1. I-Corps 10/11/2011 Advanced Chemistry for Pharmaceutical Progress Team: Kiel Neumann (EL) Stephen DiMagno (PI) Allan Green (Mentor)
2. I-Corps 10/11/11 <ul><li>PET is a non-invasive medical diagnostic technique for cardiac, brain, and tumor imaging </li></ul><ul><li>GFP technology makes new (unknown) and known (but clinically inaccessible) [ 18 F]-labeled radiotracers readily available </li></ul><ul><li>Fast, multiplatform, high efficiency synthesis of these fleeting, precious agents. </li></ul><ul><li>Initial target indications: pediatric neuroblastoma, Parkinson’s disease. </li></ul>
3. General methodology for adding fluorine to lead compounds of interest The Business Model Canvas Accessibility (RCY) Purity Speed PET/SPECT Multiplatform Sensitivity (nca) Specific compounds IP PoP data Regulatory plan Understanding of the regulatory process Contract cGMP precursor manufacture Salary, Rents Clinical trials SOPs for precursors and drugs Recruit clinical sites In vivo animal studies Develop regulatory plan for pre IND meeting ID cGMP CRO Fund-raising cGMP manufacturer Radiopharmacies Nuclear Medicine and Radiology departments Technical Assistance (Image Atlas) FDA regulatory support Radiopharmacies Equipment producers Prescribing physicians Radiologist who perform studies Sales of intermediates Technology license Product license (royalty) Direct sales of precursor R&D and clinical studies presented in journals and meetings Drug developers Pharmaceutical development companies IP PoP data Radiologists Technical assistance
4. I-Corps 10/11/11 Approximately 2.2 million procedures in the US. Drug costs range from $700 (on-patent) to ~$150 (generic FDG) US sales of radiopharmaceuticals for PET and SPECT $1.2 billion US sales expected to grow to $6 billion by 2018 Global numbers approximately 2x Source: Bio-Tech Systems Report #330; data for 2010.
5. I-Corps 10/11/11 2500 installed PET scanners PET radiopharmacies cover the entire US market Radiopharmacies have an interest in proprietary agents as a basis of competition in their market.
6. I-Corps 10/11/11 Neuroblastoma Prevalence: about 6000 US cases about 1000 new cases per year Subjects receive 3-6 images/year to follow response to therapeutic protocols World market at U.S. x 2 gives potential of 40,000-70,000 scans/year Drug costs $500/per gives ~$20 - $35 M Parkinson’s Disease DatSCAN sales in Europe ~$100 M The world's highest recorded prevalence of Parkinson's Disease of any region is in Nebraska, with 329.3 people per 100,000 population US – 600,000 patients 1 scan per year @ $500 = $300 M
7. I-Corps 10/11/11 <ul><li>Radiologists and Nuclear Medicine Physicians </li></ul><ul><li>Radiopharmacy companies (Cardinal Health, Siemens, GE Healthcare, IBA, AAA) </li></ul><ul><li>Equipment manufacturers (GE, Philips, IBA, Advion) </li></ul><ul><li>cGMP manufacturers </li></ul><ul><li>Pharmaceutical companies </li></ul><ul><li>Radiologists and Nuclear Medicine Physicians </li></ul>