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Project Goals

Project Goals. Creation of a virtualized, central database committed towards facilitating the acquisition of bio-samples by researchers from bio-banks

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Project Goals

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  1. Project Goals • Creation of a virtualized, central database committed towards facilitating the acquisition of bio-samples by researchers from bio-banks • The database will allow search queries to be run through the database by researchers with the purpose of acquiring quality bio-samples with detailed annotations for use in their research endeavors

  2. Problem Statement • Bio-samples can be used by researchers for discovering biomarkers for disease and for genetic studies • Current websites house database containing data only on bio-samples specific to a tissue and/or disease type • Bio-banks are not standardized: • Need a website: • with a searchable database • to promote resource-sharing & cooperation • to optimize quality & accessibility

  3. Recommended Solutions • Three-tier network architecture • Provide bio-banks with BTM • Recommend changes to BTM • Provide members (researchers) with: • Use of search engine • A “My Page” that shows status of ordered samples

  4. Website Members - Users

  5. User Membership Plans Free Trial Target users: • New users Charges: • Search engine usage fee • 3% transaction fee Gold Membership Target users: • Academic and Non-Profit Researchers Charges: • 2% transaction fee • $40 monthly fee Platinum Membership Target users: • Industrial Researchers Charges: • 1% Transaction fee • $80 monthly fee

  6. User’s “My Page” • Membership status • Recommendation to upgrade (if applicable) based on user’s transaction history • Application status of samples that user has applied for • Link to Material Transfer Agreement form for approved samples • Shipping status of samples that are in transit • Link to feedback form for received samples • History of received samples

  7. Governmental & Funding Agency Regulations

  8. Quality Assurance & Quality Control • Problem: • Sample quality involves a variety of factors • Bio-banks use widely varying QA measures • Researchers need to know the quality of the samples they are ordering • Recommended Solution: • Add fields in BTM for bio-bank compliance with: • ISO 9000 certifications • ISBER Best Practices • Display QA information in sample results

  9. Informed Consent • Informed consent covers: • Specific types of research for donor’s sample • Use of sample by commercial entities • Protection of the donor’s identity • Bio-banks must track levels of consent, b/c: • Consent may be withdrawn • Consent must be obtained from pediatric donors when they reach the legal age of consent • We recommend that: • Bio-banks use the Informed Consent form & Patient Brochure developed by NCI • A field be added to BTM for entering level/status of informed consent

  10. Sample Donor Rights • Protection of donor’s identity • Bio-bank assumes this responsibility • Daedalus Software will not play a role in the protection of donors’ identities • Donor request for an audit of research facilities which have used their samples • Daedalus should provide audit to bio-banks for a fee

  11. Biobank IRB Approval Process • Streamline approval process • On-line electronic application to request samples from bio-banks • Upon registration, users can indicate which IRB has approved their research • Upon applying for a sample, the bio-bank would be responsible for deciphering if the user’s approval is valid • Takes liability off Daedalus Inc. • As opposed to having users upload their IRB approval upon registration and allow users to use it for all samples they apply for by facilitating the approval process • Recommendation: Create field in user registration form for users to check off that they are IRB approved, and to indicate which IRB has approved their research

  12. IRB Approval Process Steps for Institution • Conduct Self-Assessment • On-Site Evaluation • Council on Accreditation Review • Notification of Application Status AAHRPP Steps http://www.aahrpp.org/www.aspx?PageID=95

  13. Hardware Analysis

  14. Network Architecture Criteria • Latency • Network Usability • Performance • Bandwidth 2-Tier RDBMS • Efficient Network Usage over traditional DB • Simplified client communication • Improves bandwidth usage over traditional 3-Tier RDBMS -- Recommended • Different server for each Data type • Increased speed • Lower bandwidth Usage • Does not use Metadata

  15. Server Specifications Sponsor Recommendation: • HP Brand ProLaiant G4 M310 Server (Tower Model) • Fire-walled Database • 24/7 Support/Uptime Hardware Specs: • Processor: Dual Core Intel Pentium D – Intel Xeon • Memory: 1GB PC2 – 6GB PC2 • Operating System: Windows Server, SuSe Linux, RedHatLinux • Hard Drive: 72 GB – 140 GB Hot Plug, 160 – 300 GB SATA – divided into 3 HD for RAID settings • RAID Settings – based on HD selection • Raid 5 Setting for 3 HD • Allows multiple users to be online at once

  16. Server Specifications • ONRAMP Recommendation • HP Proliant DL 380 G5 Server (Rack Model) • Intel Xeon 5120 dual Core level 2 cache & Intel Xeon 5100 • Memory: 2 GB RAM • 72 GB RAID 0 or 1 • Linux OS • 128Kbps Connected to 1000 Mbps Ethernet Pipe • 24/7/365 Web-Application Maintenance • ~$600/mo with Firewall and Backup

  17. Database Management

  18. UML Diagram of Database

  19. Search Engine Workflow User enters search terms in search form and clicks “SEARCH” Search engine algorithm Server links to all accessible BTMs to search through sample data Server retrieves data on samples matching search criteria for display Main ResultsPage User clicks on hyperlink for individual item User selects desired items by checking boxes next to individual results Individual ResultPage User clicks “ADD TOCART” User clicks “BACK TOMAINRESULTSPAGE” User clicks “ADD TOCART” User clicks “CHECK-OUT”

  20. Location Website User Roles Manage Software & Hardware Upload Data Database Manager (Daedalus) Bio-Bank Worker BTM House Electronic Information Obtain Store Data Sample Application & Transfer Processes Business Contacts Cost Bio-Sample Adhere to Quality Standards Register Search Order Order History Quality Bio-Bank Manager Application Decision Researcher/ Customer Contact Info Billing Info IRB approval Info

  21. Annotation Vocabularies

  22. ICD 9 & ICD 10 ICD 9: International Classification of Diseases 9 • published by WHO in 1977 • 2-3 volumes for diagnosis, procedure codes • all items have reference numbers • ex. Bat ear = 744.2, Swimmers ear = 380.12 • reference numbers can have multiple subtitles • ex. Mammoplasty = 85.89, has 18 different subtitles ICD 10: Revised version of ICD9 • Difference b/t ICD 9: first character for the code is a letter followed by a set of numbers • ICD 9 vs. ICD 10 Bat ear Bat ear 744.29 Q17.5 Increased efficiency for billing and diagnosis

  23. EVS • EVS: Enterprise Vocabulary Services established by NCI • Uses NCI Metathesaurus and NCI Thesaurus • Contains many links for different types of bio research, genomics, proteomics and clinical trials • Type of search engine for synonyms with concentration in medical field • Does not simplify words into numeric or alphanumeric codes

  24. CPT Code CPT Sections • CPT – Current Procedural Terminology developed by AMA in 1966 • Contains close to 10,000 codes • Used for billing and fees for procedures performed • 5 numeric digit organized by six section

  25. SNOMED SNOMED Axis • SNOMED – Systematize Nomenclature formed by Department of Health and Human services • Combination of old SNOMED RT and United Kingdom National Health Services Clinical Terms • Covers 344,000 concepts including some of ICD-9/10 and others. • Contains 11 axis for heretical classification • Concepts defined by “modeling” process – essential characterizes and clinical attributes of the concept. Topography (T) – Anatomical Terms Morphology (M) – Changes found in cells, tissues, and organs Living Organisms (L) – bacteria and viruses Chemical (C) – Drugs Function (F) – Signs and symptoms Occupation (J) – Terms that describe occupation Diagnosis (D) – Diagnostic Terms Procedure (P) – Administrative, diagnostic and therapeutic procedures Physical agents, forces, activities (A) – Devices and activities associated with diseases Social Context (S) – Social conditions and important relationships in medicine General (G) – Syntactic linkages and qualifiers

  26. SNOMED for Computers 1) "Is A" Relationship The “Is A” relationship is used to create a hierarchical relationship between concepts, relating specific concepts to a more general category. For example: "Injury to the optic nerve" "is a" (kind of) "Injury to the visual pathway" 2) "Finding Site" Relationship The "Finding Site" relationship identifies the part of the body affected by the specific disorder or finding. For example: "Injury of cornea" (has) "finding site" "Corneal structure" 3) "Causative agent" Relationship The "Causative agent" relationship identifies the direct cause of the disorder or finding. The causative agent is the bacterium, virus, toxin or environmental agent that causes the disorder. For example: "Staphylococcal eye infection" (has) "Causative agent" "Staphylococcus" 4) "Associated morphology" Relationship The “Associated morphology” relationship identifies the abnormal physical condition that is characteristic of a given disorder or finding. For example: "Foreign body under eyelid" (has) "Associated morphology" "Foreign body" • Used for data entry for most electronic health records • Current version contains 90% of terminology needed today for health care • Hierarchical relationship allows for more general concepts known by most researchers • SNOMED uses relationships between concepts for computer readability

  27. Recommendation • SNOMED and ICD9 both displayed on the website. Both contain significant advantages • Site should contain link that allows users to go to SNOMED and ICD code references • Alternative would be to follow WebMD’s symptom checker strategy and have a clickable human body image that allows specific area search for bio-samples.

  28. FINANCIAL ANALYSIS

  29. Sponsor Server Estimate Cost with Shipping $4,500 per server Total of 8 servers: Two tiers Hot Standby and Duplicate Copy Estimated Total Costs for Servers $36,000

  30. Onramp Server Estimate Cost with Shipping $5,300 per server Total of 8 servers: Two tiers Hot Standby and Duplicate Copy Estimated Total Costs for Servers $45,000

  31. Labor Cost Time frame for software development: ~ 3 months Graphical User Interface, Programmer (1 Sr., 1 Jr.) 2 months = $30,000 System Architect (search engine workflow) 1 week coding,10 follow-up meetings = $8,000 Database Administrator 1 month coding, 10 follow-up meetings = $15,000 Quality Assurance Starts mid-way through completion = $3,000-$10,000 Total Estimated Labor Cost = $60,000

  32. Market Growth and Size • Estimated to be 282 million specimens in 1998 in the US accumulating at a rate of 20 million/year – from NBAC • Potential market size is estimated to be 10 billion dollars – March 2000 • In 2001 Cost of biological samples averaged around $50 for 20-100 milligram extract. • Constant growth for 1998 was 7%. Not practical • Theoretical Growth Estimated from exponential means.

  33. Bio-Sample Market Growth

  34. Assumptions for Market Growth • Exponential Growth based on projected rates of 7% yearly in 1998 • Market will be effected by the following: • Aging population leading to higher hospital visit • Increase in cancer due to environmental factors • Increase in toxins in nature • Exponential growth based on 1998 values: conservative estimate • Exponential growth curve will be accurate since we are in middle region of the graph • Only 20% of the Bio-Samples are useful

  35. Revenue Generated • Revenue (per tissue section ordered): • Academic researchers • On Gold Membership • $50 monthly fee • 2% transaction fee: $ 5 • On Free Trial • 3% transaction fee: $ 7.50 • Industrial Researchers • On Platinum Membership • $150 monthy fee • 0% transaction fee • On Free Trial • 3% transaction fee: $ 22 • Cost for 4-6 tissue sections • High end • Academic Price - $300 • Industrial Price - $900 • Low end • Academic Price - $45 • Industrial Price - $135 • Average Price • Academic Price - $250 • Industrial Price - $750

  36. NPW for Cash Flow • Initial Investment $105,000, t = 0 • NPW = $105,000 • Monthly Maintenance Cost $1600/ 60mo. • NPW = $75,305 • Estimated Monthly Revenue • $2,351 @ t = 1mo • $29,271 @ t = 13mo • $97,032 @ t = 25mo • $164,793 @t = 37mo • $237,836 @t = 49mo • $358,665 @ t = 61mo • NPW $1.41 million assuming avg. monthly revenue of $30,000 Profit = $1,410,000 - $180,000 = $1.22 million $244,000/yr

  37. Demonstration

  38. User Registration Form

  39. User Registration Form

  40. Users’ “My Page”

  41. WebMD Symptom Checker

  42. WebMD Symptom Checker

  43. WebMD Symptom Checker

  44. WebMD Symptom Checker

  45. WebMD Symptom Checker Modified

  46. URL DEMO Website URL: http://www.daedalussoftware.com/BIN1/BIN-Invest/default.asp Initial Recommendations: 1) Fix to work with Firefox

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