White papers (driven by BAA) All areas of relevance and interest Current funding – RTD modeling (Muzzio – $2.2 M) Pending – API continuous manufacturing (Muzzio, 3.75 M)
Leaders TBD – Open to all of NIPTE
$3M per project (1M/y – 3y)
WP – before 3/4/2022 Full prop by invitation (30 day turnaround)
FDA
GDUFA
Collaborative Research Projects on Complex Generics and Education Priorities
Open to all of NIPTE
TBD
TBD
FDA
ETF
Emerging Technologies (CM for biologics, vaccines, 3D printing, Aerosols) Pending – API continuous manufacturing (Muzzio, 3.5 M)
TBD (laboratory for rapid product and process development? – scalable API manufacturing? Other?) Theme needs to enable research that is otherwise not possible
TBD Muzzio, Gurvich
$6M-$20M (over 5 years)
TBD
Other
Funding source
Program
Theme
Team Members
Funding target
Due Dates
NIST
Advanced Manufacturing Roadmap
Advanced manufacturing of API, OSD, injectables
Muzzio, Gupton, Burgess, Gurvich
$300K
8/15/2021
NIST
Manufacturing Institutes
Advanced Manufacturing of API, OSD, injectables
All of NIPTE
$70M
Anticipated 7/2023
USP – BARDA
New initiatives in Advanced/continuous manufacturing
Training in Advanced/Continuous manufacturing
TBD
TBD
TBD
Generic Industry
Formulation Science (New prior knowledge)
Membership program focused on developing platform formulations, advanced batch manufacturing, training programs
TBD
TBD
TBD
BARDA
Tech Watch
Bring Manufacturing back to US: -Advanced Manufacturing Laboratories -Platform Formulations -Training Programs