Conversations on Today's Priorities

Each day join a panel of thought-leaders on global, interdisciplinary, cutting-edge topics about the future of drug development and how these issues affect you. These combined flagship sessions bring together innovators from industry, academia, government agencies and patient advocates to have a conversation on today’s priorities.

Explore the Eight DIAmond Sessions for 2018

• European Regulatory Town Hall Meeting
• Payer Town Hall Meeting: WHO Fair Pricing
• Realising the Potential of Future Biomedical Innovation
• Will Big Data Change Drug Development's Approach?
• International Pharmacovigilance
• Evidence Generation in Medicines Development for Fragmented and Rare Patient Populations
• Exploring Use of Artificial Intelligence
• Patient-Centricity Beyond the Talk

• European Regulatory Town Hall Meeting: EMA Relocation and Implications for Centralised Activities

  
  17 April, 11:00 - 12:30
  
  The Regulatory Townhall is a must-attend for anyone who wants to hear the recent developments and future direction of the EU regulatory network. Come listen to the latest issues from a panel consisting of senior leadership from the EMA and National Competent Authorities (NCA).
  
  Moderator: Melanie Carr, Head of Stakeholders and Communication, European Medicines Agency (EMA), EU
  Panelists:

  • Nicola Bedlington, Secretary General, European Patient’s Forum, Belgium
  • Karl Broich, President, BfArM, Germany
  • Nathalie Moll, Director General, EFPIA, EU
  • Csilla Pozsgay, Director General, National Institute of Pharmacy and Nutrition, Hungary
  • Guido Rasi, Executive Director, European Medicines Agency (EMA), EU
  • Andrzej Rys, Director for Health Systems and Products, European Commission, EU
  • Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, MPA, Sweden

  
  Go back to top

• Payer Town Hall Meeting: WHO Fair Pricing

  
  17 April, 11:00 - 12:30
  
  Discussions in health care are moving from innovation and science to economics and affordability. Due to current developments in technology (many new, effective products), combined with high prices demanded by companies, the sustainability of health care systems is threatened. Expensive treatments for some patients displace effective treatments for other patients: the concept of solidarity, on which our health care systems are build, is disappearing.
  In this session we will explore the possibility of Fair Pricing by turning the process upside down: Can society decide the price for the products, treatments and healthcare they want access to? If so, can manufacturers deliver these products at a price the health care system is willing and able to pay?
  
  Moderator:A.R. (Ad) Schuurman, Head of the International Department of the National Health Care Institute (ZIN), Netherlands
  Panelists:

  • Andrew Rintoul, Innovation, Access and Use, WHO, Switzerland
  • Ann Bucsics, Project Advisor, MoCA, Austria

  
  Go back to top

• Realising the Potential of Future Biomedical Innovation: The Role of Intensified EU Cooperation on HTAs

   
  17 April, 14:00 - 15:30
  
  In light of the evolving medicine development paradigm and the limited resources of national HTA agencies it becomes increasingly apparent that the currently national and sub-national approach to the assessment of relative clinical efficacy of medicines will unlikely allow EU patients to optimally realize the potential benefits of the evolving drug development paradigm and future biomedical innovation. Panelists will present their perspectives on how to further advance the EU cooperation between national HTA agencies, EMA and other stakeholders on the assessment of the relative efficacy of medicines.
  
  Moderator:Tim Wilsdon, Vice President, Charles Rivers Associates, UK
  Panelists:

  • Michael Berntgen, Head of Product Development Scientific Support Department, European Medicines Agency (EMA), EU
  • Ansgar Hebborn, Head, Global Market Access Policy, F. Hoffmann-La Roche, Switzerland
  • Ioana Siska, Policy Officer, Health Technology Assessment, European Commission, EU

  
  Go back to top

• Will Big Data Change Drug Development's Approach?

   
  17 April, 14:00 - 15:30
  
  Will Big Data enable change in clinical development and how? Hear the views of senior leaders from regulatory and pharmaceutical organisations will share their view on the impact of Big Data in clinical development, submission and reimbursement.
  
  Moderator:Thomas Senderovitz, Director, Danish Medicines Agency (DKMA) Denmark
  Panelists:

  • Karl Broich, President, BfArM, Germany
  • Ameet Nathwani, Group Chief Medical Officer, Executive Vice-President, Sanofi, France
  • Dimitrios Athanasiou, Duchenne Patient Advocate, Muscular Dystrophy Association Hellas, Board Member in UPPMD and EMA Patient Expert for DMD, Greece

  
  Go back to top

• International Pharmacovigilance

   
  17 April, 14:00 - 15:30
  
  Pharmacovigilance is of increasing focus and importance internationally, Although welcome, huge variations in approach, legislative maturity, resource and fast-moving change are a challenge for all. We all have a responsibility to support development of effective pharmacovigilance systems globally to protect patients and support medicine delivery. With multiple activities worldwide and scarce resources, important key stakeholders must understand each other’s activities and support each other to achieve the same ultimate objectives. A panel of experts (stakeholders, regulators, industry, emerging market) will discuss the latest issues.
  
  Moderator:Esteban Herrero-Martinez, Regulatory Policy and Intelligence, AbbVie, UK
  Panelists:

  • Raj Long, Senior Regulatory Officer, Integrated Development, Global Health, Bill and Melinda Gates Foundation (BMGF), UK
  • June Raine, Chair PRAC, Director Vigilance and Risk Management of Medicines Division, Medicines & Healthcare products Regulatory Agency (MHRA), UK
  • Amr Saad, Founder,The Egyptian Pharmacovigilance Center (EPVC), Egypt
  • Sue Rees, EU QPPV, Executive Director, Global Safety, Amgen, UK
  • Bahija Gouimi, Founder, AMAL, Morocco
  • Fergus Sweeney, Head of Division, Inspections, Human Medicines Pharmacovigilance and Committees, European Medicines Agency (EMA), EU

  
  Go back to top

• Evidence Generation in Medicines Development for Fragmented and Rare Patient Populations

   
  18 April, 08:30 - 10:00
  
  This session will focus on new innovative ways of evidence generation, such as single arm trials (Phase 1b), indirect comparisons (historic controls) and the impact of next generation sequencing on evidence generation. To discuss these complex topics, regulators, HTA bodies, patients and industry will review challenges and opportunities on the basis of case studies. The session will touch but not focus on real world data and as such complement other sessions on that theme.
  
  Co-Chairs:

  • Michelle Rohrer, Global Head of PD Regulatory and Policy at F. Hoffmann-La Roche and Genentech, Switzerland
  • Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, MPA, Sweden

  
  Panelists:
  

  • Rob Hemmings, Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA), UK, UK
  • Niklas Hedberg, Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
  • Additional Speakers Invited.

  
  Go back to top

• Exploring Use of Artificial Intelligence: Trust in Technology, or Trust in Each Other?

   
  18 April, 08:30 - 10:00
  
  Technology is transforming how we do business. As technological capabilities such as artificial intelligence and machine learning rapidly advance, how will we work together and interact with such innovative technologies to augment knowledge and analytical capacity? What skills are needed for success and what does it mean for trust and relationships?
  
  Moderator:Patrick Brady, VP, Regulatory Policy and Intelligence, Bayer, USA
  Panelists:

  • Detlef Hold, Global Strategy Lead Knowledge Cycling, PD Faster Filing PMO, Genentech/Roche, USA
  • Additional Speakers Invited.

  
  Go back to top

• Patient-Centricity Beyond the Talk

     
  18 April, 08:30 - 10:00
  
  Patient-centricity is the talk of the day - but what does successful and systematic implementation really look like? What works? What doesn’t? And why? Join us for an in-depth discussion about patient-centricity with thought leaders in their respective fields of work.
  
  Moderator:Bettina Ryll, Founder, Melanoma Patient Network Europe, Sweden
  Panelists:

  • Philippe Legenne, Executive Medical Director, Amgen, Belgium
  • Christopher McCabe, Executive Director & CEO, Institute of Health Economics, Canada
  • Marisa Papaluca-Amati, Head of Scientific Support Office, Specialised Scientific Disciplines Department, European Medicines Agency (EMA), EU

  
  Go back to top