The Road to the Biologic IND

Nov 14 2013

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

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

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

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.