CINCINNATI, Sept. 16, 2020 /PRNewswire/ -- Aprecia, the 3DP Pharmaceutical Company, today announced the appointment of Kathi Rinesmith, R.Ph., MS as Senior Vice President of Regulatory Affairs. Rinesmith will lead the company's regulatory strategy, objectives, policies, and programs pertaining to the development and marketing of drug products manufactured with Aprecia's proprietary three-dimensional printing (3DP) technology platform, ZipDose® Technology.
Rinesmith brings more than thirty years of experience related to the development and registration of pharmaceutical products ranging from early and late-stage product development, product approvals, and life-cycle management across several therapeutic areas. Prior to joining Aprecia, Rinesmith served as Director of Global Regulatory Affairs and Global Pharmacovigilance at the specialty CDMO company Adare Pharmaceuticals. Rinesmith's regulatory and pharmacovigilance experience spans commercialized Rx, OTC, and dietary supplement products, as well as fulfillment of commercial product regulatory reporting obligations. Earlier in her career, Rinesmith held senior executive product development and regulatory roles at Camargo Pharmaceutical Services, Prasco Laboratories, Barr Labs, and Duramed Pharmaceuticals.
"Kathi has comprehensive experience and qualifications that will be instrumental in advancing Aprecia's pipeline and will be a resource for our partners to achieve regulatory and commercial success," said Aprecia CEO, Chris Gilmore. "Her leadership and strategic vision will enhance the future of Aprecia."
"Aprecia's 3DP drug delivery platform provides unique opportunities to improve the medication experience and make a difference in patients' lives," Rinesmith stated. "I'm delighted to join the high performing team at Aprecia and I look forward to engaging with world-class partners who are addressing complex formulation challenges and advancing pharmaceutical science and development."
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. For more information, visit www.aprecia.com.
SOURCE Aprecia Pharmaceuticals
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