Nanotechnology for Healthcare in the UK - BioNanoMed Cat Barcelona - Mike Fis… · Nanotechnology...
Transcript of Nanotechnology for Healthcare in the UK - BioNanoMed Cat Barcelona - Mike Fis… · Nanotechnology...
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Nanotechnology for
Healthcare in the UK
Dr Mike Fisher Theme Manager, Healthcare & Life Sciences,
NanoKTN
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Slide |2
Presentation
• Intro to NanoKTN and BNC
• Why Nano is a technology and not just a size
• Technology Adoption
• Applications & UK Examples
• NanoKTn Focus Groups (& Join the KTN!)
• What the future does & doesn’t hold
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NanoKTN & BNC
NanoKTN BNC
• UK Knowledge Transfer Network for Nanotech
• TSB funded to support uptake of nanotech by industry
– Focus on TSB priority areas
• Run by CPI
• BNC subcontracted to run the Life Science Theme (Healthcare & Life Sciences)
• JV between UCL and
Imperial College
• Partnership with NPL
• Provide industry access to
the research skills of
– London Centre for
Nanotechnology
– Institute for Biomedical
Engineering (Imperial)
– NPL Bionano Labs
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The Nanotech Buzzword!
• Not New
– Molecular Biology
– Colloidal Chemistry
– Molecular Imaging
– Virology...?
Ancient Greece: Lycurgus Cup:
dichroic glass produced by
addition of gold nanoparticles –
size affects light absorption
What’s new is the ability to manipulate
objects and particles at the nanoscale
and understand what is happening
HIV virus 100 nm
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Size Matters.... • Physical properties
– Surface Area
– High thermal and electrical conductivity
– High strength to weight ratio
– Size dependent Optical, Magnetic and Electrical properties
• Compact devices – Microelectromechanical systems (MEMS)
devices as biosensors
– High density packing
– Implantability
• Transport across physiological barriers – Blood brain barrier
– Cell membranes
– Vascular capillary endothelium
• Physiological constraints – Angiogenesis permeability
– Agglomeration
1 (nm)
100 nm
0.1 nm
10-6
10-7
10-8
10-9
10-10
Visible Spectrum
DNA ~2 nm wide
Sub-Atomic
RBC 2-5 μm
Quantum Dots 100nm
Atom 0.1nm
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Examples of changes in physical properties at the nanoscale
Paramagnetic iron oxide particles become superparamagnetic below 10nm (eg IR opaque, but visible light transparent)
Attaching nano-sized biomolecules to microcantilevers increases resonance frequency when their thickness is in the order of nanometres but decreases resonance frequency when their thickness is of order of microns
Quantum dot fluorescence varies
with size when diameter is less than
the Excitation Bohr Radius
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Surface effects • Increased Surface to Mass Ratio
– Heat transfer
• Surface Plasmon Resonance
• Magnetic Plasmon Resonance
• Multiphoton Plasmon Resonance Microscopy
• Surface Enhanced Raman Spectroscopy
• Chemical Reactivity
• Agglomeration – Shelf Life
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Slide |8
Where are we on the Hype-
Adoption Curve?
Plateau of
Profitability
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Slide |9
Applications of
Nanotechnology in Healthcare
• Pharmaceuticals
– Formulation
– Discovery & Research
Tools
• Imaging
– Clinical Diagnosis
– Surgical
– Drug Distribution
Tissue Engineering & Regenerative Medicine
- Materials
- Scaffolds
Sensors & Diagnostics
- Biosensors
- Lab on a Chip
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Applications - Pharmaceuticals Product/Brand
Name Nano component Active Ingredient
Delivery
Route Companies FDA Indications Approval Date
Abraxane Albumin Nanoparticles
(~130 nm) Paclitaxel IV Abraxis/ AstraZeneca
Metastatic Breast cancer patients who
have failed combination therapy 2005
AmBisome Liposomes
(~45-80 nm) Amphotericin B IV
Gilead Sciences /
Astellas Fungal Infection 1997
DaunoXome Liposome
(35-65 nm) Daunorubicin IV Gilead Sciences
Advanced HIV-related Kaposi’s
sarcoma 1996
DepoCyt Liposome Cytarabine IV Enzon
Pharmaceuticals
Intrathecal treatment of lymphomatous
meningitis 1999
Diprivan Liposomes Proprofol IV AstraZeneca (now
generic) Anaesthetic 1989
Doxil/Caelyx
(Myocet) Liposomes
Pegylated Doxorubicin HCl
(Doxorubicin Citrate) IV
OrthoBiotech/
Schering-Plough
(Cephalon)
Metastatic ovarian cancer, AIDS-
related Kaposi’s sarcoma and ovarian
cancer
1995
Estrasorb Micellular nanoparticles Estradiol hemihydrates Trans
dermal Novavax
Reduction of hot flushes and night
sweats in menopausal women 2003
Lupron Depot® PLG microspheres Luprolide acetate IV TAP Pharma
Prostate Cancer, endometriosis,
fibroids and central precocious
puberty
1989
Nutropin Depot® PLG microspheres Somotropin: rDNA Human
growth hormone (HGH) IV
Alkermes
/Genentech
Stimulation of Longitudinal bone
growth 1999
Neulasta PEG G-CSF (filgrastim) IV Amgen Boost white blood count following
chemotherapy 2002
Oncaspar PEG asparaginase Enzon/ Rhone-Poulenc
Rorer acute lymphoblastic leukemia (ALL) 1994
Pegasys PEG IFN- α-2a Subcut-
aneous Nektar/Roche Chronic Hepatitis C Infection 2002
Peg-Intron PEG IFN-α-2b IV Enzon/Schering-
Plough Hepatitis C 2001
Renagel Cross-linked
Polyallylamine resin
Cross-linked Polyallylamine
resin (phosphate binder) Oral Genzyme
Control of serum phosphorus in
patients on dialysis 2005
Trelstar Depot® PLGA microspheres Octreotide acetate IV Debiopharm / Watson
Pharma
palliative treatment of advanced
prostate cancer 2000
Tricor/ Lofibra /
Lipanthyl Nano crystals Fenofibrate Oral
Abbott Labs / Teva /
Solvay
Pharmaceutical.
Reduction of triglycerides, LDL and
total cholesterol. Increase abnormally
low HDL
2005
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Is Nanotech the New Biotech?
Biotech 20 years ago:
• Unclear regulatory pathway
• Unproven technology
• Adoption issues
• The ‘Biotech & GM’ labels
• Complete change in manufacturing methods
• Skills issues
• Supply chain questions
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Is Nanotech the New Biotech?
Biotech Today:
• 2 of the top 20 pharma are biotechs
• 2 of top 10 blockbusters are biologics
• Every pharma co. investing heavily in the
technology
– BMS: “We are a leader, creating a new kind of
enterprise: a next-generation BioPharma
company.”
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Pharma Issues with Nanotech
• Enormous existing patent base in novel formulations
– Issues with using nanotech as a platform
• Formulation patents often hard to defend
– Extensive early academic literature
– Inventive step frequently marginal
– ‘Expert’ technical opinion frequently critical at
opposition
• Much work now in public domain through patent expiry
– ‘Nanosimilar’ products?
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Pharma Issue 2
• Formulation work is ‘post-patent’ NB: Blockbusters =
$20m a week!
– Fully developed (‘ready-to-go’)
– Robust performance (Often declines with complexity!)
– Manufacturability at scale/GMP
– Potential regulatory acceptability
– Protectable through IP/Acceptable license terms
– Fills unmet medical need
– Security of supply
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• Lena Nanoceutics
– Formulation processes
for prescription drugs
• CMP Therapeutics
– Micronised Chitin for
allergies and infectious
disease
• Critical
Pharmaceuticals
– Drug delivery
• Nanomerics – Moleculare envelope
technology (peptide pill)
• Nanotherics – Nanoparticle delivery of
DNA into cells
• Iota Nanosolutions – Dispersion of
hydrophobics in water and hydrophilics in oil
Example UK Companies
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Applications - Diagnostics
• Lab on a Chip
– Closed Loop
– Wearability
– Rapid Response
– Point of Care
• Lab on a Pill
Sphere Medical
Patients want empowerment
and knowledge. They don’t
want systems to take control
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Slide |17
UK International Comparison Lab on a chip Nanotechnology
Source: Innovation Hotspots: IP market Report. Thompson Reuters. 2009
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Point of Care Issues
• Quality Control
– Selectivity Vs Specificity
– False Negatives Vs False Positives
– 99.99% accuracy in the lab → ? by the patient
– Who’s liable?
• Adoption by the NHS
– Is it really appropriate for GPs to become mini path labs?
– So What - Now What?
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• Orla Protein
Technologies
– Immobilisation of
proteins on sensor
surfaces
• Avacta Group
– Analytical and
Diagnostic technology
• Applied Nanodetectors
– Diagnostic sensor for
mobile applications
• QuantumDx – Handheld DNS
sequencing & multi-variant
• Lumora – BART (Bioluminescent
Assay in Real-Time)
• Argento Diagnostics – Hand-held
electrochemical based immunoassay
Example UK Companies
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Applications – Tissue Engineering
• ‘Simple’ tissue replacement close to market
• Organs not been created in the lab yet
• Three Issues: – Reproducible cell
cultivation
– Nano and micro environment
– Regulation and Standards
Synthetic nose. Courtesy Prof. Alex
Seifalian, University College London
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Slide |21
• The Electrospinning Company – Electrospun tissue
scaffolds
• Orthox Ltd – Spider silk based
structures for cartilage and meniscal tissues
• Repregen Ltd – StronBoneTM modified
bioactive ceramics
• ReInnervate
– 3D Cell Culture
• Neotherics
– Bioresorbable scaffolds
for tissue regeneration
and repair
• Pharmidex
– Nano-structured
scaffolds for tissue
repair
Example UK Companies
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Slide |22
• NanoPharm
– Pfizer, AZ, GSK,
Wellcome Trust,
Cyclofluidic
• NanoMed
– Leeds Royal Infirmary,
GE Healthcare, IoN,
Swansea Centre for
Nanohealth,
Healthtech &
Medicines KTN
• NanoRegen – Smith & Nephew,
Orthox, University of Manchester, Chemistry KTN
• NiMeD (Nano in Medical Devices) – Sharp Research Labs,
Cambridge Consultants, OJ Bio, MHRA, Queen Mary Univ. of London
NanoKTN Focus Groups
www.nanoktn.com
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Slide |23
The Future....
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Slide |24
Questions?
Thank You
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Dr Mike Fisher
Bio Nano Consulting
338 Euston Road, London NW1 3BT
t: +44 (0) 20 7396 1053
f: +44 (0) 20 7396 1056
e: [email protected] w: www.bio-nano-consulting.com