Above: Logo for Laureate Biopharmaceutical Services.
Join us for a series of presentations, on November 15th from 11am-1:30pm, hosted by Laureate Biopharmaceutical Services, exploring the basic requirements and considerations that you need to be aware of when planning for a successful biologic IND submission.
Prescience International invites you for 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.
Presentations will highlight the following:
• Key components of the Chemistry/Manufacturing/Controls
• 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
11:30 AM | Development of a Process Suitable for Manufacturing a Biologic Drug
- Cell Culture
- Protein Purification
- Product Characterization
- Formulation & Stability
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
- Data requirements: CMC, Safety, Clinical plan
- Pre-IND Meetings
1:00 PM | Discussion and Q&A
1:30 PM | Program Close
1:30 PM | Optional Tours of Janssen Labs
For more information, visit http://biologicind.eventbrite.com/
Location: Janssen Research & Development, 3210 Merryfield Row, San Diego, CA 92121 Google Map