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Lessons learned and potentials for improvement in cns drug development: Isctm section on designing the right series of experiments

Publication ,  Journal Article
Szabo, ST; Kinon, BJ; Brannan, SK; Krystal, AK; van Gerven, JMA; Mahableshwarkar, A; Sachs, GS
Published in: Innovations in Clinical Neuroscience
March 1, 2015

Once a molecule has been characterized as engaging an identified target at the appropriate location (affinity and potency), the next step involves designing experiments that will determine its pharmacodynamic activities both for efficacy (on target) and safety-tolerability (on/off target). Two expert presentations focused on looking back at completed programs and two concentrated on looking forward at ongoing programs. Specific discussions pertain to assessment of pharmacologic agonists (mGluR2/3, kopiate, peroxisome proliferatoractivated receptor gamma) and antagonists (orexin and cannabinoid) in disorders of cognition, mood, and anxiety. Advanced experimental study designs using genetics to guide a treatment trial in Alzheimer’s disease and neural target-based approaches as the primary outcome measure in the National Institute of Mental Healthsponsored Fast-Fail Trials (FAST)- Mood and Anxiety Spectrum Disorders (MAS) initiative for depression showcases novel methodological approaches. Of interest, some of these initiatives were successful, while others were not, and two are currently ongoing. In conclusion, methodologies that were utilized and are currently employed to reach a successful clinical drug trial outcome are appreciated, and in case of failure, approaches to reviewing programs to enable learning that would be helpful to future programs are brought forth. This article is based on proceedings from the “Designing the Right Series of Experiments” session, which was held during the International Society for Clinical Trials Meeting (ISCTM) in Philadelphia, Pennsylvania, September 30 to October 2, 2013.

Duke Scholars

Published In

Innovations in Clinical Neuroscience

EISSN

2158-8341

ISSN

2158-8333

Publication Date

March 1, 2015

Volume

12

Issue

3-4

Start / End Page

11S / 25S
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Szabo, S. T., Kinon, B. J., Brannan, S. K., Krystal, A. K., van Gerven, J. M. A., Mahableshwarkar, A., & Sachs, G. S. (2015). Lessons learned and potentials for improvement in cns drug development: Isctm section on designing the right series of experiments. Innovations in Clinical Neuroscience, 12(3–4), 11S-25S.
Szabo, S. T., B. J. Kinon, S. K. Brannan, A. K. Krystal, J. M. A. van Gerven, A. Mahableshwarkar, and G. S. Sachs. “Lessons learned and potentials for improvement in cns drug development: Isctm section on designing the right series of experiments.” Innovations in Clinical Neuroscience 12, no. 3–4 (March 1, 2015): 11S-25S.
Szabo ST, Kinon BJ, Brannan SK, Krystal AK, van Gerven JMA, Mahableshwarkar A, et al. Lessons learned and potentials for improvement in cns drug development: Isctm section on designing the right series of experiments. Innovations in Clinical Neuroscience. 2015 Mar 1;12(3–4):11S-25S.
Szabo, S. T., et al. “Lessons learned and potentials for improvement in cns drug development: Isctm section on designing the right series of experiments.” Innovations in Clinical Neuroscience, vol. 12, no. 3–4, Mar. 2015, pp. 11S-25S.
Szabo ST, Kinon BJ, Brannan SK, Krystal AK, van Gerven JMA, Mahableshwarkar A, Sachs GS. Lessons learned and potentials for improvement in cns drug development: Isctm section on designing the right series of experiments. Innovations in Clinical Neuroscience. 2015 Mar 1;12(3–4):11S-25S.

Published In

Innovations in Clinical Neuroscience

EISSN

2158-8341

ISSN

2158-8333

Publication Date

March 1, 2015

Volume

12

Issue

3-4

Start / End Page

11S / 25S