Biomedical Devices: The University Perspective
Heather Sheardown McMaster University Department of Chemical Engineering and School of Biomedical Engineering
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Universities as a Source of Research
Industry versus Academia Source of talented people with interesting (often crazy) ideas Patents, copyrights, devices and systems Lack of business expertise and know how Funding potential for projects
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Funding Potential
NSERC and CIHR Matching funds Industry sponsored projects
OCE Matching programs Industry sponsored funding
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NSERC Partnerships Programs – Brief Overview
Innovation Projects
Strategic Projects Research Networks Collaborative R&D Grants Research Partnership Agreements
Research Development
IPM
I2I (2) I2I (1)
Chairs RPA IRCs s
CRDs
Building Critical Mass
Chairs
RNs
SPP
Technology Transfer
Industry Participation
Idea to Innovation Intellectual Property Management & Networked Training
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Biotech at McMaster University
• One of the country's "most innovative" research-intensive universities, ranking #2 in Canada (2007) in research dollars per researcher – Research Infosource • Affiliated with research centres at Hamilton Health Sciences, St Joseph’s Healthcare Hamilton, Juravinski Cancer Centre • Member of C4, Ontario’s Technology Transfer Community, comprised of ten universities and research institutions
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McMaster Commercialization
Recent commercialization successes include:
– Quality of life Questionnaires
• Assisting in the evaluation of novel therapies for diseases worldwide
– Startups:
• Prosensus (innovative imaging and data analysis) • Nysa Membrane Technologies (novel membranes for bioprocessing, wastewater treatment and food and beverage manufacturing)
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Biomedical Research and Technology Strengths at McMaster
Autoimmune and inflammatory disorders
-novel treatments for hypersensitivity, sepsis, Multiple Sclerosis -use of probiotics to treat inflammation
Cardiovascular and Circulatory system applications
-thrombosis: novel methods and agents -modulation of cardiac hormone -new agents to reduce cholesterol levels -novel target involved in atherogenesis -identification of novel anticoagulant -biomarkers for early detection of heart failure
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Biomedical Research and Technology Strengths at McMaster
Cancer
-Software for the management of chemotherapeutic regimens -non-invasive biomarker for radiotherapy response -molecular biology techniques to identify novel targets -New oncolytic viruses
Ophthalmic Materials and Devices
-Novel biomaterials for drug delivery to the eye -Materials developed for extended wear contact lenses -Novel drugs developed for the prevention and inhibition of cataract development
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Biotech Research Networks at McMaster
SENTINEL Bioactive Paper Network Researchers from 10 universities across Canada, nine industry partners, and federal and provincial government agencies Develop low-cost and easy-to-use paper-based products with biologically active chemicals that can protect the public against increasing incidents of food-, water- and air-borne illnesses. ENVISION – Ophthalmic Materials Network Currently 10 researchers from 5 universities Industry partners
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The Need for New Ophthalmic Materials
Aging population with associated ocular diseases •Other effects on health •Associated health care costs •New therapeutic agents developed but cannot be effectively delivered •New cellular techniques that will ultimately require some method of delivery
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Drug Delivery to the Eye as an Example
Current drug delivery modalities are insufficient for delivery of increasingly sophisticated pharmaceuticals
Delivery Alternatives
Proteins
a)
Target Zone
Hormones
b)
c)
DNA/RNA
a) b) c) d)
Trans-scleral Topical Intra-vitreal Systemic
Modified from Invest Ophthalmol Vis Sci. 41(5):961, 2000
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Potential Solution: A wirelessly controlled,
integrated microfluidic drug delivery device
Microcoil Receiver Fully implantable Wireless control Localized delivery Refillable Flexible microneedle arrays and housing Generic device
Remote AC Waveform
Disruptive Technology
Painless, non-interventional and customizable - while minimizing required drug volumes (90% reduction)
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Underlying Technology
IP Protected Micrompump Technology Radical Hybrid IP Protected Micromanufacturing Approach Precision + Low-cost + Mechanical Flexibility (Biomedical Microdevice)
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Potential Customers
Primary Market: Ocular Therapy
– Age related macular degeneration (AMD) – Glaucoma – Diabetic Retinopathy
Secondary Markets:
– Cancer therapy – Diabetes – Nicotine / birth control patches
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Competing Technologies
VITRASERT
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Example 2: Combining the Best of Two Worlds: IP Protected PDMS and Hydrogel Interpenetrating Networks
PDMS Advantages – Transparent – Good biocompatibility, mechanical properties – Oxygen permeable Disadvantages – Highly hydrophobic – Low glucose permeability Hydrogels Advantages – Hydrophilic polymer with high water swellability – Good ophthalmic compatibility Disadvantages – Low oxygen permeability – Poor mechanical properties in swollen state
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IPNs – Synergistic Properties
1.4 1.2
Stress at Max Load (MPa)
PDMS control (40K)
PNIPAAM IPN
1.0 0.8 0.6 0.4 0.2 0.0
1 2 ol ol ntr ntr Co Co MS MS PD PD .2 10 .4 13 .3 22 .7 24 .7 26 .7 30
PNIPAAM Content (wt %)
25
1e-7
Permeability (cm2/s)
Oxygen Conc in Receptor (ppm)
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Permeability (cm2/s)
1e-8
15
10
1e-9
5
PDMS Control 16.3% IPN 27.0% IPN
1e-10 24 26 28
o
30
32
0 0 5 10 15 20
Temperature ( C)
Time (hours)
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Properties Can Be Altered by Copolymerizing with or Incorporating Other Hydrogel Polymers
140 120
10% AAm 20% AAm 30% AAm 8% AAc 30% AAc 100% AAc
140 120 100 80 60 40 20
30 40 50
o
Water Uptake (%)
100 80 60 40 20 0
% Wt Increase or Water Uptake
PDMS-OH, Wt increase PDMS OH, Water uptake PDMS-V, Wt increase PDMS-V, Water uptake
60
0 PVP PAAM PAAC PHEMA Hydrophilic Polymer Incorporated
HEMA AAC AAM NVP NIPAAM
Temperature ( C)
1.6
120 100
PDMS-V HEMA IPN PDMS-OH HEMA IPN
Cumulative Lysozyme Release (mg)
1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 0 50 100 150 200 250 300
Water Contact Angle (o)
80 60 40 20 0 100 50 30 10
Time (h)
Fraction of Co-Monomer (%)
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LCST Can Be Used to Facilitate Release of Protein and Low Molecular Weight Drugs
30 25
1.0
Lysozyme Cumulative Release (mg)
Chymotrypsin Release (mg)
0.8
20 15
7 6 5 4 3 2 1 0 0 20 40 60 80 100 120
2% Crosslinker 1% Crosslinker 32.2% IPN-OH 27.6% IPN-OH 19.8% IPN-OH IPN-V
0.6
0.4
0.2
Lysozyme, 13.1% IPN Lysozyme, 20% IPN Lysozyme, 58% IPN
0.0
140
160
180
0
50
100
150
200
250
300
Time (h)
1.2
Time (h)
Cumulative Levothyroxine Release (%)
60 40 20 15 10 5 0 0 100 200 300 400
1.0
Albumin Cumulative Release
0.8
38.6% 20.2 % 15.0% PDMS Control PNIPAAM Control
0.6
0.4
0.2
Albumin, 13.1% IPN Albumin 20% IPN Albumin 58% IPN
0.0 0 50 100 150 200 250 300
500
600
700
Time (h)
Time (h)
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Materials Properties Can be Significantly Altered by Adding “PDMS Hydrogel” 25% Tris
TRIS
50% Tris
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Potential Applications
Drug delivery to the front of the eye Scaffold materials for artificial cornea
Cellular delivery to the back of the eye
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