 Inteleos User Guide
Version 1.1, updated August 2006
IMPORTANT NOTICE BEFORE USING INTELEOS · Inteleos is built for 1024x768 pixel resolution · Java script must be enabled in your Internet browser · Java JRE applet must be installed · Cookies need to be activated · Your Internet security software must allow pop-up windows from Inteleos · Inteleos uses US English spelling – important for searching terms
1.1 Access via User name and Password 1.2 Access for user with IP-access 1.2.1 IP-users: creating your user profile 2.4.2 Adding terms to your watch lists 2.4.3 Editing terms and watch lists 2.4.4 Deleting terms and watch lists 2.5.4 Viewing content items in the folders 2.5.5 Managing content items in the folders 2.6.2 Group folder creation and view 2.6.3 How to share content items with other group members 2.6.4 Unsubscribing from a group 3.1.1 Parent and child term relationships 3.2.1 Exporting search results 3.2.2 Saving search queries and exports 4.1.1 How to use the Drill-Down Analysis 4.2.1 How “Comparison Analysis” works
1 USER ACCESS1.1 Access via User name and Password· To prevent having to login for following visits, we recommend you check the “Remember Me” box beneath the login fields. A “cookie” will be downloaded onto your computer and will recognize you on your next visit (see Elsevier Privacy Policy for information about “cookies”) · Before accessing Inteleos it is necessary to read and accept the terms of the Registered User Agreement. To accept, check the box and click the now activated “Agree” button · If you forget your user name or password, click the “Forgotten password” icon and enter your email address into the field provided; an email will be sent to you notifying you of your new password · To change your password or any of your personal details, go to “My Profile” · If you have any difficulties, please email us at inteleos@elsevier.com or call one of our Helpdesk Operators 1.2 Access for user with IP-access· You have entered Inteleos as an anonymous group member and can only utilize the standard features once you have set-up your own user profile. We highly recommend all users set-up their own profile within Inteleos to make use of our state-of-the art personalization and alerting features, “My Watch Lists” and “My Folders”
1.2.1 IP-users: creating your user profile· Go to “My Profile”, you will be prompted to either login with a user name and password or create a user profile · Click on the icon to create a new user profile and enter your details into the fields provided. Click “Create” to save your details · Once your profile has been successfully created you will automatically enter Inteleos · Before accessing Inteleos it is necessary to read and accept the terms of the Registered User Agreement. To accept, check the box then click the now activated “Agree” button · Subsequent visits to Inteleos will take you to the generic workspace; to automatically see your own workspace go to “My Profile” and in the first screen check the “Remember Me” box. A “cookie” will be downloaded onto your computer and will recognize you on your next visit (see Elsevier Privacy Policy for information about “cookies”) · If you forget your user name or password, click the “Forgotten password” icon and enter your email address into the field provided; an email will be sent to you notifying you of your new password · Once you have created your personal profile you can change your password or any of your personal details by clicking on “My Profile” and click "Update" to save · IP-access also entitles you to be part of a user group(s) (see “My Groups”) · If you have any difficulties, please email us at inteleos@elsevier.com or call one of our Helpdesk Operators
2 MY WORKSPACE“My Workspace” is personalized to each user and collates and organizes information of high interest in “My Watch Lists” and “My Folders”. Selected new articles on drug development activities and conference reports are also available. The personalized section on the left of the screen uses expandable and collapsible icons for easy viewing. Click on the minus icon (-) next to the section heading to collapse the section. To expand again, click the plus icon (+).
· Inteleos runs an automatic check on all records that are new or have been updated within the product every 7 days. Should one of these terms be included in a watch list you have created or part of a search result that has been saved then it is possible to view these changes online (see next sections). · Notifications of changes are displayed as “View Changes” next to the term or search result in your workspace · To view the records that have been updated, click “View Changes”, updates are highlighted in red text on screen
2.1 Latest NewsThis is available on “My Workspace” and is a rolling list of selected articles from key Elsevier publications during the previous 30 days. The news feature is covered in more detail further in the guide (see “News”).
2.2 Quick Search“Quick Search” is located in the main menu bar and accessible from each page. This is a free-text search feature and will retrieve any drug record that contains one or more of the search terms used. For more complex searching use the feature “Search” in the main menu.· Enter your term(s) into the Quick Search field · You can use more than one term by using the operators AND, OR, and NOT between words · To search the drug records or news articles select either “Drug” or “News” from the drop-down box · Click the arrow icon to begin searching. All records retrieved will be displayed on screen
SEARCH TIPS: · Only one operator can be used within a search query, i.e. Phase II NOT Phase III · “Quick Search” is not case sensitive
An ontology file of 1.25 million terms has been applied to “Quick Search”; this means that should you enter a term that is not found in Inteleos, our ontology file will search for like-words. For example: enter “heart attack” and you would normally receive zero results, but using the ontology file it matches “heart attack” with “myocardial infarction” and returns an extensive list of records.
Defining Ontology: "An ontology can be compared to a dictionary or glossary, but has greater detail and structure enabling computers to process its content. An ontology consists of a set of concepts, relations, and axioms that formalize a specific domain, such as medical or healthcare."
2.3 Recent SearchesAvailable as a link in the main menu, “Recent Searches” stores all search queries created during a single Inteleos session. IMPORTANT: these queries will be lost when you log-out. Save the queries to “My Folders” to prevent loss. · Click “Recent Searches” to view all searches created during the session · Click on a search query to view the results generated by that search
2.4 My Watch ListsWatch lists provide shortcuts to records that have a special interest to you. Items included in a watch list are based on the drug name, company, or therapy area fields. There is no limitation on the number of watch lists, or number of items included in a watch list. Inteleos provides alerts weekly online and via email notifying users of changes to records within their watch lists and what those changes are. If you do not wish to receive notification by email, go to “My Profile” and uncheck the box in “My Preferences”.
2.4.1 Creating watch lists· Click “My Watch Lists” from the menu · In the section “Add New Watch List”, enter name and a description (optional) of your new watch list into the associated fields · In the Status Field, select “Active”. Active indicates that the system will monitor the terms within the watch list and notify you of any changes. Inactive indicates that you no longer wish to receive updates from the watch list · Click “Add” to create the watch list · The watch list can also be viewed from “My Workspace”
2.4.2 Adding terms to your watch lists· Select the watch list you wish to add terms to and click “Edit” · Select “Drug”, “Company” or Therapy Area from the “Watch List Type” drop-down list and click “Update”. This determines the list of terms you will select from · In the section “Add New Term”, click “Select Terms”; a pop-up window will appear · The pop-up window will display a list of terms specific to the “Watch List Type” selected. You can add terms from the list in 3 ways: - Select a letter from the alphabet and the list will display all terms starting with that letter; scroll through the list - Select a letter from the alphabet list and then type directly into the field, the list will filter based on your entry - As above, but check the “Containing” radio button in case you aer unsure of the exact spelling · Once the correct term has been found double-click on it, or highlight the term and click “Add”. The term will appear in the lower field · When all terms within that “Watch List Type” have been added to the lower field, click “Apply”; this will close the pop-up window and the terms will appear in the “Select” field · Click “Add” to move your selected terms to your watch list displayed on the right of the screen · Terms from drug, company or therapy area fields can be combined into a watch list. To do this repeat as above, selecting a different “Watch List Type” from the menu; click “Update”, click “Select” to open a new pop-up window, find the terms and move them into the lower field; click “Apply” to move the terms to the “Select” field and then “Add” to include your selected terms into the watch list
SEARCH TIPS: Using the “Starting with” or the “Containing” in your search often produces different search results, as containing will find all terms including the word
2.4.3 Editing terms and watch lists· Select the watch list you wish to edit and click “Edit” · A new screen called “Edit Watch List” appears; here you can change the name, description, status (Active/Inactive), click “Update” to save · The right of the screen displays the individual terms, it is possible to edit the description and status fields specific to each term · Click “Update” on the right of the screen to save the changes to terms
2.4.4 Deleting terms and watch lists· To delete term(s) from a watch list, check the box(es) to the left of the term and click “Delete” located beneath the check boxes · To delete an entire watch list, click “My Watch Lists” from the menu and click “Delete” located next to the name of the watch list
2.5 My FoldersFolders can be created to save and organize search queries and/or exports of content or graphics. Changes to search query results can be automatically tracked over time and compared to the original document.
2.5.1 Creating folders· Click “My Folders” from the menu · Click “Add Folder” and complete the fields listed, the description field is optional · It is possible to create a hierarchy amongst the folders. In the “Parent” field select “none” for the highest level. To create a subfolder, select the parent folder from the drop-down box · Click “Create” · See Saving search queries and exports
2.5.2 Edit and manage folders· Click “My Folders” from the menu · Folders with hierarchy display a plus icon next to the folder name (+); click the icon to expand the hierarchy · To modify the details of a folder (name, note/description, parent), click “Edit” · Click “Update” to save · See Viewing content items in the folders
2.5.3 Deleting folders· Click “My Folders” from the menu · Expand folders to view the hierarchy, click “Delete” to the right of the folder name you wish to delete. Inteleos will ask you to confirm that you wish to delete the folder and its contents, click “Delete” again. IMPORTANT: deleting a folder will also delete any child folders and associated saved items as well
2.5.4 Viewing content items in the folders· Click on a folder icon to display any hierarchy and/or click on the folder name to view its contents · The contents are displayed to the right side of the screen · Folders can contain results from saved search queries and export files – Click the item name, a new screen appears called “Saved Search Result” – ”Query Information” shows the properties of the search query, including the creation date and when it was last updated by the system – “Check changes” identifies the frequency of the automated updates (weekly, biweekly or monthly). To set or modify the frequency, select the period from the drop-down box and click “Update” – “View current results”, click to run the query in real time – “Saved Results and Changes” is displayed on the right of the screen and operates when “Check changes” is active – “Saved Date” identifies when the query was last run – “Results” links to the search results as they were per the saved date – “Changes” links to a MS Excel sheet that highlights the new records or changes to existing drug records within your search query. If “N/A” is displayed, no new changes have been detected since the previous query date – Click “View Results” and the screen will revert to the “Search Results” page and display the records. Click the back button in your browser to return to the overview screen or “My Folders” if you wish to view other content items – To delete the saved query, check the box next to the query name and click “Delete” located beneath the check boxes
2.5.5 Managing content items in the folders· Click on the folder that you wish to view · In the right of the screen, check the box next to the search query or export you wish to modify and carry out one of the following actions: - Click “Move” to move an item to a different folder. Select the name of the folder you wish to move your content item to from the drop-down box - Click “Share” if you have rights to share documents with other users (see “My Groups”), select the user group from the drop-down list - Click “Delete” to delete an item from a folder
2.6 My GroupsThis feature is for users who are part of a multi-user subscription agreement or have IP-access. “My Groups” is a way for you to share your search queries or exported reports with other users within your Organization. The Inteleos team will create groups in collaboration with your internal Administrator. Each group requires a Moderator, often somebody within the Organization, who sets-up and manages folders in which users can place their content items for sharing. The Inteleos team can also create folders for your group(s) if an internal Moderator can not be found.
For example, we can set-up a group “Company X”, allowing all users who have access to Inteleos within Company X to share content items with each other. It is also possible within Company X to create sub-groups per division, project team, etc. This will allow users who are assigned to this sub-group to share with other group members rather than all Company X users. For users with IP-access, the latter option is only available if users set up their own personal profiles. The Inteleos team can then assign these users to sub-groups.
· Click on “My Groups” to see the group you have access to · Click on a Group name to see the folder structure and click on the folder name to see any content items within (this functions as “My Folders”)
2.6.1 Group ModeratorThe Moderator has additional rights within Inteleos. The role is to organize and manage the folder structure for the group(s). The users can share their saved search queries with other users by placing them into one of the folders created.
2.6.2 Group folder creation and view· Click “My Groups” from the menu · Users will see the groups they have access to - Click on the name of the group to view the group folders. If a group folder contains a content item it will also be displayed on your workspace · Moderators will see the groups they have access to and also an “Add” button - To view the contents of a group follow the actions listed above for a User - To create new folders, click “Add”
2.6.3 How to share content items with other group members· This feature is only available to users who have group access rights. If you want more information contact inteleos@elsevier.com · Click “My Folders” from the menu · View the content you wish to share; first click on the folder icon, if you have set-up a hierarchy; then click on the folder name to display the content items on the right of the screen · The group folders available to you are listed in a drop-down box to the left of the “Share” icon · Check the box next to the search query or export; select the group folder you wish to move the content item to and click “Share” · Other users who are members to this group will now see the shared search queries on their workspace; shared exports can be viewed from “My Groups” only · NOTE: only the Group Moderator can determine the automated alerting frequency for saved search queries shared with the group. Group members will receive notification by email or on their workspace based on the personal preferences they have set-up (see “Preferences”)
2.6.4 Unsubscribing from a groupUsers may choose to unsubscribe from a group if they wish. · Click “My Groups” from the menu · Check the box next to the group(s) you wish to unsubscribe from · Click “Unsubscribe”
Please contact inteleos@elsevier.com if you wish to set-up groups for your Organization or need any assistance.
2.7 My ProfileThis feature allows you to manage your own personal data, including modifying your password. You can also manage how you view the information on “My Workspace” and the format of alerts received. The screen displays the user’s personal details and preferences. · Select “My Profile” from the menu· My Information- Displayed on the left of the screen - To update, change the information within the appropriate fields - Click “Update” to save - Check the box to receive information about other Elsevier products · Preferences- Select your alerting preference i.e. by email, when in Inteleos or both, from the “Notify Me” drop-down box - Manage the number of items displayed per watch list or folder on your workspace - Click “Update” to save
2.8 User Tips? icon displays short descriptions about the page it is appearing on. To view the description, place your mouse over the icon
2.9 LogoutClick here to end your Inteleos session. In order to maintain security levels your session will time-out after 60 minutes of inactivity within Inteleos (see Security measures for more information) IMPORTANT: Any search queries listed in “Recent Searches” will be deleted if your session times out or you logout (see Saving search queries and exports)
3 SEARCHOur search features enables you to investigate simple and complex scenarios; giving you the choice to decide what fields you wish to include and how you want to combine them. Inteleos offers 2 types of search: “Quick Search” for free-text searching of records or news items, and “Search” for more comprehensive searching in key fields.
3.1 Search· Click “Search” from the main menu. The screen is split into two sections; the left view is for selection of terms to be used in the search query; the right view is the collation of terms for inclusion in your search query · Click “Select Field” and select a field you wish to use in your search from the drop-down box. The search terms associated with the selected field will appear in the field below. · Select the terms you wish to include in your search query. Terms can be found by: - Selecting a letter from the alphabet list, for example “B” and scroll through all the terms beginning with B - Typing directly into the text field; this will activate the word wheel to find the term you are looking for - Typing directly into the field, but selecting the ‘Containing’ radio button; only terms that contain the phrase entered will be displayed - If viewing the hierarchy structure (therapy area, company, country), add a keyword into the field to find all terms that apply · Once the term is found double-click on it or highlight it and click “Add”; both actions move the term into “My Search Query” on the right of the screen · To combine terms from multiple fields select a new field from the “Select Field” drop-down box, identify the terms in the list and move them into “My Search Query”. This also applies to Advanced Search · To remove terms from “My Search Query” double-click the term or highlight it and click “Delete” · Select the number of records you wish displayed per search results screen from the drop-down box located below “My Search Query” · When your search query is complete, click “Begin Search”
SEARCH TIP: · If combining terms from different fields, the AND operator is used (for example, heart failure AND Phase II). For terms from the same field, the OR operator is used (for example, Phase I OR Phase II, heart failure OR hypertension) · Use “Quick Search” to combine different fields with the OR or NOT operator
3.1.1 Parent and child term relationshipsInteleos uses a complex system of content relationships. The search fields “Therapy Area”, “Company”, and “Country/Region” all display varying levels of hierarchical relationships. These fields are represented in two ways, as a straight forward list of terms or with the hierarchical structure included. · To select terms from the list and include the subcategories that are linked, check the box “Include sub-categories” located above the “My Search Query” field · To include terms from the hierarchy view, double-click on the term, the inclusion of subcategories is defaulted for the hierarchy views, but the box can be unchecked if you prefer to only include the higher term IMPORTANT: the check box is not specific to the term selected, but to all terms included in the search that have a hierarchy Field hierarchy: · Therapy Area: this field is indexed using Elsevier’s EMTREE thesaurus displays a lineal hierarchy between terms. To facilitate searching, the hierarchy includes the higher terms as headings to illustrate the scientific path. For example, physical disease by etiology and pathogenesis · Company: this field includes parent and subsidiary companies. For example, Johnson & Johnson with subsidiaries (sub-categories) including Janssen Pharmaceutica; Ortho-Biotech, etc. · Country/Region: Europe is the only region in our list that displays hierarchy as it reflects the EMEA as a separate regulatory body from the individual countries. Associated child terms of Europe are the 25 member countries of the European Union (see Glossary)
3.1.2 Advanced SearchThe fields listed in Advanced Search were selected following user feedback and will continue to expand as Inteleos develops. · Select “Advanced Search” from the list in the “Select Field” drop-down box · To add terms to “My Search Query”, select the terms you want by checking the relevant box, selecting a term from the drop-down list or entering a date range · Click “Add” IMPORTANT: It is necessary to click “Add” as the double-click action does not function due to the different selection formats in this section. · Fields available are: - New Molecular Entity (select: yes/no) - FDA Orphan Designation (select: yes/no) - EMEA Orphan Designation (select: yes/no) - Fixed-dose combination (select: yes/no) - Product Type (select from the drop-down menu) - Method of Delivery (select from the drop-down menu) - Special Age Population (select from the drop-down menu) - FDA Approval Type (select from the drop-down menu) - FDA Submission (select a date range) - FDA Approval (select a date range) - Estimated User Fee Deadline (select a date range)
3.2 Search Results“Search Results” summarizes the key information available per drug record. · Click the drug name(s) to access the full drug record · Click on the company name to company contact details (headquarters only) · Roll your mouse over the indications that end with”…” to see the full description appear
Links and icons are displayed above the results; these all you to: · “Edit Search Query”, click on the link · Navigate through the next 25 records using the forward and previous arrows · Export to MS Excel, MS Word, Adobe PDF · Save the search query to a folder · Print a print-friendly summary of search results
3.2.1 Exporting search resultsThrough the export feature it is possible to export a range of drug records or a specific drug record. Exporting a range of records enables you to select which records and which fields you wish to include in your report, these will be presented in an excel format and can be saved to a folder or to your computer desktop. · To select specific records from the search you have just performed check the boxes to the left of each record · From the search results screen select the MS Excel icon and a pop-up window will appear with export options · Choose if you wish to export all fields or only selected fields by clicking the relevant radio button · To export only a selected range of fields, click on the fields listed in the box below and click “Add” to transfer them to the right side · If you wish to only include the fields you been checked in the search results screen check the respective radio button · When all selections are complete, click Export · A new pop-up window will open and display the options to save the export to a folder in your workspace or export directly to your computer NOTE: some fields have been grouped for ease and are identified by *. To view the grouping click on the field required and the associated fields will show beneath the box.
3.2.2 Saving search queries and exports· Keep a record of the results from a search query or exports by saving it to “My Folders”. It is necessary to create your folders beforehand · Perform a search and display search results (or click “Recent Searches”) · To save results from a search QUERY - Click on the floppy disk icon displayed above the search results; a pop-up window will open - In the pop-up window, check the boxes of fields you wish to monitor and receive notifications of updates as they are entered into Inteleos - Select the folder you want to store the saved search query in from the drop-down box - Set the frequency (weekly, biweekly or monthly) of the automatic monitoring of updates of the records - Click “Save” - The search query is now found in “My Folders” and “My Workspace” · To save search EXPORT - Click on the icon depicting the format you wish to export to; a pop-up window will open - Follow the instructions on the screen to save the export to your local drive or complete the few fields to save the export into a folder and click “Save” - Once saved, the report can be viewed in “My Folders”
3.3 View a drug recordA drug record offers a detailed overview of the information held in the database. In order to make the information easily digestible, it has been split into 2 tabs: “Development Phase” and “Drug Summary”. · Click on the drug name in the search results view · To export an individual record select one of the export icons (MS word or PDF) in the top-right section of the record 3.3.1 Development StatusThis tracks the clinical development per indication, including filing submission and approvals in the key markets (see Glossary). The content is structured to allow users to peruse the most valuable information quickly in the summary or collapsed indication view. · Click on the + icon to expand the indication to view additional information. For drugs submitted or approved, click on the + icon next to “Approval Process” to expand the regulatory information · “Status Comment” is an editorial field written by Inteleos’ scientific editors and summarizes information known at the time of entry. Wherever possible the source and publication date of the source will be listed (see Sources Used) · “Key Notes” field only appears in drug records that have high priority information impacting the development of the drug or its market status. For example, FDA & EMEA label warnings; withdrawals from market; discontinuation of drug development; major safety issues; companies seeking licensing partnerships, etc. We are in the process of linking all supplementary FDA submission/approval filings with the original filing (e.g. sNDA with relevant NDA). This represents the actual filing information as provided by the FDA and better reflects the development of the drug and the indications is has been approved for or is currently running in trials. For products that have been successful in achieving many additional indications this can result in an expansive “Status Comments” field as it documents the timelines the filings were granted.
3.3.2 Drug Summary“Drug Summary” offers an overview of the properties of the drug. Expansion of the parameters used to define a product will continue and be based on user feedback. · “General Comments” and “Licensing Information” are fields completed by the scientific editors. These are editorial fields used to provide more background to the drug properties or licensing transactions that have occurred
3.4 Company informationClick on a company name listed in the “Search results” or drug record and a pop-up window will appear listing the key contact details for that company. Links to associated companies, such as parent company, are also available.
4 ANALYSISInteleos offers a range of tools available that allow graphical and numerical analysis of the drug records in the database. These analyses can be exported as graphics or as reports. · Drill-Down Analysis · Comparison Analysis · Pipeline Matrix
USER TIP: Inteleos defines the drug products
by their indications; therefore, one product could be represented several times
within a graphic because its indication is expected to file in more than one
country and in different phases or is classified by more than one therapy area.
4.1 Drill-Down AnalysisThis tool allows you to take a large scenario and narrow that down to smaller scenarios by filtering the fields you wish to view, and by grouping the data into different views. · Click “Analysis” from the main menu · Select the “Drill-Down Analysis” radio button · As per the drug search select the field from the dropdown box and add required terms to “My Analysis Query” · Click “Begin Analysis” · These scenarios can be graphically represented three times before you see the individual drug records · At any time you can click “Edit Analysis Query” to modify your search · Exporting a chart or the final drug record summary is possible by clicking on the icon, listed beneath the chart, you wish to export to and following the instructions. The export can also be saved to “My Folders”
4.1.1 How to use the Drill-Down AnalysisThe results from your analysis query can be displayed in various ways. It is possible to change the format of the chart and also group the content in different ways thereby changing the outcome. · “Group by Clinical Phase” is the default content group for the first chart; to modify this, select the required group from the drop-down box above the chart · “Bar Chart” is the default presentation type; to modify this to Pie or Line Chart, select the chart type from the drop-down box above the graphic. If a 2D view is preferred uncheck the 3D box · A legend is visible on the right side of the chart and displays the items on the x-axis · To narrow your findings, double-click on the chart segment you are interested and the next chart will appear. For example, to view all Phase II records in more detail double-click on the Phase II bar, the next chart will contain all drug records identified by your query that have an indication in Phase II development. The query profile is listed in the black bar at the bottom of the chart · The second chart is defaulted to “Group by Therapy Area”; as before you can change the grouping and/or chart type by using the drop-down boxes above this chart · Repeat the process to see the third graph; this is defaulted to “Group by Country/Region” · To see the specific drug records, click on a chart segment and a list of records will appear · Click on a drug name to see the individual drug records
4.1.2 Interactive elementsThe graphics are interactive and it is possible to do the following:· Roll your mouse over each bar column/pie segment/line to view the number of records specific to that item. Rolling over the legend items will offer the same view. · Change the scale of the axes by clicking the lines at each end of the x- or y-axis; holding the left mouse button down, drag the bar horizontally or vertically to see the items move (good eye-sight and a steady hand are required for this feature) IMPORTANT: if more than 15 items are displayed the legend will not appear. To identify the properties of each chart segment place your mouse over the item and a text box will appear 4.2 Comparison AnalysisThis tool provides direct comparison of up to 10 terms. The “Comparison Analysis” tool is most effective when comparing like-terms, but it is possible to create complex scenarios. An example of a simple comparison would be “Pfizer vs. Sanofi-Aventis vs. AstraZeneca vs. Roche vs. Merck”. · Click “Analysis” from the main menu · Select the “Comparison Analysis” radio button · Select the terms you wish to include in your head-to-head comparison and place them in “My Analysis Query” · In “My Analysis Query” 2 fields will appear: “Compare” and “Group by” - “Compare” refers to the field you wish to compare in the analysis; using the example above you would select “Company” from the drop-down box - “Group by” is defaulted to “Clinical Phase” · Click “Begin Analysis” once your query is complete · At any time you can click “Edit Analysis Query” to modify your search · Exporting a chart or the final drug record summary is possible by clicking on the icon, listed beneath the chart, you wish to export to and following the instructions. The export can also be saved to “My Folders”
ANALYSIS TIP: If you are using “Clinical Phase” in the “Compare” field select a different option from the “Group by” drop-down box
4.2.1 How “Comparison Analysis” worksThis tool operates using the same functionality as the “Drill-Down Analysis”; the drop-down boxes above the graphic can modify the grouped field and chart type · The results will be presented only once in a graphical format; double-clicking on a segment will display the list of drug records · Click on a drug name to see the individual drug records
4.3 Pipeline MatrixThe Pipeline Matrix creates a numerical display of the drug records and differs in style and functionality from the other two analysis tools. · Click “Analysis” from the main menu · Select the “Pipeline Matrix” radio button · Select the terms you wish to include and place them in “My Analysis Query” · In “My Analysis Query” two fields will appear: “Column” and “Row”. We recommend you use the defaulted fields at first to understand how the tool works · “Row” is defaulted to “Therapy Area”; to change select a new field from the drop-down box. “Column” is defaulted to “Clinical Phase”; to change select a new field from the drop-down box · Click “Begin Analysis”
A table format will appear listing the content per the rows and columns selected. To modify either, select the term from the drop-down boxes and click “Apply”. To export the results, click the MS Excel icon.
4.3.1 Interactive tipsThe graphic operates using many of the features of MS Excel. · To change the width of the columns, place your mouse over the split between columns and when the horizontal arrow appears, click and move left or right to make the column narrower or wider · Click on the column heading to sort in an ascending or descending order. Zero results are displayed as blank · Apply an alphabetical filter to a column; this is possible on the first column. For example, if you find a specific term, type the first few letters into the last row and press the Enter key. This will display terms that start with or contain the phrase/letters entered. To release, right-mouse-click on the filter cell · Apply a numerical filter to a column; this can be done by entering a distinct number into a column or include the less-than symbol (<) or more-than symbol (>) and click the Enter key
5 NEWSThe latest news will be displayed on your workspace, but a larger collection of articles can be found by clicking on “News” in the main menu.
5.1 News by SourceLists the selected news items by source. Elsevier will continue to expand the sources included within this section. Any name changes made to items within the watch lists will be reflected in the drop-down menu used for filtering. · Select a term listed in the drop-down box in the upper right section of the page. These terms are from your watch lists. Our ontology file links to your selected terms in the watch lists and expands the results retrieved from the filter. · Select “All News” from the drop-down box to return to all articles · Click the link “View All” to see all news articles displayed by source
5.2 News ArchivingThe articles are only available on “My Workspace” for 30 days; this ensures the screen stays current. The articles will be linked to the drug records for an unlimited period of time, or until a decision is made, in conjunction with users, to set a time limit.
6 SOURCES USED· Pharmaceutical & Biotech company annual reports · Pharmaceutical & Biotech company corporate websites · Pharmaceutical & Biotech company press releases · US registered Pharmaceutical & Biotech company SEC filings: 10-K and 10-Q · Pharmaceutical & Biotech company annual reports · Pharmaceutical & Biotech company press releases · US registered Pharmaceutical & Biotech company SEC filings: 10-K and 10-Q · Pharmaceutical & Biotech company corporate website · Elsevier F-D-C Reports Pharmaceutical Approvals Monthly · Elsevier F-D-C Reports The Pink Sheet · Elsevier F-D-C Reports The Pink Sheet Daily · EMEA website · FDA website and advisory committee reviews
7 GLOSSARYThis section provides additional information about the structure of the content and the definitions that have been applied.
7.1 Content FieldsBelow is a breakdown of the content fields (as of July 2006) specific to a drug product during the developmental cycle. Some fields only display if they contain content, e.g. method of delivery and key notes, other fields will only appear at a specific point in the drug development, e.g. submission and approval information.
Per Drug Profile
Per Indication
Indications that are pending approval or approved
7.2 Dates and sources quotedInteleos has several editorial fields. The purpose of these fields is to provide more information beyond that found in the general fields. The information is added by our highly qualified Editorial team and as a rule the date the information was published and the source are included at the end of each update. This is not always possible for drug records that are updated retrospectively, but as a rule if the exact date is known it will be included. Abbreviations have been created for both dates and sources:
*if filing or submission dates are quoted in these sources the information will be added to the status comment and the source and date the information was added to Inteleos will be placed in parentheses.
7.3 Company fields
7.4 EMEAInteleos will expand the fields associated to EMEA submissions and filings. Member countries (per 2006):
7.5 General Comments fieldThe field mostly contains expanded MoA or method of delivery (MoD), but you will find other information present, including explanation if multiple brand names exist.
7.6 Key Notes fieldUsed to identify information of high importance, such as: • Any drugs withdrawn from market • Any trial or total drug development that is suspended • Any trial or total drug development that is discontinued • Any drugs or indications that were previously not approved (e.g. for safety reasons) and have now been approved • Any warning letters from regulatory agencies (also referred to as “black box warnings” • Any information regarding patent expiry for a specific drug, e.g., “Patent is expected to expire in 2008 (4/2005)” – this may need to become a separate field when we include generic drugs • Any information highlighting a company’s intention to file with the regulatory body for an ‘over the counter switch’ (also referred to as OTCx) after being in clinical trials. If it only refers to a specific indication it should be included in the status comment field of the indication affected • If a company is looking for licensing partners to continue further development. This is often sited as a reason to suspend or discontinue development in smaller companies
7.7 Phase definitionThe Inteleos definition for phase classification: • Preclinical: late-stage animal trials checking for safety and toxicity • IND filing (FDA): submitted after the molecule has been studied in cells and animals but prior to human testing • Phase I (can be split into Phase Ia and Phase Ib): small trials in healthy human populations, if successful company is awarded a “proof of concept” and can move into the next phase • Phase II (can be split into Phase IIa and Phase IIb): Phase IIa refers to trials in small patient populations affected with the disease; Phase IIb are larger patient populations • Phase III: large-scale patient population trials, often carried out in multiple centers across multiple regions. Some products run multiple trials and brand them, e.g. Humira has phase III trials called CHARM and GAIN. These trial names should be recorded in the status comment field • Pending Approval: once a drug has been filed for approval Inteleos classifies it as pending approval; it is an extension of Phase III as often trials for other indications are still ongoing • Approved: drug has been approved for a specific indication by a specific regulatory agency • Phase IV: becoming more common now as companies are required to run additional safety trials post-launch (also referred to as post-marketing trials/studies)
7.8 Product Type field• Antibody: an immunoglobulin molecule that has a specific amino acid sequence by virtue of which it interacts only with the antigen that induced its synthesis in cells of the lymphoid series (especially plasma cells), or with antigen closely related to it • Biologic: medicinal preparations made from living organisms and their products, including serums, stem cells, antibody/monoclonal antibody (MAb) vitamins, gene therapy, vaccine, and some hormones • Drug: any chemical compound used on or administered to humans or animals as an aid in the diagnosis, treatment, or prevention of disease or other abnormal conditions for the relief of pain or suffering or to control or improve any physiologic or pathologic condition, e.g. Salts or antibiotics • Drug-Device Combination*: when a device is used as part of the standard administration and release of the drug to the patient e.g. transdermal patch, oral or nasal inhalers etc. • Gene Therapy: The treatment of disease by replacing, altering, or supplementing a gene that is absent or abnormal and whose absence or abnormality is responsible for a disease • Vaccine: a suspension of attenuated or killed micro-organisms, or of antigenic proteins derived from them, administered for the prevention, amelioration, or treatment of infectious and/or malignant diseases *Drug Device Name: Some drugs require a delivery system to enter the body and often the delivery systems are branded separately. In such instances we record the name of the delivery system in this field. If the name is also the brand name it is repeated here as well, e.g. Nuvaring.
7.9 Special PopulationsThis refers to indications that are specifically targeted at pediatric (0 – 18 years) or senior/geriatric (>65 years) patient populations.
8 SECURITYBefore a user may enter Inteleos, the access and entitlement system checks if the access route (via IP or login fields) is correct, using industry-accepted, standard HTTP authentication. The Inteleos server is situated behind a fire-wall with only the necessary ports enabled and the utmost care and attention is paid to the updating of patches on the servers and operating systems to secure any potential vulnerabilities as identified by the software manufacturers.
Following authentication, a session is created between the Inteleos server and the user’s browser. A session contains all user activities and communications with the server and is isolated from all other Inteleos users. Only the session owner can see information exchanged within the session. Inteleos generates two types of data:
1. Transient Data
2. Permanent Data
Session length After 60 minutes of inactivity, the Inteleos session will time-out and close access. This maintains security levels and removes any transient data generated during the session.
Secure Socket Layer Similar to other pipeline databases, Inteleos does not employ Secure Socket Layer (SSL) and encryption. SSL increases the bandwidth required to run Inteleos effectively and reduces performance of the product as it communicates between the user and the server. |