Career/Promoting Translational Research Resources
Accelerating Medicines Partnership (AMP)
Launched in 2014, the Accelerating Medicines Partnership® (AMP®) program is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), multiple biopharmaceutical and life science companies, non-profit and other organizations to transform the current model for developing new diagnostics and treatments.
The Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a revolutionary new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space. Long desired by researchers seeking new ways to treat, cure, and even prevent brain disorders, this picture will fill major gaps in our current knowledge and provide unprecedented opportunities for exploring exactly how the brain enables the human body to record, process, utilize, store, and retrieve vast quantities of information, all at the speed of thought.
Collaborating for Novel Solutions CNS Summit
Founded in 2009 by R&D leaders in Life Sciences, CNS Summit was created to advance clinical development, with a focus on innovation, collaboration and technology. Our mission is to have a positive impact on the success of clinical development programs. We believe this mission is our ethical duty to the patients we serve by developing new treatments. By joining the CNS Summit community, you gain access to emerging technologies with practical applications, curated networking and idea sharing, and collaborative opportunities to propel the future of drug development.
Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium
The Biomarkers Consortium brings together various partners to identify, develop and qualify potential biomarkers to improve drug development and regulatory decision-making.
The Helping to End Addiction Long-term Initiative (NIH HEAL Initiative)
The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Almost every NIH Institute and Center is accelerating research to address this public health emergency from all angles.
The initiative is funding hundreds of projects nationwide. Researchers are taking a variety of approaches to tackle the opioid epidemic through:
- Understanding, managing, and treating pain
- Improving treatment for opioid misuse and addiction
The International Society for CNS Clinical Trials and Methodology (ISCTM)
ISCTM is an independent multi-disciplinary organization devoted to promoting advances in, and dissemination of, clinical research methods related to development and use of CNS therapeutics. The ISCTM accomplishes this by bringing together international stakeholders representing academia, industry, government, payers, policymakers, and the public to address strategic clinical, regulatory, and policy challenges in clinical research.
National Center for Advancing Translational Sciences (NCATS) Drug Repurposing
Discoveries about the molecular basis of disease provide unprecedented opportunities to translate research findings into new medicines. However, developing a brand-new drug takes an enormous amount of time, money and effort, mainly due to bottlenecks in the therapeutic development process. Delays and barriers mean that translation of a promising molecule into an approved drug often takes more than 14 years. It is crucial to advance strategies to reduce this time frame, decrease costs and improve success rates.
Drug repurposing is one such strategy. Many agents approved for other uses already have been tested in humans, so detailed information is available on their pharmacology, formulation and potential toxicity. Because repurposing builds upon previous research and development efforts, new candidate therapies could be ready for clinical trials quickly, speeding their review by the Food and Drug Administration and, if approved, their integration into health care.
National Center for Advancing Translational Sciences (NCATS) Expertise and Resources
NCATS staff are experts in many different fields relevant to translational research and science policy, from small molecules to human subjects protections. NCATS also offers a variety of tools and other resources for preclinical and clinical investigators.
NIDA Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research (U18 – Clinical Trials Not Allowed)
The overall goal of The Step Up for SUD initiative is to advance fundamental discoveries into medicines to treat substance use disorders (SUD) for the benefit of society. The purpose of this funding opportunity is to enhance and accelerate research on drug targets for SUD aiming to expand the range of targets and mechanisms in development for SUD therapies. The initiative will provide both funding and the in-kind access to biomedical product development experts. It will be administered as a unique, short-term and nimble funding opportunity to support the confirmatory research in robust drug target validation/invalidation to allow for early decision to either proceed to a next step or stop the projects. At this point, only research projects on potential drug/biologic therapeutics, not diagnostics or devices, will be supported.
NIH Blueprint MedTech
Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and/or treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to:
- Planning resources to support concept development, team building, needs assessment, and other early translational activities.
- Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring).
- Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
- Advice from industry experts (e.g., meetings with an external oversight committee).
The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.
NIH Blueprint Neurotherapeutics Network
The Blueprint Neurotherapeutics Network provides non-dilutive support for small molecule drug discovery and development, from hit-to-lead chemistry through phase I clinical testing. We offer funding for work that you wish to do yourself, access to NIH-funded contract research organizations (CROs) for activities that you prefer to outsource, and access to consultants with expertise in various aspects of drug discovery and development. You decide what combination of funding, CROs, and consultants will best fit your needs. Your institution gets assignment of the intellectual property rights to compounds discovered and developed within the program.
NIH Blueprint Neurotherapeutics Network for Biologics
BPN-Biologics provides non-dilutive funding and resources for biotherapeutic drug discovery and development, from lead optimization through phase I clinical testing. We offer grant funding for work that you intend to do yourself and in-kind access to NIH-funded contract research organizations (CROs) for activities that you prefer to outsource and consultants with expertise in various aspects of drug discovery and development. You decide which combination of funding, CROs, and consultants will best fit your drug development needs. In addition, your institution is assigned the intellectual property rights to therapeutic agents discovered and developed within the program.
NIH Blueprint Neurotherapeutics Network – Current Development Projects
NIMH Psychoactive Drug Screening Program
This service provides screening of novel psychoactive compounds for pharmacological and functional activity at cloned human or rodent CNS receptors, channels, and transporters. Bryan Roth MD, PhD (University of North Carolina Chapel Hill) will perform pharmacological and functional screening of novel compounds as a contractor to NIMH. Screening of compounds is provided to qualified academic investigators at no cost.
BRAD 2023 is just around the corner! Register for your BRAD box by April 1st to celebrate on April 20th. Any celebration - big or small - is important as we work together to show support for animal research and to educate the public on the role of animals in medical advancements.
In Memoriam to Dr. Robert Hirschfeld, @ACNPorg Emeritus Fellow. Dr. Hirschfeld was well known for development of the Mood Disorder Questionnaire (MDQ), one of the most widely used screening assessments for bipolar disorder.
It's #WomensHistoryMonth! This month, and throughout the year, we celebrate the legacies of women in the field of psychiatry, both past and present, who have advanced the field and improved the lives of those with mental health issues.