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DCMC Session
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Embracing Change Together: Adapting to Price Pressures, Regulatory Shifts, and Technology Revolution for Accelerated Biopharma Time-to-Market | 2023 Digital CMC Summit On-Demand | Presentation

How forward-thinking drug developers are leading the way by embracing Digital CMC principles and technology

How a burgeoning tech stack is accelerating CMC's transformation into a true digital ecosystem

How the industry's digital leaders reshaping their organizational cultures and embracing modern regulatory frameworks

How these shifts have exponentially advanced productivity across development, approval, and manufacturing phases

Adapting to Price Pressures, Regulatory Shifts & a Technology Revolution

In the opening minutes of the 2023 Digital CMC Summit, Daniel R. Matlis, Founder and President of Axendia, stepped up and hit the room between the eyes: change is happening faster than ever, and it’s time for the life sciences to accept and welcome it. Not prepare for it or evaluate it, but embrace it as one industry committed to improving patient outcomes.

You won't want to miss this thought-provoking introduction to the Summit, or Daniel’s compelling case of collaboration across companies, departments, regulatory frameworks, and markets. In his opening presentation, he takes a bracing look at:

  • The growing challenges and accelerating changes that are pushing drug developers, technology innovators, and regulators to embrace transformation
  • How competitive, regulatory, and economic pressures are finally breaking down industry silos and driving a shift toward holistic life cycle approaches
  • Where regulators like the FDA are using their leverage to promote digitalization, advance innovation, and push the industry toward harmonization
  • Why now is the time to unify around industry-scale efforts to establish data management standards, harness AI innovation, and address major challenges like pricing reform

Register today to watch his full keynote!

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Axendia
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Daniel R. Matlis

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA's Case for Quality Initiative. Dan is also a member of the FDA's advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.