Do or Do Not… There is No Try in Digital Transformation

Digital CMC Summit Event Brief

The 1st Annual Digital CMC Summit brought together more than 20 expert industry speakers presenting to an engaged audience representing over 50 companies. All were in attendance to explore opportunities to simplify and modernize the chemistry, manufacturing, and controls (CMC) process by breaking down barriers that hold back the future of high-performance drug development.

The international crowd of invited guests, speakers, sponsors came together from November 2-4 in Austin, Texas where they were treated to a full program spanning a variety of industry topics  during the two-and-a-half-day event. Discussions ranged from Tech Transfer, Control Strategy, Quality and Risk Management, to MES implementation and the digital transformation of CMC processes.

In addition to the riveting presentations by a diverse group of thought leaders and collaborative breakout sessions, silos were broken as discussions took place between organizations on industry and regulatory trends, real life use cases, success stories, best practices, and product updates. Fostering a culture of collaboration among the attendees sharing the same goal of accelerating development and launching life-saving drug therapies around the world.

QbDVision hosted the event and brought together forward thinking innovators to unlock knowledge, increase process understanding and collaboration, and reduce quality risks to truly harness the power of scientific discovery. 

QbDVision’s CEO & Co-founder Yash Sabharwal opened the summit and perfectly captured the mood by stating that the intent of this event was to share ideas for the success of digital transformation, “We need to be transparent in our conversations about digital transformation,” he said. “We need to speak to the good, the bad and the ugly about it.”

Keynote Recap

Axendia President and CEO Daniel R. Matlis delivered the opening keynote, “Transforming the CMC Lifecycle: Why the Bio-Pharma Industry Can’t Afford to Wait,” by explaining that we are living in the age of continuous disruption.

“Necessity is the mother of invention,” he said, quoting an ancient proverb. “In my opinion, the corollary is: ‘disruption is the matriarch of transformation,’ especially for the life science industries. With all the disrupting events around us–COVID, hurricanes, war–how do we ride the wave of disruption to positive transformation?”

“We adjust,” he says. “Disruption is accelerating digital transformation and driving life science companies to adapt their culture and their systems.”

Paper is one of those systems that needs change. The crowd laughed when Matlis said, “Paper is our industry’s blankie.”

“We need to give it up and quit implementing reactive technology,” he continued. “We need to move to a proactive position and digital transformation is the way to do this.  Regulators are taking away our excuses for hanging onto the old way of doing things.  FDA is already implementing digital transformation solutions. Are you being left behind?”

Matlis explained that compliance does not equal quality.  Axendia research in the MedTech industry shows that 10% of the survey responders said the primary role of quality is to drive product / process improvement. In sharp contrast, 85% indicated the primary role of quality is ensuring compliance. To compete in today’s global markets, life science companies must change their approach to quality, from meeting compliance requirements, to driving product and process improvements across the product life cycle.

FDA says remote regulatory assessments are here to stay.  FDA requires that all product data submitted for review be provided electronically, not on paper.  “Data is the basis for everything,” he added. “But you can’t just collect data and throw it into a lake.  Data needs structure to be useful and shareable across an organization. And when you gather data, question whether it is of value to the organization or just an auditor.”

He wound up the presentation by stating, “If you are not modernizing, you are always behind or out of compliance.”

“The last thing you want is to lag behind your regulator in digital transformation,” he said. “If you are, you’re in trouble.”

Data is the Basis for Everything

Yash Sabharwal shared his opinion that, “data is the basis for everything.”  Saying that structure is the way to improve data quality, which is imperative in product decision-making. “The future is Digital CMC. Structured data drives data quality which drives decision-making.”

He discussed the importance and benefits of digital transformation of CMC processes on the second day of the conference. Covering, among other topics, the increased prioritization of digital transformation within pharma and biotech and why digital CMC is the ideal starting point for the successful acceleration of drug development.

Real Case Studies

Among some of the speakers at the Digital CMC Summit were Joschka Buyel, a process and knowledge management scientist; Amol Thote, senior director; and Justin Grahek, associate development scientist who all shared their personal digital deployment stories at Bayer Pharmaceuticals. They discussed what worked, what did not work and their usage strategies. John Maguire, director of manufacturing sciences for the Sanofi mRNA Center of Excellence, and Artisan Bio’s Steve Keizer, senior quality assurance director, discussed digital CMC deployment in their respective organizations using QbDVision. They spoke to the audience candidly about their digital CMC implementation process as well as tips and tricks they learned along the way.

Zaether’s Michael Cody, director of digital & clinical manufacturing; Apprentice.io’s Adam Cormack, director of product management; Michalle Adkins, life science consulting director from Emerson Automation Solutions; and Kalypso’s Sachin Misra, principal and global lead, shared the podium to cover “Accelerating MES Implementations with Digital CMC.” Together, they spoke about the evolving role of MES, often the centerpiece of the transition to commercial production, and various solutions for the current and new therapeutic modalities.

Finally, as a closing keynote, Dr. Christoph Herwig, professor, Vienna University of Technology, addressed, “Lifecycle Approaches for Robust Control Strategies.” Dr. Herwig discussed in depth, how important data management is to CMC understanding as well as the deployment of digital twins and its link to MES.

In Brief

Digital transformation is not a one and done activity.  Life science companies are reimagining the way they operate by leveraging advanced process, product, and commercialization technologies. This summit was a reminder that we must start with an understanding of how people work together in CMC, understand master data management and governance, move that data to the cloud, form value networks instead of supply chains, and transition from point solutions to platforms. More importantly, this space must continue to collaborate, educate, and innovate on the benefits of and best practices for digitizing all CMC. Only then will this industry truly unlock the full potential of the science and technology at its  fingertips.

The conference ended with affirmations that the summit would and needs to happen again next year and every year thereafter. After all, digital CMC transformation is a continuous activity and QbDVision believes the success of the summit is a reflection of that.

Ryan Shillington, CTO at QbDVision, Luke Guerrero, COO at QbDVision, Daniel Matlis, President and Founder at Axendia, Yash Sabharwal, President and CEO at QbDVision.

We will continue to provide updates on QbDVision as they become available.

If you are an industry member or regulator, feel free to contact us for a complimentary 30-minute life sciences inquiry.  If you are a technology and/or service provider, contact us to establish an analyst engagement.

The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this report is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This report is not intended to endorse any company or product and should not be attributed as such.

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