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Personalized medicine: needs, challenges and considerations. Montserrat Vendrell, CEO, Biocat. EPTA - “From genes to jeans: challenges on the road to personalized medicine ” . World’s population is ageing. Imperative for change : The few cost the most. % Population.

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personalized medicine needs challenges and considerations

Personalized medicine: needs, challenges and considerations

Montserrat Vendrell, CEO, Biocat

EPTA - “From genes to jeans: challenges on the road to personalized medicine”

slide3

Imperative for change: The few cost the most

% Population

% of Total Healthcare

Expense

Mean Annual

Cost per Person

1%

29%

$ 101,000

9%

39%

$ 15,000

20%

21%

$ 3,700

70%

11%

$ 580

sustainability of health care systems
Sustainability of Health Care Systems

Total health expenditure as a share of GDP, 2009

disruptive innovation
Disruptive innovation

Elements of disruptive innovation

Christensen CM, G.J. Hwang J (2009). The Innovator’s Prescription

technology trends transforming hc
Technology trendstransforming HC
  • Wireless Sensors and Devices
  • Genomics
  • Social Networking
  • Mobile Connectivity and Bandwidth
  • Imaging
  • Health Information Systems
  • The Internet
  • Computing Power and the Data Universe (Big Data)
slide9

Bilions of Data Points are Emerging Around Each Individual

Epigenome

TeleHealth

Phenome

Social Media

110101000

101010101

101010101

001000101

101010001

Na143K3,7

BP110/70

HCT32 BUN

12,9 Pulse

110 PLT150

110101000

101010101

101010101

001000101

101010101

110101000

101010101

101010101

001000101

101010000

Genome

Transcriptome

UUAGUG

AUGCGUCU

AGGCAUGC

AUGCC

GCGTAG

ATGCGTAG

GCATGCAT

GCCATTATA

GCTTCCA

Single Cell

Transactional

Proteome

iPS Cells

arg-his-pro

gly-leu-ser

Thr-ala-trp

fyt-val-met

phe-asp-cys

110101000

101010101

101010101

001000101

101010001

110101000

101010101

101010101

001000101

101010001

110101000

101010101

101010101

001000101

101010001

Source: Institute for Systems Biology

slide10

The Grand Challenge of the 21st Century in S & T is Complexity

  • Medicine as an informational science
  • Systems approaches allow one to understand wellness and disease – holist rather than atomistic
  • Emerging technologies will allow us to explore new dimensions of patient data space
  • Transforming analytic tools will allow us to decipher the billions of data points for the individual

Single individual

Single cell

Single molecule

Source: Institute for Systems Biology

slide11

Digitalization of Biology and Medicine Will Transform Medicine

  • (P4) Medicine
  • Predictive, Personalized, Preventive and Participatory
slide12

“We have, in truth, learned nothing from the genome other than probabilities. How does a 1 or 3 % increased risk for something translate into clinic?

It is useless information.”

J.Craig Venter, chairman of the J.Craig Venter Institute

July 2010 Interview with Der Spiegel

-----------------------------------------------------------------------------------------

slide14

Current response to therapies

  • Deterioration of patient’s quality of life
  • Increase cost of healthcare
slide17

If we know more about how living beings work, this knowledge will help us correct body functions when they are not what we want.

slide18

Location: Barcelona Science Park

Fonder: Dr. Roger Gomis

Focus: development of an assay to validate the capacity of its marker to predict future metastases to bone in cancer patients

slide19

Pharma’s transition to bio-therapeutics

Pharma annual sales trend

Pharma business model is changing

Medium efficency

Traditional

Pharmaceuticals

Sales $17B

High efficiency

Bio-therapeutics

Sales $23B

slide21

"A thriving biotech ecosystem is crucial for the success of the pharmaceutical industry as a whole. Recent challenges in the economic environment have made it difficult for many emerging biotech companies.  We believe that supporting and nurturing these companies will be good for the entire industry."

Our goal with Janssen Labs is to give novel technologies a greater opportunity to reach the patient by reducing some of the hurdles of early stage discovery."

Diego Miralles, J&J

Head, West Coast Research Center

slide22

How to choosetherighttarget to ensureefficacy

  • Preclinicaltox. in human cells
  • Reprofiling of existingdrugs (bypass patent expiration)

Budget 2012: 577 M$.

Goal: shortenthepathtoclinics

slide23

Imperativesforgenomic medicine

  • Making genomics-based diagnostics routine
  • Defining the genetic components of disease
  • Comprehensive characterization of cancer genomes
  • Practical systems for clinical genomics informatics
  • The role of human microbiome in health and disease
slide24

Bioinformatics and computationalbiology

  • Data analysis
  • Data integration
  • Visualization
  • Computational tools and infrastructure
  • Training
slide25

Education and training

  • Strengthening primary and secondary education
  • Conducting public outreach
  • Building HC providers’ genomic competences
  • Preparing the next generation genomic researchers
slide26

Genomics and society

  • Psychosocial and ethical issues in genomics
  • (from research to medicine)
  • Legal and public policy issues
  • Broader societal issues
drivers
Drivers
  • Patients - enabled by new technologies. Want safer more effective drugs. Want to take a more active role in their own HC
  • Payers - more certainty that the money spent generates medical benefit for the patient: cost-effective solution
  • Regulators - evidence that a drug that’s approved will work in the patients that receive it
  • Industry - cuts down development time and cost and increases their successrate
barriers
Barriers
  • Scientific/technical - data management, storage and analysis
  • Regulation - need for clear guidelines (reimbursement processes are uncertain, difficult for molecular Dx companies to get paid for the value they provide)
  • Physicians
    • a structural barrier: incentives are not aligned to prioritize prevention versus treatment.
    • not trained to adopt it in their daily practice
    • (in US, 20% of MD received PM education in medical school)
  • Pharma and Dx companies working together

Strategyneeded to implementgenomicsinto HC

slide29

Incorporatinggenomicsinto HC systems

  • Translation of research into quality-assured care pathways
  • Developing a service delivery infrastructure (from commissioning initial tests to counseling patients and their families)
  • Bioinformatics platform (storing and managing data)
  • Training NHS workforce
  • Addressing legal and ethical issues
  • Raising public awareness
slide30

Summary: challenges ahead

  • From data-collecting HC to data-driven HC
  • Development of a mid- & long-term strategy(at policy and clinical levels)
  • Linking technology to health outcomes. Monitor performance
  • Realignment of incentives: punish waste and reward quality and results
  • Innovation vs. Cost (Role of HTA)
  • LeanerR&Dapproaches. Variabilizationof fix costs (virtual companies)
  • The technology revolution is limited by economic, organizational and technology disparities among countries
  • Whole new range of competences:
    • Systemic thinking
    • Project management
    • Communication
    • Clinical + Genomics + IT

$