ground flour pharma lecture 5 cust relationships
TRANSCRIPT
Advanced Chemistry for Pharmaceutical Progress
Team: Kiel Neumann (EL)
Stephen DiMagno (PI)
Allan Green (Mentor)
2
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
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)
Drug developers
Pharmaceutical development companies
IPPoP data
Radiologists
Technical assistance
Direct sales of precursor
R&D and clinical studies presented in journals and meetings
Sales of precursor through global finished pharmaceutical distributor
I-Corps 10/11/11 4
1) Radiologists and Nuclear Medicine Physicians2) Radiopharmacy companies (Cardinal Health, Siemens, GE
Healthcare, IBA, AAA)3) Equipment manufacturers (GE, Philips, IBA, Advion)4) cGMP manufacturers
1) Pharmaceutical companies2) Radiologists and Nuclear Medicine Physicians
- 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
I-Corps 10/12/11 5
I-Corps 10/12/11 6
- 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
Face to Face meeting with president of small radiopharmaceutical company
Face to face with a clinician at Memorial Sloan-Kettering
Face to face with Global Production Manager of Molecular imaging for one of world’s largest radiopharmaceutical companies
OncoKinib collaboration between Geurbet, OncoDesign, and Ariana pharmaceuticals
Face to face meeting with head of R & D and International Production Manager from Linz, Austria
Eckert and Zeigler – German PET modular synthesis provider
Face to face meeting with Executive Director and CEO of Scott Tech Center in Omaha, NE
Introductory teleconference to CEO of Innovation Accelerator
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Significant Interest in our technology
Radiopharmacies want GMP product
No interest in GMP reagent preparation
Third-party manufacturers would use our developed synthetic pathways
Internal competition with one world radiopharmaceutical leader
Best to approach one of other two world leaders
Scott Tech Center
Willing to offer free advice on startup strategy
Provided introduction to Innovation Accelerator
Offered introduction to Director of Venture Technology of one of world’s leading radiopharmaceutical companies
8
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)
Drug developers
Pharmaceutical development companies
IPPoP data
Radiologists
Technical assistance
Direct sales of precursor
R&D and clinical studies presented in journals and meetings
Sales of precursor through global finished pharmaceutical distributor
10
We provide accessibility
Only want GMP precursor in modules without development
Could license precursor synthesis for incorporation in modules
Require GMP precursor (or cassette) to develop our product with their synthesizer
Conference call with top 40 Fortune 500 chemical distribution company Open to cGMP production of our potentially proprietary precursors Interested in developing a general “plug-and-play” cassette
Would allow implementation of our methodology and precursors for any radiochemistry module
Important for FDA compliant production of any drug used in patient diagnostics
Face to face meeting with Director of Business Development of a leading drug discovery outsourcing company Discussed preclinical studies and contract manufacturing of
proprietary intermediates
- Face to face with former Director of Chemistry of major pharmaceutical company- Significant interest in general methodology application to proprietary
compound syntheses
I-Corps 10/18/11 11
-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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I-Corps 10/11/11 13
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.
I-Corps 10/11/11 14
2500 installed PET scannersPET radiopharmacies cover the entire US marketRadiopharmacies have an interest in proprietary agents as a basis of competition in their market.
I-Corps 10/11/11 15
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