CATO SMS Acquires Nuventra To Expand Drug Development Offering Into Clinical Pharmacology

Cary, NC /PRNewswire/ - CATO SMS, a global provider of regulatory and clinical research services, announced today that it has acquired Nuventra, Inc. to extend its offering into the critical area of clinical pharmacology. Headquartered in Durham, N.C., Nuventra is one of the industry's leading clinical pharmacology science and services providers. The acquisition expands CATO SMS' portfolio of specialized solutions that support biopharmaceutical companies with drug development, adding a key set of capabilities focused on significantly reducing development risk, costs and timelines.

With the addition of Nuventra, CATO SMS offers customers cutting-edge clinical pharmacology services that include strategic consulting, pharmacokinetics/pharmacodynamics (PK/PD), pharmacometrics (population PK), and biosimulation services. Nuventra is renowned for its track record of translating complex data into actionable insights across a range of therapeutic areas for more than 650 biopharmaceutical companies. Its team of scientific experts and senior consultants perform the industry's foremost mathematical modeling and simulation techniques to inform clinical design and predict trial outcomes.

Nuventra's range of solutions include:

• pharmacokinetics and pharmacodynamics (PK/PD), which describes the movement of drugs through the body from absorption to elimination (PK), as well as the body's biological response to drugs (PD) to determine optimal dosing paradigms, safety margins and efficacy characteristics.
• population pharmacokinetics (popPK and popPK/PD), which studies the variability in drug concentrations among individuals in a group of interest receiving clinically relevant doses of a drug.
• clinical pharmacology strategic consulting, which includes overall and targeted clinical pharmacology strategy in support of marketing applications for drugs and biologics.
• physiologically based pharmacokinetics (PBPK), which incorporates blood flow and tissue composition of organs to predict the absorption, distribution, metabolism and excretion (ADME) of drugs.
• quantitative systems pharmacology (QSP), which models the interplay of the drug (dose, dosing regimen, etc.) with target biology, using computational systems to characterize the interaction between drugs, biological systems and disease processes.
• model-informed drug development (MIDD), which uses modeling techniques to improve the decision-making process in drug development, thereby leading to clinical trial efficiencies and, in some cases, replacing trials altogether.

To learn more about these services, visit: https://www.nuventra.com/services

Quotes

• Mark A. Goldberg, M.D., executive chairman, CATO SMS
  "We are excited to welcome the impressive Nuventra team to CATO SMS. They are an excellent fit with our expertise-driven organization. Their deep and highly specialized scientific knowledge in clinical pharmacology means that we will have more opportunities to support our clients in their drug development journey. Pharmacometrics and model-informed drug development offer new and, increasingly, regulatory grade insights that can impact key decision-making and accelerate marketing approval, even eliminating the need for certain trials, in some cases."
• Geoffrey Banks, Ph.D., chief executive officer, Nuventra
  "CATO SMS provides us with a powerful platform to expand and enhance our core offerings toward a market-leading position in clinical pharmacology science and services. There is strong cultural alignment between our organizations centered on providing high-quality, innovative and customer-focused solutions. Coming together with CATO SMS also enables us to offer our customers access to a broader set of complementary clinical research solutions, particularly in terms of regulatory and biostatistical services."

Nuventra's co-founders Dr. Banks and M. Alexander Shaw, Ph.D. will continue to spearhead its operations in the new clinical pharmacology business being created at CATO SMS.

CATO SMS' acquisition of Nuventra marks another advancement in its strategic expansion. The company has acquired three businesses in the past two years to deepen its oncology and regulatory expertise and bolster its suite of solutions encompassing product development consulting, biostatistical services, clinical pharmacology and full-service clinical trial operations. With offices across North America, Europe, and the Middle East, CATO SMS employs more than 450 staff, including approximately 200 physicians, senior scientists, consultants and regulatory experts.

About Nuventra
Nuventra is the pharmaceutical industry's go-to resource for clinical pharmacology, pharmacokinetic, and pharmacometric consulting services. Nuventra gives pharmaceutical companies and CROs rare access to a hands-on team of industry-leading consultants experienced in complex studies and analyses. We embrace the notion that simplicity and clarity lead to good decisions by taking complex pharmacokinetic and pharmacometric principals and making them understandable and usable for common sense drug development. For more information, visit www.nuventra.com.

About CATO SMS
CATO SMS is a provider of specialized clinical research solutions that was formed in 2019 when Cato Research merged with SMS-oncology. With more than 30 years of experience focusing on the needs of small and emerging biopharmaceutical companies, CATO SMS effectively designs and executes studies ⁠— from strategy to approval ⁠— in complex indications and modalities across a variety of therapeutic areas with a proven center of excellence in oncology. CATO SMS' regulatory, therapeutic and operational expertise enables the company to meet goals and exceed expectations. Visit CATO-SMS.com for more information.