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Compelling Need for Oncology Drug Development Expertise. 860 oncology drugs in development . Acquire select early stage drug candidates; develop through POC (PIIb); sell to PharmaManage development of select Pharma compounds; participate in project financing. ASCALON Strategy . Richard Love - Chair, Board of Directors Partner in TRAC ILEX Founder and CEO (purchased by Genzyme - $1B) On PAREXEL BOD Daniel Von Hoff, MD
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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 USON’s 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 USA’s 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 world’s largest and most experienced CRO’s
Over 25 years of experience
Approximately 9,000 employees
Operates in 71 locations throughout 52 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 – TGen’s 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