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Workshop

Preclinical development & IND Filing: Nuts, Bolts and Best Practices


Speakers: Tracy Chen, Jim Zhang, Peter Staehr, Anne Bonneville, Xingrong Liu
Organizers: Tracy Chen, Shichang Miao
Date: 1/22/2018
Time: 8:30-17:00
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For major-sponsor rep (incl lunch): $0; For vendor-show rep: $35;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (2)Catalent Pharma Solutions; Medpace
Vendor show vendors registered to date: (23)Absorption Systems; Alcami; Applied StemCell Inc.; BioDuro; BRI Biopharmaceutical Research Inc.; Celerion; ChemPartner; Cyprotex; Cytovier LLC; Intertek; JOINN Labs; MicroConstants; Pacific BioLabs; PHARMout Laboratories; Pion Inc.; QPS; Quotient Sciences; Sekisui XenoTech, LLC; SNBL USA; SOLVO Biotechnology; Spaulding Clinical Research; Worldwide Clinical Trials; WuXi AppTec
Registration: http://www.PBSS.org
Registration deadline:1/21/2018  (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.

The following topics will be covered:

- Overview of preclinical development and IND filing 
- Various preclinical studies required (Safety, DMPK & CMC)
- Clinical Development plans
- Interfacing with regulatory agencies including FDA

 

Workshop Agenda:

8:45-9:15   PBSS Welcome and Introduction (Tracy Chen)

9:15-10:30  1. Chemistry, Manufacturing, and Controls (Jim Zhang)

10:30-10:40  Major Sponsor’s Presentation (Medpace)

10:40-10:55  Break

10:55-12:25  2. NonClinical Pharmacology & Pharmacokinetics (Xingrong Liu)

12:25-1:25  Lunch

1:25-3:25  3. Toxicology in Drug Development (Anne Killam Bonneville)

3:25-3:45  Break

3:45-3:55  Major Sponsor’s Presentation (Catalent)

3:55-5:00  4. Clinical Development Plan and Interaction with FDA (Peter Staehr)

5:00-5:30  Panel Discussion (All Speakers)


2018-09-27, Small Molecule Formulation Development: Strategies for challenging APIs (jointly with AAPS-BADG)
2018-10-16, Drug-Drug Interactions: Update on Risk Assessment, Clinical Evaluation, and Regulatory Requirements
2018-11-01, cGMP Compliance for Quality Control and Laboratory Operations
2018-11-16, Protein therapeutics and biomarkers: Recent developments in characterization and quantification by hybrid LC-MS
2018-12-04, Challenges in Peptide Drug Discovery & Development: Biology, Chemistry, PK, Delivery, Regulatory and Beyond
2019-02-07, Covalent Inhibitor Drug Discovery & Development: Biology, Chemistry, PK, Safety and Case Studies
2019-03-07, Promising therapeutic approaches and transnational medicine from SPARK: an academic-industry collaboration to advance novel therapeutics (A Joint Symposium by PBSS and Stanford SPARK Program)
2019-03-11, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
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