ground flour pharmaceuticals lecture 3 value prop
TRANSCRIPT
I-Corps 10/11/2011
Advanced Chemistry for Pharmaceutical Progress
Team: Kiel Neumann (EL)
Stephen DiMagno (PI)
Allan Green (Mentor)
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PET is a non-invasive medical diagnostic technique for cardiac, brain, and tumor imaging
GFP technology makes new (unknown) and known (but clinically inaccessible) [18F]-labeled radiotracers readily available
Fast, multiplatform, high efficiency synthesis of these fleeting, precious agents.
Initial target indications: pediatric neuroblastoma, Parkinson’s disease.
General methodology for adding fluorine
to lead compounds of
interest
General methodology for adding fluorine
to lead compounds of
interest
The Business Model Canvas
Accessibility (RCY)PuritySpeedPET/SPECTMultiplatformSensitivity (nca)Specific compounds
IPPoP dataRegulatory planUnderstanding of the regulatory process
Contract cGMP precursor manufactureSalary, RentsClinical trials
SOPs for precursors and drugsRecruit clinical sitesIn vivo animal studiesDevelop regulatory plan for pre IND meetingID cGMP CROFund-raising
cGMP manufacturerRadiopharmaciesNuclear 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
IPPoP data
Radiologists
Technical assistance
- Face to face with attending Radiologist at Stanford University
- Face to face with radiopharmacist at UCSF
- Conference call with Nuclear Radiologist at Memorial Sloan Kettering
- Conference call with president of medium size drug company with PET product at the FDA
- Telephone conference with cGMP facility
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- Immediate need for our product
- Currently used SPECT product for neuroblastoma is limited by absence of correlative CT data
- Our lead PET agent would provide more information on existing imaging equipment base
- Two customers offered to participate in clinical trials
- Potential for further development of other tracers identified in interviews
- Actual need for the general procedure
- Allow access to previously unknown tracers
-Initially seeking to market method technology
-too diffuse, but many opportunities (i.e. product-driven opportunities more than general technology-driven)
-Need to identify specific imaging product opportunities
-Validated hypothesis for immediate need of tracers
-Raised question on identity of lead compound pipeline for Parkinson’s disease
-Recruited two potential partners for clinical trials
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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.
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2500 installed PET scannersPET radiopharmacies cover the entire US marketRadiopharmacies have an interest in proprietary agents as a basis of competition in their market.
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Neuroblastoma
Prevalence: about 6000 US cases about 1000 new cases per year
Subjects receive 3-6 images/yearto 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