NATIONAL INSTITUTES OF HEALTH

Dr. Nora Volkow, NIDA Director, discusses her mission to revolutionize addiction treatment, emphasizing the need for critical interventions, novel prevention and treatment approaches, and the potential of GLP1 medications. She highlights the importance of prevention strategies and future research areas, bridging laboratory research and clinical application.

PDS Biotech is preparing a Phase 3 trial for Versamune HPV + pembrolizumab as a first-line treatment for recurrent or metastatic HPV16-positive HNSCC. CEO Frank Bedu-Addo discusses the company's history, technology, and clinical successes, including Versamune HPV's potential in HPV-positive cancers with a TAM exceeding $6B in the U.S.

A polygenic score, UAB36, developed by researchers at the University of Alabama at Birmingham, predicts tamoxifen treatment resistance in breast cancer patients better than conventional methods, offering potential for personalized medicine.

Virginia J. Howard, Ph.D., FAHA, distinguished professor at UAB, will receive the 2024 Population Research Prize at the American Heart Association's Scientific Sessions 2024. Her research focuses on stroke disparities, cognitive functioning, and stroke risk factors, particularly in the REGARDS study. Dr. Howard's work has significantly contributed to stroke prevention and treatment, emphasizing early life factors, sex, race, and geographic location.

NU-9, developed by Northwestern University, shows promise in reversing ALS and may treat other neurodegenerative diseases like Alzheimer’s and frontotemporal degeneration by addressing shared underlying mechanisms. Funded by the National Institute on Aging, NU-9 aims to improve neuron health by targeting protein aggregation, with ongoing FDA trials for safety and efficacy.

Jaguar Health announces FDA renewal of Canalevia-CA1, the only approved treatment for chemotherapy-induced diarrhea in dogs, extending conditional approval until December 2025.

Pradipta Ghosh advocates for using lab-made 'organoids' to replace animal testing in drug development, highlighting their potential for more ethical and accurate clinical trials. She will discuss this at the TEDx conference, emphasizing the need for standardized processes and the promise of personalized therapies.

Article references on heart failure epidemiology, sex differences in etiology and burden, inclusion of women in clinical trials, improving trial representativeness, global mortality variations, factors associated with non-use of medical therapy, AHA/ACC/HFSA guidelines, ESC guidelines, rapid evidence-based sequencing of foundational drugs, safety and efficacy of up-titration of guideline-directed medical therapies, bridging treatment implementation gaps, pharmacological treatment of heart failure with reduced ejection fraction, collection of race and ethnicity data in clinical trials, factors associated with racial and ethnic diversity among trial participants, lesser response to ACE inhibitor therapy in black patients, efficacy of angiotensin-converting enzyme inhibition, efficacy of angiotensin-receptor blockers, efficacy of SGLT2 inhibitors, regional and ethnic influences on response to empagliflozin, efficacy of dapagliflozin in black versus white patients, lifetime risk for heart failure among white and black Americans, sex- and age-related differences in management and outcomes, sex disparities in longitudinal use of medical therapy, effects of empagliflozin on cardiovascular and renal outcomes according to age, MRAs in elderly HF patients, efficacy and safety of LCZ696 according to age, efficacy and safety of dapagliflozin according to age, effect of age and sex on efficacy and tolerability of beta blockers, effect of nebivolol on mortality in elderly patients, safety and efficacy of up-titration of medical therapies in elderly patients, vericiguat in patients with heart failure, cardiac myosin activation with omecamtiv mecarbil, trial characteristics associated with under-enrolment of females, NIH policy on inclusion of women and minorities, FDA guideline for study and evaluation of gender differences, EMA gender considerations in clinical trials, Tri-Council Policy Statement on ethical conduct for research involving humans, heart failure with preserved ejection fraction, evaluation of causes of sex disparity in heart failure trials, inclusion of pregnant and lactating women in clinical trials, eligibility criteria of randomized controlled trials, gender paradox in congestive heart failure, sex differences in willingness to participate in clinical trials, women's participation in cardiovascular clinical trials, interactions between left ventricular ejection fraction and sex, sex-specific differences in efficacy of heart failure therapies, sex-based differences in effect of digoxin, sex-specific differences in heart failure pathophysiology, risk factors, management, and outcomes, identifying optimal doses of heart failure medications, sex-specific analysis of up-titration of medical therapies, age, sex, and outcomes in heart failure with reduced EF, impact of socioeconomic status on incident heart failure and left ventricular dysfunction, heart failure and socioeconomic status inequality, associations of healthy lifestyle and socioeconomic status with mortality and incident cardiovascular disease, socioeconomic status and cardiovascular outcomes, lower socioeconomic status predicting higher mortality and morbidity in heart failure patients, trends in cause-specific heart failure outcomes by sex, socioeconomic status, and place of diagnosis, association between socioeconomic status, sex, race/ethnicity and in-hospital mortality, risks of subgroup-specific analyses in randomized trials.