8:00 am Chair’s Opening Remarks

The Future of Neuropsychiatric Drug Development

8:15 am What is Needed to Develop More Efficacious Treatments for Neuropsychiatric Disorders?

Synopsis

• Heterogeneity of psychiatric disorders
• Societal disease burden
• Human disease genetics

Eric Schaeffer, Senior Director, Neuroscience Innovation, Johnson & Johnson

8:45 am Moving from Treatment to Cure in Neuropsychiatric Disorders: What Will It Take?

Synopsis

• Current efforts to address unmet need in neuropsychiatric disorders are focused on symptomatic improvement
• Recent advances in the genetics of neuropsychiatric disorders as well as longitudinal studies in patients have led to a renewed focus on development of effective therapies in this area
• This talk will raise the exciting idea of moving from treatment to cure and how the recent advances in the genetics and biology of neuropsychiatric disorders might outline a path

Gopi Shanker, Director, Head of Psychiatry, Novartis

9:15 am Understanding the Role of Genetics in Neuropsychiatric Disorders

Synopsis

• Introducing types of genetic variation
• Exploring our current understanding of the role of genetics in different
neuropsychiatric disorders
• Discussing how this may affect our ability to treat these disorders in the future

Elise Robinson, Assistant Professor, Harvard University

9:45 am Developing of Cannabis-Derived Therapeutics for Neuropsychiatric Indications

Synopsis

• What does it take to bring a CBD product to market for an unmet medical need?
• Discussing development considerations for CBD and other cannabis-derived products for neuropsychiatric indications from a clinical, preclinical
(pharmacology/toxicology), CMC, and regulatory perspective
• Delving into the unique development challenges and promising therapeutic
potential

Dana Minnick, Senior Regulatory Scientist, Rho

10:00 am Speed Networking

Synopsis

This session is the ideal opportunity to meet face-to-face with the key thought leaders working in the neuropsychiatric drug development field. Specifically designed to connect you with new contacts from the most active companies in the field, the renowned Speed Networking session will be one of the most valuable hours you will spend at NPD

10:45 am Morning Refreshments

Learn of Translational Strategies to Confidently Translate into Clinical Development

11:45 am Reducing the Translational Gap in Neuropsychiatry

Synopsis

• What is the translational gap and why is it important?
• How might the translational gap be addressed?
• Lessons learned from discovery efforts at Merck

Jason Uslaner, Executive Director, Neuroscience, Merck

12:15 pm A Novel Approach Using PANSS to Characterize Specificity & Effectiveness of New Mechanisms Among the Symptom Dimensions of Schizophrenia

Synopsis

• Understanding the specificity of symptom change in schizophrenia can facilitate the evaluation of antipsychotics’ efficacy profiles across symptom domains
• Existing clinical trial databases identified a transform of PANSS using an uncorrelated PANSS score matrix (UPSM) to reduce pseudospecificity among symptom domains in antipsychotic-treated patients with schizophrenia
• We propose novel constructs for more-accurate depictions of drug efficacy, and to apply these to the clinical development and differentiation of novel therapeutics

Seth Hopkins, Executive Director, Translational Medicine, Sunovion

12:45 pm Lunch & Networking

Developing Novel Biomarkers to Power Future Preclinical & Clinical Research

1:45 pm How Are Digital Biomarkers Transforming Neuropsychiatric Drug Development?

Synopsis

• Discussing the need for digital biomarkers in neuropsychiatry
• Exploring the evolving technology
• Discuss the use case for digital biomarkers in autism

Kevin Sanders, Global Development Lead Autism, Roche

2:00 pm Afternoon Refreshments & Networking

Assessing Methods for Improving Pharmaceutical Success

2:15 pm An Overview of Developing PET/SPECT Ligands for CNS Drug Research & Development

Synopsis

• Application of nuclear imaging techniques in CNS drug R&D
• Recent developments and learnings

Shil Patel, Vice President, Codiak BioSciences

3:45 pm Adjunctive Therapies in the Treatment of Primary Symptoms of Schizophrenia

Synopsis

• Atypical antipsychotics represent the main drug class in treating schizophrenia
• Adjunctive medications can enhance the benefits of atypical antipsychotic drug monotherapy
• Current approaches to adjunctive therapy for schizophrenia will be reviewed

James Cassella, Chief Development Officer, Concert Pharmaceuticals

4:15 pm Application of FDA Driving Guidance in New Drug Development

Synopsis

• Drugs subject to the guidance
• Study methodology acceptable to agency
• Application of guidance in a successful drug submission
• Video Demonstration of CRC-MiniSim Driving Simulator

Gary Kay, President, Cognitive Research Corporation

4:30 pm Panel Discussion: The Future of Digital Therapeutics – Working Alongside Pharmaceuticals to Transform Therapeutic Success

Synopsis

• Reviewing the potential for digital therapeutics in different neuropsychiatric disorders
• Assessing research success in this field this far
• Accounting for the challenges and risks involved with digital therapeutics

Joris Van Dam, Executive Director, Head of Digital Therapeutics, Novartis

Kevin Sanders, Global Development Lead Autism, Roche

5:00 pm Chair’s Closing Remarks

5:15 pm Scientific Poster Session

Synopsis

After the formal presentations have finished, the learning and networking carries on. The Poster Session allows you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. You will have the opportunity to present and review presentations displaying new data from neuropsychiatric disease research, such as novel therapeutic targets and advances in clinical development.