Formulation Strategies for Protein Therapeutics
9th October 2012 — 10th October 2012
Practical Solutions for Today's Formulation and Device Scientists
Event Overview
For 2012, Formulation Strategies focuses on the challenges of emerging drug products and the analytical methods employed by formulators to achieve the depth of product understanding required in today's regulatory environment.
A Unique Combination of Scientific Advances and Practical Advice
Conference Sessions Geared Towards Protein Formulation Scientists, Analytical/Process Development
- Formulation Strategies for Biosimilars and Next-Generation Biologics
- Rational Selection and Design for Improved Pharmacokinetics
- Quality by Design for Drug Product Development
- Product Characterization for Formulation Development
- Predictive Methods in Formulation Development
Find Practical Solutions to Today's Formulation Challenges:
Featuring 25 Case Studies Presentations from these Companies and more:
- Abbott
- Amgen
- Biocon Limited, India
- Bristol-Myers Squibb
- Genzyme Corporation, a Sanofi company
- Human Genome Sciences
- MedImmune, Inc.
- Novartis Pharma AG, Switzerland
- Pfizer, Inc.
- Regeneron Pharmaceuticals Inc.
- Shire
- Zyngenia
Presentation Highlights:
- Hospira presents a risk-based strategy for biosimilar drug product formulation and process development, in alignment with the scientific considerations needed to demonstrate biosimilarity.
- A panel including speakers from Pfizer, Genentech, Merck and Human Genome Sciences explores Ten Key Questions for Subvisible Particle Characterization, Monitoring and Control.
- Abbott outlines an approach to preformulation screening and candidate selection involving an interdepartmental collaboration between analytical, formulation and PK groups.
- Genentech shares its experiences with a QbD-based FDA regulatory filing and the impact of using this approach on drug product study design, processes, and control systems.
- Biogen Idec and Bristol-Myers Squibb examine the role of thermal stability screening in candidate selection and protein formulation design.
Keynote Presentations
The Next Generation of Biotherapeutic Dosage Forms
Kevin R. King, Ph.D.,
Senior Director, Formulation & Process Development, Pfizer Inc.
Experiences in a QbD-Based FDA Regulatory Filing: Drug Product Considerations
Mary E.M. Cromwell, Ph.D.,
Director, Late Stage Pharmaceutical Development, Genentech, Inc.
The Next Generation of Biologics and the Role of Drug Delivery and Device Technologies
William J. Lambert, Ph.D.,
Fellow, Drug Delivery and Device Development, MedImmune, Inc.
Expected Number of Attendees
NA
View Conference Website: Formulation Strategies for Protein Therapeutics
Contact
Name: Howard Choi
Email: hchoi@ibcusa.com
Tel.: 508.614.1494
URL: Website
Price of Attendance
n/a
Brochure
Location
Rhode Island Convention Center
Providence
United States
RI 02903
