Annual Review - Summary Sheet
This Summary Sheet captures the headlines on programme performance, agreed actions and learning
over the course of the review period. It should be attached to all subsequent reviews to build a complete
picture of actions and learning throughout the life of the programme.
Title:
PATH Product Development Programme 2013 to 2018
Programme Value: £16,000,000 + £50k for external
evaluation purposes.
Programme Code: 204139
Start Date:
9 September 2013
Review Date:
August 2014
End Date:
31 March 2018
Summary of Programme Performance
2014
Year
A
Programme Score
High
Risk Rating
Summary of progress and lessons learnt since last review
PATH has made excellent progress during the year and has had a number of significant achievements in
their work to reduce morbidity and mortality from diarrhoea and malaria. The pipeline of new or
advancing drugs/ vaccines remains healthy and there is good reason to expect notable advances (in the
near future) in both the treatment and prevention of diarrhoea and malaria, targeting young children.
This PDP brings three funding streams together; PATH Enteric and Diarrhoeal Diseases (EDD); PATH
Drug Solutions (PDS) and PATH G6PD (G6PD) which resides within the PATH Diagnostic Group (DxG).
Both EDD and PDS (previously known as the Institute for One World Health) received DFID funding
from 2009-14 and the research in this programme follows on from previously funded work.
PATH is on track or has achieved all of its logframe indicators for the reporting period and we fully
expect further progress in the future. There have been positive advances within their portfolio and some
drugs/ vaccines, in the early stages are advancing rapidly towards pre-clinical trials.
By combining the three research streams there are proportionate reductions in management overheads
which frees a greater proportion of the core funding to spend on identifying diagnostic tests and drug/
vaccine development. PATH has a robust governance structure and has a strong commitment to
financial propriety and to tackling fraud and corruption.
Key achievements include:
 The successful Phase 3 efficacy study of the 116E rotavirus vaccine (now known as
ROTAVAC®) in India and the Biologics License Application (BLA), submitted to Indian regulatory
authorities in July 2013. In January 2014, ROTAVAC® was licensed by the Drugs Controller
General of India.
 Advanced development efforts at China National Biotec Group’s (CNBG) Wuhan Institute of
Biological Products (WIBP) of a bovine-human reassortment rotavirus vaccine (BRV) candidate
by conducting preclinical studies, finalising new manufacturing facility designs, preparing clinical
protocols, and improving quality management systems (QMS).
 Completed a phase 1 trial of a novel subunit vaccine candidate against Enterotoxigenic
Escherichia coli (ETEC) given intradermally; the stage-gate review of safety and immunology
Phase1 data resulted in recommendation to advance vaccine to descending-age studies in a
developing country site.
 The initial stages to build a robust pipeline of therapeutic agents, treatments and diagnostics for
treating diarrhoea.
 Established a collaboration with GlaxoSmithKline (GSK) to develop a G6PD point-of-care test to
support the safe launch of tafenoquine.
1

PATH’s advocacy efforts resulted in some significant wins, including exclusion of vaccines
containing the preservative thiomersal from the global environmental treaty on mercury, to protect
access to lifesaving vaccines.
This is the first annual review of this funding round.
Summary of recommendations for the next year
 PDS should report on the work with Applied Strategies to develop tools for portfolio development
and the management of the pipeline in their Funders Annual Report for 2014 and highlight how
the work has informed their portfolio management strategies.
 PATH G6PD should ensure that its market landscape studies to define the market for point of
care diagnostic tests should use standardised methodologies where possible, to allow country by
country comparisons to be made.
 PATH G6PD should ensure it has the appropriate staff (numbers and skills) to enable
negotiations to ensure appropriate march-in rights and licence rights in the agreements with the
different diagnostic companies can be tailored to each partner.
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A. Introduction and Context (1 page)
DevTracker Link to Business Case:
DevTracker Link to Log frame:
http://devtracker.dfid.gov.uk/projects/GB-1204139/documents/
http://devtracker.dfid.gov.uk/projects/GB-1204139/documents/
Outline of the programme
DFID will provide support over the period 2013/14 to 2017/18 to PATH, for Product Development
research to develop new diagnostics, drugs and vaccines for diarrhoea and enteric diseases, and a new
G6PD test for P. vivax malaria treatment to prevent relapse. DFID’s funding will support the development
of the most promising candidates to contribute to the improvement of health in developing countries.
Diarrhoea and malaria are two of the leading causes of severe and life-threatening illness in the poor,
especially in children. Prevention and treatment of diarrhoea have historically received significantly less
attention than in other diseases. Vivax malaria, the predominant form in South Asia, has received much
less attention than P. falciparum malaria.
There are no theoretical reasons that vaccines to prevent several of the major causes of diarrhoea
cannot be developed and deployed, reducing incidence of disease and transmission. Better treatment for
diarrhoea would help reduce mortality; most children who die or are permanently harmed by diarrhoea
do so from dehydration. With better treatment that is available in the periphery patient outcomes should
be significantly improved.
The majority of P. vivax malaria is recurrent malaria (relapse). There are drugs which can prevent these
relapses by killing the dormant forms in the liver, but both the current drug (primaquine) and its
successor (tafenoquine) cause potentially life-threatening haemolysis and anaemia in people who have
the genetic enzyme deficiency G6PD deficiency. There are tests available for this in high-resource
settings, but they require laboratories not available in low-resource settings. Since between 8% and 15%
of people in malaria areas have G6PD deficiency this means the drugs to prevent relapse cannot be
used safely. Getting a cheap near-patient test would be a massive step towards controlling P .vivax
malaria.
There are market failures around the development of new technologies for diseases of poverty. In the
years between 1975 and 2000 only 13 new drugs were registered for use for neglected diseases
(approx. 1% of the total new drugs). With increased investment by Governments, Donors, Philanthropic
Foundations and others, there have been 43 new products registered in the last 10 years with a further
350 in development. These products, including drugs, vaccines and diagnostics for a wide range of
diseases (e.g. malaria, sleeping sickness, visceral leismaniasis, pneumonia, diarrhoea, meningitis,
encephalitis, TB), have the potential to save many hundreds of thousands of lives.
Support to PATH will, in the long term, contribute to the impact goal of reduced poverty through the
improved prevention, diagnosis and treatment of two leading causes of death and illness among the poor
– diarrhoea and malaria. The shorter term, specific outcome will be to take innovative and lifesaving
technologies to scale in low-resource settings.
Expected outputs include:
 WHO prequalification of at least 2 rotavirus vaccines;
 Advancement of bacterial diarrhoea vaccines to Phase 3 trials;
 Industrial partnerships for diarrhoea vaccine manufacturing in emerging economies;
 New oral rehydration therapies for the management of diarrhoea approved and launched
in 3+ countries;
 New therapeutic drugs and diagnostics tools for treatment and diagnosis of leading
causes of childhood diarrhoeal and enteric-causative agents
 New point-of-care tests for G6PD deficiency developed and ready for launch in vivax
malaria endemic countries.
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B: PERFORMANCE AND CONCLUSIONS (1-2 pages)
Annual outcome assessment: A – Outcome met expectation
It is early in the life of the programme but progress during the reporting period, for all outputs, means that
the programme is on track to meet its outcome ‘innovative and lifesaving technologies taken to scale in
low-resource settings’ in the longer-term.
Overall output score and description: A – Outputs met expectation
PATH has made good progress on all three workstreams and in addition to meeting its logframe targets
for the reporting period, is well on it’s way to achieving the longer term outcome. There is a significant
portfolio of drugs and vaccines at various stages of development some of which are showing
encouraging signs of success – particularly in relation to the recent licensure of “ROTAVAC” for use in
India, the initiation of a Phase 3 study of the bovine-human reassortant rotavirus vaccine (BRV)
candidate from Serum Institute of India, Ltd. (SIIL), and advancement of the BRV candidate from Wuhan
Institute of Bilogical Products (WIBP towards clinical studies in China. There has also been increasing
interest in the enteric vaccine development field where by using combination vaccines against diarrhoea
(ETEC and Shigella) could potentially streamline production and reduce production cost.
Different groups of diarrhoeal and enteric pathogens have been assessed by prevalence and health
needs, withtarget pathogens and diagnostic test development needs identified for soil-ransmitted
helminths (STH) and Cryptosporidium. Target Product Profiles (TPP) have been drafted for
Cryptosporidium therapeutics and two partners have been identified to move forward the work for
Cryptosporidium therapeutic development. TPP have been drafted for STH diagnostics.The initial TPPs
were developed using an extensive literature review and consultative meetings with experts.
The programme has collaborated with private sector partners (e.g. GlaxoSmithKline) for point of care
diagnostic tests for G6PD deficiency, in support of a radical cure for malaria with tafenoquine. PATH
DxG have engaged with diagnostic product developers with the intention of having proof-of-prototype
proposals evaluated by an expert scientific advisory committee in mid- 2014. The programme has
defined a regulatory policy for programme investments and engaged with 17 diagnostic companies
involved in developing G6PD diagnostics. They have also established standard operating procedures
for and initiated the generation of a G6PD development specimen panel.
Key lessons
In January 2013 India’s Central Drugs Standard Control Organisation issued new regulations on the
informed consent process and compensation for deaths and injuries in clinical trials. These regulations
created turmoil for implementation of new clinical research projects in India, halting required regulatory
reviews and approvals. PATH has continued to adapt to the new regulations and has a communications
strategy and crisis communications training to address any issues as they arise.
Key actions
PATH should keep DFID advised of any further changes to the clinical trials regulations which might
impact on the commissioned research;
Has the logframe been updated since the last review? No
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C: DETAILED OUTPUT SCORING (1 page per output)
Output Title
Expanded pipeline of effective vaccines and vaccine approaches for rotavirus,
Shigella and ETEC.
Output Score
Output number per LF
1
A
Risk:
High
Impact weighting (%):
30%
Risk revised since last AR?
No
Impact weighting % revised
since last AR?
No
Indicator(s)
Number of Shigella vaccines
ready for Phase 1 Clinical Trials
Milestones
1 Shigella vaccine ready for
Phase 1 in 2014
Progress
Trivalent Shigella whole cell
vaccine delayed from 2014 to
2015, due to technical issues,
Phase 1 trial of 2nd candidate
on schedule for 2015 start.
Number of ETEC vaccines ready
for phase 2 studies in infants and
children.
1 ETEC vaccine ready for Phase
2 in 2014
Number of new partners engaged
for early diarrhoea (Shigella,
ETEC) vaccine development.
1 new partnership agreed by
2014
Number of rotavirus candidates
produced by developing country
manufacturers ready for Phase 1
clinical trials.
1 rotavirus candidate ready for
Phase 1 in 2015
On track,1 candidate progressed
through pipeline as anticipated
and preparing for Phase 2 to
start in 2014.
Signed vaccine development
agreement with CNBG;
Advanced negotiation with
Sanofi Pasteur to collaborate on
development of subunit ETEC
and Shigella vaccine candidates.
Provided technical support in
preclinical development of
WIBP’s BRV candidate and
preparation for clinical studies.
Key Points
PATH EDD is making good progress in developing new vaccines for Shigella, rotavirus and ETEC, and
is on track to meet the milestones, except indicator 1 (where dates have been revised), by the end of
2014, 15 and 16 as highlighted above.
The programme has completed one Phase 3 efficacy study of the Bharat Biotec International Limited
(BBIL) 116E rotovirus vaccine (known as ROTAVAC®) in India and prepared and submitted a licence
application to Indian regulatory authorities. The Drugs Controller General of India granted licensure to
ROTAVAC in January 2014. They have initiated a Phase 3 efficacy trial, of the Serum Institute of India
Ltd’s (SIIL) bovine-human reassortant rotavirus vaccine (BVR) candidate. Finally, they have completed
pre-clinical studies and prepared for clinical trials of the BRV candidate from Wuhan Institute of
Biological Products (WIBP).
A Phase 1 trial with the fimbral tip adhesion protein (CfaE) vaccine candidate for ETEC was completed
and a Phase 2b challenge trial of the vaccine candidate to evaluate protective efficacy is underway.
Plans are underway to develop a protocol for descending-age trial down to six months of age for a
tetravalent inactivated ETEC whole cell vaccine candidate (ETVAX) in collaboration with icddr,b in
Bangladesh. This vaccine is also targeted for a field efficacy trial in adult travelers to Africa in 2015. The
manufacture of a trivalent inactivated Shigella whole cell vaccine candidate to be used in a Phase 1 trial
with US adults has been completed and the process development for a single fusion process of IpaB and
IpaD, conserved Shigella proteins to form DB Fusion Shigella candidate has also been completed.
Summary of responses to issues raised in previous annual reviews (where relevant)
This is the first annual review of this programme cycle.
Recommendations: None at this stage
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Output Title
Number of new diarrhoea therapeutic agents, treatments and diagnostics across the
pipeline.
Output Score
Output number per LF
2
A
Risk:
High
Impact weighting (%):
35%
Risk revised since last AR?
No
Impact weighting % revised
since last AR?
No
Indicator(s)
Number of new therapeutic agents
ready for Phase 1 trials.
Milestones
1 preclinical candidate
selected by 2015
Number of new diagnostics
developed.
1 new diagnostic
developed by 2017
Number of new ORS products
developed.
1 manufacturing
partnership
established by 2015
Progress
A portfolio of potential therapeutic
agents against diarrhoeal causing
organisms is being developed,
including the identification of two
projects for Cryptosporidium.
User and stakeholder needs for STH
diagnostics developed and landscape
analysis for STH and Cryptosporidium
diagnostics are being conducted
Initiated studies on fermentable starch
– ORS and identifying potential
collaborators to manufacture ORS
Key Points
PDS has made significant progress in starting to build a robust pipeline of therapeutic agents, treatments
and diagnostics for treating diarrhoea, completing the early work required to achieve the milestones in
2015 and 2017.
Examples of work conducted during the reporting period include:
 Target Product Profile (TPP) drafted and identified two projects and partners for Cryptosporidium
therapeutics
 Determined needs for Cry5b project and identified partner for next steps
 Health needs of resource poor communities assessed in relation to diarrhoeal pathogens, based on
prevalence and health needs, and the target pathogens for diagnostic test development identified
(soil-transmitted helminths (STH) and Cryptosporodium). Potential technology partners and
stakeholders for product development have been identified
 TPPs developed using an extensive literature review and expert consultative meetings. Case-specific
TPPs for STH created in August 2013 at the Task Force for Global Health meeting. A consultative
meeting for Cryptosporidium was held in November 2013 at the Gates Foundation
 Completed preliminary industry analysis (shortlist of companies established in several regions) to
identify market leaders in over the counter (OTC), gastrointestinal, wellness and consumer health
products
 Generally Regarded as Safe (GRAS) process initiated for two starch ORS products. GRAS dosier
expected in late 2014
Summary of responses to issues raised in previous annual reviews (where relevant)
This is the first annual review of this programme cycle.
Recommendations:
 PDSshould report on the work with Applied Strategies to develop tools for portfolio development
and the management of the pipeline in their Funders Annual Report for 2014 and highlight how
the work has informed their portfolio management strategies.
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Output Title
Number of G6PD POC tests evaluated.
Output number per LF
3
Output Score
A
Risk:
Medium
Impact weighting (%):
35%
Risk revised since last AR?
No
Impact weighting % revised
since last AR?
No
Indicator(s)
Number of G6PD tests field evaluated.
Milestones
3 companies funded for
proof of prototype in
2014
Progress
On target with 6 companies
to submit proof of prototype
in 2014 for funding
decisions to be taken in
2014.
Key Points
The G6PD programme has made very good progress and is on track to exceed the targets set for 2014.
During the reporting period the G6PD Programme expanded its activities, from implementing market
landscape activities and product concept development, to supporting point of care diagnostic
developments. As a result the programme has made a number of new appointments and ensured that
the programme board has members with relevant scientific and technical expertise.
The main achievements during the reporting period included:
 Developed consensus guidelines for the evaluation of G6PD tests for application to malaria
treatment
 Finalised the Target Product Profile (TPP) for G6PD point of care diagnostic tests, with input from
six national malaria programmes from target countries. Developed and published normative
guidelines for evaluation of these tests;
 Initiated a study on market size and demand-forecasting for G6PD diagnostic tests
 Engaged with 17 diagnostic companies
 Announced funding opportunity to diagnostic development companies
 Initiated funding of one diagnostic development project;
 Established standard operating procedures (SOPs) for and initiated generation of G6PD
development specimen panel
Summary of responses to issues raised in previous annual reviews (where relevant)
This is the first annual review of this programme cycle.
Recommendations
 The G6PD diagnostic group should ensure that its market landscape studies to define the market
for point of care diagnostic tests should use standardised methodologies where possible, to allow
country by country comparisons to be made.
 The G6PD diagnostic group should ensure it has the appropriate staff (numbers and skills) to
enable negotiations to ensure appropriate march-in rights and licence rights in the agreements
with the different diagnostic companies can be tailored to each partner.
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D: VALUE FOR MONEY & FINANCIAL PERFORMANCE (1 page)
Key cost drivers and performance
Drug, vaccine and diagnostic development is a very costly process, particularly in the final stages of
development. As new products progress through the pipeline they enter into successively more costly
phases of development. The main drivers are staff time, costs associated with complying with stringent
regulatory standards (including training), costs of delivering health care, and commodities. PATH works
collaboratively (with programmes within PATH, other PDPs and research networks) to develop the
capacity of clinical trial sites, particularly in Sub-Saharan Africa and Asia. This helps to reduce the costs
of running clinical trials. PATH actively tries to manage resources to ensure that there are funds
available to test the most promising products as they are developed. This includes widening partnership
with the private sector in low, middle and high income countries and leveraging of resources, in-kind
contributions and expertise; working with other not-for-profit organisations to share costs wherever
possible.
VfM performance compared to the original VfM proposition in the business case
Funding product development through a PDP such as PATH provides value for money through:
•
Supple organisational structures with small core teams and open research models which
reduce operating costs;
•
The use of a portfolio approach which allows funding to be redistributed if individual projects
are stopped if they do not meet their milestones;
•
Support for the continued development of the most promising candidates: facilitating
opportunities to explore innovative partnerships with private and public sector organisations
(in many different countries including low and middle income) to reduce costs
•
Leveraging contributions from the private sector and/or in-country funds, by fostering country
ownership and encouraging emerging economies to invest in drug development.
•
Developing partnerships with other entities to support joint activities (e.g. clinical trial site
development, development of assays).
Assessment of whether the programme continues to represent value for money
PATH continues to represent value for money as a DFID investment. Throughout product development
PATH use stage gates as decision points for down-selection of a product candidates. Decision trees are
also used to analyse the probability that a candidate will make it to each stage gate. These analyses are
used to ensure that there is a robust portfolio containing candidates with a high probability of becoming
licenced products, mitigating risk and encouraging greater value for money.
In addition to supporting lead candidates, PATH continues to maintain and support the development of a
portfolio of pipeline candidates. These candidates are generally in preclinical and early clinical
development (proof-of-concept), so they require fewer resources than lead candidates. This provides
stable alternative candidates for later-stage development should any of the lead candidates be found to
be ineffective at one of the gate stages.
Quality of financial management
We have worked closely with PATH to agree a payment plan and to ensure that forecasting is accurate
and paid at the point of need. Year 1 payments (2013/14) were paid in line with the Memorandum of
Understanding (MoU). For the current financial year (2014/15) we have recently agreed timing and
amounts to be paid. Disbursement of the first tranche was slightly delayed due to a misunderstanding
over the revision of the MoU, however this has now been resolved and the next payment due in
November 2014 will be on time.
The 2013 approved audited financial statement, including a narrative statement, has been received.
PATH have a robust policy on Fraud, Corruption and Dishonesty and in addition provide protection to
informants through their Whistleblowing policy. No changes were made to these policies in 2013 and no
incidents of fraud or corruption were identified during the past year.
Date of last narrative financial report
Date of last audited annual statement
15/05/2014
15/05/2014
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E: RISK (½ page)
Overall risk rating: High
Overview of programme risk
Product development research is high risk with the potential for new drugs, vaccines, diagnostics to fail
at any stage in the development process, PATH have demonstrated strong results and there is no
reason to suspect this should change. The product development partnership model represents a
mechanism to mitigate the risk associated with the development of products for diseases where there is
little likelihood of pharmaceutical companies recovering drug development costs. PATH's portfolio
approach to product development reduces the overall risk of failure due to the existence of multiple
potential candidates for a single disease in the pipeline.
In common with other PDPs, PATH and its partner organisations have robust mechanisms in place to
manage their development portfolios, drawing on global experts to identify milestones and stop/go
decision points. PATH’s strategy of discovery of new products, while in parallel improving existing
products mitigates the risk that it will fail to identify any further new drugs.
An important risk associated with new product development is that the products developed are not
rapidly approved for use or are not deployed to those people who need them, due to supply chain
constraints, Regulatory delays emanating from new licencing laws in India have impacted on the
initiation of clinical trials of vaccine candidates in the portfolio. In most cases PATH has systems in
place, including an access strategy, to work with the relevant authorities to minimise these risks. In India
however they have had to adopt new approaches to comply with the new regulations.
PATH have a strong governance structure and there is little likelihood of fraud/ corruption. PATH have
appropriate anti-corruption, counter fraud and conflict of interest policies in place and has ensured its
partners have similar robust policies in operation.
Outstanding actions from risk assessment
There are no outstanding actions.
F: COMMERCIAL CONSIDERATIONS (½ page)
Delivery against planned timeframe - Yes
PATH had 17 organisational objectives in 2013 across the three separate units (Enteric and Diarrhoeal
Diseases 7; PDS 6; and Diagnostics Group 4), of which 15 have met or exceeded expectations. The two
exceptions are; “Build evidence base for G6PD testing through demonstration studies” where there has
been no activity and; ORS Objective “Initiate Generally Regarded as Safe (GRAS) declaration for two
starch ORS products”, where the process has been initiated but the GRAS dossier not expected until
late 2014.
Performance of partnership (s)
The DFID-PATH partnership is functioning well and has maintained the strong relations and
communications that were evident during the initial PDP interventions. In addition there is good
coordination within PATH and this has ensured that funding and reporting is consistent across the
organisational units.
Asset monitoring and control
PATH are core funded and therefore DFID does not fund any specific assets through the programme.
PATH does however maintain an appropriate asset register.
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G: CONDITIONALITY (½ page)
Update on partnership principles (if relevant)
DFID provides core funds to PATH. There are no specific conditions attached to this funding.
H: MONITORING & EVALUATION (½ page)
Evidence and evaluation
In 2013, results from post-introduction studies in South Africa, Latin America, Australia, and the United
States added to the growing body of evidence that rotavirus vaccines are highly effective in reducing
rotavirus and all-cause diarrhoea deaths and hospitalizations and their associated healthcare costs.
As of December 2013, 20 GAVI-eligible countries have introduced rotavirus vaccines, increasing the
number of children who can receive the vaccine. PATH has played a key role in assisting developing
countries with decision-making on rotavirus vaccine introduction. Growing demand, particularly in
developing countries, emphasizes the need for a healthy market for rotavirus vaccines and underscores
affordability as an important priority in regions where burden is greatest.
While data from post-marketing surveillance in some countries that are using the current vaccines
indicate the possibility of a small increased risk of intussusception shortly after the first dose, the
documented benefits of vaccination against rotavirus-related disease far exceed any potential risk.
WHO, the US Centers for Disease Control and Prevention, and the European Medicines Agency all
support the continued use of rotavirus vaccines but advise that additional post-marketing surveillance for
intussusception be conducted. These bodies will continue to review new data as it becomes available.
Monitoring progress throughout the review period
The review was carried out by members of the Human Development Team in DFID’s Research and
Evidence Division, with input from other funders of PATH. Members of the review team met with PATH
on a number of occasions over the last year. Most recently during a review meeting in Seattle in April
2014, where discussions covered a range of topics including progress, technical challenges, future
plans, financial and risk management. there was also an open a frank discussion about fund raising and
the need to diversity the funding base.
The DFID funding awarded in 2013 is to three discreet organisational units within PATH. There have
been regular interactions between DFID and PATH to develop a working relationship that fully addresses
DFID and PATH needs from both a technical and a financial perspective. PATH has fully delivered on
their reporting responsibilities and in addition has kept DFID up to date through emails, newsletters and
Press Releases.
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Smart Guide
The Annual Review is part of a continuous process of review and improvement throughout the programme cycle.
At each formal review, the performance and ongoing relevance of the programme are assessed with decisions
taken by the spending team as to whether the programme should continue, be reset or stopped.
The Annual Review includes specific, time-bound recommendations for action, consistent with the key findings.
These actions – which in the case of poor performance will include improvement measures – are elaborated in
further detail in delivery plans. Teams should refer to the Smart Rules quality standards for annual reviews.
The Annual Review assesses and rates outputs using the following rating scale. ARIES and the separate
programme scoring calculation sheet will calculate the overall output score taking account of the weightings and
individual outputs scores
Description
Outputs substantially exceeded expectation
Outputs moderately exceeded expectation
Outputs met expectation
Outputs moderately did not meet expectation
Outputs substantially did not meet expectation
Scale
A++
A+
A
B
C
Teams should refer to the considerations below as a guide to completing the annual review template.
Summary Sheet
Complete the summary sheet with highlights of progress, lessons learnt and action on previous recommendations
Introduction and Context
Briefly outline the programme, expected results and contribution to the overall Operational Plan and DFID’s
international development objectives (including corporate results targets). Where the context supporting the
intervention has changed from that outlined in the original programme documents explain what this will mean for
UK support
B: Performance and conclusions
Annual Outcome Assessment
Brief assessment of whether we expect to achieve the outcome by the end of the programme
Overall Output Score and Description
Progress against the milestones and results achieved that were expected as at the time of this review.
Key lessons
Any key lessons you and your partners have learned from this programme
Have assumptions changed since design? Would you do differently if re-designing this programme?
How will you and your partners share the lessons learned more widely in your team, across DFID and externally
Key actions
Any further information on actions (not covered in Summary Sheet) including timelines for completion and team
member responsible
Has the logframe been updated since the last review? What/if any are the key changes and what does this
mean for the programme?
C: Detailed Output Scoring
Output
Set out the Output, Output Score
Score
Smart Guide
i
Enter a rating using the rating scale A++ to C.
Impact Weighting (%)
Enter the %age number which cannot be less than 10%.
The figure here should match the Impact Weight currently shown on the logframe (and which will need to be
entered on ARIES as part of loading the Annual Review for approval).
Revised since last Annual Review (Y/N).
Risk Rating
Risk Rating: Low/Medium/High
Enter Low, Medium or High
The Risk Rating here should match the Risk currently shown on the logframe (and which will need to be entered on
ARIES as part of loading the Annual Review for approval).
Where the Risk for this Output been revised since the last review (or since inception, if this is the first review) or if
the review identifies that it needs revision explain why, referring to section B Risk Assessment
Key points
Summary of response to programme issues raised in previous annual reviews (where relevant)
Recommendations
Repeat above for each Output.
D Value for Money and Financial Performance
Key cost drivers and performance
Consider the specific costs and cost drivers identified in the Business Case
Have there been changes from those identified in previous reviews or at programme approval. If so, why?
VfM performance compared to the original VfM proposition in the business case? Performance against vfm
measures and any trigger points that were identified to track through the programme
Assessment of whether the programme continues to represent value for money?
Overall view on whether the programme is good value for money. If not, why, and what actions need to be taken?
Quality of Financial Management
Consider our best estimate of future costs against the current approved budget and forecasting profile
Have narrative and financial reporting requirements been adhered to. Include details of last report
Have auditing requirements been met. Include details of last report
E Risk
Output Risk Rating: L/M/H
Enter Low, Medium or High, taken from the overall Output risk score calculated in ARIES
Overview of Programme Risk
What are the changes to the overall risk environment/ context and why?
Review the key risks that affect the successful delivery of the expected results.
Are there any different or new mitigating actions that will be required to address these risks and whether the
existing mitigating actions are directly addressing the identifiable risks?
Any additional checks and controls are required to ensure that UK funds are not lost, for example to fraud or
corruption.
Outstanding actions from risk assessment
Describe outstanding actions from Due Diligence/ Fiduciary Risk Assessment/ Programme risk matrix
Describe follow up actions from departmental anti-corruption strategies to which Business Case assumptions and
risk tolerances stand
F: Commercial Considerations
Delivery against planned timeframe. Y/N
Compare actual progress against the approved timescales in the Business Case. If timescales are off track
provide an explanation including what this means for the cost of the programme and any remedial action.
Performance of partnership
How well are formal partnerships/ contracts working
Are we learning and applying lessons from partner experience
How could DFID be a more effective partner
Smart Guide
ii
Asset monitoring and control
Level of confidence in the management of programme assets, including information any monitoring or spot checks
G: Conditionality
Update on Partnership Principles and specific conditions.
For programmes for where it has been decided (when the programme was approved or at the last Annual Review)
to use the PPs for management and monitoring, provide details on:
a. Were there any concerns about the four Partnership Principles over the past year, including on human
rights?
b. If yes, what were they?
c. Did you notify the government of our concerns?
d. If Yes, what was the government response? Did it take remedial actions? If yes, explain how.
e. If No, was disbursement suspended during the review period? Date suspended (dd/mm/yyyy)
f. What were the consequences?
For all programmes, you should make a judgement on what role, if any, the Partnership Principles should play in
the management and monitoring of the programme going forward. This applies even if when the BC was approved
for this programme the PPs were not intended to play a role. Your decision may depend on the extent to which the
delivery mechanism used by the programme works with the partner government and uses their systems.
H: Monitoring and Evaluation
Evidence and evaluation
Changes in evidence and implications for the programme
Where an evaluation is planned what progress has been made
How is the Theory of Change and the assumptions used in the programme design working out in practice in this
programme? Are modifications to the programme design required?
Is there any new evidence available which challenges the programme design or rationale? How does the evidence
from the implementation of this programme contribute to the wider evidence base? How is evidence disaggregated
by sex and age, and by other variables?
Where an evaluation is planned set out what progress has been made.
Monitoring process throughout the review period.
Direct feedback you have had from stakeholders, including beneficiaries
Monitoring activities throughout review period (field visits, reviews, engagement etc)
The Annual Review process
Smart Guide
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