Institute for Scientific Exchange, Inc. Presents:

3rd International Drug Discovery and Development Summit: Pre-Conference: Emerging Technologies November 30, 2004  Main Summit: Strategies and Novel Preclinical and Clinical Approaches for Successful Drug Development December 1-2, 2004 San Diego, CA , USA Symposium Venue:  Coronado Island Marriott

The following institutions are represented:  Advanced Pharmaceutical Sciences, Inc.; Chiron Corporation; Brock Scientific Consulting, LLC; Capgemini US, LLC; GeneGo; ChemSilico LLC; Kyoto University; Hurel Corp.; BioSeek, Inc.; Molecular Devices Corporation; KineMed Inc.; Cyprotex Discovery Ltd.; J&J Pharmaceutical R&D; Hoshi University; University of Tokyo; Santen Pharmaceutical Co., LTD.; AstraZeneca R&D Sodertalje; Pfizer Global R&D; Sankyo Pharma Development; Millennium Pharmaceuticals Inc.; Eisai Co., Ltd.; CeeTox, Inc.

 

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Tuesday, November 30, 2004

8:00 AM – 9:00 AM - Registration

 

8:00 AM – 5:00 PM – Exhibits

 

9:00 AM – 9:45 AM

Merging Predictive ADME/TOX with Systems Biology (Sean Ekins, GeneGo; St. Joseph, MI) The development of computational methods for the early assessment of metabolism and toxicity may allow the removal of potentially undesirable compounds from early drug discovery. I will describe the development of MetaDrug^TM, a tool for the prediction of human drug metabolism and toxicity using predictive models and a database of annotated metabolic, and regulatory networks onto which gene expression, proteomic and metabolomic data can be overlaid. This approach represents a step towards merging computational models for predicting human metabolism, toxicity and systems biology which will assist in improving the quality of drug discovery candidates.

 

9:45 AM – 10:30 AM

Recent Advances in Development of In Silico Predictors for Important ADME/Tox Properties (Joseph Votano, ChemSilico LLC; Tewksbury MA) Application of in silico ADME/T predictive tools in both the early and enhancement drug discovery stages can be of immense help in development of successful therapeutic drug, or the converse. Robust ADME/T predictors, able to handle new chemical entities, depend on the chemical space of compounds used, types of molecular descriptors employed, and learning or training algorithms used in QSAR model development. These factors are difficult in practice to bring together. Recent results in use of topological descriptors(2D descriptors) coupled to various QSAR modeling algorithms will be discussed as applied to aqueous solubility, HIA (human intestinal absorption), and Ames genotoxicity covering over 11,000 compounds contained within three datasets. What are the most important molecular descriptors among these models and their physio-chemical interpretation for the chemist are discussed. Several comparisons of results found among different training and learning algorithms (who wins) and several comparisons of results with other published models will be examined. Finally, the extent of applicability so far found for use of topological descriptors and modeling techniques is summarized for other ADME/T properties.

 

10:30 AM – 10:45 AM – BREAK

 

10:45 AM – 11:30 AM

In Silico Pharmacokinetics for Accelerating Early Drug Discovery (Fumiyoshi Yamashita, Kyoto University; Sakyo-ku Kyoto, JAPAN) Application of computation algorithms such as genetic algorithm and neural network greatly improves structure/activity relationship modeling for pharmacokinetic properties of a variety of compounds. However, we often meet the problem that pharmacokinetic data from different sources cannot be compiled due to significant difference between each other.  We developed an algorithm to extract a hidden relationship common to plural data sets based on their positive correlations.  Data visualization greatly helps us to make a decision.  We developed a novel method to visualize a focused chemical space in the whole space.  I will also talk about our method to visualize large-scale data in a limited display space.

 

11:30 AM – 12:15 PM

Predictive, Structure Based, In Silico CYP450 Metabolism: Principle, Problems, and Progress (Dan L. Harris, Molecular Research Institute, Mountain View, CA) We are at the dawn of an era where the seminal crystallization of the principal hepatic P450s is at hand. This enables us to develop structure-based methods of P450 metabolite prediction that, unlike multivariate statistical methods, does not require the use of training sets. We can now rapidly predict the principal products of CYP450 metabolism of drugs by a combination of ligand-P450 configurational sampling and electronic determinants of metabolism by the active heme species of P450s. Principles, problems, progress and prospects of this approach will be described by discussion of test problems related to development of a desktop computer predictive toxicology tool for rapid screening of lead compound databases.

12:15 PM – 1:45 PM – LUNCH BREAK

 

1:45 PM – 2:30 PM

Integrated Discrete Multiple Organ Culture (IdMOC):  A Novel In Vitro System for the Estimation of In Vivo Drug Properties (Albert P. Li, APSciences, Inc., Baltimore, MD) In vitro assays involving primary cells are used routinely to evaluate organ-specific toxic effects, for instance, the use of primary hepatocytes to evaluate hepatotoxicity. A major drawback of an in vitro system is the lack of multiple organ interactions as observed in a whole organism. A novel cell culture system, the Integrated Discrete Multiorgan Culture (IDMOC) is described here which allows the culturing of primary cells from multiple organs in a single plate. The idMOC which is specially manufactured to have wells inside a well, thereby allowing each cell type to be placed in an inner well in a medium developed for optimal growth and differentiation. As each cell type may have different growth requirement, the cells are cultured so that the multiple cell types are ready for toxicity test on the same day. On the day of testing, the wells are connected via an overlying medium with the test chemical. After testing, the overlying medium is removed and each cell type is evaluated for toxicity using appropriate endpoints. Results on the cytotoxicity of two anticancer agents:  tamoxifen and cyclophosphamide with an idMOC with primary cells from multiple human organs:  liver (hepatocytes), kidney (kidney cortical cells), lung (small airway epithelial cells), central nervous system (astrocytes), blood vessels (aortic endothelial cells) versus that of the MCF-7 tumor cell lines showed that the IDMOC represent a useful in vitro model for the evaluation of chemical toxicity. 

 

2:30 PM – 3:15 PM

Hurel, An In Vivo Surrogate Assay Platform for Cell-Based Studies (Gregory Baxter, Hurel Corp; Beverley Hills, CA) Accurate prediction of human response to potential pharmaceuticals is difficult, often unreliable, and invariably expensive. Traditional in vitro cell culture assays are of limited value because they do not accurately mimic the complex environment a drug candidate is subjected to within the human body. While in vivo animal studies can account for the complex intercellular and inter-tissue effects not observable from in vitro assays, animal studies are expensive, labor intensive, time consuming, and unpopular. In addition, there is considerable concern whether animal studies can predict human risk precisely enough because, first, there is no known mechanistic basis for extrapolation to low doses, and second, cross-species extrapolation has been found to be frequently problematic with respect to toxicity and pharmacokinetic characteristics. To address these limitations, Hurel Corp. has developed an interactive, cell-based microfluidic biochip. The Hurel system consists of living cells segregated into interconnected “tissue” or “organ” compartments. The organ compartments are connected by a re-circulating culture medium that acts as a “blood surrogate”. The fluidics are designed such that the primary elements of the circulatory system and more importantly, the interactions of the organ systems, are accurately mimicked. Drug candidates are exposed to a more realistic animal or human physiological environment thus providing higher and more accurate informational content than traditional in vitro assays. By affording dynamic assessment of potential toxicity, metabolism, and bioavailability, the device’s capabilities hold the potential to markedly improve the prioritization of drug leads prior to animal studies.

 

3:15 PM – 4:00 PM

High Throughput Human Biology for Improved Drug Discovery (Ellen L. Berg, BioSeek, Inc., Burlingame, CA) Incorporating human disease biology early in drug development can reduce the frequency of compound attrition downstream due to unanticipated biological effects. BioSeek’s proprietary BioMAP^® primary human cell systems allow rapid and in-depth functional profiling of compounds across a broad range of disease-relevant pathways providing necessary biological rationale for compound selection and prioritization.  BioMAP profiling has been applied for 1) understanding drug mechanisms of action, 2) discovery of off-target and secondary target activities, and 3) characterization of gene function networks.

 

4:00 PM – 4:15 PM – BREAK

 

4:15 PM – 5:00 PM

Advances in Hit-to-Lead and Lead Optimization for Ion Channel Targets Using the IonWorks* HT High-Throughput Electrophysiological Screening System (Shawn Handran, Molecular Devices Corporation; Sunnyvale, CA) Many cardiovascular and neurological disorders have the potential for therapeutic treatment by ion channel modulators. However, ion channels have been nearly intractable as clinical therapeutic targets due to the lack of direct ion channel assays and the low-throughput nature of the conventional patch clamp technique. Several indirect methodologies exist for screening and pharmacological studies of ion channel targets, but lack voltage control, which is critical for determining state-dependant drug binding on the ion channel of interest.  IonWorks HT, a high-throughput voltage-clamp screening instrument, permits direct electrophysiological assays in much earlier phases of the drug discovery process, such as hit-to-lead and lead optimization activities.

 

5:00 PM - 5:45 PM

Stable Isotope/Mass Spectrometric Measurements of Molecular Fluxes In Vivo: Emerging Applications in Drug Development (Scott Turner, KineMed Inc; Emeryville, CA) Therapeutics require not only targets and chemical entities, but tools for measuring actions in vivo. Technologies for evaluating activities, filtering leads, and predicting clinical response have lagged behind molecular discovery.  The flow of molecules through complex pathways reflects the connectivity relationships and emergent control features of fully assembled networks, and is a quantifiable therapeutic target. Here, advances in critical pathway flux measurement utilizing stable isotopes/mass spectrometry are described. Several fundamental advantages of kinetic measurements are demonstrated.  Measurement of molecular fluxes represents a powerful addition to drug development technology.

 

5:45 PM - PANEL DISCUSSION: Emerging Technologies

 

END OF PRE-CONFERENCE

 

MAIN SUMMIT:

Strategies and Novel Preclinical and Clinical Approaches for Successful Drug Development

 

Wednesday, December 1, 2004

 

8:00 AM – 9:00 AM - Registration

 

8:00 AM – 5:00 PM – Exhibits

 

8:50 AM - 9:00 AM - Exhibitor Presentation - Simulations Plus, Inc.

9:00 AM – 9:35 AM

Main Summit-Keynote Address

Innovative Strategies for Successful Drug Development (Dale Johnson, Chiron Corporation, Emeryville, CA)  It has been estimated to cost $800 million and 10 to 15 years to bring a drug to the market using the "conventional" approach.  Innovative strategies for drug development, taking advantage of the latest technological advances to decrease the cost and time via the enhancement of rate of success, will be presented.

 

9:35 AM – 10:10 AM

Partnerships In Pharmaceutical Preclinical Development: The Role of the CRO (William J. Brock, Brock Scientific Consulting, LLC, Montgomery Village, MD) Early lead candidate selection is dependent upon balancing the potential toxicity of the candidate compound, the cost associated with that development and ultimate market potential.  Although lead candidate selection relies more on new technology, e.g., genomic data, it is the development of reliable preclinical data that can determine the long-terms success of a new molecular entity.  A professional partnership with contract research organizations (CRO) is a necessary part of a successful, cost effective preclinical program that results in outcomes that are scientifically defensible.  The needs for CRO support are different for the small companies compared with “big pharma” and these differences are often reflected in timing and cost.  We will explore these differences, demonstrating successes of partnerships in cost effective, scientifically valid programs. 

 

10:10 AM – 10:25 AM – BREAK

 

10:25 AM – 11:00 AM

Organizational Trends in Early Stage Drug Development (Larry Kupeli, Capgemini US, LLC; Cupertino, CA) A robust Early Stage Development (ESD) organization continues to emerge as a key competency.  The presenter will discuss a study focusing on: (1) different organizational models used in pharmaceutical and biotechnology companies to support ESD, (2) the factors and triggers that prompt the use of different models, (3) the advantages and disadvantages of alternative models and (4)  critical success factors in implementation.

 

11:00 AM – 11:30 AM - PANEL DISCUSSION: Session 1

 

 

11:30 AM – 12:05 PM

Decision-making from In Vitro ADME Data by Extrapolation to In Vivo PK (Gareth King, Cyprotex Discovery Ltd., Cheshire, UK) Discovery compounds are typically assessed for absorption, distribution, metabolism, excretion (ADME) and physicochemical properties at different stages in the discovery process.  The data is used to make decisions regarding lead optimisation and prioritisation.  This approach does not necessarily result in compounds that have acceptable exposure levels.  Physiologically-based pharmacokinetic (PBPK) prediction can be a valuable tool to integrate and interpret key ADME data for more effective decision-making.  By considering core ADME and physicochemical properties at the same time, PBPK modelling can estimate likely plasma concentration/time profiles in humans or rats for hundreds of compounds at a time.  This approach has resulted in enrichment of lead series for compounds with better pharmacokinetic potential and identification of the compound properties that effect the greatest improvement in pharmacokinetics.  Predicting plasma concentrations from ADME and physicochemical data has been facilitated by high throughput in vitro screening capability which cost-effectively delivers consistent, accurate compound data within days as a result of a highly automated plate-based process.

 

12:05 PM – 1:35 PM – LUNCH BREAK

 

1:35 PM – 2:10 PM

The Potential of Preclinical Biomonitoring and the Use of EEG and Microdialysis in Drug Discovery: Optimization on Interfacing with Drug Development (W.H.I. (Pim) Drinkenburg, J&J Pharmaceutical Research and Development; Beerse, BELGIUM) The biomonitoring concept aims to de-risk CNS compound transition from pre-clinical to clinical phases of DD based on in vivo data, such as rodent sleep-wake architecture analysis or brain microdialysis in freely-moving animals. Biomonitoring models are characterized by stress-free environments, multiple simultaneous physiological and behavioral variables, and prolonged registration periods allowing to directly link to PK/PD models. Biomonitoring data that helped bridging the gap between animal and human research will exemplify this approach’s value, especially for novel drugs in psychiatry.

 

2:10 PM – 2:45 PM

New Models/Techniques in Discovery to Study In Vivo PK  - How These Techniques Can be Extended to Study PK/PD (Claire Mackie, J&J Pharmaceutical Research & Development; Beerse, Belgium) Ideal drug candidates should possess both acceptable PK and PD  properties in line with the desired target product profile. The importance of early in vivo PK screening is well-recognized and combinations of studies can be used to optimize the relevant property. These should be carried out in parallel with the pharmacology/PD studies. Some new in vivo models/surgical techniques which have been set up in our lab to study various in vivo PK and/or PD properties will be presented, using recent project work as examples.

 

2:45 PM – 3:00 PM – BREAK

 

3:00 PM – 3:35 PM

Is the Oral Route Possible for Peptide and Protein Drug Delivery? (Mariko Morishita, Hoshi University; Shinagawa; Tokyo, JAPAN) For the past few decades, a great deal of work has focused on attempts to develop noninvasive methods of delivering peptide/protein drugs with the oral route clearly being the most convenient and desired. The current status of the development strategies of peptide/protein drugs delivery systems in the pharmaceutical industry, various challenges associated with the oral delivery of peptide/protein drugs, and how these challenges may be overcome by specific strategies, including our successful carrier systems based on smart polymer, will be discussed

 

3:35 PM – 4:10 PM

Assessment of Transcellular Transport of New Drug Candidates to Predict their Hepatobiliry and Renal Clearances (Yuichi Sugiyama, University of Tokyo, Tokyo, JAPAN) In the new drug development, the recombinant transporters and enzymes for drugs can be used for the screening of new drug candidates. Vectorial transport across epithelial cells is involved in the uptake and elimination of drugs in the liver and kidney. We have established double-transfected MDCK II cells where OATP2/OATP-C and some ABC transporters are expressed on the basal and apical membrane, respectively, as an in vitro model for hepatobiliary transport.  Kinetic analysis suggested that the uptake is the rate determining process for the transcellular transport of pravastatin and some other drugs. Examples of the use of double transfected cells to assess the drug-drug interaction and the effect of genetic polymorphism of transporters in the hepatobiliary transport of drugs will be shown in my presentation. Similar trials to make the double transfected cells to assess the renal secretion of organic anions will be also presented.

 

4:10 PM – 4:40 PM – PANEL DISCUSSION: Session 2

 

END OF DAY

MAIN SUMMIT

Thursday, December 2, 2004

 

 

8:00 AM – 9:00 AM - Registration

 

8:00 AM – 5:00 PM – Exhibits

8:50 AM - 9:00 AM - Exhibitor Presentation - APSciences, Inc.

 

9:00 AM – 9:35 AM

Use of Mechanistic PK/PD Modeling and Simulation in Evaluating the Potential of New Targets, Bridging Animal Data to Human data, and Help Design Clinical Trials (Malaz A. AbuTarif, Johnson and Johnson Pharmaceutical Research & Development, LLC; Raritan, NJ) An example of mechanistic PK/PD modeling and simulation will be presented. The example will demonstrate how understanding the computational side of the mechanism of action of the drug in relation to the physiology and pathophysiology of the target disease can help build an ideal theoretical PK and PK/PD profile that discovery can then try to achieve. Also, the example will demonstrate how mechanistic PK/PD modeling and computer assisted clinical trial design (CATD) can help extrapolate data from animals to human and from healthy volunteers to patients.

 

9:35 AM – 10:10 PM

PK/PD Analysis and Clinical Trial Simulation for Drug Development (Yuichiro Nakada, Santen Pharmaceutical Co., LTD; Osaka, Japan) A clinical study should be scientifically based and be conducted according to the protocol. The importance of PK/PD information has been reaffirmed in the Japanese guidance “Clinical Pharmacokinetic Studies of Pharmaceuticals”. Clinical trial simulation has also been recognized as a powerful tool for designing a clinical study. This presentation will introduce the current view on developing a clinical pharmacology study with emphasis on the PK/PD analysis and clinical trial simulation in Japan.

 

10:10 AM – 10:25 AM – BREAK

 

10:25 AM – 11:00 AM

Scientific Aspects of Human Microdosing (Nenad Sarapa, Pfizer Global Research & Development; San Diego, CA) Optimizing exploratory drug development by means of doing first-in-human studies earlier is an attractive option for pharmaceutical companies to select more successful drug candidates. Traditional registration-driven clinical Phase I programs could be preceded by studies with sub-pharmacological single doses (‘microdoses’) of one or several lead candidates, whereby human pharmacokinetic/drug disposition data are generated by highly sensitive analytical methods. European Union guidance (EMEA/CPMP, effective from July 2003) defines the abbreviated nonclinical safety package to support human microdosing studies. The US FDA screening IND procedure may also be followed, albeit on basis of the full IND package. In appropriately chosen cases, human microdosing could allow for patients’ quicker access to safer and more efficacious doses of novel drugs, reduce attrition in clinical trials and facilitate more economical drug development.  This presentation will outline the principles of human microdosing with emphasis on the scientific rationale, choice of dose, study design and endpoints, bioanalytical methodologies and regulatory requirements for nonclinical data in support of human microdosing. Data from animal and human microdosing studies will be presented.

 

11:00 AM – 12:00 PM – PANEL DISCUSSION: Session 3

 

12:00 PM – 1:30 PM – LUNCH BREAK

 

 

1:30 PM – 2:10 PM

Role of Toxicologists in Early Stage Drug Development (Sunao Manabe, Sankyo Pharma Development; Edison, NJ) Toxicologists now play an essential role in the earliest stages of drug discovery and often have responsibility for Go/No-Go decision on lead compounds prior to initiation of formal GLP toxicology studies. To increase the success of extrapolating preclinical data to predict human risk, toxicologists must integrate advanced technologies such as omics and safety pharmacology into conventional toxicology assessments.  Identification of the most relevant biomarkers is a key factor in designing a successful screening strategy.

 

2:10 PM – 2:45 PM

Novel Testing Paradigm for Prediction of Development Limiting Barriers and Human Drug Toxicity (Vito G. Sasseville, Millennium Pharmaceuticals, Inc.; Cambridge, MA) The financial investment grows exponentially as a NCE advances through each stage of discovery and development.  The opportunity exists to significantly impact expenditures by the early prediction of potential toxicity/side effect barriers to development. Improved efficiency lies in leveraging “best in class” technology and integration with pharmacologic activities during hit-to-lead and early lead optimization stages. To meet this challenge, a novel discovery testing paradigm will be discussed.

 

2:45 PM – 3:00 PM – BREAK

 

3:00 PM – 3:35 PM

Transcriptomic and Proteomic Analyses of a Series of Sulfonamide Anticancer Agents (Takashi Owa; Laboratory of Seeds Finding Technology; Eisai Co., Ltd.; Tsukuba, Ibaraki, JAPAN) Sulfonamide-focused compound libraries have been synthesized in our laboratory to discover a novel class of cancer chemotherapeutics. Three compounds, selected from these libraries, have progressed to clinical trials as an orally active microtubule-destabilizer, a G1-targeting cell cycle inhibitor and an angiogenesis inhibitor, respectively. In my presentation, our research programs based on DNA microarray gene expression analysis and quantitative proteomic analysis will be discussed, with particular focus on the application of these new technologies to profiling our sulfonamide anticancer agents.

 

3:35 PM – 4:10 PM

An Evaluation of Troglitazone, Trovafloxacin, and Nefazadone Using an Aggressive In Vitro Screening Paradigm Identified Unique Toxicity Profiles (James M. McKim, CeeTox, Inc.; Kalamazoo, MI) Late stage attrition due to unanticipated toxicity or post-market toxic events is costly.  In vitro toxicity screening based on multiple endpoints, dose-response, and in vivo validation provides valuable information early in the drug discovery process.  Troglitazone, Trovafloxacin, and Nefazadone have been removed from the market because of unanticipated and potentially lethal toxicity. The toxicity of these compounds was evaluated in vitro and the unique toxicity profiles obtained will be discussed in this presentation.

 

4:10 PM – 4:40 – PANEL DISCUSSION: Session 4

 

END OF CONFERENCE

 

POSTER PRESENTATIONS:

 

Poster Presentations are always encouraged.  Please submit your poster abstract for approval by the organizing board by October 30^th.  Poster size should be no larger than 4 feet high by 7 feet long.  Abstracts of posters will be included in the participant binder and in the ISE website.  There is no formal poster presentation scheduled.  All posters will remain displayed throughout the conference.  Please be prepared to display your poster during registration on Sunday, November 28^th or before the first session begins on Monday, November 29^th. Poster presenters will have ample time for discussion during breaks and the Welcome reception.

 

Submit posters abstracts for approval to Nola Mahaney, VP, Operations; ISE, Inc.; 5707 Calverton Street, Suite 2C; Baltimore, MD 21228 or fax at (410) 869-9560 or email file attachment to nola@isciencex.com.  Approved poster presenters are responsible for completing a conference attendance registration form, payment of fee (visit www.isciencex.com/register.htm) and for the shipping of the poster itself.  Please contact Nola Mahaney for any questions or concerns.  Please refer to “Travel Information” for hotel address and shipping information.

 

 

Travel Information

Like a magical land rising from the sapphire blue sea, the Coronado Island Marriott transports you into a world of complete tranquility and European elegance. Do you know how to Spa Coronado Our fabulous spa, plus our location on 16 glorious waterfront acres, will immerse you in a setting that feels far removed from everything, yet conveniently close to everything. 20 minutes from San Diego International Airport.

 

Hotel Information

Coronado Island Marriott Resort; 2000 Second Street; Coronado, CA 92118 USA; Phone: (619) 435-3000; Fax: (619) 435-4183

International Toll-Free: 1-800-228-9290.  A limited number of rooms have been reserved at the Coronado Island Marriott Resort, San Diego, CA, USA, or www.marriott.com.  Please ask for “DDDS-2004” block for ISE, Inc.

 

Payment

Payment may be made by check or credit card.  Checks should be made in US $, payable to Institute for Scientific Exchange, Inc.  Mail to: ISE, Inc., 5707 Calverton Street, Suite 2C, Baltimore, MD 21228, USA

 

Cancellation Policy

All cancellations are subjected to a $250.00 cancellation fee. Longer than 30 days, 100% refund (less $250.00). Less than 30 days, no refund but registration may be transferred to another person.  All refund requests must be in writing.  All refunds will be issued after the meeting has occurred. No refunds requests will be accepted after October 30, 2004. Please submit cancellation and refund requests including transferring of registration to:

 

Fax:  410-869-9560

E-mail: nola@isciencex.com

Deadline: October 30, 2004

 

Email to nola@isciencex.com or mail/fax completed form with remittance to: ISE, Inc. 5707 Calverton Street, Suite 2C, Baltimore, MD 21228, USA; FAX No:  (410) 869-9560.  Payment may be made by check in US$, payable to Institute for Scientific Exchange, Inc. or by credit card.

 

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Pre-Conference: US $850.00 __________

 

Main Summit: US $1500.00 ____________

 

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Exhibitors: US $2000.00_________________

 

Contact Nola Mahaney for Exhibitor or Sponsorship Opportunities at nola@isciencex.com, or phone (410) 869-9166); or visit www.isciencex.com/exhibitors

 

Academic/Government participants will receive a 50% discount.