In today’s healthcare landscape, regulatory and commercial barriers continue to delay life-changing therapies from reaching the patients who need them most. Here, Managing Partner Mike Mortimer and Operating Partner Alistair Macdonald explore how our portfolio companies are tackling these bottlenecks through innovation, digitalisation, and advanced drug discovery technologies to deliver better, faster, more accessible healthcare.
At the heart of Better, Faster, and More Accessible healthcare is the enablement of innovative treatments to be developed and manufactured to the highest standards, both quickly and efficiently. Approval of a new drug, however, is multi-faceted and time-consuming; from the start of the discovery phase, it takes approximately 10 years for a drug to reach the market. This rigorous path through preclinical trials and a minimum of three phases of clinical trials with increasingly more complex human cohorts is designed to protect patients, but importantly the process also protects companies from commercialisation risks. Despite efforts to reduce the average length of a trial, regulatory and commercial barriers continue to impact efficiencies across the healthcare landscape, prolonging the time it takes to deliver new innovations to patients.
Receiving regulatory approval is a significant milestone. However, an additional two years is often required to navigate the complexities of the sales and marketing of a new drug or therapy. This phase is characterised by challenges that impede the product’s successful entry into the market, such as its positioning, pricing, and reimbursement negotiations, which is extended by the varying processes at both national and sub-national levels. This is further complicated by considerations surrounding the allocation or distribution of a product and the prioritisation of certain patient populations.
These hurdles underscore the necessity for a more streamlined approach to post-approval processes, ensuring that new drugs or therapies not only receive approval but reach patients who need them most without compromising financial viability. GHO’s portfolio companies are at the forefront of addressing these barriers, employing innovative strategies to revolutionise the healthcare landscape.
ELIQUENT Life Sciences, for example, provides regulatory, compliance and quality consulting which ultimately shortens the regulatory review process for its clients, enabling ‘Faster’ access to therapies for patients in need. Adhering to the ‘Better’ principle is RoslinCT, a leading Contract Development and Manufacturing Organization (CDMO) focused on advanced cell therapies. We invested heavily with them to create and augment its world leading technology. Through strategic development of a company’s specific services, GHO Capital is helping to mitigate the commercial barriers inherent to drug development and bring life-changing therapies to patients.
The cost of developing a new drug or therapy is increasing, driven by more stringent regulatory requirements and the need for more extensive data collection. However, companies are turning to digitalisation to use data more efficiently and real-world data is becoming a valuable tool for identifying patient groups and solving challenges in the post-regulatory approval stage. Genesis Research Group, another key player in GHO’s portfolio, focuses on providing companies with the essential information required for pricing and reimbursement strategies. Its expertise aids companies in executing well-informed decisions, ensuring that life-changing therapies are ‘More Accessible’ to a broader population.
The ability to link data together and interpret and analyse it more effectively contributes to reducing the time and money it takes to bring a drug to market and lowers the chances of failure. Regulatory bodies such as the EMA and FDA are becoming more receptive to these data-driven methods. Our portfolio company ClearView Healthcare Partners is currently exploring the best methods to use these big open data sets to drive more cost-effective and higher quality experiments. There is also a wider application of drug discovery software and a surge in high-quality science, leading to the identification of new targets and a better understanding of the root causes of diseases. This not only improves the chances of finding effective treatments but also drives innovation and improves health and quality of life for patients.
The future of the healthcare industry will continue to be characterised by a need to overcome commercial and regulatory challenges without compromising on quality. Our mission for Better, Faster, and More Accessible healthcare is focused on solving the regulatory barriers that prolong the delivery of new drugs and therapies to patients who desperately need them. By investing in companies that provide solutions within the regulatory pathway, we are helping to streamline this process and accelerate innovation to the patients who need it.