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Bio and Nanotechnology: Emerging Medical Miracles on the Horizon


Understand biotechnology and nanotechnology. Describe the biotechnology market size ... List a number of new therapies resulting from bio and nanotechnology ... – PowerPoint PPT presentation

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Title: Bio and Nanotechnology: Emerging Medical Miracles on the Horizon

Bio- and Nanotechnology Emerging Medical
Miracles on the Horizon
  • Marsha K. Millonig, MBA, RPh
    President CEO

  • Catalyst Enterprises, LCC
  • ASAP Annual Industry Technology Issues
  • January 15-17, 2009
  • St. Petes Beach, FL

Todays Objectives
Understand biotechnology and nanotechnology
Describe the biotechnology market size
Explain what fields are parts of the emerging
business of life science List a number of new the
rapies resulting from bio and nanotechnology
Discuss the implications of these new therapies
on pharmacy and its technology partners
Why is it Important?
Global Population Growth
  • Earths capacity is estimated at 12 billion
  • It took 100 million years before Earth had 1
    billion people in 1830
  • Yet only 170 years for the population to reach 6
    billion plus
  • 2005 6,436,562,930
  • 2009 6,752,560,109
  • ½ the people who have ever lived are on the
    planet today
  • Less than 100 years before we reach capacity

Biotechnology is needed to
  • Create better fuels that dont harm environment
  • Create tools to clean environment, feed a
    burgeoning global population, cure untold human

Biotechnology Definition
  • Use of cellular and biomolecular processes to
    solve problems or make useful products. Life
    sciencesbiology/chemistry technology affecting
    discovery and development of products for
  • Healthcare (therapeutics, diagnostics, drug
    delivery, cell and gene therapy, devices,
    drug/device combinations)
  • Agriculture (food, feed, fibers, transgenics)
  • Industrial and Environment (reduce pollution,
    clean energy)
  • All driven by a new set of enabling technology
    (genomics, combinatorial chemistry, SNPs,
    proteomics, sequencing)

The firsts
Development is evolutionary
  • 4000-2000 BC biotech used to leaven bread
    ferment beer
  • 1830 Proteins discovered
  • 1833 First enzyme discovered
  • 1865 Genetic science begins-Mendel discovers
    laws of heredity
  • 1879 Chromosomes discovered

Development is evolutionary
  • 1906 The term genetics introduced
  • 1919 The word biotechnology is first used in
  • 1938 The term molecular biology coined
  • 1941 The term genetic engineering is first used

Development is evolutionary
  • 1953 Watson and Crick DNA Structure
  • 1958 DNA made in test tube
  • Sickle cell caused by AA change
  • 1960 Messenger RNA discovered
  • 1967 First automatic protein sequencer is
  • 1969 Enzyme synthesized in vitro the first time
  • 1970 First enzyme discovered to cut DNA
    molecules at a specific site

Development is evolutionary
  • 1971 First complete synthesis of a gene
  • 1973 First time DNA fragments linked
  • 1975 First monoclonal antibodies made
  • 1976 First NIH research guidelines
  • Boyer co-founds Genentech, 1st bio co.
  • 1978 Recombinant insulin first produced
  • 1980 Oil-eating microbes patented by Exxon
  • 1982 First recombinant DNA vaccine for
  • 1983 First whole plant grown from biotechnology

Development is evolutionary
  • 1980 First gene-synthesizers developed
  • 1981 First transgenic animals
  • 1982 First biotech drug insulin
  • 1983 First artificial chromosome synthesized
  • First genetic markers for inherited disease

Development is evolutionary
  • 1984 DNA fingerprinting developed
  • 1985 Genetic fingerprinting entered as evidence
    in courtroom
  • 1986 Interferon first anti-cancer drug from
  • First genetically engineered vaccine for humans
    Hepatitis B
  • Microbes used to clean oil spill

but speeding up.
  • 1988 First US patent for genetically altered
    animala transgenic mouse
  • 1989 First DNA exoneration now 216 (4/08)
  • 1990 First food product from biotech approved
    modified yeast
  • 1994 First FDA approval for first whole food
    product FLAVRSAVR tomato
  • 1997 First weed insect resistant crops
  • First cloned animal Hello Dolly!

but speeding up.
  • 1998 Human embryonic stem cells lines
  • Herceptin approved-considered first
    pharmacogenomic (personalized) medicine
  • First complete animal genome roundworm
  • 2000 First complete map of a plant genome
  • First draft human genome

but speeding up.
  • 2004 First genetically modified pet the
  • FDA clears genotyping test to aid in medication
  • First cloned pet, a kitten
  • 2005 Skin cells converted to embryonic stem
  • 1 billionth acre biotech seed planted
  • First complete dog genome boxer
  • 2006 FDA approves Gardasil-first vaccine for
    cancer-causing virus

but speeding up.
  • 2007 Successful reprogramming human skin cells
    to create cells indistinguishable from embryonic
    stem cells
  • Biotech cattle that cannot develop prionsno mad
    cow disease
  • 2008 draft corn genome
  • 10 disease bearing stem cell lines created
  • Mature human embryos created from adult skin
    cells personalized stem cells for disease
  • First synthetic genome the road to creating
  • First complete map of cancer patient genome
  • First US FDA application for gene-therapy/cancer

2005 and Today
  • 2005 Biotechnology will transform industries,
    including health care
  • Today Biotechnology IS transforming industries
  • Industrial convergence of farmers, doctors,
    drugmakers, chemical processors, computer and
    communication companies, energy companies and
    many others into the business of life science.
  • Is revolutionizing healthcare and transforming
    economics of the Rx business. Will need to craft
    ways of dealing with industrys new economic
  • A single herd of goats may soon replace a 150
    million drug factoryHBR 4/2000
  • 2006 ATryn approved for DVT

The Human Genome Biotechnology
  • A milestone in biology unlike any other.
  • Weve called the human genome the book of life,
    but its really 3 books Its a history book.
    Its a shop manual and parts list. And, its a
    textbook of medicine more profoundly detailed
    than ever.
  • --Francis Collins, former director NHRI director
  • A short 50 years after the discovery of DNA by
    Watson and Crick in 1953
  • A complete list of coded instructions to make a
  • Would fill a stack of paperbacks 200 feet high
  • 50 years to type at 8 hours/day, 60 wpm

The Human Genome Fun Facts
30,000-40,000 genes not the 100-120,000 thought
earlier Five times as many as in bakers yeast A
bout twice as many as that needed to grow a worm
or fly! Bananas share about ½ our genome while
mice share 90! BUT, each single human gene
can make 10 proteins vs. a worm or flys genes
making just one or two. We have the Cuisinart vs
. the paring knife --Francis Collins
5 million strands of DNA can fit through the eye
of a needle All our DNA laid end to end wou
ld go to the sun and back 600 times!
The genetic instructions for making a person take
up less than 1 of the 6-ft long strand of DNA in
each cell
Since HGP
  • ENCODE the Encyclopedia Of DNA Elements, in
    9/2003, to ID all functional elements in the
    human genome sequence
  • HAPMAP haplotype map, will allow researchers to
    find genes/genetic variations that affect health
    and disease 100 IDd so far
  • 1000 Genomes extends HAPMAP through global
    collaboration to map 1,000 genomes in 3 years

Since HPG
  • NIH Roadmap Project on genotype tissue
    expression are variants of disease risk
    associated in relevant tissue
  • Knock-Out Mouse Project (KOMP)
  • Mammalian gene collection
  • Cancer Genome Atlas feasibility of full-scale
    effort to systematically explore entire spectrum
    of genomic changes involved in human cancer
  • Molecular manual of disease created 12/2008
  • Proteinpedia being created largest free resource
    of experimental info human proteins

  • Diagnostics to prevention
  • Pharmacogenomic knowledge transfer to
    therapeutics for gene therapy, drug therapy
  • Personalize genome family historypersonalized
  • Other non-profit commercial efforts underway

(No Transcript)
Other Efforts
  • Bringing the genome into the light, Church says,
    is the great project of our day.
  • To Church, who built his first computer at age 9
    and taught himself three programming languages by
    15, all of this is unfolding according to the
    same laws of exponential progress that have
    propelled digital technologies, from computer
    memory to the Internet itself, over the past 40
    years Moore's law for circuits and Metcalfe's
    law for networks. These principles are now at
    play in genetics, he argues, particularly in DNA
    sequencing and DNA synthesis.
  • ---Wired

Personal Genome Mapping
  • Polonator G.007 150K machine using open
    architecture like IBM in 80s fueling PC
  • DeCodeMe
  • 23andMe
  • Navigenics
  • Price range 400 to 350,000

Gene Map Becomes a Luxury Item
  • 3/2008
  • Id rather spend my money on my genome than a
    Bentley or an airplane.
  • Dan Stoicescu, millionaire retired Biotech exec
  • X Prize Foundation 10 million to first group to
    sequence 100 human genomes in 10 days for 10K or
  • Commercial goal get price to 1K or less
  • Has dropped by 4 orders of magnitude in 5 years
  • Scientists call for better government regulation
    of genetic tests
  • DNA databases blocked from public by NIH after
    study show a new type of DNA analysis could
    confirm ID of individual in a pool of masked data
    if that persons gene profile was already known

Future Environment
Personalization of medicine
Personalized Medicine Poised for Progress in
  • 12/24/2008
  • poised for dramatic progress in 2009 in the
    clinic and laboratory
  • personal, predictive, preventive
  • Weve finally gotten to the point where we can
    tell people about how their DNA impacts their
    health, Elissa Levin, 23andMe

Promises and Implications BIG
Promise Rapid technological innovation and vast
number of new targets identified and predictive
tests Today 483 targets account for all Rx drugs
marketed, tomorrow 5-10,000 targets
Rapid acceleration in pace of new therapeutic
introductions Drugs and treatments that are mor
e tailored to specific patients
Implications Development becomes a bottleneck
Shorter product life cycles Market fragmentation
Blurring distinction between product and
service Gary Pisano, HBS 3/2000, adapted

Specialty Pharmaceuticals
  • Created when many products moved from medical
    side to the pharmacy side of the budgetPBM
  • No specific criteria, but general attributes
  • Expense with annual therapy costs between 20,000
    and 250,000
  • Treatment for chronic condition, possible
    lifetime therapy
  • Special handling, route of administration,
    patient support

What Does It Mean to the Market?
  • IMS Health estimates specialty pharmacy sales of
    85 billion in 2008
  • Expected to reach 100 billion in 2010
  • 18 growth next 2 years
  • Global biotech Rx sales grew 12.5 2007 to 75
  • Biotech growing 2x pharma (6.4)
  • US sales 56 of total (42 billion)

Market Trends
  • 22 biotech products generated 1 billion sales
    compared to 6 in 2002
  • Biotech products represent 25 of the Rx
  • http//

Biotech Product Trends
Development of biotech compounds is explosive
633 biotech medicines in US pipeline
2001 Most compounds focused in the oncology
arena, followed by infectious disease, CV and
neuroscience 2007 Cancer 254, infectious disease
162, autoimmune disease 59, HIV/AIDS 34, CV 25,
diabetes 19 Breakthrough treatments may provide n
ew hope of some diseases
(No Transcript)
Major Diseases
  • Autoimmune rheumatoid arthritis, MS, lupus,
    chronic fatigue syndrome
  • CV CHF, MI, PAD, hypercholesterimia
  • Gene disorders CF, Gauchers
  • ID Hep A, B, C, tuberculosis, anthrax, bird flu
  • Neurodisorders AD, PD, muscular dystrophy,
    spinal cord injuries

Impact on People
  • Cancer 1.5 million US 219 B
  • CVD 71 million US 403 B
  • Alzheimers 5 million US 148 B
  • Parkinsons 1 million US 35.5 B
  • MS 400,000 US 10 B
  • Diabetes 24 million US 132 B
  • HIV 1.2 million US 37 B
  • Hep A B C 5 million US 3 B

Therapeutic Technologies
  • FDA guidelines governing genetic engineering of
    animals for food, drugs, or medical devices
  • Released 9/2008

  • Plant produced therapeutic proteins mabs,
    antigens, growth factors, hormones, enzymes,
    blood proteins, collagen
  • Alfalfa, corn, duckweek, potatos, rice,
    safflower, soybeans, tobacco
  • Across the array of diseases

Product Characteristics
65-70 of products estimated injectable
(protein-based) Demand for refrigerator/freezer c
apacity Product shelf life inventory management
Availability issues almost assured Patient inst
ruction for administration/reimbursement
Oral vaccines under development
Oral delivery of proteins under development
Patient-specific tissue-derived products
Express handling Safety/hazmat concerns Timeline
ss of delivery
  • Knowledge of biology
  • Knowledge of DNA
  • Knowledge of diseases
  • Devices, Diagnostics, Therapeutics
  • Theranostics

Diagnostic Advances
  • 1,200 tests based on biotechnology in clinical
  • New pregnancy, strep/ID faster, more accurate
  • Early diagnosis of type 1 diabetes, CF, AD, PD,
    CVD, autism, Lou Gehrigs, ovarian cancer (99
  • Survival predictions for lung cancer
  • Gene test for aggressive breast cancer marketed

2008 Advances
  • Protein behind cancer spread IDd
  • Biomarkers for breast, oral, prostate cancer
  • Researchers find memory gene
  • Gene mutations linked to breast, colon, prostate
    cancers, heart attacks, hypertension, lupus,
    baldness, schizophrenia
  • Gene variants linked to obesity
  • Protein lack tied to autistic savant qualities
  • Proteins causing PD, tumor response to chemo,
    curing macular degeneration/diabetic retinopathy
  • Gene therapy for alcoholism, transplant patients

2008 Advances
  • Turning off 2 proteins stimulates nerve-cell
    regeneration in mice
  • Satellite cells in mice that act like stem cells
    could regenerate skeletal muscle
  • Cell regeneration in mice inner retina triggered
    by growth factor injection
  • Beating heart created in lab with dead rat/pig
  • Therapeutic cloning (somatic-cell nuclear
    transfer) txts PD in mice
  • Neurons created from an ALS patients skin cells

2008 Advances Stem Cells
  • Multipurpose cells crafted from adult skin cells
    not ESC
  • Stem cells reverse neural damage in mice exposed
    to heroin in womb
  • Mature cloned human embryos created-personalized
    stem cells/tissue replacements
  • Red blood cells made from HE stems
  • Tests to tell good from bad stem cells
  • Safer method to produce stem cells without
    retroviruses that may cause tumors
  • Discovery of brain stem cells that may restore
  • Barriers overcome to using stem cells to build
    patches for damaged hearts

2008 Advances Stem Cells
  • Mice ESC used to grow muscles
  • ESC used to create a functional immune system
  • Protein in ESC inhibits skin cancer
  • International Society for Stem Cell Research
    Guidelines for Stem Cell Treatmentsimpetus use
    of unproven therapies in China, Costa Rica and

2008 Advances
  • Quicker method to create human antibodies
  • Technique to improve artificial antibody action
  • Technique to improve stem cell capture
  • Gene modification to change one cell to another
    without stem cells/embryos
  • Artificial DNA developed
  • 16-year frozen mice cloned with nuclear transfer

Next Up Synthetic Biology
  • The only limit if the imagination of the
    scientist who takes on the role of innovator and
  • Employed to produce biological systems free from
    evolutionary constraint
  • J. Craig Ventor Institute building designer bugs
    to absorb greenhouse gas
  • Synthetic genomics

J Craig Venter 6-2008
  • What is life?
  • Can we pare it to basic components?
  • Can we digitize it?
  • Can we regenerate it back to the analogue world?
  • 2007 Report for Governance Synthetic Genomics

Now, Add Nanotechnology
  • The creation of functional materials, devices and
    systems through control of matter at the scale of
    1 to 100 nanometers, and the exploitation of
    novel properties and phenomena at the same

  • 1980 the scanning tunneling microscope-allowed
    pictures of individual atoms
  • 1990 buckytubes-strong rolled up sheets of
  • Today Promises are big
  • The Next Industrial Revolution4/27/2005 Pew
    Trust Launch Emerging Nanotech Project
  • 377 billion 2015
  • 70 billion 2015 from 165 million 2004 in

  • Tools Now
  • Materials 3 years
  • Energy 5 years
  • Healthcare 8 years
  • Nanoelectronics 10 years

Consumer Applications Then
  • Hummer H2 Sport Utility Truck nanocomposite
    material cargo bed lighter and more scratch
  • NanoDynamics golf ball nanoparticles spin less,
    which should mean less slices and hooks
  • Samsung fridges washing machines with
    nanocoatings to prevent nasty bugs
  • Samsung 8 GB Compact Flash Card
  • LabNow portable blood analyser

Consumer Applications Now
  • 800 manufacturer-identified nanotechnology-based
    consumer products from 420 cos. in 21 countries
  • http//
  • Products tripled between 3/2006 and 2/2007

(No Transcript)
What are they? Everything!
  • Cosmetics (126 products), Clothing (115),
    Personal Care (153), Sporting Goods (82),
    Sunscreen (33), and Filtration (40)
  • Cleaners, sheets, iPhone, golfshafts, toothpaste,
    processors, curling irons/hair dryers, functional
    sportwear, graffiti shields, more

Nanotechnology in Health
  • Nanodiagnostics
  • Nanotherapeutics
  • Nanobiodevices
  • Better ways to sense disease, deliver treatments
  • Future nanoprobes, nanoneedles, substrates,
    on/off switches for drug delivery devices,
    sensors for heart patients

Nanotechnology in Medicine
  • CytImmune- Gold nanoparticles for targeted
    delivery of drugs to tumors
  • Nucryst-Antimicrobial wound dressings using
    silver nanocrystals
  • Nanobiotix-Nanoparticles that target tumor cells,
    when irradiated by xrays the nanoparticles
    generate electrons which cause localized
    destruction of the tumor cells.
  • Oxonica- Disease identification using gold
    nanoparticles (biomarkers)
  • Nanotherapeutics-Nanoparticles for improving the
    performance of drug delivery by oral, inhaled or
    nasal methods 
  • NanoBio-Nanoemulsions for nasal delivery to fight
    viruses (such as the flu and colds) and bacteria
  • BioDelivery Sciences-Oral drug delivery of drugs
    encapuslated in a nanocrystalline structure
    called a cochleate
  • NanoBioMagnetics-Magnetically responsive
    nanoparticles for targeted drug delivery and
    other applications

Advances 2008
  • Nanotech sensor detects toxins in living cells,
    including cancer inducers/drugs
  • Device uses nanoparticles to control drug
  • Nanotechnology used to create designer enzymes
    not normally catalyzed in nature using
    chemistry, mathematics, physicsmolecular
  • Used to study vancomycin mechanisms with
    potential to combat resistant infections
  • Nano-diamond covered patches used to reduce
    cancer patients exposure to adverse effects

Not Without Issues
  • Nanotube effects may lead to cancer 5/2008
  • Scientists call for more safety research
  • NRC report calls for more research into nanotech
    risks government should craft a more
    comprehensive plan
  • Could become the next asbestos or worseA
  • International Risk Governance Council Conference
    on Nanotechnology 1/2006 inclusive, globally
    focused risk governance framework addressing
    ST/LT applications of nanotech

2005Medical Devices and Implants
  • Converging and changing rapidly with computer,
    nano and bio-science

  • The science of Neurotechnologybiotechnology and
  • Neuroengineering evolved machines
  • NIO Neurotechnology Industry Organziation
  • Combines engineering, physiology, chemistry,
    computer science
  • New solutions for damaged sensory systems, neuro

  • Artificial device for hearing for deaf
  • Work underway for the blind
  • BrainGate transfer motor signals from brain to
    language computer understands to control devices
    allowing paralytics to control a machine by
    altering their brain waves
  • Two-way transmission under research
  • Implantable chips to strengthen neural
    connections spinal injuries

2005 Neuromorphic Electronics
The Mind Machine Interface
  • Researchers combine brain cells and computer
    chips -3/2006
  • HRL Labs researches neuromorphic electronics that
    function like the brain SyNAPSE-10/2008
  • Cognitive enhancers?
  • Engineering soldiers?

NIO Founder Zack Lynch
  • Historical pattern of human progression
    hunters/gatherers to agricultural to industrial
    to informational society
  • Neurotechnology is the answer to the next new
    society, the neuro-society

Imagine the Impact on People.
  • 2 billion people worldwide
  • 100 million people in North America
  • Brain disorders cost 1 trillion annually
  • And the impact on you and your partners

Emerging Pharmacists Role...
Manufacturers make drugs, pharmacists make drugs
work More accurately pharmacists help patients
make drugs work, because the patient is the
ultimate risk manager Or notand drug-related mor
bidity and mortality results Significant cost,
177 billion How will current, emerging care model
s change in a world of bio and nanotechnology?
Practice Impact
  • Genomic tests the domain of primary care doctors?
    Some now offered in pharmacies.
  • Pharmacists recommend appropriate therapy--how to
    parlay pharmacy Rx care programs? Assay tests
    for individualized therapy.
  • Models to manage products that have high-risk,
    are in short supply, have short shelf life and be
  • Performance-based networks and other specialty
    networks Mirixa

Impact on Pharmacy Partners
  • Direct to MD results from new deviceschallenge
    to how to keep pharmacists engaged with needed
  • MD/Pharmacist interface even more important for
    non-Rx data
  • Start by getting MD/Rx connection
  • More and new kinds data related to specific
    therapeutic disease states and conditionssystem
    flexibility and size

Impact on Pharmacy Partners
  • Closer working relationships to evolve
    provider-driven patient care platformsinteroperab
    le with other practitioners, systems, EHRs, PHRs
  • More standardized, integrated, interoperable data
    and systems across practice settings/sites/caregiv
  • Continuous system improvement, faster, better,
    cheapersystems that repurpose data
  • with state of the art privacy/security

Most Are Unprepared
  • Study finds health professionals, public
    unprepared for genomic medicine
  • RAND 3/2008
  • Need for large scale educational effort
  • Primary docs need to incorporate
  • Consumers worried about testing, loss of privacy,

  • Genetic Information Nondiscrimination Act (GINA)
    signed into law 5/2008
  • Prohibits employers from using genetic
    information in hiring, firing, pay or promotion
  • Forbids health insurers from requiring a genetic
  • Bars them from rejecting coverage/raising
    premiums based on personal/familial genetic

How Can You Prepare?
  • Keep up on technology developments Computer Talk
    Magazine the American Society of Automation in
    Pharmacy Meetings
  • Position yourself as knowledge broker Biotech
    and nanotech shows great opportunity but often
    pharmacy is left out
  • Read all you can on biotechnology, nanotechnology
  • Attend biotech sessions at professional meetings

Resources to Keep Up
  • pipeline and approvals
  • pipeline database/newsletters
  • and meds in
  • IMS of Biotech
    Burrill Company
  • http//

  • 2/3rds of all people have at least 1 copy of a
    DNA sequence that makes them more likely to be
    depressed after stressful life event.
  • I think its just easier to develop
    neurotechnologies that will enable us to make
    people as happy and intelligent as possible.
  • Ed Boyden, MIT neuroengineering group
  • Im inherently an optimist. I want to improve
    human life. Playing God is a crappy phrase.
  • -James Watson

  • Normal is merely a statistic. Ed Boyden
  • The most exciting breakthrough of the 21st
    century will occur not because of technology, but
    because of an expanding concept of what it means
    to be human.
  • John Naisbitt

Anything is possibleweve come a long way in 40
Thanks for Having Me!
  • Tel 651-905-9002