Biotech China 2014

Cancer Biology: Food and Drug Administration

Total Score People Score Events Score
49 37 39
Date Event Presentation Speakers
April 6, 2013 AACR Annual Meetings Personalized Medicine in Clinical Trials: What You Need to Know Now Elizabeth Mansfield, U.S. Food and Drug Administration, Rockville, MD Elizabeth Mansfield
January 31, 2013 11th Cytokines and Inflammation Differential Responsiveness of Human Hepatocytes and Blood Leukocytes to Interferon-alpha and -lambda Raymond Donnelly
December 8, 2012 54th American Society of Haematology Annual Meeting and Exposition Career-Development Lunch Sessions Albert B. Deisseroth
April 11, 2011 Personalized Medicine Partnerships Conference Companion Diagnostics | FDA's Current Thinking Elizabeth Mansfield
April 4, 2011 RNAi & Single Cell Biology-2011 Summit TBA Hao Zhu
February 6, 2011 Electronic Data in Clinical Trials Part I Q&A with FDA: Improving Communication and Understanding for All Stakeholders Michael Marcarelli, Jonathan Helfgott
August 25, 2010 Co-Development of Drugs and Diagnostics Evidence Based Evaluation of New Molecular Diagnostic Tests – Going for the Gold Steven Gutman
August 24, 2010 Enabling Point-of-Care Diagnostics - Moving Towards Rapid Diagnosis Regulation of Novel Molecular Diagnostic Devices for POC Testing Francisco Martinez-Murillo
August 18, 2010 Challenges in Pre-Clinical & Clinical Development - Top 5 Challenges in Vaccines & Immunotherapeutics Perspectives on the Changing Regulatory Paradigm Elaine Esber
August 17, 2010 Production & Manufacturing of Vaccines Opening Keynote Presentation | Regulatory Authority Perspective on Handling Vaccine Production, Manufacturing and Process Change Norman Baylor
May 20, 2010 Antibody Optimization Trastuzumab Conjugate for the Treatment of Trastuzumab-Resistant Human Breast Cancer: Increasing Magnitude and Duration of Response Wen Jin Wu
May 4, 2010 Biomarker World Congress 2010 Biomarkers and the Development of Personalized Medicine: A Regulatory Perspective Francis Kalush
Role of Biomarkers in Drug Development: Application in Late Phase Clinical Trials Yaning Wang
November 6, 2009 Clinical Applications for Age Management Medicine Update on FDA Policies and Procedures Peter D Rumm
Panel Discussion and Q & A: Legal Issues Surrounding GH and Testosterone Peter D Rumm
September 24, 2009 TRACK 1: Optimizing Clinical Trials : Third Annual clinical biomarkers The Potential Impact of Recently Approved and Emerging Molecular Diagnostics in Drug-Diagnostics Co-Development Francis Kalush
September 24, 2009 Track 2: Implementing Personalized Medicine : Inaugural Targeted Therapy The Potential Impact of Recently Approved and Emerging Molecular Diagnostics in Drug-Diagnostics Co-Development Francis Kalush
September 23, 2009 Track 2: Implementing Personalized Medicine : Inaugural Personalized Medicine Safety and Efficacy Considerations for Biomarkers in Retrospective Analysis of Completed Clinical Trials Robert L. Becker
August 18, 2009 Inaugural Novel Vaccines: Adjuvants & Delivery Systems Development of Human Cell-Based Assays for Early Evaluation of Adjuvant Safety Hana Golding
August 17, 2009 Fourth Annual Novel Vaccines: Design & Development Plenary Keynote Presentation Vaccines: Challenges for the Future Norman Baylor
August 17, 2009 Inaugural Production & Manufacturing of Vaccines Plenary Keynote Presentation Norman Baylor
August 10, 2009 Second Annual Trends in Cancer Diagnostics Ensuring the Safety and Validity of Molecular Diagnostic Tests Alberto Gutierrez
August 10, 2009 Third Annual Enabling Point-of-Care Diagnostics Ensuring the Safety and Validity of Molecular Diagnostic Tests Alberto Gutierrez
August 5, 2009 Drug Safety Strategies to De-Risk Compounds Application of Omic Technologies to Identify Biomarkers of Toxicity Donna L. Mendrick
What Is Needed From Biomarkers for Preclinical and Clinical Testing? Wendy Sanhai
Applying "Omics' Technologies to Identify Toxicity Biomarkers Donna L. Mendrick
June 9, 2009 Third Annual Cardiotoxicity and Drug Safety Improving Safety in Medical Products Wendy Sanhai
June 4, 2009 Structure-Based Drug Design Main Conference Norman Baylor
November 10, 2008 The Burrill Personalized Medicine Meeting Keynote Interview: The FDA and Regulatory Approval Alberto Gutierrez
October 12, 2008 15th North American Regional Meeting - International Society for the Study of Xenobiotics Regulatory Approaches for Safety Assessment of Drug Metabolites Aisar Atrakchi
August 13, 2008 Advances In Cancer Vaccines A CBER Perspective on the Use of Novel Adjuvants in Vaccines: Challenges and Opportunities Norman Baylor
June 18, 2008 Accelerating Anticancer Agent Development and Validation Workshop Faculty Richard Pazdur
Panel Discussion: Obstacles to Development--Ten Barriers to Proving Agents are Effective and Safe Joseph Gootenberg
FDA Drug INDs Haleh Saber
Panel Discussion Haleh Saber
Dinner Panel: "Major Oncology Topics in the Press" Richard Pazdur
Drug Registration Strategies Richard Pazdur
Panelists Richard Pazdur
May 30, 2008 ASCO Annual'08 Meeting cancer genetics-- Integration of Molecular Testing into Clinical Decision Making Steven Gutman
clinical trials-- Beyond RECIST: Meaningful and Acceptable Endpoints in Phase II Trials Robert L. Justice
tumor biology-- Integration of Molecular Testing into Clinical Decision Making Steven Gutman
March 25, 2008 Molecular Diagnostics Regulation of Diagnostic Tests Steven Gutman
March 25, 2008 PATHWAY ANALYSIS Pathway Tools in the Interpretation of Genomic Data in VXDS Federico Goodsaid
March 25, 2008 R&D Risk Mitigation Regulation of Diagnostic Tests Steven Gutman
March 25, 2008 Preclinical Development SDAR: Spectrometric Data Activity Relationship Modeling Dan Buzatu
March 25, 2008 CYTOKINE-BASED THERAPEUTICS Cytokine Receptor Signaling in Hematopoietic Stem Cells andMyeloprolferative Diseases Weida Tong
March 25, 2008 CANCER MOLECULAR MARKERS Regulation of Diagnostic Tests Steven Gutman
December 4, 2007 7th World Drug Discovery & Development Summit 2007 FDA KEYNOTE ADDRESS: REGULATORY ASPECTS OF BIOMARKER DEVELOPMENT AND VALIDATION Dr. Courtney C. Harper
November 12, 2007 Well Characterized Biologicals - Continuous Evolution of Chemo- and Bioanalytical Approaches Nov(12 - 14) Regulatory Perspectives (13:25-17:00) Emily Shacter, Malcolm Moos, Kathleen A. Clouse
Regulatory Perspectives: Assessing Impurities in Biotherapeutics (16:00-16:30) Kathleen A. Clouse
Regulatory Perspectives: Potency Issues - Cell-Based Functional Assays vs. Binding Assays (14:30-15:00) Emily Shacter
Regulatory Perspectives: Problems and Limitations with Analytical Methods - A Regulator's Perspective (15:30-16:00) Malcolm Moos
Impact of Extractables and Leachables on Well Characterized Protein Products (10:45-13:25) Ingrid Markovic
Impact of Extractables and Leachables on Well Characterized Protein Products: Regulatory Considerations for Evaluating the Impact of Extractables and Leachables - A Risk-Based Approach (10:45-11:15) Ingrid Markovic
October 15, 2007 Thirs Annual Quantitative PCR, MicroArrays, And Biologican Validation: Capturing the Complete Biological Story (Oct 15-17) Acceptance Criteria for Gene Expression Data (14:00-15:30) Bharat Joshi
Acceptance Criteria for Gene Expression Data: Common Challenges and Considerations for Validation and Standardization of Gene Expression Data (14:35-15:05) Bharat Joshi
September 17, 2007 Biomarker Discovery Summit: Bridging the Silos in Biomarker Discovery & Validation (Sep17-19) Eight Annual Metabolic Biomarkers; METABOLITE BIOMARKERS OF TOXICITY (13:30-15:00) Laura K. Schnackenberg
Eight Annual Metabolic Biomarkers; METABOLITE BIOMARKERS OF TOXICITY: NMR Metabolomics: Characterization of Multi-Age Rodent Pediatric Models of Toxicity (14:00-14:30) Laura K. Schnackenberg
Third Annual Toxicity Biomarkers; METABOLITE BIOMARKERS OF TOXICITY (13:30-15:00) Laura K. Schnackenberg
Third Annual Toxicity Biomarkers; METABOLITE BIOMARKERS OF TOXICITY: Characterization of Multi-Age Rodent Pediatric Models of Toxicity (14:00-14:30) Laura K. Schnackenberg
Pre-Conference Workshops; Biomarker Assay Development and Validation: Part II FDA Perspective on Development and Qualification of Biomarkers (13:00-13:30) Reena Philip
4th Annual Pharma R&D Asia Congress
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