

The African Development Bank has plans to support ANDI financially and has been a part of the Task Force since its inception. As part of its goals to strengthen capacity for research and development will continue to support ANDI.

Dr Maged Al-Sherbiny – Ministry of Science and Higher Education, Egypt

The Ministry of Science and Higher Education pledges the support of the Egyptian Government to provide resources for the implementation of ANDI.  We must commit our support for ANDI in order for our health challenges to be addressed.

Dr Richard Nduhuura – Ministry of Health, Uganda

R&D is the backbone of innovation. The diseases plaguing Africa have been neglected in the past and this has resulted in poor health indices. ANDI is timely as it comes to strengthen R&D, as well as address our health challenges. To achieve this, what is required is strong leadership. The Ugandan government is fully behind ANDI.

Mr Gabriel Namulambe ­– Ministry of Science and Technology, Zambia

No country can develop without strengthening science and technology. Zambia is keen to adopt key development in science and technology. As a minister, he will work to influence the budget to support ANDI. The president of Uganda supports efforts of Africans in the Diaspora and they will support the roadmap for ANDI implementation.

Keynote address: Ms Naledi Pandor –Department of Science and Technology, South Africa

The government of South Africa is committed to R&D so that South Africa is not left wanting. ANDI will be a key contributor to medical progress that will turn fundamental research findings into innovative treatments that are not only available but also accessible to those who need them (particularly on the African continent). Our weakness is the manner in which we develop in isolation and we lack venture capitalists, on the continent that will support products to commercialization. There is an urgent need to ensure a robust research pipeline full of newer, more effective and easier to use medicines. The establishment of ANDI will help us deal with the crisis in R&D for neglected diseases and develop human capital for sustainable development. The Department of Science & Technology supports ANDI and urges the MRC President to hold her accountable to delivering on her promise.

Rapporteurs: Somto Amechi and Foluke Fakorede