| Vision
The Pharmaceutical Technology & Education
Center (PTEC) will facilitate engagement of the scientists, researchers
and engineers from academia, the FDA and the pharmaceutical industry
to spark discovery and to promote continuous learning in the science,
regulatory affairs and the manufacturing technology of high quality
pharmaceuticals.
Mission
The mission of this center is to advance pharmaceutical
technology and pharmaceutical manufacturing throughout the world.
The center will become the preeminent organization for research,
education and training in areas related to critical path initiative
of the FDA, application of basic sciences to drug development
and pharmaceutical manufacturing, mechanistic understanding of
processes, industrialization, and cGMPs.
Major Focus Areas
PTEC will have several major areas of activities:
1. Research Aimed at Reduction of Cost of Marketed Pharmaceutical
Products
Reduce the cost of drug development and manufacturing
and the time required to bring a new drug to the market:
a. Develop fundamental mechanistic understanding of the drug development
and drug manufacturing processes, including but not limited to
development of processes for Active Pharmaceutical Ingredients,
different types of dosage forms, interaction of materials, drug
delivery systems, resource allocation and resource optimization
issues.
b. Improve predictability and increase robustness of processes,
heuristics for process identification and process selection, factors
that impact quality of final product manufactured either as a
solid dosage form or by aseptic processing, and other related
issues that directly impact the timeline for drug development
and cost of pharmaceuticals.
2. cGMP and Regulatory Services
a. Develop and improve cGMP practices in drug manufacturing
in countries around the world
b. Train industry professionals and regulatory agency personnel
in cGMP’s and its application in modern drug manufacturing
practices
3. Education
a. Develop and offer courses in interdisciplinary programs
such as Pharmaceutical Engineering
b. Develop and offer pharmaceutical engineering executive training
programs for practicing engineers and pharmacists in the industry
4. Making Legacy Drugs Available to Developing Countries
at Lower Costs
Lower the cost of legacy drugs and making the manufacturing
technologies more easily available in countries where they are
needed the most.
a. License technologies of legacy drugs from pharmaceutical companies
b. Develop improved and cheaper manufacturing processes
c. Transfer technology to developing countries
d. Train professionals in developing countries
5. International Education and Training
Programs to help developing countries with education
and training programs on:
a. Modern cGMP practices in drug development and manufacture.
b. Hands-on training on cGMP practices
c. Pharmaceutical engineering
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