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Welcome
to NIPTE
The goal of NIPTE will be to become the pre-eminent interdisciplinary
national resource for research and education on science and engineering
based understanding of pharmaceutical development and manufacturing.
Scientists, researchers and engineers from academia, the FDA and the
industry will collaboratively engage in developing state-of-the-art
science and technology to enable the pharmaceutical industry to develop
products faster, and at a significantly lower cost with less variability
and higher predictability of performance.
Workshop on the Strategic Pharmaceutical Technology
and Education Roadmap
September 7-8, 2006 at FDA facilities in Rockville
, MD
NIPTE members have been working on developing
a Strategic Roadmap for Research and Education to
address the gaps that exist in today's science and
technology for pharmaceutical product development
and manufacturing. This strategic roadmap is essential
for the allocation of available funds and resources
to areas of research and education that we all agree
should be the highest priority for the NIPTE members.
The goal of this meeting is to present the draft roadmaps
and to receive feedback before the strategic plan
is finalized. Read
More >>>
FDA/URI
Joint Conference CDER on CMC: 21st Century Pharmaceutical
Manufacturing & Control Strategies - A New Paradigm
October 17-18, 2006 at the Hyatt Regency Reston Center,
VA
The U.S. Food and Drug Administration (FDA)
and the University of Rhode Island College of Pharmacy
(URI) are co-sponsoring a conference on October 17-18,
2006 at the Hyatt Regency Reston Town Center, Reston,
VA on the progress the FDA has made on the 21st Century
Initiative since the final report. This event will
include discussions with the Director of each CMC
review Office in CDER and the Director of the Office
of Testing and Research. Details of specific efforts
to better meet Critical Path Industrialization goals
will be provided.
Read
More >>>
Road-Mapping
for the Future of Pharmaceutical Technology: Critical
Research and Education Issues
October 30, 2006 at Henery B. Gonzalez Convention
Center in San Antonio , TX
In the FDA’s white paper on the critical
path to development of pharmaceutical products, industrialization,
or what we call pharmaceutical technology, was highlighted.
The document points out that, "the pharmaceutical
industry generally has been hesitant to introduce
state-of-the-art science into its manufacturing processes,
in part due to high in-process inventories, low factory
utilization rates, significant product wastage, and
compliance problems, driving up costs and decreasing
productivity." Read
More >>>
ISPE
- NIPTE Seminar on Pharmaceutical Technology and Education
November 5–7, 2006 Walt Disney World in Lake Buena
Vista , Florida
The ISPE Annual Meeting is your yearly opportunity
to get broad exposure to the widest range of hot topics
and industry issues in pharmaceutical manufacturing.
Take your knowledge to the next level with in-depth
sessions and workshops in your chosen field - or expose
yourself to a new discipline. By picking and choosing
the educational sessions that meet your needs, you'll
be able to build a customized learning experience.
Read
More >>>
Technology
Roadmap: Pharmaceutical Product Development &
Manufacturing
NIPTE Leadership presents Technology and Education
Roadmap for Pharmaceutical Product Development and
Manufacturing at the Annual Meeting of the American
Institute of Chemical Engineers on November 15, 2006.
Read
More >>>
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Sen. Roberts Co-Sponsors Bill
We are pleased to report that Sen. Pat Roberts of Kansas has
agreed to cosponsor the NIPTE authorization bill, S. 2793,
the Pharmaceutical Technology and Education Enhancement Act.
Senate bill would benefit NIPTE
Sen. Richard Lugar, R-Ind., has introduced a bill in the Senate
that would give a boost to a multi-university consortium created
to develop pharmaceutical products faster, more safely and
at a lower cost to consumers.
Read
More | View
Bill
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Workshop on Pharmaceutics Education identifies NIPTE for possible source for curriculum for pharmaceutics.
Please see Pharmacy Today, July 2006, Volume 12, Number 6.
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Lilly exec says drug development costs could top $2 billion
The costs of producing a successful new drug could reach $2 billion by 2010 if pharmaceutical firms do not improve the drug development process, says Eli Lilly executive vice president Steven Paul. Several factors are working against the industry, such as soaring research and development costs, fewer drug approvals, the loss of patent protection, safety issues and pricing pressures, he said. Read More >>>
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FDA
and NIPTE signed a
Memorandum of Agreement
FDA
& NIPTE agree to cooperate in:
• Establishment of a multi-partner organization with
strong research programs in drug development, pharmaceutical
manufacturing and regulatory science.
• Development of science based understanding of pharmaceutical
materials and manufacturing processes, where appropriate.
• Development and conduct of educational programs for
scientists from FDA and industry.
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For webpage enquiries, please contact: nipte@purdue.edu
Some Photos Copyright © 2005 Havione and GlaxoSmithKline