Capturing and creating value 
with biomarkers 
ACI Biomarker Utilisation & Commercialisation conference 
Dean Griffiths Ph...
Introduction to Cambridge Consultants - A world leader in technology and product innovation 
 Established out of The Univ...
Summary 
Understand user needs 
Solutions require 
biomarker and platform 
Enable solutions which 
scale 
5 September 2014...
Agenda 
1 How do users benefit from biomarkers? 
2 Creating value by aligning to user needs 
3 Enabling user adoption 
4 S...
Researchers, clinicians and consumers 
5 September 2014 5 S4998-P-634 v1.0
Data, therapies and advice 
5 September 2014 6 S4998-P-634 v1.0
Agenda 
1 How do users benefit from biomarkers? 
2 Creating value by aligning to user needs 
3 Enabling user adoption 
4 S...
Creating value by aligning to user needs 
5 September 2014 8 S4998-P-634 v1.0
Creating value by aligning to user needs 
Biomarkers are not new; 
"Shushrut statue" by Alokprasad at en.wikipedia 
5 Sept...
Creating value by aligning to user needs 
The need for biomarkers is growing as more targeted cancer therapies increase 
t...
Although many targeted cancer therapies still lack biomarkers 
16% 
48% 
2008 2013 
37% 
Drugs with FDA-approved 
CDx 
Dru...
Creating value by aligning to user needs 
5 September 2014 12 S4998-P-634 v1.0
Creating value by aligning to user needs 
5 September 2014 13 S4998-P-634 v1.0
Creating value by aligning to user needs 
Where are the tumour cells? 
Folate receptor-α 
targeted fluorescent agent 
Van ...
Creating value by aligning to user needs 
Where are the tumour cells? 
Folate receptor-α 
targeted fluorescent agent 
Van ...
Creating value by aligning to user needs 
Biomarkers used in vivo can detect more tumours 
Van Dam et al Nature Medicine 
...
Creating value by aligning to user needs 
Multiple companies are already active in this space 
5 September 2014 17 S4998-P...
Agenda 
1 How do users benefit from biomarkers? 
2 Creating value by aligning to user needs 
3 Enabling user adoption 
4 S...
Enabling user adoption 
5 September 2014 19 S4998-P-634 v1.0
Enabling user adoption 
Demonstrate utility 
Image: Illumina 
5 September 2014 20 S4998-P-634 v1.0
Enabling user adoption 
Enable users to be able to access the platform and biomarkers 
The Economist 
5 September 2014 21 ...
Enabling user adoption 
Ensure that the platform and biomarker are easy to use and interpret 
Image: Illumina 
5 September...
Enabling user adoption 
Information not just data 
Image: Illumina 
5 September 2014 23 S4998-P-634 v1.0
Agenda 
1 How do users benefit from biomarkers? 
2 Creating value by aligning to user needs 
3 Enabling user adoption 
4 S...
Scaling user adoption 
Scale is king 
5 September 2014 25 S4998-P-634 v1.0
Scaling user adoption 
5 September 2014 26 S4998-P-634 v1.0
Scaling user adoption 
Decrease barriers to entry 
Image: Abcam 
5 September 2014 27 S4998-P-634 v1.0
Scaling user adoption 
Increase data confidence 
Image: Abcam 
5 September 2014 28 S4998-P-634 v1.0
Scaling user adoption 
Generate publicity and goodwill 
Image: Abcam 
5 September 2014 29 S4998-P-634 v1.0
Agenda 
1 How do users benefit from biomarkers? 
2 Creating value by aligning to user needs 
3 Enabling user adoption 
4 S...
Where next for biomarkers 
New analytes 
Image: Senior Airman Sandra Welch 
5 September 2014 31 S4998-P-634 v1.0
Where next for biomarkers 
Non-invasive 
5 September 2014 32 S4998-P-634 v1.0
Where next for biomarkers 
Predictive 
Image: Sgt Eric T. Sheler - USAF 
5 September 2014 33 S4998-P-634 v1.0
Agenda 
1 How do users benefit from biomarkers? 
2 Creating value by aligning to user needs 
3 Enabling user adoption 
4 S...
Summary 
Understand user needs 
Solutions require 
biomarker and platform 
Enable solutions which 
scale 
5 September 2014...
Dean.Griffiths@Cambridgeconsultants.com 
+44 1223 392139 
Cambridge UK 
Registered No. 1036296 England 
Boston USA Singapo...
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Creating and capturing value with biomarkers

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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.

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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
  • Creating and capturing value with biomarkers

    1. 1. Capturing and creating value with biomarkers ACI Biomarker Utilisation & Commercialisation conference Dean Griffiths PhD 5 September 2014 S4998-P-634 v1.0
    2. 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 5 September 2014 2 S4998-P-634 v1.0
    3. 3. Summary Understand user needs Solutions require biomarker and platform Enable solutions which scale 5 September 2014 3 S4998-P-634 v1.0
    4. 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 5 September 2014 Commercially Confidential 4 S4998-P-634 v1.0
    5. 5. Researchers, clinicians and consumers 5 September 2014 5 S4998-P-634 v1.0
    6. 6. Data, therapies and advice 5 September 2014 6 S4998-P-634 v1.0
    7. 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 5 September 2014 Commercially Confidential 7 S4998-P-634 v1.0
    8. 8. Creating value by aligning to user needs 5 September 2014 8 S4998-P-634 v1.0
    9. 9. Creating value by aligning to user needs Biomarkers are not new; "Shushrut statue" by Alokprasad at en.wikipedia 5 September 2014 9 S4998-P-634 v1.0
    10. 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) 5 September 2014 10 S4998-P-634 v1.0
    11. 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 5 September 2014 11 S4998-P-634 v1.0
    12. 12. Creating value by aligning to user needs 5 September 2014 12 S4998-P-634 v1.0
    13. 13. Creating value by aligning to user needs 5 September 2014 13 S4998-P-634 v1.0
    14. 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) 5 September 2014 14 S4998-P-634 v1.0
    15. 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) 5 September 2014 15 S4998-P-634 v1.0
    16. 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) 5 September 2014 16 S4998-P-634 v1.0
    17. 17. Creating value by aligning to user needs Multiple companies are already active in this space 5 September 2014 17 S4998-P-634 v1.0
    18. 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 5 September 2014 Commercially Confidential 18 S4998-P-634 v1.0
    19. 19. Enabling user adoption 5 September 2014 19 S4998-P-634 v1.0
    20. 20. Enabling user adoption Demonstrate utility Image: Illumina 5 September 2014 20 S4998-P-634 v1.0
    21. 21. Enabling user adoption Enable users to be able to access the platform and biomarkers The Economist 5 September 2014 21 S4998-P-634 v1.0
    22. 22. Enabling user adoption Ensure that the platform and biomarker are easy to use and interpret Image: Illumina 5 September 2014 22 S4998-P-634 v1.0
    23. 23. Enabling user adoption Information not just data Image: Illumina 5 September 2014 23 S4998-P-634 v1.0
    24. 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 5 September 2014 Commercially Confidential 24 S4998-P-634 v1.0
    25. 25. Scaling user adoption Scale is king 5 September 2014 25 S4998-P-634 v1.0
    26. 26. Scaling user adoption 5 September 2014 26 S4998-P-634 v1.0
    27. 27. Scaling user adoption Decrease barriers to entry Image: Abcam 5 September 2014 27 S4998-P-634 v1.0
    28. 28. Scaling user adoption Increase data confidence Image: Abcam 5 September 2014 28 S4998-P-634 v1.0
    29. 29. Scaling user adoption Generate publicity and goodwill Image: Abcam 5 September 2014 29 S4998-P-634 v1.0
    30. 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 5 September 2014 Commercially Confidential 30 S4998-P-634 v1.0
    31. 31. Where next for biomarkers New analytes Image: Senior Airman Sandra Welch 5 September 2014 31 S4998-P-634 v1.0
    32. 32. Where next for biomarkers Non-invasive 5 September 2014 32 S4998-P-634 v1.0
    33. 33. Where next for biomarkers Predictive Image: Sgt Eric T. Sheler - USAF 5 September 2014 33 S4998-P-634 v1.0
    34. 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 5 September 2014 Commercially Confidential 34 S4998-P-634 v1.0
    35. 35. Summary Understand user needs Solutions require biomarker and platform Enable solutions which scale 5 September 2014 35 S4998-P-634 v1.0
    36. 36. Dean.Griffiths@Cambridgeconsultants.com +44 1223 392139 Cambridge UK Registered No. 1036296 England Boston USA Singapore www.CambridgeConsultants.com Cambridge Consultants is part of the Altran group, a global leader in Innovation. www.Altran.com The contents of this presentation are commercially confidential and the proprietary information of Cambridge Consultants © 2014 Cambridge Consultants Ltd. All rights reserved. 5 September 2014 S4998-P-634 v1.0

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