Webinar Day One

12:25 pm - 12:30 pm PharmaIQ Welcome

12:30 pm - 1:10 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

1:10 pm - 1:50 pm Collection and Application of Real World Data (RWD) through Early Access Programs in Europe

Graham Sidorowicz - VP Business Development - Early Access Programs, Bionical Emas


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

Graham Sidorowicz

VP Business Development - Early Access Programs
Bionical Emas

1:50 pm - 2:30 pm Covid-19 as a catalyst for innovation and development within J&J’s Managed Access Programmes

Torunn Thingstad - Director, Global Program Leader - Managed Access, Janssen
Veronique Ollivier-Guillon - Director, Global Program Leader - 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

Torunn Thingstad

Director, Global Program Leader - Managed Access
Janssen

img

Veronique Ollivier-Guillon

Director, Global Program Leader - Managed Access
Janssen

2:30 pm - 3:00 pm Coffee Break

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 Designing Strategic Early Access Solutions for Rare Disease Drugs

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


img

Karen Frascello

Director, Global Medical Affairs, Early Access
Alnylam Pharmaceuticals

4:20 pm - 6:00 pm Co-Creating Expanded Access Resources: Transforming information for transparency

Christine MacCracken - Director, Patient Strategies & Solutions, Office of the Chief Medical Officer, Janssen


In this session, you will have the opportunity to:

  • Discuss experiences in identifying potential treatment options
  • Review and provide input into new EA patient resource
  • Join a global dialogue about EA
img

Christine MacCracken

Director, Patient Strategies & Solutions, Office of the Chief Medical Officer
Janssen

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