- Email: [email protected]
News from the Controlled Release Society, Inc.
163
Journal of Controlled Release, 25(1993) 163-171 @ Elsevier Science Publishers B.V., All rights reserved 0168-3659/93/$6.00
NEWS FROM THE
Q
CONTROLLED RELEASE SOCIETY, INC.
ADMlNISTRATIVEOFFICE:1020MilwaukeeAvenue,Suite235,
THE 2oTH INTERNATIONAL CONTROLLED RELEASE MATERIALS
SYMPOSIUM ON OF BIOACTIVE
JULY 25-28,1993 GRAND HYATI- WASHINGTON WASH.INGTON,D.C.,U.S.A. INVITATION TO EXHIBITORS
Your company is invited to join in the Controlled Release Society’s special 20th anniversary exhibition during the 20th International Symposium in Washington, D.C. At previous meetings, attendees included government personnel and research and development professionals, qualityassurance/controlspecialists,productionengineers, marketingcoordinatorsandmanagersfrompharmaceutical, agricultural and cosmetic industries. More than 800 participants registered from all over the world, including Canada, Europe, the Middle East, the Far East and the U.S.A. Similar participation is expected during the 20th Symposium, which will provide the exhibitor an excellent opportunity to promote products and services related to controlled release technology. TheExhibitionwillopenonMonday,July26,1993,at9:30 a.m.and willcloseonWednesday,July28,atnoon. Coffee breaks and poster sessions will take place in or near the Exhibitionarea. TheboothfeeisUS$1,6OOper8’xlO’unit (approximately 2.50 m x 3 m), and a deposit of 50% of the total booth space fee is required if the application is
Deerfield, IL60015, U.S.A.Tel. (708)8087071
Fax0’08)8087073
receivedbeforeMarch 151993. Thereafter,theapplication must be sent with full payment. Exhibits, advertising materials and samples are entitled to duty free and tax free entry privileges under U.S. Customs Regulations. For further information, please contact: Controlled Release Society Administrative Office 1020 Milwaukee Avenue, Suite 235 DeerIield,IL 60015 U.S.A. Tel: (708) 808-7071 Fax: (708) 808-7073 Exhibition space is limited, and space is reserved on a first come, first serve basis, except previous years’ exhibitors will be given priority for their preferred space. Potential exhibitors should note that in past years, space has been soldout well in advance, preventing some companies from promoting their products and services. Program Announcement: CONTROLLED RELEASE SOCIETY, INC. 20TH INTERNATIONAL SYMPOSIUM ON CONTROLLED RELEASE OF BIOACTIVE MATERIALS JULY 25-28,1993 GRAND HYATT HOTEL WASHINGTON, D.C.,U.S.A.
YOUR INVITATION TO ATTEND! Reduced Registration Fees until May 1st An excellent opportunity to participate in this unique and special meeting.
164
Since our beginnings in 1973, many issues have taken on global significance. This expanding world view of controlled release will come into focus in historic Washington, D.C., as leading researchers from around the world present new and contemporary topics in the field of controlledrelease. lhere will bepapers relating to all areas of controlled delivery, including: Agrichemical Delivery Chronopharmacology Mathematical Modeling Oral Delivery Peptide/Protein Delivery Transdermal Delivery Vaccines Biotcchnological Advances Consumer Products Modulated Drug Delivery Parenteml Administration Targeting Transmucosal Delivery Veterinary Delivery As part of this special meeting, we will present two half days of plenary speakers who will address the current and future technical as well as business aspects of the field. We have given special attention to the symposium designed to address the timely topic of Peptide/Protein Delivery and current trends in drug delivery associated with biotechnological advances. The program is completed with mini-symposia on Drug Targeting and Advances in Materials Development, and lectures featuring special invited speakers. ..,.. Plan to be part of this milestone event!. ........L.ookingforward to seeing you in Washington!
PLENARY LECTURERS Dr. Paul Blake, Vice President and Medical Director, North America, SmithKline Beecham, U.S.A. Drug Delivery in AIDS Therapeutics Prof. Pierre Buri, Dean of Sciences, University of Geneva, Switzerland Future Directions in European Controlled Release Prof. Egon Diczfalusy, Professor Emeritus, Karolinska Institute, Sweden, and Senior Consultant, WHO In Search of a Broader Contraceptive Choice Mr. Martin Gerstel, Co-Chairman & CEO, ALZA Corporation, U.S.A. The Ups and Downs of Building a Successful Business through Controlled Delivery Prof. JordanGuttennan,Chairman,DepartmentofClinical Immunology and Biological Therapy, University ofTexas, M.D. Anderson Cancer Center, U.S.A. Current and Future Prospects for Protein Therapeutics Dr. David Kessler, Commissioner, Food and Drug Administration, U.S.A. TheStateofthe ArtofControlled ReleaseSubstances: The FDA Perspective Prof. JoscphRobinson,ProfessorofPharmacy,University of Wisconsin, U.S.A. The Hype, Reality & Future Prospects of Controlled Release - The Polymer/Biology Era Prof. Hitoshi Sezaki, ProfessorofPharmaceutics, Setsunan University, Japan Controlled Release: Current Applications and Future Trends in Japan
PLENARY AND SPECIAL INVITED LECTURERS OF THE 20th INTERNATIONAL SYMPOSIUM ON CONTROLLED RELEASE OF BIOACTIVE MATERIALS JULY 25-28,1993 WASHINGTON, D.C.,U.S.A.
Prof. Richard Wilkins, Agricultural and Environmental Science, University of Newcastle, United Kingdom The Role and Potential of Controlled Release Technology in Crop Protection
T. J. Roseman,Ph.D., N. A. Peppas, Sc.D., H. L. Gabelnick, Ph.D., Program Chairs
SPECIAL INVITED LECTURERS Dr. Neil Ackerman, Glycomed, Inc., U.S.A. Carbohydrate Based Drugs Dr. William Connick, Jr., United States Department of
165
Agriculture, U.S.A. Advances in Formulation of Microbial Pesticides Prof. Edward Cussler, University of Minnesota, U.S.A. Fick’ s Second Law Dr. Michael Francoeur, Pharmenix, U.S.A. ControlledDrugDeliveryAcrosstheSkintoSubcutaneous Tissue Prof. Franklin R. Hall, Ohio State University, U.S.A. AspectsofDosageTransferinControlledRelcasePesticides Prof. John Herr, University of Virginia, U.S.A. Contraceptive Vaccine Immunogens and Their Antibody Response Profiles Dr. Kwang-Jin Kim, University of Southern California, U.S.A. Peptide andProtein Transport Across Alveolar Epithelium Prof. Sung Wan Kim, The University of Utah, U.S.A. Self-Regulated Insulin Delivery Prof. Bjom Lemmer, J.W. Goethe University, Germany Time - A Key in Drug Treatment Prof. Gabriel Lopez-Berestein, M. D. Anderson Cancer Center, U.S.A. Liposomes: Trends in Clinical Application Dr. Lendon Payne, Virus Research Institute, U.S.A. Antigen Delivery: Immunological Requirements and Technological Possibilities Dr. Colin Pitt, Amgen, Inc., U.S.A. Drug Delivery Challenges in Biotechnology Dr. Felix Theeuwes, ALZA Corporation, U.S.A. Future Oral Delivery Systems Prof. Curt Thies, Washington University, U.S.A. Characterization of Microcapsules Dr. Stanley Tacker, E. I. DuPont de Nemours & Co., U.S.A. Controlled Release Formulations of Pesticides Prof. Dan Urry, University of Alabama, U.S.A.
Use of Biomimetic Mechanisms in Controlled Release Dr.TheovanBerkel,UniversityofLeiden,TheNetherlands LDL-Mediated Delivery of Antineoplastic Drugs Dr. Srinivasan Venkateshwaran, ThemTech, Inc., U.S.A. Mechanistic Analysis of Iontophoretic Transport
MINI-SYMPOSIA SPEAKERS RECENT ADVANCES IN MATERIALS DEVELOPMENT FOR CONTROLLED RELEASE AND BIOMEDICAL APPLICATIONS Chairs: N. Peppas, Purdue University, U.S.A., and J. Hubbell, University of Texas, U.S.A. Prof. Pablo Debcnedetti, Princeton University, U.S.A. Supercritical Fluids: A New Medium for the Formation of Particles of Biomedical Interest Prof. Allan Hoffman, University of Washington, U.S.A. SynthesisandApplicationsofSolubleStimuli-Responsive Polymer-Biomolccule Conjugates Prof. Jeffrey Hubbell, University of Texas, U.S.A. Poly(ethyleneglycol)-basedGelsfortheReleaseofProteins and the Encapsulation of Cells Prof. Nicholas Peppas, Purdue University, U.S.A. Dendrimers and Star Polymers forPharmaceutical/Medical Applications Prof. Matthew Tirrell, University of Minnesota, U.S.A. Measurement of Forces Between Surfaces of Polymeric Amphiphiles Prof. Garth Wilkes, Virginia Polytechnic Institute, U.S.A. HybridNetworkMaterialsbySol-GelChemistry-Structure and Property Response
DRUG TARGETING Chair: R. Margalit, Tel Aviv University, Israel Dr. Richard Kirsh, SmithKline Bcecham, U.S.A. Opportunities for Drug Targeting in Infectious Disease Therapeutics
166
Prof. Jindrich Kopecek, University of Utah, U.S.A. Targetable Water-Soluble Polymeric Anticancer Drugs: Achievements and Unsolved Problems Prof. Rimona Margalit, Tel Aviv University, Israel Drug Targeting in Topical and Regional Therapies CRS is approved by the American Council on Pharmaceutical Education as a provider of Continuing Pharmaceutical Education (Program Credit No. 689-160-93-01).
CONTROLLED RELEASE SOCIETY WORKSHOP ON REGULATORY AFFAIRS July 29 and 30, 1993, Grand Hyatt Washington Washington, D.C., U.S.A. Thomas J. Atkins, Ph.D. and Mark Chasin, Ph.D. Co-Chairs
Consideration for Oral Controlled Release Products Harriet Benson, Ph.D., Vice President, Regulatory Affairs & Technical Publications, ALZA Corp., U.S.A. An Industrial Perspective of the Regulatory Aspects of Agricultural Products: Veterinary and Agrichemical Susan Cady, M.S., Group Leader, American Cyanamid Company, U.S.A.
Biopharmaceutical and Clinical Sciences: Bridging the Communications Gap Carl Peck, M.D., Director, Center for Drug Evaluation and Research, FDA, U.S.A. Nova Pharmaceutical Corporation - How We Work with the FDA StevenRochelle,M.S.,Diitor,DrugRegulatoryAffairs, Nova Pharmaceutical Corporation, U.S.A. Leupron Depot Development and U.S. Approval Dean Sundberg, Ph.D., Director Regulatory Affairs, TAP Pharmaceuticals, U.S.A. GeneTherapy: Regulation in Europeand theunited States of America Eric Tomlinson, Ph.D., President and Chief Executive Officer, Vector Therapeutics, Inc., U.S.A Status of European Regulatory Unification Malcolm VandenBerg, BSc, MBBS, MRCP, Chairman MCRC, United Kingdom Submitting Manufacturing and Controls Information to NDAs for Extended Release Products Robert Wohers,Ph.D., SupervisoryChemist,Cardio-Renal Drug Products, FDA, U.S.A.
q
CRS is approved by the American Council on Pharmaceutical Education as a provider of Continuing Pharmaceutical Education (Program Credit No. 689- 160-93-02).
Getting a Transdermal Delivery System Ready for Commercialization Gary Cleary, Ph.D., Chairman & Chief Technical Officer, Cygnus Therapeutic Systems, U.S.A.
CONTROLLED RELEASE SOCIETY WORKSHOP ON ORAL DRUG DELIVERY and DESIGN OF CONTROLLED RELEASE DOSAGE FORMS
Regulatory Issues Related to Oral Controlled Release Products Henry Malinowski, Ph.D., Deputy Director, Division of Biopharmaceutics, FDA, U.S.A.
July 29 and 30,1993, Grand Hyatt Washington Washington, D.C.,U.S.A. Gordon L. Amidon, Ph.D. and Joseph R. Robinson, Ph.D., Co-Chairs
The Final Step - The New Drug Application Harold Nash, Ph.D., Senior Scientist, The Population Council, U.S.A.
GI Physiology: Transit and Permeability Considerations Gordon L. Amidon, Ph.D., The University of Michigan, U.S.A.
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TransportMechanismsinControlledReleaseDosageForms Ping I. Lee, Ph.D., University of Toronto, Canada Technology for Oral Controlled Release Joseph R. Robinson, Ph.D., University of Wisconsin, U.S.A. In Vivo Methodology for Evaluating Oral Controlled Release: Animal Models and Human Permeabilities William H. Barr, Ph.D., Virginia Commonwealth University, U.S.A. In vitro-In vivo Performance of Oral Controlled Release Dosage Forms Lewis J. Leeson, Ph.D., CIBA-GEIGY Pharmaceuticals, U.S.A. Scale-up Considerations for Controlled Release Dosage Forms GlennA.VanBuskirk,Ph.D.,R.W.JohnsonPharmaceutical Research Institute. U.S.A. Regulatory Requirements for Controlled Release Dosage Forms LawrenceJ.Lesko,Ph.D., FoodandDrugAdministration, U.S.A.
CRS is approved by the American Council on Pharmaceutical Education as a provider of Continuing Pharmaceutical Education (Program Credit No. 689-160-93-03). Please make your own hotel reservations at the Grand Hyatt. Telephone: 800/233-1234 or202/582-1234 (Hyatt Direct) Fax: 202/637478 1 Ask for the CRS special group rate.
TheControlledReleaseSccietyispleasedtooffercontinuing education credits (ACPEE - American Council on Pharmaceutical Education) for the 20th Symposium and the two workshops following the Symposium: CRS Workshop on Regulatory Affairs and the CRS Workshop on Oral Drug Delivery and Design of Controlled Release Dosage Forms.
2OTI-IINTERNATIONAL SYMPOSIUM ON CONTROLLED RELEASE OF BIOACTIVE MATERIALS JULY 25JULY 28,1993 Goals and Objectives: After attending the Symposium, the pharmacist will be knowledgeable on: Transdermal patches The latest developments in peptide/protein drug delivery The science of drug targeting The design and science of controlled release systems for consumer products CRS attendees who desire ACPE credit are requested to obtain evaluation forms from the CRS registration desk. Total credits earned for this symposium are 2.8 (Program Credit No. 689-160-93-01).
CONTROLLED RELEASE SOCIETY WORKSHOP ON REGULATORY AFFAIRS JULY 29-30,1993 Goals and Objectives: After attending the Workshop, the pharmacist will be knowledgeable on: How drugs are brought through theFDA approval process How various pharmaceutical companies approach drug approval Viewpoints of both industry and government officials on the drug approval process The international viewpoint of drug approval A variety of approaches for a variety of dosage forms, including oral, implantable and transdermal forms Howcontrollcdreleasedosageformsaretreateddifferently from more traditional forms CRS attendees who desire ACPE credit are requested to obtain evaluation forms from the CRS registration desk. Total credits earned for this workshop are 1.3 (Program Credit No. 689-160-93-02). CONTROLLED RELEASE SOCIETY WORKSHOP ON ORAL DRUG DELIVERY & DESIGN OF CONTROLLED RELEASE DOSAGE FORMS
168
JULY 29-30,1993 Goals and Objectives: After attending the Workshop, the pharmacist will be knowledgeableon: Basic physiological, technological and regulatory background needed to develop successful oral controlled release dosage forms. Considering drug absorption mechanisms, gastrointestinal transit considerations, drug physical and transport properties, controlled release material properties and FDA regulatory requirements in developing a successful product. TheworkshopisdesignedtoaJlowampletimefordiscussion by the audience. CRS attendees who desire ACPE credit are requested to obtain evaluation forms from the CRS registration desk. Total credits earned for this workshop are 1.3 (Program Credit No. 689-160-93-03).
All sessions will be highly interactive between students and faculty. Cases, problems, exercises, etc. will be used to maximize participation. Attendance is limited. Registration is on a first paid, first served basis. Early signup is encouraged. Audience:
Designed for scientists and technical experts representing various areas of expertise. The primary concern of the program is to update and increase the participant’s knowledge in the areas of leadership and management skills. Program site:
This management program will be held July 24-25,1993, prior to the CRS Annual Meeting at theGrand Hyatt Hotel, Washington, D.C., U.S.A. The program is intensive with sessions conducted throughout the day and early evening. Theschedulewillalsopermittimeforrecreation,exchange of ideas and development of business associations and friendships. Program objectives:
CONTROLLED RELEASE SOCIETY, INC. PRESENTS: SHORT COURSE IN MANAGEMENT SKILLS IN RESEARCH JULY 24251993 GRAND HYATT HOTEL WASHINGTON, DC. U.S.A.
Among the many objectives of this program are the following: To improve management techniques and thus reduce research costs while improving productivity. To sharpen the participant’s knowledge in areas of management communication, team building, leadership, proposal and grant writing, and strategic planning. To increase the participant’s knowledge of new findings and techniques in the field of management. Toprovideandintensivebusinessandmanagementlearning experience.
Faculty;
Robert C. Myrtle, Ph.D. Professor,HealthServicesAdministrationandGerontology Director, Health Services Administration Programs Norman B. Sigband, Ph.D. Distinguished Emeritus Professor of Management Communication, USC, Adjunct Professor, School of Pharmacy Andre B. van Niekerk, Ph.D. VicePresident,ProductDevelopment&larketing,National Medical Enterprises cur?-icu1um: Topic area selected will include the following: Communication skillsConflict management and resolution: General management, leadership and behavior, Strategic planning in research; Teambuilding in research; Session Methodology.
Program Schedule SATURDAY, July 24,1993
7:3Oam - S:OOam,Registration Continental Breakfast 8:3Oam - 1O:OOam,” Teambuilding in Research”, R. Myrtle lo:ooam - 10:15am,
BREAK
10:15am- ll:45am, “ConflictManagementandResolution” R. Myrtle 12:00 noon
LUNCH
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l:OOpm- 2:3Opm, “Communication for Best Results” N. Sigband 2:3Opm - 2:45pm
Card Number
Exp. Date
Nameon Card
Amt. Chg./Encl. !§
BREAK Authorized Signature.
245pm - 4: 15pm, “Listening:A VitalTool in Research N. Sigband 4:15pm - 5:45pm, “The Strategy of Proposal and Grant Writing”, N. Sigband 6:OOpm- 7:OOpm,
DINNER
7:15pm - 8:45pm, “Speaking: One To One Thousand. Briefing for Science”, N. Sigband SUNDAY, July 25,1993 7:3Oam - 8:OOam,Continental Breakfast 8:3Oam - 10:0&m, “Strategic Planning in Research”,
Registration instructions and information: Name
Member #
Title. Organization. Address. City, State, Zip. Country
Phone/Fax.
Send Registration for Management Skills Workshop to: Controlled Release Society Administrative Office 1020 Milwaukee Avenue, Suite 235, Deerfield, IL 60015, U.S.A. Fax: 708/808-7073 Phone: 708/808-707 1
A. Van Niekerk 1o:ooan-l-
10:15am,
BREAK
10:15am - 11:45am, “Strategic Planning in Research”, A. Van Nieketk 123Opm - 2:3Opm, SUMMARY, EVALUATIONS, CLOSING Registration fee schedule: After:
By : May
May 1,1993 1,1993 U.S.$590 for member U.S.$525 for member U.S.$595 for non-member U.S.$660 for non-member Fee includes one dinner, one lunch, all coffee breaks and a booklet with hard copies of most of the slides presented. Non-member fee also includes a 1993 membership to CRS. Cancellations before June 15, $60 charge; after June 15, no refund. Payment Method: 0
Check(mustbedmwnonaU.S.bankinU.S.Funds)
OVisa
0 MasterCard
0 American Express
Please make your own hotel reservations at the Grand Hyatt Telephone: 800/233-1234 or 202/582-1234 (Hyatt Direct) Fax. 202/637-478 1 Ask for the CRS group rate FIRST EUROPEAN WORKSHOP AND EXHIBITION ON CONTROLLED DELIVERY IN CONSUMER PRODUCTS WARWICK HOTELGENEVA, SWITZERLAND OCTOBER 21-22,1993 Program Chairs:
Prof. Dr. Hans E. Junginger Leiden-Amsterdam Center for Drug Research Leiden, The Netherlands Dr. Jack Burger Quest International Naarden, The Netherlands Professor Nicholas Peppas Purdue University West Lafayette, Indiana U.S.A.
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TENTATIVE SCHEDULE l:OOp.m, Thursday, October 21,1993 Noon - I:30 p.m., Registration 6:30 p.m., Reception and Dinner
1:30 p.m., Introduction 1:4Opm.,Controlled Delivery in Consumer Products What you need to know to get started Wayne Beimesch, The Procter & Gamble Co., Cincinnati, Ohio, U.S.A. 2:3Opm.,Release Mechanisms from Polymeric Carriers Nicholas A. Peppas, Purdue University, West Lafayette, Indiana, U.S.A. 3:3Opm.,Coffee Break 4:OOpm.,Controlled Release from Toiletry Products Richard A. Birch, Quest International, Ashford, United Kingdom
Lunch Break
2:OOp.m, Industrial Preparations of Liposomes for CosmeticProducts,MiklosGhyczy,Nattermann Phospholipids, Cologne, Germany 3:OOp.m,Controlled Interactions of Liposomes and Niosomes in Cosmetic Products with Human Skin Hans E. Junginger, Leiden-Amsterdam Center for Drug Research, The Netherlands 4:OOp.m,
Coffee Break
4:3Op.m, Skin Effects of Liposomes and Niosomes containing Cosmetic Products, Sven Gohla, Beiersdorf, Hamburg, Germany 5:3Op.m,
Concluding Remarks
The Controlled Release Society reserves the right to make changes in instructors or subjects without notice.
POSTER SESSION
11:0&m, New MethodsforEncapsulationandGmnulation of Flavors, Robert E. Sparks, Washington University, Seattle, Washington, U.S.A.
A session forposterpapers by participants of this workshop is planned for the evening of Thursday, October 21,1993. Original research summarizing recent developments in the fields featured in this workshop may be submitted for presentation. The work submitted must be of scientific or technical nature. Poster papers will be reviewed for acceptance. Please submit a 200 word abstract by September 1,1993, to the ControlledReleaseSociety EuropeanOfficeortoProfessor Dr. Hans E. Junginger, Leiden-Amsterdam Center for Drug Research, Einsteinweg 55, 2300 RA Leiden, The Netherlands. Abstracts should contain the title, authors’ names with main presenter’s name underlined, and exact address. Abstracts should be specific and should describe the subject, product, phenomenon or process presented. Generalexpressionssuchas“datawillbepresented,””new products will be discussed” should be avoided. EXHIBITION
12:OOnoon,Industrial Preparation and Properties of Nanoparticles Fred Zulli, Mibelle, Buchs, Switzerland
We have made special arrangements for a table-top exhibition during the workshop. At previous meetings, attendees included government personnel and R&D
6:3Opm.,Reception and Dinner Friday, October 22,1993 8:30am,UseofSilica-basedMaterialsfortheEncapsulation and Delivery of Flavoring Materials in Food Applications Gary Reineccius, University of Minnesota, St. Paul, Minnesota, U.S.A. 9:30a.m, Flavor Encapsulation into Yeast, Jack J. Burger, Quest International, Naarden, The Netherlands 10:30a.m,
Coffee Break
171
professionals, quality control/assurance specialists, producti~engineers,marketingcoordinatorsandmanagers from various industries. Excellent participation is expected during this workshop which will provide the exhibitors a goodopportunitytopromoteservicesforconsumerproducts related to controlled release technology. TheexhibitionwillstartonThursday,Gctober2l,1993,at 12:OOnoonandendonFriday,October22,1993,5:30p.m. The cocktail hour, coffee breaks and poster sessions will take place in or near the Exhibition area. The display fee is SFr 1,500, US $1,000 per table-top display (which includes one exhibitor registration). A deposit of 50% of the total display space fee is required if the application for space is received before August 15,1993. Thereafter, the application must be sent with full payment. There is limited exhibition space. Space is reserved on a first come, first servebasis except that 1990 exhibitors will be given priority for their preferred space. Potential exhibitors should note, that in past years, space has been
sold out well in advance, preventing some companies from promoting their goods and services. Controlled Release Society, Inc. Administrative Office 1020 Milwaukee Avenue, Suite 235 Deerfield, Illinois 60015 U.S.A. Telephone: 708/808-7071 Facsimile: 708/808-7073 Controlled Release Society European Office c/o School of Pharmacy 30, Quai E. Ansermet CH-1211 Geneva, Switzerland Telephone and Telefax: (01141) 22346 4347
Please contact the CRS Administrative Office for detailed information.
Journal of Controlled Release, 25(1993) 163-171 @ Elsevier Science Publishers B.V., All rights reserved 0168-3659/93/$6.00
NEWS FROM THE
Q
CONTROLLED RELEASE SOCIETY, INC.
ADMlNISTRATIVEOFFICE:1020MilwaukeeAvenue,Suite235,
THE 2oTH INTERNATIONAL CONTROLLED RELEASE MATERIALS
SYMPOSIUM ON OF BIOACTIVE
JULY 25-28,1993 GRAND HYATI- WASHINGTON WASH.INGTON,D.C.,U.S.A. INVITATION TO EXHIBITORS
Your company is invited to join in the Controlled Release Society’s special 20th anniversary exhibition during the 20th International Symposium in Washington, D.C. At previous meetings, attendees included government personnel and research and development professionals, qualityassurance/controlspecialists,productionengineers, marketingcoordinatorsandmanagersfrompharmaceutical, agricultural and cosmetic industries. More than 800 participants registered from all over the world, including Canada, Europe, the Middle East, the Far East and the U.S.A. Similar participation is expected during the 20th Symposium, which will provide the exhibitor an excellent opportunity to promote products and services related to controlled release technology. TheExhibitionwillopenonMonday,July26,1993,at9:30 a.m.and willcloseonWednesday,July28,atnoon. Coffee breaks and poster sessions will take place in or near the Exhibitionarea. TheboothfeeisUS$1,6OOper8’xlO’unit (approximately 2.50 m x 3 m), and a deposit of 50% of the total booth space fee is required if the application is
Deerfield, IL60015, U.S.A.Tel. (708)8087071
Fax0’08)8087073
receivedbeforeMarch 151993. Thereafter,theapplication must be sent with full payment. Exhibits, advertising materials and samples are entitled to duty free and tax free entry privileges under U.S. Customs Regulations. For further information, please contact: Controlled Release Society Administrative Office 1020 Milwaukee Avenue, Suite 235 DeerIield,IL 60015 U.S.A. Tel: (708) 808-7071 Fax: (708) 808-7073 Exhibition space is limited, and space is reserved on a first come, first serve basis, except previous years’ exhibitors will be given priority for their preferred space. Potential exhibitors should note that in past years, space has been soldout well in advance, preventing some companies from promoting their products and services. Program Announcement: CONTROLLED RELEASE SOCIETY, INC. 20TH INTERNATIONAL SYMPOSIUM ON CONTROLLED RELEASE OF BIOACTIVE MATERIALS JULY 25-28,1993 GRAND HYATT HOTEL WASHINGTON, D.C.,U.S.A.
YOUR INVITATION TO ATTEND! Reduced Registration Fees until May 1st An excellent opportunity to participate in this unique and special meeting.
164
Since our beginnings in 1973, many issues have taken on global significance. This expanding world view of controlled release will come into focus in historic Washington, D.C., as leading researchers from around the world present new and contemporary topics in the field of controlledrelease. lhere will bepapers relating to all areas of controlled delivery, including: Agrichemical Delivery Chronopharmacology Mathematical Modeling Oral Delivery Peptide/Protein Delivery Transdermal Delivery Vaccines Biotcchnological Advances Consumer Products Modulated Drug Delivery Parenteml Administration Targeting Transmucosal Delivery Veterinary Delivery As part of this special meeting, we will present two half days of plenary speakers who will address the current and future technical as well as business aspects of the field. We have given special attention to the symposium designed to address the timely topic of Peptide/Protein Delivery and current trends in drug delivery associated with biotechnological advances. The program is completed with mini-symposia on Drug Targeting and Advances in Materials Development, and lectures featuring special invited speakers. ..,.. Plan to be part of this milestone event!. ........L.ookingforward to seeing you in Washington!
PLENARY LECTURERS Dr. Paul Blake, Vice President and Medical Director, North America, SmithKline Beecham, U.S.A. Drug Delivery in AIDS Therapeutics Prof. Pierre Buri, Dean of Sciences, University of Geneva, Switzerland Future Directions in European Controlled Release Prof. Egon Diczfalusy, Professor Emeritus, Karolinska Institute, Sweden, and Senior Consultant, WHO In Search of a Broader Contraceptive Choice Mr. Martin Gerstel, Co-Chairman & CEO, ALZA Corporation, U.S.A. The Ups and Downs of Building a Successful Business through Controlled Delivery Prof. JordanGuttennan,Chairman,DepartmentofClinical Immunology and Biological Therapy, University ofTexas, M.D. Anderson Cancer Center, U.S.A. Current and Future Prospects for Protein Therapeutics Dr. David Kessler, Commissioner, Food and Drug Administration, U.S.A. TheStateofthe ArtofControlled ReleaseSubstances: The FDA Perspective Prof. JoscphRobinson,ProfessorofPharmacy,University of Wisconsin, U.S.A. The Hype, Reality & Future Prospects of Controlled Release - The Polymer/Biology Era Prof. Hitoshi Sezaki, ProfessorofPharmaceutics, Setsunan University, Japan Controlled Release: Current Applications and Future Trends in Japan
PLENARY AND SPECIAL INVITED LECTURERS OF THE 20th INTERNATIONAL SYMPOSIUM ON CONTROLLED RELEASE OF BIOACTIVE MATERIALS JULY 25-28,1993 WASHINGTON, D.C.,U.S.A.
Prof. Richard Wilkins, Agricultural and Environmental Science, University of Newcastle, United Kingdom The Role and Potential of Controlled Release Technology in Crop Protection
T. J. Roseman,Ph.D., N. A. Peppas, Sc.D., H. L. Gabelnick, Ph.D., Program Chairs
SPECIAL INVITED LECTURERS Dr. Neil Ackerman, Glycomed, Inc., U.S.A. Carbohydrate Based Drugs Dr. William Connick, Jr., United States Department of
165
Agriculture, U.S.A. Advances in Formulation of Microbial Pesticides Prof. Edward Cussler, University of Minnesota, U.S.A. Fick’ s Second Law Dr. Michael Francoeur, Pharmenix, U.S.A. ControlledDrugDeliveryAcrosstheSkintoSubcutaneous Tissue Prof. Franklin R. Hall, Ohio State University, U.S.A. AspectsofDosageTransferinControlledRelcasePesticides Prof. John Herr, University of Virginia, U.S.A. Contraceptive Vaccine Immunogens and Their Antibody Response Profiles Dr. Kwang-Jin Kim, University of Southern California, U.S.A. Peptide andProtein Transport Across Alveolar Epithelium Prof. Sung Wan Kim, The University of Utah, U.S.A. Self-Regulated Insulin Delivery Prof. Bjom Lemmer, J.W. Goethe University, Germany Time - A Key in Drug Treatment Prof. Gabriel Lopez-Berestein, M. D. Anderson Cancer Center, U.S.A. Liposomes: Trends in Clinical Application Dr. Lendon Payne, Virus Research Institute, U.S.A. Antigen Delivery: Immunological Requirements and Technological Possibilities Dr. Colin Pitt, Amgen, Inc., U.S.A. Drug Delivery Challenges in Biotechnology Dr. Felix Theeuwes, ALZA Corporation, U.S.A. Future Oral Delivery Systems Prof. Curt Thies, Washington University, U.S.A. Characterization of Microcapsules Dr. Stanley Tacker, E. I. DuPont de Nemours & Co., U.S.A. Controlled Release Formulations of Pesticides Prof. Dan Urry, University of Alabama, U.S.A.
Use of Biomimetic Mechanisms in Controlled Release Dr.TheovanBerkel,UniversityofLeiden,TheNetherlands LDL-Mediated Delivery of Antineoplastic Drugs Dr. Srinivasan Venkateshwaran, ThemTech, Inc., U.S.A. Mechanistic Analysis of Iontophoretic Transport
MINI-SYMPOSIA SPEAKERS RECENT ADVANCES IN MATERIALS DEVELOPMENT FOR CONTROLLED RELEASE AND BIOMEDICAL APPLICATIONS Chairs: N. Peppas, Purdue University, U.S.A., and J. Hubbell, University of Texas, U.S.A. Prof. Pablo Debcnedetti, Princeton University, U.S.A. Supercritical Fluids: A New Medium for the Formation of Particles of Biomedical Interest Prof. Allan Hoffman, University of Washington, U.S.A. SynthesisandApplicationsofSolubleStimuli-Responsive Polymer-Biomolccule Conjugates Prof. Jeffrey Hubbell, University of Texas, U.S.A. Poly(ethyleneglycol)-basedGelsfortheReleaseofProteins and the Encapsulation of Cells Prof. Nicholas Peppas, Purdue University, U.S.A. Dendrimers and Star Polymers forPharmaceutical/Medical Applications Prof. Matthew Tirrell, University of Minnesota, U.S.A. Measurement of Forces Between Surfaces of Polymeric Amphiphiles Prof. Garth Wilkes, Virginia Polytechnic Institute, U.S.A. HybridNetworkMaterialsbySol-GelChemistry-Structure and Property Response
DRUG TARGETING Chair: R. Margalit, Tel Aviv University, Israel Dr. Richard Kirsh, SmithKline Bcecham, U.S.A. Opportunities for Drug Targeting in Infectious Disease Therapeutics
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Prof. Jindrich Kopecek, University of Utah, U.S.A. Targetable Water-Soluble Polymeric Anticancer Drugs: Achievements and Unsolved Problems Prof. Rimona Margalit, Tel Aviv University, Israel Drug Targeting in Topical and Regional Therapies CRS is approved by the American Council on Pharmaceutical Education as a provider of Continuing Pharmaceutical Education (Program Credit No. 689-160-93-01).
CONTROLLED RELEASE SOCIETY WORKSHOP ON REGULATORY AFFAIRS July 29 and 30, 1993, Grand Hyatt Washington Washington, D.C., U.S.A. Thomas J. Atkins, Ph.D. and Mark Chasin, Ph.D. Co-Chairs
Consideration for Oral Controlled Release Products Harriet Benson, Ph.D., Vice President, Regulatory Affairs & Technical Publications, ALZA Corp., U.S.A. An Industrial Perspective of the Regulatory Aspects of Agricultural Products: Veterinary and Agrichemical Susan Cady, M.S., Group Leader, American Cyanamid Company, U.S.A.
Biopharmaceutical and Clinical Sciences: Bridging the Communications Gap Carl Peck, M.D., Director, Center for Drug Evaluation and Research, FDA, U.S.A. Nova Pharmaceutical Corporation - How We Work with the FDA StevenRochelle,M.S.,Diitor,DrugRegulatoryAffairs, Nova Pharmaceutical Corporation, U.S.A. Leupron Depot Development and U.S. Approval Dean Sundberg, Ph.D., Director Regulatory Affairs, TAP Pharmaceuticals, U.S.A. GeneTherapy: Regulation in Europeand theunited States of America Eric Tomlinson, Ph.D., President and Chief Executive Officer, Vector Therapeutics, Inc., U.S.A Status of European Regulatory Unification Malcolm VandenBerg, BSc, MBBS, MRCP, Chairman MCRC, United Kingdom Submitting Manufacturing and Controls Information to NDAs for Extended Release Products Robert Wohers,Ph.D., SupervisoryChemist,Cardio-Renal Drug Products, FDA, U.S.A.
q
CRS is approved by the American Council on Pharmaceutical Education as a provider of Continuing Pharmaceutical Education (Program Credit No. 689- 160-93-02).
Getting a Transdermal Delivery System Ready for Commercialization Gary Cleary, Ph.D., Chairman & Chief Technical Officer, Cygnus Therapeutic Systems, U.S.A.
CONTROLLED RELEASE SOCIETY WORKSHOP ON ORAL DRUG DELIVERY and DESIGN OF CONTROLLED RELEASE DOSAGE FORMS
Regulatory Issues Related to Oral Controlled Release Products Henry Malinowski, Ph.D., Deputy Director, Division of Biopharmaceutics, FDA, U.S.A.
July 29 and 30,1993, Grand Hyatt Washington Washington, D.C.,U.S.A. Gordon L. Amidon, Ph.D. and Joseph R. Robinson, Ph.D., Co-Chairs
The Final Step - The New Drug Application Harold Nash, Ph.D., Senior Scientist, The Population Council, U.S.A.
GI Physiology: Transit and Permeability Considerations Gordon L. Amidon, Ph.D., The University of Michigan, U.S.A.
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TransportMechanismsinControlledReleaseDosageForms Ping I. Lee, Ph.D., University of Toronto, Canada Technology for Oral Controlled Release Joseph R. Robinson, Ph.D., University of Wisconsin, U.S.A. In Vivo Methodology for Evaluating Oral Controlled Release: Animal Models and Human Permeabilities William H. Barr, Ph.D., Virginia Commonwealth University, U.S.A. In vitro-In vivo Performance of Oral Controlled Release Dosage Forms Lewis J. Leeson, Ph.D., CIBA-GEIGY Pharmaceuticals, U.S.A. Scale-up Considerations for Controlled Release Dosage Forms GlennA.VanBuskirk,Ph.D.,R.W.JohnsonPharmaceutical Research Institute. U.S.A. Regulatory Requirements for Controlled Release Dosage Forms LawrenceJ.Lesko,Ph.D., FoodandDrugAdministration, U.S.A.
CRS is approved by the American Council on Pharmaceutical Education as a provider of Continuing Pharmaceutical Education (Program Credit No. 689-160-93-03). Please make your own hotel reservations at the Grand Hyatt. Telephone: 800/233-1234 or202/582-1234 (Hyatt Direct) Fax: 202/637478 1 Ask for the CRS special group rate.
TheControlledReleaseSccietyispleasedtooffercontinuing education credits (ACPEE - American Council on Pharmaceutical Education) for the 20th Symposium and the two workshops following the Symposium: CRS Workshop on Regulatory Affairs and the CRS Workshop on Oral Drug Delivery and Design of Controlled Release Dosage Forms.
2OTI-IINTERNATIONAL SYMPOSIUM ON CONTROLLED RELEASE OF BIOACTIVE MATERIALS JULY 25JULY 28,1993 Goals and Objectives: After attending the Symposium, the pharmacist will be knowledgeable on: Transdermal patches The latest developments in peptide/protein drug delivery The science of drug targeting The design and science of controlled release systems for consumer products CRS attendees who desire ACPE credit are requested to obtain evaluation forms from the CRS registration desk. Total credits earned for this symposium are 2.8 (Program Credit No. 689-160-93-01).
CONTROLLED RELEASE SOCIETY WORKSHOP ON REGULATORY AFFAIRS JULY 29-30,1993 Goals and Objectives: After attending the Workshop, the pharmacist will be knowledgeable on: How drugs are brought through theFDA approval process How various pharmaceutical companies approach drug approval Viewpoints of both industry and government officials on the drug approval process The international viewpoint of drug approval A variety of approaches for a variety of dosage forms, including oral, implantable and transdermal forms Howcontrollcdreleasedosageformsaretreateddifferently from more traditional forms CRS attendees who desire ACPE credit are requested to obtain evaluation forms from the CRS registration desk. Total credits earned for this workshop are 1.3 (Program Credit No. 689-160-93-02). CONTROLLED RELEASE SOCIETY WORKSHOP ON ORAL DRUG DELIVERY & DESIGN OF CONTROLLED RELEASE DOSAGE FORMS
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JULY 29-30,1993 Goals and Objectives: After attending the Workshop, the pharmacist will be knowledgeableon: Basic physiological, technological and regulatory background needed to develop successful oral controlled release dosage forms. Considering drug absorption mechanisms, gastrointestinal transit considerations, drug physical and transport properties, controlled release material properties and FDA regulatory requirements in developing a successful product. TheworkshopisdesignedtoaJlowampletimefordiscussion by the audience. CRS attendees who desire ACPE credit are requested to obtain evaluation forms from the CRS registration desk. Total credits earned for this workshop are 1.3 (Program Credit No. 689-160-93-03).
All sessions will be highly interactive between students and faculty. Cases, problems, exercises, etc. will be used to maximize participation. Attendance is limited. Registration is on a first paid, first served basis. Early signup is encouraged. Audience:
Designed for scientists and technical experts representing various areas of expertise. The primary concern of the program is to update and increase the participant’s knowledge in the areas of leadership and management skills. Program site:
This management program will be held July 24-25,1993, prior to the CRS Annual Meeting at theGrand Hyatt Hotel, Washington, D.C., U.S.A. The program is intensive with sessions conducted throughout the day and early evening. Theschedulewillalsopermittimeforrecreation,exchange of ideas and development of business associations and friendships. Program objectives:
CONTROLLED RELEASE SOCIETY, INC. PRESENTS: SHORT COURSE IN MANAGEMENT SKILLS IN RESEARCH JULY 24251993 GRAND HYATT HOTEL WASHINGTON, DC. U.S.A.
Among the many objectives of this program are the following: To improve management techniques and thus reduce research costs while improving productivity. To sharpen the participant’s knowledge in areas of management communication, team building, leadership, proposal and grant writing, and strategic planning. To increase the participant’s knowledge of new findings and techniques in the field of management. Toprovideandintensivebusinessandmanagementlearning experience.
Faculty;
Robert C. Myrtle, Ph.D. Professor,HealthServicesAdministrationandGerontology Director, Health Services Administration Programs Norman B. Sigband, Ph.D. Distinguished Emeritus Professor of Management Communication, USC, Adjunct Professor, School of Pharmacy Andre B. van Niekerk, Ph.D. VicePresident,ProductDevelopment&larketing,National Medical Enterprises cur?-icu1um: Topic area selected will include the following: Communication skillsConflict management and resolution: General management, leadership and behavior, Strategic planning in research; Teambuilding in research; Session Methodology.
Program Schedule SATURDAY, July 24,1993
7:3Oam - S:OOam,Registration Continental Breakfast 8:3Oam - 1O:OOam,” Teambuilding in Research”, R. Myrtle lo:ooam - 10:15am,
BREAK
10:15am- ll:45am, “ConflictManagementandResolution” R. Myrtle 12:00 noon
LUNCH
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l:OOpm- 2:3Opm, “Communication for Best Results” N. Sigband 2:3Opm - 2:45pm
Card Number
Exp. Date
Nameon Card
Amt. Chg./Encl. !§
BREAK Authorized Signature.
245pm - 4: 15pm, “Listening:A VitalTool in Research N. Sigband 4:15pm - 5:45pm, “The Strategy of Proposal and Grant Writing”, N. Sigband 6:OOpm- 7:OOpm,
DINNER
7:15pm - 8:45pm, “Speaking: One To One Thousand. Briefing for Science”, N. Sigband SUNDAY, July 25,1993 7:3Oam - 8:OOam,Continental Breakfast 8:3Oam - 10:0&m, “Strategic Planning in Research”,
Registration instructions and information: Name
Member #
Title. Organization. Address. City, State, Zip. Country
Phone/Fax.
Send Registration for Management Skills Workshop to: Controlled Release Society Administrative Office 1020 Milwaukee Avenue, Suite 235, Deerfield, IL 60015, U.S.A. Fax: 708/808-7073 Phone: 708/808-707 1
A. Van Niekerk 1o:ooan-l-
10:15am,
BREAK
10:15am - 11:45am, “Strategic Planning in Research”, A. Van Nieketk 123Opm - 2:3Opm, SUMMARY, EVALUATIONS, CLOSING Registration fee schedule: After:
By : May
May 1,1993 1,1993 U.S.$590 for member U.S.$525 for member U.S.$595 for non-member U.S.$660 for non-member Fee includes one dinner, one lunch, all coffee breaks and a booklet with hard copies of most of the slides presented. Non-member fee also includes a 1993 membership to CRS. Cancellations before June 15, $60 charge; after June 15, no refund. Payment Method: 0
Check(mustbedmwnonaU.S.bankinU.S.Funds)
OVisa
0 MasterCard
0 American Express
Please make your own hotel reservations at the Grand Hyatt Telephone: 800/233-1234 or 202/582-1234 (Hyatt Direct) Fax. 202/637-478 1 Ask for the CRS group rate FIRST EUROPEAN WORKSHOP AND EXHIBITION ON CONTROLLED DELIVERY IN CONSUMER PRODUCTS WARWICK HOTELGENEVA, SWITZERLAND OCTOBER 21-22,1993 Program Chairs:
Prof. Dr. Hans E. Junginger Leiden-Amsterdam Center for Drug Research Leiden, The Netherlands Dr. Jack Burger Quest International Naarden, The Netherlands Professor Nicholas Peppas Purdue University West Lafayette, Indiana U.S.A.
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TENTATIVE SCHEDULE l:OOp.m, Thursday, October 21,1993 Noon - I:30 p.m., Registration 6:30 p.m., Reception and Dinner
1:30 p.m., Introduction 1:4Opm.,Controlled Delivery in Consumer Products What you need to know to get started Wayne Beimesch, The Procter & Gamble Co., Cincinnati, Ohio, U.S.A. 2:3Opm.,Release Mechanisms from Polymeric Carriers Nicholas A. Peppas, Purdue University, West Lafayette, Indiana, U.S.A. 3:3Opm.,Coffee Break 4:OOpm.,Controlled Release from Toiletry Products Richard A. Birch, Quest International, Ashford, United Kingdom
Lunch Break
2:OOp.m, Industrial Preparations of Liposomes for CosmeticProducts,MiklosGhyczy,Nattermann Phospholipids, Cologne, Germany 3:OOp.m,Controlled Interactions of Liposomes and Niosomes in Cosmetic Products with Human Skin Hans E. Junginger, Leiden-Amsterdam Center for Drug Research, The Netherlands 4:OOp.m,
Coffee Break
4:3Op.m, Skin Effects of Liposomes and Niosomes containing Cosmetic Products, Sven Gohla, Beiersdorf, Hamburg, Germany 5:3Op.m,
Concluding Remarks
The Controlled Release Society reserves the right to make changes in instructors or subjects without notice.
POSTER SESSION
11:0&m, New MethodsforEncapsulationandGmnulation of Flavors, Robert E. Sparks, Washington University, Seattle, Washington, U.S.A.
A session forposterpapers by participants of this workshop is planned for the evening of Thursday, October 21,1993. Original research summarizing recent developments in the fields featured in this workshop may be submitted for presentation. The work submitted must be of scientific or technical nature. Poster papers will be reviewed for acceptance. Please submit a 200 word abstract by September 1,1993, to the ControlledReleaseSociety EuropeanOfficeortoProfessor Dr. Hans E. Junginger, Leiden-Amsterdam Center for Drug Research, Einsteinweg 55, 2300 RA Leiden, The Netherlands. Abstracts should contain the title, authors’ names with main presenter’s name underlined, and exact address. Abstracts should be specific and should describe the subject, product, phenomenon or process presented. Generalexpressionssuchas“datawillbepresented,””new products will be discussed” should be avoided. EXHIBITION
12:OOnoon,Industrial Preparation and Properties of Nanoparticles Fred Zulli, Mibelle, Buchs, Switzerland
We have made special arrangements for a table-top exhibition during the workshop. At previous meetings, attendees included government personnel and R&D
6:3Opm.,Reception and Dinner Friday, October 22,1993 8:30am,UseofSilica-basedMaterialsfortheEncapsulation and Delivery of Flavoring Materials in Food Applications Gary Reineccius, University of Minnesota, St. Paul, Minnesota, U.S.A. 9:30a.m, Flavor Encapsulation into Yeast, Jack J. Burger, Quest International, Naarden, The Netherlands 10:30a.m,
Coffee Break
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professionals, quality control/assurance specialists, producti~engineers,marketingcoordinatorsandmanagers from various industries. Excellent participation is expected during this workshop which will provide the exhibitors a goodopportunitytopromoteservicesforconsumerproducts related to controlled release technology. TheexhibitionwillstartonThursday,Gctober2l,1993,at 12:OOnoonandendonFriday,October22,1993,5:30p.m. The cocktail hour, coffee breaks and poster sessions will take place in or near the Exhibition area. The display fee is SFr 1,500, US $1,000 per table-top display (which includes one exhibitor registration). A deposit of 50% of the total display space fee is required if the application for space is received before August 15,1993. Thereafter, the application must be sent with full payment. There is limited exhibition space. Space is reserved on a first come, first servebasis except that 1990 exhibitors will be given priority for their preferred space. Potential exhibitors should note, that in past years, space has been
sold out well in advance, preventing some companies from promoting their goods and services. Controlled Release Society, Inc. Administrative Office 1020 Milwaukee Avenue, Suite 235 Deerfield, Illinois 60015 U.S.A. Telephone: 708/808-7071 Facsimile: 708/808-7073 Controlled Release Society European Office c/o School of Pharmacy 30, Quai E. Ansermet CH-1211 Geneva, Switzerland Telephone and Telefax: (01141) 22346 4347
Please contact the CRS Administrative Office for detailed information.