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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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 5 September 2014 2 S4998-P-634 v1.0
- 3. Summary Understand user needs Solutions require biomarker and platform Enable solutions which scale 5 September 2014 3 S4998-P-634 v1.0
- 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. Researchers, clinicians and consumers 5 September 2014 5 S4998-P-634 v1.0
- 6. Data, therapies and advice 5 September 2014 6 S4998-P-634 v1.0
- 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. Creating value by aligning to user needs 5 September 2014 8 S4998-P-634 v1.0
- 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. 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. 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. Creating value by aligning to user needs 5 September 2014 12 S4998-P-634 v1.0
- 13. Creating value by aligning to user needs 5 September 2014 13 S4998-P-634 v1.0
- 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. 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. 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. 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. 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. Enabling user adoption 5 September 2014 19 S4998-P-634 v1.0
- 20. Enabling user adoption Demonstrate utility Image: Illumina 5 September 2014 20 S4998-P-634 v1.0
- 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. 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. Enabling user adoption Information not just data Image: Illumina 5 September 2014 23 S4998-P-634 v1.0
- 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. Scaling user adoption Scale is king 5 September 2014 25 S4998-P-634 v1.0
- 26. Scaling user adoption 5 September 2014 26 S4998-P-634 v1.0
- 27. Scaling user adoption Decrease barriers to entry Image: Abcam 5 September 2014 27 S4998-P-634 v1.0
- 28. Scaling user adoption Increase data confidence Image: Abcam 5 September 2014 28 S4998-P-634 v1.0
- 29. Scaling user adoption Generate publicity and goodwill Image: Abcam 5 September 2014 29 S4998-P-634 v1.0
- 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. Where next for biomarkers New analytes Image: Senior Airman Sandra Welch 5 September 2014 31 S4998-P-634 v1.0
- 32. Where next for biomarkers Non-invasive 5 September 2014 32 S4998-P-634 v1.0
- 33. Where next for biomarkers Predictive Image: Sgt Eric T. Sheler - USAF 5 September 2014 33 S4998-P-634 v1.0
- 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. Summary Understand user needs Solutions require biomarker and platform Enable solutions which scale 5 September 2014 35 S4998-P-634 v1.0
- 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
Editor's Notes
- 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