In October, 2021, Pinnacle 21 was successfully acquired by Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation and regulatory science. In this post, we recap P21's founding impetus, share the benefits of joining Certara, and set expectations for the great things to come.

P21's Founding: Clean Data, Informed Decisions

Seeing the industry's need, we created P21 to accelerate standards compliance for submission data. The goal was not to enforce "compliance for compliance's sake." Rather, it was to serve downstream stakeholders by speeding up key decisions at the FDA (and later, other health authorities, too).

Standardized submission data leading to faster and more targeted regulatory reviews is an instance of a larger pattern: clean data can enable automated and informed decision-making at every step in the drug development life cycle. P21's core competency of connecting data to decisions thus had broad applications.

P21 already has the privilege of serving industry-wide, with our products supporting hundreds of therapies across thousands of companies and many trillions of validated data points. We've always been eager to drive this data standardization activity upstream across the entire drug development life cycle. The benefits are immense, and we were eager for a key partner to catalyze our progress...

Enter Certara: Integrated Drug Development via Tech

Certara's expertise is biosimulation and technology to transform the drug development process from discovery and clinical development to regulatory submission and commercial launch. Certara’s industry-leading products use mathematical modeling to predict how the body affects a drug and how the drug affects the body, as well as how safe and effective the drug is for populations of virtual patients.

Biosimulation, machine learning, and predictive analysis all help to inform critical decisions through the drug development life cycle: decisions about trial design, dosing optimization, go/no-go assessment, commercial viability, etc.

And because these activities are all quantitative, they are hungry for clean, standardized data to tighten their margin of error and control for statistical noise. This clear fit between the strengths and goals of P21 and Certara prompted us to join forces. The cultural match was clear, and the missional fit was even more so.

Together, we bring about a platform that connects all key decision points, informing critical junctions in biopharmaceutical R&D with a clean, standardized data pipeline.

Next Steps: Expanded Solutions, Novel Integrations

We remain 100% committed to delivering on our near-term product roadmap (as many of you previewed at our P21 Live webcast last month) and maintaining an even better level of service, thanks to our more robust backing and corporate infrastructure.

In the short term, expect continuity in our operations and deliveries. As our integration activities ramp up, we'll keep you informed of new offerings. In fact, the majority of P21's customers are already also customers of Certara–albeit via different departments, such as clinical or market access teams. If so, "Certara" is likely already a familiar and trusted name at your organization.

In the long term, you should start seeing cleaner, better standardized data coming from upstream, opportunities to integrate your processes across multiple products/services in the Certara suite, and standards engineering initiatives to underpin your entire clinical data pipeline.

At P21, we're thrilled to join the Certara family and are looking forward to the added value this will unlock for our large and growing customer base. Feel free to see the latest official press release and learn more about Certara, as we close with these quotes from our leaders:

“The fuel for biosimulation, machine learning and statistics is high-quality, standardized data. Pinnacle 21 is a leader in biopharmaceutical data fitness, which streamlines quantitative analyses needed by our clients.” —William F. Feehery, Ph.D., CEO of Certara

“Both companies empower customers to collect, validate, and analyze data to inform critical decisions in drug development and achieve regulatory success. We are eager to integrate and expand our software platforms to continue our mission to speed up lifesaving therapies to patients.” —Max Kanevsky, Founder and CEO of P21, now CTO at Certara