Webinar Day One

12:50 pm - 12:55 pm PharmaIQ Welcome

12:55 pm - 1:00 pm Chairperson's Opening Remarks

1:00 pm - 1:40 pm Managing Your Country Selection and Product Allocation for Effective and Equitable Market Management

Jean Godin - Global Head of Humanitarian Aid and Managed Access Programs, Sanofi Genzyme


  • Factors to consider when designing an effective strategy for your programme country selection
  • Discuss the ongoing challenges of product allocation and supply management across global markets
  • Identify – in so far as it is possible – the critical success factors in proactively managing your product and programme portfolio across global markets

img

Jean Godin

Global Head of Humanitarian Aid and Managed Access Programs
Sanofi Genzyme

1:40 pm - 2:20 pm Collection and Application of Real World Data (RWD) through Early Access Programs in Europe


  • Outline key regulatory considerations in the EU5
  • Discuss practical examples of application and utilisation of RWD

2:20 pm - 3:00 pm Covid-19 as a catalyst for innovation and development within J&J’s Managed Access Programmes

Gregory Tuyteleers - Global Operations Lead - Managed Access, Janssen


·        Direct to patient models

·        Putting the patient at the center of your trial – ways of incorporating different product formats etc

·        Global distribution management and lessons learned


img

Gregory Tuyteleers

Global Operations Lead - Managed Access
Janssen

3:00 pm - 3:40 pm Expanded Access, a strategic imperative for Pharmaceutical companies

Dennis Akkaya - Corporate Development, myTomorrows

·        Analyse the continued evolution of Expanded Access

·        Assess opportunities of Real-World Data: a viable option to create value for all stakeholders

·        Case Study: Expanded Access & RWD Collection

·        Discuss what to expect going forward?

 

Dennis Akkaya, Corporate Development, myTomorrows

img

Dennis Akkaya

Corporate Development
myTomorrows

3:40 pm - 4:20 pm Mapping Out Your EAP Strategy From POC Through To Mature Programme And Closure

Karen Frascello - Director, Global Medical Affairs, Early Access, Alnylam Pharmaceuticals


·        Outline your philosophy and access principles as the basis for formulating your patient access strategy

·        Consider your market selection and individual market requirements while selecting access approach and strategy

·        Begin with the end in mind – look at your late stage access requirements and plans for commercialisation as you map your strategy to avoid the need for back peddling

img

Karen Frascello

Director, Global Medical Affairs, Early Access
Alnylam Pharmaceuticals

4:20 pm - 5:00 pm Moving from Talk to Action – Collaborating to Drive Access To Medicines Forward

Beverly Harrison - Head, Patient Support , Johnson and Johnson
Paul Aliu - Head Global Governance Office, Chief Medical Office, Novartis
img

Beverly Harrison

Head, Patient Support
Johnson and Johnson

img

Paul Aliu

Head Global Governance Office, Chief Medical Office
Novartis

5:00 pm - 5:40 pm Considerations When Collecting RWD and Extracting RWE: A Statistician's Perspective

Hayley Belli - Assistant Professor, Biostatistics Division, Department of Population Health, New York University School of Medicine

·        Establishing a Delineation between RWD and RWE

·        Decisions on collecting data - what is meaningful and what you can draw evidence from

·        Analysing why the data was collected, how much data is or needs to be collected and what is the quality of the data


img

Hayley Belli

Assistant Professor, Biostatistics Division, Department of Population Health
New York University School of Medicine

5:40 pm - 5:50 pm Chairperson's Closing Address