Gottlieb Calls on Clinical Trial Operators to Find Ways to Enroll More Women

May 21, 2018

Clinical trial sponsors must step up their efforts to address underrepresentation of women among trial subjects, FDA Commissioner Scott Gottlieb said Wednesday during a meeting in White Oak, Maryland, to commemorate National Women’s Health Week. He cited the FDA-led Decadal Review that studied clinical trial efficacy and safety by sex for 34 drugs and five cardiovascular disease indications over a 10-year period from 2005 to 2015. The study analyzed the inclusion and exclusion criteria for five of the trials to get a clearer picture of whether such criteria affected subject enrollment. The results, Gottlieb said, indicated there were minimal gender differences in drug profiles, and that while women were well-represented in trials for hypertension and atrial fibrillation drugs and overrepresented for pulmonary arterial hypertension (PAH) drugs, they were underrepresented in trials for heart failure, acute coronary syndrome and coronary artery disease drugs. “These findings support the need for the FDA to issue a call to action to clinical investigators. In this case, the bottom line was that more work is needed to identify factors leading to under-participation of women in cardiovascular clinical trials in certain areas, notably heart failure, coronary artery disease and acute coronary syndrome,” Gottlieb said. One possible reason for under-enrollment of woman subjects may be of advanced age at disease onset, Gottlieb said, indicating sponsors should look into prevalence-adjusted representation of women in cardiovascular trials across relevant age categories. On the other end of the spectrum, sponsors are often hesitant to expose new or expectant mothers, who tend to be younger women, to experimental drugs, which can be a major barrier to developing drugs for conditions that are prevalent in younger women. To correct this, the FDA is using the Medication Exposure in Pregnancy Risk Evaluation Program to model pregnant women’s responses to drugs at reduced risk, he said. Other agency efforts to remedy gender parity issues include the agency’s Diverse Women in Clinical Trials Initiative consumer awareness campaign and a planned series of webinars on recruitment and retention of women in clinical trials. The agency is also conducting several research initiatives to aid in its regulatory decision-making with regard to sex differences, he said.


Pipeline new from Genentech, UCB, Pfizer, and Faxitron

May 21, 2018

Company Drug/Device Medical Condition Status
Entasis Therapeutics ETX0282 and ETX0282CPDP (combination of ETX0282 with cefpodoxime) Oral therapy for infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including MDR and carbapenem-resistant Enterobacteriaceae (CRE) Phase I trial initiated enrolling healthy subjects from Australia
BioMarin Pharmaceutical Inc. Valoctocogene roxaparvovec Hemophilia A patients with pre-existing AAV5 antibodies Phase I/II trial initiated
Alkahest, Inc. ALK4290 and ALK4290-201 newly-diagnosed wet age-related macular degeneration and refractory wet age-related macular degeneration, respectively Phase II trials initiated
Regeneron Pharmaceuticals, Inc.and Sanofi DUPIXENT (dupilumab) moderate-to-severe atopic dermatitis in adolescents ages 12-17 Phase III trial initiated enrolling 251 subjects
MC10, Inc. BioStamp nPoint system data collection platform 510(k) clearance granted by the FDA
Caliber Imaging & Diagnostics Inc. VIVASCOPE System Reflectance confocal microscopy (RCM) devise 510(k) clearance granted by the FDA
CurveBeam LineUP Multi-extremity weight bearing CT system orthopedic extremity imaging 510(k) clearance granted by the FDA
Faxitron VisionCT fully enhances the clinician’s ability for detailed margin assessment by automatically taking images around the entire specimen and reconstructing a navigable 3D render in real time 510(k) clearance granted by the FDA
Turnstone Biologics MG1-HPV Human papillomavirus (HPV)-positive solid tumors IND clearance granted by the FDA
Amneal Pharmaceuticals, Inc. Generic Welchol (colesevelam HCI) 625 mg tablets Cholesterol aNDA approval granted by the FDA
US WorldMeds Lucemyra (lofexidine hydrochloride) mitigation of opioid withdrawl symptoms in adult Approval granted by the FDA
Pfizer Retacrit (epoetin alfaepbx) biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV infection Approval granted by the FDA
Genentech Actemra Active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age or older Approval granted by the FDA
UCB BRIVIACT (Brivaracetam) monotherapy or adjuctive therapy in patients four years of age and older with partial-onset seizures Approval granted by the FDA
BMG Pharma GelX oral mucositis Approval granted by the EMA
Castle Creek Pharmaceuticals diacerein 1% ointment (CCP-020) Epidermolysis bullosa (EB) Pediatric Disease Designation granted by the FDA
Immunicom, Inc. Immunopheresis therapy cancer tumors Breakthrough Device Designation granted by the FDA
Trial Results

Lilly’s Galcanezumab Meets Primary Endpoint in Phase III Study

May 21, 2018

Eli Lilly and Company announced that galcanezumab met its primary endpoint in a Phase III study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. The episodic cluster headache study was a randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of galcanezumab (300 mg once-monthly) administered subcutaneously compared with placebo in 106 patients with episodic cluster headache. Patients who participated in this trial had an average of 17.5 cluster headache attacks per week at baseline. The primary endpoint was the overall mean change from baseline in weekly cluster headache attack frequency across weeks one to three with galcanezumab compared with placebo. In this study, eight percent of patients treated with galcanezumab discontinued treatment during the study compared to 21 percent of patients treated with placebo. Discontinuations due to lack of efficacy occurred in two percent of patients treated with galcanezumab, compared to 14 percent of patients treated with placebo.


May 21: Job openings, upcoming industry conferences, webinars and training programs

May 21, 2018

Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.

  For conferences, webinars, training programs and job postings, join the LinkedIn JobWatch group.
More Jobs

Clinical Research Specialist
Planned Parenthood of Southern New England
New Haven, CT

Clinical Trial Project Manager
Eli Lilly and Company
Indianapolis, IN

Clinical Study Account Executive
BBK Worldwide
Needham, MA

Clinical Research Coordinator
Charleston, SC

Clinical Site Manager
Bristol-Myers Squibb
Princeton, NJ

Clinical Research Coordinator
The University of Pittsburgh
Pittsburgh, PA

Sr. Clinical Project Manager
Syneos Health Clinical
Washington, DC

Manager-Clinical Development
Eli Lilly and Company
Indianapolis, IN

Upcoming Conference

JUNE 5-6, 2018
FDA Data Integrity: For Device and Pharma Firms and Their Suppliers
Philadelphia, PA

JUNE 7-8, 2018
SOPs and Policies for the 21st Century
Philadelphia, PA

JUNE 13-14, 2018
Ensuring The Quality Connection with Your CMO
Philadelphia, PA

JUNE 19-20, 2018
Medical Device Risk Management
Raleigh, NC

Training Programs

JUNE 1-31, 2018
Program Phlebotomy Training— Two Day Training
Various locations


MAY 30, 2018
Cutting the Costs of Clinical Trial Subject Recruitment. Insights into Patient Outreach: Traditional vs. Digital
Discover outreach techniques to bring your drugs and devices to market faster and cheaper.

JUNE 14, 2018
Setting and Measuring Quality Objectives for Medical Devices
Dan O’Leary will walk you through the process and give you compliance tools to make warning letters a thing of the past.


Tufts: Facing Many Challenges, Orphan Drugs Take 18% Longer to Develop

May 14, 2018

Orphan drug development takes 15.1 years to go from first patent filing to product launch, 18 percent longer than the average time required for all new drugs, according to the Tufts Center for the Study of Drug Development. And development time for drugs to treat ultra-orphan diseases—which affect only a few hundred patients in the U.S.—is even longer: 17.2 years.