Dr Will Maier | Chief Scientific Officer
Mapi Group

Dr Will Maier, Chief Scientific Officer, Mapi Group

Mapi is the only Global CRO specializing in late phase research. We also provide strategic consulting and related services in Epidemiology and Product-Related Risk Management . This includes market forecasting, health burden and economic assessments, pharmacovigilance and risk management plans, and the conduct of observational studies in Europe and the US. Dr. Maier has over 20 years of experience in the pharmaceutical industry and academic appointments in the UK (Dundee) and USA (North Carolina). In addition to publications on several topics, Dr. Maier is an active speaker on Epidemiology, Product Safety, Outcomes Research and Product Risk Management. In July 2006, he presented the Risk Management Plan at the FDA public advisory board meeting for Tysabri


Pre-congress Workshop Day Orphan @ 13:10

Afternoon Pre-congress Workshop Monday 13 November

Assuring success from Regulatory to Global Market Access of Rare Disease Treatments
13.30 – 17.00:
Partnering with patients for clinical success
  • This interactive workshop will introduce participants to a 360° approach to obtaining patient insights and applying them for the successful design and execution of clinical studies. Through engaging activities, we will address how to get to the heart of the patient’s decision-making process, assess their physical/emotional/social needs, and identify their motivators, barriers and influencers as they relate to clinical study participation.
  • Participants will then learn how insights are analysed and applied in order to:
    • Design studies that appeal to the targeted patients
    • Determine effective and motivating recruitment methods
    • Engage and communicate with patients and caregivers
    • Identify retention methods that meet the needs of a specific patient population
    • Develop materials that resonate with patients and caregivers
Kelly Franchetti, Vice President Global Patient Insights and Engagement, Mapi Group
An introduction to the science of endpoint design in the current regulatory and HTA environment in the US and Europe
  • Regulatory strategies for early scientific advice: FDA & EMA scientific advice, PRIME & adaptive pathways link to scientific advice
  • The creation, categorization and hierarchy of endpoints and requirements of different stakeholder groups, including: regulatory agencies, clinicians, HTA bodies, payers, increasingly active patient groups
  • Real-life examples of endpoints used in selected therapeutic area & techniques for the development and validation of new endpoints
  • Highlighting guidance and publications that will be of use to newcomers to the area
  • Solving the non-alignment between different agencies and geographical  differences in approach
Rory Graham, Senior Director, EU Regulatory Services, Mapi Group
Martine Zimmermann, Global Head of Regulatory Affairs, Alexion pharma GmbH
Methodologies in developing Real World Data: Engaging stakeholders in developing evidence strategies
  • How is expanded access used to provide treatment for patients with rare diseases?
  • Compassionate Use Programs in the window between submission and commercialization
  • What are the benefits of conducting clinical studies and registries for rare diseases?
  • What are the types of studies conducted during different phases of orphan drug development?
  • How are patient registries used to generate real-world data for rare diseases and orphan drugs?
  • Ethical Patient Warehousing – working with Advocacy to identify populations in advance of research
  • What are the unique challenges of conducting rare disease/orphan drug registries?
  • How can proactive study management strategies successfully address these challenges?
  • Potential risk mitigation strategies, and alternative registration strategies will be discussed.  
Dr Will Maier, Chief Scientific Officer and Head of Patient-Centered Sciences, Mapi Group
17.00 End of Workshop Followed by Networking Drinks Hosted by Mapi Group

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