Unlocking Cures: Navigating the Therapeutics Frontier in Collaboration with the Federal Government [Fall 2024 HRA Members Meeting; October 1, 2024]

• View Zoom recording
• Susan Monarez's slides
• Amir Tamiz's slides
• Anath Shalev's slides

As non-profits, we want to make sure any investments we make in potential new therapeutics are as impactful as possible. In this session, we explored how we can complement what federal agencies support in this space, and make sure we catalyze the therapeutics development ecosystem. We heard from NIH and ARPA-H how their efforts support innovative drug discovery and development, and talked about how to effectively engage with these agencies. We also heard from a trailblazer investigator who has taken a drug from conception to the clinic and discussed how different types of funding sources have helped them in their journey.

Moderator
Raeka Aiyar, PhD
Vice President, Scientific Outreach & Diversity, Equity, Inclusion and Belonging | The New York Stem Cell Foundation
Dr. Aiyar is a geneticist turned science communicator, with over a decade of experience in disseminating the impact of biomedical research to diverse audiences. She has led several international, interdisciplinary collaborations in functional genomics, synthetic biology, and precision medicine. Dr. Aiyar oversees NYSCF’s scientific communications and outreach, driving communications materials and initiatives, leading discussions and event programming for scientists and the public. She also leads NYSCF’s diversity, equity, inclusion, and belonging efforts across communications, events, health equity research, and grantmaking.

Presenters
Susan Monarez, PhD
Deputy Director | Advanced Research Projects Agency for Health (ARPA-H)

Dr. Susan Coller Monarez is a globally recognized leader with more than 20 years of experience in health innovation. Throughout her career, Monarez has focused on understanding the critical challenges within the health ecosystem and the greatest opportunities for innovation to meet these challenges. Prior to serving as ARPA-H deputy director, Monarez led innovation at the Health Resources and Services Administration, focused on ethical use of AI/ML to support improved health outcomes, novel approaches to addressing social determinants of health, expanding access to behavioral health, ending the opioid epidemic, addressing health equity gaps in maternal and infant mortality, and improving the country’s organ donation and transplantation programs. 

Monarez has also served at the White House as the assistant director for National Health Security and International Affairs in the Office of Science and Technology Policy and as the director of Medical Preparedness Policy on the National Security Council. In both White House roles, she led efforts to enhance the nation’s biomedical innovation capabilities including combating antibiotic resistant bacteria and MDR/XDR TB, expanding telehealth and remote patient monitoring, establishing safeguards to ensure personal health data privacy, and improving pandemic preparedness. Monarez led the development of several Presidential-level national strategies, action plans, and policy directives related to domestic and global health. 

Monarez also served in leadership positions at the Homeland Security Advanced Research Projects Agency within the Department of Homeland Security and the Biomedical Advanced Research Projects Agency within HHS. In addition to leadership roles within the federal government, Monarez has served on numerous advisory panels, including for the National Academies of Science, the National Science Advisory Board for Biosecurity, and the Organization for Economic Cooperation and Development. Monarez has also served as the U.S. representative on several international cooperative initiatives including with the European Union, Canada, France, the Netherlands, and the United Kingdom in bilateral and multilateral engagements. 

Anath Shalev, MD
Professor and Director, UAB Comprehensive Diabetes Center | Heersink School of Medicine, The University of Alabama at Birmingham

Dr. Anath Shalev received her MD and training at the University of Basel, Switzerland. After a Postgraduate Course in Experimental Biology/Medicine at the University of Zurich, she came to the U.S. and did a research fellowship at Harvard Medical School and her fellowship training in Endocrinology, Diabetes and Metabolism at the National Institutes of Health in Bethesda. In 2002, she became an Assistant Professor at the University of Wisconsin-Madison and was later promoted to Associate Professor and Director of Endocrinology, Diabetes and Metabolism Research there. Dr. Shalev moved to the University of Alabama at Birmingham (UAB) as a Professor of Medicine in 2010 to become the Director of the UAB Comprehensive Diabetes Center and the Nancy R. and Eugene C. Gwaltney Family Endowed Chair in Juvenile Diabetes Research. Dr. Shalev’s laboratory has pioneered the role of thioredoxin-interacting protein (TXNIP) in pancreatic islet biology and continues to work on the translation of the molecular findings into novel therapeutic approaches for diabetes. She is also the co-founder of TIXiMED, Inc., a UAB start-up company developing a first-of-its-kind oral medication for Type 1 Diabetes.

Amir Tamiz, PhD
Director of the Division of Translational Research | National Institute of Neurological Disorders and Stroke

Dr. Tamiz is the Director of the Division of Translational Research at the National Institute of Neurological Disorders and Stroke (NINDS). Prior to that he was a program director overseeing the NIH Blueprint Neurotherapeutics network (BPN) and Innovation Grants to Nurture Initial Translational Efforts (IGNITE). Blueprint Neurotherapeutics network is a collaborative effort among 15 of the agency’s institutes and centers, leveraging their resources to offer neuroscience researchers grant funding for drug discovery and development activities to confront major, cross-cutting challenges in neuroscience. The program was established as a pipeline between academic and industry drug development research and offers neuroscience researchers a “virtual pharma” to develop promising hit compounds from chemical optimization through Phase I clinical testing. Principal Investigators receive grant funding and in kind discovery and development resources such as medicinal chemistry, API synthesis and manufacture, formulation and drug product manufacture, IND enabling studies, and clinical trial capabilities. Launched in December 2014, IGNITE program is intended to create a more contiguous source of support from discovery to preclinical development. Prior to joining NIH in 2012, Dr. Tamiz had held scientific and management positions in research and development of therapeutic programs at Corvas International (acquired by Dendreon), CovX (now part of Pfizer), and Alba Therapeutics. Dr. Tamiz received his Ph.D. at University of Oregon and conducted postdoctoral research at the Department of Neuroscience at Georgetown University Medical Center.