3 rd Annual Academic & Industry Intersection Conference: Commercialization of Discoveries February 9, 2012 Emory Conference Center.

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1 3 rd Annual Academic & Industry Intersection Conference: Commercialization of Discoveries February 9, 2012 Emory Conference Center Presented By

2 Welcome David S. Stephens, MD Principal Investigator, Atlanta Clinical & Translational Science Institute; Vice President for Research Robert W. Woodruff Health Sciences Center, Emory University Academic & Industry Intersection: Commercialization of Discoveries

3 ACTSI Academic Partners ACTSI Healthcare Consortium Georgia Collaborators National Collaborators

4 Translating scientific discoveries to impact the Atlanta community and beyond

5 Figure 3 Programs

6 Current CTSAs CTSA Consortium launched in October 2006: Class of awards Class of awards Class of awards Class of awards Class of awards Class of awards Total 60 awards Currently, 60 medical research institutions in 30 states and the District of Columbia are active members of the CTSA Consortium. These institutions are working together to speed the translation of research discovery into improved patient care.

7 National Center for Advancing Translational Sciences (NCATS) o Sept NIH Roadmap launched NIH Roadmap Initiatives Re-engineer Clinical Research Enterprise o Jan Creation of NCATS New NIH Center, authorized by Congress 12/11 Mission: catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions Recognition of many costly, time-consuming bottlenecks in the translational pipeline for new drugs, biologics, devices and diagnostics Working in partnership with the regulatory, academic, public, nonprofit and private sectors, NCATS will develop innovative ways to reduce, remove or bypass bottlenecks to speed delivery of new drugs, biologics, diagnostics and medical devices to patients

8 NCATS o Office of Rare Diseases Research o Division of Preclinical Innovation Cures Acceleration Network National Human Genome Research Institute Programs o Division of Clinical Innovation: CTSAs o Webinar: A Virtual Town Hall with NCATS Leadership, Feb 27, 2012, 1:00-2:00 p.m.

9 Welcome Charles Craig President, Georgia Bio Academic & Industry Intersection: Commercialization of Discoveries

10 Welcome Leslie Saunders, AIA, ACHA, LEED AP Senior Strategic Facilities Planner Flad Architects Academic & Industry Intersection: Commercialization of Discoveries

11 Keynote Speaker George Painter, PhD Principal Scientist Emory College, Emory Institute for Drug Discovery Academic & Industry Intersection: Commercialization of Discoveries

12 Dennis Liotta, Ph.D. Executive Director, EIDD Director, DRIVE George Painter, Ph.D. Director, EIDD CEO, Director, DRIVE

13 Patent expiration cliff Big Pharma rate of discovery and development slowing R&D spend increasingly shifted to biotech M&A Opportunities For Life Sciences Investing Health reform in the U.S. Need for compelling economic rationale Need for breakthrough products Regulatory climate U.S., Europe converging, increasingly complex Safety concerns concentrate focus on unmet need Globalization, Economic Development Growing wealth drives demand for healthcare Winners exploit regional opportunities and expertise Megatrends Forcing Change

14 Antiviral-focused private company Research Triangle Park, North Carolina Over $100M of venture financing to date Sanderling, Canaan, New Leaf, Alta, Pappas, Asset Management, Morningside, Frazier Over $60 million in government funding to date $36M NIH grant to develop drug for smallpox 2011 BARDA contract ($24.8 base year, up to $81.8M) for smallpox ~50 employees Novel technology yielding therapies to address large markets Proprietary Lipid-Conjugate technology platform CMX001 (Phase 2): Broad spectrum antiviral for life-threatening diseases in immunocompromised patients Biodefense countermeasure against smallpox CMX157 (Phase 1): Anti-HIV/HBV therapeutic 14

15 Innovation = Creativity x Risk

16 The number one contributor to discovery of new products is NIH (22), followed by the UC system (11), Memorial Sloan- Kettering (8), Emory (7)*, and Yale (6). * - For the period studied Emory was the top single university at producing FDA-approved drugs.

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18 Worldwide Director of Research Process and International Deputy Therapeutic Head for Antiviral Research, GlaxoWellcome Founder and EVP of R&D, Triangle Pharmaceuticals Oversaw the development of Emtricitabine through NDA filing Founder and CEO ( ) of Chimerix Raised $120M in non-dilutive capital and over $600M in venture capital to date Brought CMX-001, a broad spectrum antiviral, through Phase 2b Brought CMX-157 through Phase 1

19 Corporate Partners Venture Capitalist Emory Government Investments Therapeutic Opportunities Grants Leverage pipeline DRIVE Experienced pharma leadership Ability to contract on a shared risk basis Focus on infectious diseases and cancer Interface with the EU/UAB/SR consortium Management Oversight Project based Investments Contract work Foundations Spin-outs 3 rd Party Licenses EIDD A management team with over 175 years of combined pharma experience Experienced scientists State of the art labs on the Yerkes National Primate Center site

20 Clinical Development Phase 1/2 Drug Metabolism Pharmacokinetics Medicinal Chemistry Pharmacology, Toxicology, & Pharmaceutics Process Chemistry Process Development Cellular and Molecular Biology Computer Aided Drug Design Emory Vaccine Center Winship Cancer Institute Human Genetics High Throughput Screening

21 Proven reliability and expertise: EIDD / DRIVE personnel have a proven record of success in drug development in a research intensive environment. Risk mitigation and cost control: EIDD / DRIVE partnerships provide a cost effective alternative to traditional biotech start-ups that avoids the duplication of personnel and equipment each time funding is committed to a new technology. Access to significant assets: Partnerships also provide access to the intellectual and physical assets of Emory University and its allied academic institutions (UAB / SR and the University of Queensland / UniQuest).

22 Utilize infectious disease expertise (DRIVE, DRIVE SAB, Emory ID, UAB) to define therapeutic profile DRIVE licenses leads from the EIDD, other universities or companies DRIVE contracts with the EIDD to conduct the necessary experiments DRIVE defines experiments, target / compound profiles and development timelines to identify clinical candidate DRIVE, SAB, ID collaborators identify clinical candidate and EIDD conducts IND enabling studies DRIVE files IND and conducts clinical trials

23 Keynote Speaker Douglas B. Schumer, PhD General Manager Global Center for Medical Innovation Academic & Industry Intersection: Commercialization of Discoveries

24 Medical Devices from Concept to Market The Atomic Theory of Translational Research Doug Schumer, Ph.D. Global Center for Medical Innovation Georgia Bio ACTSI Academic & Industry Intersection Conference Commercialization of Discoveries February 9,

25 Time is the Enemy Concept Planning Design Evaluation Clin-Reg Market Too Long 25

26 Environmental Trends 26

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34 Percentage Change Median Earnings / Share Median P/E Ratio

35 120 Total Total Share Share of of Capital Raised Cos. > $1B Revenues Cos. > $1B Revenues All Others All Others Data taken from Ernst & Young Medical technology report 2011

36 Houston, we have a problem (time = $$$) 36

37 Those aren t bumps in the road, that is the road. Michel Mirowski, inventor of the AICD 37

38 What Does MedDev Product Development Look Like? Concept Planning Design Evaluation Clin-Reg Market Too Long 38

39 (Or Worse) Concept Planning Design Evaluation Clin-Reg??? 39

40 Higher, Faster, Stronger Concept Planning Design Evaluation Clin-Reg Market Concept Product Need to Go Faster 40

41 Traditional Design Methodology A Sequential Process Marketing R & D Mfg & Mfg Eng. Sales & Marketing 41

42 Collaborative Multidisciplinary Marketing Process Clin / Reg R&D Mfr Eng Brings "downstream" considerations into process earlier Data sharing, faster/ better decisions 42

43 43 Translational Research in SE

44 44 Translational Research in SE

45 45 Translational Research in SE

46 Translational Research in SE APDC 46

47 Translational Research in SE Cardiac Rhythm Management Lab 47

48 48 Translational Research in SE

49 The Atomic Theory of Translational Research Everything starts and ends with people.. 49

50 The Next Frontier: Integrated Multidisciplinary Process Yesterday Marketing R & D Mfg & Mfg Eng. Sales & Marketing Today The Next Frontier Clin / Reg Marketing Mfr Eng R&D Clin / Reg Marketing Mfr Eng R&D 50

51 What we know What we don t know we don t know 51

52 $$$ understanding $$$ helping peer recognition mentoring 52

53 Questions? Comments? 53

54 GCMI is Providing the Infrastructure for Medical Device Commercialization EARLY-STAGE COMPANIES 54 INVESTORS DEVICE/DRUG COMPANIES UNIVERSITIES RESEARCH CENTERS CLINICIANS Not for profit Only comprehensive medical device development center in Southeastern US Resource Rich Broad Network Continuum of Services & Programs Prototype Development Center Pre- Clinical/Clinical/Regulatory Innovation Management Services STTR/SBIR Support System Seed fund for early stage medical device companies Health IT Test Beds