Cardinal Health Specialty Solutions Provides Regulatory Support to Help National Institutes of Health Develop Therapeutics for Rare, Neglected Diseases

Cardinal Health Specialty Solutions Provides Regulatory Support to Help National Institutes of Health Develop Therapeutics for Rare, Neglected Diseases

DUBLIN, Ohio – February 6, 2012 – The Scientific and Regulatory Consulting business of Cardinal Health Specialty Solutions (Beckloff Associates) will provide regulatory support to the National Institutes of Health's (NIH) Therapeutics for Rare and Neglected Diseases (TRND) program under a research subcontract with SAIC-Frederick, Inc.

SAIC-Frederick, under contract with the National Cancer Institute, operates the Frederick National Laboratory for Cancer Research. It also supports other parts of the National Institutes of Health through this contract if approved by NCI.

The TRND program helps expedite small molecule and biologic therapies through the pre-clinical testing phase of drug development, and the submission of an investigational drug application (IND) to the U.S. Food and Drug Administration.

According to the NIH, the need and opportunity for therapeutics for rare and neglected diseases are enormous. According to the NIH's Web site, "Of the 7,000 human diseases, fewer than 300 are of interest to the biopharmaceutical industry, due to limited prevalence and/or commercial potential. More than 6,000 of these diseases are rare[1], and the remainder are neglected because they affect impoverished or disenfranchised populations."

Cardinal Health Specialty Solution's Scientific and Regulatory Consulting business (Beckloff Associates) will work with SAIC-Frederick and the NIH TRND program to prepare, submit and maintain IND regulatory submissions for drugs and biologics for various rare diseases for selected TRND projects. The three parties will work with TRND partners to accelerate development timelines, reduce development costs and mitigate development risks for select programs. 

"Although considerable research and development resources are dedicated to providing solutions for the world's primary diseases, there remain thousands of disease states with very limited or no therapeutic intervention," said Rick Friederich, director of finance and acting general manager, Cardinal Health Specialty Solutions, Scientific and Regulatory Consulting business (Beckloff Associates). "We are honored to work in collaboration with the NIH's TRND program to help bring hope and new therapeutic solutions to patients with unmet medical needs."

About SAIC_Frederick, Inc.
SAIC-Frederick Inc., a wholly owned subsidiary of SAIC, operates the Frederick National Laboratory for Cancer Research for the U.S. National Cancer Institute. FNL is one of 39 Federally Funded Research and Development Centers and the only one focused exclusively on biomedical research. Through the FFRDC contract, SAIC-Frederick also provides support to other institutes of the U.S. National Institutes of Health

About Cardinal Health Specialty Solutions
Cardinal Health Specialty Solutions provides regulatory, clinical, reimbursement, technology and distribution services to help health care professionals, payors and pharmaceutical and biotech companies improve the quality and cost-effectiveness of caring for patients who are managing complex diseases.  Cardinal Health Specialty Solutions partners with customers to alleviate day-to-day administrative burdens, optimize business functions and to implement new innovations that move their businesses forward.  To learn more, visit www.cardinalhealth.com/specialtysolutions.

About Cardinal Health
Headquartered in Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $108 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers and physician offices focus on patient care while  reducing costs, enhancing efficiency and improving quality. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products to more than 60,000 locations each day. The company is also a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #21 on the Fortune 500, Cardinal Health employs more than 30,000 people worldwide. More information about the company may be found at cardinalhealth.com and @CardinalHealth on Twitter.

[1] http://rarediseases.info.nih.gov/Resources.aspx?PageID=32

Suggested Articles

All 12 members of an FDA advisory committee voted to recommend the approval of teprotumumab for a rare, autoimmune eye disease.

Early data out of former Fierce 15 winner Gritstone Oncology have been heralded as a big win for the early-stage biotech by analysts.

Biogen will drop work on gosuranemab in progressive supranuclear palsy but continue on in Alzheimer's.