Excellence in Commercial Oncology Drug Development - PowerPoint PPT Presentation

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Excellence in Commercial Oncology Drug Development

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    3. Acquire select early stage drug candidates; develop through POC (PIIb); sell to Pharma Manage development of select Pharma compounds; participate in project financing

    5. ASCALON Experience

    7. US Oncology (USON) Leadership in developing new treatments is hallmark of USONs mission to advance cancer care in USA USON supports a national network of over 1,300 community-based cancer research physicians covering 25% of US cancer patients US Oncology has played a pivotal role in the development of 36 of the cancer drugs most recently approved by the FDA One of the USAs largest research networks specializing in Phase I-IV oncology clinical trials US Oncology joined with the Molecular Profiling Institute to create the Tissue Banking and Analysis Center US Oncology Clinical Development, an oncology-focused contract research organization (CRO) launched in 2009 to complete the continuum of research services offered through US Oncology

    8. PAREXEL One of the worlds largest and most experienced CROs Over 25 years of experience Approximately 9,000 employees Operates in71 locations throughout52 countries around the world Significant oncology drug development experience In the previous 5 years managed oncology trials involving 175,000 patients

    9. Translational Genomics Research Institute/TD2 TGen Internationally recognized genomics research institution focused on personalized medicine TD2 TGens oncology drug service subsidiary providing genomic pathway analysis, preclinical in vivo testing and Phase I clinical trials coordination Currently ~ 45 biopharmaceutical clients

    10. ASCALON identifies and agrees co-development oncology product opportunities In consultation with partners provides high caliber development plan and project management oversight, plus shared investment and risk TGen/TD2 identifies efficacy biomarkers with proprietary tumor clonal genomics technology for rational drug development Guiding selection of drugs chosen for development Increasing success of biomarker based clinical trials due to new FDA biomarker guidelines USON/Parexel implement and execute clinical trials and submit FDA/EMEA marketing applications Outstanding international execution

    11. A more creative, financially attractive, operationally effective, and risk reducing drug development path for any partner (Major Pharma potential partner ) Apply expert clinical insights, genomic tools and preclinical models to determine the context of vulnerability (COV) and how to positively impact it Prove/disprove COV hypothesis in small clinical trials at USON, Parexel Design FDA acceptable pivotal trials If desired by pharma partner manage international registration-directed program

    13. ASCALON Summary