Using real life data to design and optimise an early phase programme with two example drug molecules
Your opportunity to design early phase strategies using real-life drug molecule data

Registration is at 09:00 for a 09:30 start. The workshop will finish no later than 16:30. Workshop documents, refreshments and lunch will be provided.

Session leaders:
Daren Austin, Head, Biopharm Clinical Pharmacology & Biometrics, GlaxoSmithKline
Alan Xiao, Director Clinical Pharmacology, AstraZeneca, USA

Your task is to implement design strategies to take two drug molecules from preclinical throughout the early phase process to the next stage. At the end of the process you will ‘go’ or ‘no go’ each molecule. Use everything that you have learned/discovered/ heard from the conference to help make your decisions.

Preclinical data
Take a look at your real life preclinical data
Assumptions
What main assumptions will you make?
Go/no go decision
What are your go/ no go decision criteria?
Clinical pharmacology
What will you include in your clinical pharmacology development plan?
Protocol design
Which points will you choose in your protocol to get it approved first time?
Biomarkers
Which biomarkers will you choose?
Decision making
What are your Phase I and IIa study options?
What are your main priorities?
Choosing your studies: Benefit-risk analysis
Identifying the critical path
What data will you require to move forward
as quickly as possible?
Which studies should you prioritise to move
forward as quickly as possible?
Risk management and mitigation
Identifying what could go wrong
What risks do you need to mitigate?
How will these risks be mitigated?
Dose escalation
What will your dose escalation and expansion plan be?
Will you go or no go?

Project management and influencing skills for the early clinical phase professional
Make the most of your time out of the office and build on these key skills – vital to your early phase role

Registration is at 10:00 for a 10:30 start. The workshop will finish no later than 17:30.  Workshop documents, refreshments and lunch will be provided.

• Project management for early clinical phase development
• How to use project management to cope with accelerated timelines
• Applying and implementing key project management skills and techniques to early phase clinical development:
  - Defining what needs to be done in the early phase trial
  - Sharing real life strategies to put in place to deliver to timelines
  - Planning including key activities, budget and risk considerations
  - Implementation and successful completion of trial activities
• Developing key project meeting skills
  - Effective management and participation at meetings to draw attention to the most important points
  - Ensuring that your opinions and perspectives are heard particularly when communicating with colleagues / other departments and key stakeholders in the project

Session leader: Laura Brown – Course Director, MSc Clinical Research, School of Pharmacy, Cardiff University and Project Management and Training Consultant in the Pharmaceutical Industry

Influencing skills

• Real life strategies for how to influence within the
  early clinical phase arena
• Examples of what works and what does not work
• Implementing key influencing skills for the early clinical phase professional:
  - Conveying your key message
  - Persuading your colleagues and managers
  - Communicating effectively with other departments
• Leadership skills
  - Examining different leadership styles – what works and what doesn’t work in different situations?- - Real-life examples of how leadership can impact on the success or downfall of an early phase project
  - How to practically implement effective leadership skills in early clinical phase projects

Session leader: Nanna Keeling, MSc Dip Pharm, MRPharmS, Management Consultant, Wenell Management AB, Gothenburg, Sweden