Conference: accelerating drug product development and approval: a critical need in response to national emergencies

Ended Project Grant Awarded Last action

Award ID
2232197
Recipient
Awarding agency
Obligated
$84,996

Award facts

Assistance listing
47.041 Engineering
Completion date
Funding agency
Division of Engineering Education and Centers National Science Foundation
Place of performance
Minneapolis, MN 55414, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
The drug discovery, development, and regulatory evaluation process, from the point where a molecule is identified as a potential therapeutic agent to when IT is approved for commercialization as a drug product, can take up to 15 years. This lengthy process involves many stages, including the determination of efficacy, safety, toxicity, and therapeutic regime, identification of target populations, side effects, and interactions, selection of a feasible synthetic pathway, and development of a product formulation and a reliable manufacturing process. This lengthy time frame makes IT hard to respond to emergencies requiring new therapies, deprives patients of faster access to life-saving medicines, decreases the profitability period of pharmaceutical companies, and contributes to the high cost of new medicines. Moreover, the covid-19 pandemic has made clear the need for faster drug development and regulatory evaluation process. To address these issues, a workshop is proposed to bring together a focused group of thought leaders from academia, industry, and regulatory agencies to discuss the critical elements needed to accelerate drug discovery, development, and regulatory evaluation based on recent scientific and technical advances in medicine, biology, materials science, biostatistics, and advanced manufacturing technologies. Acceleration mechanisms will be examined from multiple perspectives, including the strength of the underlying science, technical feasibility, and regulatory acceptability. The systemic brainstorming and analysis with the participation of experts across the relevant disciplines will enable significant outcomes, including the production of a strategic plan to implement the workshop findings. The project leadership team propose to organize and conduct a structured workshop that will bring together a focused group of thought leaders from academia, industry, and regulatory agencies, to discuss the critical elements needed to accelerate drug discovery, development, and regulatory evaluation based on recent scientific and technical advances in medicine, biology, materials science, biostatistics, and advanced manufacturing technologies. These discussions will be led by pre-selected panelists with established track records in their respective fields. Acceleration mechanisms will be examined from multiple perspectives, including the strength of the underlying science, technical feasibility, and regulatory acceptability. The systemic brainstorming and analysis with the participation of experts across the relevant disciplines will generate significant outcomes, which would not be achieved in any existing scientific communication forum or conferences. Acceleration mechanisms deemed to be potentially effective will be selected for further analysis by a focused multidisciplinary team of workshop participants, which will be tasked to integrate these mechanisms into a strategic plan and an implementation pathway. These documents, which will be the main output of the workshop, will serve as a blueprint for the federal government, industry, and academia to direct efforts in this field. The workshop will be held in the washington, DC area 24-26 january 2023 and will be attended by leaders from industry, academia, and government organizations such as NSF, NIH, NIST, and FDA. The proposed workshop will achieve two goals, to: 1) identify scientific, technological, and regulatory mechanisms capable of significantly reducing the drug discovery, development, and commercializing time frame with improved efficiency and reduced risks to patients; and 2) integrate these mechanisms into a coherent strategy and integrated implementation plan. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.

Quick answers

Who received award 2232197?

2232197 was awarded to National Institute For Pharmaceutical Technology & Education Inc. by Division of Chemical, Bioengineering, Environmental, and Transport System (National Science Foundation) on February 15, 2023.

How much is award 2232197 worth?

$84,996 has been obligated on 2232197.

Which agency awarded 2232197?

Division of Chemical, Bioengineering, Environmental, and Transport System (National Science Foundation) awarded 2232197, with funding from Division of Engineering Education and Centers (National Science Foundation).

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