| The Road to the Biologic IND | |
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United States - MA - Cambridge |
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| Hosted by: | Janssen Labs and the Boston Innovation Center |
| Venue: | Johnson & Johnson Boston Innovation Center | One Cambridge Center |
| Dates: | Nov 14, 2013 through Nov 14, 2013 |
| Early Registration Deadline: | 2013-11-13 |
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Description |
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| Janssen Labs and the Boston Innovation Center 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 presentation exploring the basic requirements and considerations that you need to be aware of when planning for 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 Speakers: Barry Springer, Vice President of Technology, Strategy & Operations at Janssen Pharmaceutical Companies of Johnson and Johnson Steven Lang, Ph.D., MBA, Director, Biologics Research J&J Biotechnology Center of Excellence Timothy Coogan, Vice President, Biologics Toxicology, Janssen R&D Robert G. Burford, Ph.D., Managing Director, American Clinical and Regulatory Consultants LLC Agenda: 11:00 AM | Registration, Lunch, and Networking 11:15 AM | Welcome - The case for biologics - The legacy of Janssen/Centocor biologics 11:30 AM | Drug Discovery for Success in Development and Manufacture of a Biologic Drug - Evaluating clinical candidates early - Creating options with parallel processing - Harmonizing platforms and methods - Transitioning programs to Pharmaceutical Development 12:00 PM | Toxicology of Biotechnological Products - Preclinical toxicology program objectives, endpoints, findings of concern - Factors to consider for biotechnology products: Species specificity, Immunogenicity, Antibody response - Testing considerations 12:30 PM | Regulatory – Satisfy Statutory Legal Requirements for Testing in Humans - Strategy - Data requirements: CMC, Safety, Clinical plan - eCTD - Pre-IND Meetings 1:00 PM | Discussion and Q&A 1:30 PM | Program Close Who Should Attend: Life science industry executives, investigators and regulatory directors, founders, CEOs, and managers of start-ups and other private companies. Cost: Academic/Student Rate $20 General Public $35 On-site, if space allows: $45 Register at http://jlabslc-roadtobiologicind-vc.eventbrite.com Venue: Johnson & Johnson Boston Innovation Center | One Cambridge Center | Cambridge, MA 02142 |
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| Additional Information | |
| Event URL: | http://jlabslc-roadtobiologicind-iscb.eventbrite.com |
| ISCB Member Discount: | None |
| Contact Person: | Madelaine Holden ([javascript protected email address]) |
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