Events

Description:

Golden Gate Polymer Forum
2004 Spring Symposium
Tuesday, March 16, 2004
Michael's At Shoreline

Polymer's In Medicine

The Golden Gate Polymer Forum (ggpf.org) is proud to announce our 2004 Spring Symposia, Entitled “Polymers In Medicine”. Our 2004 Spring Symposium features 8 outstanding speakers, including three from academia and five from industry. A diverse range of topics will be covered, from nanoscale work on the cell/polymer interface and vesicle stabilization, to polymer membranes and medical device technology, to novel custom medical polymers. Our talks tend to be technology and research oriented, and interactive audience participation is encouraged. Each talk will allow for a substantial question and answer period, and attendees will also have the opportunity to meet with the speakers during four schedule breaks.

In addition to the great lectures and fine food, attendees will also have the opportunity to meet many people from a diverse range of industries. GGPF is also offering attendees the opportunity to use the GGPF website to post relevant job openings from their respective company, as well as enabling job seekers to post their C.V.

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Schedule of Speakers
8:00 – 8:45
Registration, Continental Breakfast

8:45 – 9:45
“Surface-Modified Biomaterial Control of Inflammatory Cell Interactions: In Vivo and In Vitro Studies”
Prof. James Anderson, Case Western Reserve University

9:45 - 10:30
“Stabilization and Destabilization Issues in Lipid Monolayers and Bilayers with Medical Applications”
Prof. Marjorie Longo, UC Davis

10:30 – 11:00
Break

11:00 – 11:45
“Injectable drug delivery based on polymer solutions”
Prof. Anthony McHugh, Lehigh University

11:45 – 12:30
“Mass transport of drug in polymeric coatings on implantable medical devices”
Syed Hossainy, Guidant

12:30 – 2:00
Lunch

2:00 – 2:45
“Poly(Ortho Esters) – From Concept to Reality”
Jorge Heller, AP Pharma

2:45 –3:30
“Use of biodegradable polymers in the medical device and drug delivery industries"
David Gale, Vascular Solutions

3:30 – 3:45
Break

3:45 – 4:30
“Independent Control of Surface and Bulk Properties in Biomedical Polyurethanes: Synthesis Technology and Surface Characterization by SFG”
Robert Ward, Polymer Technology Group

4:30-5:15
“Modeling polymers in medicine”
Simon McGrother, Accelrys

5:15 – 6:30
Wine and cheese party/meet the speakers
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Registration
The one day symposium fee is $150 ($75 for students, unemployed). Please pay by credit card. Credit card payment is preferred. However, registrants can also register by mailing a check to:

Russell Beste, PO Box 391143, Mountain View, CA, 94039. Please make the check out to “Golden Gate Polymer Forum”

Registration is not confirmed until payment is received. The symposium is limited to the first 100 registrants on a first pay basis, and this event usually fills up quickly, so be sure to register early!

Meals
Lunch is a Pacific Rim buffet, with vegetarian options.

Parking and Directions
Parking: Ample parking is available free of charge at Michael’s At Shoreline Restaurant at 2960 North Shoreline Blvd, in the Shoreline Park in Mountain View, CA. From San Francisco, take Hwy 101 South. Turn right on Shoreline to cross over the freeway, and proceed about 2 miles. From San Jose, take Hwy 101 North, turn left on Shoreline, and proceed about 2 miles.

SPEAKER ABSTRACTS AND BIO’S
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“Surface-Modified Biomaterial Control of Inflammatory Cell Interactions: In Vivo and In Vitro Studies”
Prof. James Anderson, Case Western Reserve University

JAMES M. ANDERSON, M.D., Ph.D.

ABSTRACT
Implantation of biomedical polymers and drug delivery systems results in the normal sequence of inflammatory and wound healing events, resulting in the foreign body reaction at the tissue/material interface. Even with biocompatible and biodegradable materials, the normal foreign body reaction consists of macrophages and foreign body giant cells at the tissue/material interface. Macrophages and foreign body giant cells are capable of not only facilitating degradation of biomedical polymers and drug delivery systems, but also are capable of modulating bioactive agent release patterns and adversely influencing bioavailability of agents from drug delivery systems. Our studies have focused on developing a mechanistic understanding of the influence of biomaterial surface chemistry on the formation and activity of macrophages and foreign body giant cells in the foreign body reaction. Studies utilizing materials with a broad range of surface chemistries have been used to investigate the capability of surfaces to induce macrophage and foreign body giant cell apoptosis, i.e., programmed cell death. Correlative in vitro and in vivo studies will be presented that identify certain surface chemistries that facilitate programmed cell death and a reduction in the foreign body reaction.

ABOUT
James M. Anderson, M.D., Ph.D., is Professor of Pathology, Macromolecular Science, and Biomedical Engineering at Case Western Reserve University, Cleveland, Ohio. His research interests range from implant retrieval and evaluation, to tissue reactions of controlled release devices, and inflammatory cell interactions with biomaterials. He is currently the Editor-in-Chief of the Journal of Biomedical Materials Research and is Chair of the ISO 10993-1 Committee, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing". In October 2003, Dr. Anderson was elected as a member of the Institute of Medicine of the National Academies.

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“Stabilization and Destabilization Issues in Lipid Monolayers and Bilayers with Medical Applications”
Prof. Marjorie Longo, UC Davis

ABSTRACT
Stabilization and Destabilization Issues in Lipid Monolayers and Bilayers with Medical Applications

Marjorie Longo
Department of Chemical Engineering and Materials Science
University of California, Davis

Micron-scale bubbles (microbubbles) coated with a phospholipid/PEG-emulsifier monolayer have a variety of industrial and medical applications. The lipid monolayer shell stabilizes the microbubble against rapid dissolution and coalescence, and can be engineered to serve a variety of functions. Our results demonstrate the relationship between composition, processing history, microstructure and transport properties of the lipid shell by using electrochemical, phase-contrast and fluorescence microscopy on microbubbles and model Langmuir monolayers.

Amphiphilic molecules or sections of molecules will partition into the lipid bilayer. Partitioning (or incorrect partitioning) is related to healthy states as well as unhealthy states such as solvent exposure, viral infection and Alzheimer’s disease. We have used both experiment (micropipette aspiration) and computer simulations to study partitioning of small molecules into the lipid bilayer and draw conclusions relating partitioning to membrane destabilization. Our recent studies on the partitioning of short-chain alcohols and amphiphilic peptides will be presented.

ABOUT
Marjorie L. Longo
Associate Professor

Department of Chemical Engineering and Materials Science
and Biophysics and Biomedical Engineering Graduate Groups
University of California, Davis
(530) 754-6348
mllongo@ucdavis.edu
http://www.chms.ucdavis.edu/research/web/longo/

Education
B.A. in Biochemistry-Molecular Biology
University of California, Santa Barbara, September 1983 - June 1988

Ph.D. in Chemical Engineering, University of California, Santa Barbara
September 1988 - June 1993
Dissertation: Microstructure of Synthetic Lung Surfactants
Advisor: Professor Joseph Zasadzinski

Postdoctoral Associate Position, Cornell University, School of Chemical Engineering, June 1993 to August 1996 Research in: Membrane Mechanics of Viral Infection and Biomembrane Materials Advisor: Professor Daniel Hammer

Honors:
Graduated with Honors and Distinction in Biochemistry-Molecular Biology, 1988
University of California President's Undergraduate Research Fellowship, 1987
Patricia Robert Harris Fellowship, 1988-1991
University of California President's Dissertation Year Fellowship, 1992-1993
National Institutes of Health NRSA Postdoctoral Fellowship, 1994-1996
NSF Career Award, 1998-2002
Joe and Essie Smith Professor of Chemical Engineering, U C Davis, 2000-2005
U C Davis Chancellor’s Fellow, 2003-2008

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“Injectable drug delivery based on polymer solutions”
Prof. Anthony McHugh, Lehigh University

ABSTRACT
Injectable drug delivery based on polymer solutions

Anthony J. McHugh, Department of Chemical Engineering, Lehigh University, 111 Research Drive, Iacocca Hall, Bethlehem, PA 18015

Injectable polymer solutions based on biodegradable polymers dissolved in suitable biocompatible solvents are a relatively new addition to the controlled release drug delivery scene, particularly for protein-based systems. With these systems, the drug-encapsulating membrane forms in-vivo, on contact of the injected polymer solution with the mostly saline water body fluid. Hence, the dynamics of phase inversion play an important role in controlling the resultant drug release profiles. This paper will describe work in our laboratory aimed at quantifying the effects of polymer and solution type and composition on the in-vitro drug release characteristics. The effects of crystallizable versus amorphous polymers, as well as the role of additives on the phase inversion and drug release profiles, will be described. We have also been modeling the drug release kinetics using diffusion-controlled mass transfer models and will present results showing comparisons of the models with experiment.

ABOUT
Anthony J. McHugh

Education:
B.S., Cleveland State University, 1966 (Chemical Engineering)
M.S., University of Delaware, 1970 (Chemical Engineering)
Ph.D. University of Delaware, 1972 (Chemical Engineering)

Honors and Awards:
Rossin Professorship, Lehigh University, 2003-present
Senior U.S. Scientist Award, (Humboldt Award), Alexander von Humboldt Foundation, 1988
Alumni Professorship, Department of Chemical Engineering, University of Illinois, 1989 - 1994
Janet and William H. Lycan Professorship, School of Chemical Sciences, 1995-2000
J.W. Westwater Professor, Department of Chemical Engineering, 2000-2002
School of Chemical Sciences Teaching Award, University of Illinois, 1990, 1995, 2002
Engineering Council Award for Excellence in Advising, University of Illinois, 2002

Professional Experience:
Professor of Chemical Engineering and Chair of Chemical Engineering Department,
Lehigh University, 2003-present
Professor of Chemical Engineering, University of Illinois, 1979-2002
Professor of Chemical Engineering, Lehigh University, 1971-1979

Research Interests:
Membrane formation, drug delivery, polymer rheology, polymer processing and modeling

Graduate Theses Directed:
M.S. – 44; Ph.D. - 33

Research Publications ~ 150
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“Mass transport of drug in polymeric coatings on implantable medical devices”
Syed Hossainy, Guidant

ABSTRACT
Release rate of drugs in DES application is a predominantly important parameters. The release rate determines the safety and efficacy of a DES system. The release rate is dependent on a host of variables. Some of these are inherent materials properties while others are process variables. Process variables include Initial solid phase concentration distribution IC (z), drug:polymer (D/P) ratio, thickness of blank polymer top-coating, total drug content, selection of solvents, thermal history of processing. Materials property include Polymer Glass transition temperature (Tg), melting temperature (Tm), heat of fusion DHf, percent crystallinity, water absorption, lipid-induced swelling , Degree and type of microphase interaction of drug and the polymer, olymorphism (amorphous/crystalline) of drug, etc.

ABOUT
SYED FAIYAZ AHMED HOSSAINY

TECHNICAL SKILLS:

Different coating methods for biomedical devices.

Controlled Release technology
•Process and material selection for coating application.
•Drug delivery coating formulation.
•Process and material selection for tailoring sustained release.
•Dosing algorithm for local release of targeted lesion.

Mathematical modeling of dosing profile from a coating.
Mathematical modeling of local mass transport into tissue for efficacy and safety of a coated device. Modeling of mass transport and local pharmacokinetics and verification with experimental data.

Application of principles of surface/interfacial phenomena to biomedical devices.

Surface modification by various coupling techniques. Application of Pulsed plasma, Flow discharge reactive chemistry (FDRC) for attachment of functional groups on biomaterials. Surface IPN, incorporation of non-fouling components.
Characterization of surfaces- XPS, ToF-SIMS, Submerged AFM,
Polymer synthesis and characterization by GPC, NMR, FTIR

EDUCATION:
Ph.D., December 1994, University of Texas at Austin
MS, August 1992, University of Texas at Austin
BS, October 1988, Bangladesh University of Engineering and Technology

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“Poly(Ortho Esters) – From Concept to Reality”
Jorge Heller, AP Pharma

ABSTRACT
Poly(Ortho Esters) – From Concept to Reality

Poly(ortho esters) have been under development since the early 1970’s and are the only bioerodible drug delivery system that was designed de nuovo. The polymer has evolved over the years through four distinct families. The latest family, known as POE IV, trademarked as Biochronomer ™ has now reached a commercialization stage and a Phase II clinical trial on post-operative pain control has been initiated in late October, 2003. In this presentation, we will trace the evolution of the polymer, present a rationale why an ortho ester linkage was selected and present details of POE IV synthesis, erosion mechanism, applications and a summary of the toxicological studies.

ABOUT
Dr. Jorge Heller

Dr. Jorge Heller received a B.S. degree in chemistry from the University of California in Berkeley and a Ph.D. degree in organic chemistry from the University of Washington, in Seattle. Dr. Heller spent most of his professional life at the Stanford Research Institute, now SRI International, where he was Director of the Controlled Release and Biomedical Polymers Department. In 1994, Dr. Heller joined Advanced Polymer Systems, now AP Pharma, as Principal Scie
tist. He holds adjunct appointments at a number of Universities, is the founder and former Editor-in-Chief of the Journal of Controlled Release and Past President of the Controlled Release Society. He is the author of about 200 publications and about 50 patents. He has recently semi-retired to become an independent consultant.

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“Use of biodegradable polymers in the medical device and drug delivery industries"
David Gale, Bioabsorbable Vascular Solutions (BVS)

ABSTRACT
Abstract for David Gale’s talk

Title: Use of biodegradable polymers in the medical device and drug delivery industries

Biodegradable polymers have been widely used in the medical device and drug delivery industries since the introduction of biodegradable sutures in the 1960’s. The most widely employed polymers are based on alpha-hydroxy acids such as lactic acid, glycolic acid and e-caprolactone. Other commonly used materials include polyorthoesters, polyanhydrides, poly(dioxanone), and poly(trimethylene carbonate). This talk will review the structure, properties and applications of biodegradable polymers. Promising future applications will also be reviewed.

ABOUT
Dr. David Gale

Dr. Gale is a Principle Scientist at Bioabsorbable Vascular Solutions (BVS), a subsidiary of Guidant Corporation. Dr. Gale’s research interests cover the use of bioabsorbable polymers in the medical device and drug delivery industries. Prior to joining BVS, Dr. Gale was Production Manager at Birmingham Polymers, Inc., a manufacturer of bioabsorbable polymers for the pharmaceutical and medical device industries.

Dr. Gale earned his Ph.D in Material Science at the University of Alabama, Birmingham, and his Masters in Chemical Engineering at Auburn University, Auburn, AL. Dr. Gale has also completed his Masters in Instrumentation and Analysis and B.Sc. in Chemistry from the University of Manchester, Manchester, England.
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“Independent Control of Surface and Bulk Properties in Biomedical Polyurethanes: Synthesis Technology and Surface Characterization by SFG”
Robert Ward, Polymer Technology Group

ABSTRACT
Independent Control of Surface and Bulk Properties in Biomedical Polyurethanes: Synthesis Technology and Surface Characterization by SFG

Robert Ward
The Polymer Technology Group Inc.
Berkeley, CA 94710
rward@polymertech.com

A useful method in R&D/manufacturing of biomedical polyurethanes uses multipolymers made from two or more reactive oligomers and a ‘hard segment’. Bulk properties are tailored via soft segment concentrations, and surface properties are controlled by incorporating Surface Modifying End Groups (SME), e.g., during continuous bulk synthesis. Exceptional biostability has been established in specific compositions by in vitro and in vivo testing, and high-strength polymers with these mixed ‘soft segments’ are being used successfully in medical devices and prostheses. Newer SME variations include amphipathic versions that control surface end group conformation, and/or SMEs with specific binding sites for biologically active materials including heparin.

Sum Frequency Generation Spectroscopy (SFG) is a relatively new, laser-based surface analytical method using nonlinear optics. SFG is extremely surface sensitive, correlating perfectly with contact angle information, but also giving a characteristic vibrational spectrum of the outer monolayer, and information re. surface group orientation via optional beam polarization. SFG characterizes just the outer monolayer of device surfaces for improved correlation to in vivo performance.

The ability to tailor and accurately characterize bulk and surface properties simplifies optimization of biomaterials for demanding applications.

ABOUT
Robert Ward

Bob Ward is a chemical engineer and president of The Polymer Technology Group (PTG) in Berkeley, California, a company he founded in 1989. PTG’s business includes custom synthesis, and the R&D/manufacturing of polymeric biomaterials and medical devices. PTG uses a vertically-integrated approach ranging from molecular design of biomaterials to the cleanroom manufacturing of devices.

Bob has applied a similar approach over his 33-year career in biomaterials, including 10 years at Thoratec Corporation, and 7 years at Avco Medical Products, where he produced Avcothane-51, one of first polymers ever developed to be a biomaterial.

He has developed a wide range of medical products and novel polymer compositions currently in clinical use. These include chronically-implanted biomaterials and components for cardiovascular, urological, ophthalmic and orthopedic applications.

Bob won the 2003 Technology Innovation and Development Award from the Society for Biomaterials.

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“Modeling polymers in medicine”
Simon McGrother, Accelrys

ABSTRACT
Modeling polymers in medicine

Simon McGrother, Senior Product Manager, Accelrys.

There is enormous potential for the use of polymers in medical applications. Uses stretch from packaging, to targeted delivery devices, from the delivery of poorly soluble drugs to controlled release systems. Material properties that are relevant to such applications include: mechanical properties, chemical stability, diffusion rates of penetrant molecules, solubility of drugs in polymers, membrane transport, miscibility of two polymers, partition of material between hydrophobic and hydrophilic regions, self-assembly of block copolymers, to name but a few.

Computer modeling is a perfect complement to laboratory endeavors, answering questions with no experimental analogue, interpreting known data and validating hypotheses. The statistical nature of polymers makes simulation an ideal method of studying the thermodynamic, physical, mechanical and kinetic properties of these complex fluids. With advances in hardware putting rapid processors within modest budgets, the developments of force-fields which quantitatively reproduce known polymer behavior and the linking of modeling scales to capture the multi-level complexity of real materials, we stand at a pivotal moment in the deployment of modeling tools in industrial and academic research.

This presentation will discuss the state of the art in simulation of polymers, consider how these methods map on to common challenges in medical and pharmaceutical applications and offer case studies where such technology has been successfully applied in the medical field. Specifically the use of modeling at multiple length scales to rationalize the observed behavior of a complex formulation will be discussed.

ABOUT
Simon McGrother

PhD: Theoretical Chemistry, Prof. George Jackson, Sheffield University, UK, 1996.
Post-Doc (EU funded): Prof. Demetri Photinos, Department of Physics, Patras University, Greece, 1996.
Post-Doc (NSF funded): Prof. Keith Gubbins, School of Chemical Engineering, Cornell University, USA, 1997.
Post-Doc (NSF funded): Prof. Keith Gubbins, Department of Chemical Engineering, North Carolina State University, USA, 1998.
Post-Doc (funded by L’Air Liquide, France): Prof. Nick Quirke, Chemistry Department, Imperial College, UK, 1999.

Joined MSI in 1999 as product specialist in polymers.
Became Polymer Consortium director in January 2002.
Promoted to Senior Product Manager July 2003.

Research interests: nanotechnology in drug delivery, complex fluids, fluid-phase equilibria.