Dr Eugene Durenard, CEO of Hyperbolic Holdings GmbH, discusses the importance of improving access to healthcare innovation on an international scale
The 2020 COVID-19 pandemic has highlighted several structural inefficiencies that prevent the world from reaping the full benefits of the sizzling global innovation in life sciences. We focus here on Regulatory, Innovation Sourcing, and Procurement.
Hyperbolic has been involved in healthcare innovation for several years, acting as direct investor, business developer and impact investment advisor. We have seen the pace of innovation accelerate dramatically, mirroring the celebrated Moore’s Law. The combination of falling computation costs and the commoditisation of contract research and manufacturing are lowering barriers to entry. R&D in Life Sciences is now more democratised and globalised than ever and is no longer the exclusive domain of big pharma or government institutions.
In this highly dynamic global environment, we continually strive to keep ahead of competitors and identify synergistic forces. We are expanding our network of relationships containing more than 40 clusters of life science innovation, numerous strategic investors and health services operators on five continents.
This extended view of innovation and product development landscape allows us to grasp opportunities and analyse pitfalls, helping our partners and clients to successfully navigate the global healthcare system.
System under stress
In 2020 the COVID Crisis has uncovered and highlighted several weaknesses and inefficiencies of the global system.
Here we describe three concrete situations we experienced in recent months and our involvement in helping to achieve better regulatory coordination and more efficient information sharing for product development and procurement.
Regulatory mis-coordination (Test it again, Sam!)
There is very little acceptance and coordination between different countries’ medical regulatory systems despite the fact that each systems standards are ultimately quite similar.
As an example, Hyperbolic is involved with one of the most competitive and efficacious COVID rt-PCR tests. Despite the fact that it was CE-marked then approved in the USA for the EUA at the beginning of 2020, almost every single country (even within the EU) insisted on doing their re-validation. Thus, the same validation assays were performed tens of times at different labs, in Europe, South America, Asia and Africa.
Despite those multiple reinventions of the wheel, all validations showed similar results and the test is being sold in more than 50 countries. This inefficient approach, however, ended up costing those countries months of time and lost opportunity, as their population was not being adequately tested and triaged for isolation and treatment. As a consequence, indiscriminate lockdowns were enforced in several countries as their Governments panicked. The money lost on economic output is incommensurate to what could have been invested into fast effective population testing strategies and rational quarantine policies.
A “Metric System” for clinical trials?
This massive inefficiency permeates the global clinical trial validation landscape. It increases drug/device/diagnostic development time and costs, and those costs are directly passed to the population in the form of higher prices. It is no wonder that healthcare as the percentage of GDP has been rising and medical inflation in some countries still runs in double digits.
Hyperbolic assembled a group of experts to propose concrete solutions to address this blatant gap. In our age of global Internet, it is high time that regulatory agencies across the world agreed to form a “Bureau of Clinical Standards” to guarantee fungibility of trial protocols and fast-tracking of approvals across jurisdictions. The adherence to quality standards, honesty of process and traceability of results can be implemented through modern blockchain and smart contract technology.
So long as such global coordination is not in place we will continue helping our clients implementing the most rational clinical validation strategies to minimise costs and time to market.
Pro-actively filling procurement gaps
This year Hyperbolic also observed an acute lack of preparedness, openness and capacity by some countries to adopt foreign innovation in a timely fashion to help alleviate the unfolding COVID pandemic.
In order to present vetted COVID-relevant technologies to health decision-makers, we had to overcome either a lack of access points and portals, or lack of acknowledgement and follow-up from the ministries.
It is evident that not a single country is fully self-sufficient in terms of R&D and production of medical supplies and drugs. This points to a necessity of some Governments to establish accessible systematic innovation-sourcing capabilities designed to provide knowledge and options for future fast procurement, or at least to outsource such expertise to competent entities.
Sourcing and analysing healthcare innovation on a global scale is a difficult task, as it requires scientific and market expertise, wide-ranging contacts and the commitment of constantly keeping a finger on the pulse. Hyperbolic’s ability to due-diligence and evaluate innovative ideas comes from years of experience and relationship building. Such an approach is mission-critical, as it helps us to gauge emerging competition and opens opportunities to assembling synergistic technologies.
Competitive threats or synergistic opportunities?
Our multi-year experience in building our network has highlighted that very little communication happens between innovation clusters. Many innovators and institutions are working on similar problems, without realising that their approaches can be complementary or synergistic. As a result, they often do not solve the problem fully on their own.
A case in point, clearly highlighted by COVID, is the lack of integration between cutting-edge hardware and chemistry in point-of-care diagnostics. In particular, that gap is most apparent in molecular diagnostic tests detecting viral RNA or DNA with a PCR or LAMP technique, which are considered to be the gold standard by health authorities. Such tests are routinely performed in large professional labs, with turn-around times of several hours if not days and associated high costs. At the same time, fast miniaturised PCR and LAMP technology exists but has yet to be implemented for point-of-care. This is a real unmet need, especially in situations of pandemic stress where millions of people need to be tested quickly and the capacity of labs is limited.
While we are analysing some hardware-chemistry merger potentials we are also working on aligning interests of various players with the goal of aggregating commercial innovation opportunities into a searchable portal.
If there were only 3 problems…
In conclusion, despite an incredibly dynamic and global healthcare innovation environment, several systemic weaknesses are preventing people, companies and Governments from benefiting from its true potential.
Here we focused on 3 major stress points and will elaborate on others in a forthcoming article. Meanwhile, we are ready to help you navigate around those difficulties thanks to our established global expertise and networks.
Please note: This is a commercial profile