Nanomedicine and NanoDiagnostics: Innovation, Regulation ...Nanomedicine and NanoDiagnostics: Innovation, Regulation, and Investment _ Mostafa Analoui, PhD, Session Chair: Head of

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