CNS drugs have had relatively lower success rates owing to a multitude of factors: poor predictive value of pre-clinical efficacy models, limited understanding of relevant mechanism of action, inability of large molecules to cross the BBB and underappreciation of the heterogeneity of neurobiological phenotypes.
Because our team has been in the industry for so long, we understand that CNS programs have many challenges. The following roadblocks are frequently encountered during development:
KreaMedica’s core expertise in CNS drug development and services spans right from validating pre-clinical efficacy data across relevant animal models and optimizing formulation development to ensure target engagement, through to IND-enabling toxicology studies and beyond.
Before becoming a consultant, Dave spent twenty-three years reviewing nonclinical data submitted to the FDA/CDER Divisions of Neurology 1 and 2 in support of 266 commercial INDs, 22 NDA/BLAs, 203 Pre-INDs, and 113 Research INDs. In this role he reviewed nonclinical study reports (pharmacology, safety pharmacology, ADME, toxicology, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and other toxicity studies), draft protocols (carcinogenicity, juvenile animal study, combination toxicity), meeting packages (Pre-IND, EOP1/2/3, pre-NDA), requests for clarification, Investigator’s Brochures, Informed Consent Documents, and responses to full or partial clinical holds.
With a PhD from Columbia University in Neuroscience and Pharmacology and postdoctoral studies at NIH on the mechanisms underlying bipolar disorder and Alzheimer’s disease, in addition to his extensive FDA experience, Dave is uniquely positioned to provide guidance on the non-clinical development of your CNS drug.
During her 30+ years in industry, Aurora worked for over 20 years in international regulatory affairs, both within biotech & pharma companies as well as in a regulatory consultancy role. She has in-depth experience within many therapeutic areas such as neurology, (including neuroimmunology and neuroinflammatory disease), gastrointestinal disease, anti-infectives, infectious disease, cardiovascular, anti-inflammatory disease, dermatological disease, respiratory, ophthalmology, rare disease, unmet medical need and rare pediatric diseases, as well as working with plasma derived drug products for rare blood disorders such as hemophilia, factor IX and for alpha 1 antitrypsin deficiency and weakened immunity. She is a proven team leader having worked successfully in cross functional team environments.
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