ON TARGET
COMPLIMENTARY NEWS LETTER OF TARGET HEALTH INC.

30 March 2008

Annual Update From Target Health Inc.  --  "Expect More - Not Trying To Be The Biggest, Just The Best"

We would like to thank the loyalty and feedback of our over 2,400 readers, some of whom have been receiving ON TARGET since 1995, when we started as a weekly Fax.  

Here is a comment we just received fron our good freind and colleague Professor Ned Heindel: "As always...a great newsletter but I especially enjoyed that yarn about  Dr. James Miranda Barry.  I'd never run into that before. On Target not only enriches my in-field mastery of med chem/regulatory affairs but also my cultural awareness of medical history.  Keep it up." Professor Heindel is the H. S. Bunn Chair Professor of Chemistry atLehigh University and one of the top pharmaceutical chemists in the world. 

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.

A. Corporate Summary

In 2008, Target Health has celebrated its 15th 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:

B. Regulatory Affairs 

1. Represent over 25 companies at FDA including France, Germany, Israel, Australia, Korea and the US.
2. 2008
• February: Ferring Pharmaceuticals submitted applications in Europe and the United States for the marketing authorization of its prostate cancer treatment, degarelix, a new GnRH receptor blocker intended for patients in whom androgen deprivation is warranted. Target e*CRF® was used for all Phase 2 and Phase 3 studies.  In addition to degarelix, Target Health has collaborated with Fering on 3 marketed NDAs for products sold in the US, Canada and Europe. Two of these programs also used  Target e*CRF®.
• February: Regeneron Pharmaceuticals, received FDA marketing approval for ARCALYST™ (rilonacept) Injection for Subcutaneous Use, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. ARCALYST is the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.
• February - IND submitted in ulcerative colitis
• January - IND submitted in ulcerative colitis
3. 2007
• November - NDA submitted in the area of immunology that used Target e*CRF® for validation study - Fileable
• November - eIND submitted in the area of bone metabolism.
• September – SyntheMed, Inc., a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, received approval from the Circulatory System Devices Advisory Panel of the FDA  of REPEL-CV® Adhesion Barrier for use in pediatric patients (21 and younger) who are likely to need secondary open heart surgery. Target e*CRF® was used for the pivotal trial and Target Health submitted the PMA as an eCopy, monitored the study and performed statistical analyses and medical writing.
• June - NDA submitted in the area of Dermatology.  Target e*CRF® was used for the pivotal and Phase 2 trials and, and Target Health prepared the NDA which was submitted as an eCTD, monitored the study and performed statistical analyses and medical writing. NDA was fileable.
• 9 PMAs approved  in the diagnostic area which used Target e*CRF for data management.  "PMAs submitted within 30 days of LPLV. Flawless FDA BIMO (Bioresearch Monitoring) audits."

• EDC vendor for 2 NIH grants in Juvenile Rheumatoid Arthritis at the Cleveland Clinic and University of Washington.
• EDC project completed in the newborne under an HHS grant at Stanford University.
• Target Encoder® Version 1 Released.
• 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.
• Target Document® Version 1.0 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) email alerts; 5) communication tool,
• Target  e*CRF®: Version 3.2  - Release 30 April 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.
• Target  e*CRF®: Version 1
• Target e*CRF® is currently being or has been used in over 10 NDA and PMA programs.
• Over 130 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
• Implemeted the Target Health BLOG
• Updated the website

• Asian Clinical Trials 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.
• Regulatory Affairs:
• PMA submitted
• NDA submitted
• FDA Agent for 25 companies at FDA
• 10 FDA meetings
• Pre-IND meeting with HPB (Canada); Agent for 2 companies 
• 2 INDs approved in the US
• One Orphan Drug Designation approved
• 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, 1,600 subjects, 47 sites; Target e^CRF
• Phase 3 program in metabolic disease (orphan drug, global program; 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)
• 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
• Biostatistics
• Pancreatic cancer
• Emergency contraception
• Infectious disease
• PMA pivotal trial
• Rheumatology
• Fracture healing
• Created Statistical Analysis Plans for 4 projects
• 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. Endometrioisis
9. Fibromyalgia
10. Gout
11. Gaucher’s disease
12. Hereditary angioedema
13. Head lice
14. Hepatitis diagnostic
15. HIV diagnostic
16. Hypotension
17. Imaging
18. Infertility
19. Jaundice prevention
20. Juvenile rheumatoid arthritis
21. Macular degeneration
22. Menopausal symptoms
23. Nocturia
24. Osteoarthritis
25. Osteoporosis
26. Pancreatic cancer
27. Periodontal disease
28. Pre-eclampsia diagnostic
29. Prostate cancer
30. Scleroderma
31. Stem cell therapy
32. Ulcerative colitis

1. Abbott Laboratories
2. Amit Ltd. (Israel)
3. Bioline Ltd. (Israel)
4. Anterios, Inc.
5. Argentis Inc.
6. Barrier Therapeutics
7. Biomimetic Therapeutics
8. Brightech international
9. Cellgate Inc.
10. Cleveland Clinic
11. Combinent, LLC
12. Devirex, Ltd. (Switzerland)
13. Digestive Care Inc.
14. Ferring Pharmaceuticals (Denmark/US)
15. GalMed Medical Research, Ltd. (Israel)
16. GPC-Biotech, Inc.
17. HRA Pharmaceuticals (France)
18. Infacare Pharmaceuticals
19. Jerini, AG (Germany)
20. Lifebond, Ltd. (Israel)
21. Luitpold Pharmaceuticals
22. Meditor Pharmaceuticals (Israel)
23. Mediwound Ltd (Israel)
24. Morria Ltd. (Israel)
25. Natrogen Therapeutics
26. Nexgenix Pharmaceuticals
27. NST Ltd (Israel)
28. Pluristem, Ltd (Israel)
29. Prochon Biotech, Ltd.
30. Prometheus Laboratories
31. Protalix, Ltd. (Israel)
32. Regeneron Pharmaceuticals
33. Samyang Pharmaceuticals (Korea)
34. Se-Cure Pharmaceuticals (Israel)
35. Stanford University
36. Summers Laboratories
37. Synthemed, Inc.
38. TNI Pharmaceuticals
39. TransPharma (Israel)
40. University  of Washington
41. Vicor Technologies, Inc.
42. White Mountain Pharma

1. Writning 2 book chapers 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