6 January 2008

We would like to thank the loyalty and feedback of our over 2,300 readers, some of whom have been receiving ON TARGET since 1995, when we started as a weekly Fax. Please let us know how long you have been a reader.

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.  --  "Never Wanted To Be The Biggest, Just The Best" so-o "Expect More"

In 2007, Target Health 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 From 2007

1. Represent over 25 companies at FDA.
2. NDA submitted in the area of Dermatology that used Target e*CRF® for pivotal trials - Fileable
3. PMA submitted in the area of Cardiology that used Target e*CRF® for pivotal trial - FDA Panel recommended approval
4. BLA submitted in the area of Rheumatology that used Target e*CRF® for pivotal trial - Fileable
5. NDA submitted in the area of immunology that used Target e*CRF® for validation study - Fileable
6. Initiated our 120th EDC trial
7. Implemented the Target Health BLOG
8. Updated the website
9. FDA pre-approval inspection (PAI) including EDC.
10. A client told us that they used Target e*CRF® for 9 approved PMAs in the diagnostic area.  "PMAs were submitted within 30 days of LPLV. Flawless FDA BIMO (Bioresearch Monitoring) audits."
11. EDC vendor for 2 NIH grants in Juvenile Rheumatoid Arthritis at the Cleveland Clinic and University of Washington.
12. Completion of EDC project in the newborn under an HHS grant at Stanford.
13. Beta release of Target Document® - Final release 31 January 2008
• 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) email alerts; 5) communication tool,
14. Target Encoder® Version 1 Released, 2007.
• Target Encoder is a USER-FRIENDLY, INEXPENSIVE; HIGHLY SOPHISTICATED, Web-based, coding system that allows authorized users to automatically code MedDRA and WHO Drug and other types of dictionaries.
15. Target  e*CRF®: Version 3.1  - Final release June 2007
16. Target  e*CRF®: Version 3.2  - Final release 31 January 2008
• We revamped Target e*CRF Version 3.1 to include new features and a better work flow. Target  e*CRF® Version 3.2, 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.
17. Target  e*CRF®: Version 1
• Target e*CRF® is currently being or has been used in over 10 NDA and PMA programs.
• Over 120 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 disease
• Largest trial to date is over 7,000 patients
• Clients include major pharmaceutical to small biotechnology companies
18. Asian Clinical Trial Network
• Target Health is 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.
19. Regulatory Affairs:
• 1 PMA submitted
• 2 NDAs submitted
• 1 BLA submitted
• FDA Agent for 25 companies at FDA
• 8 FDA meetings
• Pre-IND meeting with HPB (Canada); Agent for 2 companies 
• One Orphan Drug Designation approved
• Assisted 2 companies to respond to FDA issues in support of an regulatory submissions
20. Clinical Monitoring
• Phase 2 program in pancreatic cancer (completed; Target e*CRF®)
• Phase 2 program hypotension (ongoing; Target e*CRF®)
• Phase 3 program woman's health (ongoing, 1,300 subjects, 47 sites; Target e*CRF®)
• Phase 3 program in metabolic disease (orphan drug, global program; Target e*CRF®)
• Phase 3 database lock prostate cancer (Target e*CRF®)
• Phase 4 program in periodontal disease (ongoing; Target e*CRF®)
• Phase 3 program in skin infection (completed, NDA submitted; Target e*CRF®)
• Pivotal program in cardiac surgery in the newborn (completed, PMA approved by FDA Panel; Target e*CRF®)
• Questionnaire hereditary angioedema (completed; Target e*CRF®)
21. Data Management
• Contract received to provide web-based data management for program in ophthalmology, rheumatology and other indications
• Oncology
• Periodontal disease
• Women's heath
• Metabolic disease
22. Biostatistics
• Pancreatic cancer
• Infectious disease
• PMA pivotal trial
• Rheumatology
• Fracture healing
• Created Statistical Analysis Plans for 4 projects
23. Medical Writing
• Wrote multiple ICH study reports

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

1. Atopic Dermatitis
2. Autoinflammatory Diseases
3. Cystic Fibrosis
   
4. Drug Delivery
5. Enzyme Deficiency
6. Gaucher Disease
7. Herpes Simplex infection
8. Inflammatory bowel disease
9. Psoriasis
10. Scleroderma
    
11. Topical Drug Products

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

1. Writing 2 book chapters in: Principles of Clinical Oral Health Research” Editors: William Giannobile, Brian Burt and Robert Genco 
2. Manuscript - European Pharmaceutical Contractor - September 2007 -  Impact of EDC and EHR on Clinical Data Management - Past, Present and Future
3. Manuscript - Applied Clinical Trials - March 2007 - The Critical Path Initiative and It’s Impact on Device Development
4. Abstract accepted: A Complex Protocol Design To Accelerate Clinical Trial:  How To Implement Multiple Database Lock In An Electronic Data Capture System (Bio-IT World, 2008)
5. Attended Meeting - American Academy of Dermatology, ASCPT, DIA 2007