CRS Workshop
Development and Regulatory Challenges for Controlled Release Formulations Workshop
Co-sponsored with AAPS
November 9 – 10, 2007
San Diego Convention Center
San Diego, CA
Goals and Objectives
- To provide understanding of the development challenges for controlled release formulations utilizing proven and evolving new technologies;
- To discuss and understand the regulatory challenges encountered (and overcome) in the development of a controlled released drug formulation;
- To provide a venue to informally meet with other scientists/regulatory authorities; and
- To share and discuss fundamental science and experiences that may be of value to individuals dealing with various CR technologies.
What the Attendee will Gain and How to Apply it
- To increase an individual’s knowledge about a variety of controlled release technologies that may not be found in the literature through shared experiences and panel discussions;
- To apply newly acquired knowledge and a suitable approach to the potential design of the attendees' own pharmaceutical products;
- The opportunity for informal discussion on topics of mutual interest with other attendees as well as renowned speakers; and
- The opportunity to share individual experiences and opportunity to gain insights that may be applicable to the current activities of the attendee.
Workshop Agenda
Friday, November 9
7:30 am
Registration
8:30 am
Welcome and Workshop Objectives
Avinash ThombrePfizer, USA
8:30 am – 12:00 pm
Session I : Mature CR Technologies: Non-oral Route
8:45 am
The Road to the Six Month ELIGARD® Product
Rick Norton
QLT, Inc., USA
9:30 am
Developmental Considerations for Innovative Passive Transdermal Drug Delivery
David Kanios, Juan A. Mantelle, Christopher W. McDaniel
Noven Pharmaceuticals, Inc.
10:15 am
Coffee Break
10.45 am
Development and Regulatory Challenges in Pulmonary Products
Andy Clark
Nektar Therapeutics, U.S.A.
11:30 am
Panel Discussion
12:00 pm
Lunch
1:30 pm – 5:00 pm
Session II: Mature CR Technologies: Oral Route
1:30 pm
Development and Regulatory Challenges in Osmotic Technology
Suneel Gupta
ALZA Corporation, U.S.A.
2:15 pm
Developing Multiparticulate-Based Drug Products: Process Understanding and Control
Scott Herbig
Pfizer, Inc.
3:00 pm
Coffee Break
3:30 pm
Scientific and Regulatory Challenges in Controlled Release Formulations
Krishnan Tirunellai
Health Canada
4:15 pm
Panel Discussion
Saturday, November 10
8:00 am
Registration
9:00 am – 5:00 pm
9:00 am – 9:30 am
Summary of Day 1
Introduction of Day 2
Ron Ortiz3M Drug Delivery Systems, USA
Session III: Biologicals and Nanotechnology
9:30 am
MF59 is a Safe and Potent Vaccine Adjuvant for Human Use
Manmohan Singh
Novartis Vaccines & Diagnostics
9:15 am
Needle Free Epidermal Delivery of DNA-based Vaccines
Speaker to be Announced
10:15 am
Coffee Break
10:45 am
Nanotechnology: Opportunities in Drug Delivery
W. Mark Saltzman
Yale University
11:30 pm
Panel Discussion
12:00 pm
Lunch
1:30 pm
Drug Nanosuspensions: From PK Modification to Disease Targeting
Barrett E. Rabinow
Baxter HealthCare Corporation
2:15 pm
Protosphere or Nab Technology – Abraxane
Patrick Soon-Shiong
Abraxis BioScience
3:00 pm
Coffee Break
3:30 pm
The Science and Regulatory Perspectives of Controlled Release Products with Emerging Technologies
Mansoor Khan, Ph.D.
U.S. Food and Drug Administration
4:15 pm
Panel Discussion
5:00 pm
Adjournment
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