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Principal Investigator: Charles W. Flexner
Organization: JOHNS HOPKINS UNIVERSITY
Fiscal Year: 2024
Award: $796,698
Funding agency: National Institute of Allergy and Infectious Diseases
The Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP) provides broadly based
scientific support to accelerate the development of novel drugs, formulations, and technologies for the
treatment and prevention of HIV and related epidemics. The LEAP Process to facilitate drug and formulation
development begins with a landscape analysis, identifying knowledge gaps and barriers, simulating best
product characteristics, communicating potential solutions, and then tracking product outcomes. The Program
serves as a focal point for the global conversation on the development of LA/ER formulations, and has brought
many of the world's key stakeholders into this conversation. LEAP's seminal accomplishments include
foundational input for FDA draft guidance on the development of LA/ER formulations for HIV; promoting
development of the first candidate LA/ER formulations for tuberculosis and malaria; organizing the first
conference on use of LA/ER formulations for HIV in children, adolescents, and pregnant women; producing the
first publically accessible website devoted to LA/ER anti-infective products and strategies; and supporting
development of novel devices like anti-HIV implants and microneedles through its Modeling and Simulation
Core. Established in 2015, LEAP is now poised to apply its acquired expertise to new challenges. During the
next five years, we will leverage the infrastructure we have created to: 1) apply our scientific resources to
identify and facilitate development of the most promising new drugs and drug delivery platforms in order to
overcome the limitations of available products; 2) build upon our existing modeling and simulation expertise to
develop better ways to more rapidly identify those approaches with the most desirable pharmacologic
properties; and 3) expand the scope of LEAP to include diseases that overlap the HIV epidemic, where the
availability of LA/ER drugs and formulations could most profoundly affect treatment and prevention –
specifically, tuberculosis, hepatitis B virus, and hepatitis C virus infections. Expected outcomes include an
increased number of new long-acting drugs and formulations in preclinical and clinical development, enhanced
funding mechanisms to bring more such products into testing, and accelerated pathways for more rapid
translation of laboratory-based research into clinical trials and eventual drug approvals.
Terms: <0-11 years old><AIDS Virus><AIDS prevention><Acceleration><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Adolescent><Adolescent Youth><Affect><Anti-Infective Agents><Anti-Infective Drugs><Anti-Infectives><Anti-Retroviral Agents><Anti-infective Preparation><Area><Award><Benchmarking><Best Practice Analysis><Capsid><Characteristics><Child><Child Youth><Children (0-21)><Clinical Treatment Moab><Clinical Trials><Communication><Communities><Consultations><Development><Devices><Disease><Disorder><Dose><Drug Approval><Drug Combinations><Drug Delivery><Drug Delivery Systems><Drug Exposure><Drug Implants><Drug Interactions><Drug Screening><Drug Targeting><Drugs><Ensure><Epidemic><Failure><Formulation><Funding Mechanisms><Future><HBV><HCV><HCV infection><HIV><HIV Prevention><HIV/AIDS prevention><Hepatitis B Virus><Hepatitis C><Hepatitis C virus><Hepatitis C virus infection><Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted><Hepatitus C><Homologous Serum Hepatitis Virus><Human><Human Immunodeficiency Viruses><Hydrogels><Implant><In Vitro><Infection><Infection prevention><Infrastructure><Injectable><Intramuscular Injections><Knowledge><LAV-HTLV-III><Laboratories><Low-resource area><Low-resource community><Low-resource environment><Low-resource region><Low-resource setting><Lymphadenopathy-Associated Virus><M tuberculosis infection><M. tb infection><M. tuberculosis infection><M.tb infection><M.tuberculosis infection><MTB infection><Malaria><Medication><Modeling><Modern Man><Monoclonal Antibodies><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><NIAID><National Institute of Allergy and Infectious Disease><Needles><Oral><Outcome><Paludism><Pathway interactions><Patients><Pharmaceutical Agent><Pharmaceutical Preparations><Pharmaceuticals><Pharmacologic Substance><Pharmacological Substance><Phase><Physiologic><Physiological><Plasmodium Infections><Pregnant Women><Prevent infection><Prevention><Process><Property><R24><Regimen><Research><Research Resources><Resource-constrained area><Resource-constrained community><Resource-constrained environment><Resource-constrained region><Resource-constrained setting><Resource-limited area><Resource-limited community><Resource-limited environment><Resource-limited region><Resource-limited setting><Resource-poor area><Resource-poor community><Resource-poor environment><Resource-poor region><Resource-poor setting><Resources><Risk><Seminal><Services><TB infection><Technology><Testing><Therapeutic Implant><Time><Toxic effect><Toxicities><Toxicology><Translations><Tuberculosis><Viral><Viral hepatitis><Virus-HIV><Vulnerable Populations><Work><animal data><anti-retroviral><benchmark><biodegradable polymer><bioresorbable polymer><clinical development><communicable disease control agent><computer based prediction><conference><consultation><convention><degradable polymer><develop drug resistance><developmental><disseminated TB><disseminated tuberculosis><drug action><drug resistance development><drug/agent><expectant mother><expecting mother><hep C><hepatitis non A non B><hepatitis virus infection><improved><in silico><infection by hepatitis c virus><infection due to Mycobacterium tuberculosis><inhibitor><intramuscular drug administration><juvenile><juvenile human><kids><mAbs><model-based simulation><models and simulation><monoclonal Abs><new approaches><new chemical entity><new drug treatments><new drugs><new pharmacological therapeutic><new technology><new therapeutics><new therapy><next generation><next generation therapeutics><non A, non B hepatitis><non-A, non-B hepatitis><novel><novel approaches><novel drug treatments><novel drugs><novel pharmaco-therapeutic><novel pharmacological therapeutic><novel strategies><novel strategy><novel technologies><novel therapeutics><novel therapy><open source><pathway><pharmaceutical><pharmacokinetic model><pharmacologic><pill><pre-clinical development><preclinical development><predictive modeling><pregnant mothers><prevent><preventing><product development><programs><summit><symposia><symposium><trait><translation><tuberculosis infection><tuberculous spondyloarthropathy><vulnerable group><vulnerable individual><vulnerable people><web site><website><work group><working group><youngster>