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communication design that starts a conversation




            CHRISTY SCHWINDT
!
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!   Strategy + Opportunity
                             5pt BRAND conversation



!   Brand Mission
                             The Mission: To design a brand that drives and motivates
                             consumers.

                             The Notion: 5pt BRAND conversation is a brand


!
                             conversation that is designed to engage consumers with
    Define Brand Community   products and services. Effective communication design
                             creates a dialogue and encourages the consumer to
                             start a conversation about their experience in the brand


!
                             community.

    Develop Identity         “To grow now, companies must innovate and perform on
                             every level, and that is where design comes into play.”
                               - Warren Berger

!   Communication Design
!
                                                                "#$%&''' ()*+,-./01)*
                                                                Case Study: iC42




  C42
www.bioanalytics.us
                      integrated solutions in systems biology
                      clinical research & development
!
                                                                                         "#$%&''' ()*+,-./01)*

!   Strategy: To become a leader in bioanalytical services.
    Opportunity: Brand the service center and introduce it’s
    capabilities to the iC42 community.                                                  Case Study: iC42



!   Brand Mission: To serve science with integrated solutions
    to systems biology.




!   iC42 Brand Community

    University of Colorado
    Research Community
                                                                        C42
                                                                   www.bioanalytics.us
                                                                                         integrated solutions in systems biology
                                                                                         clinical research & development

    Global Collaborations
    Novartis
    Siemens
    Thermofisher
    Kaiser
    Pain Clinics
    Toxicology Patients
    Vitamin D Patients
    Transplant Patients
    Pediatric Pharmacology




!
    Develop Identity: Trademarked Brand : iC42
                      Trademarked Mark for Commerce
                      Trademarked IP for iC42
                      Trademarked Colors: Custom Yellow, Gray & Black
                      Typography: Myraid Pro
!                                                                                                                                                                                                                                                                                       !
    Communication Design: Business Cards
                                                                                                                                                                                                                                                   "#$%&''' ()*+,-./01)*
                                                                                                                                                                                                                                                   Case Study: iC42

         C42
       www.bioanalytics.us
                                                                        integrated solutions in systems biology
                                                                       clinical research & development
                                                                                                                                                                                             •Highly Sensitive HPLC, LC-MS, GC-MS Bioanalytics
                                                                                                                                                                                             •Complex Assay Development & Validation
                                                                                                                                                                                             •GLP Compliant, CAP Accredited, CLIA Certi ed
                                                                                                                                                                                             •Quanti cation of Drugs & Metabolites
       Uwe Christians, MD, PhD, MRQA                                                                                                                                                         •Isolation of Drug Metabolites & Structural ID
       Professor & Laboratory Director                                                                                                                                                       •Clinical Therapeutic Drug Monitoring
                                                                                                                                                                                             •Complete PK/PD Package Managed Under One Roof
       SEND SAMPLES TO:                                                                                                                                                                      •Molecular Marker Discovery, Quali cation
       Bioscience East, Suite 100                                                                                                                                                              & Development
       1999 North Fitzsimons Parkway                                                                                                                                                         •Consulting & Strategic Research Partnerships
       Aurora, CO 80045-7503

       email: uwe.christians@ucdenver.edu                                                      phone: 303.724.5665                                                               www.bioanalytics.us
    Communication Design: Highlights from 35 page Service Catalog

                   C42
                 www.bioanalytics.us
                                       integrated solutions in systems biology
                                       clinical research & development                                                     C42
                                                                                                                       www.bioanalytics.us
                                                                                                                                                              integrated solutions in systems biology
                                                                                                                                                              clinical research & development



                                                                                                                     1.1 Quantitative Bioanalytical Methods
                                                                                                                                                                                                          Compound                Matrix              Sensitivity      Instrument

                                                                                                                                                                                             ADMA, Homocysteine, Arg             Plasma                 0.3 M           API 4000




                                                                                                                     Quantitative Bioanalytical Methods
                                                                                                                                                          Compounds
                                                                                                                                                                                                           Alfentanil            Plasma               0.1 ng/mL         API 5000

                                                                                                                                                                                                           Aprotinin        Tissue (Rat Kidney)        80 ng/mL          ELISA

                                                                                                                                                                                                           Biolimus        Blood, Tissue, Stents      0.05 ng/mL        API 5000

                                                                                                                                                                                            Cyclosporine / Metabolites            Blood              0.1-1.0 ng/mL      API 5000

                                                                                                                                                                                                            DMXB              Plasma/Brains           0.1 ng/mL         API 5000

                                                                                                                                                                                                          Duet DNA             Monocytes                 Ratio           GC-MS

                                                                                                                                                                                                          Everolimus              Blood               0.1 ng/mL         API 5000

                                                                                                                                                                                                          Felbamate         CSF, Brain, Serum         0.1 ng/mL         API 5000

                                                                                                                                                                                                           Fentanyl              Plasma               0.01 ng/mL        API 4000

                                                                                                                                                                                                        Free-Fatty Acids   Plasma, Tissue, Blood        100 M            GC-MS

                                                                                                                                                                                                             GSH                 Plasma                 10 M            API 4000

                                                                                                                                                                                                        Glucocorticiods          Plasma               0.1 ng/mL         API 5000

                                                                                                                                                                                                         [13C] Glucose           Plasma                 10 M             GC-MS

                                                                                                                                                                                                         [13C] Glycerol          Plasma                 10 M             GC-MS

                                                                                                                                                                                              High Energy Phosphates             Tissues                0.25 M          API 4000



                       Summary of Services                                                                                                                                                               Isoprostanes

                                                                                                                                                                                                           Ketamine

                                                                                                                                                                                                           Ketarolac
                                                                                                                                                                                                                              Plasma, Urine

                                                                                                                                                                                                                                  Blood

                                                                                                                                                                                                                                 Plasma
                                                                                                                                                                                                                                                      0.01 ng/mL

                                                                                                                                                                                                                                                      1.0 ng/mL

                                                                                                                                                                                                                                                      1.0 ng/mL
                                                                                                                                                                                                                                                                        API 5000

                                                                                                                                                                                                                                                                       UPLC-MS/MS

                                                                                                                                                                                                                                                                        API 4000

                                                                                                                                                                                                         Lamotrigine             Plasma               1.0 ng/mL         API 4000

                                                                                                                                                                                                         Le unomide               Blood               0.1 ng/mL         API 5000

                                                                                                                                                                                                           Lidocaine             Plasma               0.5 ng/mL         API 4000

                                                                                                                                                                                                          Lovastatin             Plasma               0.1 ng/mL         API 5000

                                                                                                                                                                                                   Metabolic Pro ling      Plasma, Urine, Tissue       _______          Exactive

                                                                                                                                                                                               Morphine / Metabolites            Plasma             0.25 - 2.5 ng/mL    API 5000

                                                                                                                                                                                                             MPA                 Plasma               1.0 ng/mL         API 4000

                                                                                                                                                                                                          Naltrexone             Plasma               0.1 ng/mL         API 5000

                                                                                                                                                                                                           Nicotine                Hair               0.1 ng/mL         API 5000

                                                                                                                                                                                                          Pravastatin            Plasma               0.5 ng/mL         API 4000

                                                                                                                                                                                                          Phenytoin              Plasma               0.1 ng/mL         API 5000

                                                                                                                                                                                                             PhIP          Plasma / Microsomes        0.1 ng/mL         API 4000

                 Bioscience East, Suite 100                                                                                                                                                                Propofol              Plasma               0.5 ng/mL         API 4000
                 1999 North Fitzsimons Parkway                                                                                                                                                             Sirolimus          Tissues / Blood         0.01 ng/mL        API 4000
                 Aurora, CO 80045-7503
                                                                                                                                                                                                   Steroid Hormones              Plasma               0.1 ng/mL         API 5000
                 303-724-5665
                                                                                                                                                                                              Tacrolimus / Metabolites            Blood               0.1 ng/mL         API 4000

                                                                                                                                                                                            Temsirolimus / Metabolites            Blood               0.1 ng/mL         Exactive

                                                                                                                                                                                                         Valproic Acid            Serum               1.0 ng/mL          GC/MS
                 Summary of Bioanalytical Services                                                                     Summary of Services
                 iC42 Colorado, June 2010                                                                              iC42 Colorado, June 2010                                              Vitamin D and Metabolites           Plasma               0.1 ng/mL         API 5000    7
"#$%&''' ()*+,-./01)*        !
                                                                                                                                                     Case Study: iC42
 Communication Design: Email Announcements                                               Communication Design: Student Program Letter


Did you know that a comprehensive bioanalytics lab is available to you and is located
             on the University of Colorado’s Premier Medical Campus?




  C42
www.bioanalytics.us
                                   integrated solutions in systems biology
                                  clinical research & development
                                                                                            Welcome, we thank you for your interest in iC42.

                                                                                            We are looking forward to supporting you and assisting you with your clinical trials as well as
                                                                                            providing state-of the-art bioanalytical services. In addition, we are offering you world-class training in
                                                                                            clinical research and development. At iC42, you will find abundant opportunities to participate in
   Highly Sensitive HPLC, LC-MS, GC-MS Bioanalytics                                         clinical, translational and benchtop research activities.
   Complex Assay Development & Validation
   GLP Compliant, CAP Accredited, CLIA Certi ed        SEND SAMPLES TO OR VISIT US AT:      iC42 Clinical Research & Development is a regulatory compliant mass spectrometry laboratory (cGLP
   Quanti cation of Drugs & Metabolites                Bioscience East, Suite 100           complaint, CAP accredited and CLIA certified) with currently 17 mass spectrometers and is part of the
   Isolation of Drug Metabolites & Structural ID       1999 North Fitzsimons Parkway        Department of Anesthesiology. We are a unique clinical research and development facility that
   Clinical Therapeutic Drug Monitoring                Aurora, CO 80045-7503                combines quantitative mass spectrometry (drugs, drug metabolites, other small molecules and large
   Complete PK/PD Package Managed Under One Roof                                            molecules, endogenous compounds), metabolic and protein profiling technologies all under one roof.
   Molecular Marker Discovery, Quali cation
    & Development                                                                           We are designed and uniquely qualified to carry out the bioanalytics for complex clinical trials
                                                                                            involving drug quantification and molecular marker strategies. In addition, iC42 carries out research
   Consulting & Strategic Research Partnerships
                                                                                            and development projects including: molecular marker discovery and qualification, translational
                                                                                            research, strategy development and the identification of molecular mechanisms. Projects range from
              For more information or to schedule a lab tour please email:                  the development and validation of assays and strategies with only a few study samples and clinical
                                                                                            therapeutic drug monitoring to serving as the central laboratory for phase III clinical trials with more
                            christy.schwindt@ucdenver.edu
                                                                                            than 50 clinical centers and more than ten thousand samples. In addition to research and
                                                                                            bioanalytical services, activities include consulting and interactions with regulatory agencies.

                                                                                            iC42 is committed to advancing individual medicine by examining the unique biology of an individual
                                                                                            to assess truly personalized treatments. Other major foci are the evaluation of pediatric
                                                                                            pharmacokinetics, the development of clinical management tools for pediatric patients, advancement
                                                                                            in transplantation and drug metabolism. In addition, we promote and enhance research through the
                                                                                            Colorado Center for Transplantation Care, Research and Education and the Colorado Center for the
                                                                                            Advancement of Pediatric Pharmacology.

                                                                                            For additional information please contact:
                                                                                            Jaimie Henthorn
                                                                                            303-724-5663
                                                                                            jaimie.henthorn@ucdenver.edu
                                                                                            and please visit us at www.bioanalytics.us

                                                                                            Sincerely,




                                                                                             Uwe Christians MD, PhD, MRQA
                                                                                             iC42 Laboratory Director

                                                                                                                 “Where the future is made today…” - Dr. Bunsen Honeydew
Communication Design: USB Business Cards
                                                                                                                                                                                             "#$%&''' ()*+,-./01)*                 !
                                                                                                                                                                                              Case Study: iC42




                                                                                                                                             C42           www.bioanalytics.us




                                                                                                                                                                                                                                                      C42          www.bioanalytics.us
                                                                                                                                                                                                       SEND SAMPLES TO:
                                                                                                                                                                                                    Bioscience East, Suite 100
                                                                                                                                                                                                 1999 North Fitzsimmons Parkway
                                                                                                                                                                                                        Aurora, CO 80045
                                                                                                                                                                                                         (303) 724-5665




        Communication Design: 8” x 8” Marketing Conference Cards



pediatric
 pharmacokinetics
 Dr. Galinkin is a leader in the eld of Pediatric Pharmacology and Anesthesiology, he
           is a leader in pediatric research here at the University of Colorado.
    Internationally, Dr. Galinkin is recognized for his expertise in pediatric pharmacokinetics. He
                                                                                                        discover
                                                                                                         integrity intelligence innovation
                                                                                                                                                  integrated solutions in systems biology


                                                                                                                                                       Extensive Experience &
                                                                                                                                                       Interactions with Small Biotech
                                                                                                                                                                                                  C42                       clinical research & development
                                                                                                                                                                                                     integrated Solutions in Systems biology
                                                                                                                                                                                                     biotech pharmaceutical academia
    regularly lectures at international scienti c meetings and locally on drug pharmacokinetics.                                                       Companies
    He has designed and conducted many clinical studies in all stages of clinical development and                                                                                            We are a unique comprehensive facility that combines quantitative mass spectrometry,
    has served on multiple steering committees for multi center trials and for multiple
                                                                                                        contact
                                                                                                                                                       Bench top-to-Bed Drug                 metabolic and protein pro ling technologies in a regulatory compliant environment.
    pharmaceutical company studies.                                                                                                                    Metabolism Studies                    We are designed and uniquely quali ed to carry out the bioanalytics for complex
                                                                                                                                                                                             clinical trials involving drug quanti cation and molecular marker strategies. In




                                                                                                              C42
    Locally, Dr. Galinkin is one of the Chairs of the IRB for the University of Colorado. He also co-
                                                                                                                                                       Consulting & Strategic Research       addition, iC42 carries out research and development projects including: molecular
    chairs the Scienti c Advisory Committee for the University of Colorado’s Clinical Translational                                                    Partnerships                          marker discovery & quali cation, translational research, strategy development and the
    Science Institute, a NIH funded vehicle that provides infrastructure to clinical investigators
                                                                                                                                                                                             identi cation of molecular mechanisms. Projects range from the development and
    throughout the University. Additionally, Dr. Galinkin is the Chair of the Pharmacy and                                                             Complete Molecular Marker             validation of bioanalytical assays and strategies to serving as the central bioanalytical
    Therapeutics Committee at The Children’s Hospital.                                                                                                 Discovery, Quali cation &             laboratory for phase III clinical trials with more than 50 clinical centers and more than
                                    contact us for...                                                      www.bioanalytics.us
                                                                                                                                                       Development                           ten thousand samples. In addition to research and bioanalytical services, activities
                                                                                                                                                                                             include consulting and interactions with regulatory agencies.
    design & conduct of                                                                                                                                Clinical Therapeutic Drug



                                                                                                                                                                                            pediatric pharmacokinetics
                                                                                                                                                       Monitoring
pharmacogenomics pharmocokinetics pharmacodynamics                                                      phone: 303-724-5665
     clinical trials in pediatric populations                                                                                                          Novel Translational Technologies

                                                                                                                                                                                            drug metabolism phase I clinical trials
                                                                                                        email: christy.schwindt@ucdenver.edu           in a GLP-Compliant Environment

highly sensitive LC/MS assays in low volume samples
                                                                                                                                                                                            predictivedrug eluting stents
                                                                                                                                                                                                          biomarkers
                                                                                                                                                       Complete PK/PD package
                     in a regulatory compliant environment                                                                                             Managed “Under One Roof”

bioanalytics in plasma samples &
                               dry blood spots on lter paper
                                                                                                         visit us at Bioscience East, Suite 100
                                                                                                                     1999 N. Fitzsimons Parkway
                                                                                                                                                       Complex Assay Developments &
                                                                                                                                                       Validations                           metabolomics
development of new pain management strategies
population pharmacokinetics pediatric drug metabolism studies
                                                                                                                     Aurora, CO 80045
                                                                                                                                                       High-Impact Publications &
                                                                                                                                                       Presentations                        pk/pd studies proteomics
                              www.bioanalytics.us
                                                                                                                                                                                            isolation of drug metabolites
                                                                                                                                                                                                                          !"##$%&#$'(%()#*$+,($-.//0$1$2,34
                  phone: 303.724.5665 email: christy.schwindt@ucdenver.edu
Communication Design: Interior Signage
                                                                                                                             !
                                                                                                             "#$%&''' ()*+,-./01)*
                                                                                                              Case Study: iC42




  C42
www.bioanalytics.us
                             integrated solutions in systems biology
                             clinical research & development


       50”w x 20”h Entry Wall color on clear vinyl




         50” x 20” Entry Wall color on clear vinyl




discover                                       integrated solutions in systems biology
                                                                                         15” diameter color LOGO on clear vinyl
                                                                                         to be used on all (5) entry doors. Needs to be removable



                                                                                         20” diameter color LOGO on clear vinyl
   15”w x 8”h Entry Door color on clear vinyl
                                                                                         to be used on all (5) interior windows. Needs to be removable


      15”width x 8”height color on clear vinyl
5. Communication Design: Website
                                                                                                        "#$%&''' ()*+,-./01)*                           !
                                                                                                            Case Study: iC42
                                                                                                                 When you roll over the logo with the cursor the i’s spins clockwise
iC42 Homepage Design                       3/12/11 2:53 PM                                                       and our 3 key words pop out:
                                                                                                                 individualized medicine, innovation, intelligence,


                                                                                   Current logo




                                                                                                                                                         individualized medicine




                                                                                          innovation

                                                                                                                                                                                        intelligence

                                                                      C42
                                                                 www.bioanalytics.us
                                                                                            integrated solutions in systems biology
                                                                                            clinical research & development

                                                                                                                                                                                        !
                                                                            !!!!!!!!                                                !!!!!
                                                                                                                      LABORATORY REQUISITION

                                                                        SERVICE REQUESTED BY:                           !!!!!!!!!!!!!!!!!!            BILLING INFORMATION:                        !
                                                                      ! Name         ! !   !                      !            !           !       !! Name!     !   ! !    !        !       ! !           !       !   !   !
                                                                        Address    !                                                                  Address     !

                                                                       Phone                                                                         Phone
                                                                       Email                                                                   !       !
                                                                                                                                                     Email  !    !     !
                                                                                                                                                                                 !                    !
                                                                       Budget
                                                                                                                                                                            !!
                                                                                                                                                                             !
                                                                                                                                                     PROFORMA INVOICE WILL BE SENT



                                                                                                  ! !                                    !                         SEND SAMPLES TO:
                                                                      CHECKLIST BEFORE SENDING SAMPLES:
                                                                      PO or Service Agreement accepted by iC42                                                     iC42 Laboratory
                                                                      Samples Inventory (excel) emailed to iC42 before samples are shipped                         ATTN: SAMPLE DEPT
                                                                      Laboratory Requisition Form included with samples that are shipped                           Bioscience East, Suite 100
                                                                                                                                                                   1999 Fitzsimons Pkwy
                                                                      all correspondence to uwe.christians@ucdenver.edu                                            Aurora, CO 80045
                                                             !
                                                                                                                                                                   phone 303-724-5665
                                                             !
                                                                                                                                                                                                              !
                                                                                                                      SPECIMEN INFORMATION
                                                             !
                                                                       Routine!!         Stat!

                                                                 # of Samples sent:!"""""""""""""""!
                                                                                    !                        Sample Matrix:! !     URINE! !         PLASMA  !            SALIVA
                                                                                                                                                                          !
                                                                 !                                                             !                                        !
                                                                 Storage Instructions:_________________________________          Freezer Location/Intials___________________(iC42)
                                                                 Test Requested:!!!
                                                                 !
                                                                    Bioanalytical Analysis        Vitamin D          Therapeutic Panels                Clinical Therapeutic Monitoring
                                                                                                                                                                  !
                                                                    please specify:                                   please specify:                  please specify:
                                                                                                                                                         !

                                                                  Additional test(s) requested: """""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""
                                                                                                                                                                                 !
                                                                  !"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""
                                                                  !
                                                                                                                      REPORTING INFORMATION                            !
                                                                                                        !        !          !           !      !       !         !     !
                                                             !           EMAIL             FAX                  OTHER                   Additional Report(s) to:!"""""""""""""""""""""""""""""""""""""!
                                                                                                                                                               !
                                                             !
                                                                      Please SEND Report(s) to:
                                                                                              !             !          !
                                                                                                                                               Phone: """"""""""""""""""""!!!Fax: """"""""""""""""""""!
                                                             !
                                                             !
                                                             !
5. Communication Design: Diagnostic Tool Product Launches                       !
                                                                       "#$%&''' ()*+,-./01)*
                                                                        Case Study: iC42




                               i
     HyperION
           clinical research & development




                                                            intelligent sample kits
!
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Case Study: Book Illustrations
4. Communication Design : Medical Book Illustrations

                                                                  Proteomics and the Kidney      105                                                          Proteomics and the Kidney      107




           Figure 4.1 Time-dependency of kidney tubular epithelium injury and molecular
           markers in urine.13,14 Injury will affect cell function before histological and patho-
           physiological damage can be detected. At an early point in the process, this is re ected
           in protein and metabolite patterns in urine, as absorption and excretion are altered,
           repair proteins are formed and cells release proteins into urine. The resulting extent of
           urine metabolite and protein pattern changes depends on the intensity of the injury
           and how many cells/tubules are affected. Proteins that have been found to be changed
           in urine and that may serve as early kidney injury markers are listed in Table 4.5 and are
           shown in Figure 4.4. As increasing numbers of cells die by necrosis and/or apoptosis,
           the biochemical phase of injury will progress towards the symptomatic phase. These
           cells will release at least some of their contents, such as metabolites, proteins, RNA and
           DNA, into the urine. Cell death will also trigger secondary reactions such as in am-
           mation and brosis. Once this occurs, a complete recovery may no longer be possible.
           The injury results in histological changes and kidney function will be reduced. It is not
           until the symptomatic phase that currently established diagnostic markers such as
           serum creatinine concentrations and blood urea nitrogen will signi cantly change.
                                                                                                        Figure 4.2 Proteomics sample analysis.17 Proteomics analysis is a multiple step
                                                                                                        procedure that typically involves sample preparation, pre-separation and/or digestion,
               During the biochemical stage, changes in gene expression, protein                        ionization, mass spectrometry analysis, protein identi cation, biostatistics and anno-
           expression and biochemical profiles occur, but the cells and organs are still                 tation. Proteomics strategies can be divided into ‘bottom up’ and ‘top down’
                                                                                                        approaches. Bottom up approaches are most frequently used and involve digestion of
           able to compensate for this. At this stage, an injury process should be
                                                                                                        the proteins of interest and, after mass spectrometry analysis, identi cation of proteins
           detectable if sufficiently sensitive assays are available. During the bioche-                 using database searching based on the detected peptides. Top down proteomics does
           mical phase, no notable histological damage has occurred, and the disease                    not involve a digestion step and analyses the intact proteins. As discussed, both
           process may be fully reversible if an appropriate therapeutic intervention is                strategies have their advantages and limitations.
           available.
Metabolomics and the Kidney   45   90     Uwe Christians, Jeska Albuisson, Jost Klawitter and Jelena Klawitter




                                                                                   Figure 3.6 The role of metabolomics and metabolomics-derived combinatorial
                                                                                   metabolite markers for individualized medicine and molecular epidemiology.
Figure 3.1 Interactions between the mammalian system, the microbial metabolome,
diet and environment.13
                                                                                   information into robust and meaningful clinical information. Another
                                                                                   problem is that most of the hundreds and thousands of data points generated
defined as biological compounds that are generally hydrophobic in nature
                                                                                   are not relevant to the disease or drug effect. Instead of conveying additional
and soluble in organic solvents. Lipids are membrane components, medi-
                                                                                   information they only cause random statistical noise including falsely
ators in cell signaling and are utilized as fuel and energy storage.15 Their       positive results and may mask valid information. However, while non-
distinct solubility properties often require separate extraction and analysis in   targeted ‘omics’ technologies are mostly hypothesis-generating technolo-
metabolomics experiments.14                                                        gies, this information is valuable to develop new targeted diagnostic
    The metabolome is considered the most predictive phenotype and holds           strategies and tools.163
the promise to extensively contribute to the understanding of phenotypic               A ‘bottom up’ approach will start with metabolite markers already
changes as an organism’s answer to disease, genetic changes, and nutritional,      established in clinical practice and will look at them not as single markers but
toxicological, environmental and pharmacological influences.4 Another               will combine them into patterns. New markers that may have been
advantage of metabolomics is that in contrast to genes and proteins,               discovered using non-targeted metabolomics-based discovery may be
metabolites are often tissue- and species-independent. This facilitates            added. This will result in the development of ‘combinatorial biomarkers’.
translation of molecular markers strategies from bench-to-bedside or vice          Those are molecular marker patterns that typically consist of 3e10 indi-
versa,12 which is of advantage for drug development and molecular marker           vidual parameters.164 In general, specific combinatorial biomarker patterns
qualification (see below). Also, while it may take hours, days and sometimes        confer significantly more information than a single measurement and, thus,
weeks for protein and mRNA expression to change in response to a chal-             can be expected to have better specificity and sensitivity than clinical
lenge, metabolic responses can often be measured within seconds or                 chemical and biochemical markers currently used in nephrology. Such
minutes.4
4. Communication Design : Medical Book Illustrations
             108       Uwe Christians, Stephanie McCrery, Jost Klawitter and Jelena Klawitter                                                                    Proteomics and the Kidney     111




             Figure 4.3 Main proteomics strategies.2 The goal of comparative approaches is to
             detect differences between samples and, therefore, requires semi-quantitative
             comparison. Descriptive studies are usually qualitative and provide information about
             which proteins are present in a de ned sample. In either approach, study designs can
                                                                                                           Figure 4.4 Protein markers of kidney injury and their mapping to the nephron.
             be pathway- or non-pathway-driven. Pathway-driven studies are targeted e they focus
                                                                                                           Potential marker proteins frequently mentioned in the literature are shown. Thus, this
             on selected speci c pathways, a protein interaction network or a speci c sub-
                                                                                                           list should not be considered complete. The mapping represents the most abundant
             population of proteins. Some previous knowledge or a hypothesis is required. By
                                                                                                           locations; however, in the case of some proteins, this may be an over-simpli cation. For
             contrast, no prior biological knowledge is used in the design of non-pathway-driven or
                                                                                                           more information about these proteins, please see Table 4.5, page 142.
             non-targeted studies. Global analysis is undertaken (although steps are usually taken to
             reduce sample complexity) and the data generated can be regarded as hypothesis-
             generating. Most clinical protein marker discovery studies have been non-targeted and         intracellular osmolyte concentrations (NUP88) and tight junction integrity
             comparative, and they identify proteins differing between study groups. Often such
                                                                                                           (MUPP1).22 As indicated, these distinct functions require the expression of
             studies do not produce protein identities, but generate algorithms to classify samples
             on the basis of protein separation pro les (‘ ngerprinting’). The output in descriptive       specific sets of proteins. Exact knowledge of these distinct proteomes will not
             studies is a list of proteins. This list typically represents the catalogue of all proteins   only allow for characterizing the type of injury and yield information
             detectable with a particular technology.2                                                     regarding the associated mechanisms, but also for locating the injury. As
                                                                                                           shown in Figure 4.4, patterns of protein kidney injury markers can be
             Proteomics inherently is a hypothesis-generating discovery technology.                        mapped in the nephron.
             Proteomic studies can be classified as comparative studies that try to establish                   As urine can harbor proteins from all kidney subproteomes, and the
             quantitative or qualitative protein differences between samples and                           protein composition of urine is perturbed by kidney injury or disease, the
             descriptive studies that focus on the identification of proteins2 (Figure 4.3).                urine proteome can subsequently signal the status of kidney health as well as
             In both cases, the study designs can be either pathway-driven (targeted) or
!
                                       "#$%&''' ()*+,-./01)*
                                       Case Study: stephanie O.




     stephanie                     .

stephanie O. logo white/Grey PDF
Size: 6.6869” W x 1.7671” H
Typeface: Raleway Thin
Color: White
O logo: Grey, stroke .25
!
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!   Strategy: To become a leader in Denver Fashion. stephanie O. to
    become a black label (custom line) and white label (ready-to-wear
    line). Opportunity: Black label start’s as a custom suiting line
    and the white label to be a high-fashion ready to wear travel
    collection. Once these have reached success, develop further by
                                                                                                    Case Study: stephanie O.

    introducing a bridal collection under the black label and fragrance
    line under the white label to compliment the stephanie O. brand
    conversation.

                                                                          !       Develop Identity: Brand: stephanie O.
                                                                                                    Colors: White, Black, Gray
                                                                                                    Typography: Raleway Thin




!   Brand Mission: Designs for the fashionable, modern woman




!
     stephanie O. Community

            Black Label:
            Age Demographic: All ages
            Fashionable, Modern Women
            Successful Career Women
                                                                               stephanie                                     .
            Collage Graduates Interviewing
            Brides
            Bridal Party
            Mother of the Bride
            Special Occasion

            White Label:
            Age Demographic                                               stephanie O. logo white/Grey PDF
            Fashionable, Modern Women                                     Size: 6.6869” W x 1.7671” H
            Travel Fashionista’a                                          Typeface: Raleway Thin
                                                                          Color: White
            Weekend Fashionista’s                                         O logo: Grey, stroke .25
!        Communication Design: Business Cards & Price Tags

                                      stephanie O. business card design layout and specifiations
                                                                                                                                            !
                                                                                                                          "#$%&''' ()*+,-./01)*
                                                                                                                          Case Study: stephanie O.
3 1/2”
                                                                Business Card (front)
                                                                stephanie O. design

                                                                Size: 1.75” x 3.5”
                                                                Typeface: Raleway Thin
                                                                Logo: Custom O

                                                                                                  5. Communication Design: Fashion Labels


                                                                                                                 stephanie O. clothing label design specifications




             stephanie                        .

                                  1 3/4”                                                                                                       Clothing: Black Label
                                                                                                                                               Custom and Trunk Show Pieces
                                                                                                    stephanie     .
                                                                                                                                               Size: 1.5”W x .5”H
                                                                                                                                               Typeface: Raleway Thin
          ready to wear fashion




                                                                Business Card (back)                                                           Typeface Color: White
                                                                stephanie O. design                                                            O logo color: Light Grey, stroke .25
                                                                                                                                               Color background: Black
                                                                Size: 1.75” x 3.5”
                                                                Typeface: Raleway Thin
                                                                Logo: Custom O
                                                                                                                                               Clothing: White Label
                                                                                                     stephanie        .                        Ready to Wear

                                                                                                                                               Size: 1.5”W x .5”H
                                                                                                                                               Typeface: Raleway Thin
                                                                                                                                               Typeface Color: Black
                                                                                                                                               O logo color: Light Grey, stroke .25
           stephanie Ohnmacht                                                                                                                  Color background: White

           303.549.5320
           stephanie@stephanieodesigns.com
!
"#$%&''' ()*+,-./01)*
Case Study: The Room Tailor
!
                                                                                           "#$%&''' ()*+,-./01)*

!   Strategy: To become a leader in Interior Design Consultation.
    Opportunity: Create a brand identity to compliment The Room
    Tailor, that attracts new business. Marketing design recommended:
    “At your Service” door hangers and custom design canvas totes for
    clients.
                                                                                           Case Study: The Room Tailor




                                                                        !   Develop Identity: Brand: The Room Tailor
                                                                                              Colors: Custom
                                                                                              Typography: Pilo Thin



!   Brand Mission: “the art of living.”




!     The Room Tailor Community

      Homeowners selling their homes
      First time homebuyers
      Contractors
      Architects
      Interior Design Showrooms
      Real Estate Agents
      Wedding Planners
!    Communication Design: Business Cards                                                                           !
                                                                                                           "#$%&''' ()*+,-./01)*
                                                                                                            Case Study: The Room Tailor
Business Cards
Size: 2.5” x 2.5” print 50 of each color




       the art of living                      the art of living      the art of living      the art of living          the art of living


    Front Side




conni newsome                              conni newsome          conni newsome          conni newsome              conni newsome
       720.422.8235                           720.422.8235           720.422.8235           720.422.8235               720.422.8235




Backside
Communication Design: Postcard           !
                                 "#$%&''' ()*+,-./01)*
                                 Case Study: The Room Tailor




                                                  the art of living
Communication Design: Custom Stamp & Ink Colors
                                                                               !
                                                                       "#$%&''' ()*+,-./01)*
                                                                       Case Study: The Room Tailor




                               Pantone Solid to Process 262 EC




                               Pantone Process DS159-2C




                                Pantone Metallic Coated 877 C




                                Pantone Color Bridge CMYK EC 2955 EC




                               Pantone Solid Matte 124 M
!
"#$%&''' ()*+,-./01)*
Case Study: Blues
!
                                                                                       "#$%&''' ()*+,-./01)*

!   Strategy: To become a leader in creative concept development.
    Opportunity: Target the tea and coffee industry.
                                                                                        Case Study: The Room Tailor




                                                                    !   Develop Identity: Brand: Blues
                                                                                          Colors: Custom
                                                                                          Typography: Optima




!    Brand Mission: creative + concept + development




!    Blues Community

     Tea Cafe’s
     Coffee Cafe’s
     Small Business
     Start Up’s
     Tea & coffee product development
     Retail
!   Communication Design: Creative Concept Development Menu                                                                "#$%&''' ()*+,-./01)*  !
                                                                                                                            Case Study: Blues




           $*#-%&'# 3 $),$#4% 3 1#'#.)4/#,%
            !"#$%&'#()$"*#%&+,
            ( ( ( !""#$%&'#()*&+&,-.(/-*0#%&,+(((((((((
                                                                                                       L"$+:(3#'#06GD#+%
                 ( 1#2&+,(3(4*)/)%&),($-/4-&+,25          !6+2#G%(3#'#06GD#+%                          ( ( ( E1#,%&"8&,+(3($*#-%&,+($*#-%&'#(
            -"&'$%#(.$/#0&+,(1(-$2*$,&+,(3#4&,+(          ( ( ( D#'#.)4(-(,#<(*#%-&.($;-&,(3(              ( $),$#4%25
                 ( 6#&,'&+)*-%#(7*-,1(.)8-.%85                 ( $),2:/#*(7*-,15                       )$"*#%(=#4#$"2A( (
            56&+%7)$"*#%&+,(800&$+2#4                     HGG6"%>+&%<(8+$0<4&4                             ( K,1#*2%-,1($),2:/#*2(3(
            ( ( ( 9*#-%#(2:$$#22":.($)..-7)*-%&),2(       ( ( ( >*#,1(E1#,%&=&$-%&),(3(-,-.82&25           ( 4)2&%&),($.&#,%2(%)(7#(*#%-&,#15
                 ( %;-%(-..)<(8):*(7*-,1(%)(=.):*&2;5     .&?#4%<0#()$"*#%&+,                          ;$0#4(3#'#06GD#+%( (
            966:(;%<0&+,                                  (      !2%-7.&2;(3(1#=&,#(%;#($)*#(          (      !'-.:-%#($)/4#%&%&),(3(1#'#.)4(
            ( ( ( (>-0#(4*#2#,%-%&),(%)(-                 (      '-.:#2()"(8):*(7*-,1(%)($*#-%#(       (      #""#$%&'#(2%*-%#+&#25
            ( ( ( ($)/4#%&%&'#(.#'#.5                     (      $:2%)/#*(.)8-.%85                     ;$0#4(;>GG6"%(
            =#4%$>"$+%(1(!$?@()#"2A$+:&4&+,(              ;%"$%#,&2(-0$++&+,
                                                                                                           ( G*)"#22&),-..8(*#4*#2#,%($.&#,%2(
                 ( ?#%('&2:-.(4#*$#4%&),(#,;-,$#(         ( ( ( E1#,%&"8(,#<(/-*0#%2A(.)$-%&),2(
                                                                                                           ( -%(":,$%&),2A(%*-1#("-&*2(3(
                 ( 8):*(7*-,15                                 ( 3(#@4-,2&),()44)*%:,&%&#25
                                                                                                           ( /##%&,+25
            =#%$&0(3#4&,+(1(.$<6>%                        =#%$&0(9"$+2A&4&+,
                                                                                                       ;$0#4(B"$&+&+,
            ( ( ( 9*#-%#(-,(#,+-+&,+(24-$#(%;-%(          (      F22&2%(-,(#@&2%&,+(*#%-&.($;-&,(%)(
                                                                                                       ( ( ( >*-&,(<;).#2-.#(2-.#2(2%-""(3(
                 ( 2:44)*%2(8):*(7*-,1(#@4#*&#,$#5        (      "*-,$;&2#5
                                                          9&+$+2&$0(;#"'&2#4                               ( 1&2%*&7:%)*2(%)(7#$)/#(/)*#(
            !"#$%#(B6(;$'6"                                                                                ( #""#$%&'#(<&%;L(
            ( ( ( ?#-*,(%;#(-*%()"("))1(4-&*&,+5          ( ( ( G*)H#$%(%;#(4*)=&%(4)%#,%&-.()"(
                                                               ( ,#<(3(#@&2%&,+(.)$-%&),25             (      J#*'&$#(J%-,1-*12
            =#%$&0(;&,+$%>"#(C%#D4                                                                     (      >#-M*&2%-(>*-&,&,+
            ( ( ( 9*#-%&'#(2&+,-%:*#(/#,:(&%#/25          )#",#"4(I(82J>&4&%&6+4
                                                                                                       (      N-*&2%-(>*-&,&,+
            )#:&$(-0$++&+,                                ( ( ( G:*$;-2#(3(2#..(.)$-%&),I25            5 ( ( N:&.1&,+(!""#$%&'#(%#-/4
            ( (    9*#-%#(/#1&-(-,1(#'#,%(4.-,2A(         K>$0&%<(8+$0<4&4
                                                                                                       -"62#44(CDG"6'#D#+%
            ( (    %;#,(2##(%;*):+;(&%2(#@#$:%&),5        ( ( ( E/4*)'#(%-2%#(3(C:-.&%85               (      J:$$#22":.()4#*-%&),2(&2(%;#(0#8(
            E#,6%&$%&6+                                   )#+>(;%"$%#,<                                (      %)(.),+#'&%85
            ( ( ( B#+)%&-%#($.&#,%(-,1(1&2%*&7:%)*(       ( ( ( J#%(/#,:(2%*-%#+8(3(4*&$#25            M'#+%()$"*#%&+,
                 ( -+*##/#,%2(<&%;("-')*-7.#(                                                          (      D#'#.)4(3(-1/&,&2%*-%#(
                 ( *#2:.%25                                                                            (      $)/4-,8(#'#,%2(3$)/4#%&%&),25
            90$'6"(-"6F&0#(3#'#06GD#+%
            ( ( ( 9*#-%#(:,&C:#(=.-')*(4*)=&.#25
                                                                    choose blues, contact Paul at 303- 775-3856

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BRAND conversation

  • 1. ! "#$%&''' ()*+,-./01)* communication design that starts a conversation CHRISTY SCHWINDT
  • 2. ! "#$%&''' ()*+,-./01)* ! Strategy + Opportunity 5pt BRAND conversation ! Brand Mission The Mission: To design a brand that drives and motivates consumers. The Notion: 5pt BRAND conversation is a brand ! conversation that is designed to engage consumers with Define Brand Community products and services. Effective communication design creates a dialogue and encourages the consumer to start a conversation about their experience in the brand ! community. Develop Identity “To grow now, companies must innovate and perform on every level, and that is where design comes into play.” - Warren Berger ! Communication Design
  • 3. ! "#$%&''' ()*+,-./01)* Case Study: iC42 C42 www.bioanalytics.us integrated solutions in systems biology clinical research & development
  • 4. ! "#$%&''' ()*+,-./01)* ! Strategy: To become a leader in bioanalytical services. Opportunity: Brand the service center and introduce it’s capabilities to the iC42 community. Case Study: iC42 ! Brand Mission: To serve science with integrated solutions to systems biology. ! iC42 Brand Community University of Colorado Research Community C42 www.bioanalytics.us integrated solutions in systems biology clinical research & development Global Collaborations Novartis Siemens Thermofisher Kaiser Pain Clinics Toxicology Patients Vitamin D Patients Transplant Patients Pediatric Pharmacology ! Develop Identity: Trademarked Brand : iC42 Trademarked Mark for Commerce Trademarked IP for iC42 Trademarked Colors: Custom Yellow, Gray & Black Typography: Myraid Pro
  • 5. ! ! Communication Design: Business Cards "#$%&''' ()*+,-./01)* Case Study: iC42 C42 www.bioanalytics.us integrated solutions in systems biology clinical research & development •Highly Sensitive HPLC, LC-MS, GC-MS Bioanalytics •Complex Assay Development & Validation •GLP Compliant, CAP Accredited, CLIA Certi ed •Quanti cation of Drugs & Metabolites Uwe Christians, MD, PhD, MRQA •Isolation of Drug Metabolites & Structural ID Professor & Laboratory Director •Clinical Therapeutic Drug Monitoring •Complete PK/PD Package Managed Under One Roof SEND SAMPLES TO: •Molecular Marker Discovery, Quali cation Bioscience East, Suite 100 & Development 1999 North Fitzsimons Parkway •Consulting & Strategic Research Partnerships Aurora, CO 80045-7503 email: uwe.christians@ucdenver.edu phone: 303.724.5665 www.bioanalytics.us Communication Design: Highlights from 35 page Service Catalog C42 www.bioanalytics.us integrated solutions in systems biology clinical research & development C42 www.bioanalytics.us integrated solutions in systems biology clinical research & development 1.1 Quantitative Bioanalytical Methods Compound Matrix Sensitivity Instrument ADMA, Homocysteine, Arg Plasma 0.3 M API 4000 Quantitative Bioanalytical Methods Compounds Alfentanil Plasma 0.1 ng/mL API 5000 Aprotinin Tissue (Rat Kidney) 80 ng/mL ELISA Biolimus Blood, Tissue, Stents 0.05 ng/mL API 5000 Cyclosporine / Metabolites Blood 0.1-1.0 ng/mL API 5000 DMXB Plasma/Brains 0.1 ng/mL API 5000 Duet DNA Monocytes Ratio GC-MS Everolimus Blood 0.1 ng/mL API 5000 Felbamate CSF, Brain, Serum 0.1 ng/mL API 5000 Fentanyl Plasma 0.01 ng/mL API 4000 Free-Fatty Acids Plasma, Tissue, Blood 100 M GC-MS GSH Plasma 10 M API 4000 Glucocorticiods Plasma 0.1 ng/mL API 5000 [13C] Glucose Plasma 10 M GC-MS [13C] Glycerol Plasma 10 M GC-MS High Energy Phosphates Tissues 0.25 M API 4000 Summary of Services Isoprostanes Ketamine Ketarolac Plasma, Urine Blood Plasma 0.01 ng/mL 1.0 ng/mL 1.0 ng/mL API 5000 UPLC-MS/MS API 4000 Lamotrigine Plasma 1.0 ng/mL API 4000 Le unomide Blood 0.1 ng/mL API 5000 Lidocaine Plasma 0.5 ng/mL API 4000 Lovastatin Plasma 0.1 ng/mL API 5000 Metabolic Pro ling Plasma, Urine, Tissue _______ Exactive Morphine / Metabolites Plasma 0.25 - 2.5 ng/mL API 5000 MPA Plasma 1.0 ng/mL API 4000 Naltrexone Plasma 0.1 ng/mL API 5000 Nicotine Hair 0.1 ng/mL API 5000 Pravastatin Plasma 0.5 ng/mL API 4000 Phenytoin Plasma 0.1 ng/mL API 5000 PhIP Plasma / Microsomes 0.1 ng/mL API 4000 Bioscience East, Suite 100 Propofol Plasma 0.5 ng/mL API 4000 1999 North Fitzsimons Parkway Sirolimus Tissues / Blood 0.01 ng/mL API 4000 Aurora, CO 80045-7503 Steroid Hormones Plasma 0.1 ng/mL API 5000 303-724-5665 Tacrolimus / Metabolites Blood 0.1 ng/mL API 4000 Temsirolimus / Metabolites Blood 0.1 ng/mL Exactive Valproic Acid Serum 1.0 ng/mL GC/MS Summary of Bioanalytical Services Summary of Services iC42 Colorado, June 2010 iC42 Colorado, June 2010 Vitamin D and Metabolites Plasma 0.1 ng/mL API 5000 7
  • 6. "#$%&''' ()*+,-./01)* ! Case Study: iC42 Communication Design: Email Announcements Communication Design: Student Program Letter Did you know that a comprehensive bioanalytics lab is available to you and is located on the University of Colorado’s Premier Medical Campus? C42 www.bioanalytics.us integrated solutions in systems biology clinical research & development Welcome, we thank you for your interest in iC42. We are looking forward to supporting you and assisting you with your clinical trials as well as providing state-of the-art bioanalytical services. In addition, we are offering you world-class training in clinical research and development. At iC42, you will find abundant opportunities to participate in Highly Sensitive HPLC, LC-MS, GC-MS Bioanalytics clinical, translational and benchtop research activities. Complex Assay Development & Validation GLP Compliant, CAP Accredited, CLIA Certi ed SEND SAMPLES TO OR VISIT US AT: iC42 Clinical Research & Development is a regulatory compliant mass spectrometry laboratory (cGLP Quanti cation of Drugs & Metabolites Bioscience East, Suite 100 complaint, CAP accredited and CLIA certified) with currently 17 mass spectrometers and is part of the Isolation of Drug Metabolites & Structural ID 1999 North Fitzsimons Parkway Department of Anesthesiology. We are a unique clinical research and development facility that Clinical Therapeutic Drug Monitoring Aurora, CO 80045-7503 combines quantitative mass spectrometry (drugs, drug metabolites, other small molecules and large Complete PK/PD Package Managed Under One Roof molecules, endogenous compounds), metabolic and protein profiling technologies all under one roof. Molecular Marker Discovery, Quali cation & Development We are designed and uniquely qualified to carry out the bioanalytics for complex clinical trials involving drug quantification and molecular marker strategies. In addition, iC42 carries out research Consulting & Strategic Research Partnerships and development projects including: molecular marker discovery and qualification, translational research, strategy development and the identification of molecular mechanisms. Projects range from For more information or to schedule a lab tour please email: the development and validation of assays and strategies with only a few study samples and clinical therapeutic drug monitoring to serving as the central laboratory for phase III clinical trials with more christy.schwindt@ucdenver.edu than 50 clinical centers and more than ten thousand samples. In addition to research and bioanalytical services, activities include consulting and interactions with regulatory agencies. iC42 is committed to advancing individual medicine by examining the unique biology of an individual to assess truly personalized treatments. Other major foci are the evaluation of pediatric pharmacokinetics, the development of clinical management tools for pediatric patients, advancement in transplantation and drug metabolism. In addition, we promote and enhance research through the Colorado Center for Transplantation Care, Research and Education and the Colorado Center for the Advancement of Pediatric Pharmacology. For additional information please contact: Jaimie Henthorn 303-724-5663 jaimie.henthorn@ucdenver.edu and please visit us at www.bioanalytics.us Sincerely, Uwe Christians MD, PhD, MRQA iC42 Laboratory Director “Where the future is made today…” - Dr. Bunsen Honeydew
  • 7. Communication Design: USB Business Cards "#$%&''' ()*+,-./01)* ! Case Study: iC42 C42 www.bioanalytics.us C42 www.bioanalytics.us SEND SAMPLES TO: Bioscience East, Suite 100 1999 North Fitzsimmons Parkway Aurora, CO 80045 (303) 724-5665 Communication Design: 8” x 8” Marketing Conference Cards pediatric pharmacokinetics Dr. Galinkin is a leader in the eld of Pediatric Pharmacology and Anesthesiology, he is a leader in pediatric research here at the University of Colorado. Internationally, Dr. Galinkin is recognized for his expertise in pediatric pharmacokinetics. He discover integrity intelligence innovation integrated solutions in systems biology Extensive Experience & Interactions with Small Biotech C42 clinical research & development integrated Solutions in Systems biology biotech pharmaceutical academia regularly lectures at international scienti c meetings and locally on drug pharmacokinetics. Companies He has designed and conducted many clinical studies in all stages of clinical development and We are a unique comprehensive facility that combines quantitative mass spectrometry, has served on multiple steering committees for multi center trials and for multiple contact Bench top-to-Bed Drug metabolic and protein pro ling technologies in a regulatory compliant environment. pharmaceutical company studies. Metabolism Studies We are designed and uniquely quali ed to carry out the bioanalytics for complex clinical trials involving drug quanti cation and molecular marker strategies. In C42 Locally, Dr. Galinkin is one of the Chairs of the IRB for the University of Colorado. He also co- Consulting & Strategic Research addition, iC42 carries out research and development projects including: molecular chairs the Scienti c Advisory Committee for the University of Colorado’s Clinical Translational Partnerships marker discovery & quali cation, translational research, strategy development and the Science Institute, a NIH funded vehicle that provides infrastructure to clinical investigators identi cation of molecular mechanisms. Projects range from the development and throughout the University. Additionally, Dr. Galinkin is the Chair of the Pharmacy and Complete Molecular Marker validation of bioanalytical assays and strategies to serving as the central bioanalytical Therapeutics Committee at The Children’s Hospital. Discovery, Quali cation & laboratory for phase III clinical trials with more than 50 clinical centers and more than contact us for... www.bioanalytics.us Development ten thousand samples. In addition to research and bioanalytical services, activities include consulting and interactions with regulatory agencies. design & conduct of Clinical Therapeutic Drug pediatric pharmacokinetics Monitoring pharmacogenomics pharmocokinetics pharmacodynamics phone: 303-724-5665 clinical trials in pediatric populations Novel Translational Technologies drug metabolism phase I clinical trials email: christy.schwindt@ucdenver.edu in a GLP-Compliant Environment highly sensitive LC/MS assays in low volume samples predictivedrug eluting stents biomarkers Complete PK/PD package in a regulatory compliant environment Managed “Under One Roof” bioanalytics in plasma samples & dry blood spots on lter paper visit us at Bioscience East, Suite 100 1999 N. Fitzsimons Parkway Complex Assay Developments & Validations metabolomics development of new pain management strategies population pharmacokinetics pediatric drug metabolism studies Aurora, CO 80045 High-Impact Publications & Presentations pk/pd studies proteomics www.bioanalytics.us isolation of drug metabolites !"##$%&#$'(%()#*$+,($-.//0$1$2,34 phone: 303.724.5665 email: christy.schwindt@ucdenver.edu
  • 8. Communication Design: Interior Signage ! "#$%&''' ()*+,-./01)* Case Study: iC42 C42 www.bioanalytics.us integrated solutions in systems biology clinical research & development 50”w x 20”h Entry Wall color on clear vinyl 50” x 20” Entry Wall color on clear vinyl discover integrated solutions in systems biology 15” diameter color LOGO on clear vinyl to be used on all (5) entry doors. Needs to be removable 20” diameter color LOGO on clear vinyl 15”w x 8”h Entry Door color on clear vinyl to be used on all (5) interior windows. Needs to be removable 15”width x 8”height color on clear vinyl
  • 9. 5. Communication Design: Website "#$%&''' ()*+,-./01)* ! Case Study: iC42 When you roll over the logo with the cursor the i’s spins clockwise iC42 Homepage Design 3/12/11 2:53 PM and our 3 key words pop out: individualized medicine, innovation, intelligence, Current logo individualized medicine innovation intelligence C42 www.bioanalytics.us integrated solutions in systems biology clinical research & development ! !!!!!!!! !!!!! LABORATORY REQUISITION SERVICE REQUESTED BY: !!!!!!!!!!!!!!!!!! BILLING INFORMATION: ! ! Name ! ! ! ! ! ! !! Name! ! ! ! ! ! ! ! ! ! ! ! Address ! Address ! Phone Phone Email ! ! Email ! ! ! ! ! Budget !! ! PROFORMA INVOICE WILL BE SENT ! ! ! SEND SAMPLES TO: CHECKLIST BEFORE SENDING SAMPLES: PO or Service Agreement accepted by iC42 iC42 Laboratory Samples Inventory (excel) emailed to iC42 before samples are shipped ATTN: SAMPLE DEPT Laboratory Requisition Form included with samples that are shipped Bioscience East, Suite 100 1999 Fitzsimons Pkwy all correspondence to uwe.christians@ucdenver.edu Aurora, CO 80045 ! phone 303-724-5665 ! ! SPECIMEN INFORMATION ! Routine!! Stat! # of Samples sent:!"""""""""""""""! ! Sample Matrix:! ! URINE! ! PLASMA ! SALIVA ! ! ! ! Storage Instructions:_________________________________ Freezer Location/Intials___________________(iC42) Test Requested:!!! ! Bioanalytical Analysis Vitamin D Therapeutic Panels Clinical Therapeutic Monitoring ! please specify: please specify: please specify: ! Additional test(s) requested: """"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""" ! !""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""" ! REPORTING INFORMATION ! ! ! ! ! ! ! ! ! ! EMAIL FAX OTHER Additional Report(s) to:!"""""""""""""""""""""""""""""""""""""! ! ! Please SEND Report(s) to: ! ! ! Phone: """"""""""""""""""""!!!Fax: """"""""""""""""""""! ! ! !
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  • 12. 4. Communication Design : Medical Book Illustrations Proteomics and the Kidney 105 Proteomics and the Kidney 107 Figure 4.1 Time-dependency of kidney tubular epithelium injury and molecular markers in urine.13,14 Injury will affect cell function before histological and patho- physiological damage can be detected. At an early point in the process, this is re ected in protein and metabolite patterns in urine, as absorption and excretion are altered, repair proteins are formed and cells release proteins into urine. The resulting extent of urine metabolite and protein pattern changes depends on the intensity of the injury and how many cells/tubules are affected. Proteins that have been found to be changed in urine and that may serve as early kidney injury markers are listed in Table 4.5 and are shown in Figure 4.4. As increasing numbers of cells die by necrosis and/or apoptosis, the biochemical phase of injury will progress towards the symptomatic phase. These cells will release at least some of their contents, such as metabolites, proteins, RNA and DNA, into the urine. Cell death will also trigger secondary reactions such as in am- mation and brosis. Once this occurs, a complete recovery may no longer be possible. The injury results in histological changes and kidney function will be reduced. It is not until the symptomatic phase that currently established diagnostic markers such as serum creatinine concentrations and blood urea nitrogen will signi cantly change. Figure 4.2 Proteomics sample analysis.17 Proteomics analysis is a multiple step procedure that typically involves sample preparation, pre-separation and/or digestion, During the biochemical stage, changes in gene expression, protein ionization, mass spectrometry analysis, protein identi cation, biostatistics and anno- expression and biochemical profiles occur, but the cells and organs are still tation. Proteomics strategies can be divided into ‘bottom up’ and ‘top down’ approaches. Bottom up approaches are most frequently used and involve digestion of able to compensate for this. At this stage, an injury process should be the proteins of interest and, after mass spectrometry analysis, identi cation of proteins detectable if sufficiently sensitive assays are available. During the bioche- using database searching based on the detected peptides. Top down proteomics does mical phase, no notable histological damage has occurred, and the disease not involve a digestion step and analyses the intact proteins. As discussed, both process may be fully reversible if an appropriate therapeutic intervention is strategies have their advantages and limitations. available.
  • 13. Metabolomics and the Kidney 45 90 Uwe Christians, Jeska Albuisson, Jost Klawitter and Jelena Klawitter Figure 3.6 The role of metabolomics and metabolomics-derived combinatorial metabolite markers for individualized medicine and molecular epidemiology. Figure 3.1 Interactions between the mammalian system, the microbial metabolome, diet and environment.13 information into robust and meaningful clinical information. Another problem is that most of the hundreds and thousands of data points generated defined as biological compounds that are generally hydrophobic in nature are not relevant to the disease or drug effect. Instead of conveying additional and soluble in organic solvents. Lipids are membrane components, medi- information they only cause random statistical noise including falsely ators in cell signaling and are utilized as fuel and energy storage.15 Their positive results and may mask valid information. However, while non- distinct solubility properties often require separate extraction and analysis in targeted ‘omics’ technologies are mostly hypothesis-generating technolo- metabolomics experiments.14 gies, this information is valuable to develop new targeted diagnostic The metabolome is considered the most predictive phenotype and holds strategies and tools.163 the promise to extensively contribute to the understanding of phenotypic A ‘bottom up’ approach will start with metabolite markers already changes as an organism’s answer to disease, genetic changes, and nutritional, established in clinical practice and will look at them not as single markers but toxicological, environmental and pharmacological influences.4 Another will combine them into patterns. New markers that may have been advantage of metabolomics is that in contrast to genes and proteins, discovered using non-targeted metabolomics-based discovery may be metabolites are often tissue- and species-independent. This facilitates added. This will result in the development of ‘combinatorial biomarkers’. translation of molecular markers strategies from bench-to-bedside or vice Those are molecular marker patterns that typically consist of 3e10 indi- versa,12 which is of advantage for drug development and molecular marker vidual parameters.164 In general, specific combinatorial biomarker patterns qualification (see below). Also, while it may take hours, days and sometimes confer significantly more information than a single measurement and, thus, weeks for protein and mRNA expression to change in response to a chal- can be expected to have better specificity and sensitivity than clinical lenge, metabolic responses can often be measured within seconds or chemical and biochemical markers currently used in nephrology. Such minutes.4
  • 14. 4. Communication Design : Medical Book Illustrations 108 Uwe Christians, Stephanie McCrery, Jost Klawitter and Jelena Klawitter Proteomics and the Kidney 111 Figure 4.3 Main proteomics strategies.2 The goal of comparative approaches is to detect differences between samples and, therefore, requires semi-quantitative comparison. Descriptive studies are usually qualitative and provide information about which proteins are present in a de ned sample. In either approach, study designs can Figure 4.4 Protein markers of kidney injury and their mapping to the nephron. be pathway- or non-pathway-driven. Pathway-driven studies are targeted e they focus Potential marker proteins frequently mentioned in the literature are shown. Thus, this on selected speci c pathways, a protein interaction network or a speci c sub- list should not be considered complete. The mapping represents the most abundant population of proteins. Some previous knowledge or a hypothesis is required. By locations; however, in the case of some proteins, this may be an over-simpli cation. For contrast, no prior biological knowledge is used in the design of non-pathway-driven or more information about these proteins, please see Table 4.5, page 142. non-targeted studies. Global analysis is undertaken (although steps are usually taken to reduce sample complexity) and the data generated can be regarded as hypothesis- generating. Most clinical protein marker discovery studies have been non-targeted and intracellular osmolyte concentrations (NUP88) and tight junction integrity comparative, and they identify proteins differing between study groups. Often such (MUPP1).22 As indicated, these distinct functions require the expression of studies do not produce protein identities, but generate algorithms to classify samples on the basis of protein separation pro les (‘ ngerprinting’). The output in descriptive specific sets of proteins. Exact knowledge of these distinct proteomes will not studies is a list of proteins. This list typically represents the catalogue of all proteins only allow for characterizing the type of injury and yield information detectable with a particular technology.2 regarding the associated mechanisms, but also for locating the injury. As shown in Figure 4.4, patterns of protein kidney injury markers can be Proteomics inherently is a hypothesis-generating discovery technology. mapped in the nephron. Proteomic studies can be classified as comparative studies that try to establish As urine can harbor proteins from all kidney subproteomes, and the quantitative or qualitative protein differences between samples and protein composition of urine is perturbed by kidney injury or disease, the descriptive studies that focus on the identification of proteins2 (Figure 4.3). urine proteome can subsequently signal the status of kidney health as well as In both cases, the study designs can be either pathway-driven (targeted) or
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