2008 Young Scientist Events in New York

Young Scientist Workshop - Regulatory Aspects of Pharmaceutical Sciences

Generously Co-sponsored by Intervet, Inc., a Part of Schering-Plough Corp

Saturday, July 12
Chairs: Farid Dorkoosh, Nobleceuticals Ltd., The Netherlands, and Roderick Walker, Rhodes University, South Africa

This year the Saturday Young Scientist Workshop is focused on regulatory aspects of pharmaceutical sciences. As a young scientist, it is valuable to have some basic knowledge about the registration process of a medicine. Regulatory aspects of medicine are an integral part of pharmaceutical sciences and all the industries which are involved in production of medicines need to work with regulatory authorities, e.g. FDA and EMEA. In our program for this year, we have invited speakers from various organizations to cover the topics of registration processes for a medicine from various angles. All scientists who are willing to work in an industry should attend this workshop in order to get valuable insight into regulatory aspects of pharmaceutical sciences.

• 07:30-08:00 – Continental Breakfast compliments of the CRS
• 08:00-08:05 – Introduction – Farid Dorkoosh, Nobleceuticals Ltd., The Netherlands
• 08:05-08:45 - Regulatory Science in the Drug Approval Process in U.S.A. - Rakhi Shah, Food and Drug Administration, U.S.A.
• 08:45-09:25 - Introduction to Investigational New Drug (IND) Applications for Anti-cancer Agents – Julie K. Rhie, National Cancer Institute, U.S.A.
• 09:25-09:45 - BREAK
• 09:45-10:25 - Analytical Validation: An FDA Perspective – Patrick Faustino, Food and Drug Administration, U.S.A.
• 10:25-11:05 - The CMC Section of an IND – Raj Misra, National Institutes of Health, U.S.A.
• 11:05-11:45 - Regulatory Aspects of Excipients Used in the Formulation of Oral Solid Dosage Forms – Ali Rajabi-Siahboomi, Colorcon, Inc., U.S.A.
• 11:45-13:30 – LUNCH break on your own
• 13:30-14:10 - The Regulatory Perspective of Generic Drugs – Devinder Gill, Food and Drug Administration, U.S.A.
• 14:10-14:50 - The NDA Trends: Importance of FDA Initiatives – Mansoor Khan, Food and Drug Administration, U.S.A.
• 14:50-15:15 - BREAK
• 15:15-15:55 - Management of Innovation in Pharmaceutical Sciences – Farid Dorkoosh, Nobleceuticals, The Netherlands
• 15:55-16:35 - Innovation, Metrology and USP – Roger L. Williams, United States Pharmacopeia, U.S.A.
• 16:35-16:45 – Closing – Roderick Walker, Rhodes University, South Africa

Young Scientist Workshop - The World of Veterinary Drug Delivery

Generously Co-sponsored by Pfizer Animal Health

Sunday, July 13, 2008
Chairs: Raid Alany, University of Auckland, New Zealand; Terry Bowersock, Pfizer Animal Health, U.S.A.; and Sevda Senel, Hacettepe University, Turkey

The CRS Vet Young Scientist Workshop will focus on drug delivery in veterinary medicine. This workshop is a must for anyone interested not only in veterinary research, but in applied medical sciences. There is a growing need for novel drug delivery systems in animal health. This workshop will provide insights into ways to broaden applications of delivery systems to areas perhaps not considered previously and to a broad range of animal species. Veterinary delivery scientists can also generate efficacy data in a target species not always available in rodent models. Information gained can provide more timely answers of the usefulness of a delivery system. The topics of this workshop will vary from how basic physiology and anatomy of animals and selection of proper species can be leveraged to test a delivery system, to applications for oral, transcutaneous, as well as injectable formulations of pharmaceuticals and vaccines. Topics will also cover aspects of novel challenges to drug delivery, how these can be overcome in ways that can enhance drug delivery research, expand use of delivery systems to animals as well as humans, and increase awareness of the need for drug delivery systems in animal health. This workshop will complement and serve as an introduction to the 2008 mini-symposium "Enhancing Drug Delivery - Using Novel Animal Models" as well as the Veterinary Session entitled "2008, A Veterinary Delivery Odyssey".

• 07:30-08:00 – Continental Breakfast compliments of the CRS
• 08:00-08:20 - Introduction to Veterinary Delivery Systems – Sevda Senel, Hacettepe University, Turkey
• 08:20-08:40 - Differences in Physiology and Anatomy ‘The Patient’ – Simon Wheeler, Novartis Global, U.S.A.
• 08:40-09:00 - Oral Delivery Systems – Taste Masking – Avinash Thombre, Pfizer, Inc., U.S.A.
• 09:00-09:20 - Animal Model Selection for Dermal Drug Delivery – Jim Riviere, University of North Carolina, U.S.A.
• 09:20-09:40 - The Role of Efflux Pumps in Veterinary Drug Delivery – David Brayden, University College Dublin, Ireland
• 09:40-10:00 - BREAK
• 10:00-10:20 - Intravaginal/Intraruminal Drug Delivery – Michael Rathbone, InterAg, New Zealand
• 10:20-10:40 - Alternative Delivery of Vaccines in Veterinary Medicine: Opportunities for Collaboration – Terry Bowersock, Pfizer Animal Health, U.S.A.
• 10:40-11:00 - Injectable Formulations in Veterinary Medicine – Todd Foster, Pfizer Animal Health, U.S.A.
• 11:00-11:20 - Critical Appraisal of Current Intramammary Formulations for Mastitis Control – Raid Alany, University of Auckland, New Zealand
• 11:20-12:00 – PANEL DISCUSSION

Get Up; Get Educated!

Students, and those new to controlled release and delivery, should set their alarm clocks and get up early for these informational presentations. You won’t want miss these two talks that are guaranteed to enlighten. Join chairs Farid Dorkoosh and Rod Walker at these early morning gatherings.