Nanotechnology for

Healthcare in the UK

Dr Mike Fisher Theme Manager, Healthcare & Life Sciences,

NanoKTN

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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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Where are we on the Hype-

Adoption Curve?

Plateau of

Profitability

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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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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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• 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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• 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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The Future....

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Questions?

Thank You

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: mike.fisher@bio-nano-consulting.com w: www.bio-nano-consulting.com