Nanomedicine and NanoDiagnostics: Innovation, Regulation ...Nanomedicine and NanoDiagnostics:...
Transcript of Nanomedicine and NanoDiagnostics: Innovation, Regulation ...Nanomedicine and NanoDiagnostics:...
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
Nanobiotechnology: Domain of Challenges
Engineering
Life
Sciences
Business
Safety &
Regulatory
Nano Investment: From Excitement to Reality
Future is not the way it used to be*
Courtesy of M. Roco and Yogi Berra
Publication Race: Quality Matters
Nano IP Real Estate Rush
Nanotechnology Market Forecast
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
Global Market Projection
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
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
NanoBio: R&D Activities by Applications, Jan 2007-Nov 2009
Source: Business Insight, 2010
Formulation & Delivery, 62%
Diagnostics, 20%
Implant & Coatings, 14%
Regenerative, 4%
Early Phase Late Phase
Seed Series A/B/C
Novel Dx/BM Accepted BM
IPO +ROI
Genomics Product
FIPCO VIPCO
Disease Health
Management Management
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
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.
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