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Scientific Resources

Navigate the complexities of drug development with confidence through Smithers comprehensive bioanalytical services. Learn more about the latest processes and discover insights from our seasoned team of scientific experts with our resources below:

From Bench to Boardroom: Why Bioanalysis Strategy Matters for VC-Backed Biotech Companies

Smithers Pharmaceutical Development Services partners with emerging and established biotechnology companies to develop, validate, and execute bioanalytical strategies that support efficient drug development from early discovery through late-stage clinical programs.

Speed to Data Means Speed to Decisions: Why Consultants Need More Than Just a CRO

In today’s drug development environment, timelines are tighter, investor expectations are higher, and regulatory pressure continues to increase. For consultants supporting biotech and pharmaceutical sponsors, every recommendation matters. Choosing the wrong bioanalytical partner can create delays, force difficult conversations, and ultimately put a program at risk.

Beyond the Assay: Why ADA Programs at Smithers Feel Like a True Partnership

In bioanalysis, the final product is data, but the experience of getting there often determines whether sponsors return for their next study. In the world of anti-drug antibody (ADA) testing, where timelines are compressed and variables are numerous, sponsors increasingly seek partners who operate as an extension of their internal teams.

Smithers Pharmaceutical Development Services to Present at the 3rd Global Cell & Gene Therapy Summit

Representing Smithers Pharmaceutical Development Services throughout the conference will be Connie Scott and Agostinho G. Rocha. Both executives will be available to host meetings at Exhibit 1 during the event.

More Than Numbers: How PK Data from Smithers Pharmaceutical Development Services Shapes Better Drug Development Decisions

At Smithers, PK data is delivered with that purpose in mind, helping sponsors move forward with clarity, confidence, and momentum.

Smithers Pharmaceutical Development Services at the 42nd SQA Annual Meeting and Quality College

Smithers Pharmaceutical Development Services will attend the 42nd Annual Meeting and Quality College hosted by the Society of Quality Assurance. The event takes place April 11–16, 2026, in National Harbor, Maryland. This annual meeting serves as a central forum for quality assurance professionals operating in FDA-regulated industries, including pharmaceuticals, biotechnology, and bioanalysis.

Unlock Next-Level Gene Therapy Insights with ddPCR

Biodistribution is a critical step in developing safe and effective gene therapies, but traditional qPCR methods can fall short in sensitivity and precision. Droplet digital PCR (ddPCR) is changing the game, and a white paper from Smithers Pharmaceutical Development Services shows exactly how.

Beyond ADA: The Expanding Role of Biomarkers in Large Molecule Development

Smithers delivers the bioanalytical expertise required to build, validate, and scale biomarker programs for large molecule therapeutics. Sponsors seeking to strengthen clinical outcomes, reduce development risk, and align with evolving regulatory expectations should engage with Smithers to define a biomarker strategy tailored to their program.

The Best Bioanalytical Partnerships Begin by Understanding Your Science, Your Timeline, and Your Goals

n the first installment of the Smithers Pharmaceutical Development Services “A Chat with the President” video series, Christina Satterwhite, PhD, discusses a principle that has shaped her approach throughout her career: understanding the customer experience.

Build Stronger qPCR and ddPCR Programs With the Right Molecular Biology Strategy from Smithers

The most successful molecular biology programs are rarely defined by platform selection alone. They are built through thoughtful assay design, careful sample preparation, appropriate sensitivity planning, strong normalization strategies, and a clear understanding of how the data will support development decisions.

What Consultants Should Really Look for in a Bioanalytical Partner… and Why It Matters

At Smithers Pharmaceutical Development Services, the philosophy is simple: speed only works when supported by strong science, operational discipline, and transparent communication.

Smithers Pharmaceutical Development Services to Present Molecular Bioanalysis Insights at the AAPS 2026 Summer Scientific Forum

Sponsors attending the AAPS 2026 Summer Scientific Forum are encouraged to connect with Smithers Pharmaceutical Development Services during the conference to discuss molecular bioanalysis strategy, assay development, and preclinical analytical support requirements.

Smithers Pharmaceutical Development Services to Attend AAPS National Biotechnology Conference 2026

Smithers Pharmaceutical Development Services will participate in the AAPS National Biotechnology Conference, taking place May 11–14, 2026, at the Sheraton San Diego Resort in San Diego. The event convenes biotechnology and pharmaceutical professionals focused on advancing biologics development, manufacturing, and regulatory strategy. Smithers will host meetings at booth 304 with senior leadership in attendance

Navigating Immunogenicity with Confidence: ADA and NAb Assays Done Right

Successful immunogenicity testing begins with the right strategy, the right assay design, and the right scientific expertise. From ADA assay development and validation to complex NAb assay design and validation, Smithers Pharmaceutical Development Services helps sponsors generate reliable data that support clinical trials.

Designing Biomarker Programs That Scale — When Scientific Rigor Meets Clinical Reality

As biomarkers assume a more central role in large molecule development, the challenge is no longer whether to use them—but how to implement them correctly, reproducibly, and at scale. From assay development to validation and long-term clinical execution, biomarker programs introduce a level of complexity that demands early planning and experienced scientific leadership.

Overcoming Matrix Interference in High Drug Tolerant ADA Assays: Smithers to Present at the 17th Ann

Smithers presents on overcoming matrix interference in ADA assays at the Immunogenicity & Bioassay Summit. Learn about our advanced immunogenicity testing.

Bispecifics and Bioanalysis: Navigating Complexity with Custom Assays

Smithers Pharmaceutical Development Services provides bioanalytical support for complex biologics from discovery through late-stage clinical development. Sponsors gain access to experienced scientists, flexible assay strategies, and collaborative project support designed to reduce development risk and accelerate progress.

Making the Most of Your Molecular Biology Platform: Why qPCR and ddPCR Success Starts Before the Assay Runs

At Smithers Pharmaceutical Development Services, the molecular biology team works with sponsors to look beyond the instrument itself and evaluate the full analytical strategy surrounding each assay. That means considering sample handling, extraction methods, assay optimization, sensitivity requirements, normalization strategy, data interpretation, and regulatory expectations from the beginning.

Beating the Clock Without Cutting Corners: How Smithers Delivers Pharmacokinetic Data on Sponsor Timelines

In today’s drug development environment, speed is no longer a competitive advantage, it’s a requirement. By the time sponsors engage a pharmacokinetic (PK) partner, the science is often well defined, the program is funded, and the next milestone is already looming.

Smithers Pharmaceutical Development Services to Attend the 22nd Annual PEGS Boston Conference

Smithers Pharmaceutical Development Services will attend the 22nd Annual PEGS Boston Conference from May 11–15, 2026, at the Omni Boston Hotel at the Seaport in Boston. The conference remains a leading event for professionals involved in antibody development, biologics, immunotherapy, cell therapy research, and protein engineering.

Smithers at WRIB: Advancing Large Molecule Bioanalytical Science

Organizations developing large molecule therapeutics or facing bioanalytical challenges are encouraged to connect with Smithers during WRIB. Smithers urges attendees to schedule their meeting in advance to discuss specific program needs and explore strategies to advance development timelines with confidence.

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.

Antidrug Antibody Testing in Immuno-Oncology: Building Reliable Data Under Clinical Timelines

For sponsors developing large-molecule therapies in oncology and immuno-oncology, antidrug antibody (ADA) testing is rarely a “check-the-box” activity. Instead, it is a foundational component of clinical decision-making, one that must deliver reliable, reproducible data under aggressive timelines and evolving regulatory expectations.

Global CRO Perspectives on ICH M10, NGS and Immunogenicity Harmonization

In June 2023, leaders from across the global bioanalytical community gathered in Orlando, FL, for the 16th Closed Forum of the Global CRO Council for Bioanalysis (GCC). The outcome, now published in Bioanalysis, captures candid discussions, survey data, and consensus recommendations on some of the most pressing scientific and regulatory challenges facing our industry today.

Choosing the Right Tool for Cell and Gene Therapy Development: qPCR vs. ddPCR

At Smithers Pharmaceutical Development Services, qPCR and ddPCR are not viewed as competing technologies, but as complementary tools. The real question is not “which is newer,” but “which platform best answers the scientific and regulatory question at hand.”

Anti Drug Antibody Sample Testing and Reporting Harmonization

Download our whitepaper for harmonized recommendations on reporting clinical anti-drug antibody (ADA) assay results to facilitate agency filings.

Neutralizing Antibody Sample Testing and Report Harmonization

Download our expert-developed white paper for practical insights and an editable template to streamline your neutralizing antibody sample analysis reporting process.

Mitigation Strategy for Eliminating NAb-arm-2 False Negative Response

Optimized NAb Assay Strategies for Bi-Specific Therapeutics

Validating ddPCR for Gene Therapy Biodistribution in Minipigs: A New Industry Benchmark

As gene therapy programs advance toward IND-enabling studies, robust biodistribution data are more critical than ever. But while regulatory expectations for vector biodistribution are clear, detailed guidance on validating droplet digital PCR (ddPCR) assays, particularly in large animal models, remains limited.

Advancing Bioanalytical Best Practices: Key Insights from the GCC

The bioanalytical landscape is evolving faster than ever, driven by complex molecular therapeutics, innovative assay platforms, and a growing need for regulatory harmonization. In response, the Global CRO Consortium (GCC) has published a comprehensive white paper highlighting critical discussions, industry trends, and best practices across pharmacokinetics (PK), immunogenicity, biomarker analysis, and emerging regulatory oversight. This summary captures the key insights, while the full white paper provides detailed guidance, case studies, and actionable recommendations.

Precision Molecular Biology Services to Advance Cell and Gene Therapy Development

Smithers molecular biology services integrate seamlessly into your development pipeline—bringing clarity, consistency, and confidence to every stage.

How We Support Virtual Biotechs: Scalable Services for Lean, Fast Teams

The future of drug development is increasingly virtual, and consultant driven. Smithers Pharmaceutical Development Services has intentionally designed its style of scientific engagement to support this reality. Their model gives growing companies what they need most: clarity, predictability, and a partner who understands the pressures and constraints of early-stage development.

Best Practices for Biomarker Assay Validation in Tissues

Accurate biomarker analysis in tissue samples is critical for understanding drug effects, supporting clinical decisions, and advancing therapeutic development. Yet validating these assays can be complex, especially given the diversity of tissue types, biomarker molecules, and analytical platforms.

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