7:45 A.M.

Registration Desk Opens

8:30 A.M.

Welcome/Opening Remarks

Dr. Murti Vemuri, Sanofi-Aventis

Morning Session Moderators

Dr. Thomas Lee, Novartis - Dr. Raghu Cavatur, Sanofi-Aventis

9:00 A.M.

Novartis Pharmaceuticals

Regulatory initiatives to improve the access of children to new therapeutics are directly linked to the increasing number of pediatric clinical trials. However, the success of these trials often depends on the availability of a pediatric appropriate formulation, which are adopted to the needs of this very special target population. This presentation will address some of the issues faced during formulation of a pediatric product; such as, problems and limitations of common dosage forms for children of various ae groups; overview on dosage forms of choice for children; and critical aspects related to excipients for pediatric formulations.

9:45 A.M.

Regulatory Opportunities and Challenges of

Ms. Chin Koerner, Novartis Regulatory Liaison & Policy Office

The current framework of U.S. "stick and carrot" legislation under the Pediatric Research Equity Act and Best Pharmaceuticals for Children Act has resulted in a record number of pediatric use information in lebeling. Both pieces of legislation sunset on September 30, 2007 and it is expected that both pieces of legislation will be reauthorized. In this year of multiple must-pass FDA-related legislation, lessons learned over the last 5 years will help guide policy makers in shaping the next generation of pediatric policies.

10:30 A.M.

Coffee Break

10:40 A.M.

Fast Dissolve Development

Dr. Gopi Venkatesh, Eurand USA

About 50% of patients, especially the elderly, have problems swallowing tablets and cpsules. Hence, a patient-friendly dosage from such as an orally disintegrating tablet is most desirable. Since many active pharmaceutical ingredients have a bitter taste, the process of taste-making is utilized which usually involves coating with a water-insoluble polymer alone or in combination with a water-soluble polymer/pore-former. This results in a slower dissolution of the active ingredient(s) of the dosage form, resulting in a product which is not bioequivalent to its marketed claims. This presentation will explore possible solutions to this problem.

11:25 A.M. 

The Importance of Pharmaceutical Crystal

Forms from a Scientific

and Intellectual Property Perspective

Dr. Andrew V. Trask, Jones Day

Analyzing pharmaceutical crystal forms form an intellectual property standpoint requires a thorough understanding of the particular scientific challengs and opportunities that accompany this important area of study. This presentation provides an outlook on pharmaceutical crystal forms as patentable inventions by examining current scientific progress in the field, with a particular focus on the growing field of pharmaceutical crystals. The presentation also highlights several recent court decisions that could affect the future impat of pharmaceutical crystal forms on the intellectual property landscape.

12:10 P.M.

Lunch

Afternoon Session Moderator

Dr. Esteban Bornancini, GlaxoSmithKline

1:30 P.M.

Formulation Approaches to

Inhaled Products

Dr. Michiel M. Van Oort, GlaxoSmithKline

Inhaled therapeutic aerosols are the most common means of treating respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). There is also a significant interest and effort in the pharmaceutical industry of using the lung for systemic delivery for compounds such as insulin. Formulating and characterizing products for inhalation can be extremely challenging since one has to work with very potent compounds (typically 10 to 500 mcg) which have to be reproducibly manufactured and delivered to the lungs of patient generally in the range of 1-5 microns. This presentation will cover some of the typical and novel formulation approaches used in the area of inhaled products as well as some of the methods used to characterize those products.

2:15 P.M.

Novel Delivery Systems:

Intelligent Biosynthetic Nanobiomaterials

(IBNs) as Novel Translational Platforms

for Drug, Gene, and Protein Delivery

Dr. Darin Y. Furgeson, The University of Wisconsin-Madison

Exploiting nature’s mRNA templates through biomolecular engineering is a harbinger of the next evolutionary advance in nanobiomaterial design strategies for macromolecular drug delivery. Facile genetic strategies provide precise control over several physicochemical properties including macromolecular architecture, molecular weight, and stereochemistry – abilities which are unparalleled with traditional synthetic polymer chemistry. By continued genetic manipulation, multiple targeting modalities many be introduced with intelligent or stimuli-sensitive behaviours and cell-targeting peptides. This presentation will detail the design and development of intelligent biosynthetic naoniomaterials (IBNs) as novel translational platforms for drug, gene, and protein delivery. Herein we report the successful application of IBNs for chemotherapy with the delivery of geldanamycin (1), a potent heat shock protein 90 (HSP90) inhibitor, and hyperthermic cancer gene therapy (2). The additive and synergistic effects of hyperthermia as an adjuvant therapy and targeting modality will be addressed.

3:00 P.M.

Parenteral Delivery: Injectable Delivery

Systems to Meet the Needs of Biologicals

Dr. Philip Green, BD Pharmaceutical Systems

Over the last few years there has been a tremendous growth in the worldwide sales of injectible biological drugs. This trend is likely to continue for many years as evidenced by the large number of new biological agents in clinical trial testing as well as the number of licensing deals between pharmaceutical companies and small biotechnology companies. Among the most promising areas for future growth are monoclonal antibodies and prophylactic and therapeutic vaccines. There agents present considerable delivery challenges and various delivery technologies are being investigated that may facilitate the delivery and improve efficacy for the treatment of chronic diseases such as rheumatoid arthritis, psoriasis, asthma and allergy, MS, osteoporosis, Alzheimer’s, etc., in addition to certain types of metastatic cancers.

3:45 P.M.

Closing Remarks

Dr. Murti Vemuri, Sanofi-Aventis

4:00 P.M.

Reception