ON TARGET - Weekly Journal from Target Health Inc.

(Complimentary Newsletter from Target Health Inc.)

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13 November 2006

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.

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

In 2007, Target Health will celebrate 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 advisors in the areas of Discovery, Toxicology, Product and Process Development, Quality Assurance, Validation and Manufacturing.

Highlights over the past 12 months include: 

  1. Target Document® Released
    • 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.
  2. 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. Previews are available now.
  3. Target  e*CRF®:
    • Target e*CRF® is currently being used in over 10 NDA and PMA programs.
    • Over 100 protocols ongoing or completed
    • Indications include:
      • 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
  4. 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.
  5. Regulatory Affairs:
    • FDA Agent for 16 companies at FDA
    • 8 FDA meetings
    • NDA approved in Canada
    • HPB (Canada) Agents for 2 companies 
    • 2 INDs approved in Canada
    • 2 INDs approved in the US
    • One 510(k) approved in the US
    • One Orphan Drug Designation submitted 
    • Assisted 2 companies to respond to FDA issues in support of an NDA submission
  6. Clinical Monitoring
    • Phase 2 program in pancreatic cancer (ongoing)
    • Phase 3 program woman's health (ongoing)
    • Phase 4 program in periodontal disease (ongoing)
    • Phase 3 program in skin infection (just completed)
    • Pivotal program in cardiac surgery in the newborn (just completed)
  7. 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
    • Bone fractures
  8. Biostatistics
    • Interim analyses  - pancreatic cancer
    • PMA pivotal trial
    • Rheumatology
    • Fracture healing
    • Created Statistical Analysis Plans for 4 projects
  9. Medical Writing
    • Wrote multiple ICH study reports

A. CURRENT INDICATIONS

  1. 3rd degree burns
  2. Autoinflammatory diseases
  3. Cystic fibrosis
  4. Fibromyalgia
  5. Gaucher’s disease
  6. Hereditary angioedema
  7. Human head lice
  8. Infertility
  9. Jaundice prevention
  10. Macular degeneration
  11. Nocturia
  12. Osteoporosis (combination drug/device)
  13. Osteoarthritis
  14. Osteoporosis
  15. Pancreatic cancer
  16. Periodontal disease
  17. Public health
  18. Prostate cancer
  19. Rheumatoid arthritis
  20. Small cell lung cancer
  21. HIV diagnostic
  22. Cardiology diagnostic
  23. Hepatitis diagnostic
  24. Pre-eclampsia diagnostic
  25. Periodontal disease device
  26. Bone fracture device
  27. Cardiac implant device
  28. Wound healing device

B. STRATEGIC PLANNING

   1.   Atopic Dermatitis
   2.   Topical Drug Products
   3.   Gaucher's Disease
   4.   Cell Therapy
   5.   Enzyme Deficiency
   6.   Autoinflammatory Diseases
   7.   Topical Antimicrobials
   6.   Drug Delivery

C. CURRENT CLIENTS

     1.      Abbott Laboratories
     2.      Bioline Ltd. (Israel)
     3.      Biomimetic Pharmaceuticals
     4.      Braintact, Ltd. (Israel)
     5.      Brightech international
     6.      Digestive Care Inc.
     7.      Ferring Pharmaceuticals (Denmark/US)
     8.      GPC-Biotech, Inc.
     9.      Healthpoint, Ltd.
    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.    Protalix, Ltd. (Israel)
    19.    Recordati (Italy)
    20.    Regeneron Pharmaceuticals
    21.    Samyang Pharmaceuticals (Korea)
    22.    Summers Pharmaceuticals
    23.    Synthemed, Inc.
    24.    TransPharma (Israel)
    25.    Veraxis
    26.    Vicor Technologies, Inc.
    27.    Wellspring Pharmaceuticals
    28.    White Mountain Pharma

D. MEETINGS AND PUBLICATIONS

  1. Dr. Jules Mitchel was appointed to the Executive Committee of the New Jersey/New York CDISC Users Network
  2. Manuscript - Parexel Statistical Yearbook, 2006. "The Impact of Internet-based Clinical Trials (IBCTs) on the Efficiency of Data Entry, Monitoring and Data Management: A Case Study"
  3. Manuscript - Monitor: 2005;October:17-21.  "The Role of CRAs in the Development and Implementation of Internet-Based Clinical Trial Applications: New Career Opportunities"
  4. Workshop Chair (FDA co-Chair) - ASCPT, 2006. "The Use of New Methods in the Assessment of Drug Absorption in the Skin"
  5. Public Forum Chair (FDA co-Chair) - ASCPT, 2006. "Regulatory Challenges in a Crisis Environment"
  6. Poster - American Academy of Dermatology, 2006. "The Efficacy and Safety of a Non-Pesticide Lice Asphyxiator for the Treatment of Head Lice"
  7. Poster - Society For Investigative Dermatology, 2006. "Using the Internet to Assign Randomization Numbers in a Large Multicenter Study in 3rd Degree Burns"
  8. Manuscript - Applied Clinical Trials - August 2006 - Impact of Internet-based Clinical Trials (IBCTs) on the Efficiency of Data Entry, Monitoring and Data Management
  9. Manuscript - Applied Clinical Trials - In Press - The Critical Path Initiative and It’s Impact on Device Development

E. CONTACT INFORMATION

TARGET HEALTH INC.
261 Madison Avenue
24th Floor
New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105
Target Health Ad
www.targethealth.com
Dr. Jules T. Mitchel, President 
Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved