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Pliant Therapeutics
This highly visible leadership role thrives through fierce collaboration with multidisciplinary teams, embracing broad experience in modern DMPK science to optimize and advance both small and large molecule candidates.
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FibroGen
Senior Director Clinical Pharmacology
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Xencor
Scientist, Immuno-Oncology
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Xencor
Research Associate 3, Immuno-Oncology
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Genentech
Senior Scientist, Small Molecule Analytical Chemistry
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Workshop
[In-Person] Preclinical Development & IND Filing for Small Molecules: Nuts, Bolts and Best Practices
Speakers:
Christine Wu, Arcus Bioscience; Werner Rubas, Sutro Biopharma; Anne Bonneville, Terns Pharmaceuticals; Jim Zhang, Olema Oncology; Peter Staehr, Consultant
Organizers:
Snow Ge, BridgeBio Pharma; Shichang Miao, Amgen
Date:
2023-04-24
Time:
8:45-17:00 Pacific Time
Registration fee:
Regular attendees: $295; Academic/Students/Postdocs: $125; Major Sponsorship: $3000 (sold out); Vendor Show: $675
Location:
Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor:
Vendor show vendors registered to date:
(15)Actylis; Altasciences; Alturas Analytics; BioAgilytix; BioTether Sciences; Curia; Frontage Laboratories; IRBM; KCAS Bioanalytical & Biomarker Services; Meadowhawk Biolabs; PharmaBlock; QPS, LLC; Quotient Sciences; SOLVO/CRL; Worldwide Clinical Trials
Registration: http://www.PBSS.org
Registration deadline:2023-04-23
(it will close sooner if the seating cap is reached)
About the Topic
Investigational new drug (IND) application is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations, and processes of assembling and filing an IND is the key to not only a successful filing but also a promising clinical development path forward. Often, there are cases where too many nice-to-have studies crowd in the package but critical studies/issues are not addressed, and this can lead to significant delays in clinical development. Additionally, the regulatory environment is changing as rapidly as the industry. Therefore, keeping up to date on the regulatory requirements and the industry’s best practices in different aspects including non-clinical safety, PK, CMC, and clinical plan is paramount. In this workshop, our speakers highly experienced with IND filings will discuss systemically the preclinical studies required for small molecule IND filings and the nuts, bolts, and best practices for putting together a high-quality IND package, as well as how to interact with various regulatory agencies.
Below are the topics to be covered:
· Overview of preclinical development and IND filing for small molecules
· Key preclinical studies required (Safety, DMPK & CMC)
· Clinical Development plans
· Regulatory strategies
· Interacting with regulatory agencies About the Speakers
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Time
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Topic
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Presenter
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8:45-9:00am
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PBSS Welcome and Introduction
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Shichang Miao (Amgen), Snow Ge (BridgeBio Pharma)
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9:00-9:40am
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1. IND filing and interaction with FDA
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Christine Wu (Arcus Bioscience)
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9:40-10:45am
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2. NonClinical Pharmacology & Pharmacokinetics
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Werner Rubas (Sutro Biopharma)
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10:45-10:55am
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Major Sponsor’s Presentation
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BioIVT
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10:55-11:10am
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Break Period & Vendor Show
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-
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11:10am-12:10pm
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3. Nonclinical Drug Safety
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Anne Killam Bonneville (Terns Pharmaceuticals)
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12:10-1:00pm
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Lunch
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Sponsor TBD
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1:00-1:45pm
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3. Nonclinical Drug Safety (cont’d)
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Anne Killam Bonneville (Terns Pharmaceuticals)
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1:45-2:45pm
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4. Chemistry, Manufacturing, and Controls
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Jim Zhang (Olema Oncology)
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2:45-2:55pm
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Major Sponsor’s Presentation
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Veloxity Labs
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2:55-3:10pm
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Break
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-
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3:15-4:15pm
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4. Clinical Development Plan
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Peter Staehr (Clinical Development Consultant)
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4:15-4:55pm
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6. FDA’s Perspective
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TBD
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4:55-5:30pm
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Panel Discussion
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All Speakers
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2023-04-03, [Free Online Symposium] Pediatric Drug Development: Regulatory and Clinical Considerations and Clinical Pharmacology Approaches
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2023-05-24, [In-Person] Preclinical Development and IND Filing for Antibody-Based Therapeutics: Nuts, Bolts and Best Practices
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2023-05-26, [Free Online Workshop] Nonclinical Carcinogenicity Studies: Fundamentals, Case Studies and Regulatory Trends
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2023-06-20, [Free Online Symposium] Highlights of 2022 FDA Approvals
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Ads (in random order)
Submit a Text Ad
($250 for 2 months)
BioTether Sciences
CRO focused on bioanalysis and cell-based assays. Regulated analysis for immunogenicity and PK/PD. Gene and cell therapy product characterization.
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Origin Bioanalytical Laboratory, Inc.
Bioanalytical CRO specializing in LC-MS/MS method development, validation, non-GLP and GLP analysis to support PK/TK studies, with ocular expertise.
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Hypha Discovery
Synthesis, purification & NMR characterization of phase I and II drug metabolites & API impurities at mg-g scale with COAs.
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Alturas Analytics, Inc.
Expert GLP & non-GLP LC-MS/MS, GC-MS/MS bioanalytical & PK/TK analysis services of small & large molecules in any matrix. Discovery through phase IV.
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Submit a Text Ad
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