IBT Laboratories A Journey From A Basic

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An Academic Career Has Many Advantages? • Close to the frontier of knowledge in a variety of disciplines • Surrounded by many bright and stimulating scientists • Freedom to pursue any area of interest • Opportunity to pursue in depth a field of interest and become “the recognized expert” • Teaching and working with students can be very gratifying © 2007 IBT Laboratories. All rights reserved. Slide 2

There Can Be Disadvantages in an Academic Career • Always competing for grant support • Funding is getting tighter • Life without a grant in an academic institution can be difficult • Although academic salaries are good, there is not much upside potential © 2007 IBT Laboratories. All rights reserved. Slide 3

What are some of the options for a scientist in the commercial sector? – Type of Industry? • • • Pharmaceutical Company In Vitro Diagnostic Company Contract research & testing laboratory Contract research organizations Clinical laboratories – Size of Company? • Start up or established company • Big company (40, 000) • Small company (< 1, 000) © 2007 IBT Laboratories. All rights reserved. Slide 4

Commercial Career May Have Advantages? • Salary and upside earnings are usually better (e. g. bonuses, options and profit sharing) • Work on projects that the public cares about • Opportunity to do something that more directly impacts patient care • Project funding can be much quicker • Funds readily available for travel to meetings © 2007 IBT Laboratories. All rights reserved. Slide 5

There are Some Disadvantages with a Career in the Commercial Sector • Research projects can be changed or terminated by corporate management • The company’s strategic goals can be altered by factors outside of the company’s control • Companies get merged and acquired • Good science is not enough to keep a project going. It has to generate revenue sometime • It is a one way street – usually not possible to go back to academia • Too much travel © 2007 IBT Laboratories. All rights reserved. Slide 6

Personal Career Path Taken – Graduate School (JHU) & Post Doctoral Research (UVa & MUSC) – Faculty Positions (OU & KU Medical) – KUMC research in mucosal immunology, synthetic vaccines & Ig. A metabolism – Consulting • Vancouver meeting changed my career view – Start up - a clinical laboratory focused on allergen-specific Ig. E testing • Beg/borrow start up money from family and friends • Sign a lease and start and forget about a salary – IBT from 1984 to 2008 • A lot of work with a number of diversions along the way e, g, IVD manufacturing, Environmental testing, Consumer laboratory © 2007 IBT Laboratories. All rights reserved. Slide 7

IBT Laboratories - Today • Nature of Business: Research-Based Clinical Lab and Pharmaceutical Services Business and a Custom Reagent Business • Primary Expertise: Development and commercialization of unique assays for cellular and molecular immunology and immunogenomics • History: Founded in November 1983. 100% founder-owned until Ampersand Ventures’ investment in November 2004 • 2007 Revenues: $10. 7 MM • Company Size: 72 FTEs (80 Employees) • Customers: Major Clinical Labs, Pharmaceutical Companies, CROs, Hospitals, University Medical Centers (clients in 50 states, Europe, Asia, South America) • Facility: Modern 26, 500 ft 2 lab and office space (occupied in August 2004) © 2007 IBT Laboratories. All rights reserved. 2008 Revenues: $15 MM(Projected) Slide 9

Laboratory Focus • Immunology Biomarkers – Specific Immunoglobulins, Inflammatory Mediators, Cytokines, Allergy • Innate Immunity – Cellular and Molecular (e. g. MBL and TLRs) • Cellular Immunology – Lymphocytes, Basophils, Eosinophils, Phagocytes, Cell signaling pathways © 2007 IBT Laboratories. All rights reserved. Slide 11

Technical Operations Team • John F. Halsey, Ph. D, CEO and Founder • Rene Pfaltzgraff, BS, MT, Vice President for Laboratory Operations • Joanne Parker, Ph. D, Director of Pharmaceutical Research Services • Mark Colwell, M. S. , VP of Quality Systems • Michelle Altrich, Ph. D, Director of New Test Development • Marilyn Smith, Ph. D, Senior Scientist • Dominic Warrino, Ph. D, Senior Scientist • Rebecca Horvat, Ph. D, KUMC Associate – – – – Licensed Clinical Immunology Lab Director Previous, (Interim President of Inc. Star Corp & Faculty at Univ. Kansas School of Medicine) Johns Hopkins University and University of Virginia Clinical Reference Laboratory (CRL) Osborn Laboratories Cellular/Cancer Immunology (Biomira, Inc. Globeimmune, Inc. ) Product development & regulatory affairs (Meloy Laboratories, Pro. Gene Corporation) Cellular/Cancer Immunology University of Nebraska & University of Virginia Virology and Cellular Immunology Post Doctoral at UNC, Clinical Researcher Montreal, Faculty, KUMC Clinical Immunology, Flow Cytometry Streck, Inc and University of Pittsburgh School of Medicine Director of Clinical Microbiology and Immunology University of Kansas School of Medicine © 2007 IBT Laboratories. All rights reserved. Slide 12

Current Technology Platforms • Flow Cytometry - Beckman Coulter, Guava • • Microbead Array - Luminex PCR - ABI and Roche Gene Sequencing - ABI Elispot - CTL ELISA – Bio-Tek Luminometry – Ph. L Light and Fluorescence Microscopy – Olympus • Radioimmunoassay – Perkin • Electrochemiluminescence Microarray - Meso Scale Discovery • Rate Nephelometry – Beckman Immage • Allergy – Phadia Immuno. CAP • Fluorescence Immunoassay – Molecular Devices • Cell Culture • Automated Immunoanalyzer – Siemens DPC Elmer © 2007 IBT Laboratories. All rights reserved. Slide 13

Confidential Top Five Clinical Lab Clients (2007) Client 1. Quest Diagnostics 2. Laboratory Corporation of America 3. ARUP – Salt Lake City 4. Mayo Medical Labs - Rochester 5. PAML - Spokane © 2007 IBT Laboratories. All rights reserved. Slide 15

What Drives the Clinical Lab Growth? • Unique test menu (sole provider of some tests) • Long term, contractual relationships with major national labs (e. g. Quest, Lab. Corp, ARUP, Mayo) • History of commercializing new tests via internal R&D and academic collaborations • Successful marketing to clinician “end user” • Ability to provide the high level technical support needed for the specialized menu © 2007 IBT Laboratories. All rights reserved. Slide 16

Examples of New Tests Launched by IBT • Latex Allergy Test • Pneumococcal Serology • Innate Immunity – MBL and TLR Genotypes • Baso. Function™ test for drug allergy • CU Index™or Autoantibody Test for Chronic Urticaria © 2007 IBT Laboratories. All rights reserved. Slide 17

Where Does IBT Find New Tests? 1. Close relationships with the physician specialists who order the tests 2. Active participation at meetings and conferences 3. Research partnerships with specialists at medical centers throughout the world 4. Significant investment in the new test development IBT team of immunology scientists 5. In-licensing of technology from IVD companies with new tests and technologies © 2007 IBT Laboratories. All rights reserved. Slide 18

Key Trends Driving IBT’s Pharma Business • FDA driving an immunotoxicology focus • Pipeline of drugs targeting the immune system • Use of immunological biomarkers increasing • Pharma doing more outsourcing • FDA and industry focus on companion diagnostics • A revival of the vaccine development business © 2007 IBT Laboratories. All rights reserved. Slide 20

Immunotoxicology • Immunogenicity • Immunosuppression • Autoimmunity • Hypersensitivity/Allergy • Adverse Immunostimulation From the US FDA Guideline, “Guidance for Industry: Immunotoxicology Evaluation of Investigational New Drugs”. © 2007 IBT Laboratories. All rights reserved. Slide 21

IBT Growth Opportunities (2008 and 2009) Clinical Laboratory Pharma Services Kits and Reagents Developing New Tests And Entering New Markets Vaccine Efficacy & Cell-Based Testing Companion Diagnostics (MBL, Fce. R Binding Test) In-Licensing of Unique Tests Immunotoxicology © 2007 IBT Laboratories. All rights reserved. Slide 22

Summary Comments • A clinical laboratory career can be an exciting learning experience • It is likely to be a fast-changing, dynamic career • Being a consultant to physicians who are taking care of patients can be rewarding • There is an opportunity to train and help develop young scientists interested in applied immunology • The financial rewards can be good © 2007 IBT Laboratories. All rights reserved. Slide 23

What Personal Characteristics Can Be Helpful In A Commercial Career? – – – – Adaptability – willing to change directions Major time commitment and family support Not be intimidated by what you do not know Willingness to take risk Get over the arrogance of the ivory tower Singles, doubles & home runs Interest in gaining business knowledge: • Accounting & Finance • Operations • Management © 2007 IBT Laboratories. All rights reserved. Law Regulatory affairs Marketing & Sales Slide 24