intro to ohio state's drug development bootcamp: practical aspects of positioning your research
TRANSCRIPT
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DDI: Ohio State’s DrugDevelopment Institute
Accelerating Innovative Research to Speed Cures to Cancer Patients
The Ohio State University Comprehensive Cancer Center –Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James)
Drug Development Bootcamp: Practical aspects of positioning your research
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DDI Bridges the Gap Between OSU’s Strengths in Early Discovery and Clinical Development
DDI
InvestmentReturns
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We are accelerating innovative research to speed cures to cancer patients
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DDI Team
Erandi De Silva, PhD Director of Biology Molecular biologist with experience
in genomics, genetics and target discovery
Previously at Genentech
Chad Bennett, PhD Director of Chemistry Organic chemist with experience in
synthesis, medicinal and process chemistry
Previously at Merck & Schering-Plough
Larry Schaaf, PhD Director of Strategic Alliances Clinical pharmacologist with experience in
oncology discovery and clinical trials Previously at Upjohn, Pharmacia & Pfizer
Diverse Industry Experience Molecular Biology Medicinal and Process
Chemistry Clinical Pharmacology Phase I-IV Clinical Trials
Proven track record of progressing therapies through the pipeline Milestone based project
management approach
Jeffrey Patrick, PharmD Director Clinical scientist with experience in
preclinical and clinical development Previously at Dyax Corp., Mallinckrodt,
and New Haven Pharmaceuticals
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What We Do & How We Do It
Identify partners Deal negotiation Generate money
to fuel new research
PARTNER
Scientific rationale Unmet medical need Commercial viability Intellectual property
Strategic investments Milestone focused Efficient management Advance projects quickly
DE-RISKPROJECTS
IDENTIFY PROMISING MOLECULES &
TECHNOLOGIES
DDI
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Coordinate project teams:• Independent labs• OSU shared resources • External resources
Facilitate access to experts inside and outside Ohio State
Lead independent validation studies
Manage external & internal relationships
Leverage principal investigator’s expertise to advance research
Lead key studies Target validation Proof-of-concept Assay development Design new molecules
DDI PROJECT PLAN ACTIVITY
DDI DIRECTEDPRINCIPALINVESTIGATOR DIRECTED
Project Team ApproachDDI implements a unique, collaborative execution strategy
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Talk to us about your drug development questions:
Email: [email protected]
Phone: 614-685-6957
Website: cancer.osu.edu/ddi
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AGENDA Drug Development “Boot Camp”: Practical Aspects of Positioning Your Research
9:00 am Welcome and Introduction Erandi De Silva, PhD Director of Biology, OSUCCC – James Drug Development Institute
9:10 am Target Validation / Biochemical and Cellular Assay Development David Fischer, PhD Executive Director, Biology, DMPK Discovery Charles River Laboratories, Inc.
10:05 am Case Study: Difference Between Tool Compound and Clinical Candidate Joe Cornicelli, PhD Director, Inflammation and Cardiovascular Pharmacology, Discovery Research Services Charles River
11:00 am Break 11:15 am Early in vivo Safety Toxicology Considerations
Brian Roche, PhD Director, Safety Pharmacology Charles River
11:30 am Cell-Based Ion Channel and Cardiac Safety Assays Jim Kramer, PhD Principal Scientist, Early Discovery Services Charles River
11:45 am In vitro ADMET Considerations for Drug Discovery and Lead Generation Adrian Sheldon, PhD Associate Director of In Vitro ADMET Charles River
12:10 pm Break12:30 pm LUNCH & PANEL DISCUSSION: Career Pathways for Scientists
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The roadmap to an approved drug
Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006. PR Tufts CSDD 2014 Cost Study, Nov. 18, 2014.
Discovery Preclinical Clinical TrialsPhases
FDAReview
Scale-Upto Mfg.
Post-MktgMonitoring
3-6 Years 6-7 Years 0.5-2 Years Indefinite
IND
SUBM
ITTE
D
NDA
SUBM
ITTE
D
1 2 3
~5k–10k1
APPROVED DRUG
5250candidates
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The roadmap to an approved drug
Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006. PR Tufts CSDD 2014 Cost Study, Nov. 18, 2014.
Discovery Preclinical Clinical TrialsPhases
FDAReview
Scale-Upto Mfg.
Post-MktgMonitoring
3-6 Years 6-7 Years 0.5-2 Years Indefinite
IND
SUBM
ITTE
D
NDA
SUBM
ITTE
D
1 2 3
~5k–10k1
APPROVED DRUG
5250candidates
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Stages of Drug Discovery and Early Development
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Research & Development Value Chain
PHASE IPRE-CLINICALCANDIDATE
LEADOPTIMIZATION
LEADIDENTIFICATION
TARGETVALIDATION
TARGETID
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Stages of Drug Discovery and Early Development
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TARGET ID
Function of target and its role in disease
Research & Development Value Chain
PHASE IPRE-CLINICALCANDIDATE
LEADOPTIMIZATION
LEADIDENTIFICATION
TARGETVALIDATION
TARGETID
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Stages of Drug Discovery and Early Development
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TARGET VALIDATION
Demonstrate modulation of target has therapeutic effect
Research & Development Value Chain
PHASE IPRE-CLINICALCANDIDATE
LEADOPTIMIZATION
LEADIDENTIFICATION
TARGETVALIDATION
TARGETID
9:10 am Target Validation / Biochemical and Cellular Assay Development
David Fischer, PhD Executive Director, Biology, DMPK Discovery Charles River Laboratories, Inc.
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Stages of Drug Discovery and Early Development
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LEAD IDENTIFICATION
Identify drug-like lead molecule Active in validated assays Acceptable specificity and selectivity
Research & Development Value Chain
PHASE IPRE-CLINICALCANDIDATE
LEADOPTIMIZATION
LEADIDENTIFICATION
TARGETVALIDATION
TARGETID
10:05 am Case Study: Difference Between Tool Compound and Clinical Candidate
Joe Cornicelli, PhD Director, Inflammation and Cardiovascular Pharmacology, Discovery Research Services Charles River
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Stages of Drug Discovery and Early Development
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LEAD OPTIMIZATION
Identify a candidate forIND-enabling studies SAR defined Acceptable PK Druggability
(permeability, metabolism, etc.) In vivo efficacy Pilot toxicology & safety Scale up feasibility
Research & Development Value Chain
PHASE IPRE-CLINICALCANDIDATE
LEADOPTIMIZATION
LEADIDENTIFICATION
TARGETVALIDATION
TARGETID
11:15 am Early in vivo Safety Toxicology Considerations Brian Roche, PhD Director, Safety Pharmacology Charles River
11:30 am Cell-Based Ion Channel and Cardiac Safety Assays Jim Kramer, PhD Principal Scientist, Early Discovery Services Charles River
11:45 am In vitro ADMET Considerations for Drug Discovery and Lead Generation Adrian Sheldon, PhD Associate Director of In Vitro ADMET Charles River
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Stages of Drug Discovery and Early Development
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PRE-CLINICAL CANDIDATE
Conduct IND-enabling studies Acceptable PK Acceptable safety margin & profile Feasibility of GMP manufacture Pre-IND Meeting Submit IND
Pharmaceutical Development Value Chain
PHASE IPRE-CLINICALCANDIDATE
LEADOPTIMIZATION
LEADIDENTIFICATION
TARGETVALIDATION
TARGETID
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Stages of Drug Discovery and Early Development
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PHASE I
Human safety assessment Identify maximum tolerated dose PK PD exploratory biomarkers Preliminary activity assessment
Research & Development Value Chain
PHASE IPRE-CLINICALCANDIDATE
LEADOPTIMIZATION
LEADIDENTIFICATION
TARGETVALIDATION
TARGETID
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AGENDA Drug Development “Boot Camp”: Practical Aspects of Positioning Your Research
9:00 am Welcome and Introduction Erandi De Silva, PhD Director of Biology, OSUCCC – James Drug Development Institute
9:10 am Target Validation / Biochemical and Cellular Assay Development David Fischer, PhD Executive Director, Biology, DMPK Discovery Charles River Laboratories, Inc.
10:05 am Case Study: Difference Between Tool Compound and Clinical Candidate Joe Cornicelli, PhD Director, Inflammation and Cardiovascular Pharmacology, Discovery Research Services Charles River
11:00 am Break 11:15 am Early in vivo Safety Toxicology Considerations
Brian Roche, PhD Director, Safety Pharmacology Charles River
11:30 am Cell-Based Ion Channel and Cardiac Safety Assays Jim Kramer, PhD Principal Scientist, Early Discovery Services Charles River
11:45 am In vitro ADMET Considerations for Drug Discovery and Lead Generation Adrian Sheldon, PhD Associate Director of In Vitro ADMET Charles River
12:10 pm Break12:30 pm LUNCH & PANEL DISCUSSION: Career Pathways for Scientists
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Panel Discussion: Career Pathways for Scientists
David Fischer, PhD Executive Director, Biology, DMPK Discovery
Joe Cornicelli, PhD Executive Director, Biology, DMPK Discovery
Brian Roche, PhD Director, Inflammation and Cardiovascular Pharmacology, Discovery
Research Services
Jim Kramer, PhD Director, Safety Pharmacology
Adrian Sheldon, PhD Associate Director of In Vitro ADMET
Tracey Papenfuss, DVM, PhD Veterinary Pathologist II
Tom Claggett Regional Sales Manager
Andy Vick, PhD Corporate Vice President, Safety Assessment