nanomedicine and nanodiagnostics: innovation, regulation ...nanomedicine and nanodiagnostics:...
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![Page 1: Nanomedicine and NanoDiagnostics: Innovation, Regulation ...Nanomedicine and NanoDiagnostics: Innovation, Regulation, and Investment _ Mostafa Analoui, PhD, Session Chair: Head of](https://reader031.vdocument.in/reader031/viewer/2022011918/600974993a68f047865000e2/html5/thumbnails/1.jpg)
Mostafa Analoui, PhD Head of Healthcare and Life Sciences The Livingston Group, New York, NY
Nano-Manufacturing Summit 2011, and the 10th Annual NanoBusiness Conference
Boston, MA September 26, 2011
Nanomedicine and NanoDiagnostics:
Innovation, Regulation, and
Investment
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Nanobiotechnology: Domain of Challenges
Engineering
Life
Sciences
Business
Safety &
Regulatory
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Nano Investment: From Excitement to Reality
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Future is not the way it used to be*
Courtesy of M. Roco and Yogi Berra
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Publication Race: Quality Matters
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Nano IP Real Estate Rush
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Nanotechnology Market Forecast
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Market Saturation and Maturity: Healthcare Market is Posed to Explode
Electronics
Traditional CMOS scaling
Drug Formulation
Elan nanocrystal formulation
of FDA approved drugs Abraxis Deal, …
Cosmetics
Nano-sized zinc-oxide sunscreen for
clear/colorless lotions
New Materials
Scratch-resistant car paint, Mercedes-Benz
Traditional Materials
Colored glass filters, ceramics and metals derive their properties
from their nanostructure Electronics
Post silicon nanodevices
Theranostics
Nano-entities used in a diagnostic test that identifies biological
conditions and delivers therapy based on test results
Targeted
Delivery
Tagged nanoparticles
Imaging
Tagged nanoparticles
Technology Maturity
Mar
ket
Sat
urat
ion
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Global Market Projection
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Celgene strikes $2.9B deal to acquire Abraxis June 2010
Taxol
Supplied As Paclitaxel 6 mg/ml Cremophor 537 mg/ml Ethanol 396 mg/ml
Reconstituted Paclitaxel 5 mg/ml Albumin ~45 mg/ml No Solvents
Abraxane is a Cremophor-free Formulation of Paclitaxel Received FDA Approval January, 2005 for metastatic breast cancer 2009 Sale: $350M
Abraxane
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Science-Market Push-Pull Technology-to-Application Map
Simple Nanomaterials
Functionalized Nanomaterials
2D Nanostructures
3D Nanostructures
Complex Systems
Therapeutic Agents
Nano-entities that are biologically active
compounds or tissue regenerative
Formulation & Delivery
Nano-entities used to increase bioavailablity
and/or delivery to a specific internal target
Clinical Diagnostic,
Measurement & Monitoring
Nano-entities used to measure biological
processes, diagnose conditions & monitor
disease states
Theranostics Nano-entities used in a diagnostic test that identifies biological
conditions and delivers therapy
based on test results
Discovery And Preclinical Technologies
Nano-entities enabling drug discovery and scientific research
Adjacent Markets
Nano-entities whose primary use is outside
therapeutics and diagnostics but might find applications in life
sciences
Adaptive Complex Systems
Characterization & Fabrication
Application
Tech
no
log
ies
Courtesy of IBM and Pfizer
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NanoBio: R&D Activities by Applications, Jan 2007-Nov 2009
Source: Business Insight, 2010
Formulation & Delivery, 62%
Diagnostics, 20%
Implant & Coatings, 14%
Regenerative, 4%
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Early Phase Late Phase
Seed Series A/B/C
Novel Dx/BM Accepted BM
IPO +ROI
Genomics Product
FIPCO VIPCO
Disease Health
Management Management
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Healthcare IPOs Since 1996*
45
27
7
11
66
7
4
7
29
17 19
28
1 3
7
$1,465
$688
$369 $670
$6,490
$440 $445 $456
$1,701
$819 $920
$2,041
$6
$1,114
$541
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
0
10
20
30
40
50
60
70
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
$M
illio
ms
Nu
mb
er
of
IPO
s
Number of IPOs
$ Millions
*2010 data is not comprehensive
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Deal Flow in NanoBio: 2007-2010
0.0
50.0
100.0
150.0
200.0
250.0
2007 2008 2009 2010
$M
VC
Public
Grant
• Based on 191 Private and Public Companies in our database • Not all financings are disclosed • Not including IPO and Abraxis-Celgene deal.
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Nanomedicine and NanoDiagnostics: Innovation, Regulation, and Investment
_ Mostafa Analoui, PhD, Session Chair: Head of Healthcare & Life Sciences, Livingston Securities
_ Piotr Grodzinski, PhD Director of NCI Alliance for Nanotechnology in Cancer, NIH-NCI
_ Anil Diwan, PhD _ Chairman & President, Nanoviricides, Inc
_ Subhas Malghan, PhD
_ FDA, Deputy Director in the Office of Science and Eng Lab, CDRH
_ Scott Minick President and CEO of Bind Biosciences
_ Misti Ushio, PhD Managing Director, Harris & Harris
_ Hong Guo, PhD VP of Research, pSivida