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Expect More –
The Best Doesn’t Have To Be The Biggest
Highlights of the Year
We would like to thank the loyalty and feedback of our over 3,000 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.
As of 2010, Target Health celebrates 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. Target Health also provides a fully validated tool kit of software for clinical trials.
Highlights of the year included:
- Four regulatory approvals (2 US, 1 Europe and 1 Canada)
- Pfizer’s license of taliglucerase alfa (Protalix Biotherapeutics). Target Health assisted Protalix from pre-IND to NDA in 5.5 years, including a full eCTD NDA submission.
- Release of:
Target e*CRF® v1.9 (EDC made simple)
Target Document® v1.4 (document management)
Target e*CTMSTM v1.1 (Clinical trial management system)
Target e*PharmacovigilanceTM v1.0 (Safety monitoring)
Target Encoder® v1.1 (MedDRA and WHO Drug coder)
Target e*CTRTM v1.0 (electronic health record for clinical trials)
- Full management of a 90 center study in ulcerative colitis
- Dr. Glen Park on the FDA biomarker task force for Gaucher disease
- In-license of eCTD software
- Target Health joins the CTTI
- Net increase of 4 employees, totaling 45 fulltime staff
- Expansion to a 2nd floor
- In 2009, Target Health was directly involved with four regulatory approvals (2 US, 1 Europe and 1 Canada). There are now 18 unique products that used Target e*CRF® for their pivotal trials
- US-NDA – ULESFIA (Head Lice – Summers Laboratories, Inc./Sciele) – EDC; Monitoring; DM; Statistics; Writing; Toxicology; NDA (eCTD)
- US-PMA – REPEL CV (Adhesion Prevention Synthemed, Inc.) – EDC ; Monitoring; DM; Statistics; Writing; PMA (Submission)
- EMEA-MAA – ellaOne® (Emergency Contraception – HRA Pharma) EDC ; Monitoring; DM; Statistics; Writing
- MDL-CANADA – AUGMENTTM Bone Graft (Biomimetic Therapeutics) – EDC
The following approvals are anticipated in 2010
- US-NDA – Cystic Fibrosis – Submitted 2008 – Monitoring; DM; Statistics; Writing; NDA preparation
- US-NDA – Emergency Contraception – Submitted 2009 – EDC ; Monitoring; DM; Statistics; Writing; NDA preparation
- US-NDA – Gaucher Disease Submitted 2009 – EDC ; Monitoring; DM; Statistics; Writing, NDA Submission
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. 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 e*CRF® was used for the pivotal trial.
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 a full turn-key CRO services including regulatory consultations, toxicology, monitoring, data management, biostatistics and medical writing services to NDA submission. Target e*CRF® was used for all Phase 2 and Phase 3 studies.
4. 2009: MDL AUGMENTTM Bone Graft (Biomimetic Therapeutics)
December 2009: 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.
5. INDs / CTAs
Gaucher disease (Canada)
6. Orphan Drug
Scleroderma (US and EU)
7. FDA Meetings
Hormone replacement therapy
8. 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).
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:
- 21 CFR Part 11 compliance
- Routing for electronic signatures
- eMail alerts
- 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 ChecksTM:
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 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):
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.
- 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).
- Dr. Jules Mitchel was appointed Course Director for Center for Biotechnology, Fundamentals of the Bioscience Industry program: Spring 2009.
- 3rd degree burns,
- DermatologyMenopausal symptoms
- Adhesion prevention
- Emergency contraception
- Atopic dermatitis
- Gaucher’s disease
- Bone fractures
- Growth Impairment
- Pre-eclampsia diagnostic
- Brain Imaging
- Hereditary angioedema
- Prostate cancer
- Cardiac implant device
- Head lice
- Cardiology diagnostic
- Transdermal drug delivery
- Colorectal cancer
- HIV diagnostic
- Ulcerative colitis
- Cushing’s disease
- Wound Healing
- Cystic fibrosis
- Juvenile rheumatoid arthritis
- 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.
- Mitchel J, Kim, YJ, Choi JH. Et al. The Integration of Electronic Data Capture (EDC) and the Electronic Medical Record (EMR); Challenges and Opportunities (submitted to Applied Clinical Trials, 2009).
- Morrison, B, Neaton, J. Mitchel, J. et al. A CTTI Survey of Current Monitoring Practices (submitted to Society For Clinical Trials 2009).
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.
Ms Joyce Hays, CEO
Dr. Jules T. Mitchel, President
©2010 Target Health Inc. All rights reserved