PRACTICE MANAGEMENT

Aprecia Announces New Leadership Team

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.

About Aprecia
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.

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C-Path and Replica Analytics Collaboration Aims to Accelerate Rare Disease Research

Replica Analytics | June 30, 2022

Critical Path Institute and Replica Analytics, an Aetion company, announced a new partnership that involves leveraging synthetic data to further catalyze the generation of actionable solutions to accelerate drug development for rare diseases. Replica Analytics will help generate synthetic datasets across rare and orphan indications in which patient-level datasets are often quite small, which heightens considerations regarding data privacy and accessibility. Together with real data, these synthetic data will help maximize the utility of C-Path's Rare Disease Cures Accelerator-Data and Analytics Platform which provides a centralized and standardized infrastructure to support and accelerate rare disease characterization targeted to accelerate drug development. Additionally, the platform includes a framework that supports the rigorous conduct of natural history studies, with attention to established data quality standards, to be most useful to clinical trial design and regulatory review. It includes a robust, integrated database and analytics hub that allows for the aggregation of rare disease data from various sources and the efficient and effective interrogation of that data. Once added to RDCA-DAP, the synthetic data will also represent valuable real-world, electronic health record (EHR) based data available on the platform, opening doors to modeling and research based on longitudinal focused analyses. "Our collaboration with Replica Analytics is important because synthetic data can add value to real-world data while observing data privacy considerations, which will help accelerate overall rare disease drug development. The goal of RDCA-DAP is to provide a centralized and standardized infrastructure to support and accelerate rare disease characterization and therapy development, this collaboration is in line with our efforts." RDCA-DAP Scientific Director Alexandre Betourne, Pharm.D., Ph.D Synthetic data generation is a privacy enhancing technology that has been gaining rapid adoption, particularly in the life sciences sector. SDG uses AI to create machine learning models that learn the statistical patterns and properties of real datasets to generate data that retain the same characteristics as the original dataset, but with no one-to-one mapping back to an identifiable person. SDG can help amplify small datasets, simulate virtual patients to augment patients in existing datasets, and optimize the design of small sample clinical trials. "We are certainly seeing a growing opportunity to partner with organizations like C-Path for generating datasets that are fit-for-purpose," says Khaled El Emam, Ph.D., SVP and GM of Replica Analytics. "Synthetic data, which preserves the integrity and utility of source data, as well as being privacy-protective, can be a very valuable tool to enable this collaboration." In May 2022, C-Path hosted a webinar in which the Replica Analytics team introduced SDG and discussed the role the technology can play in researching and treating rare diseases. The event was recorded and can be viewed on C-Path's YouTube channel. About C-Path Critical Path Institute is an independent, non-profit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations. Critical Path Institute is supported by the Food and Drug Administration of the U.S. Department of Health and Human Services and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government sources, totaling $11,196,634. The contents are those by the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government. About Replica Analytics, an Aetion company Replica Analytics is the premier science-based SDG technology provider to the healthcare industry. The company a pioneer in the development of unique technologies for generating privacy-protective synthetic data that maintain the statistical properties of real-world data. 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PHARMACY MARKET

To Form a Worldwide CDMO for Inhalation Treatment Drugs, Formosa Laboratories, HCmed, and Formosa Pharmaceuticals Signed MoU

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PHARMACY MARKET

Cascade Chemistry Initiates $14 Million Expansion of cGMP Pharmaceutical Manufacturing Capacity

Cascade Chemistry | February 19, 2021

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