Talk presented at ACI Biomarker Utilisation & Commercialisation conference 2014.
Talk provides an overview of the key considerations in developing and launching biomarkers and the associated platforms.
Cracking the ‘Business Process Outsourcing’ Code Main.pptx
Creating and capturing value with biomarkers
1. Capturing and creating value
with biomarkers
ACI Biomarker Utilisation & Commercialisation conference
Dean Griffiths PhD
5 September 2014 S4998-P-634 v1.0
2. Introduction to Cambridge Consultants - A world leader in technology and product innovation
Established out of The University of Cambridge in 1960
Approximately 430 scientists and engineers
For clients globally, we
– design and develop breakthrough products
– create and license intellectual property
– provide business consulting in technology critical issues
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3. Summary
Understand user needs
Solutions require
biomarker and platform
Enable solutions which
scale
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4. Agenda
1 How do users benefit from biomarkers?
2 Creating value by aligning to user needs
3 Enabling user adoption
4 Scaling user adoption
5 Where next for biomarkers
6 Summary
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7. Agenda
1 How do users benefit from biomarkers?
2 Creating value by aligning to user needs
3 Enabling user adoption
4 Scaling user adoption
5 Where next for biomarkers
6 Summary
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8. Creating value by aligning to user needs
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9. Creating value by aligning to user needs
Biomarkers are not new;
"Shushrut statue" by Alokprasad at en.wikipedia
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10. Creating value by aligning to user needs
The need for biomarkers is growing as more targeted cancer therapies increase
their market share
Reproduced from (Aitken, 2014)
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11. Although many targeted cancer therapies still lack biomarkers
16%
48%
2008 2013
37%
Drugs with FDA-approved
CDx
Drugs with FDA-approved
biomarkers
Other Drugs
Creating value by aligning to user needs
13%
57%
30%
Cambridge Consultants analysis 2014
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12. Creating value by aligning to user needs
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13. Creating value by aligning to user needs
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14. Creating value by aligning to user needs
Where are the tumour cells?
Folate receptor-α
targeted fluorescent agent
Van Dam et al Nature Medicine
17, 1315–1319 (2011)
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15. Creating value by aligning to user needs
Where are the tumour cells?
Folate receptor-α
targeted fluorescent agent
Van Dam et al Nature Medicine
17, 1315–1319 (2011)
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16. Creating value by aligning to user needs
Biomarkers used in vivo can detect more tumours
Van Dam et al Nature Medicine
17, 1315–1319 (2011)
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17. Creating value by aligning to user needs
Multiple companies are already active in this space
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18. Agenda
1 How do users benefit from biomarkers?
2 Creating value by aligning to user needs
3 Enabling user adoption
4 Scaling user adoption
5 Where next for biomarkers
6 Summary
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20. Enabling user adoption
Demonstrate utility
Image: Illumina
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21. Enabling user adoption
Enable users to be able to access the platform and biomarkers
The Economist
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22. Enabling user adoption
Ensure that the platform and biomarker are easy to use and interpret
Image: Illumina
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23. Enabling user adoption
Information not just data
Image: Illumina
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24. Agenda
1 How do users benefit from biomarkers?
2 Creating value by aligning to user needs
3 Enabling user adoption
4 Scaling user adoption
5 Where next for biomarkers
6 Summary
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27. Scaling user adoption
Decrease barriers to entry
Image: Abcam
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28. Scaling user adoption
Increase data confidence
Image: Abcam
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29. Scaling user adoption
Generate publicity and goodwill
Image: Abcam
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30. Agenda
1 How do users benefit from biomarkers?
2 Creating value by aligning to user needs
3 Enabling user adoption
4 Scaling user adoption
5 Where next for biomarkers
6 Summary
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31. Where next for biomarkers
New analytes
Image: Senior Airman Sandra Welch
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32. Where next for biomarkers
Non-invasive
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33. Where next for biomarkers
Predictive
Image: Sgt Eric T. Sheler - USAF
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34. Agenda
1 How do users benefit from biomarkers?
2 Creating value by aligning to user needs
3 Enabling user adoption
4 Scaling user adoption
5 Where next for biomarkers
6 Summary
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35. Summary
Understand user needs
Solutions require
biomarker and platform
Enable solutions which
scale
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Biomarkers are used by 3 types of people
All have different needs, the data, information, actions, advice, regulations
Wearables leverage biomarkers
Be mindful of what those needs are
They could be discrete or mixed
Biomarkers inform clinically actionable events
Implementation is evolving in clinical practice
Shushrut and Chakrat described a method for diagnosing what we now know as diabetes
They described the sweetness of urine – first by taste, but also they quantified it. Counted the number of ants attracted.
Bring things up to date
Data from IMS show how the utilisation of cancer drugs is changing
Targeted therapies as the name suggests hit a particular mutation
Significant growth in targeted theratpies
Decline in general cytotoxics
Occuring in all areas; both developed ecomies and emerging economies
However many of these therapies still lack an approved FDA diagnostic test, either as a lab test or a companion diagnostic
Targeted therapies are only going to increase, pharma pipelines are bulging with targeted cancer therapies
Immunotherapies – need for biomarkers, often used in combination with targeted therapies
Switching gears; but sticking with cancer
Pathologists tool kit use H&E staining to identify tumours
Simple, reliable, inexpensive and accessible
But while these data are useful for diagnosis and showing what has been removed
They don’t show what should be removed
Dissecting tumours to ensure that all the material is removed, while removing as little healthy tissue as possible improves outcomes
But distinguising between healthy and cancerous tissue can be challenging
Some may be able to identify some of the lumps here in a cervical cancer
A trained eye may be able to idetify some more
But wouldn’t it be better to use a biomarker, in vivo to distinguish normal and cancer cells
Van Dam and colleagues used a folate receptor alpha targeted fluorescent agent
Expressed on the surface of up to 95% of cervical cancers
Readily highlights the cancer cells – enabling cleaner removal
This experiment was done in humans – the first demonstration of in human efficacy
When this was quantified there is a significant increase in number of lumps
Lots of companies
Dyes, Abs, imaging system, other optical techniques e.g. endofotonics and Raman – physical properties of the cells – parallels with circulating tumour cells detectio
Illumina more than anyone else have changed the biomarker landscape over the last few years following the acquisition of Solexa
This started in research, and continues in research however Illumina are targeting the clinical market as a significant growth area
They woud like to provide the companion diagnostic for virtually every drug
How are they doing it
They are able to highlight stories about people
Shelley Valiant – diagnosed that her phyciscial symptoms as a small child including poor motor control were due to mutation in neurotransmitter metabolism
Using whole genome sequecing
Dopamine
Reduce cost of data – combination of reagents and instruments
Make instruments easier to use
Provide panels, enable panels to be made
Bespoke or multiple companies now offfer cancer panels, infectious disease panels etc
Don’t just give raw data
Scale is the buzzword in the start up and investment community
Talk to an executive from GE and if they don’t say scale they have not been there very long
Abcam are actively scaling from a company started over a conversation about the cost and margins for antibodies at a dinner party to a globally recognised brand
Knew who their customers were Phd students and postdocs
Wanted to use the web – not some catalogue; it seems obvious now but 10 years ago this was changing the may research tools were sold
Lots of themes from Amazon
Researchers are price sensitive – abs were notorious for not working and there was nothing you could do about it.
If you wanted a new Ab you might see what someone had published or ring a collegues
Abcam gave you money back
Reviews
Got word out
Tony Kouzarides wanted to get some winter sun
VOCs
X prize tricorder
Scanadu
Voice recognition for depression
Gait analysis
Can all speculate where this will go
While it may not be gattaca growth of 23&me show public interest