Accelerating the Development of New Drugs and Diagnostics Maximizing the Impact of the Cures Acceleration Network: Workshop Summary (2012) / Chapter Skim
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4 Application of Flexible Research Authority
4 Application of Flexible Research Authority
Pages 39-50
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From page 39... ...
a Identified by individual speakers. The section of the CAN authorizing legislation establishing the Cures Acceleration Flexible Research Awards states: "If the Director of NCATS determines that the goals and objectives of this section cannot adequately be carried out through a contract, grant, or cooperative agreement, the Director of the Center shall have flexible research authority to use other transactions to fund projects in accordance with the terms and conditions 39
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From page 40... ...
To help facilitate government contracting with civilian companies while minimizing the administrative burden, legislation passed in 1989 2 permitted the secretaries of military departments to "enter into transactions (other than contracts, cooperative agreements, and grants) for basic, applied and advanced research projects." This OTA confers great flexibility upon program managers and contracting officers in setting up an agreement that meets the needs of a given project.
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From page 41... ...
First, participating companies are not bound by most procurement laws and regulations, though they are bound by other regulations tied to appropriations, such as the Civil Rights Act or lobbying restrictions. 3 32 CFR subchapter C (Parts 2137)
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From page 42... ...
They allow flexibility and cost savings by reducing timeframes for technology development and encouraging streamlined ways of operating. Under OTA, there are no mandatory cost principles or accounting standards, except for generally accepted accounting principles, which is much more acceptable for companies.
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From page 43... ...
When everything is negotiable, some points may require extended discussions. Ulrey noted that this can be addressed by getting everyone who is involved into the same room, including program managers, lawyers, and contracting officials, rather than having the parties work in isolation and sending proposals and proposed changes to the others.
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From page 44... ...
Under a march-in provision, if the patent owner does not commercialize the patented technology, the government has the right to license the patented technology to a commercial competitor to ensure that the taxpayerfunded technology reaches the marketplace. This provision can dissuade some prospective private-sector partners, Maarbjerg noted.
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From page 45... ...
"Unlike you all, I hope that we never have to use the products that we're developing and stockpiling," said Kovacs, but BARDA's experiences also offer important lessons for commercial drug development. BARDA's mission is "to develop and provide countermeasures for CBRN threats, pandemic influenza, and emerging infectious diseases by product development, stockpile acquisition/building, manufacturing infrastructure building, and product innovation." Its current budget is $1.6 billion, with an additional $5.6 billion in a special reserve fund for Project BioShield, which is designated for licensure, production, and delivery of medical countermeasures.
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From page 46... ...
It also makes rapid-go/no-go decisions through what is called in-process review, where interagency partners meet to determine whether a performer has met the milestones in a contract and whether the work should go forward. BARDA's core services include regulatory and clinical affairs, an animal studies network, a manufacturing network, centers for innovation in advanced development and manufacturing, and technical expertise.
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From page 47... ...
First, as noted by other speakers in the session, the process of approving OTA agreements is slow. Using OTA opens many issues to negotiation, and coming to agreement on each of these issues takes time.
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From page 48... ...
CHDI also organizes workshops and meetings and makes reagents and other research tools available to the Huntington's disease research community. The CHDI Foundation has the advantage of working on a single, 7 This section is based on remarks given by Robi Blumenstein, President, CHDI Management.
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From page 49... ...
APPLICATION OF FLEXIBLE RESEARCH AUTHORITY 49 focused disease and having access to very generous private donors so that it does not have to raise money. Under these circumstances, it is able to experiment to try to figure out how to solve problems.
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