Navigation Links
FDA Awards NIPTE Potential $35 Million in Grants to Reform Drug Manufacturing Process

CHICAGO, Oct. 4, 2011 /PRNewswire-USNewswire/ -- In a move that seeks to cut health care costs, create jobs, and improve drug safety, the U.S. Food and Drug Administration (FDA) has awarded a grant worth up to $35 million over the next five years to the National Institute for Pharmaceutical Technology and Education (NIPTE) to improve drug manufacturing standards. The grant comes at a time when the current cost of bringing a drug to market in the U.S. exceeds $1 billion and an increasing number of drugs and drug ingredients are being imported from abroad. Investment in research of drug development and manufacturing will not only improve America's manufacturing competitiveness and create high-paying jobs at home, but will help to reverse the current outsourcing trends in the pharmaceutical industry in the long term by decreasing the cost of manufacture and by improving quality and safety of our drugs.

"Over the last several years, NIPTE has contributed a great deal of research toward our understanding of quality pharmaceutical manufacturing," said Helen N. Winkle, Director, FDA Office of Pharmaceutical Sciences. "Progress in this area will mean safer, more efficient, and less costly drug production here in the U.S., and we are looking forward to NIPTE's findings."

NIPTE, Inc. is an academic not-for-profit organization dedicated to fundamental research and education in pharmaceutical product development and manufacturing. NIPTE's goal is to increase science and engineering-based understanding of this area so that novel state-of- the-art technologies can be developed and science-based regulations can be implemented. These technologies will also enable new drug discoveries to be brought to market faster with less variability, higher predictability of performance and at a significantly lower cost.

"Outsourcing of drugs and drug intermediates are increasing at an alarming rate, potentially threatening overall quality of our drugs accompanied by huge job losses in this country," said NIPTE Executive Director Prabir Basu. "Development and manufacturing costs can be reduced, quality of our drugs can be improved, and outsourcing trends can be reversed by developing science-based standards for drug development and manufacturing."

The FDA grant will support programs to rectify these drug development and manufacturing problems, by creating ways to reduce time to market, enabling new performance attributes, improving small-batch production, promote continuous manufacturing, saving money or energy, or reducing environmental impact from the manufacturing of products. 

"We are thrilled to see the FDA's commitment to invest in the science of pharmaceutical manufacturing," said Basu. "I sincerely hope that other federal funding agencies will take the lead from the FDA and will take similar steps to fund this critical area of translational and manufacturing research to improve health care in the U.S."  

NIPTE partners with 10 U.S. universities that are leaders in pharmaceutical science and engineering. The member universities are Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kentucky, University of Maryland - Baltimore, and the University of Minnesota. It is the only partnership of universities of its kind.  Research conducted by NIPTE faculty is collaborative by design to provide for coordinated publication of the cutting edge research results.                  

SOURCE National Institute for Pharmaceutical Technology and Education
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Niaid / Barda Awards Elusys a $12 Million Contract to Further Develop Anthim, the Companys Anthrax Therapeutic
2. NIST Awards $2 Million to Velcura Therapeutics, Inc. for Innovative Technology R&D - Dual-Action Therapies for Bone Disease
3. Michael J. Fox Foundation Awards Up to $3 Million to Industry Teams to Jumpstart Promising PD Drug Development
4. The Foundation for Biomedical Research Announces Winners of the 7th Annual Michael E. DeBakey Journalism Awards
5. Small Business Innovation Research Program Awards Grant to Biomoda
6. Michael J. Fox Foundation Awards $2.4 Million for Validation of Nine Promising Therapeutic Targets for Parkinsons Disease
7. Michael J. Fox Foundation Awards $2.7 Million for Industry Efforts to Speed New Parkinsons Therapeutics
8. Michael J. Fox Foundation Funds $1.1 Million for Cutting-Edge Approaches to Parkinsons Disease Under Rapid Response Innovation Awards 2008
9. Michael J. Fox Foundation Awards $2 Million for Research on Cognitive and Mood Symptoms of Parkinsons Disease
10. Premier Research Honored as Clinical Research Team of the Year at 2008 GCPj Awards
11. Michael J. Fox Foundation Awards $2.7 Million to Four Industry Teams for Pre-Clinical Parkinsons Disease Research
Post Your Comments:
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
(Date:6/23/2016)... , June 23, 2016 Research ... Devices Global Market - Forecast to 2022" report to ... the treatment method for the patients with kidney failure, it ... excess fluid from the patient,s blood and thus the treatment ... potassium and chloride in balance. Increasing number ...
(Date:6/23/2016)... , June 23, 2016 Research and ... Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data derived ... Assessment of major trends with potential impact on the market ... of market segmentation which comprises of sub markets, regional and ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... recently awarded their highest five-star ... , Millions of individuals in the United States and Canada wear eyeglasses. Once considered ... both correct vision and make a fashion statement. Even celebrities use glasses as a ...
(Date:6/26/2016)... ... , ... PawPaws brand pet supplements owned by Whole Health Supply ... health of felines. The formula is all-natural and is made from Chinese herbs that ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root ...
(Date:6/25/2016)... ... 2016 , ... Austin residents seeking Mohs surgery services, can now turn to ... Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to ... fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of ...
(Date:6/25/2016)... , ... June 25, 2016 , ... As a lifelong ... Cum Laude and his M.D from the David Geffen School of Medicine at UCLA. ... to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
Breaking Medicine News(10 mins):