Science Weekly: Gone fishin’

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ANNUAL UPDATE FROM TARGET HEALTH INC. – Highlights of the Year

We would like to thank the loyalty and feedback of our over 3,200 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.

In 2010, Target Health celebrated its 17th 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, and Strategic Planning.  We also provide fully validated software for clinical trials.

Highlights of the year included:

  1. Three regulatory approvals using Target e*CRF (NDA 1; PMA 1; Canadian 1)
  2. Pfizer’s license of Protalix’s taliglucerase alfa. Target Health assisted Protalix from pre-IND to NDA in 5.5 years, including a full eCTD NDA submission
  3. eCTD IND/NDA programs
  4. Full management of a 90 center study in ulcerative colitis
  5. Dr. Park on the FDA biomarker task force for Gaucher disease
  6. Target Health member of the CTTI Steering Committee
  7. Release of:
    1. Target e*CRF® v1.10 (EDC made simple)
    2. Target Document® v 1.6 (Document management)
    3. Target e*CTMS™ v 1.3 (Clinical trial management system)
    4. Target e*Pharmacovigilance™ v 1.0 (Safety monitoring)
    5. Target Encoder® v 1.2 (MedDRA and WHO Drug coder)
    6. Target e*CTR™ v 1.0 (Electronic Clinical Trial Record)

 

In 2010, Target Health was directly involved with three regulatory approvals (2 US, 1 Canada). There are now 19 unique products that used Target e*CRF® for their pivotal trials

 

  1. NDA/MAA – ellaOne® (HRA Pharma) EDC ; Monitoring; DM; Statistics; Writing
  2. CANADIAN DEVICE – AUGMENT™ Bone Graft (Biomimetic Therapeutics) – EDC
  3. NDA – ULESFIA – (Summers Laboratories, Inc./Sciele) – EDC; Monitoring; DM; Statistics; Writing; Toxicology; NDA (eCTD)
  4. NDA/MAA – DEGARELIX – (Ferring Pharmaceuticals) -EDC
  5. BLA – ARCALYST (Regeneron Pharmaceuticals) – EDC
  6. NDA/MAA – MENOPUR (Ferring Pharmaceuticals) – EDC ; DM; Statistics
  7. NDA/MAA – BRAVELLE (Ferring Pharmaceuticals) – EDC; DM; Statistics
  8. PMA – GEM 21S (Biomimetic Therapeutics) – EDC ; Monitoring; DM; Statistics; Writing
  9. PMA – REPEL CV (Synthemed, Inc.  Approved) – EDC ; Monitoring; DM; Statistics; Writing; PMA (eCopy)
  10. PMANine (9) Diagnostic Approvals (Abbott Laboratories) – EDC
  11. 510(k) – One (1) Diagnostic Approval (Abbott Laboratories) – EDC

Pending Approvals

  1. NDA Cystic Fibrosis – Submitted 2008 – Monitoring; DM; Statistics; Writing; NDA preparation
  2. NDA Gaucher Disease – Submitted 2009 – Monitoring; DM; Statistics; Writing; NDA preparation

Regulatory Affairs

Target Health now represents over 30 companies at FDA from all over the world including England, France, Germany, Israel, Korea, Switzerland and the US.

1.      2010: NDA ellaONE (HRA Pharma)

HRA Pharma was granted marketing authorization by the European Commission for ellaOne® (ulipristal acetate), the next generation emergency contraceptive. For this program, Target Health provided monitoring, data management, biostatistics and medical writing services.  Target e*CRF® was used for the Phase 3 studies.

2.      PMA (Abbott Diagnostics)

Abbott Diagnostics received approval of the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.  Target e*CRF® was used for the pivotal trial.

3.      MDL AUGMENT™ Bone Graft (Biomimetic Therapeutics)

Biomimetic Therapeutics received Health Canada approval of Augment Bone Graft for use as an alternative to autograft in foot and ankle fusion surgery. For this program, Target e*CRF® was used for the pivotal trial.

4.      INDs / CTAs

a. Cardiology

b. Counterterrorism

c. Dermatology

d. Fatty liver

e. Gaucher disease (Canada)

f. Growth Impairment

g. Somnolence

h. Vaccine

5.      Orphan Drug

a. Scleroderma (US and EU)

6.      FDA Meetings

a. Cushing’s syndrome

b. Emergency contraception

c. Gaucher disease

d. Hereditary angioedema

e. Hormone replacement therapy

f. Ulcerative colitis

g. Women’s Health

7.      Electronic Submissions

Target Health has expertise in preparation and publishing of electronic submissions and is an FDA approved vendor for electronic submissions through the Electronic Submissions Gateway (ESG).

CLINICAL TRIAL SOFTWARE PACKAGES

Clinical Trial Software Packages

Target e*CRF®: Target e*CRF has now been used in over 250 clinical trials since 1999.  Largest trial to date is over 7,000 patients.

Target Document®: 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 tools.

Target Encoder®: 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 Encoder is fully integrated with Target e*CRF.

Target e*CTMS™:  Target e*CTMS is a user-friendly, inexpensive; highly sophisticated, Web-based, clinical trial management system. A new clinical trial starts with identification of the sponsor and project name.  Investigators, IRBs and users are maintained within the CTMS and can be easily assigned to a project.  All staff within a clinical site can be identified with their title and contact information, as well as shipping addresses which could be different from the head office.  As the site commits to participate in the clinical trial, a site number can be assigned.  Once IRB approval is obtained, and all regulatory documents have been identified as received, an alert can be sent out via email to allow for drug shipment.  Target e*CTMS provides many additional features such as: 1) Decision Logs, 2) Meeting Logs with uploading of the meeting minutes, 3) Questions and Answers, 4) Status of Regulatory Submissions and Deliverables, and 5) Monitor Site Visit Tracking with document upload.

Target Batch Edit Checks: With Target e*CRF®, batch edit checks are now integrated with the electronic query system within the study.  Target e*CRF® runs the edits and displays the results of those edits through a discrepancy review screen integrated with the query system.

Target e*Pharmacovigilance™: Target e*CRF integrates EDC with a pharmacovigilance module by 1) allowing the principle investigators to enter a narrative, 2) allowing the medical monitor to enter a narrative and then have the EDC system generate an approved version of Form 3500A or CIOMS for regulatory submission with the ability to control the original and followup submissions.

Target eClinical Trial Record (Target e*CTR™): Target e*CTR allows the clinical study sites to perform direct data entry into any EDC system, and at the same time generates a read-only electronic document, which can be designated as the primary source data (eSource). These data, maintained in a secure, read-only trusted 3rd party environment, are available to the clinical study sites, monitors and regulatory agencies in a human readable format. 

Academic Collaborations

EDC vendor for 2 NIH grants in Juvenile Rheumatoid Arthritis at the Cleveland Clinic and University of Washington.  Collaboration with the Biotechnology Center at SUNY Stony Brook, Rutgers and UMDNJ (the Medical School of New Jersey) and NYU School of Medicine.

Dr. Mitchel is a Course Director for Center for Biotechnology, Fundamentals of the Bioscience Industry, SUNY Stony Brook School of Medicine.

Indications

3rd degree burns Dermatology Menopausal symptoms
Adhesion prevention Emergency contraception Nocturia
Atopic dermatitis Erectile dysfunction Osteoporosis
Bladder cancer Gaucher’s disease Ovarian cancer
Bone fractures Growth Impairment Pancreatic cancer
Brain Imaging Hereditary angioedema Pre-eclampsia diagnostic
Cardiac implant device Head lice Prostate cancer
Cardiology diagnostic Hemostasis Scleroderma
Colorectal cancer HIV diagnostic Transdermal drug delivery
Cushing’s disease Infertility Ulcerative colitis
Cystic fibrosis Juvenile rheumatoid arthritis Wound Healing

Publications

1.     Mitchel J, Park G, Lynch S. Phase 1 Clinical Trials and Exploratory Phase 2 Clinical Trials. Book Chapter in Principles in Clinical Oral Health Research, Edited by: William Giannobile (University of Michigan Clinical Center), Brian Burt and Robert Genco (State University of New York at Buffalo) Chapter 11: 2009.

2.     Dye, BA and Mitchel J. Data Management in Oral Health Research. Book Chapter in Principles in Clinical Oral Health Research, Edited by: William Giannobile (University of Michigan Clinical Center), Brian Burt and Robert Genco (State University of New York at Buffalo) Chapter 6: 2009.

3.     Mitchel, J, Kim, YJ, Choi, JH, et al. The Final eFrontier. Applied Clinical Trials, Online, 1 May 2010

4.   Morrison, B, Cochran, C, Giangrandec, J, et al. A CTTI Survey of Current Monitoring Practices. Society For Clinical Trials, May 2010

Target Health (www.targethealth.com) is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND (eCTD), IDE, NDA (eCTD), BLA (eCTD), PMA (eCopy) and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, EDC utilizing Target e*CRF®, and Medical Writing.

Target Health has developed a full suite of eClinical Trial software including:

1) Target e*CRF® (EDC plus randomization and batch edit checks)

2) Target e*CTMS™

3) Target Document®

4) Target Encoder®

5) Target Newsletter®

6) Target e*CTR™ (electronic medical record for clinical trials).

Target Health’s Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.