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Bringing biotech solutions to market

Posted: 19 September 2017
Could a digital revolution break down barriers to medical innovation?


GapSummit is Global Biotech Revolution’s (GBR) international and intergenerational leadership summit in biotechnology. Callaghan Innovation’s Max Thompson attended as one of 100 young leaders of tomorrow selected from 40+ countries to engage with more than 30 international speakers and leaders in the life sciences industry on the most pressing challenges and gaps in the bioeconomy. 

Part two of his blog series explores how technologies and regulators are working together to bring biotech solutions to market.

Leveraging digital platforms emerged as a key solution for addressing many of the issues of rising costs, access to patients, real-time monitoring, and dealing with ridiculously large datasets.

Precision Medicine and Diagnostics

Extraordinary claims require extraordinary evidence. 

Dr Vik Bajaj, GRAIL

Precision medicine has been a hot topic for some time. Now digital and medical technology advances, massive investment by the big players (Amazon, Google, etc), and a willingness to trust these solutions by both regulators and patients, mean very exciting advances.

Dr Vik Bajaj’s keynote address outlined future perspectives on cancer immunotherapy, analysing entire genomes to diagnose early and predict effective treatments. Noting that "extraordinary claims require extraordinary evidence” he reinforced the need to plan and maintain rigorous scientific evidence and clinical validation to maintain trust in new approaches that claim to "detect cancer early, when it can be cured." 

Dr Bajaj emphasised the future needs related to personalised medicine: powerful tech platforms, large clinical trials capacity, and rigorous data science. 

The panel discussion which followed canvassed the next steps in the evolution of genomic medicine - next generation sequencing, autologous cell and gene therapy and much more. 

Key questions included how to prove and interpret genomic information at provider level, how to enforce regulation for products made from autologous patient tissue when the protocols for ‘living drugs’ are being written in real-time, and price. 

It became very apparent that personalised healthcare not only redefines the way we treat patients, but fundamentally disrupts how we develop, regulate, and deliver medicine. Within this there is plenty of opportunity for startups. The key message for those venturing in to this space? Make sure your evidence supports the claims you are making, or risk losing trust. 

Science Policy and Regulation

Maybe we aren’t as regulated as we pretend to be.

Dr Bahija Jallal, Head of MedImmune

Are regulators actually working with us to enable biotech?

Regulators have had to consistently adapt current regulatory models to accommodate breakthroughs such as personalised medicine, digital health, and gene therapies. 

Speeding the journey for innovations to go from ‘bench to bedside’ through reducing regulatory hurdles and improving the regulatory regime were a hot discussion topic. The advice? It’s important to act early and engage directly with regulators to limit surprises. MedImmune chief Dr Bahija Jallal challenged the dogma of the regulations hurdle, however, saying  “maybe we aren’t as regulated as we pretend to be.”

For New Zealand biotech startups – don’t let the regulatory environment scare you away. The FDA and other regulators are more flexible than many believe, and continue to demonstrate this. You need to think about your regulatory strategy early and approach the appropriate agencies to get feedback and guidance as you develop it.

Of course, with the conference being hosted Washington DC, there was plenty of discussion around the political landscape and how changes there might affect science policy.

Some New Zealand technology companies also made an unsolicited appearance at this conference – both LanzaTech and Adherium were namechecked by various speakers – demonstrating the world class research and commercialisation capability we have here. What will the next New Zealand technology successes be?

The Technology Gap Keynotes 

This is a time for a digital revolution in healthcare through cognitive computing that understands, reasons, learns and interacts.

Dr Philip Nelson, Google Accelerated Sciences

This session examined the process of innovation and the partnerships necessary to launch successful products. GapSummit 2017 Leaders of Tomorrow had an opportunity to engage with different players in the field including tech startups, accelerators and incubators, VCs and pharmaceutical partners. 

The speakers were optimistic about the gathering momentum towards a digital health future, and soaring investment in digital health care. 

The technology keynote addresses were presented by Dr Philip Nelson, Director of Engineering, Google Accelerated Sciences and Michael S. Weiner, Chief Medical Information Officer, IBM Healthcare. Both highlighted the vast amounts of data being generated by high tech devices, and the challenge of how to apply this information to improve healthcare. “This is a time for a digital revolution in healthcare through cognitive computing that understands, reasons, learns and interacts," Dr Nelson said.

He noted, however, that “it’s very easy to do machine learning wrong. Doing the right experiments is critical...machines fail in unusual ways – but there is a lack of understanding about what the failure modes are, and how to update the models. Ultimately [machine learning] is the detection and understanding of deep correlation structures. The challenge can be finding out exactly what that correlation is.”

He also pointed to acceptance issues. “With a magic black box, it’s a little disturbing.” 

Michael Weiner summarised a healthcare system accounting for 20 percent of world GDP, yet lacking providers and funding for challenges including ageing populations. 

So how do we take technology and improve healthcare across the globe?

Plugging in new technology to old healthcare business models has increased costs, not reduced them. Quality of care remains poor despite best efforts and intentions, and diagnosis and treatment rates are low. Between clinical, genomic, and exogenous data, there is also data overload. On top of this scientific publications keep coming at a rate which makes staying up-to-date nearly impossible. 

The future of health and biotech is intertwined with digital technologies that will help address these issues. Successfully integrating them will require collaboration at all levels of the value chain. Ultimately, we will require a new paradigm with new models of care that optimise new technologies to deliver better patient care and better population health at a lower per capita cost.

It's a great opportunity for New Zealand, with our scientific and digital capability. 

I left GAPSummit ‘17 absolutely inspired by the connections I made with people from many countries, all working towards making the world a healthier, safer, and more sustainable place in their lifetimes. 

Let’s change the world through biotech!

GAPSummit 2018 is currently searching for 100 Leaders of Tomorrow to be hosted at University of Cambridge, UK, in April next year. Individuals with a passion for biotechnology and who are on their way towards impactful careers and would like to attend may find more information here.

Max Thompson is Callaghan Innovation’s Strategic Partnerships Advisor, Startup Team. Contact Max on Twitter @maxdougal

Read Part 1 of this blog series: Leading tomorrow's bioeconomy

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