DIGITAL CMC SUMMIT / ON-DEMAND SESSION

Transforming the CMC Lifecycle: Why the Biopharma Industry Can’t Afford to Wait

The biopharma industry is entering a new era of continuous disruption. Find out why transformation is now an imperative for drug developers – and how regulators are pushing them to adapt.

Session highlights & insights

Why digital transformation is now a mission-critical goal for biopharma businesses of every size and maturity level.
How regulators are taking the lead in setting new standards and expectations for data and knowledge management.
How a legacy of compliance-focused quality is holding the industry back from unlocking new levels of performance.
Good technology practices (GTPs) that can help drug developers achieve true transformation in their CMC programs.

Session Speakers

Meet the group transformation experts who share their insights and expertise in this on-demand session.

Daniel Matlis Headshot

Daniel Matlis

Founder and President, Axendia, Inc

More about Daniel

SUMMARY

The technology is here, regulators are ready. It’s industry’s move.

In today’s new age of continuous disruption, “Will we need to transform our business” is no long the question for biopharma organizations that want to achieve lasting success. Regulators are pushing ahead with new digital-first compliance frameworks. Health systems are piling on cost pressures. Society is looking for better, more valuable medications, faster than ever.

For businesses facing these challenges, the question now is “how”: How will the life sciences industry overcome the many inertial factors that hold it back technologically, and finally enable it to achieve true, sustainable transformation? 

Daniel Matlis and his Axendia team have a bleeding-edge view of the economic, scientific, and regulatory forces that are shaping the answer to this question. To open the 2022 Digital CMC Summit, he shared his expert insights on:

  • Why now is the time for biopharma organizations to embrace a new technological era of drug development.
  • How regulatory initiatives like the FDA’s KASA are pushing drug developers to finally pursue quality management maturity (QMM).
  • Key cultural factors that continue to impede industry transformation, and how leaders can start addressing them.
  • Why it’s critically important for drug developers to embrace a holistic pan-disciplinary approach to transformation.

 

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