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Cover Cancer Models Sponsor & Exhibit Opportunities About World Pharma Congress Pain Therapeutics Formulation & Drug Delivery Predictive Drug Safety Preclinical Imaging Hotel & Travel Information Short Courses Registration Information Click Here to Register Online! WorldPharmaCongress.com Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494 www.healthtech.com Register today and SAVE! Karim Dabbagh Ph.D., Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&D Glen N. Gaulton Ph.D., Professor, Pathology and Laboratory Medicine; Executive Vice Dean and Chief Scientific Officer, Perelman School of Medicine, University of Pennsylvania Peter Pitts President and Co-Founder, Center for Medicine in the Public Interest J. Rick Turner PhD, PGCE Senior Scientific Director, Clinical Communications, Quintiles & Fellow, Society of Behavioral Medicine PLENARY KEYNOTE PANEL HIGHLIGHTS June 4 - 6, 2013 Loews Philadelphia Hotel, Philadelphia, PA WPC Cambridge Healthtech Institute’s World Pharma Congress Advancing Preclinical Predictions, Faster Clinical Decisions Celebrating 12 Years of Preclinical Research Premier Sponsor Cancer Models Challenging Cancer Heterogeneity with Reproducible and Predictive Preclinical Studies Pain Therapeutics Translating Success from Preclinical Assays to the Clinic Formulation & Drug Delivery Improving Solubility and Bioavailability with Enabling Technologies Predictive Drug Safety Predicting Drug-Induced Organ Toxicities Using Functional Assays, Models and Markers Preclinical Imaging Integrating Molecular Imaging Technologies to Improve Preclinical Findings World Pharma Congress 2013 l Preclinical efforts targeted towards discovery, screening, safety and drug delivery l Attended by biologists, pharmacologists, toxicologists and drug delivery experts l Active brainstorming and networking opportunity for experts from industry and academia l Interactive pre-conference short courses taught by experts in an informal setting l Updates from leading technology and service providers on the latest tools and services l Informative roundtables, panels, posters, stimulating communication and collaboration

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  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

    and SAVE!

    Karim Dabbagh Ph.D., Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&D

    Glen N. Gaulton Ph.D., Professor, Pathology and Laboratory Medicine; Executive Vice Dean and Chief

    Scientific Officer, Perelman School of Medicine, University of Pennsylvania

    Peter Pitts President and Co-Founder, Center for Medicine in the Public Interest

    J. Rick TurnerPhD, PGCE Senior Scientific Director, Clinical Communications, Quintiles & Fellow, Society of

    Behavioral Medicine

    plEnAry kEynotE pAnEl

    highlightS

    June 4 - 6, 2013 Loews Philadelphia Hotel, Philadelphia, PAWPCCambridge Healthtech Institute’s

    World pharmaCongress

    Advancing Preclinical Predictions,Faster Clinical Decisions

    Celebrating12Years of Preclinical Research

    Premier Sponsor

    Cancer ModelsChallenging Cancer Heterogeneity with Reproducible and Predictive Preclinical Studies

    pain therapeuticsTranslating Success from Preclinical Assays to the Clinic

    Formulation & Drug DeliveryImproving Solubility and Bioavailability with Enabling Technologies

    predictive Drug SafetyPredicting Drug-Induced Organ Toxicities Using Functional Assays, Models and Markers

    preclinical imagingIntegrating Molecular Imaging Technologies to Improve Preclinical Findings

    World pharma Congress 2013 l Preclinical efforts targeted

    towards discovery, screening, safety and drug delivery

    l Attended by biologists, pharmacologists, toxicologists and drug delivery experts

    l Active brainstorming and networking opportunity for experts from industry and academia

    l Interactive pre-conference short courses taught by experts in an informal setting

    l Updates from leading technology and service providers on the latest tools and services

    l Informative roundtables, panels, posters, stimulating communication and collaboration

    http://www.worldpharmacongress.comhttp://www.healthtech.comhttp://www.jax.org/http://www.jax.org/

  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

    and SAVE!

    Monday pre-Conference Short Courses*tuesday Cancer Models pain therapeutics Formulation &

    Drug Deliverypredictive Drug

    Safetypreclinical imaging

    plenary keynote panel DiscussionWednesday Cancer Models pain therapeutics Formulation &

    Drug Deliverypredictive Drug

    Safetypreclinical imaging

    Breakout DiscussionsDinner Short Courses*

    thursday Cancer Models pain therapeutics Formulation & Drug Delivery

    predictive Drug Safety

    preclinical imaging

    About World Pharma CongressAfter a dozen years, covering various topics for the pharmaceutical industry, the World Pharma Congress has found its niche in effectively covering the latest preclinical strategies and technologies for driving better predictions. Building on its experience covering drug targets, high-throughput screening, lead optimization, ADME and drug safety, the event is now primed to move further downstream into early formulations and drug delivery.

    plenary keynote panel DiscussionAdvancing Pharma R&D through Communication & Collaborations: Bio-Connectivity at WorkPanelists:

    Karim Dabbagh, Ph.D., Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&DKarim Dabbagh collaborates with Pfizer WRD leaders to create and draw on global innovative external opportunities in both the biotech and academic space to strengthen Pfizer’s Inflammation and Immunology pipeline via the strategic integration of select assets and technologies. Karim spent 9 years at Roche Palo Alto where he was last Head of Inflammation

    Discovery Research prior to becoming the founder of Modus BioMedicine, a start-up biotechnology company aiming to development antibodies for the treatment of transplantation and autoimmune disease. Karim received his Ph.D. in Biochemistry from University College, London and completed postdoctoral fellowships at the Cardiovascular Research Institute at University of California, San Francisco and at Stanford University in the Department of Pediatrics, Division of Immunology.

    Glen N. Gaulton, Ph.D., Professor, Pathology and Laboratory Medicine; Executive Vice Dean and Chief Scientific Officer, Perelman School of Medicine, University of PennsylvaniaGlen N. Gaulton, Ph.D. is the Executive Vice Dean and Chief Scientific Officer, and Professor of Pathology and Laboratory of Medicine in the University of Pennsylvania’s Perelman School of Medicine. He received a Ph.D. in biochemistry and molecular biology from the University of California, Santa Barbara. He conducted postgraduate research in immunology at the School

    of Public Health and School of Medicine at Harvard University. Dr. Gaulton serves on the Board of Directors of two organizations, is a reviewer for nine scholarly journals, and has been chair of three NIH study sections. He has received numerous awards for teaching and research, including the Dean’s Award for Basic Science Teaching, the Berwick Memorial Teaching Award, the Lindback Award, the Harry Weaver Neuroscience Scholar Award from the National Multiple Sclerosis Society, and the Leukemia Society Scholar Award.

    Peter Pitts, President and Co-Founder, Center for Medicine in the Public InterestPeter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. From 2002-2004 Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA’s Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive

    Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce. He has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University.

    J. Rick Turner, Ph.D., QuintilesDr J. Rick Turner is Senior Scientific Director of Clinical Communications at Quintiles, in which role he facilitates publications by many colleagues in the peer-reviewed and professional literature. He is an experimental research scientist and clinical trialist, with a particular interest in the development and use of drugs for hypertension and type 2 diabetes mellitus. In the latter capacity he testified before two US Food and Drug Administration Advisory Committees in July

    2007 concerning the cardiovascular safety of the thiazolidinedione drug rosiglitazone. Before joining Quintiles, Dr Turner was Chairman of the Department of Clinical Research at Campbell University School of Pharmacy, a Clinical Submissions Scientist at GlaxoSmithKline, and President and Chief Scientific Officer at Turner Medical Communications LLC. In his preceding academic career he conducted experimental clinical research in the field of Cardiovascular Behavioral Medicine, receiving two international research awards (from the American Psychosomatic Society and the Society for Psychophysiological Research) for his ground-breaking research in the field of cardiovascular reactivity: he also published the first student textbook on that topic. Dr Turner has published a total of 14 authored and edited books, and 130 peer-reviewed papers and articles in professional journals. He is also a Fellow of the Society of Behavioral Medicine and a Senior Fellow at the Center for Medicine in the Public Interest.

    *Separate registration required for short courses

    June 4 - 6, 2013 Loews Philadelphia Hotel, Philadelphia, PAWPCCambridge Healthtech Institute’s

    World pharmaCongress

    Advancing Preclinical Predictions,Faster Clinical Decisions

    Celebrating12Years of Preclinical Research

    http://www.worldpharmacongress.comhttp://www.healthtech.com

  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

    and SAVE!

    Sponsor & Exhibit opportunitiesCHI offers comprehensive sponsorship packages which include presentation opportunities, exhibit space and branding, as well as the use of the pre and post show delegate list. Sponsorship allows you to achieve your objectives before, during, and long after the event. Any sponsorship can be customized to meet your company’s needs and budget. Signing on earlier will allow you to maximize exposure to hard-to-reach decision makers.

    Agenda PresentationsShowcase your solutions to a guaranteed, highly-targeted audience. Package includes a 15 or 30-minute podium presentation within the scientific agenda, exhibit space, on-site branding and access to cooperative marketing efforts by CHI.

    Breakfast & Luncheon PresentationsOpportunities include a 30-minute podium presentation. Boxed lunches are delivered into the main session room, which guarantees audience attendance and participation. A limited number of presentations are available for sponsorship and they will sell out quickly. Sign on to secure your talk!

    Invitation-Only VIP Dinner/Hospitality SuiteSponsors will hand-pick their top prospects from the conference pre-registration list for an evening of networking at the hotel or at a choice local venue. CHI will extend invitations and deliver prospects. Evening will be customized according to sponsor’s objectives (i.e. purely social, focus group, reception style, or plated dinner with specific conversation focus).

    Focus GroupsCHI can help you organize and execute a focus group on-site. This exclusive gathering can be useful to conduct market research, gain feedback on a new product idea, and gather marketing intelligence from industry experts on a specific topic. Please inquire for more details.

    User Group MeetingCo-locate your user group meeting with the Biotherapeutics Analytics Summit. CHI will help market the event, manage logistical operations, develop agenda, and more. CHI can handle the entirety of the meeting, or aspects of your choice.

    Exhibit InformationExhibitors will enjoy facilitated networking opportunities with qualified decision-makers at the World Pharma Congress, making it the perfect platform to launch a new product, collect feedback and generate new leads. Exhibit space sells out quickly, so reserve yours today!

    Additional promotional opportunities are available including: • Conference tote bags• Badge lanyards • Tote bag inserts of company literature • Padfolios

    • Keynote chair drop of company literature • Session room chair drop of company literature • Program guide sponsor • Poster abstract book sponsor

    Looking for additional ways to drive leads to your sales team?CHI can help with custom lead generation programs!

    We offer clients numerous options for custom lead generation programs to address their marketing and sales needs. Some of our programs include: live webinars, white papers, market surveys, podcasts, and more!

    Benefits of working with CHI for your lead generation needs:

    •Your campaign will receive targeted promotion to CHI’s unparalleled database of over 800,000 individuals, all of which are involved in all sectors of the life sciences – lists can be segmented based on geography, research area, title and industry.

    •All custom lead generation programs are promoted through our experienced marketing team that will develop and drive targeted campaigns to drive awareness and leads to your lead generation program.

    •For our webinar programs, we offer assistance in procuring speakers for your web symposia through our extensive roster of industry recognized speakers across multiple disciplines within life sciences, as well as provide an experienced moderator and dedicated operations team will coordinate all efforts.

    • If choosing a white paper program, we can offer editorial experience and provide an industry recognized author to write your white paper.

    For additional sponsorship & exhibit information, please contact: Joseph VaccaManager, Business Development781-972-5431 | [email protected]

    Corporate SponsorsPremier Sponsor

    June 4 - 6, 2013 Loews Philadelphia Hotel, Philadelphia, PAWPCCambridge Healthtech Institute’s

    World pharmaCongress

    Advancing Preclinical Predictions,Faster Clinical Decisions

    Celebrating12Years of Preclinical Research

    http://www.worldpharmacongress.comhttp://www.healthtech.commailto:jvacca%40healthtech.com?subject=WPC%20Sponsorship%20and%20Exhibit%20Informationhttp://www.jax.org/http://www.championsoncology.com/http://www.chantest.com/http://www.coriumgroup.com/http://www.hepregen.com/http://mirimus.com/http://www.marshallbio.com/http://www.maccine.com/index.phphttp://www.quintiles.com/

  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

    and SAVE!

    Short Courses*MONDAY, JUNE 3

    Morning Courses | 9:00 am—12:00 pm

    SC1: Addressing Safety Concerns for Biologics and Biosimilars Sponsored by

    •What are typical biologics safety data and program approaches?•Application of safety studies (Tox, Safety Pharm, Safety Pharm-Reg tox hybrid)•Overview of the current guidance in ICH S6 and the ICH S6 addendum•Unique safety challenges and risk mitigation strategies•Data interpretation and follow-up studies•Overview of biosimilar drug development, including the reduced, but comparative

    nonclinical program and the choice of reference productInstructors:Noël Dybdal, Ph.D., D.V.M., Associate Director, Principal Scientist, Safety Assessment, Genentech, Inc.Ulrich Certa, Ph.D., Head, Molecular Toxicology, Non-Clinical Safety, pRED, F. Hoffman-La RocheAnne Ryan, Ph.D., Executive Director, Drug Safety Research and Development, Pfizer, Inc.

    SC2: Utilization of Cardiac Contractility Assays for Preclinical Safety Testing•Basics of cardiovascular physiology and definition of myocardial contractility• In vitro and in vivo models and measurements•Assessment of myocardial contractility and ventricular vascular coupling from

    pressure-volume loops (“gold” standard) and load dependent methods •Translational challenges: What change in myocardial contractility constitutes a drug

    liability? If we do not know, why measure it?•Data interpretation and limitationsInstructors:Robert Hamlin, Ph.D., Professor, Veterinary Biosciences, Ohio State UniversityJonathan Heyen, Principal Scientist, Global Safety Pharmacology, Pfizer Global Research & Development

    SC3: Animal Models of Pain: Progress and Challenges•Classical models of acute, tonic and chronic pain•Limitations of these classical models•Refinement of classical models via a consideration of modulatory factors (sex,

    genetics, testing environment, social modulation)•Development of new animal models (e.g., operant methods, spontaneous behaviors)Instructor: Jeffrey S. Mogil, Ph.D., E.P. Taylor Professor of Pain Studies, McGill University

    SC4: Design and Interpretation of Stability Studies for Product Development

    Developing a Line-of-Sight for Product Stability – Forced Stress Testing Through ICH Stability Requirements Robert A. Reed, Ph.D., Vice President, CMC & Technical Operations, Celsion Corp. Best practices have been established for forced stressed degradation studies that allow an accurate prediction of chemical “potential” for a reaction to occur. Furthermore, in-silico prediction software is emerging as a useful tool to fully consider likely reactive pathways that may play an important role in the drug stability. This talk will attempt to provide a high level introduction for best practices to establish degradation potential for a drug substance and some of the pit falls that one may encounter in bridging to ICH stability studies. Case examples will be presented to highlight some of the presented concepts. Overall, the goal is to develop confidence in the predictability and interpretation of early drug development product stability studies for the commercial market.

    Controlling Reactive Components in Polymeric Pharmaceutical Excipients for Improving the Stability of APIs Shaukat Ali Ph.D.,Technical Sales Manager, BASF Corp.Excipients play important roles in the stability of APIs in the drug development. The key attributes leading to instability of a drug could vary from the nature of an API and the excipients used in the formulation dosages. Most importantly, the drugs sensitive

    to peroxides may have direct implication on the stability of product development. This presentation will cover the understanding of underlying mechanisms for oxidation of drugs and identifying the appropriate measures or safe guards to improve the stability of an API from the excipients’ perspectives.

    Integrating mechanistic drug degradation pathways and mathematical modeling in stability assessment and prediction Ajit S. Narang, Ph.D., Sr. Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb, Co. Predicting the kinetics of drug degradation on storage stability can be challenging. Integrating mechanistic understanding of the drug degradation pathway along with kinetic mathematical modeling of the degradation rate can not only help predict drug product stability, but also quantify the effect of underlying variables and identify mitigation strategies. In this talk, case studies would be presented where mechanistic understanding was combined with mathematical modeling to understand and mitigate stability risks during the manufacturing and stability of an oral solid dosage form.

    Afternoon Courses | 2:00—5:00 pm

    SC5: Use of Stem Cells for Safety Screening•Types of stem cells being used for drug toxicity testing- What can they offer?•Comparing testing and use of stem cells versus primary cells•Overcoming technical challenges related to working with stem cells•Maintaining and characterizing stem cells for routine predictive safety testing•Regulatory challenges with using stem cellsInstructor: Matthew Peters, Ph.D., Principal Scientist, Safety Assessment, AstraZenecaAdditional Instructors to be Announced

    SC6: Introduction to Drug Metabolism and Its Role in Drug Toxicity•Basic concepts of drug metabolism• In vitro tools to investigate drug metabolism•Biotransformation pathways•Understanding the role of reactive metabolites in idiosyncratic drug toxicity•Role of drug transporters in toxicity• In silico tools to aid drug metabolism researchInstructor: John Erve, Ph.D., D.A.B.T., former Principal Scientist, DMPK, Elan Pharmaceuticals, Inc.

    SC7: Epigenetic Mechanisms of Pain• Introduction to epigenetic mechanisms• Identifying and validating targets•Unique challenges and opportunities with epigenetic targets•Current state of drug discovery in this areaInstructor: Chas Bountra, Ph.D., Professor of Translational Medicine & Head, Structural Genomics Consortium, University of OxfordAdditional Instructors to be Announced

    SC8: Development of Nanotechnology Application into Innovative Therapies•Fundamentals of design, formulation and nanoparticle characterization for

    nanotechnology-based therapies•Effective design & utilization of in vivo small and large animal models for preclinical

    evaluation of nanomedicine•Challenges for the successful introduction of novel nanomedicine products into

    clinical trials and the commercial marketsInstructors:Seungpyo Hong, Ph.D., Assistant Professor of Pharmaceutics and Bioengineering, Department of Biopharmaceutical Sciences, University of Illinois College of PharmacyUma Prabhakar, Ph.D., Consultant, Office of Cancer Nanotechnology Research NCI-NIH

    Indicates Short Course is cancelled

    http://www.worldpharmacongress.comhttp://www.healthtech.com

  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

    and SAVE!

    MONDAY, JUNE 3 (Continued)

    Afternoon Courses | 2:00—5:00 pm

    SC9: Roadmap for Outsourcing of Preclinical Imaging This complimentary workshop is designed as a one stop shop event for individuals from industry to get a sense of the preclinical imaging CRO landscape. With the recent trend of outsourcing more and more preclinical imaging to CROs, pharma companies are often missing the critical information of imaging and scientific capacities of various imaging CROs. Participants include: Maccine, InviCRO, Molecular Imaging

    Processing, Analyzing, Reporting and Archiving Sponsored by Images in Drug Discovery and DevelopmentMatthew Silva, Ph.D., Director, Imaging Research, inviCRO, LLCImprovements in pre-clinical imaging instrumentation over the past decade enabled an increase in novel, translational in vivo imaging applications. While molecular probes and image acquisition protocols have translated well, however, there has not been an analogous translation of image processing protocols. Using case studies, this talk will focus on improving the reproducibility and throughput of pre-clinical image processing protocols across a broad spectrum of applications.

    Application of Imaging Technologies to Sponsored by Drug Discovery and Development Studies in Nonhuman PrimatesMahesh Mistry, Ph.D., Executive Director, Business Development, Maccine Pte LtdThe wider application of imaging technologies to preclinical drug efficacy and safety research has the potential to greatly improve prediction of clinical success; especially when applied to non-human primate studies. Herein we describe how PET, CT and MRI imaging modalities are being applied to nonhuman primate efficacy, ADME/PK and safety studies.

    Pharmacology Imaging: Molecular Imaging’s Sponsored by Unique Approach to in vivo StudiesPatrick McConville, Ph.D., Chief Operating Officer/CSO, Molecular Imaging, Inc.This is an overview of pharmacoimaging at Molecular Imaging. By combining extensive pharmacological expertise with broad imaging capabilities, our preclinical studies benefit from richer and clinically relevant data enabling better decision making, improved clinical trail design and more confident lead candidate selection.

    WEDNEsDAY, JUNE 5

    Dinner Short Courses | 6:00 pm—9:00 pm

    SC10: Advances in Imaging Quantitation• Image Segmentation – the State-of-the-Art and Applications• Image Registration – the State-of-the-Art and Applications•Multivariate Image AnalysisInstructor: James Gee, PhD, Professor and Director, Penn Image and Computing Science Laboratory, University of PennsylvaniaAdditional Instructors to be Announced

    SC11: Genetically Engineered Mouse Models Versus Patient-Derived Xenograft Models: Comparing Strengths and Limitations. Instructors:Serguei Kozlov, Ph.D., Principal Scientist, Center for Advanced Pre-Clinical Research, SAIC-Frederick, Inc.M. Raza Zaidi, Ph.D., Assistant Professor of Biochemistry, Fels Institute for Cancer Research & Molecular Biology, Temple University School of MedicineGwenn Danet-Desnoyers, Ph.D., Director, Stem Cell and Xenograft Core, Adjunct Associate Professor, Hematology-Oncology, University of Pennsylvania School of MedicineDylan Daniel, Ph.D., Investigator III, Oncology Pharmacology, Novartis Institutes for Biomedical ResearchHui Gao, Ph.D., Investigator III, Novartis Institutes for Biomedical Research

    *Separate Registration Required

    Present a poster and save $50!Cambridge Healthtech Institute encourages attendees to gain further exposure by presenting their work in the poster sessions. To secure a poster board and inclusion in the conference materials, your abstract must be submitted, approved and your registration paid in full by April 19, 2013. Please see registration page for details.

    Reasons you should present your research poster at this conference:•Your poster will be exposed to our international delegation•Receive $50 off your registration•Your poster abstract will be published in our conference materials•Your research will be seen by leaders from top pharmaceutical, biotech, academic

    and government institutes

    Indicates Short Course is cancelled

    http://www.worldpharmacongress.comhttp://www.healthtech.com

  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

    and SAVE!

    2nd Annual

    predictive preclinical Models in oncologyChallenging Cancer Heterogeneity with Reproducible and Predictive Preclinical Studies

    Recommended Short Course* Roadmap for Outsourcing of Preclinical Imaging (Complementary) * Separate registration required; please see page 4 for details

    TUEsDAY, JUNE 4

    7:45 am Registration and Morning Coffee

    »KEYNOTE sEssION8:30 Chairperson’s Opening Remarks

    8:50 Application of Complex Animal Models in Oncology Drug Design and Early DevelopmentNorman M. Greenberg, Ph.D., Vice President, Research and Development, MedImmuneOne of our goals is to establish and strengthen tied with leading investigators at academic, government, biotechnology and pharmaceutical organizations that have expertise in, and access to, complex and robust in vitro and in vivo models for oncology research. This presentation will focus on select programs that leverage our investment and growing expertise in sophisticated model systems to advance important medicines to unmet medical needs.

    9:30 Validation of Animal Models of Cancer: It Takes a VillageTerry A. Van Dyke, Ph.D., Head, Mouse Cancer Genetics Program; Program Director, Cancer Pathways and Mechanisms, National Cancer Institute

    10:10 Coffee Break

    10:40 Pre-Clinical Mouse Models of GliomaEric Holland, M.D., Ph.D., Director, Brain Tumor Center; Vice Chair, Translational Research, Department of Surgery, Emily Tow Jackson Chair in Oncology, Memorial Sloan Kettering Cancer Center.

    11:10 Frederick National Laboratory for Cancer Research - New Opportunities.David Heimbrook, Ph.D., CEO, SAIC-Frederick National Laboratory for Cancer Research

    11:40 Utilization of Predictive Champions TumorGraft Models Sponsored by to Guide Oncology Drug DevelopmentDavid Sidransky, MD, Chairman & Co-Founder, Champions Oncology, Inc.One of the challenges of oncology drug development is the ability to translate preclinical research into the clinical strategy. By using relevant patient derived xenografts, such as Champions TumorGraft models, oncology drug developers can better guide a compound’s development from the lab to the clinic. Other relevant uses of Champions TumorGraft models are to personalize cancer treatment for patients and facilitate biomarker discovery and validation.

    12:10 pm in vivo Complex Chimeric NOG Sponsored by

    Mice: Model Development and Use for Preclinical Evaluation of DrugsJean-François Mirjolet, Ph.D., Technology Director, OncodesignMany findings from conventional animal models (i.e. syngeneic or xenogeneic) are not easily translated and do not apply to humans due to the intrinsic differences between species (e.g. immune function…). Complex in vivo chimeric mouse models having human immune function and human tumor target cells were developed. This presentation will focus on human immune reconstitution using NOG mice, engraftment of human tumors within this context and tools to evaluate immune mediated antitumor effects.

    1:30 Plenary Keynote Panel Discussion: Advancing Pharma R&D through Communication & Collaborations: Bio-Connectivity at WorkKarim Dabbagh, Ph.D., Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&DGlen N. Gaulton, Ph.D., Professor, Pathology and Laboratory Medicine; Executive Vice Dean and CSO, Perelman School of Medicine, University of PennsylvaniaPeter Pitts, President and Co-Founder, Center for Medicine in the Public Interest

    3:00 Grand Opening of the Exhibit Hall with Poster Viewing

    4:00 The Co-Clinical Trial Paradigm: Improving Predictive Value of Preclinical StudiesDr. Andrew L. Kung, M.D., Ph.D., Director, Pediatric Hematology, Oncology and Stem Cell Transplantation, New York-Presbyterian Morgan Stanley Children’s Hospital/Columbia University Medical CenterConventional mouse studies are poor predictors of efficacy in human clinical trials. The predictive value of preclinical studies may be improved by utilizing newer models that recapitulate the complexity of human disease, along with response criteria that are better aligned with clinical measures of success. The use of genetically engineered mouse models, patient derived xenografts, and molecular imaging will be reviewed in the context of the co-clinical trial paradigm.

    4:30 Panel Discussion: Advancing Preclinical Oncology with Better Science and Better CollaborationPanelists: Speakers of Keynote Session

    5:00 pm Sponsored Presentation (Opportunity Available)

    5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

    6:30 Close of Day

    http://www.worldpharmacongress.comhttp://www.healthtech.com

  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

    and SAVE!

    WEDNEsDAY, JUNE 5

    7:45 am Registration and Morning Coffee

    METASTATIC ANIMAL MODELS AND THEIR APPLICATIONS

    8:00 Chairperson’s Remarks

    8:10 Modeling Tumor Cell Dormancy in the MouseJeffrey E. Green, M.D. Head, Transgenic Oncogenesis and Genomics Section, Center for Cancer Research, National Cancer InstituteRecurrence of breast cancer as disseminated disease years after the apparently successful treatment of the primary tumor remains a critical aspect of cancer biology that is poorly understood. It is presumed that tumor recurrence results from the metastatic outgrowth of preexisting, dormant tumor cells. The use of in vitro and in vivo models to study the dormant-to-proliferative switch and tumor recurrence, and their potential for preclinical testing will be presented.

    8:40 Preclinical Modeling of Melanoma Metastasis and ResistanceGlenn Merlino, Ph.D., Chief, Molecular Genetics Section, Laboratory of Molecular Biology, Division of Basic Science, National Cancer InstitutePost-treatment recurrence and metastasis are the main causes of cancer-related death. This problem is magnified in melanoma, which is highly metastatic and generally chemoresistant. The study of cancer recurrence and metastasis relies on appropriate animal models; however, preclinical models of cancer progression are mostly lacking. We have designed new, and improved on existing, mouse models of progressive melanoma, which we use to study mechanisms associated with drug resistance of recurrent/metastatic BRAF, NRAS and non-BRAF/NRAS melanomas.

    9:10 Therapy Model for Advanced Intracerebral B16 Mouse Melanoma Using Radiotherapy Combined with ImmunotherapyHenry Smilowitz, Ph.D., Associate Professor, Cell Biology, University of Connecticut Health CenterA reproducible therapy model for advanced intracerebral B16 melanoma is reported. Implanted tumors (D0), suppressed by a single 15 Gy radiosurgical dose of 100 kVp X-rays (D8) were further suppressed by a single ip injection of a Treg depleting Mab given two days prior to the initiation (D9) of four weekly then eight bi-monthly sc injections of GMCSF-transfected, mitotically disabled B16 cells. The trends of seven independent experiments were similar to the combined result.

    9:40 Human Tumor Xenografts in Preclinical Drug Development: Sponsored by Future Trends Towards Improved Model SystemsJulia Schueler, Ph.D., DVM, Oncotest GmbHPatient-derived tumor xenografts (PDX) have played a major role in the development of new cancer therapies and their strengths and weaknesses have gradually been elucidated. The basic model has been refined, leading to models more closely recapitulating human tumor biology. These refinements, coupled with the development of an ex-vivo PDX based 3D assay allowing simultaneous testing of agents in up to 200 PDX, represent an integrated preclinical profiling system and promise to make additional positive contributions to clinical success rates.

    10:10 Coffee Break in the Exhibit Hall with Poster Viewing

    DESIGNING MODELS FOR PARTICULAR APPLICATIONS

    10:40 Building Preclinical Capabilities for ER+ Breast CancerCelina D’Cruz, Ph.D., Principal Scientist I, Oncology Innovative Medicines, R&D, AstraZenecaPreclinical models that represent ER+ and endocrine resistant breast cancer have historically been challenging to create. We have generated and characterized several ER+ xenograft and primary tumor models that represent patient segments of interest. With this platform of models, we have compared standard of care and also selected more targetted drug approaches based on molecular information.

    11:10 The Immune Microenvironment and Immunotherapy in Preclinical Models of Melanoma and Breast CancerDylan Daniel, Ph.D., Investigator III, Oncology Pharmacology, Novartis Institutes for Biomedical ResearchModeling therapeutic responses to immune modulating agents in cancer is one of the foremost challenges facing translational researchers today. We have modeled the role of immune cells in tumor progression in autochthonous and allograft GEM models of mammary cancer and melanoma. We will present our findings on the use of targeted agents against specific immune cell types alone and in combination with agents that target tumor cells directly, and thus may indirectly modify the immune microenvironment.

    11:40 The JAX Patient Derived Xenograft Sponsored by (PDX) Resource for Clinical AdvancementNeal Goodwin, Ph. D., Senior Fellow & Director, Business Development, in vivo Pharmacology Services, The Jackson LaboratoryA unique program from The Jackson Laboratory (JAX), the UC-Davis Comprehensive Cancer Center and other centers for advancing cancer therapeutic development. Solid and liquid tumors from consenting patients are transplanted into the JAX-NSG immune deficient mouse. These patient derived xenografts (PDX) can be screened with standard and experimental therapeutics to measure and compare tumor response rates. Over 150 PDX tumor models have been established for use in research including co-clinical predictive tumor response studies.

    12:10 PDX Models of Acute Myeloid Leukemia for Pre-Clinical Screening of Novel TherapiesMartin Carroll, M.D., Associate Professor, Division of Hematology and Oncology, University of Pennsylvania School of MedicineAcute myeloid leukemia (AML) is a cancer of the blood with a poor prognosis. We describe the use of the immunocompromised mouse models for patient derived xenotransplantation and therapy testing. Although the NSG mouse is the currently most widely used model, NRG mice allow for delivery of a more physiologic dose of chemotherapy and NSGS mice provide more rapid engraftment. Studies in NSG mice with novel therapeutics begin to describe the pro’s and con’s of the NSG model for predicting responses in human trials.

    12:40 pm Luncheon Presentation (Opportunity Available)

    2nd Annual

    predictive preclinical Models in oncologyChallenging Cancer Heterogeneity with Reproducible and Predictive Preclinical Studies

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    ADDRESSING INTER-PATIENT RESPONSE HETEROGENEITY

    2:00 Chairperson’s Remarks

    2:10 Modeling Inter-Patient Response Heterogeneity Using Patient-Derived Xenograft ModelsHui Gao, Ph.D., Investigator III, Novartis Institutes for Biomedical ResearchNovartis has built a large patient- derived xenograft tumor model bank that contains over 500 models across more than 15 histology subtypes. These models have been extensively used in pre-clinical studies to further characterize genetic targets as well as novel anti- cancer agents. They are also being used to validate the predictive gene signatures derived from robust in vitro cell line model systems, and have demonstrated high predictive value when compared to clinical studies.

    2:40 Novel Tumor Culture System that Retains Primary Tumor PhenotypeTan A. Ince, M.D., Ph.D., Director, Tumor Stem Cell Division, Interdisciplinary Stem Cell Institute and Associate Professor of Pathology, Braman Family Breast Cancer Institute, Miller School of Medicine, University of MiamiCurrently available human tumor cell line panels consist of small number of lines that generally fail to retain the phenotype of the original patient tumor. We developed a cell culture medium that enables routine culture of diverse subtypes of human cancers with >95% efficiency. Importantly, these cell lines retain the genomic landscape, histopathology, and molecular features of the original tumors. Furthermore, the molecular profile and drug response of these cell lines correlate with distinct groups of primary tumors with different outcomes. Thus, tumor cell lines derived using this new methodology represent a significantly improved new platform to study human tumor biology {Feeley, 2001 #15} and treatment.

    3:10 RNAi Mouse Models for Drug Discovery Research Sponsored by

    Prem K. Premsrirut, Ph.D., CEO, Mirimus, Inc.Mirimus’ creates the most advanced RNA interference (RNAi) tools for drug discovery research. We provide innovative RNAi mice with reversible gene silencing capabilities that enable researchers to adopt novel approaches and obtain high-quality, preclinical scientific validation of targets and toxicology assessment prior to advancing into expensive clinical trials.

    3:25 LION, PUMA and the Tumour Sponsored by

    Microenvironment: Building Clinically Relevant PDX models for Oncology Drug DiscoveryAaron Cranston, Ph.D., Head, in vivo Services, PRECOS Ltd. Clinically relevant preclinical models that represent tumour-specific subsets which better recapitulate the complexity & heterogeneity of human cancers can interrogate novel agents more appropriately. Unique models of acquired resistance (PUMA) derived from our focused lung PDX subset panel (LION) will be presented & their advantages in preclinical testing discussed.

    3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

    4:10 Using Genetically Engineered Mouse Models to Study Circulating Tumor CellsAndrew Rhim, M.D., Instructor of Medicine, Gastroenterology/Medicine, University of PennsylvaniaCirculating tumor cells have recently become a robust and popular topic of study. However, major questions remain unanswered regarding the nature of this important cell population; for example, what is the role of EMT in generating these cells? How heterogeneous are CTCs? When do CTCs arise during cancer progression? Do CTCs

    display stem cell capabilities? In this talk, the use of genetically engineered mouse models to answer these questions will be reviewed. Finally, translation of these lessons to actual clinical applications will be summarized.

    4:10 Breakout Discussion Groups

    5:40 Close of Day

    6:00 Recommended Short Course*

    Genetically Engineered Mouse Models Versus Patient-Derived Xenograft Models: Comparing Strengths and Limitations. Instructors:Serguei Kozlov, Ph.D., Principal Scientist, Center for Advanced Pre-Clinical Research, SAIC-Frederick, Inc.M. Raza Zaidi, Ph.D., Assistant Professor of Biochemistry, Fels Institute for Cancer Research & Molecular Biology, Temple University School of MedicineGwenn Danet-Desnoyers, Ph.D., Director, Stem Cell and Xenograft Core, Adjunct Associate Professor, Hematology-Oncology, University of Pennsylvania School of MedicineDylan Daniel, Ph.D., Investigator III, Oncology Pharmacology, Novartis Institutes for Biomedical ResearchHui Gao, Ph.D., Investigator III, Novartis Institutes for Biomedical Research

    ThUrsDAY, JUNE 6

    8:00 am Registration and Morning Coffee

    IMAGING IN CANCER DRUG DEVELOPMENT

    8:30 Chairperson’s Remarks

    8:40 Molecular Imaging in Preclinical Oncology Models: From Concepts to PracticePeter King, Ph.D., Senior Scientist, Molecular Imaging (Oncology), Janssen, Pharmaceutical Companies of Johnson and JohnsonAn escalating number of research programs within the oncology field are focusing on the tumor microenvironment and biomarkers. By incorporating the use of novel non-invasive molecular imaging techniques to look at drug target expression, tumor-host interactions, and pharmacokinetic and pharmacodynamics of the drug within these humanized pre-clinical oncology models, it will enable us to interrogate our drugs in more human reflective systems. This in turn can accelerate the pace of drug development both in preclinical research and early clinical-translation.

    9:10 Characterization and Preclinical Application of a Therapeutic Monoclonal Antibody-Based PET TracerCharles Glaus, Ph.D., Scientist, Research Imaging Sciences, AmgenCancer immunotherapy harnesses the cytotoxic capabilities of the immune system and directs it towards the destruction of tumor cells. The development of novel molecules that induce tumor-specific immune responses has tremendous potential for patients and is an area of focus in biopharmaceutical industry. The aim of this study was to quantify the in vivo distribution of a radiolabeled immunotherapeutic in a syngeneic tumor model using SPECT/CT imaging and organ biodistribution.

    2nd Annual

    predictive preclinical Models in oncologyChallenging Cancer Heterogeneity with Reproducible and Predictive Preclinical Studies

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    9:40 Predicting Response to Folate-Targeted Drug Therapy Using the Companion Imaging Agent, 99mTc-etarfolatideChristopher P. Leamon, Ph.D., Vice President, Research Endocyte, IncVintafolide is a potent folate-targeted vinca alkaloid conjugate that is currently being evaluated in global phase 3 trials. Response to vintafolide and other folate-targeted drugs is dependent on folate receptor (FR) expression, which can be anatomically assessed in a non-invasive, real-time format using the folate-targeted companion diagnostic agent, 99mTc-etarfolatide. This novel and personalized approach may allow for the identification of pati

    10:10 Coffee Break in the Exhibit Hall with Poster Viewing

    10:40 Application of in vivo and ex vivo Imaging for Assessing PK and PD in Preclinical Cancer Models: Optimizing Discovery to DeliveryWerner Scheuer, Research Leader, Pharma Research and Early Development, Discovery Oncology; Roche Diagnostics GmbHApplication of different imaging modalities to monitor the efficacy of new compounds on primary tumor growth, metastasis and angiogenesis. Verification of in vivo imaging data by multispectral fluorescenec histology of explanted tumor tissue.

    11:10 Smart Nanoparticle Approaches for Targeted Diagnosis and Therapy of CancerWillem Mulder, Ph.D., Associate Professor of Radiology, Director, Nanomedicine Program, Translational and Molecular Imaging Institute, Mount Sinai School of MedicineMicrofluidics-based nanoparticle synthesis technology allows the creation of complex multifunctional nanoparticles. Such complex formulations permit the integration of several agents/materials and functionalities as well as smart coatings. In the context of cancer such nanoparticle platforms serve as valuable tools in preclinical research and may enable improved diagnosis and treatment for patients in the future.

    11:40 Panel Discussion: Imaging End Points in Preclinical Cancer ResearchPanelists: Speakers of the SessionModerator: Werner Scheuer, Research Leader, Pharma Research and Early Development, Discovery Oncology; Roche Diagnostics GmbH

    12:10 pm Luncheon Presentation (Opportunity Available)

    PRECLINICAL TUMOR MODELS FOR TARGETED CANCER THERAPIES

    1:30 Chairperson’s Remarks

    1:40 Derive Response Biomarker for Oncology Drug Using Preclinical ModelsTheresa Zhang, Ph.D., Associate Director, Merck Research LaboratoriesPreclinical models are widely used to discover sensitivity and resistance biomarkers for oncology drugs. This talk will use examples to discuss the best practices to design and implement preclinical studies for biomarker discovery, focusing on how to select appropriate models that best represent the human tumors of interest, and how to power the discovery and validation studies sufficiently to improve the possibility of success of the biomarker in clinic.

    2:10 Preclinical Development of LGX818: A Highly Potent and Selective RAF kinase InhibitorDarrin Stuart, Senior Research Investigator II, Novartis Institutes for Biomedical ResearchSelective RAF kinase inhibitors have demonstrated dramatic efficacy in melanoma patients whose tumors express BRAFV600E. However, the majority of patients relapse within 6 months. LGX818 was developed with the hypothesis that a more potent inhibitor with optimal pharmacological properties would improve the rate and durability of anti-tumor response in melanoma patients. This presentation will focus on the preclinical development and differentiation of LGX818 with emphasis on preventing or delaying resistance.

    2:40 Targeting Tumor Re-Initiating Cells to Prevent Therapeutic Resistance and Disease RelapseErica Jackson, Ph.D., Scientist, Research Group Leader, Genentech

    3:10 Outlier Kinases Identified by RNA-Seq Provide Personalized Therapeutic TargetChandan Kumar-Sinha, Ph.D., Research Assistant Professor, Pathology, University of MichiganAnalyzing a compendium of RNA-Seq data from diverse cancers, we shortlisted the kinases displaying the highest levels of absolute expression among all the kinases expressed within a sample that also displayed the highest levels of differential expression relative to all the samples in our compendium of 485 samples. Next, examining a panel of breast and pancreatic cancer cell lines by RNA knockdown and/or pharmacological inhibition, we observed a profound dependence on “sample-specific outlier kinases”. Our results suggest that sample-specific outlier kinases represent personalized therapeutic targets that could help improve combinatorial therapy options in a wider cohort of cancers than currently realized.

    3:40 Close of Conference

    2nd Annual

    predictive preclinical Models in oncologyChallenging Cancer Heterogeneity with Reproducible and Predictive Preclinical Studies

    http://www.worldpharmacongress.comhttp://www.healthtech.com

  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

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    6th Annual

    targeting pain with novel therapeuticsTranslating Success from Preclinical Assays to the Clinic

    MONDAY, JUNE 3

    Recommended Short Course*

    9:00-12:00 pm Animal Models of Pain: Progress and Challenges* Separate registration required; please see page 4 for details

    TUEsDAY, JUNE 4

    7:45 am Registration and Morning Coffee

    COLLABORATION & OPEN INNOVATION--A WAY FORWARD FOR PAIN

    8:30 Chairperson’s Opening Remarks

    8:40 We Must Work Together to Discover New AnalgesicsChas Bountra, Ph.D., Professor of Translational Medicine & Head, Structural Genomics Consortium, University of OxfordPatients need new analgesics, the industry is struggling and the costs of R&D are rising. The only solution is to pool the resources and capabilities ofpublic and private funders, academics, patient groups and regulators. A pre-competitive partnership with rapid dissemination of reagents and data, will reduce the current wastage and needless exposure of patients to molecules destined for failure.

    9:25 Virtual Discovery at AstraZenecaStephen Zicha, Ph.D., Project Director, Sciences, AstraZeneca Neuroscience Research & DevelopmentNeuroscience drug discovery has experienced one of the highest failure rates in terms of bringing novel medicines to the patients who need them compared to other research areas, and no therapeutic targeting a novel mechanism has been approved for analgesic use in the past decade. One strategy to overcome this drought is to work collaboratively with multiple external groups to help accelerate the drug discovery process while benefitting from access to the world’s best and newest scientific innovations. Some case studies highlighting this approach will be presented, with a particular focus on improving the translation of pre-clinical discoveries into successful clinical development.

    ION CHANNELS

    9:40 Accelerating Pain Drug Discovery Targeting Ion Channels Sponsored by by Partnering with ChanTestEmir Duzic, Ph.D., Senior Director, Discovery Services, ChanTest

    10:10 Coffee Break

    10:40 Discovery and Preclinical Validation of Novel Voltage-Gated Sodium and Calcium Channel Blockers with Analgesic PotentialMichael F. Jarvis, Ph.D., Volwiler Senior Research Fellow & Associate Director, Early Discovery, Pain, AbbVie, Inc.The complexities associated with effective pain control are manifest by variations in underlying disease etiologies, functional interactions and redundancies in sensory pathways and low efficacy and/or poor tolerability for current analgesics. Voltage-gated sodium and calcium channels serve as final common modulators of neuronal membrane excitability and neurotransmitter release, respectively. Emerging genetic validation and biophysical data coupled with improved screening technologies have led to renewed interest in the discovery of novel blockers of these channels for pain management. The development of channel isoform selective blockers will be highlighted in this presentation.

    11:10 Panel Discussion: Novel Approaches to Discovery and Development

    State-Dependent Calcium Channel Blockers for PainMargaret S. Lee, Ph.D., Vice President, Research & Translational Medicine, Zalicus, Inc.With prolonged excitation, such as during chronic pain signaling, the relative proportion of voltage gated calcium channel inactivation increases. Specifically targeting the inactivated state offers an opportunity for pharmacological selectivity that may broaden therapeutic window, minimize adverse effects and increase efficacy. We have discovered novel, first-in-class calcium channel blockers that demonstrate enhanced potency for the inactivated state. Z160 and Z944, selective, state-dependent, N- and T-type calcium channel blockers respectively, demonstrate potent effects in nonclinical pain models. Both are currently in clinical development for pain indications.

    TARGETING PAIN WITH NEW TARGETS, NEW APPROACHES

    11:40 A New Selective Sigma-1 Receptor Antagonist (S1RA; E-52862) for the Treatment of PainJosé Miguel Vela, Ph.D., Drug Discovery & Preclinical Development, EsteveSigma 1 receptor (σ1 receptor) is a unique ligand-regulated molecular chaperone which is activated under stress or pathological conditions and modulates the function of several neurotransmitter receptors and ion channels. Preclinical data obtained in sigma-1 receptor knockout mice and using several sigma-1 receptor ligands, particularly the σ1 receptor antagonist S1RA (E-52862), are consistent with a role for σ1 receptor in central sensitization and pain hypersensitivity and supports a potential therapeutic use of σ1 receptor antagonists for the management of neuropathic pain. Moreover, data support their use in opioid adjuvant therapy: combination of S1RA with opioids results in potentiation of opioid analgesia, without significant increases in opioid-related unwanted effects. Results from clinical trials are thus eagerly awaited to ascertain the potential of σ1 receptor modulation in pain therapy.

    12:10 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

    1:30 Plenary Keynote Panel Discussion: Advancing Pharma R&D through Communication & Collaborations: Bio-Connectivity at WorkKarim Dabbagh, Ph.D., Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&DGlen N. Gaulton, Ph.D., Professor, Pathology and Laboratory Medicine; Executive Vice Dean and Chief Scientific Officer, Perelman School of Medicine, University of PennsylvaniaPeter Pitts, President and Co-Founder, Center for Medicine in the Public Interest

    2:10 Using Rodent Visceral Pain Models as a “Higher-Throughput” Activity Screen in Preclinical Drug DiscoveryMichele Hummel, Ph.D., R.Ph., Principal Investigator, Discovery Research, Purdue Pharma L.P.Overall, many challenges confront the drug discovery process. The discovery of novel therapeutics to treat chronic painful conditions is not without exception. Despite the progress the pain field has made in the last two decades, much criticism still remains around the utility of existing animal models. In this regard, our group affirms the use of two rodent visceral pain models as a “higher-throughput” means of assessing compound activity in vivo. This presentation will describe these models as well as highlight their value in pain research. More importantly, we will provide evidence showing how activity in these models will provide an early and likely gauge of subsequent preclinical in vivo efficacy in more complex rat models. We will also demonstrate how these models and data have been used toadvance some candidate molecules on several of our company’s Target Teams.

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    Cancer Models

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    6th Annual

    targeting pain with novel therapeuticsTranslating Success from Preclinical Assays to the Clinic

    3:00 Grand Opening of the Exhibit Hall with Poster Viewing

    4:00 AYX1 Drug Candidate For Preventing Post-Surgical Pain and Improving Functional RecoveryJulien Mamet, Ph.D., Founder & CSO, Adynxx, Inc.AYX1 is a DNA decoy compound designed to prevent pain and facilitate functional recovery following surgery. Administered as a single intrathecal injection, AYX1 inhibits the activity of the transcription factor EGR1 focally in the spinal cord. Pharmacological studies demonstrate that AYX1 prevents mechanical hypersensitivity in preclinical models of neuropathic, incisional and inflammatory pain and improves functional recovery in models of spontaneous post-operative pain. AYX1 is under active clinical development.

    4:30 Activation of Group II Metabotropic Glutamate (mGlu2/3) Receptors as a Treatment Strategy for Chronic PainMichael P. Johnson, Ph.D., Research Advisor, Pain/Migraine DHT, Neuroscience Discovery, Eli Lilly & Co.The Group II metabotropic glutamate receptors (mGlu2 and mGlu3) are plasma-membrane associated G-protein-coupled proteins that function via presynaptic, postsynaptic and glial mechanisms to negatively modulate neuronal excitability. Within the pre-synaptic element, Group II mGlu receptors (primarily mGlu2) reside outside the synaptic zone where their activity appears to be dependent on an extrasynaptic, non-vesicular pool of glutamate. In addition, mGlu3 receptors are found within glial cells that are closely associate with neuronal synapses, and regulate sensitivity of synaptic transmission by controlling glutamate transporters and release of paracrine factors such as TGFβ. Activation of mGlu2/3 receptors by glutamate or by other exogenous agonists, such as LY379268, leads to the inhibition of synaptic glutamate release, thereby dampening downstream post-synaptic excitation. Thus, mGlu2/3 receptor agonists are efficacious in multiple animal models associated with hyper-glutamatergic tone including chronic pain [neuropathic, visceral and inflammatory pain models]. The relative importance of mGlu2 and mGlu3, as well as the novel epigenetic mechanism of some analgesic compounds will be discussed.

    5:00 Development of a Phenotypic Pain Assay for Identification of Modulators of Excitability in Native Sensory NeuronsPaul Karila, Ph.D., Head, Discovery Services, Cellectricon ABWe have developed an enabling assay platform for chronic pain based on electric stimulation of primary DRG neuronal cultures. The biological relevance of the assay in combination with its ability to characterize a medium throughput screening libraryenables identification compounds for treatment of chronic pain early in the project lifecycle. Therefore, the platform is addingtrue value to the decision-making process. In addition, our phenotypic approach provides the possibility to address previously unknown targets within disease-relevant pathways.

    5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

    6:30 Close of Day

    WEDNEsDAY, JUNE 5

    8:00 am Registration and Morning Coffee

    NOVEL APPROACHES FOR OPIOID ANALGESICS

    8:30 Chairperson’s RemarksEdward Bilsky, Ph.D., Professor, Pharmacology & Director, Center of Excellence in the Neurosciences, University of New England

    8:40 Dual Targeting μ Agonist/δ Antagonist Opioid AnalgesicsEdward Bilsky, Ph.D., Professor, Pharmacology & Director, Center of Excellence in the Neurosciences, University of New England

    9:10 Oral Inhalation of Peripherally-Restricted KOR Agonists Produces Rapid Antinociception in Multiple Pain Models without Opioid LiabilitiesAndrea Leone-Bay, Ph.D., Vice President, Pharmaceutical Research & Development, MannKind CorporationSelf-administered, rapid-acting pain medicines without opioid side effects, like addiction and respiratory depression, remain an unmet medical need. We have identified a series novel small peptide peripherally-restricted kappa opioid agonists that meet this need. These new drugs have been combined with a non-invasive, oral inhalation delivery system that provides a very rapid (5 minutes or less), dose-dependent onset of pain relief in several nonclinical pain models.

    9:40 GPCR Biased Ligands as Improved Analgesics: Promise and ProgressJonathan D. Violin, Ph.D., Head of Biology and Co-Founder, Trevena, Inc.GPCR biased ligands selectively engage a subset of the intracellular signals stimulated by full agonists, suggesting an opportunity to solve “on-target” adverse events. This concept has been demonstrated in vitro and in vivo with several molecules targeting opioid receptors, including TRV130, a G protein-biased ligand targeting the mu opioid receptor. TRV130 was potently analgesic with reduced respiratory depression and constipation compared to morphine in preclinical studies, and is now in clinical development.

    10:10 Coffee Break in the Exhibit Hall with Poster Viewing

    IMAGING IN PAIN THERAPEUTICS DEVELOPMENT

    10:40 Imaging Pain and AnalgesicsDavid Borsook, M.D., Ph.D., Director, Center for Pain and the Brain, Harvard Medical School

    11:10 The Utility of Nonhuman Primates in Pain Research Sponsored byDavid Hygate, Team Leader, Neurobiology & CNS Safety, Maccine Pte Ltd Herein we describe the development of a non-human primate neuropathic pain model as well as the use of fMRI in an inflammatory pain model as drug discovery tools with the potential for translation to early clinical studies.

    11:40 Pharmacologic Modulation of Brain Mechanisms Operative in Humans with Chronic PainRichard Harris, Ph.D., Assistant Professor, Anesthesiology, University of MichiganBrain imaging studies implicate disruption of central chemistry and function in chronic pain patients. Demonstration of changes in these outcomes to pharmacologic intervention is needed. I will present data on altered brain neurochemical and connectivity patterns during pharmacologic treatment of chronic pain patients diagnosed with fibromyalgia. These data point towards the future development of personalized analgesic therapies using neuroimaging.

    12:10 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

    INNOVATIVE TRIAL DESIGN FOR EARLY CLINICAL ASSESSMENT

    2:10 Efficient POC Studies in Pain: From Withdrawal to ConnoisseurTony W. Ho, M.D., Vice President, Clinical Innovative Medicine, AstraZeneca

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    Cancer Models

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    Predictive Drug Safety

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    2:40 The Impact of Study Design and Study Conduct on Assay Sensitivity: Scientific Review and Proposed SolutionsNathaniel Katz, M.D., MS, President & CEO, Analgesic Solutions; Tufts University School of MedicineJeremiah Trudeau, Ph.D., Director, Outcomes and Psychometrics, Analgesic SolutionsThe historical view that the observed effect of a drug is produced only by the drug itself, with superimposed random variation from study to study, can no longer be sustained. The observed effect size is in fact not only determined by the intrinsic effect of a drug at a specific regimen and in a specific population, but also by the study design, and also by study conduct: an “assay sensitivity tripod.” Failed studies have become routine in an era where the drug is expected to shoulder all the burden of assay sensitivity with little regard for optimizing study design and conduct. While the science of clinical research methods is just emerging, several study design factors have been shown to impact observed drug effects, including concomitant and rescue medication, study structure (e.g. crossover vs. parallel), patient selection criteria, randomization ratio, etc. Perhaps even more important is study conduct, where factors such as the manner in which research staff influence patient expectation of benefit, number of sites, patient pain reporting capability, and central review of eligibility have been shown to impact outcome. In this talk we will provide a rational framework for considering these factors, review the current state of the science of clinical pain research, and offer practical solutions for the major pitfalls in study design and conduct.

    3:10 A Novel Target for Chronic Migraine Therapy: Clinical Demonstration of Nasal Oxytocin Efficacy and SafetyDavid C. Yeomans, Ph.D., Founder and Chief Scientist, Trigemina; Professor and Director of Pain Research, Stanford UniversityChronic migraine affects more than 6 million people in the US alone. Pain in these patients is thought to be mediated by activity in the trigeminal nerve. We have demonstrated that there are receptors for the peptide hormone/neurotransmitter oxytocin on pain-sensing (CGRP positive) trigeminal neurons, including those that innervate the dura. We have shown that nasal application of radiolabelled oxytocin in rats preferentially concentrates this peptide throughout the trigeminal system, potentially allowing access to oxytocin receptors on those neurons and producing a trigeminal - selective analgesic effect. In rats, this is seen in that nasal oxytocin is highly analgesic for the face and head, but ineffective for non-craniofacial pain, and that this analgesia is greatly enhanced by prior inflammation, suggesting that nasal oxytocin may be useful in treating human pain states wherein there has been pre-existing inflammation. To test this, we performed a Phase IIa, double-blinded, placebo controlled trial in 40 chronic migraineurs.

    3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

    4:10 Breakout Discussion Groups

    5:40 Close of Day

    ThUrsDAY, JUNE 6

    8:00 am Registration and Morning Coffee

    PRECLINICAL ASSAYS: NOVEL MOUSE MODELS AND BEYOND

    8:30 Chairperson’s Remarks

    8:40 Use of Operant Measures for High-Throughput Drug ScreeningJohn K. Neubert, D.D.S., Ph.D., Associate Professor, University of FloridaPreclinical analgesic testing has traditionally relied on reflex-based outcome measures. Recent developments using operant assays provide for novel assessments of pain and analgesia and allow for evaluation of nociceptive processing and modulation throughout the neuraxis. Advantages of operant assays will be provided, including generation of comprehensive data sets, providing clinically-relevant outcomes, and highlighting the high-throughput aspects for pain testing.

    9:10 Expression, Neurobiology and Treatment of Pain-Related Behavioral Depression in RatsS. Stevens Negus, Ph.D., Professor, Department of Pharmacology and Toxicology, Virginia Commonwealth UniversityPain is often associated with clinically relevant depression of behavior and mood, and relief of pain-related depression is a common goal of treatment in both human and veterinary medicine. Intracranial self-stimulation (ICSS) is a type of operant conditioning procedure that has been widely used to study the neurobiology of motivated behavior, and it can also be used to generate stable behavioral baselines for studies of pain-related behavioral depression. This talk will review recent research on the expression, neurobiology and pharmacological modulation of pain-related depression of ICSS in rats. Results suggest that assays of pain-depressed ICSS may provide new insights into mechanisms of pain-related depression and serve as a useful tool to improve translation of preclinical to clinical results in analgesic drug development.

    9:40 Animal Models of Pain - “Back Translation” for Neck and Back PainBeth A. Winkelstein, Ph.D., Professor, Departments of Bioengineering and Neurosurgery, University of Pennsylvania

    10:10 Coffee Break in the Exhibit Hall with Poster Viewing

    11:10 Panel Discussion: Better Models for Better Predictive Validity

    12:10 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

    1:30 Chairperson’s Remarks

    1:40 Novel Readouts for the Analysis of Spontaneous Pain in AnimalsWolfgang Schröder, Ph.D., Scientific Director, Pain Pharmacology, Grünenthal GmbH

    2:10 Talk Title to be AnnouncedMichele Hummel, Ph.D., R.Ph., Principal Investigator, Discovery Research, Purdue Pharma L.P.

    2:40 Targeted Neurotoxin Studies in Companion Dogs: Bridging the Gap between Mice and MenDorothy Cimino Brown, D.V.M., Chair, Department of Clinical Studies, School of Veterinary Medicine, University of PennsylvaniaWhen naturally occurring diseases that cause pain in companion animals (pets) mimic the same conditions in people, studying new treatments in these animals can provide valuable insight into pharmaceutical efficacy. This presentation will detail how studies in companion dogs with bone cancer played a pivotal role in moving a TRPV1 agonist from laboratory animal studies to phase I/II clinical trials.

    6th Annual

    targeting pain with novel therapeuticsTranslating Success from Preclinical Assays to the Clinic

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    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

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    Inaugural

    Formulation & Drug DeliveryImproving Solubility and Bioavailability with Enabling Technologies

    MONDAY, JUNE 3

    Recommended Short Courses*Development of Nanotechnology Application into Innovative TherapiesDesign and Interpretation of Stability Studies for Difficult Drugs* Separate registration required; please see page 4 for details

    TUEsDAY, JUNE 4

    7:45 am Registration and Morning Coffee

    THE EVOLVING NEEDS OF DELIVERING DIFFICULT-TO-DELIVER DRUGS: OPPORTUNITIES AND CHALLENGES

    8:30 Chairperson’s Opening RemarksBobby Singh, Ph.D., Chief Technology Officer, Corium International, Inc.

    8:40 Nanomaterial for Drug Delivery: Opportunities, Challenges and Lessons LearnedAnil K. Patri, Ph.D., Deputy Director, Nanotechnology Characterization Laboratory, Advanced Technology Program, SAIC-Frederick, Inc., Frederick National Laboratory for Cancer ResearchAdvances in nanotechnology research are bringing about radical changes in early disease diagnosis and therapy. Nanotechnology based delivery systems can improve the delivery of approved therapeutics for better efficacy, and resurrect failed drugs by solving solubility, toxicity, and bioavailability issues. This talk will highlight the resources available for preclinical assessment, advances in nanomaterial technologies for cancer therapy, and the challenges in translation of nanomedicinie.

    »9:10 FEATUrED PrEsENTATION: Nanopreparations for Delivery of Non-Deliverable Pharmaceuticals

    Vladimir Torchilin, Ph.D., D.Sc., University Distinguished Professor, Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern UniversityPoorly soluble or highly unstable substances often represent promising drug candidates, however problems with their delivery and bioavailable dosage forms frequently prevents them from becoming real drugs. Various formulation strategies based on the use of nanocarrier systems to overcome poor solubility and instability of many drugs, including anticancer agents and siRNA, have been suggested, such as non-targeted and targeted polymeric micelles and layer-by-layer nanoparticles.

    9:40 Accelerating the Translation of Nanotechnology Platform in Cancer through Public-Private PartnershipsUma Prabhakar, Ph.D., Consultant, Office of Cancer Nanotechnology Research NCI-NIHThe Alliance for Nanotechnology in Cancer of the NCI initiated a public private industry partnership called TONIC to evaluate promising nanotechnology platforms for drug delivery, imaging and monitoring and, facilitate their successful translation from bench to bedside, to help, timely, effective and novel diagnosis and treatment options for cancer patients. The interactions with government, academia, patient advocacy groups and industry in advancing the translation of the will be discussed.

    10:10 Coffee Break

    NOVEL PREFORMULATION: REDUCING THE RISK OF DRUG FAILURE EARLY ON

    10:40 Proven Predictive Models in Drug Development to Anticipate Clinical OutcomesTycho Heimbach, Ph.D., Associate Director & Senior Investigator II, Biomedical Research, Novartis Pharmaceuticals CorporationSeveral case examples will be presented on predictive physiologically-based pharmacokinetics (PBPK) and PK/PD models to anticipate FIH and other clinical trials across all BCS/BDDCS class drugs. Successful integration preclinical and clinical data and application of custom (PBPK) software which significantly improved the accuracy of drug absorption and exposure prediction in humans will be discussed. In addition, examples where PBPK as a tool has impacted drug development will be shared.

    11:10 Role of Pharmaceutics and Enabling Technologies in Discovery of Novel Acute Care TherapiesAkash Jain, Ph.D., Senior Scientist I, Discovery Pharmaceutics, Cubist Pharmaceuticals, Inc.Presentation will focus on the applications of modeling and simulation, automation and novel delivery technologies during early drug discovery to enable selection of candidates with optimal developable profile for acute care therapies. Case studies will be discussed to highlight the role of early intervention of pharmaceutics in discovery to enable candidate selection and identifying novel delivery approaches to maximize a NCE’s therapeutic potential and its fit with intended clinical use.

    11:40 Improving the Bioavailability of Poorly Soluble Compounds Sponsored by with Hybrid Nanoparticle FormulationsPer Andersson, Ph.D., CEO, XSpray

    12:10 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

    1:30 Plenary Keynote Panel Discussion: Advancing Pharma R&D through Communication & Collaborations: Bio-Connectivity at WorkKarim Dabbagh, Ph.D., Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&DGlen N. Gaulton, Ph.D., Professor, Pathology and Laboratory Medicine; Executive Vice Dean and Chief Scientific Officer, Perelman School of Medicine, University of PennsylvaniaPeter Pitts, President and Co-Founder, Center for Medicine in the Public Interest

    3:00 Grand Opening of the Exhibit Hall with Poster Viewing

    4:00 Native-State Solubility and Thermal Stability Studies for Selecting De-Risked Drug Lead Candidates in DiscoveryAaron Yamniuk, Ph.D, Senior Investigator, Protein Science and Structure, Bristol-Myers Squibb Co.Solubility is a key attribute of protein therapeutics that influences the ease with which they are discovered and developed. This presentation will describe a novel method for rank-ordering native-state solubilities of drug candidates, and how this information is applied in combination with thermal stability analyses to select drug candidates that have improved biophysical behavior.

    http://www.worldpharmacongress.comhttp://www.healthtech.com

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    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

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    Inaugural

    Formulation & Drug DeliveryImproving Solubility and Bioavailability with Enabling Technologies

    4:30 Difficult DVD-Immunoglobulins: Lessons Learned from Early Screening towards Faster Formulation DevelopmentVineet Kumar, Ph.D., Senior Research Scientist II, Department of Pharmaceutics, AbbVieThe importance of preformulation work during the early screening of molecules will be discussed. Lessons learned from various DVDs were used in the adaptation of a suitable screening funnel. The screening necessitates an early interdepartmental collaboration between the different groups including PK, formulations, analytics and others. Case studies and the screening approach used will be discussed.

    5:00 Talk Title to be AnnouncedAjit S. Narang, Ph.D., Sr. Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb, Co.

    5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

    6:30 Close of Day

    WEDNEsDAY, JUNE 5

    8:00 am Registration and Morning Coffee

    NOVEL DELIVERY STRATEGIES IN DRUG TARGETING

    8:30 Chairperson’s RemarksVladimir Torchilin, Ph.D., D.Sc., University Distinguished Professor, Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern University

    8:40 FEATURED PRESENTATION: Principles of Ligand-Targeted Drug DesignPhilip S. Low, Ph.D., Ralph C. Corley Distinguished Professor, Department of Chemistry, Purdue UniversityBecause targeted therapeutics treat pathologic cells without damaging normal cells, they will likely dominate the drug market of the future. In this presentation, I will discuss the basic principles underlying the successful design of ligand-targeted therapeutics, using multiple examples of ligand-targeted drugs currently in the clinic or late preclinical development to illustrate each major principle.

    9:10 Centyrins: A Novel Scaffold for New TherapeuticsKaryn O’Neil, Ph.D., Chief Scientific Officer, Centyrex Venture, Johnson & JohnsonAlternative scaffolds share properties with antibodies in terms of their specificity and potency and with small molecules in terms of simplicity and size. The Centyrin platform, a consensus fibronectin domain, has been optimized to enable selection of Centyrins that inhibit multiple classes of proteins. We will describe how the biophysical properties of Centyrins make them ideal for novel therapeutic applications including drug conjugates and targeted nanoparticles.

    9:40 Development of Novel Targeted Cancer Therapies with BIND Accurins™Jeff Hrkach, Ph.D., Senior Vice President, Technology Research & Development, BIND BiosciencesAccurins™ are a new class of highly selective targeted therapeutics, precisely engineered to have long circulation half-lives, high drug loading levels, finely tuned pharmacokinetics and surface-bound targeting ligands that bind selectively to cell-surface receptors on diseased cells. Accurins achieve high and prolonged concentrations creating optimal therapeutic indices. BIND is developing Accurin targeted therapeutics, primarily focused on oncology.

    10:10 Coffee Break in the Exhibit Hall with Poster Viewing

    10:40 NanomAbs: New Leap in Antibody-Drug ConjugatesStephane E Allard, Ph.D., CMO, EpiCept Corp.NanomAbs platform is a conjugate of a targeting moiety to chemotherapeutic drug loaded polymeric nanoparticles. Development of Immune’s linker technology enabled the optimized drug to mAb ratio using the mAb as a targeting moiety. Extensive preclinical research recently showed improved anti-cancer effect in several cancer models and beneficial safety profile. Leveraging the technology for targeted combo cancer drug delivery is underway showing synergistic effects in advanced tumors.

    11:10 Addressing the Delivery Challenge for siRNA TherapeuticsMarian Gindy, Ph.D., Director, Pharmaceutical Sciences, Merck Research LaboratoriessiRNA represents a promising therapeutic strategy, with potential to access molecular targets considered undruggable by small molecule and protein therapeutics. Challenge toward realizing this technology is the safe and effective delivery of siRNA to target tissues. siRNAs properties prevent diffusion across most cell membranes, requiring the use of delivery systems to confer intracellular access. Presentation will illustrate the development of such oligonucleotide delivery technologies.

    11:40 Nanopharmaceutical Delivery of Toxic and Biodegradable Drugs: Case Studies of Camptothecin and siRNASonke Svenson, Ph.D., Director, Research, Cerulean Pharma, Inc.Cerulean’s nanopharmaceutical technology consists of polymeric nanoparticles carrying drug molecules conjugated to the constituent polymers. Encapsulation protects the body from toxic drugs, and protects biodegradable drugs from enzymatic or hydrolytic metabolism inside the body. Chemical conjugation of drug molecules to the carrier prevents burst release in favor of controlled drug release from the nanopharmaceuticals.

    12:10 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

    IMAGING & ADVANCED CHARACTERIZATION TOOLS IN DRUG DELIVERY RESEARCH

    2:00 Chairperson’s Remarks

    2:10 Visualizing Targeted Delivery of Polymer-Drug ConjugatesBan-An Khaw, Ph.D., George D. Behrakis Professor of Pharmaceutical Sciences, Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern UniversityMost chemotherapeutic agents are not target specific. They can be made target specific by antibody-drug conjugate technology. To improve targeting ability and highly efficient delivery of drugs, bispecific antibody complex pretargeting and targeting with polymer-drug conjugates (PDC) was developed. Targeting with radioisotope labeled or chemotherapeutic PDCs enabled visualization of very small cancer lesions, and therapy was as efficient as free drug but has no non-target toxicity respectively.

    http://www.worldpharmacongress.comhttp://www.healthtech.com

  • Cover

    Cancer Models

    Sponsor & Exhibit Opportunities

    About World Pharma Congress

    Pain Therapeutics

    Formulation & Drug Delivery

    Predictive Drug Safety

    Preclinical Imaging

    Hotel & Travel Information

    Short Courses

    Registration Information

    Click Here to Register Online!

    WorldPharmaCongress.com

    Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494www.healthtech.com

    Register today

    and SAVE!

    Inaugural

    Formulation & Drug DeliveryImproving Solubility and Bioavailability with Enabling Technologies

    2:40 PET Imaging of Antibodies for Evaluation of Distribution, Clearance and PK in vivoVania Kenanova, Ph.D., Head, Preclinical PET/SPECT/CT Imaging Laboratory, Global Imaging Group, Novartis Institute for Biomedical ResearchQuantitative PET imaging is routinely used for evaluation of antibodies in vivo. This involves radiolabeling of the antibody either by attaching radionuclide directly (I-124 to Tyr) or via a chelate (NODAGA [Cu-64], desferal [Zr-89]). The PET image is a result of the catabolism and clearance of the protein, chelate and radiolabel. This talk will go over the distribution and clearance of radiolabel alone, radiolabel-chelate and radiolabel-(chelate)-protein for PK analysis.

    3:10 Sponsored Presentation (Opportunity Available)

    3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

    4:10 Nanoscale Evaluation of Novel Dendritic Nanocarriers for Cancer TargetingSeungpyo Hong, Ph.D., Assistant Professor of Pharmaceutics and Bioengineering, Department of Biopharmaceutical Sciences, University of Illinois College of PharmacyAlthough a myriad of promising nanocarriers have been recently developed, targeted drug delivery to cancerous regions still remains a tremendous challenge. This presentation will focus on new drug delivery platforms based on dendritic structures to take advantage of multivalent binding and enhanced self-assembly. Fundamental understanding as well as biological testing of those novel nanocarriers will be discussed.

    4:40 Breakout Discussion Groups

    When and Where to Introduce Delivery into the Product Development PipelineBobby Singh, Ph.D., Chief Technology Officer, Corium International, Inc.

    Bringing Down the Silos•Technology and strategy selection and implementation•Collaboration to innovate and improve preclinical to clinical translation•The Science of Particle Size Analysis and its Impact on Translational Performance

    Moderator to be Announced

    Effect of Particle Shape, Size and Density on a Nanoparticle’s Tendency to Escape•Why do several successful preclinical technologies fail in clinic•Tools and technologies for characterization and data interpretation•Working with a Very Small Amount of API: Pros and Cons of Miniaturization

    Moderator to be Announced

    Working with a Small Amount of API: Pros and Cons of MiniaturizationWeiguo Dai, Ph.D., Scientific Director, Fellow, Drug Product Development, Johnson & Johnson•Advantages and disadvantages of miniaturization and automation in

    drug development•Data correlation between early development and late development studies and how

    it can hasten or delay product development timelines•Evolving role of preformulation in faster development

    5:40 Close of Day

    ThUrsDAY, JUNE 6

    8:00 am Registration and Morning Coffee

    NEXT-GENERATION DELIVERY TECHNOLOGIES

    8:30 Chairperson’s Remarks

    8:40 Breaching the Blood-Brain Barrier: Novel Drug Delivery Strategies for the CNSPankaj Karande, Ph.D., Assistant Professor, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic InstituteDrug delivery to the brain has been a long-standing challenge in the treatment of neurological and neurodegenerative disorders due to the formidable blood-brain barrier (BBB). I will specifically discuss the design and discovery of peptides that bind to one such protein, transferrin, as a way of chaperoning drugs from systemic circulation into the brain. Peptide-mediated delivery is an efficient and significantly less invasive alternative to current methods of CNS delivery.

    9:10 Next-Generation Transdermal Technologies for Needle-Free Delivery of BiologicsBobby Singh