drug discovery and delivery/ bioprocessing (d 3 b) 4 corners alliance march 8-9, 2007 kansas city
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Drug Discovery and Delivery/Bioprocessing (D3B)
4 Corners Alliance
March 8-9, 2007
Kansas City
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Group Expertise
Bruce Schultz: Anatomy & Physiology—KSU Target identification Drug optimization
Kevin Van Cott: Bioprocessing Facility—NU Protein to Phase I trials Purification, characterization, etc. cGMP pilot plant (10,000 sq.ft. due 2007) Small biotechs/large pharma/NIH/DoD Vaccines, therapeutics Works with Russ Middaugh at KU All money staff…limits pro bono work
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Group Expertise (cont.)
Kathy Roby: Anatomy & cell biology/KU Cancer Center—KUMC Transition to clinical trials Ovarian cancer Efficacy testing No GLP/GMP = limitation Scott Weir: leader and promotion of
collaboration Drug to clinical trial pathway
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Group Expertise (cont.)
Charles Decedue: Higuchi Bioscience Center--KU Drug discovery & development Lead compound to Phase I clinical trials Drugs on market
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Group Expertise (cont.)
Robert Powers: Structural biology, NMR, bioinformatics—NU Small molecule library Robert came from the pharmaceutical
industry (Wyeth) Drug discovery/design Metabolomics High throughput NMR NMR/mass spec technique (100’s a day)
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Group Expertise (cont.)
Jeff Aube: medicinal chemistry, NIH CMLD Center—KU “Molecules are us.” Collaborates with bioscientists Minnesota, Iowa State, and UMKC
collaborators High throughput screening center
120,000 compound library KU Pharmacy ranks #3 in NIH funding
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Group Expertise (cont.)
Wynn Volkert: Radiopharmaceutical Science Institute—MU Largest research reactor in the US
Radioisotopes All domestic P32, etc. Isotopes useful for therapy NCI in vivo cellular and imaging center Radio labeling
Peptides Identifiable target vectors…use radio isotopes? George Smith—large phage display library 17 tesla small bore magnet
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Group Expertise (cont.)
Dave VanderVelde: NMR Facility—KU 800 MHz NMR…only in area until MU’s up Smaller instruments for special uses Natural products High throughput screening Solid state NMR
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Group Expertise (cont.)
Joe Tash: male contraceptive--KUMC Collaboration with KULC and Minnesota MC developed from anti-cancer agent Derivatives into library and anti-cancer
candidates Duke plus other universities Came because the life science group was
crowded and we “looked like a nice bunch” 10.4 tesla small bore magnet in Hoglund
imaging center
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Group Expertise (cont.)
Pat Dussault: synthetic organic chemist—NU Anti-malarials Therapeutics for fungal infections
Steve DiMagno Not present. Stuck in the bioenergy
session. Imaging techniques PET
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General Observations
Having the vet schools in the alliance Swine at MU Collaborate on compound management Working issues with remote
instrumentation, e.g. mice and small bore magnets
NIH has an R01 oriented culture Difficulty in putting together a big idea
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General Observations (cont.)
Realistic outcome = program project at NIH
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Grand Challenges
Targeted therapy (molecule, tissue, tumor) Individualized therapy Identification of new novel targets
“Me too” approach of big pharma leaving potential targets behind (plus “me too” drugs)
Human genome project => drug targets Infectious diseases
Big pharma won’t touch Role for universities Gates Foundation
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Grand Challenges (cont.)
Expression regulation Preventative medicine Theoretical no. of possible compounds > no. of
atoms in universe Can you really sample the space? Other ways to search/screen molecule candidates?
High price of pharmaceuticals Reduce expenses getting to Phase I Reduce the failure rate, e.g. novel tox technique
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Grand Challenges (cont.)
Two most common failures in the clinic Efficacy Toxicity
Challenge: find the 25 hERG like tests for toxicity, ones with a history
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Theme for the AllianceNo. 1: Infectious Agents
Pharma has abandoned Third world Focus on humans Pick a disease? Don’t/can’t compete with big pharma Universities
KU(LC/MC)-molecules, natural products, probes MU-technology, radio labeling, molecular imaging NU-focus on entire organism, small molecule
screening KSU-looking across species, animal/tissue models
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Theme for the AllianceNo. 1: Infectious Agents (cont.)
Translational research Getting to Phase I clinical trials Collaborate on translation
Economic development
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Theme for the AllianceNo. 2: General Screening for Toxicity
Reduce the failure rate Animal and cell model development Universities
KULC/KUMC--Pharm & Tox NU—metabolomics MU—technology
Foundations Not an existing strength Longer term goal
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Goals
Research Spin off companies Improving health of the public Infectious disease center…part of the
Alliance NBAF support to one of the three
Alliance locations
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Large-scale Infrastructure Needs
GLP Centralized screening facility?
Large structured core service?
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Funding Opportunities
Gates Foundation Priorities are infectious diseases Gates not interested in basic research Will fund distribution of the cure Gates gave UCSF $20 million to research
anti-diarrheals (Bill Gates connection to PI) DARPA
Pre-symptomatic detection of disease Quantum leap development
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Funding Opportunities (cont.)
CDC MRCE (Wash. U.)
For Kansas, Nebraska, Iowa, Missouri, and Cleveland
Up to $1.5 million Vaccines
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An Opportunity
Personalized medicine Won’t be big pharma Small boutique companies spun out of
universities More dreaming
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Other Infectious Disease Centers
Emory? UW—focused on pediatric diseases Who would fund such a center?
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Who will play?
KU Lawrence, KUMC, NU, MU, KSU
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Expertise and Strength of Each Participant
Infectious diseases being researched Tularemia HIV Botulism Gram positive (sepsis) West Nile E. coli Salmonella
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Expertise and Strength of Each Participant (cont.)
Technology/process facilities Faculty research
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Needs, Weaknesses, or Conflicts
Surely you joke! Lack of a major funding source Building a portfolio a la Russ Middaugh
at KU is difficult Money Cooperative spirit a plus
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Likely Significant Competitors
Nobody and everybody Biotech startups
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What Value does the Alliance Add?
Infectious disease research Proposals in name of the Alliance Shared campus resources People
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Needed Support
Merged seed funds for Alliance specific collaborations
GMP Out source
Models for lead development Ad hoc seed funding Core facility at one campus Money from the Alliance (similar to way
core facilities are funded on campus)
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Needed Support (cont.)
Alliance Translational Fund Investment fund State organizations? Federal support?
Paid leader of the effort Money
Cash: $1,000,000 up front Annual:
Salary/fringe = $200,000 per year (leader) Cores = $250,000 per core
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Needed Support (cont.)
Needed actions agreed to 4 Corners Infectious Disease meeting Grad student posters, etc. Funding opportunities Provide pooled seed funds to be awarded
at meeting Communications
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Pooled Political Capital
Yes
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Action Plan
Leadership Scott Weir’s long-lost twin Person designated on each campus
Outcomes/decisions agreed to Form small groups of faculty participants 4 Corners Infectious Disease Alliance Work on model MOU, MTA, fees, etc. Start with two faculty partnerships for
example and build up
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Action Plan (cont.)
Who will carry out the plan? The Group?
Who will monitor and prompt success? Alliance VPR steering committee
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Action Plan (cont.)
Need Updated List of Expertise from the campuses Update lists of expertise and make
available Need wider net Target the response—infectious diseases
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Vision
Operate through 4 Corners Alliance Four Corners Infectious Disease Alliance
(4CIDA) Certain instruments/facilities declared
part of Alliance On-campus rates charged to Alliance
members Proposals submitted in the name of the
Alliance
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Vision (cont.)
Alliance drug discovery core facilities Chemical libraries Alliance high throughput screening Unique animal models Protein production facilities Biotech facilities Pre-clinical formulation Instruments available locally
Need: Generic Material Transfer Agreement (MTA) for the Alliance
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Vision (cont.)
Alliance will naturally spread to other drug discovery areas
Need focus to get it started
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Summary Description of Themes/Topics Selected
Infectious diseases Not limited in reality Can do other drug discovery efforts
Pathway to clinical trials