Join Smithers Pharmaceutical Development Services at Society of Toxicology (SOT) 2026 in San Diego

As the industry gathers in San Diego for SOT 2026, Smithers Pharmaceutical Development Services will be taking the stage to address one of the most pressing and practical topics in modern preclinical development: how to effectively integrate molecular platforms into regulated toxicology studies.

Agostinho Rocha will present “Key Points for Preclinical Tox Using Molecular Platforms for Regulated Bioanalysis and Biomarker Data,” a session designed to bridge science, logistics, and regulatory strategy in an era increasingly defined by cell and gene therapies. The presentation will take place on Wednesday, March 25: 10:45 AM–11:45 AM in Room 23B.

Molecular Assays Are No Longer Optional in Preclinical Tox

Over the last decade, molecular bioanalysis has moved from niche application to central requirement—particularly in cell and gene therapy programs. Quantitative PCR (qPCR), ddPCR, and other molecular endpoints are now routinely used for biodistribution, persistence, and pharmacokinetic assessments in preclinical toxicology studies.

Yet across academia, biotech, pharma, and even seasoned CRO environments, uncertainty remains. Which platform is most appropriate? How should samples be collected and preserved to ensure intact DNA or RNA? How should labeling, chain-of-custody, and LIMS integration be handled to prevent downstream delays? And perhaps most importantly, how do study directors and bioanalytical labs stay aligned against aggressive development timelines?

Agostinho’s presentation will not simply revisit theory. It will focus on the operational realities that determine whether molecular data strengthens a regulatory package—or complicates it.

Designed for Consultants, Study Directors, and Growing Biotechs

The SOT audience is diverse. For more than two decades, the annual meeting has brought together graduate researchers, academic investigators, pharma and biotech scientists, consultants, and CRO professionals. This session is expected to resonate most strongly with:

• Preclinical consultants managing in vivo studies across multiple contract labs
• Young study directors navigating outsourced bioanalysis for the first time
• Small to mid-tier biotech teams wearing multiple hats across toxicology, regulatory, and finance
• Cell and gene therapy sponsors incorporating molecular endpoints into tox packages

For consultants and outsourced study leaders in particular, the session will provide clarity on how to coordinate effectively between in-life toxicology teams and standalone bioanalytical laboratories. Misalignment in sample handling, labeling conventions, timeline expectations, or regulatory documentation can create avoidable delays. This presentation aims to help attendees prevent those issues before they occur.

Experience That Spans Startup to Clinic

Smithers authority on this topic is grounded in experience. The Smithers team has supported numerous emerging biotech programs—many beginning with biodistribution studies and progressing through regulated toxicology and into the clinic. That lifecycle perspective is critical in cell and gene therapy development, where early molecular assay decisions can have long-term regulatory implications.

Agostinho brings years of expertise spanning both academic research and contract bioanalysis environments. His perspective reflects not only scientific rigor but also practical regulatory insight—understanding how molecular data must be generated, documented, and communicated to withstand global regulatory scrutiny.

For small and mid-tier biotech companies, particularly those without dedicated in-house regulatory consultants, Smithers often serves as an extension of their internal team. Beyond generating high-quality data, the organization helps sponsors navigate study design, sample strategy, regulatory expectations, and timeline management—all while maintaining GLP-aligned standards.

Education with Immediate Application

This will be an educational session rooted in real-world application. Attendees can expect discussion around:

• Appropriate use of qPCR and ddPCR molecular platforms in regulated tox
• Sample collection and preservation strategies to protect nucleic acid integrity
• Integration of bioanalytical labs into toxicology workflows
• LIMS readiness and labeling best practices
• Timeline coordination between study directors and bioanalytical principal investigators

Whether you are an academic investigator pursuing grant-funded tox research, a consultant overseeing outsourced programs, or a biotech leader preparing a molecule for IND-enabling studies, the insights shared during this presentation are designed to elevate both scientific and operational execution.

Meet the Team at Booth 1111

Agostinho Rocha, along with Christina Satterwhite, Connie Scott, and other members of the Smithers leadership team, will be available throughout the meeting at Booth 1111. Attendees are encouraged to connect before or after the Wednesday presentation to discuss specific challenges related to molecular bioanalysis, biomarker integration, or regulated preclinical strategy.

Smithers’ mission remains consistent: to act as a true partner and extension of your development program—delivering high-quality data, regulatory clarity, and the strategic support required to advance life-changing therapies to the clinic efficiently and responsibly.

If molecular platforms are part of your preclinical tox strategy—or soon will be—this is a session you will not want to miss at SOT 2026 in San Diego.