november, 2015
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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
Partners:
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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Agenda:
| 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 |
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| 1:30 PM | | Chemistry, Manufacturing and Controls Strategies |
| – Optimizing manufacture of your Active Pharmaceutical Ingredient (API) – Drug product formulations for FIH |
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| 2:00 PM | | Clinical Pharmacology |
| – Designing FIH trials – Understanding PK/PD – Biomarkers of safety and efficacy |
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| 2:30 PM | | Regulatory Overview |
| – Data requirements: CMC, safety, clinical plan – eCTD – Pre-IND meetings – Regulatory Strategy |
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| 3:00 PM | | Discussion and Q&A |
| 3:30 PM | | Program Close |
Speakers
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»
Fees:
Free | UMass Employees, Students, and Faculty
$35 | General Public
$20 | Student/Academic
$45 | At the door
Location:
University of Massachusetts Medical School
55 Lake Ave North
Worcester, MA