Toxicology and Safety Pharmacology Investigations on the Nervous System: 2024 Industry Survey.

The American College of Toxicology (ACT), the Safety Pharmacology Society (SPS) and the Society for Toxicological Pathology (STP) conducted an industry survey in 2024 to assess current industry practices as they relate to neurotoxicity and safety testing of therapeutics. This survey was developed as a follow-up to 2015 survey conducted by the Safety Pharmacology Society (SPS) to identify industry practices as they relate to central, peripheral and autonomic nervous system ('CNS') drug safety testing. In the current survey, there were one hundred thirty (130) respondents from Asia (5 %), Europe (32 %) and North America (64 %). Most respondents (54 %) were from pharmaceutical companies of over 1000 employees. Small molecules (89 %), large molecules (73 %), gene therapy (52 %), cell therapy (41 %) and vaccines (38 %) were the types of modalities developed by respondents. Oncology (72 %) and neurology/psychiatry (64 %) were the most frequent therapeutic indications pursued by companies followed by inflammation (56 %), cardiovascular (48 %), rare/orphan (44 %), metabolic (42 %), infectious (35 %) and respiratory (28 %) diseases. Tremors (81 %), emesis (75 %) and salivation (61 %) were more frequently reported than in the 2015 CNS survey while gait/coordination abnormalities (67 %), convulsion (65 %), and peripheral neuropathy (24 %) were unchanged or decreased when compared to the 2015 survey. Most respondents reported using a modified Irwin's test (90 %) added to toxicology studies (80 %) and/or as a standalone study (71 %), a major change from the 2015 survey where most respondents reported using a standalone study. Survey results reflect an industry shift towards the development of new therapies classified as biologics, cell and gene therapies.