Sector highlights: Lhasa Limited interview
Dr Liz Covey-Crump director of Business Development at Lhasa Limited describes the opportunities, challenges and trends she has experienced over the course of 2017.
1. What has been the biggest opportunity of 2017 for your company/organisation?
One big opportunity we encountered during 2017 was the Vitic Elemental Impurities data sharing exercise, which has been generating a lot of external interest. Ultimately, this has resulted in a large and high-quality dataset that can help reduce the amount of analytical testing which is required for elemental impurities within pharmaceutical excipients. There has also been significant regulatory interest in this dataset and regulatory organisations are in the process of gaining access.
At Lhasa, we’ve also been involved in the eTRANSAFE IMI project – a five-year, €40m project for new drug safety assessments and integrative data analysis research. The venture aims to develop an advanced data integration infrastructure together with innovative computational methods to improve security in the drug development process.
The eTRANSAFE consortium is a private and public partnership, consisting of eight academic institutions, six SMEs and 12 pharmaceutical companies, in which Lhasa is playing the part of ‘Honest Broker’. The company is also taking the lead on the historical data gathering and the management of the SEND (Standards for the Exchange of Non-clinical Data) data, as well as assisting in many other work packages.
Ultimately, the knowledge we gain from our participation will also support our on-going efforts to improve toxicity predictions.
2. In your opinion, what has been the most important innovation for the year?
In 2017, the industry has gradually begun to embrace Software as a Service (SaaS) and the idea of using solutions hosted in the cloud. Pharmaceutical companies are beginning to realise that the scalability and agility of the cloud can support research and development, simplify clinical research and deliver significant cost savings. Requiring no customer installation and no additional servers or other expensive hardware, SaaS products can be made available quickly, providing pharmaceutical companies with unprecedented access to data and knowledge, without compromising the confidentiality of their own proprietary information.
We’ve recently deployed a number of our software solutions to Amazon Web Services (AWS), enabling us to scale the architecture to deliver consistent performance regardless of the number of software users, and ensure security is front and centre of our product offering. Crucially, SaaS also allows us to deliver faster resolution of support requests and, because we can manage all the updates and upgrades, users will get access to the latest features and knowledge without having to wait for their internal IT teams.
3. Which factors have driven the biggest changes to the industry in 2017?
As mentioned, SaaS has led to huge changes for the industry in 2017, with some of the world’s largest pharmaceutical companies embracing the cloud. Proving beneficial for small, mid-sized and large pharma companies, the cloud means data can be managed at lower costs, while simultaneously freeing up operating expenses.
In the coming years, once security fears are eased, the market for cloud computing will undoubtedly experience huge growth.
4. What market trends have been influential for 2017
Collaboration has increased in 2017. Pharmaceutical companies are beginning to outsource software development and are less likely to build bespoke solutions in-house, meaning they can now reap the benefits of collaborative development.
The increase in collaboration has also driven a number of different data and knowledge sharing initiatives, and those who are participating are experiencing tangible benefits.
There is a growing acceptance in the sector that in silico models can produce predictions that are equivalent to in vitro studies in their abilities to predict in vivo or human toxicity outcomes. In the past, strenuous efforts have been made to increase the transparency with which models provide in silico answers. The popularity of this method has resulted in in silico answers becoming more useful to supporting decisions than ‘black box’ in vitro studies, which are known to have complex and variable reasons as to why they do not always mirror in vivo outcomes.
In the area of skin sensitisation, there has been an acceptance that combinations of in silico and in vitro assays can effectively be combined to predict in vivo outcomes. Called a “defined approach”, this method has been widely referenced in a number of journal articles that have been written on the subject.
5. What have been the biggest challenges of the year?
The biggest challenge Lhasa has faced in 2017 related to the uncertainty around Brexit – which in turn has resulted in two common challenges.
The first of these relates to the potential of taking part in future EU funded collaborative projects. For example, the IMI (Innovative Medicines Initiative) promotes and funds collaborative research projects, such as the iPiE (Intelligent Assessment of Pharmaceuticals in the Environment) project, and helps to enhance pharmaceutical innovation in the EU. However, the IMI is jointly funded by the European Union (represented by the European Commission) and the European pharmaceutical industry, meaning domestic research investment would be likely to suffer if the UK was no longer part of this initiative. Furthermore, the advantages don’t just lie in the cost savings, as the ability to share the knowledge and experience of researchers from different EU countries may also be affected.
The second difficulty involves the future recruitment of valuable skilled EU citizens, who may be less attracted to working in the UK post Brexit.