Aprecia Pharmaceuticals | October 21, 2021
Kyle Smith has been named President and Chief Operating Officer of Aprecia Pharmaceuticals, LLC, effective immediately. Mr. Smith is a 10-year veteran with Aprecia and has served as Vice President of Operations for the past 3 years. As President and Chief Operating Officer, Mr. Smith will be responsible for leading day-to-day business activities.
Aprecia has further strengthened its leadership team by promoting Patrick Staudt to Vice President of Operations, effective immediately. A 14-year veteran of Aprecia, Mr. Staudt has led the East Windsor, NJ manufacturing operations for more than 10 years and has demonstrated the talent and experience to lead expected, expansive growth through multiple technology platforms.
Mr. Smith and Mr. Staudt have been cornerstones of Aprecia's history of technology and manufacturing innovation. They have been key contributors in establishing the company as the leader in the development and manufacturing of pharmaceutical products through 3D-Printing. Their experiences with Aprecia have helped craft the company culture and 3DP pharmaceutical manufacturing innovation, and their contributions have created a momentum which continues to accelerate through important partnerships and novel products.
"As Aprecia's technology platforms expand and industry partnerships advance, Aprecia requires additional talent and resources to meet these growing demands, We are fortunate to have these seasoned technology experts and corporate leaders to promote and guide the organizational growth well into the future."
Chris Gilmore, Aprecia's Chief Executive Officer
Mr. Kyle Smith holds a Master of Business Administration degree from Miami University, and a Bachelor of Science in Chemical Engineering from Georgia Institute of Technology.
Mr. Patrick Staudt holds a Bachelor of Science degree in Biomedical/Medical Engineering from Drexel University.
Founded in 2004, Aprecia received the first and only FDA approved three-dimensionally-printed (3DP) pharmaceutical product approval in 2015. Aprecia uses its ZipDose® Technology to create rapidly disintegrating oral dosage forms that are easy to take and easy to administer. Without compression during the 3DP manufacturing process, engineered and coated particles such as taste masking and modified release are possible on large dose products (over a 1000mg). Aprecia directly owns a patent estate for novel 3DP machines and pharmaceutical 3DP applications. It licenses its exclusive technology platform to pharmaceutical partners as a means to extend product lines, improve patient reach and experience, and address FDA requirements as a pediatric delivery form.
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.
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.
Fiercepharma | May 19, 2020
Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. As the pandemic plays out, political divisions have unfolded around hydroxychloroquine and reopening economies, for starters. At center stage last week was a House hearing over ousted Biomedical Advanced Research and Development Authority (BARDA) Director Rick Bright’s whistleblower complaint. While the hearing spanned numerous subjects relating to the U.S.' COVID-19 response, lawmakers and Bright spent considerable time discussing hydroxychloroquine. President Donald Trump backed the drug as a "game changer," but so far, hydroxychloroquine hasn't succeeded in any any large controlled studies.