Educational Workshops
Saturday, July 22, 2006
Workshop 1: CMC Regulatory Issues for Controlled Release Parenterals
Co-sponsored by Cordis Corporation, Eli Lilly and Company, and SOTAX AG
Co-chairs: Diane Burgess, University of Connecticut, United States of America
Kinam Park, Purdue University, United States of America
This workshop will focus on CMC and regulatory issues with respect to controlled release parenteral dosage forms. In particular, in vitro and in vivo testing methods and specifications for controlled release parenteral products including microspheres, liposomes, emulsions, stents and other implantable devices will be reviewed and discussed. An overview of the different dosage forms, their manufacturing and performance testing will be presented. In vitro release testing will be discussed with a view to in vivo relevance. In vitro-in vivo relationships will be addressed and a regulatory perspective on these products will be provided. Industrial case studies will be presented.
Program
Morning session
- Overview of CMC and Regulatory Issues for Controlled Release Parenterals – Diane J. Burgess, University of Connecticut, U.S.A.
- Novel Methods for Microsphere Formulation and Manufacture – Kinam Park, Purdue University, U.S.A.
- CMC Issues with Liposomal Parenterals Drug Delivery Systems – Daan Crommelin, University of Utrecht, The Netherlands
- Issues with Protein Stability in Controlled Release Parenterals Drug Delivery Systems – Steven Schwendeman, University of Michigan, U.S.A.
- In Vitro Real-Time and Accelerated Release Testing with In Vivo Relevance for MR Parenterals – Diane J. Burgess, University of Connecticut, U.S.A.
- In Vitro and In Vivo Relationships for CR Parenterals – Colm Farrell, GloboMax, U.S.A.
Afternoon session
- Case Study on Drug Eluting Stents: In Vitro and In Vivo Testing – Lori Alquier, Cordis Corporation, U.S.A.
- Case Study on Performance Testing of Sustained Release Suspensions – Mary P. Sticklemeyer, Eli Lilly, U.S.A.
- Case Study: In Vitro-In Vivo Relationships – Brian Clark, AstraZeneca, U.K.
- Regulatory Considerations: An Industrial Perspective – Mary P. Sticklemeyer, Eli Lilly, U.S.A.
- Performance of Modified Release Parenteral Products: A Regulatory Perspective – Mei-Ling Chen, Food and Drug Administration, U.S.A.
Workshop Co-chairs:
Diane J. Burgess
University of Connecticut
Storrs, CT, U.S.A.
Tel: +1.860.486.3760
d.burgess@uconn.edu
Kinam Park
Purdue University
West Lafayette, IN, U.S.A.
Tel: +1.765.494.7759
kpark@purdue.edu
See #1 on the registration form.
Saturday, July 22, 2006
Workshop 2: Drug-Device Combination Products: Novel Technologies and Regulatory Challenges
Co-sponsored by Boston Scientific and Medtronic
Co-chairs: Tejal Desai, University of California-San Francisco, U.S.A.;
John Santini, MicroCHIPS, Inc., U.S.A.
This workshop will provide attendees with a solid understanding of the concepts involved in and the challenges of developing drug-device combination products. The workshop is divided into three sessions. The first session focuses on novel technologies, primarily passive versus active drug-device combinations. The second session covers the regulatory approval processes in the United States and Europe. The third session is a case study in combination product development.
These sessions are directly useful to scientists and engineers developing (or considering the development of) drug-device combination products in their own companies. These sessions will also be useful for professors and other academic researchers who wish to gain an appreciation for the regulatory processes and other challenges involved in the development of drug-device combination products.
Program
Introduction – John Santini and Tejal Desai, Workshop Co-chairs
Session #1: Novel Technologies
Several examples of novel technologies that combine drugs and devices will be presented. The technologies included in the first session of the workshop were selected to represent a sampling of diverse technologies, primarily passive vs. active drug-device combinations. Workshop attendees will take away from Session #1 a knowledge of new combination product technologies that may impact their businesses or academic research programs in the future.
Passive Devices
- Microfabricated Devices for Controlled Delivery – Tejal Desai, University of California-San Francisco, U.S.A.
- Local Delivery of Recombinant Human bone Morphogenetic Protein-2 (rhBMP-2) in an Interbody Spinal Fusion Device as a Combination Biologic Device – Bill McKay, Medtronic Sofamor Danek, U.S.A.
- Drug Delivery from Adherent Hydrogels – Robert Miller, Genzyme, U.S.A.
Active Devices
- MicroCHIPS for Implantable Drug Delivery and Biosensing – John Santini, MicroCHIPS, Inc., U.S.A.
- The Combination of Electronic Control and Transdermal Drug Delivery – Brad Phipps, J&J/ALZA, U.S.A.
- Drug Delivery Using Pump-Based Technology – Bill van Antwerp, Medtronic MiniMed, U.S.A.
Session #2: Regulatory Process/Issues/Challenges in the United States and Europe
This session will provide workshop attendees with critical knowledge of the regulatory approval processes for drug-device combination products from regulatory officials from the United States and Europe. In addition, a regulatory affairs attorney will provide an additional perspective on the U.S.A. regulatory process.
- US Regulation of Combination Products – Mark Kramer, Office of Combination Products, Food and Drug Administration, U.S.A.
- Regulation of Medical Device/Combination Products – David Jefferys, Eisai Pharmaceuticals, U.K.
- The Challenges of FDA Regulation of Combination Products and Drug Delivery Devices – Jonathan Kahan, Hogan & Hartson L.L.P., U.S.A.
Session #3: Commercialization Case Study for a Drug-Device Combination Product
The introduction and commercial success of the drug eluting stent was a defining moment for the field of drug-device combination products. However, the development of this product involved overcoming numerous technical, regulatory, and commercial challenges. Workshop attendees will learn some of the pitfalls involved in combination product development and be able to apply these "lessons learned" to some of their own products.
- Key Considerations in the Development of a Polymer-based Drug Eluting Stent: The TAXUS Development Story – James Barry, Boston Scientific, U.S.A.
Closing remarks – John Santini and Tejal Desai, Workshop Co-chairs
Workshop Co-chairs:
Tejal Desai
The University of California-San Francisco
San Francisco, CA, U.S.A.
Tel: +1.415.514.4503
Tejal.desai@ucsf.edu
John T. Santini, Jr.
MicroCHIPS, Inc.
Bedford, MA, U.S.A.
Tel: +1.781.275.1445 x222
jsantini@mchips.com
See #2 on the registration form.
Saturday, July 22, 2006
Workshop 3: Role of Intestinal and Hepatic Transporters on Oral Bioavailabilities of Drugs
Co-sponsored by Capsugel
Co-chairs: Yuichi Sugiyama, The University of Tokyo, Japan;
Per Artursson, Uppsala University, Sweden
This workshop is particularly important for people in pharmaceutical industries who will take home with them the post Caco-2 and post CYP assay systems. The development of ideal DDS is the ultimate goal of this Society; and at present, work is in progress to examine the major factors which govern drug disposition in the body and to clarify the mechanisms involved in membrane transport in the liver, brain, kidney, and intestine. "The prediction and control of drug effects and safety" will never be fully achieved unless we develop methodology to reconstruct quantitatively in vivo phenomena from in vitro data. Before drugs can exert their ultimate effects, they have to undergo a variety of different processes. Among them absorption from the gastrointestine and first–pass hepatic removal are the most important processes for predicting drug effects. Attendees to this workshop will learn the frontier, cutting-edge approach for predicting oral bioavailability of drugs and learn how the transporters will play roles in the extent of bioavailability.
Program
Morning session
Introduction – Yuichi Sugiyama, The University of Tokyo, Japan
- Factors Affecting Oral Drug Absorption – Jennifer Dressman, Johann Wolfgang Goethe University, Germany
- Quantitative Prediction of GI absorption of Drugs (incld: in silico prediction) – Per Artursson, Uppsala University, Sweden
- Time- and Site-Dependent Oral Absorption of Drugs: Use of Caco-2 Cells in Predicting GI Absorption – Shinji Yamashita, Setsunan University, Japan
- Integration of Intraluminal Conditions into In Vitro Permeability Assessment: Effect on the Functionality of Efflux Carriers – Patrick Augustijns, Catholic University of Leuven, Belgium
- Effect of Excipients on the GI Absorption of Drugs: Influence on Dissolution or Efflux Transporters – Mariko Morishita, Hoshi University, Japan
Afternoon session
- Intestinal and Hepatic Transporters: Impact of Diet and Genetic Polymorphisms – David Bailey, University of Western Ontario, Canada
- Quantitative Prediction of Transporter-Mediated Hepatic Removal of Drugs from In Vitro Data (incld: drug-drug interaction) – Yuichi Sugiyama, The University of Tokyo, Japan
- Predicting Human Oral Bioavailability and Bioequivalence - Robert Lionberger, Food and Drug Administration, U.S.A.
- Intestinal and Biliary Excretion Studies of Drugs and Metabolites In Vivo in Humans – Hans Lennernas, University of Uppsala, Sweden
- Predicting Oral Bioavailability of Drugs: Industrial Standpoint – Kathryn Kenworthy, GlaxoSmithKline, Inc., U.K.
Workshop Co-chairs
Per Artursson
Uppsala University
Uppsala, Sweden
per.artursson@galenik.uu.se
Yuichi Sugiyama
University of Tokyo
Tokyo, Japan
Tel: + 81-3-5841-4770
yu-one.sugiyama@nifty.com
See #3 on the registration form.
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