Biotech China 2014

Drug Design: Food and Drug Administration

Total Score People Score Events Score
41 33 34
Date Event Presentation Speakers
February 6, 2011 5th Drug Discovery for Neurodegeneration: An Intensive Course for Translating Research into Drugs Regulatory Requirements in Preparing for Clinical Trials Eric Bastings
November 3, 2010 Future Direction for Orphan Drugs in Europe The FDA Perspective Katherine I. Needleman
August 25, 2010 Co-Development of Drugs and Diagnostics Evidence Based Evaluation of New Molecular Diagnostic Tests – Going for the Gold Steven Gutman
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
February 22, 2010 2010 PERSONALIZED MEDICINE PARTNERSHIPS CONFERENCE FDA's Experience with Personalized Medicine Clearances & Approvals Elizabeth Mansfield
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
August 17, 2009 Fourth Annual Novel Vaccines: Design & Development Plenary Keynote Presentation Vaccines: Challenges for the Future Norman Baylor
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 10, 2009 Second Annual Hepatotoxicity and Drug Safety KEYNOTE PANEL DISCUSSION Wendy Sanhai
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
March 17, 2009 Bio Medical Asia 2009 A regulatory approach to Quality-by-Design for biotechnology products Steve Kozlowski
March 11, 2009 Electronic Data in Clinical Trials Panel with Speakers - Regulatory Issues Associated with Electronic Systems Jonathan Helfgott
February 24, 2009 11th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials external Government Investigations and Enforcement Priorities of Clinical Practices Karena Cooper
January 26, 2009 Translational Cancer Medicine COMPANION DIAGNOSTICS : The Potential Impact of Recently Approved and Emerging Molecular Diagnostics in Drug-Diagnostics Co-Development Francis Kalush
January 26, 2009 7th Annual Partnering with Central Labs Track C : Working Together to Develop Biomarkers for Safety Monitoring and Surrogate Endpoints Wendy Sanhai
November 20, 2008 5TH LATIN AMERICAN CONGRESS OF CLINICAL RESEARCH REGIONAL PERSPECTIVES AND FUTURE TRENDS The BE/BA harmonization in The Americas. Update on the work by the BE/BA working group RED PARF/ PAHO. Justina Molzon
C) The BE/BA harmonization in The Americas. Update on the work by the BE/BA working group RED PARF/ PAHO. Justina Molzon
November 12, 2008 Third Annual Post-Approval Drug Safety Strategies: Best Practices to Mitigate Risks throughout the Product's Life Cycle Chairperson’s Opening Remarks Federico Goodsaid
Translational Safety Biomarkers and the Path to Phase-1 Studies Federico Goodsaid
November 11, 2008 Stability Testing for Biologics FDA KEYNOTE ADDRESS Stability and specifications: A regulatory perspective Philip Krause
November 5, 2008 DIA's 6th Canadian Annual Meeting: Benefit and Risk Management: An Evolution in Progress TRACK 1 : Speakers Charles A. Gaylord
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
September 29, 2008 Genomic Biomarkers Title to be Announced Alberto Gutierrez
September 29, 2008 Metabolic Biomarkers Using Metabonomics and DNA Microarrays to Find Biomarkers of Liver Injury Richard Beger
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
May 18, 2008 MAGI’s 2008 Clinical Trial Agreements, Budgets & Regulatory Conference – EAST Track D: Regulatory FDA Inspections of Research Sites Cheryl Dubenezic
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 TRENDS IN DRUG SAFETY SDAR: Spectrometric Data Activity Relationship Modeling Dan Buzatu
December 4, 2007 7th World Drug Discovery & Development Summit 2007 FDA KEYNOTE ADDRESS: REGULATORY ASPECTS OF BIOMARKER DEVELOPMENT AND VALIDATION Dr. Courtney C. Harper
October 2, 2007 IVT 's Lab Week FDA Keynote Presentation: FDA's Final OOS Guidance Paul Haynie
Regulatory Considerations for Stability Testing Barry Rothman
September 19, 2007 Baculovirus Technology (Sep 19-20) Baculovirus: The Big Picture (08:30-10:35) Philip Krause
Baculovirus - The Big Picture: KEYNOTE PRESENTATION - Regulatory Evaluation of Baculovirus-Produced Vaccines (08:40-09:20) Philip Krause
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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