The transport of pharmaceutical products involves considerable risks: With temperature-controlled products there is a risk of temperature deviations; incorrect handling can cause damage and there is also the risk of theft or the introduction of counterfeit products. Air transport in particular is very risky because it involves many different, sometimes unknown, players in the supply chain – from transport companies to handling agents and terminal operators. Pharmaceutical companies often find it difficult to assess how reliable the individual players are. However, the Good Distribution Practice (GDP) introduced in 2013 stipulates that manufacturers are responsible for transporting pharmaceutical products to the end customer – and are therefore obliged to minimize risk when selecting their supply chain partners. But so far, there is a lack of an appropriate tool to evaluate the qualifications and infrastructure of the various suppliers.
The Frankfurt/Main area based startup MYTIGATE, which is part of the network of 5-HT and participated in this year’s edition of the startup boot camp 5-HT X-Linker, is working on a solution to this problem: The risk management platform MYTIGATE shall enable logistics and quality managers of the pharmaceutical and forwarding industry to assess the risk for individual transport partners and routes – and accordingly select those with the lowest risk.
This works via self-disclosures by service providers, who can provide information on their infrastructure, processes, qualifications and certificates on the validated Software-as-a-Service (SaaS) platform. The questions that the service providers have to answer were developed together with industry partners to ensure that the statements are highly relevant. MYTIGATE counteracts potential attempts of deception by integrating plausibility checks. In addition, quality data collected by pharmaceutical companies using temperature data loggers, for example, are included. Based on this information, an individual risk figure is calculated for each supply chain partner and each transport route.
As a result, pharmaceutical companies are able to gain a transparent overview of their supply chains, minimize risks when planning their transport routes and thus work in compliance with GDP. At the same time, MYTIGATE offers the possibility to make every change traceable within the scope of audit trails, which facilitates documentation for authorities.
Why a tool for standardized data collection is urgently needed
The startup was founded in December 2017 as part of the LOEWE research project “Pharma Supply Chain Risk Assessment”. Dr. Yvonne Ziegler, who is now working as a Sales Consultant for MYTIGATE, has been working in the aviation industry for many years.
In addition to the Frankfurt University of Applied Sciences, the University of Applied Sciences Fulda and the Rhine/Main University of Applied Sciences, the pharmaceutical companies Bayer and Boehringer Ingelheim, the transport and logistics company GEFCO and the IT company Cyntegrity were involved in the research project dealing with the development of MYTIGATE. In addition, an advisory board with experts from the fields of transport, planning and quality management was set up, including experts from Merck, Roche, Lufthansa Cargo and DB Schenker.
Immediately after the research project was finished in March 2020, MYTIGATE started its operative business. The participation in 5-HT X-Linker, the startup boot camp for startups in the fields of digital chemistry and digital health, gave MYTIGATE the opportunity in February 2020 to obtain professional input and to exchange ideas with experts on topics such as pricing and financing.
Currently MYTIGATE is working on acquiring the first customers and subjecting the software to a usability test in order to integrate possible additional requests from the industry. “However, we are happy about further pharmaceutical companies and forwarding agents who are interested in using our tool”, says Dr. Ziegler. “We are also open to business angels who are interested in investing in our platform at this early stage”.
“Currently, in times of corona, the subject of supply chain is likely to take on special significance once again,” says Dr. Ziegler. “I would like everyone to leave their personal viewpoint and reflect that now is the chance to build a central, standardized tool for the entire industry. This also includes sharing the perceived risks on a supply chain route with others. This is a good opportunity for pharmaceutical companies to make their own contribution to improving the quality of transport for the entire industry and creating more transparency”.