Media and News Releases
Upcoming and Past Events
US FDA Approves IND for Bacteriophage Treatment of Patients with Resistant Infections of the Urinary Tract
03 Apr 2020
Amarex Clinical Research, LLC announces that the US Food and Drug Administration approved an IND application prepared and submitted by Amarex for their client Adaptive Phage Therapeutics, Inc. (APT). This allows APT to proceed with their Phase I/II study of a personalized bacteriophage therapeutic for the treatment of patients with multi-drug resistant (MDR) pathogenic bacteria and other complicated infections. This study helps APT expand their growing library of hundreds of bacteriophage (PhageBankTM) which kill the six highest priority MDR pathogenic bacteria.
Amarex Executes Three Rush COVID-19 Related Submissions to the FDA in March for Expedited Approval of: 1) Diagnostic, 2) Device, 3) Therapeutic
30 Mar 2020
On March 27, Amarex executed a rush submission to the US FDA of an Emergency Use Authorization (EAU) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea and Amarex and its client are therefore hopeful for a rapid FDA approval result.
Amarex Assists with Emergency Use Authorization (EUA) for COVID-19 Treatment
20 Mar 2020
In the past week Amarex worked with client CytoDyn to prepare, submit and achieve FDA approval for an EUA for CytoDyn’s leronlimab, a monoclonal antibody product, as a potential treatment for coronavirus disease 2019 (COVID-19). Amarex CEO, Dr. Kazem Kazempour, explained, “Cytodyn’s product has the potential to control the body’s hyper-immune response to coronavirus infection which contributes to life threatening side-effects of the disease.
Featured White Paper: Understanding Apative Designs for Clinical Trials
24 Jan 2020
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
Webinar: Upgrading the FDA Adverse Event Reporting System (FAERS) Based on International Council for Harmonisation (ICH) E2B (R3) Standards | April 7, 2020 11:00 AM EDT
Amarex Senior Vice President of Safety and Pharmacovigilance, Shide Badri, MD, is conducting a free webinar on Tuesday, April 7, 2020 at 11:00 AM EDT entitled Upgrading the FDA Adverse Event Report System (FAERS) Based on International Council for Harmonisation (ICH) E2B (R3) Standards.
This webinar addresses the US FDA’s plan to modernize electronic submission standards for drug, biological and drug/biologic-led combination products for the premarket and post market safety surveillance programs. The webinar summarizes upgrades to electronic submission of Individual Case Safety Reports (ICRs) in the FDA Adverse Event Reporting System (FAERS) using ICH E2B(R3) standards that are disclosed to the public, FAERSII’s implementation timeline, benefits and impacts on stakeholders and industry.
For more information or to register for this webinar, visit http://www.nsf.org/training-education/training-entry/webinar-upgrading-the-fda-adverse-event-reporting-system-faers
March Training Activities: Transitioning from MDD to MDR
In collaboration with NSF PROSYSTEM GmbH, Amarex is hosting two free training sessions covering key changes to effect clinical investigations when transitioning from the medical devices directive (93/42/EEC) (MDD) to the medical devices regulation (EU 2017/745) (MDR).
On Tuesday, March 17, 2020 at 10:00 AM EST Amarex President & CEO, Dr. Kazem Kazempour, and PROSYSTEM Managing Consultant, Clinical Affairs, Sandra Bugler, will present a free webinar reviewing regulatory requirements for clinical studies and clinical investigations.
To register for this webinar, visit https://www.nsf.org/training-education/training-entry/webinar-clinical-investigations-transitioning-from-mdd-to-mdr
On Tuesday, March 31, 2020, from 9:00 AM – 5:00 PM, in Hamburg, Germany, Amarex and PROSYSTEM will host a free seminar addressing the current regulatory status and the relevant requirements for the planning, execution and completion of a clinical investigation, with a special focus on the Regulation (EU) 2017/745.
For more information or to register, visit https://www.nsf-prosystem.com/veranstaltungen/clinical-investigation-of-medical-devices/
BIO-EUROPE Spring 2020 | March 23-25, 2020, Paris, France
UPDATE: MOVED FROM IN-PERSON TO FULLY DIGITAL
From March 23-25, in Paris, France, Amarex President & CEO, Dr. Kazem Kazempour, and Senior Vice President of Business Operations, Peter Frantz, will team up with Amarex Europe staff at BIO-Europe Spring. Amarex is currently conducting clinical trials in several European countries for clients located around the world. Amarex is also working with EU clients to bring their products to the US market. BIO-Europe is a distinct conference bringing together leaders in biotech, pharma and finance for informative networking and development relevant to European innovation and global collaboration.
On March 23rd at 5:00 PM, following Monday’s conference activities and next door to the BIO-Europe Spring Congress, at the Mercure Hotel Vaugirard Porte de Versailles, Amarex will host a Cocktail & Learn on the topic of IND/IDE Submissions and Acceptance of Foreign Clinical Data by the US FDA. This workshop will be presented by Dr. Kazempour and is free of cost.
Register for BIO-Europe at https://ebdgroup.knect365.com/bioeurope-spring/
Register for the Amarex hosted workshop at https://docs.google.com/forms/d/e/1FAIpQLScLDQxmGtubAFaunarMXQ4k9rRyfXHXQBamkPlDcIsgedqp2w/viewform
Leadership in a Multi-disciplinary Organization
On February 22, 2020, Amarex President &CEO, Dr. Kazem Kazempour, will present a new course at Montgomery College, Rockville. Join us and explore key characteristics, traits and behaviors of effective leaders.
Register for this course at:
http://aceitoc.montgomerycollege.edu/course/CourseView.aspx.
Follow-up: Amarex Keynotes at GLORIA NCKU | November 29, 2019, Tainan City, Taiwan
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.
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.
