As R&D across genetic and cellular therapies progresses, how important is the role of innovation in the world of academia to exploiting the full potential of biologics?
At the end of 2018, The Pistoia Alliance and one of its members, Clarivate Analytics, undertook research to develop the Life Sciences Innovation Report. Developed with inputs from executives at GSK, AbbVie, Cancer Research UK and Diavics, we sought to uncover the top five trends for the life sciences sector in 2019. The report highlighted a range of topics, including multi-disciplinary innovation, the implementation of new technologies, new approaches to research, the digitisation of R&D and healthcare, and academic contributions to biologics R&D. In this article, we will look more closely at one of these trends – the contribution of academia to biologics R&D, and how the industry can better collaborate with academic counterparts.
Biologics is an area likely to see considerable growth in 2019; the market is predicted to grow from $254.9bn in 2017 to $580.5bn by 2026. The key to realising this potential though – as with all successful life science endeavours – is collaboration. As R&D across genetic and cellular therapies (for example CAR-T cells, stem cells, siRNA, and CRISPR-Cas9) advances, innovations in academia will be essential in realising the therapeutic potential of biologics.
“A cultural shift is needed from industry to really get behind collaboration”
Although there is a long history of productive work between scientists in academia and pharmaceutical companies, there are barriers in place that don’t always make it easy – whether these are technical, legal or cultural. These barriers hamper collaboration, but to progress biologics research in the future, industry and academia must work together to overcome these hurdles.
Biologics research today
Our report found that of the top 30 institutions patenting biologics (see Figure 1), the majority are non-commercial, with universities making up a third of the list alone. One reason for this is that academic research, indeed basic research, is where most of the insights into disease cause originate. As that knowledge becomes available, academia is quick to exploit an increasing understanding of genetic, cellular and protein engineering to intervene in those disease processes and to test new therapeutic approaches. While traditional pharmaceutical companies also have the scientific prowess to test new therapeutic approaches based on novel disease insights, pharma is optimised for scaling up therapeutic production and manufacturing of large batches of the same formulation for all patients.
As CAR-T and other cellular therapies advance, a different paradigm emerges – the raw ingredients (for example T cells) start with the patient, are modified in a lab, and delivered back to the patient as therapy. This new form of cell-based supply chain is a completely new form of treatment paradigm, more aligned to an academic research hospital than large pharmaceutical manufacturing and supply chain. Additionally, the field of biologics and its associated disciplines are more varied, making academia a perfect proving ground for biologics R&D.
This is illustrated by the breadth of the top 10 biologics therapeutic categories (see Figure 2).
Commercial pharmaceutical companies are built to exploit knowledge of the molecular basis of a disease, while academia is typically where that knowledge originates in the first place. However, with biological therapies this process is flipped on its head, and knowledge discovered in an academic lab or research hospital can be exploited directly with investigational tools, at a small scale for individual patients.
With this approach, massive R&D infrastructure isn’t necessary (i.e. lead discovery, optimisation, and formulation development).
But one area where big pharma can help is by using its networks and know-how to get new innovations to market quicker. One project in this vein is Merck (MSD) and InnoCore’s recent partnership to develop a new drug delivery platform for biologics to bring therapies to market faster by increasing compliance.
A cultural shift
To make this kind of industry-academia collaboration possible, several obstacles currently hindering collaboration between pharma and academia must be overcome. One of the biggest is the wide variance in data formats, something that needs to be addressed to increase the interoperability of data. Another factor is that although there are incentives in place, and the benefits of collaboration are clear from other examples, a cultural shift is needed from industry to really get behind collaboration.
One of the most deep-rooted problems is the fear from both pharma and academia of sharing data, and entrenched positions from legal and regulatory advisers which often result in an unwillingness to collaborate. The establishment of programmes like National Institutes of Health’s Data Commons, a cloud-based platform that promotes the sharing of biomedical research data from government-funded grants, and the creation of resources like database of Genotypes and Phenotypes (dbGaP), is a move in the right direction. Improving ontologies and data sharing standards will accelerate the adoption of these resources.
However, as academia and private industry have inherently different goals – typically, academics are looking to publish papers on new findings, while private groups want to efficiently discover new therapies – this shouldn’t be a concern. Big pharma should nurture collaborations so both parties benefit, furthering progress in the field of biologics and fulfilling unmet needs. Today, no single company has the resources or knowledge to meet all their goals alone. The Pistoia Alliance’s mission is to work with members to enable data sharing in a precompetitive environment and ensure companies feel safe while doing so. Throughout 2019, and working with members like Clarivate Analytics, the Pistoia Alliance will continue to develop projects in the areas its members are most interested to further life science innovation.
Dr Steve Arlington is President of The Pistoia Alliance and Christopher McKenna is Global Head of Life Sciences Professional Services & Consulting at Clarivate Analytics.