Skip to main content









Donation Heart Ribbon

ADVERTISEMENT | Become a sponsor today!

Laureate Biopharmaceutical Services Presents 'The Road To The Biologic IND'


  • WHEN Thursday, November 15, 2012 at 11 a.m.
  • WHERE Janssen Research & Development | 3210 Merryfield Row | San Diego, CA 92121
  • AGES All ages
  • COST $25 - $35

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.

Program Overview:
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
- Fill/Finish
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
1:30 PM | Optional Tours of Janssen Labs

For more information, visit

Location: Janssen Research & Development, 3210 Merryfield Row, San Diego, CA 92121 Google Map

Dates and times of events are subject to change without notice. Always check the event organizer's website for the most updated schedule before attending.

Logo for Laureate Biopharmaceutical Services.

Above: Logo for Laureate Biopharmaceutical Services.


Submit a correction for this event

ADVERTISEMENT | Become a sponsor today!