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Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
Ground flour pharma final presentation
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Ground flour pharma final presentation

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  1. The Challenge: Synthesize and inject the drug within two hours.(F-18 half-life = 110 min).The Solution: Single step fluorination for PET imaging agents.GFP does this better than anyone else. PET is critical for the diagnosis and treatment of cancer, neurological disease (Parkinson’s, Alzheimer’s), and cardiac disease. F-18 is the imaging isotope of choice.Spoke to: firms covering 60%-80% of the global radiopharmaceuticalmarket, 15 clinical PET users, and 7 GMP PET manufacturers, 5 officials ofstate economic development (>90 people total)
  2. * 10X increase in production at same cost * Pure “carrier-free” product to reduce side effects * Robust manufacturing reliability * Simplified regulatory approval * Accelerate new agents to marketThis is your brain on fluorine * Global PET market estimated to grow from $6.1 billion in 2010 to $9.8 billion in 2015 * GFP addresses the large unmet clinical demand for imaging agentsI-Corps Final Presentation 12/14/11
  3. *Kiel Neumann (Entrepreneurial lead) * Graduate Student at UNL (PhD in May 2012) * Thesis project developed technology used by GFP*Stephen DiMagno PhD (PI) * University of Nebraska Professor * Expertise in the synthesis, physical properties, and medicinal chemistry of fluorinated organic compounds*Allan Green MD, PhD, JD (Mentor) * Extensive experience in the pharmaceutical industry, including the development and launch of imaging products * Currently teaches FDA Law at the Boston College Law SchoolI-Corps Final Presentation 12/14/11
  4. The Business Model Canvas - Initial Technical AssistanceNuclear Medicine and SOPs for precursors (Image Atlas) RadiopharmaciesRadiology and drugs Accessibility (RCY) FDA regulatory supportdepartments Recruit clinical sites In vivo animal studies Purity Equipment producers Develop regulatory Speed plan for pre IND PET/SPECT Prescribing physicians meeting Multiplatform Technical assistance cGMP manufacturers ID cGMP CRO Sensitivity (nca) Radiologist who Radiopharmacies Fund-raising Specific compounds perform studies Pharmaceutical General Direct sales of precursor IP development methodology for PoP data Drug developers companies adding fluorine to Sales of packaged lead compounds of precursor in cassettes IP interest PoP data Radiologists Regulatory plan Cassette manufacturers Understanding of the regulatory process Sales of intermediates Contract cGMP precursor manufacture Salary, Rents Technology license Clinical trials Product license (royalty) I-Corps Final Presentation 12/14/11
  5. • F-dopa iodonium intermediate • F-dopamine iodonium intermediate Precursor SynthesisReagents •ABX •Eckert & Ziegler GMP •GE MX module for TracerLab Precursor in Cassette Cassette •Siemens ExploraComponents •TracerLab/ GE •Eckert & Ziegler •Siemens Explora Cassette (device) GMP •Neoprobe Compliant •SynthraSynthesizer •Siemens PETNet •GE Amersham •Cardinal Health PET Drug •AAA Finished productDistributor •Iason 5 I-Corps Final Presentation 12/14/11
  6. * Increase manufacturing yields by 10-fold without increase of the cost of inputs * Confirmed by European producer of F-18 DOPA. GFP technology would increase their output 10x* Cold unlabeled drug in current PET products produces side- effects that limit clinical use * Children’s Hospital confirms side-effects of F-18-dopamine are a problem and would be solved by GFP technology* Current manufacturing technology limits the clinical availability of important PET agents * Discussion with US hospital confirms important agent (F-18 DOPA) not available due to low yield and unreliability of current synthesesI-Corps Final Presentation 12/14/11
  7. * Companies with proposed proprietary PET agents need improved manufacturing pathways for reliability and economic success * Detailed discussion with two potential R & D partners (one large pharma, one small pharma) confirm need “Value is in the finished Radiopharmaceutical Distributors product” •Siemens PETNet •GE Amersham “Plug & Play” •Cardinal Health •AAA “We are definitely •Iason interested IF you can •Neoprobe make it work on ourI-Corps Final Presentation 12/14/11 platform”
  8. The Business Model Canvas - Pivot Technical AssistanceNuclear Medicine and SOPs for precursors (Image Atlas)Radiology and drugs Radiopharmacies Accessibility (RCY) FDA regulatory supportdepartments Recruit clinical sites In vivo animal studies Purity Equipment producers Develop regulatory Speed plan for pre IND PET/SPECT Prescribing physicians cGMP manufacturers Multiplatform Technical assistance meeting Radiopharmacies Sensitivity (nca) ID cGMP CRO Radiologist who Fund-raising Specific compounds perform studies General Pharmaceutical IP methodology for Direct sales of precursor development PoP data adding fluorine to Drug developers companies lead compounds of Sales of packaged IP interest precursor in cassettes PoP data Radiologists Regulatory plan Cassette manufacturers Understanding of the regulatory process Sales of intermediates Contract cGMP precursor manufacture Salary, Rents Technology license Clinical trials Product license (royalty) I-Corps Final Presentation 12/14/11
  9. UCSFMemorial Sloan-KetteringSt. Jude Children’s Research HospitalStanford Medical Center * Provide infrastructure for commercialization and clinical trials ABX Albany Molecular * Offer large-scale cGMP precursor production * Met Biologics GMP production facility TracerLab/ GE representatives at UNMC Neptis Eckert & Ziegler Siemens Explora * Offer GMP-compliant synthesizers Neoprobe Synthra I-Corps Final Presentation 12/14/11
  10. Global PET Market ~ $6.3 billion Serviceable available market ~ $1 billion Initial Target Market (first 2 compounds) ~ $100 millionI-Corps Final Presentation 12/14/11
  11. GFP F-18 DOPAParkinson’s DiseaseSPECT DaTScan(GE) sales in Europe ~$100 M -Current price - $2800/dose -Medicare reimbursement - Current SPECT technology $600/doseCurrently 1.5 million Americansdiagnosed with 60,000 new diagnoseseach yearExpected to rise with effectiveimaging PET imagingGFP F-18 DOPA addresses this market 11with a PET agent I-Corps Final Presentation 12/14/11
  12. GFP F-18 Dopamine• Neuroblastoma • Childhood cancer with prevalence comparable to leukemia• mIBG SPECT imaging now used• PET agent sought• Carrier-free F-18 dopamine synthesis shown by GFPn I-Corps Final Presentatio 12/14/11
  13. GMP Finished GMP Precursor Drug Finished Cassette Finished Product Drug Finished Drug $10’s/cassette $300 /cassette Product Finished Drug Finished Product Drug Patients Product Drug Finished Product Hospitals Nominal Product Drug One time royalty Product setup ($50) per $140,000 cassette $1700 per dose ~100 doses/cassette 13I-Corps Final Presentation 12/14/11
  14. The Final Business Model Canvas SOPs for precursors and drugs Recruit clinical sites Accessibility (RCY) In vivo animal studies Purity FDA regulatory support Develop regulatory Speed plan for pre IND PET/SPECT meeting Multiplatform Technical assistanceNuclear Medicine and Radiopharmacies ID cGMP CRO Sensitivity (nca)Radiology Specific compoundsdepartments Fund-raising Equipment producerscGMP manufacturers Intellectual Property Sales of packagedRadiopharmacies precursor in cassettes PoP Data Cassette manufacturers FDA support Licensing fees of precursor Contract cGMP precursor manufacture Salary, Rents Clinical trials Product license (royalty) I-Corps Final Presentation 12/14/11
  15. * Limitations in current PET chemistry constrain the availability of clinically important PET drugs * Low manufacturing yields, unreliability of current procedures, and manufacturing complexity are addressed by proprietary GFP technology * GFP technology addresses attractive markets * GFP technology provides accessibility * Proven synthesis of existing tracers with proven clinical use * Improved manufacturing of third-party proprietary imaging agentsSubmitted SBIR Phase 1 proposalPI bought out of teaching commitment in springRented space for GFPNegotiated license agreement with UNLNegotiating technology demonstrationsMet with State representatives for economic development

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