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[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: (2)Bioivt; Veloxity Labs
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 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





PBSS Welcome and Introduction 

Shichang Miao (Amgen), Snow Ge (BridgeBio Pharma)


1. IND filing and interaction with FDA 

Christine Wu (Arcus Bioscience)


2. NonClinical Pharmacology & Pharmacokinetics

Werner Rubas (Sutro Biopharma)


Major Sponsor’s Presentation



Break Period & Vendor Show



3. Nonclinical Drug Safety

Anne Killam Bonneville (Terns Pharmaceuticals)



Sponsor TBD


3. Nonclinical Drug Safety (cont’d)

Anne Killam Bonneville (Terns Pharmaceuticals)


4. Chemistry, Manufacturing, and Controls

Jim Zhang (Olema Oncology)


Major Sponsor’s Presentation

Veloxity Labs





4. Clinical Development Plan

Peter Staehr (Clinical Development Consultant)


6. FDA’s Perspective



Panel Discussion

All Speakers

2023-04-03, [Free Online Symposium] Pediatric Drug Development: Regulatory and Clinical Considerations and Clinical Pharmacology Approaches
2023-05-24, [In-Person] Preclinical Development and IND Filing for Antibody-Based Therapeutics: Nuts, Bolts and Best Practices
2023-05-26, [Free Online Workshop] Nonclinical Carcinogenicity Studies: Fundamentals, Case Studies and Regulatory Trends
2023-06-20, [Free Online Symposium] Highlights of 2022 FDA Approvals
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