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SMARTT Program Infrastructure

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The National Heart, Lung, and Blood Institute (NHLBI Offsite icon) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives.

The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide.

Coordinating Center - RTI International

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The Coordinating Center (RTI International Offsite icon, Research Triangle Park, NC) serves as the hub of SMARTT Operations. All SMARTT activities will be administered through this website.  In addition, RTI International Offsite icon can provide the following services and expertise to investigators through their capacity as the Coordinating Center:

  • Strategic planning for successful IND applications
  • Preclinical and early phase clinical study consulting support
  • Assistance with investigational new drug (IND) applications

Facilities

Biologics Production Facility - Advanced BioScience Laboratories

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The Biologics Production Facility (Advanced BioScience Laboratories, Inc. Offsite icon, Rockville, MD) provides:

  • GMP and non-GMP grade production of biologic test articles
  • Cell line development
  • GMP cell banking
  • Process development and scale-up
  • Assay development and qualification
  • Drug product fill and finish
  • Assistance with investigational new drug (IND) applications

Pharmacology and Toxicology Center - SRI International

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The Pharmacology/Toxicology Center (SRI International Offsite icon, Menlo Park, CA) is a comprehensive research facility providing a highly qualified, and experienced team of scientists, modern animal testing facilities, and instrumentation suitable for conducting GLP and non-GLP pharmacology, toxicology, and other preclinical safety assessment studies to support the development of promising biologic, non-biologic, and small molecule therapeutics for the treatment of heart, lung and blood diseases.

  • Preclinical toxicology testing
  • Safety pharmacology
  • Drug metabolism and pharmacokinetics (DMPK)
  • Assistance with investigational new drug (IND) applications

Small Molecule/Non-Biologics Production Facility - SRI International

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The Small-Molecule/Non-Biologics Production Facility (SRI International Offsite icon, Menlo Park, CA) provides:

  • Medicinal and synthetic chemistry
  • Production of non-GMP and cGMP small molecule and non-biologic drug substances
  • Preformulation testing and formulation development
  • Analytical method development and validation
  • Manufacture of cGMP drug products
  • Stability and release testing of cGMP drug products
  • Assistance with investigational new drug (IND) applications

Program Oversight

The SMARTT Program operates under the auspices of the NHLBI SMARTT Committee, directed by Traci Mondoro, PhD, with support from a Steering Committee (SC) and Scientific Review Board (SRB).

NHLBI

The NHLBI SMARTT Committee oversees the SMARTT Program as a whole, and makes the final decisions on all RSAs. The Committee consists of representatives from the NHLBI program Divisions and from the Division of Extramural Affairs.

Steering Committee

The Steering Committee (SC) oversees the general operations of the SMARTT Program, and reviews Request for Service Applications (RSAs) and SRB recommendations. The SC also advises the NHLBI regarding acceptance and prioritization of RSAs. The SC consists of a Chair appointed by NHLBI (Terry O. Matsunaga, PhD, University of Arizona), the Principal Investigators and Project Directors of the Coordinating Center, Pharmacology/Toxicology Center, and production facilities, and the NHLBI Contracting Officer´┐Żs Technical Representatives. In addition, members from the FDA and the NIH Rapid Access to Interventional Development (RAID) program participate as non-voting members. The SC chair may recruit other non-voting members on an ad hoc basis to serve as expert consultants.

Scientific Review Board

The Scientific Review Board (SRB) is a group of experts that will be called upon to review RSAs. The NHLBI SMARTT Committee selects SRB members and assigns RSAs as appropriate. SRB members review applications for scientific merit and feasibility, and make recommendations to the SC. The SC advises the NHLBI SMARTT Committee on each application. The NHLBI SMARTT Committee makes the final decision on each application.


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