2019 Regulatory Affairs Year in Review

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​2019 was an exciting year of growth and discovery for Amarex Clinical Research and Amarex Taiwan, and we are excited to report the below noteworthy achievements.

Featured White Paper: Understanding Adaptive Designs for Clinical Trials

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Amarex Clinical Research, LLC is pleased to announce that a white paper authored by Hana Mekonnen, MS, Senior Vice President of Biometrics for Amarex, was published in the NSF Health Sciences Journal, Issue 46.

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The full journal is available here, and at NSF.org.

Investment by NSF International in Amarex

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On October 9th, Amarex is pleased to announce that global public health organization NSF International has made majority investment in Amarex. The investment supports both Amarex’s mission of expediting patient access to safe and effective clinical products, and NSF International’s mission of protecting and improving human health, through expanded services to the medical device and pharma/biotech industries. Amarex will be a part of NSF International’s global health science consulting business, and will be referred to as Amarex Clinical Research, LLC, an NSF International company.  Amarex founder Dr. Kazem Kazempour, will continue as President and CEO of Amarex under NSF International.

Follow-up: Amarex Taiwan’s COO, Dr. Chia-Hua Maggie Ho, Keynoted at the 2019 TFDA Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries

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On September 25th, at the National Taiwan University Hospital (NTUH) in Taipei, Taiwan, Amarex Taiwan COO, Dr. Chia-Hua Maggie Ho, gave a keynote presentation addressing the application of, and current US FDA regulatory trends for, AI/ML-based SaMD. Dr. Ho outlined the potential risks and benefits involved with smart medical device product development, and highlighted how Amarex can help with the regulatory approval process.

Taiwan President Tsai Ing-wen Meets Amarex President & CEO Dr. Kazempour At BIO Asia-Taiwan 2019, and Dr. Kazempour Keynotes for Cell & Gene Therapy

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Amarex Clinical Research, LLC is pleased to announce that Taiwan President Tsai Ing-wen attended the opening ceremony for BIO Asia-Taiwan on July 24, 2019 to show her support for Taiwanese expertise and innovation in biotechnology R&D. Amarex Taiwan exhibited services at the conference and Dr. Kazem Kazempour, as well as the company’s COO, Dr. Chia-Hua Maggie Ho, were honored to meet President Tsai at Amarex’s exhibit. The support of the Taiwanese government to the biotech industry in Taiwan indicates a distinct commitment that the people of Taiwan have to this industry, and Amarex is privileged to be a part of this growing piece of Taiwan’s economy.

US FDA Grants Orphan Drug Designation to an Oncology Drug Treating Pancreatic Cancer

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Amarex Taiwan, LLC announces today that the US FDA has granted Orphan Drug Designation (ODD) to RP-72, a 72 amino acid proprietary recombinant protein antagonist for the CXCR1 and CXCR2 receptors of interleukin-8, a drug that treats pancreatic cancer. Amarex submitted the ODD application on behalf of its client, Rise Biopharmaceuticals, Inc.

US FDA Grants Fast Track Designation to an Amarex Client Treating mTNBC

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Amarex Taiwan, LLC announces that the US FDA has granted Fast Track Designation to a novel monoclonal antibody for use in combination with carboplatin in the treatment of CCR5-positive metastatic triple-negative breast cancer (mTNBC) patients.  The FDA granted the designation to the drug sponsor following significant preclinical results demonstrating a greater than 98% reduction in human breast cancer metastasis in preclinical models.

US FDA Approves ‘Vstrip’, IVD for Rapid Diagnosis of H. pylori Infection

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Amarex Taiwan, LLC learned that, on March 14, 2019, the US FDA approved a new rapid in vitro diagnostic (IVD) kit, Vstrip, for detection of H. pylori infection. Vstrip is a single use immunochromatographic assay for the qualitative detection of H. pylori antigens developed and produced by Panion & BF Biotech Inc. (PBF), a Taiwan-based biopharmaceutical company.