Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies.

Previously, we provided an FDA/CDER perspective on nonclinical testing strategies and briefly discussed the opportunities and challenges of using new approach methodologies (NAMs) in drug development, especially for regulatory purposes. To facilitate the integration of NAMs into nonclinical regulatory testing, we surveyed the CDER Pharmacology/Toxicology community to identify the nonclinical challenges faced by CDER review staff, including gaps and areas of concern underserved by current nonclinical testing approaches, and to understand how development of NAMs with specific contexts of use (COUs) could potentially alleviate them. Survey outcomes were coalesced into CDER-identified needs for which NAMs with specific COUs could potentially be developed to address gaps and challenges in nonclinical safety assessments.

Practical Considerations in Determining Adversity and the No-Observed-Adverse-Effect-Level (NOAEL) in Nonclinical Safety Studies: Challenges, Perspectives and Case Studies.

Determining the adverse nature of findings from nonclinical safety studies often poses a challenge for the key stakeholders responsible for interpreting the results of definitive toxicity studies in support of pharmaceutical product development. Although there are instances in which responses to treatment clearly indicate intolerability or tissue injury associated with dysfunction; in practice, more often there is uncertainty in characterizing an effect of drug treatment as adverse or not. This is due to the inherent variability in responses of biological test systems to toxicological insults, leaving the ultimate analyses of adversity to individual interpretation and subjectivity.

COVID-19 Therapeutics and Vaccines: A Race to Save Lives.

COVID-19 (Coronavirus Disease 2019), the disease caused by SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) is an ongoing global public health emergency. As understanding of the health effects of COVID-19 has improved, companies and agencies worldwide have worked together to identify therapeutic approaches, fast-track clinical trials and pathways for emergency use, and approve therapies for patients. This work has resulted in therapies that not only improve survival, reduce time of hospitalization, and time to recovery, but also include preventative measures, such as vaccines.

Drug Development 101: A Primer.

Drug development is a term used to define the entire process of bringing a new drug or device to market. It is an integrated, multidisciplinary endeavor that includes drug discovery, chemistry and pharmacology, nonclinical safety testing, manufacturing, clinical trials, and regulatory submissions. This report summarizes presentations of a workshop entitled "Drug Development 101," held at the 39th Annual Meeting of the American College of Toxicology in West Palm Beach, Florida.