Effective pharmaceutical procurement and supply chain management

Effective pharmaceutical procurement and supply chain management
AFRICA PHARMACEUTICAL SUMMIT 2013 Effective pharmaceutical procurement and supply chain management Henk den Besten, Senior Supply Chain Advisor, Partnership for Supply Chain Management (PFSCM) Eric Mallard, Senior Health Specialist, The World Bank Christopher Game, Chief Procurement Officer, The Global Fund to Fight AIDS, Tuberculosis and Malaria Dr. Mark Abani, Country Director, Nigeria, Crown Agents Emmanuel Higenyi, Head, Capacity Development, Joint Medical Stores, Uganda Moderator: Dr. Guy Bertand Njambong, Technical Sales Manager, Africa, Unipex Solutions

The Partnership for Supply Chain Management
Inspiring supply chain innovation for public health August 2013

PFSCM was established in 2005 to bid on the SCMS contract, but our work is expanding
USAID SCMS 2005 Global Fund PPM 2009 UNITAID CPP

PFSCM’s public-private partnership brings the multi-sectoral expertise of non-profit and commercial organizations Unique USG contract promotes flexibility in strategy, structure, people, and processes Focus on best value for global program balanced by country requirements Enables market dynamic procurement decisions Long term master supply contracts enable large volume pooled procurement across countries to achieve lowest landed cost New logistics model tightly integrating global supply chain with country supply chains Pre-position aggregated operating inventory in sustainable regional distribution centers

PEPFAR awarded the Supply Chain Management System (SCMS) project to PFSCM in 2005
President’s mandate: Establish and operate a safe, secure, reliable, and sustainable Supply Chain Management System (SCMS) and develop self-sustaining supply chain skills and capability within the countries 8 million on treatment by 2015 have the drugs they need (not all supplied by SCMS) Ensure patient access to commodities Reduce product and supply chain costs Ensure product quality Elevate value of supply chain to health Health impact: Value proposition:

Why was SCMS needed? Supply Chain Barriers
Poor coordination among governments, funders, aid providers Little long-range planning and forecasting Limited procurement capacity Lengthy procurement cycles Lack of timely order placement Inadequate warehousing and distribution Impact on Treatment Programs Stockouts, overstocks, high product expiry, inappropriate treatments High costs, long lead times, poor quality Unreliable delivery, rationing, treatment interruptions Confusion, redundancies, gaps

Innovative design and a willingness to do things differently enabled our work
The USG’s forward-thinking design established a structure for SCMS that is: Scalable Flexible Robust Cost effective Key USG innovations: USAID working capital fund USFDA approval of generic drugs Country-led programs Unique USG contract promotes flexibility in strategy, structure, people, and processes Focus on best value for global program balanced by country requirements Enables market dynamic procurement decisions Long term master supply contracts enable large volume pooled procurement across countries to achieve lowest landed cost New logistics model tightly integrating global supply chain with country supply chains Pre-position aggregated operating inventory in sustainable regional distribution centers

Going to scale 15,600+ commodity shipments worth $1.51 billion to 57 countries Only $177K loss (0.1%) 1,644 products (128 ARVs) in e-catalog with >4,700 separate products procured over life of project [Clinton] Our regional distribution centers are probably our most significant innovation to date: Two key requirements for our part of the supply chain are: One: It must be much more responsive than anything we’ve seen in the public sector to date, delivering products in days, weeks, or months—not months, quarters, or years. Two: We must not swamp our clients’ supply chains as programs scale up. The way we accomplish both these requirements is by staging commodities through regional distribution centers on their way to the final client. The RDCs effectively separate product supply from individual client demand. This accomplishes several things: Economies of scale – world-class pharmaceutical-grade storage at beneficial rates: Sea and road freight enabled by the RDCs saves the USG millions of dollars on freight costs. One month’s storage of product in an RDC cost approximately 0.25% of the value of the goods – an amount overshadowed by freight savings. Down-stream protection of fragile in-country supply chains: By sending regular, small shipments into host-country supply chains, we avoid overwhelming their infrastructure. We can also combine many different types of products into single shipments to reduce customs clearance efforts. For example, Mozambique originally wanted to airfreight some $20M of ARVs into the Maputo central stores. By pulsing product in from the RDC over an 8-month period, we avoided exceeding their storage and handling capacity, and also saved $500K in freight costs. Rapid response: Delivery lead time for products stocked in our RDCs averages 28 days. Lead times for direct drop delivery from manufacturers can exceed 6 months. We have virtually eliminated stockouts for these products for PEPFAR-supported programs, and have also assisted the Global Fund, CHAI, and others to avoid stockouts in their programs. The RDCs are also a key part of SCMS’s sustainability strategy: all our RDCs are commercial facilities, which can and do serve other customers besides SCMS. We simply pay a per-pallet storage and handling fee, the same as any other client. As independent, commercially viable entities, the RDCs will outlast the SCMS contract, bringing these benefits to everyone who chooses to use them. Using regional distribution centers (RDCs) Smaller, regular shipments to protect local systems Rapid response to emergency and routine requests *Data are for life of project as through October 2012, except as noted

Saving money saves lives
Saved $1.38B over Accelerated Access Initiative prices USFDA approved generics ~90 percent of purchases Saved $119 M in freight costs using sea and road, and RDCs instead of air In South Africa, helped reduce ARV prices by 50 percent, saving USG $93M and the GoSA $630M 68% Reduction As you may know… Uninterrupted supply of ARVs for estimated >2M people – stockouts virtually eliminated Saved $1B on $600M of ARVs delivered $1 billion saved by buying more than 90% generic Helped lower cost of most regimens from $1,500 to $70-$200 per patient per year 29,500 metric tons of products provided to date ($1.1B) 1,500 products (260 ARVs and other pharmaceuticals) in e-catalog; >4,700 separate products procured over life of project Pooled procurement helped decrease prices 68% reduction in average generic ARV prices 30% reduction in male circumcision kit prices SCMS prices at or below all others

Connecting the global and national levels
Building capacity in 22 countries Virtually no stockouts of ARVs or HIV rapid test kits at central level in PEPFAR countries US small business participation: $51.6M* Strengthening local economies Contracts with 650 local firms and vendors * As of March 31, 2013

SCMS uses public- and private-sector best practices to institutionalize sustainable, cost- effective national supply chains Drives down prices for large and small programs through global pooled procurement Strengthens national supply chains, does not create parallel systems SCMS offices in 20 countries work to: Improve infrastructure (e.g., refurbish and equip host-country storage facilities) Improve systems (e.g., automated or manual WMS, ERP, LMIS) Improve human capacity to manage systems Improves infrastructure, including warehousing and distribution Builds systems (e.g., LMIS, forecasting/quantification, automated or manual WMS, ERP) Optimizes laboratory systems (harmonization, maintenance and rational procurement) Enhances quality assurance capacity (e.g., new technologies, waste management)

Building sustainable capacity in national supply chains
See notes page

Urgent response Responsive, flexible systems make us the emergency provider of choice for other donors Delivered $8 M in unplanned orders from October 2012 to March 2013. Helped prevent stockouts in 20 countries in the last year. Haiti In Haiti our robust supply chain helped respond to numerous crises, including hurricanes, an earthquake and cholera outbreak. In Cote d’Ivoire during the worst of the political crisis (see our looted offices in the photos) we coordinated with the Global Fund and USAID to run stock into the country before the worst of the crisis, and then positioned stock at our Ghana RDC for quick delivery after the crisis, helping avoid treatment holidays for patients. Côte d’Ivoire SCMS office/Côte d’Ivoire

Challenges on our way to 2015
Supporting countries to get to 15 million on treatment Supporting USG goal to get to 4.7 million VMMC Working with suppliers to make sure there is enough API and medicines supply Increasing capacity of African suppliers to provide quality-assured commodities Reducing costs of in-country supply chains to maximize treatment numbers Coordinating with global partners to optimize the use of available resources Taking an HIV test is no longer the death sentence it once was. Today, over 3.9 million people are receiving lifesaving treatment through the support of the American people. Through the Global Health Initiative (GHI), USAID, PEPFAR, and CDC are continuing to fight the epidemic.

Can local production help
PFSCM/SCMS uses local production sources to increase access to quality Essential Medicines - Use SRA or WHO PQ’d sources for EM - Apply country specific solutions, PV model in Tanzania, FO managed procurement in Ethiopia - Base the sourcing on a defined (short) list of products - Collaborate with local partners, both government and private PFSCM/SCMS has experience in buying from local producers - Pre qualification of vendors, including GMP and GDP audits - Experience with pharmaceutical products for use in Tanzania, Ethiopia, S Sudan, Cote Ivoire, Rwanda etc - Food products for use in various PEPFAR countries

Drug Procurement and Distribution Challenges
Key procurement aspects are - procurement planning - funding availability - meeting regulatory requirements, including NRA registration - decrease the supply intervals (RDC’s or LDC’s) Distribution challenges - public distribution models, using regional/district stores - distribution up to the last mile Opportunities - increased buying power creates demand up country - use of “ADDO” accredited shop concept as EM outlets

Thank you! Questions? 2012 Finalist

Effective procurement and supply chains
Eric Mallard Africa Pharmaceutical Summit - September 24th 2013

Find the right balance: public/private, monopoly /multiplicity
Government involvement is desired to ensure public health mission Centralized supply chains come with a number of disadvantages (limited incentives for efficiency, high capital and operating costs…) Quality assurance may be easier to manage in monopolistic situations; However, multiplicity in supply systems is desired as a risk-mitigation strategy in case of non-availability of essential products Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Africa Pharmaceutical Summit | Eric Mallard | Sept 2013
No magic bullet, need to adapt to the local situation and to the product features Local situation can determine the most effective supply chain Fragile state (e.g. Zimbabwe) Maturity of the private sector (e.g. Ghana) Country size and geographical features Product characteristics and customer needs can shape the supply chain: Direct delivery system for short shelf-life or high value products Limit redundancy of high CAPEX channels (cold chain) Supply chain segmentation will play an important role in the future Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Managing quality upstream and downstream is key to maintain safety
Procuring from qualified manufacturers and wholesalers Leverage the WHO pre-qualification process Regulatory harmonization initiatives are key to accelerate convergence towards Stringent Regulatory Authorities Opportunity for joint identification, selection and pooled procurement Sampling and testing are required to ensure quality maintenance Risk-based approach to ensure cost-efficiency Investment into a local or regional specialized QC laboratory Mobile minilab opportunity Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Can local production help strengthen weak public distribution networks? Local manufacturing provides an additional incentive to governments to strengthen supply chain: ensuring sustainable local market opportunity for this local industry Aligning supply and demand around a common interest Downstream quality management is facilitated with local production (reduced consignment or recall time) Local manufacturing can be attractive for products with specific characteristics (short shelf-life) It can end up with a win/win situation for the local industry, regulatory bodies and patients (e.g. SCMS in Tanzania) Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Effective procurement and supply chains
Eric Mallard Africa Pharmaceutical Summit - September 24th 2013

Find the right balance: public/private, monopoly /multiplicity…
Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

No magic bullet, need to adapt to the local situation and to the product features Local situation can determine the most effective supply chain Fragile state (e.g. Zimbabwe) Maturity of the private sector (e.g. Ghana) Country size and geographical features (e.g. Chad) Product characteristics and customer needs can shape the supply chain: Direct delivery system for short shelf-life or high value products (e.g. ARV in Angola) Limit redundancy of high CAPEX channels (cold chain) Supply chain segmentation will play an important role in the future Growing importance of defining successful outcomes and assessing cost-effectiveness Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Exploring options for more effective procurement
Procurement breakdown according to the type of product Central for vertical programs (ARVs, malaria, family planning…) Framework contracting for high volume essential medicines procured at the periphery to ensure economies of scale, affordable and high quality medicines (e.g. World Bank and WHO recommendations to Ghana) Performance-based financing as a tool to strengthen accountability World Bank’s Nigeria State Health Investment Project proposes to improve health systems governance at all levels local government authorities (LGA) enter into a performance contract with the State Governor, which includes quality assessment of the drugs States enter into a performance contract with the Federal Government, which includes timely funding release to LGA and LGA performance assessment transparency Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Focusing on the “enablers” to improve public central medical stores efficiency Compe-tition Efficiency CMS Auto-nomy Flexi-bility Incen-tives Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Improving logistics capacity at the district level and optimizing the distribution World Bank-funded pilot supply chain project in Zambia Number of days of stock outs in Q4 2009 Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Managing quality upstream and downstream is key to maintain safety
Procuring from qualified manufacturers and wholesalers Leverage the WHO pre-qualification process Regulatory harmonization initiatives are key to accelerate convergence towards Stringent Regulatory Authorities Opportunity for joint identification, selection and pooled procurement Sampling and testing are required to ensure quality maintenance Risk-based approach to ensure cost-efficiency Investment into a local or regional specialized QC laboratory Mobile minilab opportunity Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

Can local production help strengthen weak public distribution networks? Local manufacturing provides an additional incentive to governments to strengthen supply chain: ensuring sustainable local market opportunity for this local industry Aligning supply and demand around a common interest Major manufacturers develop an integrated distribution business (e.g. Ghana: regional distribution points, mobile vans) Downstream quality management is facilitated with local production (reduced consignment or recall time) Local manufacturing is an asset for products with specific characteristics (short shelf-life) It can end up with a win/win situation for the local industry, regulatory bodies and patients (e.g. SCMS in Tanzania) Africa Pharmaceutical Summit | Eric Mallard | Sept 2013

24 September 2013 Christopher Game Chief Procurement Officer
Effective procurement and supply chains.……. getting the first Mile right, drives the Last Mile 24 September 2013 Christopher Game Chief Procurement Officer

$3Bn What is The Global Fund ? 600 Employees 4.2 Million
4.2 Million People currently receiving ARV therapy 9.7 Million 9.7 Million New smear-positive TB cases detected and treated 310 Million 310 Million Insecticide-treated nets distributed 600 Employees $3Bn Since its inception in 2002, the Global Fund to Fight AIDS, Tuberculosis and Malaria has become the main multilateral funder in global health . It channels 82 percent of the international financing for TB, 50 percent for malaria, and 21 percent of the international financing against AIDS. It also funds health systems strengthening, as inadequate health systems are one of the main obstacles to scaling up interventions to secure better health outcomes for HIV, TB and malaria.

What started as a Procurement Transformation……..
Is directly aligned to the Global Fund’ s strategy and creates a flow into country centric operations……….. The Global Fund will endeavour to become the benchmark organisation in the sector for Sourcing and Procurement Using simple, clear leading edge processes and tools designed by and for the organisation Minimising waste and eliminating non value adding activities With measurable performance in value and lives saved Ensuring effective governance and watertight compliance Building collaborative relationships with partner agencies suppliers and donors

Industry must love us as a sector ?
We are silo’d We are fragmented We are impeded by process / bureaucracy We have poor funds flow Inadequate planning & forecasting Much of what we do is outsourced Regulatory barriers How can we become a customer of choice ? Or perhaps they don’t ? All of these carry a $$$$ premium Risk increases with fragmentation, and we pay for that risk Long lead times reduce system stress at manufacturers

What started as a Procurement Transformation……..
Turned into a process for industrializing thought leadership I soon realised that we are not a customer of choice Many inputs, few outputs Data often out of date and not easily refreshable Slow and operating in silos' That too many are thinking and too few are doing Substantial amount of people feeding at the table Numerous barriers to improvement (agent structures and cash flow) Drugs often mid-late lifecycle Partial aversion or fear of the private sector…… Our behaviors may erode the incentive to innovate Complex regulatory landscape That upstream leverage irons out some downstream supply issues

Working Upstream to improve the Downstream
I am going to illustrate how upstream transformation can drive downstream performance What we soon realised :- Lack of Accountability High Agency Costs Multiple Agencies Incentive model Agency ‘local versus Global’ expertise Poor visibility of lost innovation Lack of ownership / supplier relationships Poor funds flow driving wrong behavior Fragmentation = difficult to plan Little competition in pricing Role of many funders largely executional No volume leverage/Many spot purchases How we responded :- Subscription, (spend under control) driven by transparency and ease of application Leverage with other large funders / donors to become a customer of choice Agency accountability (track & trace) Vendors incentivized to innovate Creation of product market & supply chain experts Ownership of relationships, up and downstream Greatly improved funds flow ? Cash flow Simple user designed processes Comprehensive market intelligence Frequent price competition Scalable and can be leveraged COGS versus Market based costing

So how does this relate to local manufacture ?
It creates the foundation to attract partners We will have scale We will be able to de-couple at various process stages Funds flow will be greatly improved Risk will decrease Relationship will give better access to pipelines Where are our supply chains broken ? We lack accountability – outsourcing can lead to poor partner choice Funds flow breaks the process Track and Trace is sporadic We manage our service providers without rigid deliverables The private sector should be a source of learning and leverage Just as we are partnering upstream we should be partnering downstream to reduce redundancy

1. Fixing the Plumbing first ? Creating the Ecosystem
Upstream partnering facilitating downstream partnering creating the Ecosystem Phase 1 : Creating Partnerships Manufacturers / Logistics Substantial Duplication of Effort Funders Countries

Fixing the Plumbing first ? Creating the Ecosystem
Upstream partnering facilitating downstream partnering creating the Ecosystem Phase 2 : Creating Capacity and Capability Leveraged Funders Leveraged Regulatory Leveraged Quantification Optimized Supply Chains Leveraged Regionally Centre's of excellence Common Accountability for OTIF A Single Ecosystem Manufacturers / Logistics Underscored by common systems and transparency Countries Funders

To Reflect – How does fixing the first mile influence the last mile ?
How upstream transformation can drive downstream performance Phase 1 (Upstream) :- Make the Public Sector a customer of choice for the private sector Leverage funders / buyers Harmonize specifications Improve forecasting View longer term replenishment cycles Improve planning Standardize track & trace Open leverage to smaller buyers +cost of doing business Pay on time Create transparency Phase 2 (Downstream) :- Use savings generated to build country level capacity Take an academic approach to buffering supply chains Harmonize regulatory landscape Create regional centers of excellence building on upstream partner leverage Make logistics partners accountable and KPI to that accountability

How does one de-couple One works backwards of course………. 1 2 3 4 5 6 7
Logical Manufacturing Flow in simple terms Starting Materials Intermediates Advanced Intermediates API Formulation Primary Packaging Secondary Packaging Distribution 1 2 3 4 5 6 7 8 1 Easier Map and leverage supply chains irrespective of source Amalgamate demand Common Regulatory landscape Harmonize identification and recognition platforms Rigid KPI driven track & trace 2 3 Quick route to establishing the basics of a pharma’ plant Easier to qualify Flexible for differing donor or country requirements Allows for regional flexibility Opens up a whole new industry around the manufacture of folding boxes and other materials Implementation Logical next step Builds on experience Allows for smaller batch runs / greater variation when needed Quicker responses 4 The final step of true local industry High complexity Complex 5 High barrier to entry in terms of cost Scale needed Best sourced globally at lowest cost Local Manufacture in simple terms

How do you choose a partner ?
Important questions to ask Generic ? – large portfolio – speed – simplicity – cost Originator ? – slower – integrity – quality – infrastructure - $$$ A mix ? Understanding the reasons behind a partner wanting to enter developing markets How late in lifecycle are the drugs on offer ? Are we extending the market life and restricting new therapies ? How transferred is “Tech-Transfer” ? What is the ownership and profit model What does the pipeline look like, does the partner have the right portfolio How sustainable is the partnership, will excitement turn into complacency ?

Back Up Q&A Place Day Month Year

The Commercial Relationship
To ensure we maintain a competitive price in a longer term contractual framework we will need to change our commercial model.

i-Fund for The Global Fund
Partners Suppliers Knowledge & Collaboration Equipment , Goods and Services team Health Products Team Track & Trace The Support Group GF PSM’s Suppliers Country Ownership & Supply

Effective Procurement and Supply Chains
13/04/2017 Effective Procurement and Supply Chains Dr. Mark Abani, Country Director, Nigeria, Crown Agents

13/04/2017 Effective Procurement and Supply Chains- Transition to Country Owned Systems

13/04/2017 Effective Procurement and Supply Chains- Transition to Country Owned Systems .

13/04/2017 Effective Procurement and Supply Chains- Transition to Country Owned Systems

Discussion Themes APS-23-24 September
Emmanuel Higenyi; B.Pharm, MPH, PgD-Management , Business and Law Studies

Supply Chain definition and Information requirements
This is a system for the flow of materials, information, money, and people: between pharmaceutical scientists, regulatory authorities, manufacturers, distributors and health care providers. Supply chain information requirements include morbidity & demographics, logistics, physical & technical capacity, pharmacovigilance, and pharmacoeconomics.

Supply Chain Activities
Drug Discovery Drug Development Commercial Production Procurement Storage & Distribution Utilization and Review Disease Surveillance

Sources: Reasons: Irregular drug distribution systems Leaky supply chain systems Lack of integrity checks at various levels of the supply chain Scarcity and/or erratic medicines supply High cost of medicines Vested interests both on the part of the regulatory officials and the counterfeiters Weak laws and lack of enforcement of existing laws ignorance or low literacy rates Pervasive poverty Poorly equipped laboratories Underfunded regulatory authorities Poor handling and manufacturing practices

Challenges for the African Pharmaceutical Industry
Supply Chain Activity Challenges Drug discovery Limited scientific infrastructure to facilitate drug discovery Limited linkages between universities and pharmaceutical firms Limited know-how in translational research Drug development Regulatory hindrances on clinical trials for herbal medicines No guidelines on herbal research Commercial production Limited local production infrastructure Shortage of skill in pharmaceutical technology Small markets

Supply Chain Activity Challenges Procurement Storage and distribution Constraints from public procurement and disposal of assets regulations Substandard and Counterfeits drugs Poor inventory management at national and facility Lack of tools for forecasting and supply planning Fragmentation of the procurement process Inadequate technological infrastructure for distribution route planning Transport industry with limited experience in distribution of pharmaceuticals No guidelines on transportation of pharmaceuticals Shortage of personnel with training in supply chain

Supply Chain Activity Challenges Utilization Review and Evaluation Non adherence to treatment guidelines Inadequate collection, processing, analysis and interpretation of supply chain information Lack of monitoring and coordination mechanisms Limited skill in pharmacoeconomic evaluation of drugs Disease surveillance Limited capacity to predict outbreaks Limited data on incidence and prevalence Limited data on drug resistance

Promoting drug discovery
Zimbabwe African Institute of Biomedical Science and Technology Madagascar Madagascar drug discovery project S. Africa Drug Discover Centre E .& C Africa Natural Products Research for Eastern and Central Africa (NAPRECA) Africa Pan-African natural product library (P-ANPL) Uganda Chemotherapeutics research laboratory Madagascar drug discovery project to facilitate scientists collect and dry specimens of medicinal plants identified by traditional healers Drug Discover Centre, to bridge the gap between basic research and clinical studies

Sources

Effectiveness and Efficiency of Supply Chains for safe and quality medicines
Local production to enhance supply chains APS September Emmanuel Higenyi; B.Pharm, MPH, PgD-Management , Business and Law Studies

Supply Chain definition and Information requirements
This is a system for the flow of materials, information, money, and people: between pharmaceutical scientists, regulatory authorities, manufacturers, distributors and health care providers. Supply chain information requirements include morbidity & demographics, logistics, physical & technical capacity, pharmacovigilance, and pharmacoeconomics.

Supply Chain Activities
Drug Discovery Drug Development Commercial Production Procurement Storage & Distribution Utilization and Review Disease Surveillance

Models and formats Programme-based e.g. EMP, MCP, ACP, UNEPI
Product-based e.g. FP, MH Sector-based e.g. PNFP, Public, PFP

Experiences and Lessons
Develop METRICS, measure, monitor, evaluate Start COLLABORATIVE forecasting and replenishment Ensure supply chain SECURITY CLARIFY roles Ensure INVETORY VISIBILITY across the chain Actively perform POST MARKETING surveillance Develop SPECIFICATIONS Remove information ASYMMETRY between levels HARMONIZE clinical and logistical aspects Develop guidelines for TASK SHIFTING in pharmaceutical care

Design or Redesign supply chain
Pull vs push vs hybrid Replenishment intervals Inventory levels Quantifications rules and procedures Monitor, review and evaluate systems LMIS

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