Nanomedicine and NanoDiagnostics: Innovation, Regulation, and Investment

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1 Nanomedicine and NanoDiagnostics: Innovation, Regulation, and Investment 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

2 Nanobiotechnology: Domain of Challenges Engineering Life Sciences Business Safety & Regulatory

3 Nano Investment: From Excitement to Reality

4 Future is not the way it used to be* Courtesy of M. Roco and Yogi Berra

5 Publication Race: Quality Matters

6 Nano IP Real Estate Rush

7 Nanotechnology Market Forecast

8 Market Saturation and Maturity: Healthcare Market is Posed to Explode Cosmetics Nano-sized zinc-oxide sunscreen for clear/colorless lotions Market Saturation Imaging Tagged nanoparticles Targeted Delivery Tagged nanoparticles Electronics Post silicon nanodevices New Materials Scratch-resistant car paint, Mercedes-Benz Electronics Traditional CMOS scaling Traditional Materials Colored glass filters, ceramics and metals derive their properties from their nanostructure Theranostics Nano-entities used in a diagnostic test that identifies biological conditions and delivers therapy based on test results Drug Formulation Elan nanocrystal formulation of FDA approved drugs Abraxis Deal, Technology Maturity

9 Global Market Projection

10 Celgene strikes $2.9B deal to acquire Abraxis June 2010 Abraxane Taxol 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 Supplied As Paclitaxel 6 mg/ml Cremophor 537 mg/ml Ethanol 396 mg/ml

11 Science-Market Push-Pull Technology-to-Application Map Discovery And Preclinical Technologies Nano-entities enabling drug discovery and scientific research Therapeutic Agents Nano-entities that are biologically active compounds or tissue regenerative Application 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 Adjacent Markets Nano-entities whose primary use is outside therapeutics and diagnostics but might find applications in life sciences Simple Nanomaterials Functionalized Nanomaterials Technologies 2D Nanostructures 3D Nanostructures Complex Systems Adaptive Complex Systems Characterization & Fabrication Courtesy of IBM and Pfizer

12 NanoBio: R&D Activities by Applications, Jan 2007-Nov 2009 Regenerative, 4% Implant & Coatings, 14% Diagnostics, 20% Formulation & Delivery, 62% Source: Business Insight, 2010

13 Early Phase Seed Novel Dx/BM IPO Genomics FIPCO Disease Management Late Phase Series A/B/C Accepted BM +ROI Product VIPCO Health Management

14 Healthcare IPOs Since 1996* $7, $6,490 Number of IPOs $6,000 $ Millions Number of IPOs $1, $1,701 $ $670 $369 $440 $445 $456 $2, $920 $819 $1, $ $541 $5,000 $4,000 $3,000 $2,000 $1,000 $0 $Millioms *2010 data is not comprehensive

15 Deal Flow in NanoBio: $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.

16 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

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