VIRTUAL MONITOR 

Virtual Monitor is a software solution aimed at automating clinical trials’ monitoring. It plans to replace the clinical trial Monitors’ physical visits at hospitals, thereby reducing costs on the Pharma and CRO side, as well as automating the data recording.

Origin

The idea behind the project was first formulated by Adam Kruszewski, an experienced Contract Research Organisation executive. After serving as a long-term CEO of KCR, an international CRO, he developed very good understanding of the processes, costs and innefficiencies in the clinical trial industry. His expertiese allows us to pinpoint currently existing bottlenecks and build software focused on solving well defined problems.

He is supported by Łukasz Olek, an inventor, manager and investor with extensive experience in IT sector. Througout his career he founded, developed and exited various business ventures, including first online currency exchange platform in Poland walutomat.pl. Łukasz is responsible for the technical aspects of the Virtual Monitor.

Current Process

The current system of conducting clinical research is outdated as it utilises three different systems:

• Clinical Research Form solely for the clinical research, 
• Health Medical Record – hospitals’ own system
• Verification system

Those systems have a significant overlap when it comes to patients’ data collected, and involves many redundancies in data writing which is done manually. 

The system requires on-site visits by Clinical Research Associates in order to verify and cross-examine the data from CRF and HMR.

Data is reported using templates which differ from hospital to hospital as they are developed by respective staff.

Our innovation

• CRF and HMR systems’ communication – automated patients’ record rewriting through local server access
• Virtual Monitor can be accessed remotely so it eliminates most of the visits of Clinical Research Associates.
• Multilingual appointment templates which can be applied to an entire clinical reserach.

Clients for our solution are Contract Research Organisations which conduct clinical trials.

The global market of CROs is worth 39.6bn USD and average 12x EBITDA

Our solution can reduce the CRO costs thereby increasing EBITDA by 10% (Expert knowledge AK)

• Therefore, assuming the cost of the system at  ¼ of savings caused by it, the global market for our solution is rougly 760m USD
• Central and Eastern Europe market is roughly 15% of the global market
• As CEE is Orphinic Scientific’s (strategic investor of the project) CRO focus, this market is a viable option for initial distribution and sales
• Based on the aforementioned, Virtual Monitor CEE market size at 30% penetration is 34.2m USD

CLINICAL SERVANT

Overview

This project aims to develop and commercialise an innovative product - the CLINICAL SERVANT (CS).  The system will revolutionise the way medical substances are circulated during clinical trials. The new system will have a hardware layer in the form of SCCT® device (Smart Container for Clinical Trials), which is an intelligent container for clinical trials, and a software layer enabling monitoring and analysis of the flow of medical substances in many research centers simultaneously in real time. 

Description of product innovation

The concept of creating a new product has been based on a real existing market problem, identified based on numerous discussions with pharmaceutical companies and CROs (Contract Research Organization). The use of CS will create a unique value proposition in the clinical research industry. 

The solution planned for development will solve the current lack of advanced systems for monitoring the circulation of medical substances during clinical trials. The problem, in particular, is the inability to gather real-time information from multiple research sites on the number of substances present at a given research site, when substances were dispensed, and the quality of their storage conditions. The above information are critical and affects the safety and reliability of research processes, as well as their costs. 

In the current state of technology, there are no solutions to comprehensively monitor this data in real time through an appropriate hardware layer and dedicated software. The acquisition of the necessary information is manual. Clinical Research Assiciates (CRAs) collect the necessary information through physical visits to individual trial centers. At no point in time does a study monitor have reliable information on the amount of medical substances present in all centers at the same time. Monitoring of medical substances in the clinical trial process, although very important, is therefore currently an inaccurate and expensive process. It requires numerous physical visits by study monitors to sites, and the information obtained is only ex-post. 

Heart failure is the leading cause of hospitalization for those >65 years and the mortality is >50% within 5 years after first hospital admission. These patients' expenses amount to 2–3% of the total United States healthcare spending. The total US market for heart failure treatments is worth >40 bln USD. VT is striving to discover novel heart failure medicines using mechanisms that directly improve heart function and employing precision medicine-based patient stratification. 

The target patients for VT 1 program are Heart Failure with Preserved Ejection Fraction (HFpEF) patients after first hospitalization for which there currrently is no standard of care. The program looks into MMPs, which are biomarkers and targets of HFpEF. Vasa has developed a proprietary scaffold identified internally and filled a composition of matter filling in Q4 2021.

One in 6 men worldwide develops prostate cancer and they require a prostate biopsy as a key step in the diagnostic pathway. Over 4 million prostate biopsies are performed annually in the USA and EU; this number is growing rapidly. Despite the use of an oral antibiotic risk of infection is up to 7% and complications can be severe even fatal.

Our solution, a Drug-Eluting Biopsy Needle (DEBN) is a biopsy needle with an optimal combination of antibiotics attached to the surface. The antibiotics are released directly to the surgical site during the prostate biopsy procedure delivering the antibiotic and cutting infection rates. DEBN additionally provides (as part of its product set) a similarly coated needle for the administration of the anesthetic, reducing the infection risk associated with the anesthesia element of the procedure.   

DEBN’s needles have strong competitive advantages over the current standard in transrectal prostate biopsies. Microbes in the area of the colon through which the needle passes are killed by antibiotics that cover the surface of the DEBN needles. The reduced rate of infection results in significant improvements in patient outcomes and healthcare cost savings.

Trial preparation is advanced, with the CRO contracted, management appointed and regulatory documentation submitted. The DEBN’s product will be trialed in clinics in 8 medical centres Germany and Poland, on a total of 160 patients. The trial will be completed within 12 months (possible as the follow-up period is short).

TM is an opioid-focused project founded by Orphinic Scientific S.A. in 2020. The venture was formed to foster the development of an innovative therapy based on an analgesic pharmaceutical composition for oral administration, the concept originally sourced from the Medical University of Warsaw. The new invention is the result of 20 years of experience in the area of pain management and 10 years of intensive work by a team of outstanding scientists led by Professor Magdalena Bujalska-Zadrożny. The project received its first funding from the National Center for Research and Development (NCBiR) in the amount of 10 mln PLN.

Our Innovative solution for pain management involves a new drug formulation containing tramadol and magnesium booster. This combination provides the pain relief qualities of the opioid analgesic, further strengthened by the boosting effects of the magnesium compound. Currently, this solution is representing the Technology Readiness Level 8.

Comparative Advantages are: 

• Enhancement of analgesic effect: The addition of a magnesium compound allows to reduce the dose of an opioid which helps to eliminate/reduce side effects. 
• Reduction of opioid-related side-effects: As a result of reduced opioid content TraMag ® therapy is associated with a lower frequency of severe constipation, one of the most common side effects. The risk of this complication is eliminated by enabling the reduction of the opioid dose.

The size of the market for Tramadol reached USD 235 million in 2019. 64 736 units of Tramadol-derived drugs were sold in the EU in 2019.  It is estimated that Osteoarthritis, the primary indication for Orphinic’s TraMag®, affects about 40 million people in Europe.