Effectively Progressing through Phase I Early Development

Thursday, June 27, 2013 (8:00 AM - 1:30 PM)

Time:
8:00 am - Registration, Breakfast and Networking
8:30 am -1:30 pm - Program

Reaching First-in-Man studies is a critical milestone in the drug development
process. However, the road to a successful IND submission is long and complex,
with many important decision points along the way that can have long-term
effects on the development of the molecule. Whether you are faced with API
development challenges, bioavailability issues, financial constraints or pressure
to meet accelerated deadlines, having a well-designed development plan for your
molecule can mean the difference between success & failure.

During this seminar, you will hear case studies and analysis from industry
leading experts
on API Process Development, Preformulation and Formulation
Development for IND enablement for both sterile and non-sterile products and
Regulatory Strategies for IND Submission.

These presentations and interactive Q&A sessions will provide you with insight
into how to speed your molecule to First-in-Man studies through optimal
formulation, process development and regulatory strategies.

Presentations and case studies will focus on:

• The differences between requisites for success for medicinal chemistry and the
chemistry of process development in API process development
• Approaches to identifying drug product challenges
• Formulation strategies to quickly and effectively advance oral drug products to Proof of Concept and First-in-Man
• Preformulation strategy & solubility enhancement solutions for sterile products
• Manufacturing strategies for sterile products and biopharmaceuticals
• Strategies to progress sterile drug products to First-in-Man
• Quality by Design
• Regulatory strategies for filing an IND

Seating is limited. Register as soon as possible.

View the schedule of events

Breakfast & lunch will be served at this free seminar. Discounted parking is available.

Thank You to Our Sponsor:



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