BUSINESS INSIGHTS

CATO SMS Acquires Nuventra in order to Expand its Drug Development Offering Into Clinical Pharmacology

Nuventra, CATO SMS | May 27, 2021

CATO SMS, a global provider of regulatory and clinical research services, announced today the acquisition of Nuventra, Inc., to expand its offering into the critical area of clinical pharmacology. Nuventra, headquartered in Durham, North Carolina, is a leading company in clinical pharmacology science and services. The acquisition expands CATO SMS's portfolio of specialized solutions that help biopharmaceutical companies with drug development by providing a key set of skills targeted at significantly reducing development risk, costs, and timelines.

CATO SMS now provides customers cutting-edge clinical pharmacology services such as strategic consulting, pharmacokinetics/pharmacodynamics (PK/PD), pharmacometrics (population PK), and biosimulation. Nuventra is well-known for its track record of transforming complex data into meaningful insights for over 650 biopharmaceutical companies across a wide range of therapeutic areas. Its team of scientific experts and senior consultants use the most advanced mathematical modeling tools in the industry 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 pharmacokinetic (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.

About Nuventra
Nuventra is the pharmaceutical industry's preferred provider of clinical pharmacology, pharmacokinetics, and pharmacometrics consulting services. Nuventra provides pharmaceutical companies and contracts research organizations (CROs) with unique access to a hands-on team of industry-leading consultants with extensive experience in complex studies and analyses. By taking complex pharmacokinetic and pharmacometrics concepts and making them understandable and usable for common sense drug development, we embrace the notion that simplicity and clarity lead to smart decisions.

About CATO SMS
CATO SMS is a provider of specialized clinical research solutions formed in 2019 by the merger of Cato Research and SMS-oncology. CATO SMS, with over 30 years of professional experience focusing on the needs of small and emerging biopharmaceutical companies, effectively designs and executes studies from strategy to approval in complex indications and modalities throughout a wide range of therapeutic areas, with a proven center of excellence in oncology. The regulatory, therapeutic, and operational expertise of CATO SMS enables the company to meet and exceed expectations.

Spotlight

Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada. ICH Q3D provides a means of assessment and control of 24 elemental impurities using the principles of risk management as detailed in ICH Q9. It establishes permitted daily exposure (PDE) limits for each element, expressed in µg/day, calculated using published toxicity data and set according to the route of administration. The elements are divided into three classes based on their toxicity and likelihood of occurrence with limits applicable to finished formulations based on a maximum dosage of 10g/day. Compliance is not directly applicable to excipients or the drug substance, however, USP <232> does state “elemental impurity levels present in drug substances and excipients must be known, documented, and made available upon request.

Spotlight

Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada. ICH Q3D provides a means of assessment and control of 24 elemental impurities using the principles of risk management as detailed in ICH Q9. It establishes permitted daily exposure (PDE) limits for each element, expressed in µg/day, calculated using published toxicity data and set according to the route of administration. The elements are divided into three classes based on their toxicity and likelihood of occurrence with limits applicable to finished formulations based on a maximum dosage of 10g/day. Compliance is not directly applicable to excipients or the drug substance, however, USP <232> does state “elemental impurity levels present in drug substances and excipients must be known, documented, and made available upon request.

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BC Platforms Partners with EU Funded, AI-Driven, Cancer Data Initiative

BC Platforms | November 25, 2022

BC Platforms a global leader in healthcare data management and analytics announced that it has been chosen as key partner in a European Commission project. Under the EC's Horizon Europe program*, Helsinki University Hospital has been awarded a contract to lead a EURO 7 million consortium project termed ONCOVALUE. BCP will work closely with HUS as a key delivery partner in this major EC project. ONCOVALUE is an Artificial Intelligence-based framework which assesses, in real-time, real-life effectiveness of novel cancer therapies. It does this by standardising data processing in hospitals enabling them to efficiently measure the cost effectiveness of new cancer therapies for Health Technology Assessment (HTA) and regulatory purposes. BCP will aid in core aspects of the project, including creating the technical architecture and providing the data analysis, to ensure this technology can transform unstructured patient data from medical notes and images into structured data and real-world evidence (RWE) that clinicians can use in treatment management and with health regulatory and HTA bodies "This latest partnership with ONCOVALUE is part of our rapidly expanding Trusted Collaborative Environment solution. I'm proud our sophisticated healthcare data management and analytics products have been recognised by this significant, four-year, Horizon Europe project. By opening the door to widespread regulatory and HTA integration of real-world data, ONCOVALUE should lead to better, more environmentally sustainable therapies, technologies, and digital solutions for cancer care." Tero Silvola, CEO of BC Platforms Johanna Mattson, HUS's Senior Medical Director in Oncology, said, "ONCOVALUE aims to develop novel AI-based tools to automate the collection and analytics of clinical data. This will contribute to the increased cost-effectiveness and sustainability of European cancer care. Systematic collection and evaluation of patient reported outcomes should lead to improved health and well-being and should reduce the growing global burden of cancer treatment." The ONCOVALUE consortium is made up of eleven institutions and companies in Finland, The Netherlands, Denmark, Portugal, and Italy. Over the four-year project span, annually around 40,000 European patients will participate from hospitals in the consortium. About BC Platforms BC Platforms is a global leader in building data networks for the life sciences industry and provides versatile technology platforms for personalised medicine, accelerating the translation of innovations into clinical practice. We convert complex biological information collected in the healthcare setting into actionable insights. With our innovative technology we are creating a patient centric infinity loop between the life sciences and healthcare sectors. Data we generate, harmonise, and manage, from diverse biobanks and healthcare institutions, is made accessible for pharmaceutical and biotech companies to enhance their core strengths in research and development. In parallel, we enable stratification of patients towards targeted therapies, delivering on the promise of more personalized healthcare.

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Baseball Legend John Smoltz Featured on PLx Pharma’s Social Channels

PLx Pharma Inc. | September 13, 2022

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Vetsource Unveils New Brand Reflecting Company's Growth

Vetsource | November 17, 2022

Vetsource®, a pet health company designed to provide innovative pharmacy, technology and business services to those who care for pets, launched a new brand identity to signal the official start of three brands coming together as a single, unified portfolio of solutions for the veterinary industry. Already established as a leading provider of innovative prescription management and home delivery services for veterinary practices and pet owners since 2008, Vetsource announced the acquisitions of VetSuccess, a data and analytics provider, and Vet2Pet, a client engagement system, in 2018 and 2019, respectively. Since the acquisitions, the three companies have largely worked together under Vetsource corporate, while still maintaining their separate identities, to allow time to formalize and ease the transition for customers. Information about Vetsource's client engagement, and data and insights services can be found on Vetsource's new website at Vetsource.com, which received a complete redesign to reflect the company's rebrand and comprehensive solutions. The Vet2Pet and VetSuccess websites will be automatically redirected to Vetsource.com and will support access to customer logins. "Adding client engagement, and data and insights, to the Vetsource portfolio allows us to leverage their combined strength to add greater value for the industry. Our goal is to foster strong relationships and positive experiences so veterinarians can focus on what they do best – caring for pets." Kurt Green, Vetsource CEO The product sign-in URLs will remain the same for all three products. The Vet2Pet name will be retained as a product name under Vetsource's client engagement services. "There will be no disruption of service for any of our customers. They will receive the same support and access to services they always have," said Green. "When the companies joined, so too did the same innovative and talented team of people their customers know and trust. We're lucky to now count them as part of the Vetsource family." VMX attendees can find Vetsource at booth #1230 exhibiting its prescription management, client engagement and data and insights solutions for the first time as one united brand. About Vetsource Vetsource provides innovative pharmacy, technology and business services to the pet health industry. At Vetsource, we strive to be the most trusted advocate in a rapidly evolving world and constantly seek new ways to help our customers chart a course for a better, brighter future for pets and those who care for them. Our data-powered platform eliminates complexities and simplifies workflows to help veterinarians, retailers and others in the pet health industry foster engagement, loyalty and positive experiences that ensure strong relationships. Vetsource's solutions include prescription management, data and insights, and client engagement.

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