2014 CORPORATE OVERVIEW

Transcription

1 2014 CORPORATE OVERVIEW

2 Applied Immunology provides custom assay services to support the development of therapeutics, vaccines and diagnostics CORPORATE OVERVIEW 2

3 OUR FOCUS Applications: Immuno-oncology Immunotherapy Inflammation Autoimmunity Infectious disease Cell therapy Custom Cell- based Assays GLP Assays for Biologics Immune Monitoring Gene therapy Biomarker identification Diagnostic development 2014 CORPORATE OVERVIEW 3

4 OUR APPROACH Understand the need Develop the best method Execute the plan Mechanism of Action Efficacy Safety Regulatory Biomarker Discovery Right assays Right platforms Right cell types (e.g. primary vs. cell line, healthy vs. patient samples) Quality Responsiveness Discipline Transparency 2014 CORPORATE OVERVIEW 4

5 OUR CAPABILITIES Custom Cellbased Assays GLP Assays for Biologics Immune Monitoring Assays (Partial List): Immunophenotyping T- and B-cell proliferation Treg and TH17 induction Intracellular cytokine (TH1 / TH2) Immune function (T, B, NK, NKT, Treg, Neutrophils) Antigen-specific T-cell response ADCC / CDC Cell viability, apoptosis / necrosis Antigen presentation Cytokine production / secretion Leukocyte migration / adhesion Complement factor activity Kinase activity Reporter gene analysis GPCRs function Mast cell activation / IgE response Autoantibody production from B-cell plasmablasts Biomarker detection / analysis PK analysis Anti-drug antibody (Screening and Confirmatory) Neutralizing antibody (cell- or non cell-based) Antibody characterization, titer Technologies In House ELISA (multiple formats including Delfia / TRF) Flow Cytometry ELISpot BioScale (ViBE) AlphaScreen / AlphaLISA Luminex / DropArray (Luminex at 5µL/sample) Biolayer Interferometry (Octet) BioFlux via Local Partners PCR DNA / RNA expression profiling (e.g. Fluidigm, Nanostring) FISH IHC CTC Profiling 2014 CORPORATE OVERVIEW 5

6 OUR EXPERIENCE World-class Scientists Industry-grade: Our experts have authored white papers that are the basis of FDA/EMA immunogenicity guidance All experts have held senior scientific roles in top 10 biopharma Research-grade: Our scientific leadership has published collectively over 200 papers Our contributions to basic research have led to ground-breaking medicines (e.g. Provenge ) Uncompromising Quality Registration-grade: Our experts have not only operated labs that are GLP, cgmp, CLIA compliant, but also have established such labs from inception Experience in detailed protocol and SOP development to support regulatory submissions, technology transfer to global central labs or CMOs Dedicated Service Project Management: Our leadership has managed some of the most complex development programs the industry has ever seen e.g. denosumab, with nearly 20 studies (11 Ph 3) across 2 indications, 50 countries, 16K+ patients, $1B+ budget Service Best Practices: Leadership brings service best practices from multiple industries customer focus, transparency, discipline, resourcefulness 2014 CORPORATE OVERVIEW 6

7 OUR TEAM LEADERSHIP Eugen (Gene) Koren, MD, PhD Chief Scientific Officer Internationally renowned immunogenicity expert Prior roles: Genentech, Amgen, J&J, BioMarin, Abbott, OMRF Anita Mehta-Damani, PhD Co-Founder & SVP Research and Development Expert in cellular immunology and cell-based assays Prior roles: Genentech, Stanford, StemCells, Elan Pamela (Pam) Lim Head of Quality Assurance Quality expert; head of Quality Assurance Unit Prior roles: Chiron, J&J, Durect, StemCells, Jennerex, Ipsen Rajiv Mahadevan Chief Executive Officer Experienced general manager Prior roles: Amgen, Novo Nordisk, Gates Foundation, 23andMe, Arthur D. Little ADVISORS: David Essayan, MD, FACP Former FDA/CBER Reviewer Prior roles: NIH, Amgen Regulatory Affairs Paul Billings, MD, PhD Chief Medical Officer, Thermo Fisher Corporation Prior roles: Cellpoint, Labcorp Clay Marsh, MD Vice Chair of Research and Professor of Medicine at The Ohio State University Neil McDonnell, PharmD SVP, Cardiovascular and Metabolic Diseases, Takeda Prior roles: Gates Foundation, Zymogenetics, Immunex Robert Chess Chairman (& former CEO), Nektar Prior roles: Penderm, Intel, IBM, the White House Kenneth Kelley CEO, PaxVax; Chairman Halozyme Funded nearly 40 companies, of which 15 became public Andreas (Andy) Bakker, PhD VP Operations, Cynvenio Extensive leadership in clinical laboratory operations and quality systems 2014 CORPORATE OVERVIEW 7

8 OUR DIFFERENCE We aspire to be your scientific partner: dedicated, trustworthy, precise, focused and innovative. Experience, delivered. To find out more, please visit us at or contact us directly at 2014 CORPORATE OVERVIEW 8