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.
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
MCEDC Interviews Patrick J. Burke
19 Jan 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 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.
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:
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Keynote speaker John Tisdale, M.D., Chief, Cellular and Molecular Therapeutics Branch, National Heart, Lung, and Blood Institute, National Institutes of Health
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One-on-One Partnering program
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CGT updates
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Fantastic Therapies, Fearsome Prices
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Regulatory Reality Checks
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Innovations in Biomanufacturing
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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
