Target Validation for Non-Addictive Therapeutics Development for Pain – A Virtual Workshop

Mon, 10/19/2020 - 10:00am - 4:30pm
Tue, 10/20/2020 - 10:00am - 12:30pm

Description:

Despite advances in the understanding of pain physiology there has been a paucity of novel analgesic medications developed to address the still high unmet need of pain patients especially those who rely on addictive opioid medicines for pain relief. The successful development of novel non-opioid, non-addictive therapeutics requires advances in preclinical target validation that demonstrate sufficient human disease relevance to trigger investment in non-clinical development and subsequent clinical trials to obtain proof of biology and early proof of efficacy before registrational studies.  Translating novel target discoveries to the clinic depends on the quality of target validation and the rigorous implementation of research operating plans to provide compelling data supporting a causative link between the modulation of molecular target(s) and a disease phenotype associated with the disease state.

The full target validation process covers target identification to proof-of concept efficacy in human subjects in clinical trials. This workshop will focus on the key preclinical experimental validation package components that de-risk and provide rigorous rationale for the pursuit of novel targets with minimal side effects and a reduced potential abuse/addiction liability into drug discovery campaigns.

The focus will be on the stage appropriate data required to justify further preclinical and clinical therapeutics development activities across the translational spectrum. Several perspectives will be presented including industry, academia, and venture capital.

Attendance is free, but registration is required. For more information and to register, visit https://meetings.ninds.nih.gov/meetings/TVWORKSHOP/

AGENDA

DAY ONE  

 

10:00 – 10:15 

Welcome and Introduction (Walter Koroshetz)


10:15 – 10:25        

Goals of the Workshop (Richard Hargreaves & Karen Akinsanya)    

   
10:25 – 10:45        

Target Validation in Pain Therapeutic Development - Process and Data Package Expectations (Johan Luthman)


10:45 – 11:05        

Target Validation in Pain Therapeutic Development - Lessons Learned & Opportunities (Jenny Laird)     

              
11:05 – 11:15       

BREAK


11:15 – 11:35     

Target Validation - Target Identification Forward – Academic Perspective (Carrie Jones)

 

11:35 – 11:55        

Target Validation - Discovery to Investment – Partnering and Investment Perspective (Peter Farina)

 

11:55 – 12:15       

PANEL Discussion (Academia, Industry, and Investor Representatives) 

 

12:15 – 12:30       

LUNCH BREAK

 

Best practices for Target Validation


12:30 – 12:35       

Session A Intro: Human Evidence for Target Validation (Andrea Houghton & Narender Gavva)

 

12:35 – 01:45       

Session A Open Discussion

 

1:45 – 01:50      

BREAK

 

1:50 – 01:55       

Session B Intro: Tools and Models to Test Hypotheses in vitro (Seena Ajit & Aj Kaykas)

 

1:55– 03:05        

Session B Open Discussion

 

3:05 – 03:10      

BREAK

 

3:10 – 03:15       

Session C Intro: Tools and Models to Test Hypotheses in vivo (Annemieke Kavelaars & Gordon Munro)


3:15 – 04:25       

Session C Open Discussion


4:25 – 04:30       

Day 1 Wrap-up & Expectations for Day 2 (Richard Hargreaves & Karen Akinsanya)

 

DAY TWO


10:00 – 10:10        

Recap of Day 1 & Goals for Day 2 (Richard Hargreaves & Karen Akinsanya)


10:10 – 10:40        

Report from Session A (Andrea Houghton & Narender Gavva) 

 

10:40  – 11:10       

Report from Session B (Seena Ajit & Aj Kaykas)

 

11:10 – 11:20       

BREAK

 

11:20 – 11:50        

Report from Session C (Annemieke Kavelaars & Gordon Munro)

 

11:50 – 12:30        

General Discussion

 

Breakout Session A - Human Evidence for Target Validation

Co-Chaired by Andrea Houghton & Narender Gavva

10/19/2020

 

Breakout Session B - Tools and Models to Test Hypotheses in vitro

Co-Chaired by Seena Ajit & Aj Kaykas

10/19/2020

 

Breakout Session C - Tools and Models to Test Hypotheses in vivo

Co-Chaired by Annemieke Kavelaars & Gordon Munro

10/19/2020

 

Registration:

https://meetings.ninds.nih.gov/Home/Registration/27810