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Category archives: "Biotech"

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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Leading tomorrow’s bioeconomy

Posted: 13 September 2017
What are the most pressing challenges and gaps in the bioeconomy? Callaghan Innovation’s Max Thompson found out when he attended GapSummit as one of 100 young leaders of tomorrow

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 one of his two-part blog series will explore the capability challenges facing biotech today.

Biotechnology is one of the game-changing technology platforms that will be central to addressing many of the world’s current and future problems – in health, medicine, agriculture and environment. Already biomedical advances are responsible for half of all economic growth since 1960, and will continue to be a driving force in global economic growth. In New Zealand, Biotechnology (alongside Digital) is the largest grouping in the next wave of high-technology startup companies emerging from Callaghan Innovation’s technology incubator programme. (See Kimberlee Jordan’s recent blog series for more).

GapSummit 2017, hosted over three days at the historic Georgetown University in the McDonough School of Business in Washington DC, was about identifying some of the challenges to global competitiveness. 

It was an extremely well-organised conference, offering an incredible experience for all who attended and highlighting the number of players – researchers, large and small companies, regulators, thought leaders, institutions – whose co-operation is critical to biotech success.

GAP: Beyond Education: Success in the 21st century Life Science Industry

On top of technical chops in a rapidly shifting scientific landscape, a remarkable set of transferrable skills and experiences are required for success in today’s bioeconomy.

Commercialisation of lifescience technologies faces a complex set of challenges which are unique to this industry, including long development time-frames, significant regulatory challenges and incredible cash burn rates. This means both that business education is critical for people starting careers in the lifescience industry, and that the business and legal sectors must recognise the unique challenges. It’s critical that we expose business and law students to the distinct challenges in the life sciences (and vice-versa), to develop realistic expectations for ground-breaking discoveries, to recognise the hurdles of existing healthcare systems and the limits and assumptions embedded within cutting-edge technologies.  

One thing that struck me was an extremely high prevalence of entrepreneurship among attendees –  led by those from the East Coast USA. Nearly everyone I met was starting or involved with a biotech startup! 

Think Big Be Brave Deliver

This level of entrepreneurship in life sciences was bolstered by the support that Universities and Institutes in this region have managed to deliver – growing a vibrant deep-tech startup environment for long-time-to-market innovation. They have achieved this by valuing and encouraging entrepreneurship and exploration as part of the curriculum in scientific and technical pathways. It was awesome to see the impact and momentum created when real fluency in multi-disciplinary thinking is combined with institutional support for risk taking.

The New Zealand startup environment has come a long way over the last decade to understand near-to-market innovation very well. The next step to maturity will be greater comfort with high impact, and long-to-market technology companies. What’s great is that we are seeing the beginnings of this activity in New Zealand.

The next GAP I attended explored an emerging organisation-level capability failure and illustrated that, particularly in the pharma industry, the traditional R&D model is completely unsustainable. The number of new approvals is low, failure at clinical stage trial is all too common, R&D spend is high, and time to market is prolonged (30 years is not uncommon). 

GAP: Research and Innovation

The pharmaceutical R&D model is broken, with an exponentially increasing R&D spend resulting in a flat-line rate of innovation. 

There is a disconnect of R&D spend to commercial output in pharma, coupled to increasing complexity of stakeholders and diseases – we need a new collaborative model to see accelerated therapeutic development.

Anthony Coyle, Senior Vice President / Chief Scientific Officer, Centres for Therapeutic Innovation (CTI)

Anthony Coyle, Senior Vice President / Chief Scientific Officer, Centres for Therapeutic Innovation delivered a strong indictment. “There is a disconnect of R&D spend to commercial output in pharma, coupled with increasing complexity of stakeholders and diseases – we need a new collaborative model to see accelerated therapeutic development.” 

The focus has to shift to innovation and how R&D dollars are deployed in a collaborative and strategic way, rather than how much money is tipped into the R&D pit.

An effective innovation strategy harnessing the best of the collaboration between Industry, academia, and research institutions is key – we need to build a sustainable ecosystem leveraging collaboration to fulfil the current needs of patients.

There are some really interesting tech solutions coming through that will help – my favourite was the ‘body on a chip’ approach. This uses breakthroughs in cell culture to allow testing on human cells in early clinical trials (Phase 1/Phase 2) that will better reflect how a small molecule or biologic will respond in a human context.

Body on a chip

But first we can take some simple behavioural learnings from the experiences of big pharma. These include ensuring that pre-clinical teams are speaking to clinical teams (i.e. removing silos), and changing the incentive structure to encourage sharing failures rather than allowing them to be repeated multiple times by separate groups. (This is in both academic and industry contexts.)

Biotech is yet to be disrupted in the way many other industries have been, and it takes too long to get a medicine to market. In her inspiring keynote address, Dr Bahija Jallal (Head of MedImmune) challenged us to think about how we ethically iterate in biomedicine to maintain robust scientific and clinical evidence, ensure safety, and do it all much faster! She says the first step is “to allow experimentation and out of the box thinking, encourage disruption, measured risk, and behaviours that don’t squash innovation.”

“We need to allow experimentation and out of the box thinking, encourage disruption, measured risk, and behaviours that don’t squash innovation.” 

Dr Bahija Jallal, Head of MedImmune

To meet this capability challenge, leaders need to embrace diversity of thought and collaboration and respond to failure to encourage learning behaviour.

Thanks for reading! Part two of this series will explore how technologies and regulators are working together to bring biotech solutions to market.

Let’s change the world through Biotech!

GapSummit group

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 2 of this blog series: Bringing biotech solutions to market

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Data driven biotech

Posted: 01 September 2017
The third in a blog post series by National Technology Networks Manager Kimberlee Jordan, following her recent Biotech trip to the United States

I don’t think there was a single session I attended at BIO 2017 that didn’t mention Big Data. One fact that has stuck with me is that Craig Venter (who led the privately-funded version of the Human Genome Project and now leads the Human Longevity Project) is in the top one percent of users of Amazon servers – putting him up there with Netflix and Zynga. That is a LOT of data!!

The rate at which DNA sequencing technologies are increasing their data output is faster than the rate at which computation power is growing, which means that our ability to generate this type of data has outstripped our ability to store and analyse it.

Venter’s Human Longevity Project has sequenced over 45,000 genomes since they kicked off, and one of their rate limiting factors is computer storage and CPU usage. This costs them about $1 million a month.

In a beautiful piece of circularity, Microsoft announced earlier in 2017 that within the next year or two they plan to be able to store data on strands of DNA and expect to have an operational storage system up and running by 2020. This will be achieved through DNA synthesis and in fact is already possible as illustrated over five years ago when a Harvard geneticist encoded one of his text books on strands of DNA.  Currently it’s just a bit slow and expensive to be practical.

So, what can we do with all this data? One of the most fascinating talks I heard at BIO 2017 was given by Atul Butte – the Pricilla Chan and Mark Zuckerberg Distinguished Professor at the University of California, San Francisco (along with a long list of other impressive appointments). He is a champion for the use of public data to promote science (he was recognised by former US president Barack Obama for this commitment), and his passion is obviously infectious. More than half of his students go on to create startups in this space, even those who go into academia.  My hands down favourite quote of the conference was his comment that “If we want to change the world, we can’t sit around writing papers about it.”

Atul shared a long list of startups born to create value and improve health outcomes using big public data. He started with Carmenta Bioscience, which he co-founded in 2013 with seed investment of US$2 million. Using data mining techniques and publicly-available data from women who had suffered preeclampsia to identify biomarkers associated with this life-threatening condition, Carmenta developed an extremely accurate diagnostic for preeclampsia and in less than two years sold for an undisclosed amount to Progenity. This is how you make money from science! And the best thing is, as Atule pointed out, data is totally reusable – it’s not like oil or water.

Unlike IT startups, one does not typically think of drug discovery companies starting up in garages or mothers’ basements. But NuMedii could have done exactly that. They are a four-person company using computational prediction and big public datasets to try and work out which currently-available drugs can be used to treat other diseases. And they aren’t the only ones doing this: 9 Computational Drug Discovery Startups Using AI.

Atule emphasised the importance of tools which can analyse and manage this data. Machine learning – a subset of artificial intelligence (AI) in particular has some interesting applications. It is great for non-linear things, like pictures and pattern recognition, which means it can be used on medical data like X-rays. For a great infographic on AI see the image below, or view the full PDF online.

Artificial Intelligence infographic

Interestingly, at a recent AI meet-up in Auckland, a surgeon from Auckland Hospital noted that he spends a lot of time looking at x-rays as part of the triage process – he was keen to know if this is something that could be done by AI. The first question the crowd asked is “how much data do you have?” i.e. how many x-rays. “Heaps!” was the response…and spontaneously individuals in the room with the right expertise started mapping out potential solutions to this problem. I can’t help but wonder what goldmines of data might be lying around in our district health boards?

The convergence of AI and biotechnology offers an exciting opportunity for New Zealand – we have a wealth of the life science expertise which is essential for these types of companies, an increasing number of data scientists, and investors who love IT startups. This could be a match made in heaven.

At the end of the day, we have the data, we have the tools, in some ways the hardest part is still figuring out what question you want to ask - what is the unmet need? The answer to this question is where the opportunity lies. 

Contact Kimberlee Jordan on Twitter @kimberlee_j

Callaghan Innovation is a New Zealand government innovation agency that works with Kiwi companies to accelerate commercialisation of their new technology ideas. Our National Technology Networks team supports businesses via our four technology platforms – Advanced Manufacturing, Advanced Materials, Biotechnology and Data & IoT, with the aim of helping companies rapidly connect to new and advanced technologies. 

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New Zealand company leads the world in eczema research

Posted: 30 March 2016
A breakthrough eczema treatment has propelled a New Zealand scientist into the spotlight, leading to the invitation to deliver a keynote speech at the top global dermatology conference later this year.

Dr. Iona Weir, CEO of Auckland-based Decima Health, will be a major attraction at The International Conference on Clinical and Experimental Dermatology (ICCED) in Chicago in May on the strength of the work done on Atopis, a treatment for eczema that convinces the body’s immune system to attack the affected area.

For Dr. Weir, this is the culmination of over twenty years’ of ongoing research and product development, while she also worked as a company director of various natural product companies, playing a central role in growing several start-ups through to successful commercialisation.  This has included the number one gastrointestinal health product, Phloe™ in the New Zealand over-the-counter laxative market.

“Atopis™ has its origins in the research from my PhD from 1997 which proved there is a process of programmed cell death called apoptosis that occurs in plants.  This research was groundbreaking at the time and won an international award for best PhD.”

The research continued to gain accolades and a Marsden Fund grant allowed Weir to prove that, unlike animals, apoptosis in plants is reversible.  This discovery was able to be applied to human health needs and has been the basis of Dr. Weir’s ground breaking research.

Critical reactions that occur in plants were carefully extracted and scientifically combined and set in a natural carrier cream. When applied to the surface of the skin they gently permeate to encourage the body’s natural immune response to attack the affected area and repair damaged cells.

“By manipulating this reversibility in plants I have been able to create Atopis™ to manipulate apoptosis and immune function in human cells to stimulate cell repair and growth.  A small clinical trial in the United States verified this and opened the door to a larger study”

The trial was recruited and fully completed within a time frame rarely seen in New Zealand – Iona Weir

A Callaghan Innovation grant helped ensure a second larger double blinded placebo controlled clinical trial of Atopis™ went ahead in New Zealand, and both the trial itself and the results it produced were impressive.

“Due to an innovative design and recruitment strategy the trial was recruited and fully completed within a time frame rarely seen in New Zealand and the trial results are very conclusive, showing ‘outstanding’ clinical significance in efficacy,” says Dr. Weir.

So outstanding, that when she submitted the conference abstract to the ICCED, the organisers invited Dr. Weir to share the story as a key note speech with the assembled global leading dermatologists, product scouts and experts and pharmaceutical company scientists.


 
“To be chosen as a key note speech on a new experimental product at an event like this, signifies that the organisers saw Atopis™ as one of the most innovative and exciting new scientific breakthroughs this year.”

Bionona Ltd, a subsidiary of Decima Health will look to partner nationally and internationally to release Atopis™.  Dr. Weir said that Callaghan Innovation’s support has helped to progress the business and ensure ongoing trials and research remain a uniquely New Zealand story, where the IP, patents and research are wholly New Zealand owned.

http://www.bionona.com/

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