White Papers: Regulatory Affairs

• Designing — and Planning — for an Accelerated FDA Review

  September 27, 2022

• Expertise and Communication Support for Complex Innovative Trial Design (CID) Success

  June 10, 2022

• SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance

  October 4, 2011

  Learn the most common issues with SOP creation, management and implementation and solutions.

• An FDA Audit Is Good for You

  October 4, 2011

  Audits by the U.S. Food and Drug Administration (FDA) are perhaps the most intimidating of all events at a regulated facility, but is the only guaranteed method to ensure absolute compliance with FDA requirements.

• Resolving Scientific Disputes With FDA: Regulatory Processes and Practical Tips

  March 1, 2011

  Learn the processes for initiating an appeal, escalating a dispute and dealing effectively with the FDA.

• Meeting With FDA Can Increase the Probability of Product Approval

  October 1, 2010

  Formal meetings with reviewers at the U.S. Food and Drug Administration (FDA) are among the most important and useful resources available to sponsors of medicinal products seeking marketing approval in the U.S.

• Biosimilars: Past, Present and Future

  April 13, 2010

  Learn the regulatory history, new proposed development pathways, realities and myths about biosimilars, the politics involved and what the future holds.

• The 505(b)(2) Drug Development Pathway: When and How to Take Advantage of a Unique American Regulatory Pathway

  April 6, 2010

  The 505(b)(2) regulation offers a less expensive and faster new drug development pathway that may be particularly attractive to a manufacturer with experience in developing generic products.

• Forecasting for Success: The Power of Regulatory Gap Analysis

  December 1, 2008

  A gap analysis is a powerful tool that can be used to forecast a particular product’s success.

• Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms

  October 14, 2008

  Learn the four keys to an effective outsourcing strategy.

• The Promise of Biogenerics: Hope and Hype

  January 8, 2008

  Generic biologics hold great promise. It is inevitable that regulations for biosimilars or follow-on biologics will be implemented in the near future.

• Regulatory Considerations for Conducting Clinical Trials in India

  March 26, 2007

  Learn the history of Indian drug regulations, current regulatory processes and practical issues in outsourcing drug discovery and clinical development programs to Asia, particularly India.

White Papers: Development Strategy

• Reducing Noise with Trial Design to Improve Wound Healing Trials

  May 2, 2022

• Greater Clinical Trial Efficiency: Embracing Today’s Technology for an Improved Trial Experience

  November 30, 2021

  Dr. Kazem Kazempour highlights Amarex’s COVID-19 work.

• Considerations, Challenges and Opportunities When Designing a Successful Post-Acute COVID-19 Syndrome Clinical Trial

  November 29, 2021

  Dr. Kazem Kazempour highlights Amarex’s COVID-19 work.

• Beyond a Requirement: The Value of Highlighting Postmarketing Safety Efforts

  October 20, 2021

  PMS plan helps refine future trials for better direct drug discovery efforts and required prior to reaching market approval from regulatory agencies like FDA.

• Understanding Adaptive Designs for Clinical Trials

  April 21, 2020

  This white paper provides an overview of adaptive design in clinical trials, including its history and current application in the pharmaceutical and biotech industry.

• Safety Risk Management: A Framework for Developing and Implementing REMS Modifications and Revisions

  March 1, 2015

  To meet FDA requirements of developing and implementing changes to risk-evaluation and mitigation strategies (REMS), and to streamline this complicated process, we have detailed a framework of key concepts, standards and submissions procedures.

• Risks and Benefits of Conducting Preclinical Studies in the Global Setting

  December 20, 2011

  It is generally accepted that the preclinical studies needed for first-in-man clinical studies usually take one to three years and cost up to $10 million USD.

• Global Development of an Innovative Medical Device for the U.S. Market

  December 13, 2011

  Creating a new medical device based on new technology is a daunting task.

• Development of Wound Management Products for the U.S.

  December 6, 2011

  Wound care products are primarily aimed at ensuring timely wound healing and effective infection control.

• Strategies for Implementing the New GMPs for Dietary Supplements

  February 8, 2011

  In the last few years, there has been increasing interest in the pharmaceutical industry in outsourcing drug discovery and clinical development programs to Asia, particularly India.

• Developing Botanical Products from India for the U.S. Market

  August 4, 2009

  With only 10% of the Earth’s estimated 250,000 species of plants considered medicinal, botanicals are the “sleeping giant” of drug development.

• Developing Traditional Chinese Medicines as Botanical Drugs for the U.S. Market

  August 1, 2009

  Therapeutic products derived from medicinal plants have been used throughout the history of mankind.

• Energizing Innovation

  October 7, 2008

  Former UK Prime Minister Harold Macmillan once said, “to be alive at all involves some risk.” This statement is especially apt for a biomedical product development enterprise.

• Regulatory Harmonization Efforts in India: Keeping in Step With the Globe

  June 10, 2008

  The Indian pharmaceutical industry has established itself as a key player in the manufacturing arena, with almost half of the active pharmaceutical ingredients (APIs) worldwide being produced there.

• Designing a Global Product Development Strategy

  June 3, 2008

  Pharmaceutical products are truly global in nature—not only in terms of usage but also in terms of the strategic location of different development activities.

Other Resources

• Oncology Clinical Trials: An Emerging Paradigm Shift in Study Design

  April 27, 2022

  This white paper explains the different study designs for clinical trials and the emergence of master protocols as a way to simultaneously evaluate multiple drugs and/or disease populations in multiple studies. Find out the key features of master protocol trial designs, including the practical and statistical challenges associated with designs of this type.

Assessments

• Are you ready to submit your IND/IDE application to the FDA?

  August 5, 2021

Webinars

• Enrichment Strategies to Increase the Power/Reduce the Sample Size in Clinical Trials

  January 7, 2021

  Dr. Kazem Kazempour, presented on January 7, 2021, a webinar on enrichment strategies to increase the power and reduce sample size in clinical trials.

• Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design

  October 27, 2020

  This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints.

• Amarex in the Fight Against COVID-19

  September 27, 2020

  Dr. Kazem Kazempour highlights Amarex’s COVID-19 work.

• Upgrading the FDA Adverse Event Reporting System (FAERS) Based on ICH E2B (R3) Standards

  April 7, 2020

  Shide Badri, M.D., summarizes upgrades to electronic submission of individual case safety reports in FAERS, FAERSII’s implementation timeline, and benefits and impacts.

Videos

• Business Resiliency for the Unexpected and Expected

  October 6, 2020

  Dr. Kazempour highlights his views on business resiliency.

• Clinical Trials for Advanced Therapies

  July 24, 2020

  Dr. Kazem Kazempour presented at BioAsia-Taiwan and discussed significant differences in trial design often needed for advanced therapy products.

• TFDA Seminar: FDA Approval Process for Digital Health Devices and EUAs

  June 22, 2020

  Dr. Kazempour and Dr. Ho of Amarex Taiwan, LLC gave a seminar to the TFDA.

Publications

• One Year of Regulatory Training Abroad: Korean MFDS Staffer Working at U.S. CRO Shares Her Experience

  September 8, 2020

  The Korean Ministry of Food and Drug Safety (MFDS) has a number of international cooperation programs designed to help key staff better understand global medical product development practices.

• Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19

  May 2, 2020

  The salient features of COVID-19 pathogenesis and mortality are rampant inflammation and CRS leading to ARDS.

• PRO 140, a Monoclonal Antibody Targeting CCR5, as a Long-Acting, Single-Agent Maintenance Therapy for HIV-1 Infection

  April 20, 2018

  We evaluated the long-term efficacy, safety, and tolerability of PRO 140 monotherapy in maintaining viral suppression for over 24 months in patients who were stable on combination antiretroviral therapy on entry into the trials.

• Safety and Efficacy of a Novel Silver-Impregnated Urinary Catheter System for Preventing Catheter-Associated Bacteriuria: A Pilot Randomized Clinical Trial

  March 1, 2015

  The purpose of this study was to evaluate the safety of a novel silver-impregnated Foley catheter system designed to prevent catheter-associated bacteriuria and funguria, assess recruitment feasibility for a future pivotal trial, and preliminarily assess efficacy.

• Low-Dose Paroxetine (7.5 MG) Improves Sleep in Women With Vasomotor Symptoms Associated With Menopause

  January 6, 2015

  In two pivotal phase 3 studies evaluating the efficacy and safety of paroxetine 7.5 mg, improvements in sleep disturbances were also prospectively evaluated.

• Effects of Low-Dose Paroxetine 7.5 MG on Weight and Sexual Function During Treatment of Vasomotor Symptoms Associated with Menopause

  October 1, 2014

  Two phase 3, randomized, placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms (VMS) associated with menopause and had a favorable tolerability profile.

• Mortality and Long-Term Functional Outcome Associated With Intracranial Pressure After Traumatic Brain Injury

  August 3, 2012

  We have examined whether raised elevated intracranial pressure (ICP) is independently associated with mortality, functional status and neuropsychological functioning in adult traumatic brain injury patients.

• Craniofacial Variables in Subjects With and Without Habitual Snoring: A Cephalometric Comparison

  September 1, 2010

  The aim of this case control study was to evaluate which cephalometric variables related to craniofacial morphology discriminate between snoring and non-snoring or any other respiratory disease subjects.

• Use of a Patch Containing Heat-Labile Toxin From Escherichia Coli Against Travellers’ Diarrhoea: A Phase II, Randomised, Double-Blind, Placebo-Controlled Field Trial

  June 14, 2008

  We investigated the rate of diarrhoea attacks, safety, and feasibility of a vaccine containing heat-labile enterotoxin (LT) from ETEC delivered to the skin by patch in travellers to Mexico and Guatemala.

• Evaluation of 278 Hla-b27 Positive Patients Suspected of Seronegative Spondyloarthropathies

  October 1, 2007

  To determine HLA-B27 prevalence in patients suspected of Seronegative spondyloarthropathy referred to the Transplantation Department of Blood Transfusion Organization, and to evaluate clinical findings among HLA-B27 positive patients.

• A Phase I Trial of RX-0201 (Archexin; Akt-1 Antisense) in Patients With an Advanced Cancer

  June 20, 2007

  RX-0201 (Archexin) is designed to inhibit the expression of akt-1 within cancer cells in cancer patients (Pts). Non-clinical studies conducted on RX-0201 demonstrated that RX-0201 bears significant in vitro and in vivo anti-cancer activities with favorable safety.

• Pain Relief Methods After Thoracotomy

  January 4, 2005

  Thoracotomy is one of the surgical operations which causes severe pain.

• The Euphrates Trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock): Study Protocol for a Randomized Controlled Trial

  June 11, 2004

  EUPHRATES is a theragnostic trial (matching blood measurement to treatment capability) of PMX hemoperfusion in patients with septic shock and confirmed endotoxemia as measured by the endotoxin activity assay (EAA).

• Inhibition of Tumor Necrosis Factor Alpha Alters Resistance to Mycobacterium Avium Complex Infection in Mice

  March 26, 1998

  Increased production of tumor necrosis factor alpha (TNF-α) appears to play an important role in the progression of human immunodeficiency virus disease. One treatment strategy explored is the use of TNF-α inhibitors.

• Impact of Stratification Imbalance on Probability of Type I Error

  May 1, 1995

  Safety and efficacy of a treatment are the most important issues in any clinical trial. Often, other factors such as gender, stage of disease, etc., are taken into account as part of the trial design.

• Survivial Effects of ZDV, ddi, and ddC in Patients With CD4

  January 3, 1995

  Seven major clinical trials for the treatment of HIV-infected individuals are investigated. The treatments used in these trials were zidovudine, dideoxyinosine, dideoxycytosine, and one combination for patient with CD4 cell counts <500 cells/mm.

• TGFα Enhances Locomotion of Cultured Human Keratinocytes

  May 4, 1993

  These experiments demonstrate that keratinocytes can synthesize several forms of TGF alpha and that TGF alpha, besides being mitogenic, may have other important regulatory functions in keratinocytes.

• Confidence Bounds for Ratio of Variance Components in Unbalanced Two-Way Crossed Models

  January 1, 1993

  The problem discussed here is that of obtaining confidence bounds for the proportion of total variances for unbalanced two-way crossed classification components-of-variance models where some of the cells may be empty.

• Comparing Properties of Various Trough Peak Ratio Estimators

  January 1, 1993

  In this paper, various models for constructing trough/peak ratio (T/P) are considered along with different ways of obtaining their variances and confidence intervals.

• Length Biased Density Estimation of Fibres

  January 1, 1991

  Cox (1969) discussed several procedures used in sampling of textile fibres. One such procedure is called "length biased" or weighted sampling and occurs when the chance of selection is proportional to fibre length.

• Seeing and Believing: A Beginner's Guide to Statistical Graphics

  January 1, 1991

  This guide aims to introduce readers with no special knowledge of either statistics or graphics to some of the new and exciting ideas in this growing field.

• Effects of Grazing, Topography, and Precipitation on the Structure of a Semiarid Grassland

  May 1, 1989

  Structural aspects of the shortgrass steppe plant community, functional groups, and species populations were examined in response to long-term heavy grazing and exclosure from grazing, contiguous wet or dry years, and an environmental gradient of topography.