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Webcast
[Free Workshop from PBSS-San Diego] Leveraging Biomarkers in Drug Development: Discovery and Applications
Speakers:
Gizette Sperinde, Genentech; I-Ming Wang, Pfizer; Jen-Chieh Chuang, Takeda; Brad Ackermann, Eli Lilly & Company; Sarah Huntwork-Rodriguez, Denali Therapeutics; Marisa Dolled-Filhart, Bristol Myers Squibb; Jeffrey Siegel, FDA
Organizers:
Robyn Rourick, Genentech & Shian-Jiun (SJ) Shih, Cellentia
Date:
2023-06-29
Time:
8:30-13:40 Pacific Time
Registration fee:
Free
Location:
Webcast from PBSS SF.
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2023-06-28
(it will close sooner if the seating cap is reached)
About the Topic
The need to expand the understanding and success of potential therapeutics for patients has resulted in the increased focus on biomarkers from drug discovery to post marketing. This workshop will highlight the role of biomarkers through presentations on strategies to inform clinical development and the use of advanced technologies for detection and analysis. About the Speakers
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PT
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ET
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Topic
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Presenter
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8:30-8:40 am
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11:30-11:40 am
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Welcome Remarks/Introduction
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Robyn Rourick, MS, Director, Genentech, Inc.
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8:40-9:25 am
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11:40-12:25 pm
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Biomarkers in Clinical Development
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Gizette Sperinde, PhD, Distinguished Scientist, Genentech
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9:25-10:10 am
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12:25-1:10 pm
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Cancer Precision Medicine - Research and Applications.
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I-Ming Wang, PhD, Director of Translational Oncology, Pfizer
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10:10-10:50 am
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1:10-1:50 pm
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Biomarker Discovery for NASH
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Jen-Chieh Chuang, PhD, Associate Director, Translational Med.& Biomarker, Takeda.
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10:50-11:00 pm
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1:50-2:00 pm
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Break
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11:00-11:40 am
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2:00-2:40 am
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Application of Pharmacodynamic and Patient Phenotyping Biomarkers to Early- stage Clinical Studies in Parkinson’s Disease Patients
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Sarah Huntwork-Rodriguez, PhD, Principal Scientist and Director of Clinical Biomarkers, Denali Therapeutics
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11:40-12:20 pm
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2:40-3:20 pm
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Expanding Clinical Protein Biomarker Opportunities by Analysis of FFPE Biopsy Specimens Using LC/MS/MS
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Brad Ackermann, PhD, Associate Vice President, Eli Lilly and Company
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12:20-1:00 pm
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3:20-4:00 pm
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Biomarkers in Immuno-Oncology
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Marisa Dolled-Filhart, PhD, Vice President, Translational Development, Tumor Microenvironment Thematic Research Center, Bristol Myers Squibb
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1:00 -1:30 pm
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4:00 -4:30 pm
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Regulatory Considerations for Biomarkers
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Jeffrey Siegel, MD, Office Director, Office of Drug Evaluation Sciences (ODES), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), FDA
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1:30-1:40 pm
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4:30-4:40 pm
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QA and Closing Remarks
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All Speakers
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2024-04-30, [In-Person] Small Molecule Preclinical Development and IND Filing: Nuts, Bolts and Best Practices
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2024-10-17, [Free Online] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
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2024-10-17, [Free Online by PBSS-San Diego] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
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