The Newsletter, ON TARGET, and the BLOG, Target Health Global are on vacation, in the US Southwest and will be back in September.

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Upon returning, we will feature a new section called Molecular Medicine, which will focus on the cutting edge technologies in stem cell biology, nanotechnology, regenerative medicine, and molecular biology. 

For more information about Target Health and our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

 

TARGET HEALTH ACCOMPLISHMENTS LAST 12 MONTHS

Update From Target Health – August 2009  

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. 

We are very pleased to announce that there are now over 25 products with FDA marketing approval and 17 unique products (NDA-4; PMA-10; BLA-1; MAA-1; and 510k-1) that used Target e*CRF® for their pivotal trials.  Of these 17 products, three were approved in 2009 (MAA in Women’s Health; NDA in Dermatology; and PMA in Cardiology 

In 2009, Target Health celebrated its 16th 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. 

A.      Regulatory Affairs

1.      Regulatory Representation

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

2.      2009: MAA ellaONE (HRA Pharma)

May 2009: – 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.

3.            2009: NDA Ulesfia (Sciele Pharma Inc.) 

April 2009: Sciele Pharma Inc. received FDA approval of Ulesfia for the treatment of head lice (Pediculosis capitis) infestation for use in patients 6 months of age and older. For this program, Target Health provided full turn-key CRO services including regulatory consultations and submissions, toxicology, monitoring, data management, biostatistics and medical writing services.  Target Health prepared the NDA and Target e*CRF® was used for all Phase 2 and Phase 3 studies.

4.            2009: PMA REPEL-CV (SyntheMed Inc.) 

March 2009: Synthemed Inc. received FDA approval of REPEL-CV Adhesion Barrier for use in pediatric cardiac surgery patients. For this program, Target Health provided regulatory consultations, monitoring, data management, biostatistics and medical writing services.  Target Health prepared the PMA and Target e*CRF® was used for the pivotal trial.

5.            2008: NDA Degarelix (Ferring Pharmaceuticals) 

December 2008: Ferring Pharmaceuticals received both FDA and EMEA approvals for the marketing 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 Ferring on 3 marketed NDAs for products sold in the US, Canada and Europe. Two of these programs also used Target e*CRF®.

6.            2008: 510(k) PD2i Analyzer (Vicor Technologies Inc.) 

December 2008: The Vicor PD2i Analyzer is a device for measuring heart rate variability (HRV).  The device can use any ECG acquisition System that can digitize raw signals, in order to perform proprietary calculations from HRV and then display the results utilizing a display unit. The objective of the PD2i Algorithm is to make the PD2i Correlation Integrals (CI’s) from the input data, and then find the accepted and convergent slopes of the linear scaling regions for each embedding dimension (i.e., the PD2i values).

7.            FDA Inspection of Target Health 

In May 2008, FDA completed a 4 day, unannounced though not unexpected, inspection of Target Health for an NDA under review.  For this program Target Health performed all of the clinical and regulatory strategic planning, toxicology, regulatory, study designs, monitoring of the clinical trials (Phase 1, 2 and 3), data management, including Target e*CRF® (EDC), statistics, medical writing and preparation of the NDA. There were 2 pivotal trials and a rescue protocol for treatment failures.  The FDA audit also included a detailed review of Target e*CRF® and data management.  The outcome of the inspection was that from evaluation of the establishment inspection report and the documents submitted with that report, we conclude that you adhered to the applicable statutory requirements and FDA regulations governing the monitoring practices of clinical investigations and the protection of human subjects.

8.            NDA Submission

Digestive Care Inc. submitted an NDA for Pancrecarb for the treatment of digestive systems associated with pancreatic insufficiency.  Target Health prepared all submission data sets for the studies and the ISS, wrote the ISS and ISE and wrote most of the study reports submitted as part of the NDA.

9.      INDs / CTAs 

a.      Cushing’s syndrome

b.     HIV

c.      Gaucher disease (USA and Canada)

d.     Ulcerative colitis (n=2)

10. Orphan Drug 

a.      Scleroderma (US and EU)

11. FDA Meetings 

a.      Adhesion prevention

b.     Cushing’s syndrome

c.      Emergency contraception

d.     Gaucher disease

e.     Growth disorders

f.      Hereditary angioedema

g.     Herpes simplex

h.     Hormone replacement therapy

i.     Ulcerative colitis

j.        Uterine myoma

12. Other Major Approvals Prior to 2008 

a.      NDAs for Repronex, Bravelle and Menopur. Target e*CRF used in the 2 latter programs.

b.     8 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.”

c.      PMA approved in the area of periodontal disease for a combination drug/device. Target e*CRF® was used for the pivotal trial and Target Health monitored the study and performed statistical analyses and medical writing.

13. 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). In 2009, it is expected that an NDA will be submitted in the area of Women’s Health as well as an NDA for an Orphan Metabolic Disease.

B.            Clinical Trial Software Packages 

Target e*CRF®: Target e*CRF has now been used in over 200 clinical trial since 1999.  Largest trial to date is over 7,000 patients.  There are now 17 Approved Products in the US that used Target e*CRF® for their clinical trial programs (3-NDAs, 1-BLA, 1-MAA, 10-PMAs and 1-510(k)). This coming year, an NDA will be submitted in the area of Women’s Health as well as an NDA for an Orphan Metabolic Disease.

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*CTMSTM:  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*PharmacovigilanceTM: 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 FDA-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*CTRTM; Patent Pending): 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. An accelerated patent review has been granted.

C.            Academic Collaborations 

EDC vendor for 2 NIH grants in Juvenile Rheumatoid Arthritis at the Cleveland Clinic and University of Washington.  EDC project completed in the newborn under an HHS grant at Stanford University.  Collaboration with the Biotechnology Center at SUNY Stony Brook and UMDNJ (the Medical School of New Jersey).

D.            Current Indications 

3rd degree burns; Emergency contraception; Menopausal symptoms;

Adhesion prevention; Gaucher’s disease; Nocturia;

Atopic dermatitis; Growth Impairment; Osteoporosis;

Bone fractures; Hereditary angioedema; Pre-eclampsia; diagnostic

Brain Imaging; Head lice; Prostate cancer;

Cardiac implant device; Hemostasis; Scleroderma;

Cardiology diagnostic; HIV diagnostic; Ulcerative colitis;

Cushing’s disease; Infertility; Wound Healing;

Cystic fibrosis; Juvenile rheumatoid arthritis

E.             Publications 

Abstract: A Complex Protocol Design To Accelerate Clinical Trial:  How To Implement Multiple Database Lock In An Electronic Data Capture System (Bio-IT World, 2008).

Mitchel J., Ghilezan I., Kim, Y.J., et al., The End of the Paper Trail, European Pharmaceutical Contractor Winter 2008; 72-75.

Mitchel J, Park G, Lynch S., Pagano R. and Citron M. 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) 2009 In Press.

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) 2009 In Press.

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, Management of Clinical Trials, Biostatistics, Data Management, EDC utilizing Target e*CRF®, Project Management, 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*CTMSTM, 3) Target Document®, 4) Target Encoder®, 5) Target Newsletter®, 6) Target e*CTRTM (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.