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IntraVenous ANtibiotic Compounding Automation

Periodic Reporting for period 1 - IVANCA (IntraVenous ANtibiotic Compounding Automation)

Reporting period: 2015-03-01 to 2015-08-31

The main aim of the IVANCA project was to study the feasibility of manufacturing, sales and marketing of an intravenous (IV) medicine compounding automation system (IV ICON). The IV Icon is the first automated compounding system designed to tackle common problems related to centralised mass batch compounding of IV antibiotics. In particular, the automated process minimises human error, to ensure the quality of the end product and prevent occupational risks related to manual compounding. Its capacity is 2-4 times higher compared to manual compounding and the main competitors. As part of the feasibility study key target markets and an ongoing hospital pilot were examined. In addition, further examination of manufacturing sourcing, user needs and IPR were undertaken.
The feasibility study demonstrated a number of key features of the IV Icon central to its design, development and manufacture. These include:
• The capacity level meets the needs of the mass batch compounding of IV antibiotics;
• The ready-to-use products reconstituted by IV Icon are safe to use and IV Icon can be integrated to the compounding processes of the pharmacies conducted in clean rooms according to Good Manufacturing Practices (GMP);
• There is market demand (and willingness to pay) for IV Icon with a sizeable market already mapped out;
• Production and business operations – to manufacture and market - are scalable; and
• NewIcon has freedom to operate the business in terms of intellectual property rights (IPR).

For the full potential of IV Icon to be exploited a number of key features need to be developed:
• A flexible and reliable product in relation to running parameters, features and structures of the compounding robot, the biosafety cabinet and related ICT system;
• The validation protocol to ensure that installation is conducted according to GMP requirements;
• Maintenance and added value services, such as installation, user training and documentation
• Scale the business operations and production both horizontally in relation to market-reach and vertically in relation to exploiting the manufacturing; and
• Piloting international operations to support the market development by a demonstration and to tailor IV Icon products ready for large scale international business.

These features will be addressed through, inter alia, seeking co-financing from H2020 SME phase 2 instrument.
1. Overview of activity and main results
The IVANCA project had five main objectives:
• Cut production costs and increase supply volume capability of compounded IV medicines.
• Enable centralised, rapid mass batch production of ready-to-use IV antibiotics with long shelf life.
• Increase patient safety by increasing the quality of IV antibiotics and decrease illnesses caused by contaminated or incorrectly compounded IV antibiotics.
• Increase safety and job satisfaction of pharmacy staff while at the same time enabling them to engage in more interesting and higher value-creating tasks.
• Remove remaining obstacles standing in the way of mass-adoption of compounding robots.
These five objectives were delivered through five main tasks:
• Market Study
• Lessons Learned from ongoing University Hospital Pilot
• Initial Manufacturing Sourcing Plan
• User Needs Study
• IPR and Risk Assessment
• Preparation of Feasibility Report (including Business Plan)

A description of the task and main findings are outlined below.
Task 1: Market Study
A market study was conducted to identify and assess target countries in/outside the European Union for IV ICON. Although basic market knowledge already existed more detailed knowledge was required on areas that impacted on investment in health care automation, such as the structure and funding of health care systems, pharmacy structures, existing automation investments, health care labor costs, and national regulation.
Four companies - Corporate Council Ltd. (UK), StepAfterStep A/S (DK), S-Medical and Katkal Oy (the US) – were tasked to deliver the market study for their respective countries (UK, Denmark, Germany and US). As well as collecting information, the UK and Danish sub-contractors organised meetings with potential stakeholders to exchange views on the development of markets and opportunities and with potential end-users and procurers of the IV ICON. Here the CEO and business developers of NewIcon Oy visited hospital pharmacies, compounding centres and procuring organisations in Denmark, UK and United Arab Emirates (selected as preliminary studies suggested that these countries offered business opportunities through other products manufactured and sold by NewIcon Oy). Market information about Poland was got from NewIcon’s distributor, Sanlab. Market information from Iran and China have been collected during CEOs and business developers visits these conutries.
Reports were prepared outlining a number of key recommendations. Building on information from the market studies the IV ICON Basic and an initial version of the improved system, IV ICON twins, were presented at the European Hospital Pharmacies in Hamburg in March 2015.
The country specific studies looked at a number of themes – for example, markets, competition, procurement conditions and user requirements, including expectation for related services and possible obstacles, such as regulatory requirements. The main findings are summarised below.

Denmark
Large and middle sized retail pharmacies have widely adopted storage and retrieval systems. It is estimated that around 30 % of the Danish retail pharmacies have purchased a system. It is likely, that the ownership of the private retail pharmacies will be liberated, and that will decrease the size of pharmacies in near future and thereby, create a need for smaller sized systems.

In the case of hospital pharmacies, automation is just raising its head. Denmark is regarded as one of the strictest countries in the world what comes to regulation towards hospital pharmacies. The same applies in Finland. In addition, the hospital pharmacy structure is very similar. In this sense, these two countries are very much alike. During this feasibility study, all the key persons of IV compounding were contacted by phone and interviewed about their opinions of the product fit in Denmark. In addition, NewIcon personnel visited two organizations that had automati
2. Conclusions and update on the business plan
Recommendations and next steps

The Feasibility Study was done to arrive at an educated go / no-go decision regarding the next steps in the commercialisation and significant scaling-up of IVANCA / IV ICON. The Recommendations concluded from the study and selected next steps are described in the table below.

Recommendations Next steps
1) Markets Study

IV ICON should be target to those countries which fulfill some of the criteria below:
- excellent product fit to existing markets which have competitors present (e.g. UK, US)
- excellent or good enough market fit in evolving markets where IV ICON could be forerunner (e.g. Denmark, Poland, UEA, Iran)
- relatively low user requirements based on regulation and capability to pay (UAE, Poland, Iran, Kuwait)

Utilise early adapters to gain proven data on the efficacy and cost-effectiveness for Commissioners (e.g. UK for NHS).

Utilise selected countries as a global reference (e.g. UK, Denmark).

Utilise the opportunities which are created by

Pay attention how to localize services to gain competition advantage.

Utilize the market opportunities arising from regulatory changes that favors the use of automation and recommends the centralisation on the IV reconstitution process from ward to clean rooms.

Head for excellent product fit by localization of the product in selected, significant market areas (e.g. US, China).
Head for country pilots:
- UK: excellent product fit; utilisation of early adapters for gaining proven data, gaining a global reference
- Denmark: medium product fit; market opportunity that arises from being forerunner in new hospital building projects in 2017
- Poland: excellent product fit; relatively low user needs and forthcoming restrictions in regulation to favor IV ICON
- UAE, Iran: excellent product fit; relatively low user needs, forerunner in the markets, excellent solvency

Conduct selected and focused market studies to identify where IV ICON could be forerunner or where legislation is becoming to favor centralized IV preparation or where the market fit is excellent:
- Eastern and South Europe
- Gulf area

Conduct market studies in countries with huge market potential and expected need for product localization or need for additional regulatory work for educated go / no-go decision:
- US
- China

Positioning IV ICON and highlighting:
- ROI; high volume, small size and lower cost
- Semi-automation; Control on the process

2) Lessons learned

Develop a next generation version of the IV ICON (Basic  Twins) to:
- gain more flexibility for modular product structure
- gain more flexibility for compatible products (vials, syringes)
- gain more capacity for vial production (2x)
- change the way of loading the goods for avoiding false alarms and creating robust work flow
- create a platform to broaden the product family with a system intended for reconstitution of hazardous medicines by patient specific production manner

Produce material related on qualification the system according the GMP to easier the implementation of the system inside the pharmacy processes.

Develop and manufacture pilot version of IV ICON Twins:
- Hardware: 2 arms, loading in trays, cleaning properties
- Software: compounding recipes, IT interface

Develop a modular structure for sales.

Produce a testing system in the manufacturing site for test trials of new products to be compounded for creating added value in customer services.

Produce a layout for GMP documentation for improving after sales services.

Develop the site acceptance test phase (SAT) so that it can be performed faster.
3) Manufacturing and sourcing plan

Develop a modular product structure for:
- manufacturing
- sales
- life cycle planning

Seek vertical scaling from suppliers.

Seek scale of economics by increasing the size of purchases.

Develop added value services and sales to improve the scalability of the product and related business.

Develop a modular struc
Automated Compounding of IV antibiotics