Periodic Reporting for period 1 - LowCostTracking (Low cost tracking and data management solution for biopharma cold chain logistics)
Reporting period: 2016-09-01 to 2016-11-30
The study focuses on multiple questions for monitoring pharma integrity during transport including:
1. What is the size of the market, what are the trends, and how do recent regulatory drivers and other market requirements effect the adoption of better pharma monitoring technology, and;
2. What are the customer requirements for monitoring, limitations of current technology, and how can these gaps be filled.
New biomedicines to treat both common and complex illnesses are advancing very rapidly. These advances pose new challenges in delivering these medicines to patients safely and at lower costs. Most emerging pharma products are biopharmaceuticals that need to be distributed in a strictly controlled and refrigerated environment to protect the integrity of the drugs. The 2014 Biopharma Cold Chain Source Book indicated that most new trials globally are biologics based medicines confirming a big global trend in pharma products.
In addition, new global regulatory requirements are emerging for the transportation of pharmaceuticals with more stringent controls than in the past. The consequences of temperature excursions with these new drugs, not only has impact on patient safety, but enormous financial impact as well.
Virtually all electronic monitoring of pharmaceuticals in the supply chain is performed with recorders, so these technologies can only provide a “rear-view” of transport conditions. GT has developed technology which can provide real-time and better overall accuracy and performance.
Most of the Intellectual Property (IP) relates to designing and assembling a low cost functional device and specialized software that runs cloud based data storage and analytics solution. The solution has reached commercial traction within the reefer market since 2014 and is in the process of scaling with key logistics firms in the segment of food transportation.
An adjacent and high value market segment is that of the biopharma cold logistics chain. While similar in that it often uses the same type of refers for transporting biopharma as food, the demand on supply chain integrity is quite unique. While much of pharma today is shipped by air, there is an ever increasing trend toward refrigerated surface transport, and this presents a whole new set of issues. The key difference lies in the fact that pharma requires strict adherence with regulatory compliance such as temperature control and accurate recordkeeping, and that there may be somewhat different regulatory requirements across nations. The nature of biopharma logistics is global by nature, so this creates a very complex scenario for pharmacos and transporters across borders. GT technology can address all modes of shipment.
This study focuses on both technical feasibility and market feasibility, which includes market assessment as well. In addition, GT has designed a feasibility trial with major logistics firms in this sector in order to establish exactly what the technical requirements and the commercial opportunities are in this market.
The overall objectives of this study fall into 3 key categories as indicated below.
• Objective 1: Market Assessment and Commercial feasibility: As part of the commercial feasibility study, we explored relevant distinct pharma product segments and assessed a market need and feasibility, competitive factors, developed market gaps and requirements, and customer business cases. GT has made initial contact with several European logistics companies who are active in pharma logistics services such as (DHL, Kuehne + Nagel, DB Schenker) and pharma companies (including Eli Lilly, Novartis, Bayer, Sanofi, GSK) directly and through these discussions has identified a gap in the strict compliance of temperature and handling in their logistics chains. GT needed to deepen this understanding by selecting early adopters, working with them to analyse the pharma delivery supply chain for cold-chain pharma products and translating them into detailed user requirements.
• Objective 2: Sample shipment validation and technical feasibility: Demonstrate via multiple field trials GT’s first generation technology and partner products at reference sites to gain on-site experience and necessary feedback for further technology development. From the results of the sample shipment field trials we conducted a comprehensive technical feasibility report, that includes the specifications for monitoring and security technology that match the identified market requirements, such as different transportation modes. This is forming the basis for a draft technical roadmap in this study, to be detailed further in Phase II.
• Objective 3: Implementation and Impact: Define concrete implementation plan based on the results of the two previous objectives. Assess commercial scale-up the opportunities at European and global level past Phase II completion.
Study Assessment Conclusions
Based on our extensive market assessment. competition analysis, and discussion with customers from which we derived a framework specification for market wants and needs. These are summarized below:
• Need for real-time – rear view monitoring is ineffective for many of these sensitive biologics
• Need for sensors outside of temperature (e.g. shock) – may new medicines are also susceptible to other factors such as shock and vibration. In many case molecules making up biologics can be damaged with impact or various vibration profiles. In addition, humidity and other environmental measures many be critical
• Ease of use – many of the technologies in use today are cumbersome and require significant manual intervention. In addition the opportunity of human error being introduced is much higher.
• Transportation analytics – logistics companies can use analytics on the data they get form cargo sensors to improve their own operations and offer better and more transparent service to their customers.
• Automated regulatory compliance – The regulatory compliance factors around pharma is complex and ever changing. A system can help shippers and logistics companies decipher the compliance codes and perform automated
• Automated reporting – The reporting of compliance data is critical and time consuming. The market needs these functions automated.
• Supply Chain Automation (Future) – Just in the same manner that within a few years many cars will be automated, in the same way it will be possible to automate the supply chain. Trade lanes and routes are predefined, and the system is aware of cargo location and status, so there is a possibility of allowing the system to operate the supply chain on a normal basis and humans become involved only when there is a problem.
The importance of keeping a compliant and secure temperature control through the storage, handling and transportation of temperature-sensitive drugs, vaccines and blood products is of paramount importance. The implications of improper handling can result in negative socio- and economic impacts including:
1. Product loss and huge financial loss
2. Increased danger to the patient
3. Violation of various laws, regulations, guidelines and codes.
4. Liabilities for doctors, pharmacos, and other stakeholders
5. Brand damage (many pharma brands for example Johnson and Johnson are global and some have been built over 100 years)
6. Counterfeit proliferation which fosters illegal activity and endangers patients
7. Slower penetration of emerging markets where often patients are most in need
As part of the study we were able to confirm feasibility of technology and an execution plan that would mitigate each of these factors.