Target Health – What We Do

 

ON TARGET is now sent directly to over 5,200 readers each week, by request only and we thank our loyal readers for the very kind words we constantly receive about ON TARGET. Several times a year we dedicate an edition of ON TARGET to Target Health Inc., the parent company of ON TARGET.

 

Target Health is a New York City-based, full-service, contract research organization (eCRO), providing high level, sophisticated development services to the drug and device industries. Because we have developed software tools to optimize the paperless clinical trial, it is not uncommon for clients to also ask us to provide data management and software product services for projects where the client may be using services of other CRO (e.g. global studies or studies with highly specialized indications). As a result, we are also known as the eCRO for CROs.

 

20141020-1

View from the 24th Floor Offices of Target Health Inc. © Target Health 2014

 

The following is a detailed discussion of who we are and what we do.

 

Innovative Thinking at Target Health

 

Here are few examples of creative thinking in the development space where Target Health has made a difference:

 

For the treatment of Gaucher disease, we helped design a program that went from a Phase 1 study in normal volunteers directly to Phase 3. NDA APPROVED

 

For head lice, we designed the phase 3 study as a placebo controlled, but on the day after the initial treatment, we brought all subjects back and if lice were present, the subject was designated as a treatment failure, but then was retreated, but this time with the active drug. The subject came back the next day, and if lice were not present, the subject continued in the study. This is the standard protocol now for head lice, and we have finished working on our 3rd head lice program. 2 NDAs APPROVED

 

For a program in emergency contraception, there were delays in enrolling subjects in a study in Europe where the control drug was not approved in the US. We were able to get FDA to agree to expand the study to the US where we studied 2 unapproved drugs. We were able to demonstrate to FDA that the control drug was approved and marketed in Europe, thus there was no resistance to bring the drug into the US for the clinical trial.  NDA APPROVED

 

For a PMA device where from the client’s and our point of view a control was not necessarily needed and could delay implementation of the study, we negotiated with FDA to follow a small number of untreated controls rather than randomize to treatment and no treatment. PMA TO BE SUBMITTED THIS YEAR

 

Strategic Planning

 

Planning the drug and device development process involves broad skills including knowledge of science, medicine, chemistry, toxicology, clinical research and yes, regulatory affairs. Joining Target Health in May 2005, Sr. Director Glen Park, PharmD, now leads the regulatory group that acts as the U.S. Agent for 36 companies at FDA. We advise companies on possible/alternative regulatory pathway and how to optimize time to the market. We have also helped clients on how to communicate with potential licensors.

 

In recognition of Target Health’s commitment, knowledge and expertise in drug and device development, Dr. Mitchel, President of Target Health, was recently nominated by the Steering Committee of the Clinical Trials Transformation Initiative (CTTI) to be a member its Executive Committee. CTTI is a public/private partnership with FDA and Duke University whose mandate is to transform the way the pharmaceutical and device industries manage and execute clinical trials.

 

Data Management

 

It is all about the data when convincing regulators to approve, physicians to prescribe and for patients, to use a drug or device. Joining Target Health in May 1999, Executive Director Yong Joong Kim now leads our data management team. Whether it is helping clients in the overall data management process, designing Data Management Plans (DMPs), creating industry standard SDTM datasets, making sure that the data “make sense“ or working closely with programing to design EDC application, Yong Joong has developed the best group of DM professionals in the industry. For multiple FDA pre-approval inspections where Target Health performed DM and EDC services, there has never been a finding by FDA inspectors associated with DM.

 

Software Development

 

It is all about our commitment to the paperless trial. Joining Target Health in July 2001, Sr. Director Joonhyuk Choi now leads Target Health’s software development team which is the best in the pharmaceutical industry. Target Health started with traditional electronic data capture (EDC) software (Target e*CRF®) in 1999. Since that time and with multiple NDA, BLA, PMA and EMA approvals, Target Health has made great strides in being the industry leader and advocate for the paperless clinical trial. Flagship products include Target e*Studio®(version 2 of Target e*CRF®), Target eClinical Trial Record (Target e*CTR®; eSource); Target Document® (eTMF); Target Encoder™ (MedDRA and WHODrug coding); Target e*Pharmacovigilance (SAE management) and a development program with Life-on-Key, funded by the BIRD Foundation to integrate any EDC database with any EMR database.

 

Biostatistics

 

It is all about proving and convincing others that a product actually works. Joining Target Health in August 2002, Director Leigh Ren now leads Target Health’s Biostatistics team which is one of the best in the pharmaceutical industry. Whether we are addressing difficult statistical issues, creating statistical analysis plans (SAPs), running and validating the statistical analyses or writing reports, Leigh’s team can do it all. Supporting Leigh’s team, when necessary, is Dr. Ralph D’Agostino, Jr. Professor of Biostatistics at Wake Forest School of Medicine who has been our statistical consultant since August 1997. A partial list of accomplishments include multiple analyses supporting clinical study reports and the following regulatory approvals: NDA (Gaucher disease, head lice, emergency contraception; infertility); PMA (periodontal disease; adhesion prevention)

 

Clinical Research

 

It is all about managing the process that shows that a product actually works.  Gen Park (2005) runs the clinical research group at Target Health which includes project management, onsite/remote monitoring and medical writing. Clinical programs that have led to approved products include: Gaucher disease, head lice, emergency contraception, periodontal disease and adhesion prevention. One regulatory submission is planned for November of this year and another in Q3 2015, for which full clinical research services have been provided. Current programs include autism, men’s health, rheumatology, and multiple programs in oncology.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchelor Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor