September 2018

Briefs

Breast Cancer Trial Resumes

September 24, 2018

Mersana says it has worked out a new agreement with the FDA to resume recruiting patients for a clinical trial of its breast cancer drug months after one of the participants died.

Pipeline

New Pipeline Updates from AstraZeneca, Teva, Camurus and Ironwood

September 24, 2018

Company Drug/Device Medical Condition Status
inui™ Health In-home urine analysis platform, which includes a disposable test and smart phone app (iOS and Android) Kidney function, metabolic disorders and urinary tract infections (UTI) Granted 510(k) clearance and a Clinical Laboratory Improvements Amendments (CLIA) waiver by the FDA CE Mark certification
Camurus CAM2038 Chronic low back pain Met primary and first secondary endpoints; resulted in significantly improved relief of the average and worst pain intensity compared to placebo
Iterum Therapeutics plc Sulopenem Gram-negative, multi-drug resistant infections Initiated SURE 2 and SURE 3 Phase III clinical trials
AstraZeneca Pharmaceuticals LP FASENRA™ (benralizumab) Severe eosinophilic asthma Phase III extension BORA trial results show long-term safety and efficacy as an add-on maintenance treatment
Regeneron Pharmaceuticals, Inc. and Sanofi Dupixent® (dupilumab) mono-therapy moderate-to-severe atopic dermatitis Phase III trial demonstrated a significant improvement in signs and symptoms
Alnylam Pharmaceuticals, Inc. Patisiran Polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults APOLLO Phase III trial showed improved markers of cardiomyopathy
AstraZeneca Triple combination therapy PT010 COPD Seeking FDA approval after Phase III trial found it outperformed its dual-therapy rivals eight of nine times
Teva Pharmaceutical Industries Ajovy (fremanezumab) Migraine Granted approval by the FDA
Venture Heat® Infrared Heat Therapy using Far infrared Rays (FIR) Pain Granted approval by the FDA
Sebacia, Inc. Sebacia Microparticles Mild to moderate inflammatory acne vulgaris Granted clearance by the FDA
WAT Medical HeadaTerm Migraine Granted clearance by the FDA
AstraZeneca Lumoxiti (moxetumomab pasudotox-tdfk) Adults with relapsed or refractory hairy cell leukemia (HCL) who have had at least two previous therapies Granted clearance by the FDA
Ironwood Pharmaceuticals, Inc. Praliciguat (IW-1973) Heart failure Granted Fast Track designation by the FDA
Genentech Subcutaneous (SC) formulation of Actemra® (tocilizumab) Active systemic juvenile idiopathic arthritis (SJIA) in patients two year and up Granted approval by the FDA
STAAR Surgical Company PMA Supplement for the Visian Toric ICL Myopia with astigmatism Granted approval by the FDA
CWMarketplace

September 2018: Top 10 Industry Provider Profiles

September 24, 2018

CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at (617) 948-5100.

Click on any provider to view the company’s complete online profile or search more profiles.

CONTRACT RESEARCH ORGANIZATIONS
Accell Clinical Research, LLC

Accell Clinical Research, LLC
Culpeper, VA
(540) 321-4051
julia.kondakov@accellclinical.com

Accell has been providing clinical CRO services in Phase I-IV trials in Eastern Europe, Russia and CIS since 2007.

Celerion

Celerion
Lincoln, NE
(402) 476-2811
info@celerion.com

Celerion is a global early clinical research provider with over 40 years of experience, three facilities globally and 600 global clinic beds.

DZS Clinical Services

DZS Clinical Services
Bound Brook, NJ
(732) 764-6970
gambra@dzs.com

DZS combines a unique brand of flexibility from its services division with its proprietary ClinPlus eClinical Platform.

Medical Research Network

Medical Research Network
Skokie, IL
(847) 779-7857
enquires@themrn.co.uk

Medical Research Network specializes in the conduct of clinical trial visits in the patient’s home and supporting clinical trial sites with nursing resources.

OCT Clinical Trials

OCT Clinical Trials
Saint Petersburg, Russia
(8812)4498634
oIvanova@oct-clinicaltrials.com

OCT has eight offices in Russia, Europe and the U.S., and 1,600 investigational sites. It has conducted more than 200 studies.

Laboratory Services
Machaon Diagnostics, Thrombosis & Hemostasis Lab

Machaon Diagnostics, Thrombosis & Hemostasis Lab
Oakland, CA
(510) 839-5600
mike.ero@machaondiagnostics.com

Machaon Diagnostics is California’s only independent specialized coagulation lab, staffed by CA-licensed clinical laboratory scientists under the direction of a hematologist medical director.

Site Consortium
Wake Research Associates

Wake Research Associates
Raleigh, NC
(919) 781-2514
contactus@wakeresearch.com

Wake Research Associates, established in 1984, is a nationally recognized professional research organization specializing in conducting pharmaceuticals, device and nutrition trials.

Site Management Organization (SMO)
Consolidated Clinical Trials, Inc.

Consolidated Clinical Trials, Inc.
Monroeville, PA
(412) 273-9100
smh@consolidatedclinicaltrials.com

Consolidated Clinical Trials, Inc., established in 2000, has focused on independent physician practices located throughout the Pittsburgh region and surrounding counties.

Technology Solutions
Clinical Conductor

Clinical Conductor
Rochester, NY
(585) 272-1960
sales@clinicalconductor.com

Successfully used by over 1,800 research organizations around the world, Clinical Conductor CTMS is the premier clinical trial management system for research organizations of all types and sizes.

Forte

Forte
Madison, WI
(608) 826-6000
info@forteresearch.com

Forte provides key solutions for cancer centers, academic medical centers and health systems to unleash their research potential through software, consulting services and managed infrastructure.

 

Pipeline

New Pipeline Updates from Amryt, Loxo Oncology, Bristol-Myers Squibb and Pfizer

September 17, 2018

Company Drug/Device Medical Condition Status
Amryt AP101 Epidermolysis Bullosa, a genetic disorder that causes skin and lining of internal organs to blister and tear Granted Investigational New Drug clearance by FDA to open U.S. sites as part of EASE Phase III clinical trial
Fibrocell Science, Inc. FCX-013 Moderate to severe localized scleroderma Granted Fast Track designation by the FDA
Loxo Oncology, Inc. LOXO-292 Metastatic RET-fusion-positive non-small cell lung cancer; RET-mutant medullary thyroid cancer Granted Breakthrough Therapy designation by the FDA
Genesys Spine AIS-C Stand-Alone System a first of its kind, non-screw based, zero-profile, direct-anterior interbody system Cervical spine surgery Granted FDA clearance
Perrigo Company plc OTC equivalent of Imodium® Multi-Symptom Relief (loperamide hydrochloride and simethicone tablets, 2 mg/125 mg) Diarrhea plus bloating, pressure and cramps Granted approval by the FDA
Concentric Analgesics, Inc. CA-008, a non-opioid therapeutic Post-surgical pain Granted Breakthrough Therapy designation by the FDA
physIQ AFib detection analytics engine Atrial Fibrillation Granted FDA 510(k) clearance
Foamix Pharmaceuticals, Ltd. FMX101, tpical minocycline foam Moderate to severe acne Met endpoints in Phase III trial
Merck KGaA and Pfizer Combination of Bavencio (avelumab) and Inlyta (axitinib) Advanced renal cell carcinoma Therapy significantly improved progression-free survival in Phase III trial
Vital Therapies VT-308 Severe alcoholic hepatitis Failed Phase III clinical trial
Gilead Sciences and Galapagos NV Filgotinib Moderate to severe active rheumatoid arthritis FINCH 2 Phase III trial successfully met primary endpoints
Bristol-Myers Squibb BMS-986165 Moderate to severe plaque psoriasis Hit efficacy endpoints in Phase II clinical trial
Amygdala Neurosciences ANS-6637 Alcohol use disorder Initiated Phase II clinical trial with NIAAA
Abeona Therapeutics, Inc. Gene therapy product ABO-101 (AAV-NAGLU) MPS IIIB (Sanfilippo syndrome type B) Initiated Phase I/II clinical trial in Spain
EpicGenetics, Inc. Tuberculosis vaccine, BCG Fibromyalgia Launching Phase II clinical trial with Mass General Hospital
Checkpoint Therapeutics, Inc. CK-101 (also known as RX518), a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (TKI) Non-small cell lung cancer Positive preliminary safety and efficacy data announced from an ongoing Phase I/II clinical trial
JobWatch

September 17: Job openings, upcoming industry conferences, webinars and training programs

September 17, 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

Experienced Clinical Research Coordinator
M3 Wake Research, Inc.
Raleigh, NC

Clinical Research Coordinator
Ohio State University Medical Center
Columbus, OH

Clinical Trials Manager
BTC Network
North Quincy, MA

Clinical Data Abstractor
TARGET PharmaSolutions
Chapel Hill, NC

Clinical Studies Coordinator
Wake Forest Baptist Medical Center
Winston Salem, NC

Monitor – Remote Contractor for Site Visits
Regenesis Biomedical, Inc.
Scottsdale, AZ

Clinical Research Associate
Technical Resources International, Inc.
Bethesda, MD

Clinical Research Coordinator
Diagnamics, Inc.
Encinitas, CA

Upcoming Conference

SEPTEMBER 27, 2018
Emerging Biopharmaceutical Therapies
Washington, DC

OCTOBER 9-10, 2018
Medical Device Complaint Management
Waltham, MA

OCTOBER 23-25, 2018
FDA Inspections Summit – 13th Annual
Bethesda, MD

DECEMBER 10-12, 2018
Design of Medical Devices Conference, China 2018
Beijing, China

Training Programs

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

Webinars

SEPTEMBER 19, 2018
Medical Device Software and Risk Management
Dan O’Leary will break down the FDA’s QSR section on design validation requirements.

SEPTEMBER 27, 2018
Safety Reporting in Global Clinical Trials: Maximizing Compliance, Minimizing Costs
Steven Beales and Kendra Hayden will introduce you to new efficiencies in safety reporting and demonstrate ways to cut safety reporting costs by > 50% and more.