CRS Spotlight on Industry
At the 36th Annual Meeting & Exposition, CRS will turn the spotlight onto industry news, breakthroughs, and connections Sunday through Wednesday. Add these events and their days and times to your diaries and calendars now.
Young Scientist Workshop 1 Intellectual Property
Saturday, July 18
08:00-17:00 Auditorium 15
Generously co-sponsored by Novo Nordisk
± View Description and Schedule
Chairs: Anne-Marie Lademann, LifeCycle Pharma A/S, Denmark, and Robert C. Sullivan, Jr., Darby & Darby, U.S.A.
The Young Scientist Workshop “Intellectual Property” is designed to give participants insight into the intellectual property world, an area that cannot be ignored by anyone involved in controlled release science. The main focus of the workshop is to give participants an understanding of their own roles and contributions in this complicated field, together with global perspectives such as interactions with drug regulation and the business of pharmaceuticals. Basically, this workshop provides participants with the knowledge needed to link science and innovation with new and improved pharmaceuticals on the market. Take advantage of this opportunity to learn about various aspects of this complicated field.
| 08:00-08:10 |
Introduction, Anne-Marie Lademann, LifeCycle Pharma A/S, Denmark, and Robert C. Sullivan, Jr., Darby & Darby, U.S.A. |
| 08:10-08:50 |
Registered and Non-registered IP, the International Patent Laws and Treaties, the Path from Invention to Patent and Important Timelines Involved, Marianne Johansen, Albihns A/S, Denmark |
| 08:50-09:45 |
The Invention: The Meaning of Novelty and Understanding Inventive Step/Non-obviousness, Jay P. Lessler, Darby & Darby, U.S.A. |
| 09:45-10:10 |
Break |
| 10:10-10:45 |
Patent Claims—The Heart of the Invention: Categories of Pharmaceutical Claims, Scope, Present Trends, and No Go’s—A Worldwide Perspective, Jay P. Lessler, Darby & Darby, U.S.A. |
| 10:45-11:30 |
Patent Litigation in the Pharmaceutical Industry Illustrated by Important Case Stories and What Is to be Learned for the Future, Robert C. Sullivan, Jr., Darby & Darby, U.S.A. |
| 11:30-13:00 |
Lunch is on your own |
| 13:00-14:15 |
How to Convert Pharmaceutical Scientific Work into Patent Claims: A Study Case, Jay P. Lessler, Darby & Darby, U.S.A. |
| 14:15-14:50 |
Searching the Patent Literature, Free of Charge—Tricks and Traps, Tone K. Harrit, The Danish Patent Office, Denmark |
| 14:50-15:10 |
Break |
| 15:10-16:00 |
The Interface of Intellectual Property and Regulation of Medicine: A Worldwide Perspective, Anne-Marie Lademann, LifeCycle Pharma A/S, Denmark |
| 16:00-16:20 |
Biosimilars—Where Are We?, Robert C. Sullivan, Jr., Darby & Darby, U.S.A. |
| 16:20-16:50 |
Intellectual Property: From the Perspective of the CEO, Jim New, LifeCycle Pharma A/S, Denmark |
| 16:50-17:00 |
Questions and Closing Remarks |
Young Scientist Workshop 2 Consumer & Diversified Products: Micro and Nano-encapsulation
Sunday, July 19
± View Description and Schedule
Chairs: Ronald Versic, Ronald T. Dodge Company, U.S.A., and Teresa Virgallito, Microtek Laboratories, U.S.A.
The Consumer & Diversified Products Young Scientists Workshop will provide an overview for students, young scientists, and other scientists on how controlled release technology is utilized in the consumer and diversified products area. The workshop will cover fluid bed coating, microencapsulation formulation development, applying microencapsulation technology in industry, consumer care, and personal care areas. Attendees will develop an understanding of how to formulate products, develop controlled release products using drying techniques, and apply microencapsulation technology for commercial applications.
| 08:00-08:15 | Introduction, Teresa Virgallito, Microtek Laboratories, U.S.A. |
| 08:15-08:45 | Microencapsulation for Consumer Care and Industrial Applications, Fanwen Zeng, The Dow Chemical Company, U.S.A. |
| 08:45-09:15 | Fundamentals of Fluid Bed Microencapsulation, Charles Frey, Coating Place Inc., U.S.A. |
| 09:15-09:45 | Controlled Release of Fragrances, Claudio Ortiz, Colgate Palmolive Company, U.S.A. |
| 09:45-10:00 | Break |
| 10:00-10:30 | Coacervative Microencapsulation, Ronald Versic, Ronald T. Dodge Company, U.S.A. |
| 10:30-11:00 | Phase Change Material Encapsulation for Industrial Applications, Teresa Virgallito, Microtek Laboratories, U.S.A. |
| 11:00-11:30 | Encapsulation by Emulsion-based Methods: Industrial Processes and Solutions, Ruth Schmid, SINTEF Materials and Chemistry, Norway |
| 11:30-11:45 | Conclusion, Ronald Versic, Ronald T. Dodge Company, U.S.A. |
Tablet Manufacturing Roundtable – Tablet Manufacturing in the 21st Century
Sunday, July 19
08:00-12:00 Room A1
± View Description and Schedule
Chairs: Claudia Leopold, University of Hamburg, Germany, and L. Gino Martini, GlaxoSmithKline, U.K.
The humble tablet dosage form has been the main favored approach for dosing medicines to humans ever since the ancient Egyptians rolled herbal products into pastilles for self-medication. Despite the huge advances made in genomics and personalized medicines, the tablet or oral dosage form will continue to play a vital role in the treatment of diseases around the globe. This session is designed to allow practitioners up-to-date knowledge on this fascinating and much utilized mode of drug delivery and what aspects of development and manufacture will influence their performance, efficacy, and quality. Be a part of the Roundtable Discussion that will follow the presentations.
Formulation and Design of Veterinary Tablets, Raafat Fahmy, Center for Veterinary Medicine, Office of New Drug Evaluation, FDA, U.S.A.
Pharmaceutical Granulation Processes and Mechanisms, Sander Van Denban, GlaxoSmithKline, U.K.
Tablet Press Instrumentation in the Research and Development Environment, Walter Hegel, Korsch AG, Germany
Compression and Compaction, Sharon Inman, GlaxoSmithKline, U.K.
Tableting of Multiparticulate Modified Release Systems, Claudia S. Leopold, University of Hamburg, Germany
Preformulation Studies for Tablet Formulation Development, Raj Suryanarayanan, University of Minnesota, U.S.A.
Releasing Technology Workshops
Sunday, July 19
This series of complimentary 1- and 2-hour workshops are scheduled throughout the day and open to all registered attendees. These informative sessions focus on in-depth facets of controlled release technology.
09:00-10:00 – RTW A – Hosted by: Elan Drug Technologies – Auditorium 10
09:00-10:00 – RTW B – Hosted by: Lubrizol Advanced Materials Europe BVBA – Auditorium 11
10:30-11:30 – RTW C – Hosted by: Pii (Pharmaceutics International, Inc.) – Auditorium 10
10:30-11:30 – RTW D – Hosted by: Catalent Pharma Solutions – Auditorium 11
12:00-14:00 – RTW E – Hosted by: Eurand – Auditorium 10
12:00-14:00 – RTW F -- Hosted by: OctoPlus NV – Auditorium 11
12:30-13:30 – RTW G -- Hosted by: BÜCHI Labortechnik AG – Room 18/19
RTW A
Elan Drug Technologies - Platform Technologies for Clear Market Needs
09:00-10:00 – Auditorium 10
± View Description and Schedule
Hosted by: Elan Drug Technologies
Discussions will be on platform technologies that Elan has developed to fulfill real market needs - including technologies for poorly water soluble compounds, chrono and pulsatile release technologies. As Elan celebrates 40 years in the business, we will also provide an overview of how we have evolved to be truly one of only profitable drug delivery provider to the pharma industry.
RTW B
Carbopol® Polymers for Oral Extended Release Dosage Forms
09:00-10:00 – Auditorium 11
± View Description and Schedule
Hosted by: Lubrizol Advanced Materials Europe BVBA
Presented by: Elena Draganoiu, R&D Group Leader
This workshop will provide a forum for academia and industry scientists to learn about the key concepts and benefits of using Carbopol® polymers for extended release solid dosage forms. The following information will be reviewed:
- Available product grades and characteristics
- Formulation and processing of tablets containing Carbopol® polymers
- Mechanism of drug release
- Recommended co-excipients
- Manufacturing technologies
- Formulation techniques to achieve target release profiles - case studies
- Stability considerations
- Potential benefits of Carbopol® polymers beyond extended release
RTW C
Commercialization of Nanoparticle-based Drug Delivery Products, Challenges, and Practical Considerations
10:30-11:30 – Auditorium 10
± View Description and Schedule
Hosted by: PII
Presented by: Robin Mitchell, Senior Director Drug Delivery Solutions and Emad Hassan, Senior Director Pharmaceutical Product Development
The workshop will comprise two short presentations with some time for questions at the end:
A review of the status of nanoparticle technology in the pharmaceutical industry. The rationale for utilization of nanoparticle approaches, key challenges and options facing companies that wish to develop and commercialize nanoparticle-based drug products.
Industrial-scale production of carrier-free nanoparticles for pharmaceutical drug product applications: discussion of critical technical parameters, predicted responses and outcomes. Practical examples will be illustrated.
RTW D
Softgel Lipid Based Drug Delivery Systems
10:30-11:30 – Auditorium 11
± View Description and Schedule
Hosted by: Catalent Pharma Solutions
Presented by: Julien Meissonnier, R&D Director
Catalent Pharma Solutions has developed over years a unique know how in lipid based drug delivery systems development under a soft gelatine capsules format. Catalent will present its development strategy for formulating poorly soluble drugs enabling quick access to First in Man Studies (Phase I).
This approach supports the development of lipid based formulation on a "fit for purpose" design with the aim to maximize chances to increase exposure with poorly soluble and poorly permeable drugs. Focus will be brought on how to achieve maximum performance reduced timings and consider at the same time fill formulations belonging to the four classes of the Lipid Formulation Classification System (Pr. C. Pouton).
This presentation will bring outlines of the program, the key factors of success, the differentiating advantages of the softgel dosage form and will be illustrated by some case study of recent developments.
RTW E
Working with Insoluble Compounds: Technology Applications for NCEs and Marketed Products including Formulation of Immediate and Extended-Release Dosages
12:00-14:00 – Auditorium 10
± View Description and Schedule
Hosted by: Eurand
Presented by: Paolo Gatti, Formulation Team Leader and Steve Ellul, Director Business Development
This workshop will provide an initial overview of the field of bioavailability enhancement through the use of technologies to bring insoluble compounds into solution. The technical focus of the presentations will be amorphous and nanoparticulate systems and will cover manufacturing methods, product characterization, product performance and product stability.
This will be complemented with presentations that cover means to incorporate solubility enhancement technology into extended release dosage forms and other solubilisation methodologies that take advantage of pH dependent solubility.
A series of case studies will be presented which will demonstrate the various advantages of solubility enhancement for the enablement of NCEs and the improvement of existing products.
RTW F
Development and Immunological Aspects of Controlled-release Protein Formulations
12:00-14:00 – Auditorium 11
± View Description and Schedule
Hosted by: OctoPlus
Presented by: Huub Schellekens, Utrecht University and Ruud Verrijk, OctoPlus N.V.
Attendees of the workshop will gain in-depth knowledge of the pharmaceutical development of injectable controlled-release protein formulations with special emphasis on analytical characterization and immunological aspects. Additionally attendees will gain understanding of various analytical tools to characterize proteins and understand the potential immunological properties of proteins and protein formulations and models to investigate this.
RTW G
Spray Drying in Laboratory Scale
12:30-13:30 – Room 18/19
± View Description and Schedule
Hosted by: BÜCHI Labortechnik AG
Presented by: Cordin Arpagaus, Product Manager Spray Drying
This workshop will focus on the current state of laboratory-scale spray drying in pharmaceutical research and development. BÜCHI Labortechnik AG, the world leader in laboratory-scale spray dryers, presents the new Micro Spray Dryer B-90 and complementary lab-scale solutions to build a system tailored to customer requirements. Learn how to perform feasibility studies, parameter optimization, and production of small powder batches, as well as how to perform a scale-up from laboratory to industrial scale. Working closely with our customers enables BÜCHI to provide excellent solutions to applicative questions, like microsphere preparation for controlled drug delivery systems. Experience sub-micron spray drying of milligram amounts at high yields!
Soapbox Sessions
Sunday, July 19
10:30-13:45, Room A2
Generously co-sponsored by Molecular Profiles Ltd.
± View Description and Schedule
Chairs: Philippe Dor, MacuSight, Inc., U.S.A., and Eyal Ron, Madash LLC, U.S.A.
Identify new ideas and potential collaborations in these fast-paced presentations, where technology-driven, emerging, and established businesses present their technologies, products, and services.
| 10:30 | Introduction & Welcome Philippe J.M. Dor, MacuSight, Inc., U.S.A.; Claire Madden-Smith, Molecular Profiles Ltd., U.K.; and Eyal S. Ron, MADASH, LLC, U.S.A. |
| SESSION 1 |
| 10:35 | KiOmedine-CsU—The first GMP Ultra-pure Chitosan of Non-animal Origin for Advanced Drug Delivery Sandrine Gautier, Kitozyme |
| 10:40 | GMP—Manufacturing of Liposomes with Polymun’s Technology Andreas Wagner, Polymun Scientific GmbH |
| 10:45 | MeltDose® Technology for Improving Solubility of Poorly Soluble Compounds Eric Maulhardt, LifeCycle Pharma A/S |
| 10:50 | Micro- and Nano-encapsulation Using Biodegradable Glass Matrices Christophe Barbe, Ceramipshere |
| 10:55 | Polymers for Resorbable Controlled Release Systems—An Industrial Perspective Michiel Alst, Purac |
| 11:00 | RapidFACT™--Novel Applications of Rapid GMP Manufacturing and Formulation Design Space to Expedite Early Clinical Development Peter Scholes, Pharmaceutical Profiles |
| 11:05 | ROI on PAT—A Reality? Peter Bauer, Solvias AG |
| 11:10 | The Dynamic Gastric Model—A Powerful In Vitro Tool for Predicting Dosage Form Bio-performance Hiep Huatan, H2 Pharma |
| 11:15 | Novel Subcutaneous Drug Delivery System John Garibotto, Sub@ Solutions Inc. |
| 11:20 | Reducing the Development Time and Cost for First Time in Man (FTIM) Studies Camille Laget, Patheon Inc. |
| 11:25 | Oral and Parenteral Multi-day Delivery of Drugs Agis Kydonieus, Samos Pharma |
| 11:30-11:45 | NETWORKING BREAK |
| SESSION 2 |
| 11:45 | Nano Spray Dryer—World Novelty for Finest Particles of Minimal Power Quantities at Highest Yields! Cordin Arpagaus, Buchi Labortechnik AG |
| 11:50 | Pharmaceutical Applications of Holt-melt Extrusion Michael Crowley, PharmaForm LLC |
| 11:55 | MELTREX—A Versatile Drug Delivery Technology Thomas Merdan, Abbott GmbH & Co KG |
| 12:00 | High Definition Micro Extrusion (HDME) Technology Platform for Targeted Drug Delivery Applications George Cramer, Adhesives Research |
| 12:05 | Delivery of Parenteral Drugs Using Blow/Fill/Seal Technology Michael Valazza, Catalent |
| 12:10 | Novel Technologies for Injectable and Nasal Drug Delivery Andy Lewis, Critical Pharmaceuticals |
| 12:15 | Contract R&D Services at SwRI James Oxley, Southwest Research Institute |
| 12:20 | Temperature Measurement during Freeze Drying: A Novel Tool for Process Monitoring Using an Optical Fiber System Frank Schaubhut, Coriolis-Pharma |
| 12:25 | Egalet® ADPREM Technology Deters Misuse of Opioi Pernille Hoyrup Hemmingsen, Egalet |
| 12:30 | Breaking up in the GI Tract Howard Stevens, Bio-Images Research Ltd. |
| 12:35 | A Potential new Method for Mass Manufacture of Solid-dispersion Formulations for Poorly Soluble Drugs Clive Roberts, University of Nottingham |
| 12:40-12:55 | NETWORKING BREAK |
| SESSION 3 |
| 12:55 | IVIVC by Design Viera Lukacova, Simulations Plus |
| 13:00 | TNO: Partner for R&D and Innovations in Food and Pharma Nicole Papen-Botterhuis, TNO |
| 13:05 | Artequick—A Promising new Antimalarial Longhua Pan, ARTEPHARMCO, LTD. |
| 13:10 | Pii Drug Delivery Solutions, a New Business Model for Today’s Formulation Challenges Robin Mitchell, Pharm-Int |
| 13:15 | PROLOC™ Bioadhseive: A Promising Carrier for Intransal Vaccination Paul Foreman, Henkel |
| 13:20 | Merck Eprova Drug Delivery Compound—Development and Commercial Supply Solutions Ron Demers, Merck Eprova |
| 13:25 | Novel Device for Oral Pulsatile Delivery of Drugs (CHRONOCAP) Matteo Cerea, Unimi |
| 13:30 | RightSize™ Particle Manufacture—Technology to Enhance Oral Bioavailability Mikael Bisrat, Xspray Microparticles |
| 13:35 | Encapsulation of Silver Nitrate for Wound Dressings David Mackey, Novel Polymers |
| 13:40-13:55 | NETWORKING BREAK |
Nanomedicines Roundtable
Sunday, July 19
12:30-14:00 - Room A3
± View Description and Schedule
Chairs: Hamid Ghandehari, University of Utah, U.S.A., and Dusica Maysinger, McGill University, Canada,
At this first ever CRS Nanomedicines Roundtable, three experts will share their provocative thoughts and ask questions that will encourage your participation.
Wish List of a Clinician from Nanotechnologies, Wallace Akerley, University of Utah, U.S.A.
Engineering Liposomes for Targeted Delivery: From Material Design to Clinical Applications, Theresa Allen, University of Alberta, Canada
Probing Synaptic Remodeling with Quantum Dots and Image Correlation Spectroscopy, Paul De Koninck, University of Laval Robert-Giffard, Canada
Young Scientist Roundtable
Sunday, July 19
12:30-14:00 - Auditorium 15
Generously co-sponsored by Novo Nordisk
± View Description and Schedule
Chairs: Dody Reimer, Northern Lipids, Inc., Canada; and Louise Rosenmayr-Templeton, Tower Pharma Consulting, Austria
The CRS Young Scientist Education Initiative Subcommittee has an exciting new offering for all young scientists* attending the CRS Annual Meeting & Exposition in Copenhagen—the first-ever Young Scientist Roundtable. This is an opportunity for you to meet and interview distinguished CRS members from academia, large pharma, and specialty pharma. Ask the questions you (and likely some of your colleagues too) have always wondered about. Hear about the amazing scope of professional opportunities in a relaxed setting. Attend and participate in the roundtable discussions and gain some insight into the exciting potential opportunities available to you as you move forward in your career path. Like our student representative from the Education Initiative Subcommittee rightly states, “This is an opportunity which should not be missed!”
*Like all Young Scientist events this is open to students, those under the age of 40, and those new to CR areas of expertise within the past 5 years.
State of the Industry
Sunday, July 19
14:00-14:45 - Room A1
Generously co-sponsored by Elan Drug Technologies
± View Description and Schedule
Chairs: Vinay Chhatre, Northern Lipids, Inc., Canada; William Jones, III, Banner, U.S.A.; and Claire Madden-Smith, Molecular Profiles, U.K.
Back by popular demand – the CRS State of the Industry Session! This session will feature Keynote Speaker Nick Bennett, Research & Analysis Director for Datamonitor, presenting a review of current industry drivers and the future for drug delivery.
Partnering Sessions
Sunday, July 19
14:45-16:00 - Room A1
± View Description and Schedule
Chairs: Ted Broman, Vivus, Inc., U.S.A.; Vinay Chhatre, Northern Lipids, Inc., Canada; and Claire Madden-Smith, Molecular Profiles, U.K.
CRS is hosting the first-ever partnering sessions in Copenhagen and getting off to a great start by bringing you Genentech, Lilly, and Roche representatives to discuss the focus for their companies, the importance of controlled release technologies for their companies, what their companies are doing to invest in such technologies, to share their lists of specific services or skills sought by their companies, to share how members of CRS can contribute and who to contact, and to explain how their companies’ research and products are helping patients in particular and society in general.
Opening Exposition and Reception
Sunday, July 19
17:00-18:30 - Exhibit/Poster Hall
Generously co-sponsored by F. Hoffmann La Roche Ltd.
Join your colleagues for the official first party at the 36th Annual Meeting & Exposition of CRS…the Opening Exposition and Reception! Stroll through the exhibit stands and posters while enjoying hors d’oeuvres and refreshments. The Opening Exposition and Reception are open to all registered attendees of the CRS Annual Meeting & Exposition.
Monday, July 20
Exhibit/Poster Hall |
| 09:00 – 17:30 | Exhibit/Poster Hall will be open |
| 09:00 – 10:00 | Networking coffee break in the Exhibit/Poster Hall; coffee available for purchase |
| 11:30 – 13:00 | Networking lunch break in the Exhibit/Poster Hall; lunch available for purchase |
| 15:00 – 15:30 | Networking coffee break in the Exhibit/Poster Hall; coffee available for purchase |
Industrial Session I – Alliance, Partnership or In-house Management
Monday, July 20
10:00-11:30 - Auditorium 15
This first Industrial Session of the meeting is offering you the opportunity to learn about different management styles from Catalent, Patheon, and PII. Get to this session early! The auditorium will fill quickly.
Industrial Session II – QbD and PAT
Monday, July 20
15:30-17:00 - Auditorium 15
This afternoon’s Industrial Session offers you experts from the FDA and FMC. Join Brian Carlin, Raafat Fahmy, and Jobst Limberg for these informative presentations.
Tuesday, July 21
Exhibit/Poster Hall |
| 09:00 – 17:30 | Exhibit/Poster Hall will be open |
| 09:00 – 10:00 | Networking coffee break in the Exhibit/Poster Hall; coffee available for purchase |
| 11:30 – 13:00 | Networking lunch break in the Exhibit/Poster Hall; lunch available for purchase |
| 15:00 – 15:30 | Networking coffee break in the Exhibit/Poster Hall; coffee available for purchase |
Industrial Session III – Oral Drug Delivery around the Globe
Tuesday, July 21
10:00-11:30 - Auditorium 15
Join the CRS Oral Drug Delivery Group in their quest to learn what’s happening around the world in ODD. The expert speakers and lively audience discussions will peak your interest and maybe entice you to join the CRS ODD Group.
Wednesday, July 22
Exhibit/Poster Hall |
| 09:00 – 13:30 | Exhibit/Poster Hall will be open |
| 09:00 – 10:00 | Networking coffee break in the Exhibit/Poster Hall; coffee available for purchase |
| 11:30 – 12:30 | Networking lunch break in the Exhibit/Poster Hall; lunch available for purchase |
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