Applying SHELF in the Pharmaceutical and Biotech Industry

Reducing Risk with Go/No-go Decisions

An introductory course for those new to expert elicitation

 

The earlier you can stop development of a therapeutic intervention that will not make it all the way to the clinic the better. Getting that call right is the challenge - but increasing the chances of making the right call is one of the greatest contributions teams can make to reducing costs and increasing profits.

There are many participants with a role in ensuring that the right call is made. All need to appreciate how to apply and/or interpret a range of methods that can inform decision making. This course is on one frequently used approach – the Sheffield Elicitation Framework (SHELF). It is led by one of its developers, Professor Anthony O’Hagan.

At every stage in drug development, decisions must be made notwithstanding that data regarding a compound's effectiveness and safety are severely limited. Assurance calculations such as the Probability of Success (PoS) have become recognised as important inputs to such decisions. Development team members, colleagues in the same therapeutic area and others have substantial relevant expertise and knowledge. Expert knowledge elicitation is a formal and rigorous process that can draw these elements together, to deliver the required probability distribution of the treatment effect.

Learning outcomes: the elements of expert knowledge elicitation; the challenges to good elicitation; the SHELF protocol and how it addresses those challenges; the importance of preparation; the roles of facilitator and recorder; uses and benefits in the pharmaceutical sector.
 

 
You can view the full course details here