| The Road to the Biologic IND | Best Practices When Filing Biologic Investigational New Drug Applications | |
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United States - CA - San Francisco |
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| Hosted by: | Janssen Labs @QB3 |
| Venue: | UCSF Rock Hall | 1550 4th St |
| Dates: | Feb 18, 2014 through Feb 18, 2014 |
| Early Registration Deadline: | 2014-02-17 |
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Description |
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| Janssen Labs, the Johnson & Johnson California Innovation Center and the Janssen Biotechnology Center of Excellence invite you to an in-depth look into the process of filing a biologic Investigational New Drug (IND) application and the procedures necessary for advancing your company’s early-stage drug development program. 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 solid plan for achieving IND acceptance. Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic IND submission. The presentation will highlight the following: - Key components of the Chemistry/Manufacturing/Controls section - Expression, Purification, Analytics, Formulation, Fill/Finish - Preclinical study design, species selection, material requirements, and timelines - Regulatory requirements, strategies to minimize costs and timelines while balancing risk Preregister here: http://jlabsbay-IND2014-iscb.eventbrite.com Agenda: 8:30 AM | Registration, Breakfast, and Networking 9:00 AM | Development of a Process Suitable for Manufacturing a Biologic Drug 9:30 AM | Toxicology of Biotechnological Products 10:00 AM | Biologics Clinical Pharmacology 10:30 AM | Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans 11:00 AM | Discussion and Q&A 11:30 AM | Program Close Speakers: Barry Springer, PhD | VP of Technology, Strategy & Operations, Biotechnology Center of Excellence, Janssen R&D Steven Lang, PhD, MBA | Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D Pauline Martin, PhD | Senior Scientific Director, Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D Hugh Davis, PhD | VP and Head of Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D Salvatore Morello | Director, Global Regulatory Affairs, Janssen R&D Fees & Registration: Preregister at http://jlabsbay-IND2014-iscb.eventbrite.com $35 General Public | $20 Student/Academic | $45 Onsite |
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| Additional Information | |
| Event URL: | http://jlabsbay-IND2014-iscb.eventbrite.com |
| ISCB Member Discount: | None |
| Contact Person: | James Viola ([javascript protected email address]) |
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