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: (12)Alcami; Applied StemCell Inc.; Celerion; ChemPartner; Cyprotex; Cytovier LLC; JOINN Labs; MicroConstants; PHARMout Laboratories; Quotient Clinical Ltd; Spaulding Clinical Research; WuXi AppTec
Registration: https://www.PBSS.org
Registration deadline:1/22/2018  (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