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InnVentis
From Big DATA
to
Precision Medicine ?
Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New
Taxonomy of Disease Committee on a Framework for Development a New Taxonomy of Disease
Preparing for Precision Medicine World Economic Forum November 2012
By 2020, four out of every five drugs launched will be Precision Medicine drugs
The precision medicine revolution: Targeted treatment zeros in on disease; GE Look ahead 2013
Precision Medicine © Dr. Thomas Wilckens, InnVentis
InnVentis
Precision Medicine - Paradigm Shift
Symptom-based Cohort-based Algorithm-based
Yesterday
Intuition
Medicine
Today
Evidence-based
Medicine
Tomorrow
Precision
Medicine
DATAACTIONS
Application of rules, algorithms and reference databases enables
ACTIONABLE clinical decision support & PRECISE/EFFICIENT care
Reference
Databases
(Rules &
Algorithms)
Personal
Molecular
Profiles
(PMP, multi-omics)
Molecular
Imaging
Non-molecular content
(waveforms)
Precision
Medicine
(prevention,
diagnosis, treatment)
Mobile
Information
Communication
Technologies
Big Data
Analytics
Precision Medicine © Dr. Thomas Wilckens, InnVentis
InnVentis
From Big DATA to PRECISION MEDICINE:
We need vertically integrared flagship projects
…Although grand in overall scope, precision medicine can succeed iteratively and likely
can move forward only through pilot studies—some that will establish STANDARDS and
best practices and some that will be SCALABLE, illuminating routes toward larger and
broader efforts..
K. Yamamoto, SCIENCE Translational Medicine August 2015:
InnVentisDisrupting Biopharmaceutical R&D:
The pressing need to improve R&D of Drug and Diagnostics
Broken drug discovery paradigm,
not sustainable costs in R&D
Data overflow (*omics deluge)
No standards and SOPs:
Garbage in – Garbage out
The Cost Of Creating A New Drug (up to) $5 Billion US-$,
Pushing Big Pharma To Change
11/2013
"One of the biggest challenges in medicine and science
today is how to interpret the vast amount of biological
data we are generating... To make these data interpretable
and clinically actionable will require new computational
tools.”
Craig Venter 08/2014
5
InnVentis
6
The SNYDEROME:
Multi-omics, longitudinal mapping of one single person
 20 different snapshots in 14-months
 40,000 molecular parameters per blood
sample
 50 Terabytes of data
 $2,000 each blood sample,
only reagents, not counting costs for analysis,
staff, storage etc.
 40 co-authors
Costs: 10M US$
Mike Snyder, CELL, Volume 148, Issue 6, p1293–1307, 16 March 2012 Precision Medicine © Dr. Thomas Wilckens, InnVentis
InnVentis
Inflammation is a major driver of virtually every significant chronic human disease…
InnVentis develops products & services to enable the development of new drugs as
well as precise diagnostics & treatment decisions
Value creation from multi-omics & machine learning
InnVentisInflammation, a key driver of major chronic diseases
InnVentis 1st focus arthritis:
• Most Common Cause of Disability
• Affects all ages
• Cost in the U.S. $128 billion/year
Rheumatoid arthritis (RA)
• 1% of the worldwide population
• Major impact on productivity
• U.S. $40 billion/year in the US
• Poorly diagnosed
• “Trial & Error” treatment decision
InnVentis
Genome
25.000 genes
Proteome
1 million
Metabolome
> 6000 SM
Microbiom
1-3 % of
body mass
Existing knowledge ?
Big DATA
Pattern Discovery
Reference Database
Machine learning
Algorithms
Personal
Molecular
Profile
Drug
Molecular
Profile
Convergence of diagnostics with Big-Data & AI:
Multi-omics create Personal Molecular Profile, PMP and Drug Molecular Profile
InnVentis creates & integrates standardized data
in a proprietary analytics architecture.
Sample
collection KIT
InnVentis
105
data points
each sample
Treatment
Remission
Healthy
1 2 3 1514
Omics-derived PMP and DMP deciphered from few
allow stratification of many into specific subgroups
approximately 15 measurements in 18months
InnVentis ‘ new paradigm:
Intra-individual longitudinal multi-omics analysis replaces cohort based medicine
Disease onset
InnVentis
Precision Medicine © Dr. Thomas Wilckens, InnVentis
Disease Drug 1
Molecular profiling of drug actions:
Identifying responders with PMP and DMP
Drug 2 Drug 3 Remission
InnVentis
Team & board comprises 350+ years industry experience:
Success is about people
Leadership in ICT/Big DATA, diagnostics and biopharmaceutical R&D
invested 2000+ days in „sweat money“ & proprietary assets…
InnVentis
Precision Medicine & Big DATA
Thomas.Wilckens@InnVentis.com
InnVentis
enabling
PRECISION MEDICINE
Disclaimer:
This presentation is for educational purposes only.
No copyright violations are intended.
Distribution, also in part, for commercial purpose is illigal
Precision Medicine © Dr. Thomas Wilckens, InnVentis
InnVentisGarbage in – Garbage out?
Preclincial data
An analysis of past studies indicates that the cumulative (total)
prevalence of irreproducible preclinical research exceeds 50%,
resulting in approximately US$28,000,000,000 (US$28B)/year
spent on preclinical research that is not reproducible—in the
United States alone.
The Economics of Reproducibility in Preclinical Research, PLOS 2015
InnVentis
15
Nature Reviews Drug Discovery | 21 September 2015
Garbage in – Garbage out?
Drug discovery
Tackling reproducibility in academic
preclinical drug discovery
The reproducibility of biomedical research on novel
drug targets has become suspect. Here, we highlight
how drug discovery centres embedded in academic
institutions, but with a translational imperative, can
help address this reproducibility crisis.
InnVentisGarbage in – Garbage out?
Biomarker studies
Most biomarker discovery still takes place in government-funded
university laboratories that are ill equipped to undertake the
myriad procedures required for stringent biomarker profiling on
the scale required to achieve the evidence needed to attract
larger investment in clinical trials.
National Biomarker Development Alliance 9/2014
InnVentisGarbage in – garbage out?
Do Watson etc. create insight & value?
Nature 03 April 2013
If a job is worth doing, it is
worth doing twice
Researchers and funding
agencies need to put a premium
on ensuring that results are
reproducible
How much existing „knowledge“ can be used, how?
InnVentis
Standards and SOPs on the horizon to secure value today?
The case for vertically integrated lean, fast pilot projects
Launch of a Transformative Health Care Initiative:
The National Biomarker Development Alliance (NBDA) 1/2014
Problems with scientific research
How science goes wrong
Scientific research has changed
the world. Now it needs to
change itself 10/2013
A sea of standards for omics
data: sink or swim?
JD Tenenbaum et. al. Am Med Inform Assoc, 09/2013
SOPs
=
Value
Precision Medicine © Dr. Thomas Wilckens, InnVentis
Establishing data bases and algorithms
requires highest comparability, validity & reliability
InnVentis
Selected questions:
• Are current methods for sample collection and
biobanking aligned with hypersensitive *omics methods
• How much can you trust the sample handling
procedures at academic or CRO sites?
• How can we validate machine/deep learning algorithms
• Others …….

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Thomas Willkens-El impacto de las ciencias ómicas en la medicina, la nutrición y la biotecnología

  • 1. InnVentis From Big DATA to Precision Medicine ? Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease Committee on a Framework for Development a New Taxonomy of Disease Preparing for Precision Medicine World Economic Forum November 2012 By 2020, four out of every five drugs launched will be Precision Medicine drugs The precision medicine revolution: Targeted treatment zeros in on disease; GE Look ahead 2013 Precision Medicine © Dr. Thomas Wilckens, InnVentis
  • 2. InnVentis Precision Medicine - Paradigm Shift Symptom-based Cohort-based Algorithm-based Yesterday Intuition Medicine Today Evidence-based Medicine Tomorrow Precision Medicine DATAACTIONS Application of rules, algorithms and reference databases enables ACTIONABLE clinical decision support & PRECISE/EFFICIENT care Reference Databases (Rules & Algorithms) Personal Molecular Profiles (PMP, multi-omics) Molecular Imaging Non-molecular content (waveforms) Precision Medicine (prevention, diagnosis, treatment) Mobile Information Communication Technologies Big Data Analytics Precision Medicine © Dr. Thomas Wilckens, InnVentis
  • 3. InnVentis From Big DATA to PRECISION MEDICINE: We need vertically integrared flagship projects …Although grand in overall scope, precision medicine can succeed iteratively and likely can move forward only through pilot studies—some that will establish STANDARDS and best practices and some that will be SCALABLE, illuminating routes toward larger and broader efforts.. K. Yamamoto, SCIENCE Translational Medicine August 2015:
  • 4. InnVentisDisrupting Biopharmaceutical R&D: The pressing need to improve R&D of Drug and Diagnostics Broken drug discovery paradigm, not sustainable costs in R&D Data overflow (*omics deluge) No standards and SOPs: Garbage in – Garbage out The Cost Of Creating A New Drug (up to) $5 Billion US-$, Pushing Big Pharma To Change 11/2013 "One of the biggest challenges in medicine and science today is how to interpret the vast amount of biological data we are generating... To make these data interpretable and clinically actionable will require new computational tools.” Craig Venter 08/2014 5
  • 5. InnVentis 6 The SNYDEROME: Multi-omics, longitudinal mapping of one single person  20 different snapshots in 14-months  40,000 molecular parameters per blood sample  50 Terabytes of data  $2,000 each blood sample, only reagents, not counting costs for analysis, staff, storage etc.  40 co-authors Costs: 10M US$ Mike Snyder, CELL, Volume 148, Issue 6, p1293–1307, 16 March 2012 Precision Medicine © Dr. Thomas Wilckens, InnVentis
  • 6. InnVentis Inflammation is a major driver of virtually every significant chronic human disease… InnVentis develops products & services to enable the development of new drugs as well as precise diagnostics & treatment decisions Value creation from multi-omics & machine learning
  • 7. InnVentisInflammation, a key driver of major chronic diseases InnVentis 1st focus arthritis: • Most Common Cause of Disability • Affects all ages • Cost in the U.S. $128 billion/year Rheumatoid arthritis (RA) • 1% of the worldwide population • Major impact on productivity • U.S. $40 billion/year in the US • Poorly diagnosed • “Trial & Error” treatment decision
  • 8. InnVentis Genome 25.000 genes Proteome 1 million Metabolome > 6000 SM Microbiom 1-3 % of body mass Existing knowledge ? Big DATA Pattern Discovery Reference Database Machine learning Algorithms Personal Molecular Profile Drug Molecular Profile Convergence of diagnostics with Big-Data & AI: Multi-omics create Personal Molecular Profile, PMP and Drug Molecular Profile InnVentis creates & integrates standardized data in a proprietary analytics architecture. Sample collection KIT
  • 9. InnVentis 105 data points each sample Treatment Remission Healthy 1 2 3 1514 Omics-derived PMP and DMP deciphered from few allow stratification of many into specific subgroups approximately 15 measurements in 18months InnVentis ‘ new paradigm: Intra-individual longitudinal multi-omics analysis replaces cohort based medicine Disease onset
  • 10. InnVentis Precision Medicine © Dr. Thomas Wilckens, InnVentis Disease Drug 1 Molecular profiling of drug actions: Identifying responders with PMP and DMP Drug 2 Drug 3 Remission
  • 11. InnVentis Team & board comprises 350+ years industry experience: Success is about people Leadership in ICT/Big DATA, diagnostics and biopharmaceutical R&D invested 2000+ days in „sweat money“ & proprietary assets…
  • 12. InnVentis Precision Medicine & Big DATA Thomas.Wilckens@InnVentis.com InnVentis enabling PRECISION MEDICINE Disclaimer: This presentation is for educational purposes only. No copyright violations are intended. Distribution, also in part, for commercial purpose is illigal Precision Medicine © Dr. Thomas Wilckens, InnVentis
  • 13. InnVentisGarbage in – Garbage out? Preclincial data An analysis of past studies indicates that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US$28B)/year spent on preclinical research that is not reproducible—in the United States alone. The Economics of Reproducibility in Preclinical Research, PLOS 2015
  • 14. InnVentis 15 Nature Reviews Drug Discovery | 21 September 2015 Garbage in – Garbage out? Drug discovery Tackling reproducibility in academic preclinical drug discovery The reproducibility of biomedical research on novel drug targets has become suspect. Here, we highlight how drug discovery centres embedded in academic institutions, but with a translational imperative, can help address this reproducibility crisis.
  • 15. InnVentisGarbage in – Garbage out? Biomarker studies Most biomarker discovery still takes place in government-funded university laboratories that are ill equipped to undertake the myriad procedures required for stringent biomarker profiling on the scale required to achieve the evidence needed to attract larger investment in clinical trials. National Biomarker Development Alliance 9/2014
  • 16. InnVentisGarbage in – garbage out? Do Watson etc. create insight & value? Nature 03 April 2013 If a job is worth doing, it is worth doing twice Researchers and funding agencies need to put a premium on ensuring that results are reproducible How much existing „knowledge“ can be used, how?
  • 17. InnVentis Standards and SOPs on the horizon to secure value today? The case for vertically integrated lean, fast pilot projects Launch of a Transformative Health Care Initiative: The National Biomarker Development Alliance (NBDA) 1/2014 Problems with scientific research How science goes wrong Scientific research has changed the world. Now it needs to change itself 10/2013 A sea of standards for omics data: sink or swim? JD Tenenbaum et. al. Am Med Inform Assoc, 09/2013 SOPs = Value Precision Medicine © Dr. Thomas Wilckens, InnVentis Establishing data bases and algorithms requires highest comparability, validity & reliability
  • 18. InnVentis Selected questions: • Are current methods for sample collection and biobanking aligned with hypersensitive *omics methods • How much can you trust the sample handling procedures at academic or CRO sites? • How can we validate machine/deep learning algorithms • Others …….

Hinweis der Redaktion

  1. SUBJECT MATTER INTRO. If there are elements here that are of more importance we can highlight in some manner. 2/14 – changed “precision medicine” to “precision care” with reference to other health elements 2/27 – addition of category -non-molecular content; combined big data analytics with ref database rules/algorithms.
  2. Problem to be solved and its relevance
  3. How InnVentis Solves the Problem! Know-how and patents