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iSBTc Oncology Biologics Development Primer 

02-23-2018 14:23

The International Society for Biological Therapy of Cancer (iSBTc): Oncology Biologics Development Primer
February 28-29, 2008
Marriott Gaithersburg Washington Center in Gaithersburg, MD

Program Organizers
Susan Jerian, MD - OncoRD, Inc.
Carl H. June, MD - University of Pennsylvania
Mercedes Serabian, MS, DABT - Food and Drug Administration, CBER
Robert J. Zimmerman, SD - Zimmerman Consulting

Program Summary
iSBTc created the Oncology Biologics Development Primer (OBDP) to meet the needs of the biological therapy community by educating physicians and researchers on the worldwide regulatory paths for biological therapy development. Though facilitating collaborative interactions between regulators, preclinical scientists, clinical investigators and industry, the OBDP will help ensure that active, innovative new therapies are rapidly and appropriately moved into clinical testing.

Target Audience
Physicians and scientists in academia, industry and regulatory agencies who have an interest in the strategic, preclinical, clinical and regulatory aspects of efficient oncology biologics development.

Presentations and video recordings are available based on permission from presenters.


#PresentationSlides #ClinicalTrials #SITC #Cytokines #TherapeuticAntibodies #Vaccines #AlliedHealth #Clinician #Industry #Oncologist #Researcher #2008 #Biomarkers #HeadandNeckCancers 
#Myeloma #Leukemia #ProstateCancer #RenalCellCarcinoma #AdoptiveCellTherapy #AdverseEvents #Toxicities​

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Regulatory Overview on Oncology Biologics Product Develop...   758 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session: Keynote; Presentation: Regulatory Overview on Oncology Biologics Product Development from Bench to First-in-Man; Presenter: Raj Puri, MD, PhD - Food and Drug Administration; Date: Thursday, February 28, 2008
 
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Cell and Gene Therapy Products for Cancer Treatment   166 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 1: Preclinical Development; Presentation: Meeting: Oncology Biologics Development Primer; Session: Keynote; Presentation: Regulatory Overview on Oncology Biologics Product Development from Bench to First-in-Man; Presentation: Cell and Gene Therapy Products for Cancer Treatment; Presenter: Ying Huang, PhD - Food and Drug Administration, CDER; Date: Thursday, February 28, 2008
 
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Biological Therapeutics for Cancer Treatments   84 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 1: Preclinical Development; Presentation: Biological Therapeutics for Cancer Treatments; Presenter: Andrew J. McDougal, PhD, DABT - Food and Drug Administration, CDER; Date: Thursday, February 28, 2008
 
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Special Inclusion-Exclusion Criteria   58 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 2: Clinical Development; Presentation: Phase I Design Issues: Surrogate Markers/Selecting Pts/Special Inclusion-Exclusion Criteria; Presenter: Susan Jerian, MD - OncoRD, Inc.; Date: Thursday, February 28, 2008
 
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Phase II and Beyond Issues   1.25 MB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 2: Clinical Development; Presentation: Phase II and Beyond Issues; Presenter: John M. Kirkwood, MD - University of Pittsburgh Cancer Institute; Date: Thursday, February 28, 2008
 
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Working in the World of Regulated Research   175 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 2: Clinical Development; Presentation: Good Clinical Research Practice: Working in the World of Regulated Research; Presenter: Marta Fields - Amgen, Inc.; Date: Thursday, February 28, 2008
 
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Lessons from Double Digit Cytokines IL12, IL18 and Counting   2.30 MB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 3: Case Studies in Protein Therapeutics; Presentation: Cytokines: Lessons from Double Digit Cytokines IL12, IL18 and Counting; Presenter: Michael T. Lotze, MD - University of Pittsburgh Cancer Institute; Date: Thursday, February 28, 2008
 
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CD40 Agonist Development for Cancer   123 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 3: Case Studies in Protein Therapeutics; Presentation: Antibodies: CD40 Agonist Development for Cancer; Presenter: Robert Vonderheide, MD, D.Phil - University of Pennsylvania, Abramson Family Cancer Research Institute; Date: Thursday, February 28, 2008
 
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Academic Drug Development - Bench to First-in-Man without...   113 KB   1 version
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Meeting: Oncology Biologics Development Primer; Session 4: Industry & Academic Relationships in Biologic Development; Presentation: Academic Drug Development - Bench to First-in-Man without Industry; Presenter: Elizabeth Jaffee, MD - Johns Hopkins University; Date: Thursday, February 28, 2008
 
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What Industry Expects from Academic Partnerships   75 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 4: Industry & Academic Relationships in Biologic Development; Presentation: Industry Perspective: What Industry Expects from Academic Partnerships; Presenter: David R. Parkinson, MD - Nodality Inc.; Date: Thursday, February 28, 2008
 
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Role of Tech Transfer in Academia and Common Out-Licensi...   263 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 4: Industry & Academic Relationships in Biologic Development; Presentation: Academic Perspective: Role of Tech Transfer in Academia and Common Out-Licensing Criteria; Presenter: Chris Moulding - USC Stevens Institute for Innovation; Date: Thursday, February 28, 2008
 
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EU Perspective on Regulatory Issues for Biologics   134 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 5: Regulatory Strategies in the Global Arena; Presentation: EU Perspective on Regulatory Issues for Biologics; Presenter: Robert Charnas, PhD - Amgen, Inc.; Date: Friday, February 29, 2008
 
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Japan Perspective on Regulatory Issues for Biologics   208 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 5: Regulatory Strategies in the Global Arena; Presentation: Japan Perspective on Regulatory Issues for Biologics; Presenter: Ken Takeshita, MD - Celgene Corporation; Date: Friday, February 29, 2008
 
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Dendritic Cell Based Vaccines   747 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 6: Case Studies in Vaccines; Presentation: Dendritic Cell Based Vaccines; Presenter: Lothar H. Finke, MD - ARGOS Therapeutics; Date: Friday, February 29, 2008
 
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Nucleic Acid Based Vaccines   337 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 6: Case Studies in Vaccines; Presentation: Nucleic Acid Based Vaccines; Presenter: Laurence Elias, MD - Geron Corporation; Date: Friday, February 29, 2008
 
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NK Cell Therapeutics for Cancer   355 KB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 7: Case Studies in Cellular Therapeutics; Presentation: NK Cell Therapeutics for Cancer; Presenter: Jeffrey Miller, MD - University of Minnesota; Date: Friday, February 29, 2008
 
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Adoptive T Cell Transfer of Regulatory T Cells for GVHD   1.64 MB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 7: Case Studies in Cellular Therapeutics; Presentation: Adoptive T Cell Transfer of Regulatory T Cells for GVHD; Presenter: Carl H. June, MD - University of Pennsylvania; Date: Friday, February 29, 2008
 
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Mesenchymal Stem Cell Therapy with Prochymal for GVHD   1.17 MB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 7: Case Studies in Cellular Therapeutics; Presentation: Mesenchymal Stem Cell Therapy with Prochymal for GVHD; Presenter: C. Randal Mills, PhD - Osiris Therapeutics, Inc.; Date: Friday, February 29, 2008
 
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Oncolytic Viruses - Reovirus   2.57 MB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 8: Case Studies in Gene Therapies; Presentation: Oncolytic Viruses - Reovirus; Presenter: Matt Coffey, PhD - Oncolytics Biotech, Inc.; Date: Friday, February 29, 2008
 
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Adenovirus Vectors   1.67 MB   1 version
Uploaded - 02-23-2018
Meeting: Oncology Biologics Development Primer; Session 8: Case Studies in Gene Therapies; Presentation: Adenovirus Vectors; Presenter: Sunil Chada, PhD - Introgen Therapeutics, Inc.; Date: Friday, February 29, 2008
 
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