Schedule for GEN Theater Presentations at BIO
Wednesday, June 18 and Thursday, June 19 from 10:30 – 5:00 — Booth # 1143
The GEN Theater presentations at this year's BIO International Conference are a great opportunity for anyone on the exhibit hall floor to learn, at no cost, about the latest developments in the life sciences and the business of biotechnology from leading experts. This year's program consists of 27 talks by speakers from four continents. Presentations, which continue throughout the day on Wednesday and Thursday, will cover clinical development, diagnostics, bio-based therapeutics, and numerous industry topics. Plan to spend an several hours at our theatre, and bring a colleague!
Be sure to stop by the GEN booth #1022 after attending the theatre to meet with a member of the GEN staff, preview our new job website and enter to win a free video camera flip phone!
We look forward to seeing you at BIO.
Wednesday, June 18
Thursday, June 19
ABSTRACTS and CONTACT INFORMATION
Wednesday, June 18, 2008 10:30-10:50
Solubilization: One of the greatest challenges for new drug formulation
Abstract:
Several approaches have been used to solubilize a new compound while maintaining maximum activity with minimum toxicity. Too often the solvent presented serious toxicity issues that precluded clinical use. This presentation discusses the use of nanoparticle-doped water to enhance solubility while retaining the drug compound’s activity.
Speaker information:
Eran Gabbai
President and CTO
Do-Coop Technologies Ltd
3b Yoni Netanyahu St., Or-Yehuda, Israel 60376
Wednesday, June 18, 2008 10:50-11:10
HESylation - innovative Drug Delivery for Biologics to improve Performance
Abstract:
HESylation represents the technology of coupling drug substances with hydroxyethyl starch (“HES”) derivatives in order to modify the drug characteristics, such as pharmacokinetics or water solubility. HESylation is based on the extensive expertise of Fresenius Kabi in the field of hydroxyethyl starch (“HES”) as the world’s largest producer. HES is a modified natural polymer that has been widely used in clinical practice for decades as a plasma volume expander. Consequently, it has an impressive safety record
Speaker information:
Dr. Peter Vorstheim
Senior Vice President
Fresenius Kabi
Else-Kroener-Straße 1, 61352 Bad Homburg, Germany
Wednesday, June 18, 2008 11:10-11:30
Competing in the 4th dimension beyond Quality, Time and Price
Abstract:
Traditional drug development focuses on quality, speed and costs. Top drug development partners deliver on all these factors as a matter of course. Best-in-class companies provide a fourth dimension which adds perspective to speed, quality, and cost. Switzerland-based Solvias has found this fourth dimension to be at least as important as the other three for both small and large molecule drug development.
Speaker information:
Michael Becker
Product Manager
Solvias AG
P.O. Box, 4002 Basel , Switzerland
Wednesday, June 18, 2008 11:30-11:50
The era of glycan profiling has come
Abstract:
We present a novel glycan profiling technology "GlycoStation" using lectin microarrays (“LecChips”) and a principle of evanescent-field fluorescence excitation. This method allows us to detect very weak lectin-glycan interactions directly from a liquid phase without any washing process easily and with high-throughput fashion. This technology has great potential for rapid profiling of complex glycan structures, and thereby developing new glyco-biomarkers, or characterizing cell conditions focuing on the change of cell surface glycans.
Speaker information:
Masao Yamada, Ph.D.
Director, Glycomics Research Lab.
Moritex Corp.
1-3-3 Azamino-minami, Aoba-ku
Yokohama, 225-0012, JAPAN
Wednesday, June 18, 2008 1:00-1:20
The use of Bioengineered Listeria monocytogenes in as a live cancer vaccine
Abstract:
Listeria monocytogenes is an environmental pathogen which we regularly ingest, usually without consequence as we mount a strong cellular immune response that clears the microbe insensibly. It infects Antigen Presenting Cells and has multiple simultaneous and integrated mechanisms of action. Bioengineered Listeria delivers antigens to the immune system in a manner capable of inducing an anti-tumor response. Our techniques for bioengineering Listeria increase its efficacy beyond wild Listeria. Preclinical and clinical data will be presented.
Speaker information:
Dr. John Rothman
VP Clinical Development
Advaxis
675 Route 1
North Brunswick, NJ 08902
USA
Wednesday, June 18, 2008 1:20-1:40
“HP-PCR: A New Paradigm in Performance”
Abstract:
Finnzymes’ High Performance PCR solution combines high-fidelity Phusion™ DNA polymerase, a super speedy Piko™ thermal cycler, and ultra-thin walled vessels to improve nearly every measurable aspect of PCR. This solution consistently provides greater yields, faster protocol times, fewer errors, higher specificity and more robust activity as compared with conventional PCR. We report such improved results under a variety of demanding conditions, such as PCR direct-from-blood and PCR direct-from-tissue samples.
Speaker information:
Mike Mortillaro
President
Finnzymes, Inc.
800 West Cummings Park
Ste. 5550
Woburn, MA 01801
Industrial
Wednesday, June 18, 2008 1:40-2:00
The Clinical Application of 3D Expanded Placental-derived Mesenchymal Stromal Cells
Abstract:
Mesenchymal stromal cells (MSCs) have been documented to be value in the treatment of a variety of degenerative, autoimmune and inflammatory conditions. Traditionally, MSCs have been expanded using a variety of two dimensional (2D) techniques. However, a recently developed three dimensional (3D) expansion process for these cells has been found to result in a functional and immunological unique MSC. This talk will expand on these properties and the medical conditions they could potentially address.
Speaker information:
William R. Prather RPh, MD (VP of Corporate Development)
Pluristem Therapeutics, Inc.
PO Box 997, Edwards, CO 81632
Wednesday, June 18, 2008 2:00-2:20
State Colleges as Education and Training Resources
Abstract:
San Diego State University’s MBA for Executives in Life Sciences focuses on training executives in biotech, biomedical, and pharmaceutical companies in the “best business practices” of bringing a health care product from concept to market. Our online education model allows participants to continue their professional careers while completing the program. The 21-month program consists of four residency periods: 2 weeks at San Diego State University at the start and end of the program, plus one week in Indiana and one week in Washington D.C.
Speaker information:
Gail K. Naughton, Ph.D.
Dean, College of Business Administration
San Diego State University
5500 Campanile Drive
San Diego, CA 92182-8230
Wednesday, June 18, 2008 2:20-2:40
Scientific Career Opportunities in Southern California
Abstract:
We represent some of the leading biotechnology, pharmaceutical, and medical device companies in southern Califirnia. Our talk will present an overview of the career opportunities in southern California and how scientific professionals can most effectively apply for them and learn about the market.
Speaker information:
Jeff Prekker
CEO
BioPhase Solutions
5405 MoreHouse Drive
Suite 135
San Diego, CA 92121
Wednesday, June 18, 2008 2:40-3:00
Developing An Intellectual Property Program In An Increasingly Competitive Biotech Market
Abstract:
The Biotech market has become very competitive and funding is difficult to acquire in these lean financial times. A Biotech company must develop an intellectual property program that not only protects a company’s products but springboards the company into a position that attracts investors. This talk will touch on several approaches to structure a Biotech patent program that provides a web of protection for the company’s assets while competitively positioning the company in a market that is lucrative to investors.
Speaker information:
Eric S. Furman Ph.D., J.D.Partner
Knobbe Martens Olson & Bear LLP
550 West C Street, suite 1200,
San Diego, California 92101
Wednesday, June 18, 2008 3:00-3:20
Solutions to Integrating Commissioning & Validation
Abstract:
Over recent years the industry trend has been to attempt to lower the cost and shorten the duration of validation through the integration of preceding commissioning activities. This attempt has not always been successful, or as successful as anticipated. This talk will overview some of the reasons for this, and suggest "lessons learned" solutions for future attempts.
Speaker information:
Joe Fonte
Director, QA/QC
Turner Pharmaceutical
300 Atrium Drive, 4th Floor, Somerset, NJ 08873
Wednesday, June 18, 2008 3:20-3:40
Bringing Your Manufacturing Facility to Life
Abstract:
If you are preparing to enter the world of biotechnology manufacturing, join us for a short program focused on design/build strategies for cGMP facility delivery. We will discuss techniques that minimize time to market, maximize regulatory compliance, and optimize your investment. Learn how the Biological Process Development Facility at the University of Nebraska-Lincoln utilized this innovative approach to create its world class cleanroom facility.
Speaker information:
R. Grant Merrill
Director Of Project Development
AES Clean Technology
422 Stump Road
Montgomeryville, PA 18936
Wednesday, June 18, 2008 3:40-4:00
Learning to Think Like Big Pharma: Strategies for Protecting Your Product from Invention Through Generic Obsolescence.
Abstract:
For many biotech executives, the questions of how, what, when and where to patent are challenging in forming a strategic plan. This presentation will describe company strategies from the first steps of discovery through the end of the patent's life with an eye to how biotech companies might selectively use them to maximize their strategic plan.
Speaker information:
Dr. Dorothy R. Auth
Partner
Cadwalader, Wickersham & Taft LLP
One World Financial Center
New York, NY 10281
Wednesday, June 18, 2008 4:00-4:20
The use of fluorescent proteins for high-resolution, multiparameter in vivo imaging
Abstract:
The development of fluorescent proteins has enabled a revolution in in vivo imaging. The very high brightness and the choice of multiple colors makes this technology extremely powerful to simultaneously image multiple events in a single animal. Fluorescent-protein imaging has been demonstrated to be particularly useful for imaging metastatic cancer and the effects of drugs on this disease in mice. Examples of drug discovery using fluorescent protein-based imaging along with high-powered instrumentation will be discussed.
Speaker Information:
Robert M. Hoffman, Ph.D.
President
AntiCancer
7917 Ostrow Street
San Diego, CA 92111
Wednesday, June 18, 2008 10:30-10:50
Australia: a stepping stone to Western markets
Abstract:
Australia has excellent capabilities, skills and facilities in the field of life sciences and an efficient regulatory regime consistent with those in Europe and USA. Australia provides a unique opportunity to serve as a stepping stone for companies to Western markets and to gain insight in the product profile at a very early stage of development with >50% of early phase clinical trials being conducted for non-Australian sponsors. This presentation will review the current status of the biopharmaceutical service providers in terms of capabilities, experiences and cost/benefits.
Speaker information:
Mario Pennisi
CEO
Queensland Clinical Trials Network Inc. (QCTN)
Level 3, 88 Jephson Street
Brisbane, Australia 4066
Thursday, June 19, 2008 10:50-11:10
Innovative Approaches in Clinical Development
Abstract:
An overview will be given on recent advances in pharmacogenomics, pharmacogenetics, and pharmaco-toxicogenomics towards elucidating the genetic mechanisms of diseases and to predict drug behaviour in human beings. The therapeutic value and the use of these techniques in preclinical and early phase clinical trials, their potential to save time in the drug development process and their therapeutic value will be illustrated
Speaker information:
Prof. Lyn Griffths
Director, Genomics Research Centre
Griffith University
PMB 50, Gold Coast Mail Centre
Gold Coast
Queensland , Australia 9726
Thursday, June 19, 2008 11:10-11:30
Trials without Tribulations
Abstract:
I will discuss clinical trial program planning and how Australasia can provide solutions to the timeline juggles facing SMEs when attempting to source sufficient data to obtain further funding or meet VC milestones. Solutions presented will include stepping outside the traditional paradigms of designing trials. In particular challenging the need to invest in IDE, IND, CE mark (devices) at the very early stages. Illustrated with examples of companies who’ve pursued successful strategies, some that haven’t and others that are working through the process currently.
Speaker information:
Russell Neal
Director of Operations
CNS (Clinical Network Services)
Level 3, 88 Jephson Street , Toowong
Brisbane , Queensland
Australia 4066
Thursday, June 19, 2008 11:30-11:50
Online virtual networks: benefits in identifying global R&D service providers, collaborators and partners
Abstract:
Identifying which new therapeutics need to be developed and be prioritized requires collecting and analyzing information by appropriately qualified entities or persons. Until very recently there was no rapid and cost-effective tool to link seekers of specific biomedical expertise with those that possess the know-how and capabilities. This presentation will firstly detail how biopharmaceutical companies presently source service providers, collaborators and partners to support their R&D strategies, and secondly, provide analysis of the current virtual networking channels.
Speaker information:
Dr Jeffery L. Smith
President and CEO
BioAssayLINK Pty Ltd
Global Headquarters:
50 Shirley St. , Enoggera
Brisbane , Queensland
Australia 4051
Thursday, June 19, 2008 1:00-1:20
Site Management – It’s Not Just About Clinical Monitoring
Abstract:
Teamwork is essential for life science product development. Often the end-users, including investigator sites and patients, are left to their own devices to traverse the challenges technology brings. This session will demonstrate how attention to the human element enables teams to achieve success in life science product development.
Speaker information:
Darlene Gaddy
Director, Clinical Data Alliances
ResearchPoint
1301 S. Mopac Expy, Suite 50
Austin, TX 78746
Thursday, June 19, 2008 1:20-1:40
Third-party Audits for Facilities and Procedures: Ensuring Compliance and Marketability
Abstract:
The divide between compliant and non-compliant Contract Research Organizations increases each year, separating profitable and marketable companies from those that struggle to survive. The level of regulatory compliance that your CRO, or the CRO you employ exhibits is crucial to the ease of approval for your new products. This presentation will discuss the steps that a Sponsor or CRO can take to ensure compliance and to restore marketability to a company, focusing on third-party audits of facilities and procedures.
Speaker information:
Charles Lankford
PharmaSys
216 Towne Village Drive
Thursday, June 19, 2008 1:40-2:00
Challenges in Accelerating Novel Biological Vaccine Development from Bench to Clinic
Abstract:
The wide variety of product and process technologies being employed in the commercialization of novel biological vaccines precludes the widespread use of platform development approaches and dilutes the availability of appropriate experience and expertise. This presentation explores the challenges facing entrepreneurial organizations in identifying and managing appropriate development partners that understand the diverse technical and regulatory issues that must be addressed and have the ability to accelerate products into and through clinical development.
Speaker Information:
Roger Lias, Ph.D
Eden Biodesign Ltd.
National Biomanufacturing Centre
Estuary Banks
Estuary Commerce Park
Speke Road,
Liverpool, UK, L24 8RB
Thursday, June 19, 2008 2:00-2:20
Labeling Comprehension Studies: Mitigate Medical Product Risk and Accelerate Regulatory Approval
Abstract:
The adequacy of labeling for user instructions becomes pivotal in the benefit/risk assessment of medical products. Our research in mock product use trials has predicted medication use error rates in the range of 40-70% for drug device combination products. Early testing of proposed labeling can identify problem areas in comprehension that leads to a potential administration error and non-compliance. Cost-effective studies support labeling changes that can significantly reduce potential product misuse, improve compliance and increase product use.
Speaker information:
Peter J. Westkaemper
Executive Vice President – Clinical & Regulatory Affairs
Patient Based Research (PBR)
5927 Balfour Court, Suite 201, Carlsbad, CA 92008
Thursday, June 19, 2008 2:20-2:40
DNA Profiling For Microorganism Identification
Abstract:
The rapid and accurate identification of microorganisms is vital for tracking contamination, infection, natural epidemics or bioterrorism. This talk presents a novel approach for microorganism species and strain identification. This high resolution DNA profiling method provides sequencing like information from the conserved regions of the rRNA gene to reveal microorganism identity. This simplified technique can be much more cost-effective than full sequencing, while providing sufficient sensitivity to detect single base pair mutations.
Speaker information:
Steve Lasky, Ph.D.
CEO
Advanced Analytical Technologies
2901 S. Loop Drive
Suite 3300
Ames, IA 50010
Thursday, June 19, 2008 2:40-3:00
IgY antibodies in Mass Spectrometry Diagnostics
Abstract:
The current challenge in Mass Spectrometry Diagnostics is low-abundance of biomarkers in the plasma and the resulting masking of the biomarkers by high-abundant proteins (HAP). IgY antibodies have unique and features that allow highly-specific removal of HAPs. We have developed a novel technology for high-throughput removal of HAPs from plasma samples. Here we will present the technology of the high-throughput abundant proteins removal from the human plasma, which is subsequently used in mass spectrometry diagnostics.
Speaker information:
Sergey Sikora, PhD
Vice President of Business Development
GenWay Biotech
6777 Nancy Ridge Drive
San Diego, CA 92121, USA
Thursday, June 19, 2008 3:00-3:20
Tracking Lot-to-Lot Traceability for your Cellular Therapy Products
Abstract:
The 30-minute presentation will highlight the features of the StemLab™ system that give you the ability to track lot-to-lot traceability on your products. StemLab™ is built to ensure quality and regulatory compliance standards are met by establishing procedural protocols and monitoring manufacturing processes.
Speaker information:
Nicole Waidman
Sales and Marketing Manager
StemSoft Software Inc
401, 570 W 7th Ave
Vancouver, BC V5Z 1b3
Thursday, June 19, 2008 3:20-3:40
Overcoming Language Barriers in Global Trials
Abstract:
Clinical trials for the new drugs and treatments produced by the biotechnology sector are increasingly going global. With the need for clear communication between manufacturers, site administrators, and practitioners, and patients being of the utmost importance, how best can biotechnology firms overcome language and cultural barriers. This topic will explain best practices for consolidating language production to increase quality, reduce costs, and mitigate risk.
Speaker Information:
Jennifer Peters
Regional Director, Business Development
Life Sciences Practice Group
TransPerfect Translations
123 South Broad Street
Suite 1840
Philadelphia, PA 19109
Thursday, June 19, 2008 3:40-4:00
Southwest Research Institute Services and Capabilities
Abstract:
Southwest Research Institute is an independent non-profit research institute devoted to benefiting government, industry and science through innovative science and technology.
We provide services for custom synthesis, medicinal chemistry, formulation and drug development in addition to API/intermediate/degradant/standard synthesis. SwRI offers small-scale CTM for microencapsulation-based controlled release and drug delivery technologies for oral, injectables, implantable, nasal and transdermal platforms. SwRI also offers GLP analytical and bioanalytical support in addition to dedicated cGMP facilities for clinical API/intermediate/drug product preparation.
Speaker Information:
Sandra Drabik, Ph.D.
Southwest Research Institute
6220 Culebra Road
San Antonio, TX 78238
Thursday, June 19, 2008 4:00-4:20
'Intelligent Screening' Approach To Accelerate Drug Discovery Programs
Abstract:
BioFocus DPI's 'Intelligent Screening' approach uses high-throughput and information-rich screening to generate results faster. This approach develops customized, biologically-relevant assays for our partners’ discovery programs. In shaping Intelligent Screening, BioFocus DPI calls upon: PrimePath™, a compound screening service that uses disease-relevant complex assays in human primary cells; high-throughput and information-rich ion channel screening capabilities; and a natural product screening platform which is ideal for addressing difficult targets, such as protein-protein interactions.
Speaker Information:
David Phillips
Sr. VP of Sales and Marketing
BioFocus DPI
Chesterford Research Park
Saffron Walden
Essex
CB10 1XL
United Kingdom