Regulatory Affairs Expertise at Target Health

 

No matter what happens in the discovery phase, innovators of drugs, devices and biologics will always need to amass data and have expertise in regulatory affairs. While Target Health is well-known in the data and software space, and is the champion of the paperless clinical trial, we are also quite known and respected in the regulatory space. Our esteemed head of regulatory affairs is Glen Park, PharmD, and yes, he is the only Park at Target Health who is not of Korean descent. Glen joined us 9 years ago and has been a major asset of our company. Glen had over 20 years of experience at AVENTIS PHARMA (FORMERLY HOECHST MARION ROUSSEL), SANKYO PHARMA DEVELOPMENT and the UNIVERSITY OF IOWA, and now leads the regulatory team at Target Health which represents 36 clients at FDA. The following are major Target Health accomplishments where we made significant contributions to the regulatory approval process:

 

1. NDA  –  Gaucher Disease (orphan disease)

2. NDA  –  Cystic Fibrosis (orphan disease)

3. NDA  –  Head Lice (2)

4. NDA  –  Emergency Contraception

5. BLA  –  Auto-inflammatory diseases (orphan disease)

6. PMA  –  Surgical Adhesions

7. PMA  –  Periodontal Disease

8. PMA  –  Companion Diagnostic

9. 510(k) – Heart Rate Variability (2)

 

In addition to regulatory approvals, we obtained orphan drug designation for the following indications:

 

1.   Gaucher Disease – NDA Approved

2.   Hereditary angioedema – NDA Approved

3.   Debridement in hospitalized patients with 3rd degree burns – EMA approved

4.   Growth Hormone

5.   Scleroderma

6.   Alagille Syndrome

7.   Burn progression in hospitalized patients

8.   Caries prevention, head and neck cancer

9.   Cushing’s syndrome secondary to ectopic ACTH secretion

10. Edema-related effects in hospitalized patients with 3rd degree burns

11. Osteonecrosis of the jaw

 

As a biologist, Dr. Mitchel is fascinated by the fauna and flora of Central Park, the heart and lungs of New York City. How brilliant it was to put a park right in the middle of it all. Every week we will try to share the breath of wildlife in NYC.

 

Springtime in NYC – Central Park ©Target Health Inc.

20140519-13

Nesting Pair of Canadian Geese                                               Black Crowned Night Heron

 

ON TARGET is the newsletter of Target Health Inc., a NYC-based contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services, including the paperless clinical trial, to the pharmaceutical and device industries.

 

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. Mitchel or 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 Chief Editor of On Target

Jules Mitchel, Editor

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