(Complimentary Newsletter from Target Health Inc.)

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13 March 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.

Target Health is celebrating its 13th 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 also has 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  e*CRF:
• New software was released which allows companies to make a technology transfer
• Global contracts signed with 2 companies
• Largest trial to date is over 7,000 patients
• Indications include: oncology; dermatology; cardiology; urology; outcomes; oral care; macular degeneration; rheumatology, etc.
• Over 75 protocol ongoing or completed
• Clients include major pharma to small biotech companies
2. Regulatory Affairs:
• Approval of a PMA in the US in the area of Periodontal Disease
• FDA Agent for 16 companies at FDA
• HPB (Canada) Agents for 2 companies 
• 2 INDs approved in Canada
• 2 INDs approved in the US
• 6 FDA meetings
• 2, 510(k)s submitted 
• Assisted 2 companies to respond to FDA issues in support of an NDA submission
3. 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
4. Biostatistics
• Completed 2 analyses in rheumatology
• Created Statistical Analysis Plans for 4 projects
5. Medical Writing
• Wrote multiple ICH study reports

Proprietary Internet-Based Clinical Trial (IBCT) Software

Target e*CRF® is currently being used in 10 NDA and PMA programs. In addition to other numerous accomplishments in regulatory affairs, clinical research, biostatistics, and medical writing, Target Health has finalized Target e*CRF® version 3, a system which enables pharmaceutical companies to create, deploy, and manage web-based clinical trial applications. The new version is the next generation after 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 a time frame no longer than it would take to develop a paper case report form (CRF). Skill sets needed for application development are CRA's and SAS programmers.

ACCOMPLISHMENTS

A. REGULATORY AFFAIRS

1.   For a US company, a Canadian CTA, in the area of oncology, was submitted and approved
2.   For a US company, Orphan Drug Designation was requested in the GI area
3.   For a US company, met with FDA in the Division of Gastrointestinal and Coagulation Drug Products
4.   For an US company, received a special protocol assessment (SPA) in the Division of Dermatologic and Dental Drug Products
5.   For an Israeli company, submitted an IND in the Division of Endocrine & Metabolic Drug Products
6.   For a US company, met with FDA for an end-of-phase 2 meeting in the dermatology area
7.   For a US company, submitted a Special Protocol Assessment in the dermatology area 
8.   For an Israeli company, received IND contract in the area of neurology
9.   For an Israeli company, received IND contract for unique drug delivery in the area of neurology
10. For a Korean company, received contract to act as their agent in the area of Oncology

B. CLINICAL RESEARCH

1.   Ongoing monitoring of a 16-center, Phase 3 device study in neonatal cardiac surgery (160 patients)
2.   Ongoing monitoring of a 6-center study diagnostic study in cardiology (700 patients)
3.   Ongoing monitoring of 3, muticenter studies in patients with head lice (400 patients)
4.   Ongoing monitoring of a 15-center open-label study in oncology (45 patients)
5.   Monitored and closed out a 10-center open-label study in oncology (20 patients)

C. DATA MANAGEMENT - WEB TRIAL PROGRAMS USING TARGET e*CRF™

Programs include:

1.   Macular Degeneration (Phase 2, US)
2.   Prostate Cancer (Phase 3, US, Europe, Africa)
3.   Prostate Cancer (Phase 2, US, Europe, Africa)
4.   Prostate Cancer (Phase 2, US)
5.   3rd Degree Burns (Phase 2, US, Europe)
6.   Neonatology (Pilot, US)
7.   Epidemiology (2 Studies, US)
8.   Neonatal Cardiac Surgery (Pivotal, US)
9.   Autoinflammatory diseases (Phase 3, US)
10. Rheumatoid arthritis (Phase 2, US)
11. Osteoarthritis (Phase 2, US) 
12. Hepatitis Diagnostic (US)
13. Cardiology (Diagnostic, US)
14. Women's Health (Diagnostic, US)
15. HIV (Diagnostic, US)
16. Dermatology (Phase 3, US)
17. Bone Fracture Healing (Pilot, US)
18. Urology (Phase 2, Europe)
19. Cardiology (Diagnostic, US) 

D. BIOSTATISTICS/DATA MANAGEMENT

1.   3rd Degree Burns (Phase 2)
2.  Cardiac Diagnostic (Phase 2)
3.   Dermatology (Phase 2)
4.   Periodontal Disease (PMA approved)
5.   Infertility (Phase 4)
6.   Cystic Fibrosis (Phase 3)
7.   GI Symptoms in HIV (Phase 2)
8.   Rheumatoid Arthritis (Phase 2)
9.   Epidemiology 

E. MEDICAL WRITING

1.   Periodontal Disease
2.   Cystic Fibrosis
3.   3rd Degree Burns
4.   Male Health
5.   Dermatology
6.   Rheumatoid arthritis

F. 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

G. MEETINGS AND PUBLICATIONS

1. Dr. Jules Mitchel was appointed to the Executive Committee of the New Jersey/New York CDISC Users Network
2. Dr. Jules Mitchel was re-elected Chair of the Dermatology Section of the American Society of Clinical Pharmacology and Therapeutics (ASCPT)”
3.  Dr. Jules Mitchel was a reviewer for an NIH program in the area of HIV
4. 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"
5. Manuscript - Monitor: 2005;October:17-21.  "The Role of CRAs in the Development and Implementation of Internet-Based Clinical Trial Applications: New Career Opportunities"
6. Workshop Chair (FDA co-Chair) - ASCPT, 2006. "The Use of New Methods in the Assessment of Drug Absorption in the Skin"
7. Public Forum Chair (FDA co-Chair) - ASCPT, 2006. "Regulatory Challenges in a Crisis Environment"
8. Poster - American Academy of Dermatology, 2006. "The Efficacy and Safety of a Non-Pesticide Lice Asphyxiator for the Treatment of Head Lice"
9. Poster - Society For Investigative Dermatology, 2006. "Using the Internet to Assign Randomization Numbers in a Large Multicenter Study in 3^rd Degree Burns"

H. 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