Nanobiotechnology and Global Health:

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• Nanobiotechnology and Global Health
• Opportunities, Paradoxes, Integration
• Mauro Ferrari, Ph.D.
• Professor, Brown Institute of Molecular Medicine
• Chairman, Biomedical Engineering Department
• University of Texas Health Sciences Center,
  Houston
• Professor, Experimental Therapeutics MD Anderson
• Adjunct Professor, Bioengineering, Rice
  University
• Adjunct Professor Biomedical Engineering UT
  Austin
• President, Texas Alliance for NanoHealth

AIMBE, Washington DC, Feb 21 2008
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Three main parts

• History and Bioethics / Philosophy
• Nanotechnology examples
• Early detection from biofluids
• Sustained release therapeutic nanosystems
• Imaging contrast at low field
• Directed delivery / bio-barrier avoidance
• Models of Collaborative Research, Development and
  Deployment
• (The unspoken elephant Financial drivers?)

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Nanotechnology and Global Health

• Human Development Report, UN Development Program,
  2001 emphasis on tech, but no mention of
  nanotech
• UN Meeting on Nanotechnology Gap, Trieste 2003
• UN Task Force on Science, 2005 Technology and
  Innovation potential of nanotechnology for
  sustainable development
• Nanotechnology and the Developing World,
  Salamanca-Buentello F, Persad DL, Court
  EB, Martin DK, Daar AS, et al. (2005)
  Nanotechnology and the Developing World. PLoS Med
  2(5) e97 (Peter Singer)

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Nanotechnology and Global Health

• February 27, 2007 Using Nanotechnology to
  Improve Health Care in Developing Countries
  Washington DC (convergence of two Woodrow Wilson
  International Center Pew Foundation efforts
  the Project on Emerging Nanotechnologies and the
  Global Health Initiative).
• Singers proposed initiative Addressing Global
  Challenges Using Nanotechnology.
• Modeled after the Foundation for the NIH/Bill and
  Melinda Gates Foundation's Grand Challenges in
  Global Health, the initiative would be funded by
  national and international foundations, and from
  collaboration among nanotechnology initiatives in
  industrialized and developing countries.

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Singer study (PloS 2005) survey of 63
nanoscientists from around world

• Question Which do you think are the
  nanotechnologies most likely to benefit
  developing countries in the areas of water,
  agriculture, nutrition, health, energy, and the
  environment in the next 10 years? (see 2002 UN
  Johannesburg Summit on Sustainable Development).
• Criteria
• Impact
• Burden
• Appropriateness
• Feasibility (10 years)
• Knowledge gap
• Indirect benefits

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Correlation between the Top Ten Applications of
Nanotechnology for Developing Countries and the
UN Millennium Development Goals (from Singer et
al, 2005)
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Prioritized Health Care Applications of
Nanotechnology for Developing Countries (from
Singer et al 2005)_
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Bioethical framework (my personal views)

• Science and Society Kyoto 2005
• University of Minnesota Law School Ethics and
  Nanotechnology May 19 2006
• Presidents Council on Bioethics June 29 2007

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A Beauchamp-ChildressFrame of Reference for
Medical Ethics

• Beneficence (Do The Most Good)
• Non-Maleficence (Do No Harm)
• Respect (Autonomy, Self-Determination, Human
  Nature)
• Justice (Equal Access)

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Considerations on Beneficence What good can
medical nanotech do?

• Progress in
• Risk assessment
• Mass screening
• Early detection and treatment
• Increased treatment efficiency
• Personalized diagnostics therapy
• Reduction of undesired side effects
• Reduction in cost of medical care
• Increase in access to medical care

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Barriers to deployment of beneficial potential of
medical nanotech

• Insufficient scientific progress
• Delay in evolution of multidisciplinary
  perspective
• Delay in development of regulatory framework
• Delay in engagement of private sector
• Delay in education of practitioner base
• Delay in development of reimbursement protocols
• Insufficient/delayed engagement of stakeholders /
  general population
• Insufficient/delayed focusing on global health

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On Non-Maleficence (First
Do No Harm)

• Harm is potentially done by
• Not developing effective diagnostic/screening
  tools and prevention or therapeutic approaches
  that we are in a position to attain (Opportunity
  Cost)
• Treating when the suffering due to treatment
  exceeds the benefits to the patient, in his/her
  assessment
• Device/system malfunction
• Causing health problems in health care provider,
  non-patient population (e.g. environmental impact
  of therapeutic/diagnostic nanovectors)

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Respect

• Literacy Necessary for Informed Consent
• Performance Enhancement Issues
• What is Normal?
• What is Tolerable Risk?
• Who Decides?
• Who Pays?
• Who Benefits?
• How is Nano Different from Coffee / Steroids /
  Plastic Surgery on Normal

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Autonomy
(Right to Make Own Decisions)

• Screening and the optimizing / personalizing
  treatment necessarily will cause concerns of
• Privacy
• Self-determination
• Governmental Influence

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Privacy Matters

• Who is entitled to knowledge of risk profiles /
  prognostics / relevance of behavioral and
  environmental risk factors?
• Impact on
• Self-Determination vs. Optimal Care Algorithms
• Reimbursement / Access to Health Care
• Employment Discrimination
• Social Interaction
• Societal Layering / Cast of Ubermensch

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Justice Fair Access for All

• Will nanotech become yet another medical advance
  that will be of use only to the haves, and be
  inaccessible to the have nots in the World (and
  the USA)?
• Actually, nanotech can potentially help with
  health care in the underprivileged world, for
  instance by the development of
• Delivery vectors for single-dose vaccines
• Lower-cost medication, more accessible care
• Screening / diagnostics suitable for local
  societal environment

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Nanotechnology examples

• Early detection from biofluids
• Sustained release therapeutic nanosystems
• Imaging contrast at low field
• Directed delivery / bio-barrier avoidance

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Proteomic Nanochips for the Early Detection of
Disease from Blood and Other Biological Fluids

• Financial Support
• NCI Department of Defense (ARMY TATRC) NASA
  State of Texas Emerging Technology Fund (ETF)

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UTHSC/MDACC Proteomic Nanochip
Surface porosity
Surface patterning
Ferrari, Nature Reviews Cancer (2005)
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Blood Proteomics/PeptidomicsThe Hypothesis

• LIOTTA LA, FERRARI M, PETRICOIN EClinical
  proteomics written in blood. Nature(2003)

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Time dependent increase of Fibrinogen alpha chain
polypeptide
ABSTRACT
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Nanochannel Delivery Systems (nDS) Therapeutic
Implants

• Funding NASA, DoD, State of Texas, NMS
• Spinoff Company NanoMedical Systems (NMS)

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Nanochanneled Implants for the Controlled Release
of Therapy
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nDS1 Chip
SILICON WAFER
PYREX COVER
OUTLET
INLET
MICRO CHANNELS
NANO CHANNELS
NanoMedical Systems Confidential
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New nDS1 Structure (NanoMedical Systems)
High-Throughput 3mm X 4mm New nDS1 83160
nanochannels Apx 1000 times faster than prior nDS
designs
3D Top view
3D Bottom view
3mm
4mm
NanoMedical Systems and UTHSC Confidential