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MESM Capabilities Presentation - SMI-1
- 1. MESM Capability Presentation KateMaughan – Account Management Director sales@MESM.co.uk
- 2. Who are MESM? Exclusiveto the Clinical Trial Industry Global Medical Equipment Solutions Full product lifecycle management Purchase or hire options Working across Global Clinical Trials at all phases Equipment ensures successful Clinical Trial Facilitating your compliance with GCP/Sunshine acts ECG’s CENTRIFUGES INFUSION PUMPS FREEZERS
- 3. Typical Clinical StudyEquipment Examples of MESM Clinical Supply Products ECG’s Purchase or hire REFRIGERATION CENTRIFUGES BP MONITORS DEFIBRILLATORS PATIENT MONITORS EBC EQUIPMENT SPIROMETERS FREEZERS DATALOGGERS BALANCES CAPNOGRAPHS PULSE ORIMETERES WEIGHING SCALES INFUSION PUMPS ULTRASOUND TEMPERATURE MONITORING THERMOMETERS ULTRA LOW TEMPERATURE FREEZERS INCUBATORS SYRINGE PUMPS
- 4. Our Commitment ToEvery Clinical Trial EBC EQUIPMENTECG’s Purchase or hire REFRIGERATION CENTRIFUGES BP MONITORS DEFIBRILLATORS PATIENT MONITORS SPIROMETERS FREEZERS DATALOGGERS BALANCES CAPNOGRAPHS PULSE ORIMETERES WEIGHING SCALES INFUSION PUMPS ULTRASOUND TEMPERATURE MONITORING THERMOMETERS ULTRA LOW TEMPERATURE FREEZERS INCUBATORS SYRINGE PUMPS Providing the right equipment to the right place at the right time
- 5. Advantages of usingMESM • Clinical Supply is MESM’s core competency • Business exclusive and intrinsic to Clinical Trials • Alleviates resourcing issues from Sponsor/CRO/Central Lab • Most efficient way to outsource equipment Clinical Supply Specialists – Increased Efficiency • Equipment can be aligned to Clinical Trial protocols • Laboratory equipment supplied in line with Laboratory Manual • Standard Footprint of high quality equipment used across all clinical trials • Bespoke requests Equipment Consultation Solutions • Quantitative Real Time Diagnostic solutions • Enables Patient decisions to be made real time • Enables studies to be run quicker • Improves patient Recruitment and Retention Innovation • Eliminates need to contract with multiple different companies who provide a smaller range of products • Enables easier traceability and ordering for all products • Single Account Manager deeply involved with your studies Contract with a single vendor for all equipment requirements • Our asset management systems allow you to easily view where you have placed product. • Can also quickly understand which specific sites have which equipment • Can also track, trace and automatically reorder consumables via expiry or usage Greater equipment visibility • Global Technical Support • Calibration Solutions • Extended warranties • End of study collection • Equipment Storage • Refurbishment and Redeployment • Local Sourcing • Total Study Budgeting Global Added value services
- 6. Shift of Localto Global Study at Phase 2/3 resulting in having to work around another countries regulations and logistics in Medical Equipment – Not a sponsor core competency or area of expertise Example of issues moving to Global Study with regards to Medical Equipment – Is importation licence required? Is product approved in all countries involved in study? Have you considered importation tax into country? If Importation Licence is required in country, who will broker the import where possible? If product is not registered for use in country, or cannot be imported due to logistical reasons, who will source and implement a local product solution? Equipment maintenance and certification – Does sponsor have Global and Local solutions implemented ahead of study and equipment usage? What happens if equipment has technical issue on site during trial? Who will calibrate Medical equipment where recommended under GCP? Who is managing records of equipment purchased and installed at site level by sponsor for Clinical Trial use? Who will collect the equipment at the end of the study from the site and who will store/destroy the product? Important considerations under the Sunshine Act. All areas outlined above are part of MESM’s core competencies and areas of expertise. Typical Complexities of Clinical Supply
- 7. Your Clinical Trial Requirements Your Clinical Trial Complexity MESM Understands MESMAdded Value Services Providing Unique Solutions to the Clinical Trial Market 1. I cannot purchase equipment as it needs to be collected at the end of the study 2. My study is 3 years long and the equipment needs to be calibrated each year 3. What happens if my equipment fails during the study? 4. Our Clinical Protocol outlines a product we are unfamiliar with, how can you help? 1. The study is going to be running in countries we are unfamiliar with 2. If we import product into this country, we are going to pay a large amount of importation tax 3. The site staff will not be familiar with the product we need to supply for this clinical trial 4. Some of the items we provide have an expiry date, how can this be managed? MESM Added Value Services 1. MESM will still collect and manage the equipment at the end of the study, even where purchased 2. MESM have a global network of medical engineers who are trained to carry out calibration of medical equipment 3. MESM have a network of Medical Engineers who can attend site to repair equipment 4. MESM have a consultative approach and are experienced in almost all lines of equipment, we are happy to help! MESM Added Value Services 1. MESM have solutions and experience in the majority of countries where Clinical Trials operate, our expertise will certainly be of benefit 2. MESM have a number of local supply options for countries where importation is difficult or import tax is expensive 3. MESM can create bespoke training material for your clinical trial in numerous mediums 4. MESM have an internal asset management system and can resupply clinical sites based on expiry, usage or both. Increased Efficiency
- 8. Important Factors weconsider with all Clinical Trial Supply Product Sourcing Product Knowledge Country Knowledge Import /export Logistics Installation Training Technical Support Service Support Asset Tracking End of Study options Liability risk i i i i i ii i i i i
- 9. ECG BP MONITOR CENTRIFUGE SCALES DATA LOGGERS FREEZER THERMOMETER SYRINGE PUMP REFRIGERATOR FILTERSLINES Do yourequire any other patient monitoring equipment? What are you storing? Blood Do you need to spin the blood down? DrugBlood How is drug administered? Orally Does patient weight affect dose amount? Yes What are you centrifuging? Are these going to be used in drug dose calculation? Infusion How is drug stored? Rev1:RC/13 Key: Outbound Inbound In/Out Consultative Product Relationship MESM Thinking Ahead…
- 10. Experienced Global Logistics ProductLicensing Import/Export Specialists Cold Chain/Consumable Storage Our Specialised Departmental Structure Global Specialist Courier Solutions Supplier/Partner Relations Country Specific Requirements Local/Global Sourcing Options Sourcing And Purchasing Asset management/End Of life options Equipment Installation/Calibration Global Network of qualified Engineers Multilingual Technical Support Service DepartmentSingle Key Contact for all sites Purchase or Hire Asset Tracking Multilingual Account Co-ordination Logistics Department Sales and Account Management Varying Industry Experts working in harmony towards the same shared goal under the MESM umbrella – Providing Global Medical Equipment Supply Excellence Exclusive to Clinical Trials
- 11. Best Practice Partnerships MESMbest practice Mutually agreed MSA •Outlines prices, products, timelines, services, responsibilities etc. •Defines all contractual aspects •Allows uniformed and agreed way of working Forecast upcoming Clinical Studies •Allows us to understand upcoming workload around products required, countries involved. •Enables MESM to correctly resource for Business needs Obtain Clinical Trial Protocols for current and upcoming studies •Allows MESM to fully understand why the equipment is being used, and also identify areas where equipment may be required •Protocol also supported by Laboratory Manual to understand any equipment requirements around Laboratory Type Equipment Mutually agreed CDA •Allows MESM and your company to talk confidently around clinical studies, and be open around other partners involved Assign company dedicated Account Manager •Gives your business a single point of contact who acts as liaison with all individuals involved in study equipment •Account Manager holds close ties with cross functional departments. Escalates and coordinates all activity including shipping, technical support etc. •Escalates any issues into Senior Management as outlined in Communication protocol Hold Bi-Annual Performance Reviews •Review between MESM Senior Management and yourselves •Allows MESM to review their performance from your perspective •Enables us to learn from current way of working, take on-board comments and implement into best practice •Improve moving forward
- 12. Unique Service offeringto Clinical Trials QRTD
- 13. Innovating Clinical Trials– Next Generation MESM also provide Innovative Equipment Solutions around Quantitative Real Time Diagnostics (QRTD) also known as Point of Care (POC) QRTD can change the way Clinical Trials are run, opening up a wealth of benefits and efficiencies to the Clinical Trial Market These solutions are patient focused, whilst expediting Clinical Trials, enabling faster compound to market and an improved level of patient care These Portable Devices, with miniature chemistry reagent systems open up over 50 biomarker solutions that can be measured next to the patient in as little as 2 minutes. QRTD can be applied and used across all disease areas
- 14. What QRTD willbring to you Improved Patient Compliance and Retention • Simplification of study procedures • Elimination of excess study burden for subjects • Better patient recruitment via more appealing study management • More efficient study management Ability to expedite recruitment processes • Enables patients to be randomised and dosed on day of presentation • Allows for earlier interventional treatments resulting in better endpoint data • Eliminates cumbersome waiting times and delays • More efficient drug pathways Closer monitoring of vulnerable patients, or known drug risks • Real time monitoring of patient biomarkers • Safety testing immediately prior to next dose administration • Allows for trials to be run in more vulnerable patient populations due to increased safety Greater revenue potential • Faster market access for Investigational Products • Ability to demonstrate product efficaciousness more efficiently • Reduction in study costs due to streamlined processes • Further patient group reach
- 15. Definition - QuantitativeReal Time Diagnostics A solution which provides laboratory accurate biomarker testing “on- site” in a much reduced timeframe (15 minutes) on whole blood samples, utilizing simpler procedures and reduced error compared to current methodology. These devices are not operated by laboratory professionals, but staff who are in direct contact with the patient, the devices are very simple in design and process, making training of staff quick and efficient. This is a truly patient focused concept, whereby all features and benefits are aimed at both improving patient safety and convenience. MESM hold Clinical Partnerships with QRTD manufacturers to place their products into the Clinical Trial Industry
- 16. Current Methodology Patient Presents SampleTaken for analysis to Include/ Exclude Sample is centrifuged and stored for collection Sample is collected and sent to lab Sample received by the laboratory and analysed Results are generated by the laboratory and liaised to site Site receives results and decides on inclusion/exclusion Process usually takes 30-60 hours
- 17. QRTD Methodology -Recruitment Patient Presents Sample taken to include/exclude Cartridge dosed and inserted into device Result generated Site decides on inclusion/exclusion Process usually takes 15 to 30 minutes
- 18. Commercial Oncology Usage Patienttested in clinic •Patient has whole blood sample collected into Lithium Heparin tube •Cartridge is dosed with the sample – no pre-analytic steps required Device performs test •Cartridge is inserted into device •After 12 minutes the results are displayed and printed Results generated and interpreted • Patient receives dose of chemotherapy depending on results generated Eliminates patient waiting times due to local laboratory delays Enables better patient throughputTHEREFORE
- 19. Commercial Cardiovascular Usage Patient presentsin ED •Cardiovascular disease is suggested •Depending on symptoms, test is selected Sample collected •Patient has whole blood sample collected into Lithium Heparin tube •Cartridge is dosed with the sample – no pre-analytic steps required Device performs test • Cartridge inserted into device • Device takes 10 minutes to perform test from start to finish Results generated and interpreted • Result of test can identify past MI • Can identify and stage HF • Treatment can begin immediatelyFaster identification of such diseases allows treatment to be given much faster Patient prognosis improved
- 20. Implementing these productsinto Clinical Trials.. MESM are the market leaders in providing these solutions into the Clinical Trial Industry, the following slides example how and why these devices are being used… QRTD is not a replacement for a Central Lab Service, but a true alternative where biomarker analysis is needed in a very short turnaround time QRTD can be considered a valid option instead of a local laboratory service Efficiency Time
- 21. Example Case Study1 A trial designed to investigate a Cardiac Disease aims to include/exclude, randomise and dose with IP in under 24 hours from patient presentation. Investigation of early intervention with study medication into this disease to meet better endpoints. • Involves Quantitative Cardiac Biomarker assay which must be over a defined threshold for inclusion to the study • Onsite testing for infectious diseases, any positive result excludes patient from the study • These tests are run alongside ECG, HR, patient weight etc by Investigator Inclusion exclusion • The Cardiac disease in this case is acute, the study team aims to understand whether very early intervention from patient presentation improves morbidity/mortality in this disease. • Therefore, very early inclusion/exclusion and randomisation is key to this procedure. Outcome of this study is very important for endpoint purposes. Study Aim • Study drug is already established in the treatment of this disease area, however, this has the potential to become a blockbuster drug if administered early into presentation • Study teams would not be able to perform Biomarker assays required to include patients onto this study in the short time frame required. Without QRTD
- 22. Example Case Study2 A study drug with known potential hepatic toxicity is being administered in the investigation of a chronic progressive disease, with the aim of improving clinical scores and reduction in disease burden • Involves Quantitative Liver Function Tests performed on site by the investigator. The result of these tests are interpreted and the site makes a decision on whether the patient can accept another IP dose. Pre-dose safety testing • The patients in this study are of high dependency due to disease burden, making repeat trips to investigator sites extremely difficult. • Having testing and dosing performed at the same visit improves patient compliance and retention. Study Model • Patients would have to make twice the number of trips to site due to the lack of local laboratory testing services performed at the investigator sites. • This puts pressure on the patients and also their friends and family who are usually responsible for taking the patient to site. Without QRTD, the patients would have higher study obligations, resulting in higher non-compliance Without QRTD
- 23. Patient Recruitment Reducing number of requiredstudy visits •By performing all testing required for next dose “on site” •Patient is less burdened by study obligations How can QRTD improve patient recruitment •As study burden is not as high during the course of the trial •Especially important where patients have high disease burden and dependency on family/friends Likelihood of study fatigue is reduced •Less SAE’s = better patient retention •Especially important with vulnerable population groups such as paediatric •Allows for confidence in trial whereby a potential risk is identified Real-time biomarker monitoring reduces likelihood of SAE’s Retention
- 24. Streamlined Study Processes •Results in faster study completion • This enables the next phase of the study to commence earlier • AND/OR Faster Compound to Market • Also would reduce associated study cost due to reduced timelines required • Can also reduce cost due to much lower shipment volumes of cold chain samples More intelligent study design • Would allow for endpoint to be met with higher efficiency (such as in the case of earlier intervention) • This would demonstrate a higher drug efficaciousness and therefore easier compound to market post study phase • Critical for acute disease that can cause end organ damage if not treated immediately Greater patient populations • Bespoke protocols written for at risk individuals with greater safety management allows medication to be approved in these populations • This increases potential patient access post study completion and therefore higher revenue potential Greater Financial Potential • QRTD can be intelligently utilised to expedite clinical studies by streamlining processes and removing unnecessary delays. Or bespoke utilization to target additional patients.
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