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.
Fiercepharma | June 10, 2020
As leading coronavirus vaccines make their way through early stages of human testing, the NIH is plotting much larger efficacy studies this summer. U.S. researchers plan to run phase 3 trials of vaccines from Moderna, AstraZeneca and Johnson & Johnson in the coming months, the Wall Street Journal reports. The NIH intends to start a phase 3 trial of Moderna’s vaccine in July, followed by an August trial of AstraZeneca’s vaccine and a September study of Johnson & Johnson’s shot, a U.S. government researcher told the newspaper. All three of the shots are based on brand-new technologies, and they're all reportedly among finalists in the Operation Warp Speed program. Former FDA chief Scott Gottlieb has publicly questioned the picks, pointing out the team's reliance on new technologies. Johnson & Johnson has not previously disclosed any human testing for its vaccine and the company has previously said it’s aiming to enter human studies in September. But on Wednesday, the company said it's accelerating its timeline, with plans to start a phase 1/2a study in July.
VIEWS AND ANALYSIS
CMIC | June 25, 2021
CMIC Co., Ltd., a leading Japanese Contract Research Organization (CRO), and Lokavant, a leading clinical trial intelligence company, announced today that they have agreed to use Lokavant's predictive analytics capabilities to assist CMIC's clinical operations. This strategic collaboration, Lokavant Oversight, monitoring, and operational risk management platform, will be implemented throughout CMIC studies.
CMIC was the first firm in Japan to provide CRO services, and the company has over 28 years of pharmaceutical development expertise in the Asia-Pacific (APAC) area. CMIC Group supports more than 80% of new drug research in Japan. CMIC and Lokavant are some of the first predictive analytics collaborations for clinical trial operations in the rapidly expanding APAC region.
Trial management has gotten more complex and inefficient as the quantity of data points gathered in clinical trials has increased rapidly. The procedure for detecting and managing risks in clinical trials is still largely manual, and it is often too delayed to prevent severe consequences. The collaboration between CMIC and Lokavant goes beyond conventional risk-based monitoring by implementing an end-to-end solution backed by Lokavant's past operational data and CMIC's data. This will enable CMIC to perform next-generation risk-based monitoring, which will be capable of predicting data quality problems, research schedule delays, and budget overruns. CMIC clinical teams will be proactive, rather than reactive, in reducing problems and eventually enhancing trial results by using historical data to predict future issues. Lokavant and CMIC will also collaborate to create data-driven metrics to track study success across previous and current CMIC trials, delivering critical insights to CMIC's 1,200+ clinical trial operators.
Lokavant's data-driven solutions, including its flagship product, Lokavant Oversight, a tech-enabled risk-based monitoring solution, and Lokavant Insight, a clinical operations benchmarking tool, allow next-generation clinical trials. Lokavant Oversight collects and distributes real-time data from various trial data sources, anticipates problems throughout clinical development to reduce trial risks, and empowers monitoring teams by displaying critical research data. Lokavant Insight enables clinical teams to assess clinical trial performance and analyze critical trial success and failure indicators.
About CMIC Group
CMIC Group was established in 1992 as Japan's first Contract Research Organization (CRO). CMIC Group is now Japan's biggest clinical CRO with a worldwide presence, offering complete services in drug development, clinical site management, clinical to commercial GMP manufacturing, regulatory consultancy, and contract sales and marketing solutions. CMIC Group assists pharmaceutical, biotech, and medical device firms in entering the Japanese market, conducting clinical trials in Asia, and bridging drug development and manufacturing requirements in the United States, Europe, Japan, and the rest of Asia. CMIC Group employs approximately 7,000 people and operates from 25 locations across the globe.