Media and News Releases
Upcoming and Past Events
Amarex Client Now Enrolling Patients for a Blood Filtration Device Study Treating COVID-19 Patients Experiencing Septic Shock
02 Jun 2020
In April, Amarex Clinical Research, LLC, an NSF International company, achieved rapid, supplemental Investigation Device Exemption (IDE) approval from the U.S. FDA, on behalf of its client, to treat COVID-19 patients experiencing septic shock under an already underway Phase III clinical trial of a blood filtration device.
Amarex Co-Authors Paper on Emergency Use Treatment of Leronlimab for COVID-19
28 May 2020
In mid-March, Amarex worked with client CytoDyn to prepare, submit, and achieve FDA approval for emergency use of CytoDyn’s drug leronlimab as a treatment for severe cases of COVID-19. Since then, over 50 patients in a New York hospital have been treated with leronlimab. Initial results appear to show that leronlimab restores immune homeostasis, reduces plasma viral load, and reverses hyperimmune activation and inflammation in critically ill COVID-19 patients.
Amarex Submits a CTA to Belgium Health Authorities for a COVID-19 Clinical Trial
22 May 2020
Yesterday, Amarex Clinical Research, LLC, an NSF International company, on behalf of a client, submitted a Clinical Trial Application (CTA) to Belgium health authorities. The CTA is for a therapeutic product to treat serious side-effects of the COVID-19 disease in a special patient population.
Amarex Accelerated COVID-19 Product Authorization/Approval Services
19 May 2020
Amarex Clinical Research, LLC, an NSF International company, is an expert at streamlining regulatory and clinical trial testing services for product development and FDA approval.
We are applying additional resources to rush timelines for all COVID-19 product projects.
Amarex Achieves U.S. FDA EUA Approval for Client’s IVD for the Detection of SARS-CoV-2 Virus
15 May 2020
On May 11, Amarex Clinical Research, LLC, an NSF International company, achieved approval from the U.S. FDA on behalf of its client, 1drop Inc., for an emergency use authorization (EUA) of an in-vitro diagnostic for the detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). The product, 1copyTM COVID-19 qPCR Multi Kit, is a highly sensitive assay with a short test result time of less than two hours. Developed by 1drop Inc., a Korea-based biotechnology company, this product is already approved in several countries, including South Korea, Sri Lanka, Germany, Luxemburg, Paraguay, Georgia, Bulgaria and Canada.
New U.S. FDA Testing Guidance for COVID-19 Detection Assays as of May 11, 2020
12 May 2020
On May 11, the U.S. FDA updated the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. In the revised policy, the U.S. FDA recommends that all diagnostic manufacturers and testing labs conduct their SARS-CoV-2 assay validation using SARS-CoV-2 positive and negative clinical specimens (30 positives/30 negatives), in preference to the previously accepted ‘contrived’ test specimens.
The UK Health Authorities Approve COVID-19 Clinical Trial to Treat Immunocompromised Patients
07 May 2020
On April 27, Amarex Clinical Research, LLC, an NSF International company, achieved approval from the UK health authorities ((Medicines and Healthcare products Regulatory Agency (MHRA) as well as central ethical committee, “Health Research Authority (HRA)”) to conduct a Phase 2 clinical trial of a recombinant human protein product, on behalf of its client, as a treatment for a subpopulation of patients with COVID-19. This Clinical Trial Application (CTA) was prepared and submitted to MHRA by Amarex’s Regulatory Affairs department within a very short period of time. Patient enrollment is targeted to begin next week, and Amarex will be managing the study for the client.
Clinical Trial for Severely Ill COVID-19 Patients is Now Enrolling – Additional Sites Recruit
23 Apr 2020
Amarex Clinical Research, LLC, an NSF International, received a Safe to Proceed letter from the U.S. FDA to conduct a Phase 2b/3 clinical trial of CytoDyn’s product leronlimab (PRO 140) as a treatment for severely ill COVID-19 patients. The Safe to Proceed letter came after considerable communication with the FDA.
Enrollment for this trial was initiated on Wednesday, April 15 at a site in New York City, NY. Other clinical sites are being recruited to participate in the study.
COVID-19 Drug, Diagnostic and PPE Product Emergency Use Authorization (EUA) Services
16 Apr 2020
Amarex Clinical Research, LLC, an NSF International company located within the Greater Washington DC Area, is helping organizations prepare and submit Emergency Use Authorizations (EUAs) and expanded access, also called “compassionate use”, requests for U.S. FDA approval of drugs, medical devices and IVD kits to treat and diagnose the coronavirus disease 2019 (COVID-19).
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.
Free Webinar: Pros and Cons of Adaptive Clinical Trial Design June 16, 2020
The defining characteristic of all adaptive designs is modification of an ongoing clinical trial, based on data from interim analyses, in accordance with predetermined rules, while maintaining trial integrity and validity. Adaptive designs are complex, but with expert biostatistical knowledge, challenges and complexities can be overcome. This webinar reviews the advantages and disadvantages of adapting a clinical trial. Practical limitations to adaptive trials, and knowing when not to adapt, will be covered, along with discussion of the major benefits of adapting, including better utilization of resources and greater flexibility in clinical trials.
This complimentary webinar will be presented by Amarex President and CEO, Dr. Kazem Kazempour. He will also review relevant issues related to the COVID-19 pandemic.
Register for this webinar here.
Webinar Recording Available: Emergency Market Authorization of COVID-19 IVDs
The full recording of our complimentary webinar, reviewing insights into the Emergency Market Authorization of COVID-19 IVDs, is available on YouTube.
This webinar covers emergency authorization applications for the E.U., the U.S., Asia, Australia and the World Health Organization.
Learn from industry experts:
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Robyn Meurant, Executive Director at NSF International. Before joining NSF, Robyn acted both as a professional officer and an advisor to the WHO and assisted with the development of the EUL for IVDs.
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Chia-hua Maggie Ho, D. Phil., COO of Amarex Clinical Research, LLC, an NSF International Company. Dr. Ho specializes in APAC regulatory submission, clinical operations, business development and client services for the Pan-Pacific region.
View the full webinar here.
Contact our experts, Robyn Murant, at rmeurant@nsf.org, and Chia-hua Maggie Ho, at maggieh@amarextw.com, or get in touch with our Business Development team.
Medical Device Training & Education Courses
Sign up for an NSF International medical device course and learn from experts at your own pace. Course offerings are available in auditing, premarket regulatory, quality system regulation and eLearning.
View the medical device training and education course offerings brochure.
To register for a course, or for more information, visit visit nsfmedicaldevices.trainingfolks.com/store or contact healthsciences@nsf.org.
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.
