最新消息 | 活動

On 29 November 2019, at the Global Research & Industry Alliance of National Cheng-Kung University (GLORIA NCKU) in Tainan City, Taiwan, Dr. Kazem Kazempour, President & CEO of Amarex, keynoted on the topic of Current Regulatory Thinking on AI/ML as SaMDs. In addition, Dr. Chia-Hua Maggie Ho keynoted on the topic of Software as a Medical Device (SaMD): Verification, Validation and Clinical Evaluation and on the topic of AI and Machine Learning as Medical Device, Premarket Application to US FDA.

To view these presentations, visit:

https://www.youtube.com/channel/UCqqBV5BlRdXaEfGOqjb6ZDA.

Taipei, Taiwan (October 29, 2019) – Amarex is pleased to announce that it will participate in two fast-approaching partnership opportunities in Europe: BIO-Europe Fall 2019 and the Lunch and Learn: Health Sciences’ Industry Updates seminar hosted by NSF International, Amarex’s partner company.

BIO-Europe Fall 2019 will be held November 11-13 at the Hamburg Messe and Congress conference center in Hamburg, Germany. This conference brings together life science leaders in biotech, pharma and finance for informative networking and global collaboration with a focus on European innovation. Peter Frantz, Sr. Vice President of Business Operations for Amarex Clinical Research, LLC will join Amarex Europe and NSF International team members to participate in this BIO partnering conference. Amarex will showcase services alongside NSF International at NSF’s booth # 65.

For additional information, or to register for this conference, visit https://ebdgroup.knect365.com.

On November 13, from 11:00 AM – 3:00 PM, NSF International will host the Lunch and Learn: Health Sciences’ Industry Updates seminar at NSF Prosystem’s offices in Hamburg. This free seminar will present recent regulatory changes within the healthcare sector and offers unique networking opportunities for experts and participants. Attendees will also receive participation certification. Dr. Kazem Kazempour, President & CEO of Amarex, will present at this seminar on the topic of US FDA Regulatory and Clinical Strategies for Successful Companion Diagnostics Development.

For additional information, or to register for this seminar, view the flyer or contact Juliane Celik at jcelik@nsf.org.

Amarex Clinical Research, LLC is pleased to announce that Amarex Taiwan’s COO, Dr. Chia-Hua Maggie Ho, will keynote at the 2019 Taiwan Food and Drug Administration (TFDA) Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries. This seminar will be held on September 25 at the National Taiwan University Hospital (NTUH) in Taipei, Taiwan. The latest medical device regulations and management measures in Taiwan, as well as the development of regulations for smart medical device in worldwide countries, will be outlined. Additionally, this seminar invites clinical and regulatory experts to share case studies and practical application expertise in the area of artificial intelligence (AI) and machine learning (ML) medical devices, in order to provide reference material for product development to related manufacturers and research teams.

​​On Wednesday, September 25 at 14:15 in Conference Room 402CD, International Conference Center, NTUH, COO of Amarex Taiwan, Dr. Chia-Hua Maggie Ho, will keynote on the topic of “AI/ML-based SaMD in med tech: how should it be applied and regulated?”

To view the agenda or to register for this seminar, visit

https://wlsms.itri.org.tw/ClientSignUp/Index.aspx?ActGUID=5633D74CA0.

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媒體 | 新聞發布

Oct 08, 2019

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.

Sep 30, 2019

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.

Aug 20, 2019

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.

Jun 12, 2019

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.

May 13, 2019

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.

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