Keynote Speaker

RE-Defining, RE-Imagining and RE-Engineering the Drug Development Paradigm through the Lens of Real World Data, Patient Level Data, Machine Learning and Artificial Intelligence

Monday, September 30 | 08:30 AM

The discussion will focus on the premise that the current drug development and clinical trial paradigm is highly inefficient and has resulted in time to market timelines of up to 10 years and associated costs of almost $2Bn dollars.  This model is both unsustainable and unacceptable as it keeps critically needed medications out of the hands of patients and costs patient lives.  The explosion of real world data that is being created and made available, and the analytics via Machine Learning and AI have given us the opportunity to create Real World Evidence in ways unimaginable even a few year ago.  These capabilities have the potential to disrupt the entire drug development paradigm for the better.  This new data driven paradigm will provide greater and quicker access to clinical trials for patients by lowering the barriers to entry.  Simultaneously the ability to leverage RWD/RWE to create synthetic control arms and data for trials will ensure the most efficient use of patients in the drug development ecosystem.

Regulatory Panel

Tuesday, October 1 | 08:00 AM – 09:30 AM

The annual SCDM Regulatory Forum will offer participants an opportunity to engage our panelists from the FDA and EMA on current key topics concerning Clinical Development and the Data Management discipline. In addition to specific updates the panelists will provide, participants will be offered to the opportunity to ask their questions during the Q&A portion of the session. Do not miss the chance to determine what is critical to our regulators, to your peers, to you and your organization.

  • Moderator: Jonathan Andrus
  • Panelists: Lisbeth Bregnhøj, Ni Aye Khin, Kassa Ayalew, Jean Mulinde

Panelists will be answering your questions to determine the most critical industry challenges and to provide the relevant guidance you require. Please submit your questions by September 2.

Jonathan Andrus

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Jonathan Andrus

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Veronica Contreras

Mandy Budwal-Jagait

Lisbeth Bregnhøj

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Lisbeth Bregnhøj

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Kassa Ayalew

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Kassa Ayalew

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Jean Mulinde

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Jean Mulinde

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Panel of Experts

Wednesday, October 02 | 8:30 AM – 10:00 AM

As an Anchor Plenary session to the overall Annual Conference, we are assembling a “Panel of Experts” representing the different towers within our industry to reflect on key challenges and opportunities relevant to our discipline. We aim to identify common as well as unique challenges we are facing across the respective areas of expertise of the panelists as well as potential paths forward either based on the panelists’ experiences or key information presented during the annual conference. In essence we will be conducting an interactive SWOT analyses among the panel inclusive of questions and challenges posed to the panel by the audience.

  • Moderator: Demetris Zambas
  • Panelists: Jonathon Andrus, Lisbeth Bregnhøj, Jennifer Duff, Ni Aye Khin, Francois Torche, Patrick Nadolny

Jonathan Andrus

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Jonathan Andrus

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Lisbeth Bregnhøj

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Lisbeth Bregnhøj

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