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The Road to the Biologic IND

Janssen Labs @LabCentral

Thursday, November 14, 2013 from 11:00 AM to 1:30 PM (EST)

Cambridge, MA

The Road to the Biologic IND

Ticket Information

Ticket Type Sales End Price Fee Quantity
General Public Ended $35.00 $2.92
Student/Academic Ended $20.00 $2.09

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Event Details

JANSSEN LABS BOSTON EVENT The Road to the Biologic IND
Best Practices When Filing Biologic Investigational New Drug Applications

Program Overview:
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


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

Cost:
General Public | $35
Academic | $20
Onsite | $40

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

Who Should Attend:

Life science industry executives, investigators and regulatory directors, founders, CEOs, and managers of start-ups and other private companies.

Have questions about The Road to the Biologic IND? Contact Janssen Labs @LabCentral

When & Where



Johnson & Johnson Boston Innovation Center
1 Cambridge Center
Cambridge, MA 02142

Thursday, November 14, 2013 from 11:00 AM to 1:30 PM (EST)


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Organizer

Janssen Labs @LabCentral

Janssen Labs is part of Johnson & Johnson’s external research and development engine and provides a capital-efficient, resource-rich environment where independent emerging companies can progress their research.  The 40,000 square foot flagship facility opened in early 2012 in San Diego at Janssen’s West Coast Research Center and currently hosts 30 emerging life science companies.   Through recent expansion to additional life science hubs around the globe, Janssen Labs has established satellite locations that provide emerging companies with many of the advantages of being in a big company, without the capital investment. Janssen Labs offers a variety of offerings between the flagship and satellite facilities including singular bench tops, modular wet lab units and office space on a short-term basis, allowing companies to pay only for the space they need, with an option to quickly expand when they have the resources to do so. Companies residing at Janssen Labs sites also have access to core research labs hosting specialized capital equipment and shared administrative areas. Additionally, Janssen Labs produces a year-round curriculum designed to assist innovators along the commercialization continuum.  Janssen Labs is an open innovation model, and the agreement for space does not grant Janssen any stake in the companies, nor will the companies have a guaranteed future affiliation with Janssen; but the models is designed to initiate a dialogue early and foster long term relationships with innovators in healthcare. Janssen Labs services and amenities vary depending on location.  For more information, visit www.janssenlabs.com

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