november, 2015

17nov11:30 am3:30 pmFrom Chemical to Drug – The Path to a Small Molecule IND


Event Details

From Chemical to Drug – The Path to a Small Molecule IND
Best Practices When Filing Small Molecule Investigational New Drug Applications

Program Overview:
Do you have a solid plan to achieve IND acceptance? Filing an Investigational New Drug (IND) application might be the next step in advancing your company\’s early-stage drug development program. Johnson & Johnson Innovation, JLABS, and Janssen Discovery Sciences invite you to an in-depth look into the process of filing an IND. Whether your goal is to develop a pipeline through commercial launch or partner as early as possible, submitting an IND is a critical early milestone for every biotech company. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a clear blueprint for IND approval, and we want you to be ready.

The presentations will highlight the following:

– Janssen Research & Development – your partner of choice
– Preclinical Development strategies for pharmacokinetics, drug metabolism and toxicology
– Key CMC strategies to balance cost, time and quality risks
– Designing First-in-Human trials to highlight the qualities of your molecule
– Regulatory strategy, IND requirements, and Pre-IND meetings

This event is presented in partnership with MassTERi, the UMMS Office of Innovation and Business Development, and the UMass Center for Clinical and Translational Science.

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12:00 PM | Registration, Lunch, and Networking
12:30 PM | Janssen Research & Development -Your partner of choice
1:00 PM | Preclinical Development Strategies
– Designing drugable molecules with appropriate kinetics and metabolism
– Preclinical toxicology evaluations before and during GLP toxicology
– Considerations for typical First-in-Human (FIH) Program
1:30 PM | Chemistry, Manufacturing and Controls Strategies
– Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
– Drug product formulations for FIH
2:00 PM | Clinical Pharmacology
– Designing FIH trials
– Understanding PK/PD
– Biomarkers of safety and efficacy
2:30 PM | Regulatory Overview
– Data requirements: CMC, safety, clinical plan
– eCTD
– Pre-IND meetings
– Regulatory Strategy
3:00 PM | Discussion and Q&A
3:30 PM | Program Close

Michelle Browner | Platform Innovation & Partnership Management, Johnson & Johnson Innovation read bio»
Mark Kao | Scientific Director, Janssen R&D read bio»
Mark Krook | Sr. Scientific Director, Portfolio Management, Janssen R&D read bio»
Kenneth Turner | Sr. Scientific Director, Quantitative Sciences, Janssen R&D read bio»
Bethany Paxson | Sr. Director, Global Regulatory Affairs, Janssen R&D read bio»

Free | UMass Employees, Students, and Faculty
$35  | General Public
$20  | Student/Academic
$45  | At the door

University of Massachusetts Medical School
55 Lake Ave North
Worcester, MA


(Tuesday) 11:30 am - 3:30 pm


University of Massachusetts Medical School

55 Lake Ave North Worcester, MA