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Nanomedicine_5_

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Nano-medicine is developed with nano-biomedical nanotechnology to solve medical problems with discipline. The development of synthetic biology to develop cell or cell biology and computer robot technology, will bring a new nano-technology revolution. Nanotechnology and material of the field of medicine will bring about a profound revolution, mainly in the fight against cancer and cardiovascular disease is important.

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									Nanomedicine

           Ryan LeBlanc
      Stephen Asante-Ansong
             Shivani
Virginia Commonwealth University
            INFO 664
           May 5, 2008


                                   1
                      Outline
► Define nanomedicine - Ryan
► Explain the science behind nanomedicine - Ryan
► Analyze the nanomedicine industry
    Commercialized nanomedicine - Ryan
    Barriers and substitutes - Ryan
    Businesses and industries impacted - Stephen
    Business drives and business models - Stephen
    Discuss why nanomedicine is emerging - Stephen
► Discussethical considerations - Shivani
► Speculate on the future of nanomedicine - Shivani
                                                      2
         What is nanomedicine?
► “The  monitoring, repair, construction, and control
  of human biological systems at the molecular
  level, using engineered nanodevices and
  nanostructures”
► Application of nanoscale technologies to the
  practice of medicine
    Diagnosis
    Prevention
    Treatment
    Medical research
                                                        3
            Not if—but when?
► “Our  near-term ability to structure materials and
  devices at the molecular scale brings enormous
  immediate benefits and will revolutionize the
  research and practice of medicine.”
► “Nanomedicine is poised to revolutionize
  medical practice, bringing nanotechnologies to
  clinical reality and enabling clinicians to diagnose,
  treat and monitor disease with the most advanced,
  state-of-the art materials and tools.”

                                                      4
Science




          5
                   The nanoscale
► 1nm     = 10-9 meters (1 billionth of a meter)
       Fingernails grow at 1nm/sec
       Pigeon landing on an aircraft carrier
► Size   comparisons
       Carbon atom – 0.22nm
       Approximate size of a drug – 0.5nm
       Proteins – 3 to >100nm
       Viruses – 45 to 100nm
       Bacteria – roughly 500 to 10,000nm
       Average human cell is 10,000nm
► In   medicine, smaller is better!
                                                   6
              We’re not alone
► How   many cells in the human body?
   10 to 100 trillion
► How   many bacteria live on us?
   500 to 1,000 species
   10 times more than human cells
    ►100   to 1000 trillion




                                        7
     Complexity of a cell




                                                   8
www.temple.edu/stl/images/SignalTransduction.jpg
9
                                                                               10


http://www.proteinlounge.com/images/pathways/Antiproliferative-role-of-s.jpg
The Inner Life of a Cell




http://www.studiodaily.com/main/searchlist/6850.html   11
          Complexity of disease
Cancer
► Uncontrollable growth of our own cells
    Form tumors
► Earlydetection is essential but difficult
► Extremely difficult to distinguish between
  cancerous and healthy cells
    Over expression of a receptor
    Over production of a protein
    Elasticity
                                               12
Complexity of disease




                        13
How effective are current treatments?

► Cancer  death rates have not changed
 significantly since the 1950’s
   Second leading cause of death
   554,000 deaths annually (23%)
► Cancer diagnosis and treatment have
  remained essentially unchanged for decades
► Chemotherapy, radiation, surgery
   Non-specific
                                           14
    How can nanomedicine help?

Research
    Distinguish between cancerous and healthy cells
Early diagnosis
    Imaging
    Protein concentrations
Targeted drug delivery
    Cancer cell-specific cellular proteins
     ► Deliver   drug directly to the cancer cells
    Identify rogue DNA in cancer cells
     ► Replace   malfunctioning genes with engineered functioning
       genes
                                                                    15
How close are scientists to
 achieving these goals?




                              16
The nanomedicine industry




                            17
Volker Wagner, Anwyn Dullaart, Anne-Katrin Bock & Axel Zweck NATURE BIOTECHNOLOGY VOLUME 24 NUMBER 10 OCTOBER 2006




                                                                                                           18
Volker Wagner, Anwyn Dullaart, Anne-Katrin Bock & Axel Zweck NATURE BIOTECHNOLOGY VOLUME 24 NUMBER 10 OCTOBER 2006




                                                                                                           19
                                                                                                           20

Volker Wagner, Anwyn Dullaart, Anne-Katrin Bock & Axel Zweck NATURE BIOTECHNOLOGY VOLUME 24 NUMBER 10 OCTOBER 2006
           Drug delivery today
► Currently   no cell-specific drug delivery

► No   nanotechnology-enabled gene delivery

► Nanoparticulate   formulations
    NanaCrystal ® technology (Elan Drug Delivery, Inc.)


► Many   liposomal formulations of existing drugs
    ProtoSphere™ technology (Abraxis BioScience)
                                                          21
NanoCrystal® Technology




                      22
Benefits of NanoCrystal® Technology
► Rapamune®      (rapamycin) Wyeth 2000
   Allowed for tablet
   More convenient storage and administration
► Emend®     (aprepitant) Merk 2003
   Allowed it to be soluble
   Would not have worked without the new technology
► TriCor®   (fenfibrate) Abbott 2004
   Can be given with or without food
► Megace®    ES (megestrol) Par 2004
   Improved bioavailability
   Increased viscosity
                                                      23
► ProtoSphere™                                    technology
           nab™ technology (nanoparticle albumin-bound)
              ► 130           nanometers




                                                               24

 http://www.abraxisbio.com/rnd_platform_nab.htm
Clinical benefits of nab™ technology
► Made                   solvent-based paclitaxel more effective
           Tumor response rate doubled
               ►11.1%                   to 21.5%
► Eliminated  the need for premedicaiton to
   prevent solvent-related reactions
           Difficulty breathing, hives, swollen eyes and lips
► Reduced                            infusion time
           3 hours to 30 miniutes


                                                              25

 http://www.abraxane.com/benefits-cancer-treatment.aspx
Barriers faced by nanomedicine
► Technological   challenges




► Commercialization   challenges
                                   26
Commercialization challenges
Few near-term commercially viable
disruptively innovative products
Big pharma’s reluctance to embrace
nanomedicine
Confusion at the Patent Trade Office (PTO)
and Food and Drug Administration (FDA)
Large-scale production challenges
High production costs
Absence of clear regulatory guidelines
 ►Publicreluctance
 ►Investor caution
A well-established micrometer-scale industry   27
   Commercialization challenges
► Patents   are important
    “The critical role of patents to the nanomedicine
    “revolution” cannot be underestimated.”
    Patents generally precede funding from venture capitals
    firms

► Nanomedicine    “land-grab”
    Companies, start-ups, and universities are ascribing
    high value and importance to patents
    Obtaining broad protection for new nanoscale materials

                                                          28
Annual nanomedicine patents
                    4000




                              29
                  Patent thickets
► “adense web of overlapping intellectual
 property rights that a company must hack its
 way through to actually commercialize new
 technology”
       Massive patent litigation battles lie ahead
       Discourages and stifles innovation
       Discourages investors


► May prove to be the major bottleneck to
 viable commercialization
                                                     30
Nanomedicine industry
►   Key Players and Clients

►   Business Drivers

►   Business Models

►   Timelines

►   Why is nanomedicine emerging?
Key Players




              32
Business Drivers for nanomedicine

► Driver   1 – Ineffective current technologies

► Driver   2 – Personalized medicine

► Driver   3 – Informatics

► Driver   4 – Ageing population (baby boomers)

► Driver   5 – Healthcare economics               33
Ineffective current technologies
Current research:
                              ►   INTRADERMAL DRUG DELIVERY

►   Gene therapy
►   Genomics
►   Proteomics
►   Biosensors
►   Nano-scaffolds
►   Lab-on-a-chip
►   Nano-particles
►   Clinical diagnostics
►   Silicon quantum dots
►   Optical analysis
►   Terahertz imaging
►   Smart drug delivery
►   New generation implants
►   Biocompatible materials                                   34
 Personalized medicine

Increasingly, diagnosis and        ►   PRE-IMPLANTATION
  treatment will be                    GENETIC DIAGNOSIS
  personalized:

►   Personalized medicine –
    targeted drugs in line with
    individual patients
    metabolism.

►   Point-of-care genetic
    diagnostics – immediate
    patient prognosis will start
    to occur.
                                                           35
Informatics
Nanomedicine is creating a            ►   NANOMEDICINE AND
  demand for information                  BIOCOMPUTING
  technology:

►   Bioinformatics
►   Electronic records
►   Computerized physician order
    entry
►   Wireless technologies –
    interconnecting medical devices
    to hospital computer systems
►   Telemedicine
►   Digital information resources
►   Remote patient monitoring
►   Alarms via smart wearable
    devices
                                                             36
Ageing population (baby boomers)
                                ►   TRANSFORMATION OF HEALTHCARE
People’s lifestyles and diet        BASED ON HEALTHY LIVING
  are influencing change:

►   People are living longer.

►   People over 60 take
    more medications.

►   Population is aging –
    European Commission
    predicts a peak around
    2023 and start declining.
                                                              37
Ageing population (baby boomers)




                                   38
Healthcare economics
Nanomedicine is expected to       ►   POINT-OF-CARE DIAGNOSTIC
                                      TESTING
  reduce health care costs:

►   Proactive prevention rather
    than reactive treatment

►   Early detection approaches

►   Decentralizing healthcare –
    home visits, point-of-care
    diagnostics.
                                                             39
Restructuring commercial R&D
Increasingly, large corporation    ►   NANOMEDICINE FUNDING BY YEAR
   seek to acquire new
   technologies from small
   companies and universities:

    - Open innovation paradigm
    - Cost reduction
    - Optimize innovation

►   Funding of commercial R&D is
    soaring.

►   Cost of innovating new drugs
    has risen by a factor of 10
    since 1990s, but who pays?
                                                                  40
Business model

► Value  proposition
       - Improve patient’s quality of life.
       - Reduce healthcare costs.
► Revenue generation and margins – sales,
  leasing, subscription, support, target profit
  margin, cost structure.
► Robust patent systems develop commercially
  viable nanomedicine products
► Competitive strategy – cost, differentiation or
  niche                                             41
Business models
Market Segment

►   Tissue Engineers

►   Medical device manufacturers

►   Academic and research institutions

►   Dental community

►   Regenerative medicine community

►   Surgical tool companies

►   Biologic groups

►   Veterinary medicine
                                         42
Timelines

► Commercialnanomedicine is at a nascent stage of
  development.

     potential of nanomedicine is years or decades
► Full
  away.

► Just because a drug or medical application is
  technically feasible doesn't mean it will make it
  into production and be deployed where needed.
                                                      43
Timelines and New Challenges

► Big companies can afford to pay the license for a
  patent and then commercialize and market the
  product.

► Smaller  companies would rather collect license
  fees for the patents they possess than embark on
  the risky and expensive process of introducing a
  new drug or medical application into the market.

► Long,   difficult and research intensive.
                                                      44
Timelines and New Challenges

►   Displacement of certain classes of drugs –
    chemotherapy.

►   Legal

►   Environmental

►   Safety

►   Ethical

►   Regulatory                                   45
Why is nanomedicine emerging?

Nanomedicine – Hype or a real revolution in healthcare?

►   Extremely bad conditions (as cancer) will be treated
    easily by modifying the body’s genetic material.

►   Disease elimination will become normal, so we no longer
    will need to be worry about living with health
    conditions.

►   Diagnose diseases before there are any symptoms.

►   Administer drugs that are precisely targeted.

►   Use non-invasive imaging tools to demonstrate that the    46

    treatment was effective.
            Ethical principles
Non-instrumentalisation:
The ethical requirement of not
using individuals merely as a
means but always as an end of
their own.
Privacy
Non-discrimination
Informed Consent
Equity
Precautionary Principle
                                 47
       Precautionary Principle
► The Precautionary Principle is particularly
  important in this context
► This principle entails the moral duty of
  continuous risk assessment with regard to
  the not fully foreseeable impact of new
  technologies as is the case with
  nanomedicine


                                                48
        Ethical aspects of
          nanomedicine
Short term perspective
Nanocosmetic products
Nanodelivery vehicles / systems / implants
Nanodiagnostic tests
Middle term perspective
Nanodevices and Nanomedical products
Long term perspective:
Autonomous nanomachines

                                             49
Legal, regulatory, and insurance
issues
► Are we properly regulating new nano
  materials?
► How will our already strained health
  insurance system cope with human
  enhancements?



                                         50
              Transdisciplinarity

► A new research Paradigm - “lonely seekers
 of truth,”

► Example Average life span




                                              51
The future of nanomedicine




                             52
                     Respirocytes
►   Artificial mechanical red blood cell
►   The injection of 5ml therapeutic
    dose of 50% respriyocytes saline
    suspension a total of 5 trillion
    individual nanorobots
►   Primary Medical application include transfusable blood
    substitution; partial treatment for anemia,
    perinatal/neonatal and lung disorders; enhancement of
    cardiovascular/neurovascular procedures, tumor therapies
    and diagnostics; prevention of asphyxia; artificial breathing;
    and a variety of sports, veterinary, battlefield and other
    uses.
                                                                 53
               Microbivores
► An artificial mechanical white blood cells of
  microscopic size
► An infusion of a few milliliters of a
  microbivores would fully eliminate septicemic
  infections in minutes to hours.




                                                  54
Chromosome replacement therapy
► Medical nanorobots able to intervene at the
  cellular level
► Inheritive defective genes could be replaced
  with non-defective base pair sequences
  permanently curing a genetic disease




                                                55
       Future nanomedicine

► Nanorobot replacing neurons
http://www.youtube.com/watch?v=R-2Xw-
  GNkUQ

► Nanobots killing a virus
http://www.youtube.com/watch?v=JyThoRCiw
  qc&feature=related
                                        56
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