Media and News Releases

Upcoming and Past Events

Investment by NSF International in Amarex

09 Oct 2019

Amarex Clinical Research, LLC 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.

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

19 Apr 2019

Amarex Clinical Research, 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.

2018 Report: A Year of Successful US FDA Submissions

06 Mar 2019

Amarex’s Regulatory Affairs Department is pleased to announce a record year for new regulatory submissions to the US FDA.

Amarex-sponsored Team Awarded Gold Medal at the 2018 iGEM Competition

13 Feb 2019

Amarex is pleased to announce that its sponsored team, NTHU_Formosa, was awarded a gold medal at the 2018 International Genetically Engineered Machine Competition (iGEM).

Promoting Software as Medical Device (SaMD): Amarex Speaks Up

07 Feb 2019

Global Biotechnology Monthly recently interviewed Dr. Kazem Kazempour, President & CEO of Amarex Clinical Research, about the US FDA’s continued support for the development and marketing of digital health application products.

Watch Dr. Kazem Kazempour's Keynote Presentation and Press Room Interview at the Trans 2018 Digital Health Conference

28 Jan 2019

On September 8, 2018, Amarex’s President & CEO, Dr. Kazem Kazempour, keynoted at the Trans 2018 digital health conference in Taipei, Taiwan.

Amarex Celebrates 20 Years of Clinical Product Development and Approvals

31 Dec 2018

On December 30, 2018, Amarex celebrated its twentieth anniversary, commemorating two decades of clinical product development and approvals for our clients.

Product Development Strategy: Let Amarex Negotiate Your FDA Approval

24 Sep 2018

Amarex recently submitted an initial Pediatric Study Plan (iPSP) waiver request to the US FDA for a client’s product that is fast approaching the submission of an NDA. Amarex’s request for waiver was approved by the US FDA.

US FDA Approves Diacomit for the Treatment of Seizures in Patients with Dravet Syndrome Taking Clobazam

31 Aug 2018

On September 8, 2018, Amarex’s President & CEO, Dr. Kazem Kazempour, keynoted at the Trans 2018 digital health conference in Taipei, Taiwan. The full presentation, titled “Inside FDA’s Latest Digital Health Developments”, was released on December 2, 2018

IND for the First siRNA Oncology Drug, STP705, Filed and Deemed Safe to Proceed to Clinic by the US FDA

20 Aug 2018

Amarex Clinical Research announces today that an oncology IND application has received a safe to proceed notification from the US FDA.

Electronic Submissions to the U.S. FDA – The Time Has Arrived!

07 Aug 2018

As of May 2018 the U.S. FDA requires all submissions related to regulated medical products to be made electronically through the FDA’s Electronic Submissions Gateway (ESG).

Amarex Leadership Focus: Latest Activities in Industry

14 Jun 2018

Amarex was pleased to have two senior staff speak at two bioscience conferences over the weekend.

Primary Endpoint Successfully Achieved in a Phase 2b/3 Study for Treatment of HIV-1 Subjects

02 Apr 2018

Amarex Clinical Research helped a client successfully meet their primary endpoint in a Phase 2b/3 clinical trial of treatment-experienced HIV-1 patients.

Amarex Clinical Research Achieves Food Donor Hall of Fame Status in Nourish Now’s 2017 Food Drive

09 Feb 2018

Amarex Clinical Research was one of six companies to receive “Food Donor Hall of Fame Runner Up” status for donating to Nourish Now’s 2017 Annual Thanksgiving Food Drive.

Grand Opening Celebration of Amarex Taiwan, LLC

30 Jan 2018

Amarex Clinical Research recently celebrated the official office opening of its affiliate company, Amarex Taiwan, LLC.

Collaboration between Hanbat National University (S. Korea) and Amarex Clinical Research

19 Jan 2018

Amarex Clinical Research was pleased to welcome distinguished guests, Professor Yoon Kee Kim and Dr. Jon won Lee, from Hanbat National University as visitors to Amarex on 10 January 2018.

Amarex Clinical Research Successfully Supports a 510(k) Approval in a Gastroenterology / Urology Indication

21 Dec 2017

Amarex Clinical Research is pleased to announce that one of its clients has received a 510(k) approval from the U.S. FDA on a medical device for use in a Gastroenterology/Urology indication.  Amarex supported the regulatory efforts of this submission, along with providing full trial services for a companion study.  

Amarex Clinical Research passes GCP Audit conducted by the FDA

14 Dec 2017

Amarex Clinical Research passed a GCP Audit that the US FDA conducted at Amarex last week. The result of the audit was 'no findings' and no '483s'. The FDA auditor complimented Amarex's helpfulness and thoroughness of the employees that assisted with the audit.

Amarex Clinical Research is Featured in a Montgomery College Economic Impact Video

21 Nov 2017

Amarex is pleased to have been asked to be featured in Montgomery College’s - Economic Impact Video. This is an effort to provide more insight to the college and businesses of Montgomery County in Maryland.

Amarex Clinical Research to Attend BIO Europe in Berlin

23 Oct 2017

Amarex will be attending the BIO Europe conference in Berlin over November 6-8.  In order to further expand both its clinical trial services in Europe, and its customer base in Europe, Amarex will be attending this conference for the first time. 

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November 2019 Conference Activities and Networking Opportunities in Europe

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 to Exhibit at the DIA/FDA Oligonucleotide-Based Therapeutics Conference | October 28-30, 2019, North Bethesda, MD

Amarex Clinical Research, LLC will exhibit at the DIA/FDA Oligonucleotide-Based Therapeutics Conference, to be held October 28-30 at Bethesda North Marriott Hotel and Conference Center in North Bethesda, Maryland. This conference connects experts within the field of Oligonucleotide-based therapeutics and provides attendees the opportunity to learn about the latest industry advances and challenges. Informative networking is available through panel discussions, poster sessions and round tables during this three day conference.

 

Amarex will showcase services at the DIA/FDA Oligonucleotide-Based Therapeutics Conference exhibit hall.     

 

For additional information, or to register for this conference, visit https://www.diaglobal.org/

Amarex to Exhibit at SAWC Fall 2019 | October 12-14, Las Vegas, NV

Amarex Clinical Research, LLC will exhibit at the 2019 Symposium on Advanced Wound Care Fall (SAWC Fall), to be held October 12-14 at Caesars Palace in Las Vegas, Nevada. This conference connects researchers, scientists and healthcare professionals within the field of wound care to improve clinical outcomes through education.

Having conducted numerous wound healing clinical projects, several rescue trials included, and having helped to obtain one 510(k) and two PMA wound indication market approvals, Amarex has extensive wound care clinical trial expertise and a unique understanding of the challenges and opportunities related to wound healing product development.    

 

Amarex will showcase services at SAWC Fall 2019 in the Octavius Ballroom, booth #247. Amarex’s Vice President of Clinical Operations, Dr. Kush Dhody, will be available to offer consultative expertise on wound care clinical trials.  

 

For additional information, or to register for this symposium, visit http://www.sawc.net/fall/

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 | Taipei, Taiwan

On September 25th, at the 2019 TFDA Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries, 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. Dr. Ho stated that because of the numerous benefits offered by AI/ML products, SaMD approval increased by 400% within the past month, and the FDA is calling for industry feedback while modifying their traditional regulatory pathway to devise a potentially new regulatory framework for AI/ML-based SaMD. Typical to all other health-related products, risk/benefit analysis and other risk-related categories for AI/ML SaMD play a major role in developing a regulatory pathway for these products. Dr. Ho further explained that while the current FDA regulatory pathway requires “locked” AI/ML algorithms that discard learning strength, based on Amarex’s solid experience with 510(k) and de novo applications, along with considerable experience working closely with the FDA, we can help our clients take advantage of this regulatory pathway to obtain FDA approval for their game-changing AI/ML-based SaMD within the digital healthcare field.   

 

To view the full presentation, visit https://youtu.be/Osxn0smI338.

2019 TFDA Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries | Taipei, Taiwan | September 25

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?”

 

The number of US FDA approvals for AI/ML-based SaMD is expanding rapidly because the agency is actively developing a new regulatory framework to promote innovation in the AI/ML space. AI/ML-based SaMD can be used to support drug development, to aggregate data, synthesize information, seek patterns and optimize decisions. When used in drug development, it can help us understand the disease and targets, generate and evaluate drug candidates and combinations, improve trial design and advance precision medicine. This talk will present key principles of AI/ML-based SaMD as applied in drug development and as regulated by US FDA. Dr. Ho will present examples of AI/ML-based SaMD submissions to the FDA, and follow with a discussion of the challenges and future directions of AI/ML-based SaMD development.

 

To view the agenda or to register for this seminar, visit https://wlsms.itri.org.tw/ClientSignUp/Index.aspx?ActGUID=5633D74CA0.

Bio Innovation Conference | October 7, 2019, Bethesda, MD

Amarex will participate in the Bio Innovation Conference to be held on 07 October 2019 at the Bethesda North Marriott Hotel and Conference Center. This conference is hosted by the Maryland Tech Council, Maryland Life Sciences (MDLS) division, and invites over 300 industry leaders to share experiences and information about developments in Cellular and Gene Therapy (CGT). It is a full day of presentations, round tables, and panel discussions by industry experts. Conference features include:  

 

  • Keynote speaker John Tisdale, M.D., Chief, Cellular and Molecular Therapeutics Branch, National Heart, Lung, and Blood Institute, National Institutes of Health

  • One-on-One Partnering program

  • CGT updates

  • Fantastic Therapies, Fearsome Prices

  • Regulatory Reality Checks

  • Innovations in Biomanufacturing

  • Concluding networking reception

 

To register for this conference, please visit https://www.marylandlifesciences.com/conference/.

 

Use promotional code BICPROMO for a special discounted rate.

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

Amarex Clinical Research, LLC is pleased to announce that Taiwan President Tsai Ing-wen attended the opening ceremony for BIO Asia-Taiwan on July 25, 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. Dr. Kazempour stated to President Tsai that, “Amarex has established an office in Taipei and employs talented, well-educated, young Taiwanese staff members. Our organization is dedicated to helping local biotech and pharmaceutical companies bring their clinical products to the US market.”

 

The opening ceremony was filmed by Taiwan Television (TTV) News Channel. To view this event, visit https://youtu.be/waqawT_UQAY.

 

At BIO Asia-Taiwan 2019, Amarex Taiwan’s President & CEO, Dr. Kazempour, gave a keynote presentation in the area of Cell & Gene Therapy, which addressed clinical trial design challenges for cellular therapy products. Dr. Kazempour emphasized that CMC can be a challenge for cell therapy approval but this is always overcome with documentation of proper steps. Moreover, he recommended regulatory and clinical opportunities to consider, including newly-formed expedited programs for cell therapy and adaptive trial design to address the complexities associated with cell therapy product development.

Amarex Taiwan to Keynote at BIO Asia-Taiwan 2019 | July 24-28, Taipei, Taiwan

Amarex Clinical Research, LLC is pleased to announce that Amarex Taiwan will keynote at BIO Asia-Taiwan 2019. BIO Asia-Taiwan will be held July 24-28 at the Taipei Nangang Exhibition Center in Taipei, Taiwan. This conference brings together biotechnology and pharmaceutical leaders from around the globe to explore biotech developments and business opportunities with a focus on activities and companies in Asia.

 

On Friday, July 26 at 11:05 in Ballroom A, President & CEO of Amarex Taiwan, Dr. Kazem Kazempour, will keynote at Session 7 – Cell & Gene Therapy on the topic of Challenges and Opportunities in Clinical Design and Statistical Power of Cellular Therapy Products.

 

The design of clinical trials for cellular therapy products often differs from the design of clinical trials for other types of pharmaceutical products. In this talk, Dr. Kazempour will focus on the challenges at the design and analysis stages of clinical development for cellular therapy products, including sample size and power calculations needed to establish efficacy. By identifying the challenges of these innovative and complicated clinical trial designs, we can offer strategies from different perspectives to overcome them. There are also multiple opportunities to take advantage of special programs at different stages of clinical development, including the utilization of Expedited Programs. One such program, a new designation introduced specifically for cellular therapy, “Regenerative Medicine Advanced Therapy (RMAT) Designation”, allows close work with the FDA on the program’s development.

 

To view the agenda or to register for BIO Asia-Taiwan 2019, visit https://bioasiataiwan.com/en.

Watch Amarex’s Keynote Presentation at the 2019 Digital Medicine Summit

On May 14, 2019, Amarex’s President & CEO, Dr. Kazem Kazempour, keynoted at the 2019 Digital Medicine Summit/Matching Forum in Taipei, Taiwan.

 

The full presentation, titled “US FDA Perspective on the Latest Challenges and Opportunities to Regulate AI/ML-based Health Products”, is available at:

https://www.youtube.com/watch?v=RFMit3whXTc&list=PLh2IsYBD8fNRRpi7EPwoRWapamsWMnVV9&index=3&t=8s

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