ON TARGET
COMPLIMENTARY NEWS LETTER OF TARGET HEALTH INC.

29 May 2007

We would like to thank the loyalty and feedback of our over 2,000 readers, some of whom have been receiving ON TARGET since 1995. Several times a year we are asked what Target Health does and what are our accomplishments. The following summarizes what has happened over the last 12 months.  Our regular publication will continue next week.

DIA 2007

Visit us at Booth 137 at the annual DIA meeting in Atlanta.

Annual Update From Target Health Inc.  --  "Expect More"

In 2007, Target Health has celebrated its 14th year as a New York City-based, full-service e*CRO with full-time staff dedicated to all aspects of Drug and Device Regulatory Affairs, Clinical Research, Biostatistics, Data Management, Internet-based clinical trials (Target e*CRF), Medical Writing, Strategic Planning, Poster Design and Advertising. We also provide fully validated software for clinical trials and related processes. To round off our services, Target Health's Dream Team consists of a group of specialized advisers in the areas of Discovery, Toxicology, Product and Process Development, Quality Assurance, Validation and Manufacturing.

Highlights over the past 12 months include: 

  1. Implemeted the Target Health BLOG
  2. Updated the website
  3. Initiated our 100th EDC trial
  4. Completed the pivotal clinical trial and submitted the PMA for a device in the area of cardiology. Flawless FDA PAI (preapproval inspection) EDC audits.
  5. Completed the pivotal trials for a topical antiinfective drug and prepared the entire NDA.  Submission planned for Q2 2007.
  6. 9 PMAs approved by FDA which used Target e*CRF for data management.  PMAs submitted within 30 days of LPLV. Flawless FDA BIMO (Bioresearch Monitoring) audits.
  7. EDC vendor for NIH grant in Juvenile Rheumatoid Arthritis.  
  8. Target Document in Use
    • Target Document is a USER-FRIENDLY, INEXPENSIVE; HIGHLY SOPHISTICATED, Web-based, document management system that allows authorized users to view, download, and manage any document for their organization. - No More paper - Target Document features include: 1) 21 CFR Part 11 compliance; 2) routing for electronic signatures; 3) document ownership; 4) email alerts; 5) communication tool, 5) powerful administrator functions; etc.
  9. Target  e*CRF: Version 3.1
    • We revamped Target e*CRF Version 3 to include new features and a better work flow. Target  e*CRF Version 3.1, is a system which enables pharmaceutical companies to create, deploy, and manage web-based clinical trial applications. The new version is the next generation Target e*CRF, and was developed with critical input from Clinical, Data Management, Biostatistics and with a partnership with one of our clients. The new system is designed for users by users, and allows configuration of an entire eClinical trial in much less time and for much less money than it would take to develop, implement, closeout and qualify a paper case report form (CRF) clinical trial. Skill sets needed for application development are CRAs, clinical data manager and SAS programmers. Demos are available now.
  10. Target  e*CRF: Version 1
    • Target e*CRF is currently being used in over 10 NDA and PMA programs.
    • Over 100 protocols ongoing or completed
    • Indications include (partial list):
      • pancreatic cancer; prostate cancer; renal cell carcinoma; end stage renal disease; 3rd degree burns; head lice; cardiac surgery in the newborn; neonatology; bone fractures; pain; periodontal disease; diagnostics; in vitro fertilization; nocturia; disease outcomes; macular degeneration; rheumatoid arthritis; osteoarthritis; autoinflammatory diseases: Gaucher's disease
    • Largest trial to date is over 7,000 patients
    • Clients include major pharmaceutical to small biotechnology companies
  11. Asian Clinical Trial Network
    • Target Health is now part of the Asian Clinical Trials Network, a consortium of CROs based in Korea, Malaysia, Vietnam and Taiwan.  Studies performed by the ACTN will use Target e*CRF to bridge international studies.
  12. Regulatory Affairs:
    • PMA submitted
    • NDA to be submitted in Q2 2007
    • FDA Agent for 20 companies at FDA
    • 10 FDA meetings
    • NDA approved in Canada
    • HPB (Canada) Agent for 2 companies 
    • 2 INDs approved in the US
    • One Orphan Drug Designation approved
    • Assisted 2 companies to respond to FDA issues in support of an regulatory submissions
  13. Clinical Monitoring
    • Phase 2 program in pancreatic cancer (completed)
    • Phase 2 program hypotension (ongoing)
    • Phase 3 program woman's health (ongoing)
    • Phase 4 program in periodontal disease (ongoing)
    • Phase 3 program in skin infection (completed)
    • Pivotal program in cardiac surgery in the newborn (completed)
    • Questionnaire hereditary angioedema (completed)
  14. Data Management
    • Contract received to provide web-based data management for international studies
    • Contract received to provide web-based data management for program in ophthalmology, rheumatology and other indications
    • Oncology
    • Periodontal disease
  15. Biostatistics
    • Pancreatic cancer
    • Infectious disease
    • PMA pivotal trial
    • Rheumatology
    • Fracture healing
    • Created Statistical Analysis Plans for 4 projects
  16. Medical Writing
    • Wrote multiple ICH study reports

A. CURRENT INDICATIONS

  1. 3rd degree burns
  2. Autoinflammatory diseases
  3. Atopic dermatitis
  4. Bone fractures
  5. Cardiac implant device
  6. Cardiology diagnostic
  7. Cystic fibrosis
  8. Fibromyalgia
  9. Gaucher’s disease
  10. Hereditary angioedema
  11. Head lice
  12. Hepatitis diagnostic
  13. HIV diagnostic
  14. Hypotension
  15. Infertility
  16. Jaundice prevention
  17. Juvenile rheumatoid arthritis
  18. Macular degeneration
  19. Nocturia
  20. Osteoarthritis
  21. Osteoporosis
  22. Pancreatic cancer
  23. Periodontal disease
  24. Pre-eclampsia diagnostic
  25. Prostate cancer
  26. Small cell lung cancer
  27. Wound healing device

B. STRATEGIC PLANNING

  1. Atopic Dermatitis
  2. Autoinflammatory Diseases
  3. Drug Delivery
  4. Enzyme Deficiency
  5. Gaucher's Disease
  6. Herpes Simplex infection
  7. Inflammatory bowel disease
  8. Topical Drug Products

C. CURRENT CLIENTS

  1. Abbott Laboratories
  2. Bioline Ltd. (Israel)
  3. Biomimetic Pharmaceuticals
  4. Braintact, Ltd. (Israel)
  5. Brightech international
  6. Devirex, Ltd. (Switzerland)
  7. Digestive Care Inc.
  8. Ferring Pharmaceuticals (Denmark/US)
  9. GPC-Biotech, Inc.
  10. HRA Pharmaceuticals (France)
  11. Infacare Pharmaceuticals
  12. Jerini, AG (Germany)
  13. Luitpold Pharmaceuticals
  14. Mediwound Ltd (Israel)
  15. Morria Ltd. (Israel)
  16. Nexgenix Pharmaceuticals
  17. Pfizer Pharmaceuticals
  18. Prometheus Laboratories
  19. Protalix, Ltd. (Israel)
  20. Regeneron Pharmaceuticals
  21. Samyang Pharmaceuticals (Korea)
  22. Stanford University
  23. Summers Pharmaceuticals
  24. Synthemed, Inc.
  25. TransPharma (Israel)
  26. University  of Washington
  27. Vicor Technologies, Inc.
  28. White Mountain Pharma

D. MEETINGS AND PUBLICATIONS

  1. Manuscript - European Pharmaceutical Contractor - In Press -  Impact of EDC and EHR on Clinical Data Management - Past, Present and Future
  2. Manuscript - Applied Clinical Trials - March 2007 - The Critical Path Initiative and It’s Impact on Device Development
  3. Manuscript - Applied Clinical Trials - August 2006 - Impact of Internet-based Clinical Trials (IBCTs) on the Efficiency of Data Entry, Monitoring and Data Management
  4. Attended Meeting - American Academy of Dermatology, ASCO, ASCPT 

E. CONTACT INFORMATION

TARGET HEALTH INC.
261 Madison Avenue
24th Floor
New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105
http://BLOG.targethealth.com
Dr. Jules T. Mitchel, President 
Ms Joyce Hays, CEO
2007 Target Health Inc. All rights reserved