2018

Pipeline

New Pipeline Updates from Pfizer, Immusoft, Allergan and UCB

October 22, 2018

Company Drug/Device Medical Condition Status
Viseon, Inc. Voyant System, featuring proprietary HD imaging sensor and illumination technology Minimally invasive spine surgery Granted 510(k) clearance by the FDA
Centric Medical SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and connectors To stabilize the foot, ankle and long bone segments Granted 510(k) clearance by the FDA
Pfizer PARP inhibitor, Talzenna (talazoparib) BRCA-mutated (gBRCAm), HER2-negative breast cancer Granted approval by the FDA
Abireo Pharma, Inc. A4250 Progressive familial intrahepatic cholestasis (PFIC) Granted Fast Track designation by the FDA
Immusoft Corp. Iduronicrin genleukocel-T Mucopolysaccharidosis type I (MPS I) Granted Rare Pediatric Disease designation (RPDD) by the FDA
Cellenkos, Inc. CK0801 Treatment-resistant Guillain-Barré Syndrome (GBS) FDA has cleared its Investigational New Drug (IND) application to proceed with a Phase I clinical trial
Allergan, plc and Medicines360 LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg Prevention of pregnancy for up to five years FDA approved Supplemental New Drug Application (sNDA) to extend the duration of use
AstraZeneca and Merck LYNPARZA Pancreatic cancer Granted Orphan Drug designation (ODD) by the FDA
X4 Pharmaceuticals X4P-001-RD WHIM syndrome, a primary immunodeficiency disease Granted Orphan Drug designation by the FDA
AcelRx Pharmaceuticals, Inc. DSUVIA™ Moderate-to-severe acute pain in medically supervised settings for adult patients FDA Anesthetic and Analgesic Drug Products Advisory Committee voted in favor of recommending approval
Sutro Biopharma, Inc. STRO-001 multiple myeloma Granted Orphan Drug designation by the FDA
Grifols ID CORE XT molecular diagnostic test Molecular red blood cell typing Granted approval by the FDA for use in the U.S.
UCB CIMZIA® (certolizumab pegol) Axial spondyloarthritis (axSpA) spectrum In Phase III trial, showed clinically relevant, statistically significant improvements in patients with active disease and signs of inflammation, as measured by major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI)
CWMarketplace

October 2018: Top 10 Industry Provider Profiles

October 22, 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
Concentrics Research

Concentrics Research
Indianapolis, IN
(800) 800-5525
julie.aker@concentricsresearch.com

Concentrics has conducted over 1,100 clinical studies. Core staff includes four nurses, two study coordinators, two research assistants, 10 physicians and four dental hygienists.

Confidence Pharmaceutical Research

Confidence Pharmaceutical Research
Burlington, CA
(401) 965-3377
anna.ravdel@confidenceresearch.com

Confidence Pharmaceutical Research is a CRO and a vendor management organization that helps clinical trial sponsors run better trials. Our focus is on transparency, reducing waste, and producing rigorous metrics.

PRA Health Sciences

PRA Health Sciences
Raleigh, NC
(919) 786-8200
prahealthsciences@prahs.com

With 13,000+ employees covering 80+ countries, PRA provides a global presence combined with an in-depth knowledge of local regulations, standards of care and cultural customs.

PSI Pharma Support America Inc.

PSI Pharma Support America Inc.
King of Prussia, PA
(919) 249-2660
natania.barron@psi-cro.com

PSI is home to 1,400 employees around the world, of which 250 hold medical degrees, with capabilities across all phases of clinical development from Phase I–IV.

SDC

SDC
Tempe, AZ
(480) 344-5443
data@sdcclinical.com

With biostatistics and clinical data management services, SDC also offers scalable full service clinical trial solutions via strategic partnerships that are diverse and complementary.

CLINICAL TRIALS MONITORING SERVICES
Emericlin

Emericlin
Scotch Plains, NJ
(908) 603-1316
dberk@emericlin.com

Emericlin is a project-based staffing company with over 20 years of experience that strives to match your business needs with the CRA’s that best suit your project, budget requirements, timelines and individual personalities.

Investigative Site Network
Ancilla Services, LLC

Ancilla Services, LLC
Raleigh, NC
bd@ancillaservices.com

Ancilla Services, LLC provides business development services to independent research sites. They connects investigators to trials that most accurately meet the site’s patient population and research capabilities.

PMG Research, Inc.

PMG Research, Inc.
Winston-Salem, NC
(919) 746-7106
kcole@pmg-research.com

PMG Research is an Integrated Site Network (ISN) of 12 clinical research facilities. Since its founding in 1979, PMG has conducted over 7,700 research studies.

Laboratory Services
LabConnect, LLC

LabConnect, LLC
Seattle, WA
(206) 322-4680
info@labconnectllc.com

LabConnect, with more than 4,000 validated tests across their network, has an extensive test menu that includes specialized oncology assays, biomarker analysis, pharmacokinetic analysis and method development services.

Technology Solutions
DrugDev

DrugDev
Wayne, PA
(610) 650-1890
solutions@drugdev.com

Built around the largest global network of active opted-in investigators, DrugDev’s unified solutions suite optimizes site selection and startup, investigator payments and clinical operations.

 

Features

Adverse Event Reporting: When TMI is Risky

October 15, 2018

As sponsors and sites have expanded their global reach, they’ve run into myriad local and regional regulations requiring them to report adverse events in their clinical trials. Hoping to simplify, many sponsors or sites have tried to create a one-size-fits-all form that sends out nearly automated alerts for nearly every single glitch.

Briefs

FDA: Generic Skin Patch Trials

October 15, 2018

Generic drug developers that use patches, inhalers, eye drops or similar means to deliver meds should hold clinical trials to test for potential side effects of skin irritation and, in the case of patches, adhesion quality, the FDA says.

Pipeline

New Pipeline Updates from Akcea Therapeutics, Genentech, Eximo Medical and Valneva USA

October 15, 2018

Company Drug/Device Medical Condition Status
Akcea Therapeutics TEGSEDITM (inotersen) Polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults Granted approval by the FDA
Akcea Therapeutics AKCEA-APO(a)-LRx Cardiovascular disease (CVD) and elevated levels of lipoprotein(a), or Lp(a) Positive topline results from a Phase II clinical trial
Bausch Health Companies, Inc. BRYHALI™ (halobetasol propionate) Lotion, 0.01% Plaque psoriasis in adults FDA tentatively approved New Drug Application; final OK pending expiration of exclusivity for related product
Eximo Medical Ltd B-Laser™ Atherectomy System Peripheral artery disease (PAD) Granted 510(k) clearance by the FDA
YiSheng BioPharma Co. PIKA® rabies vaccine Rabies Granted clearance by the China FDA to proceed with a clinical trial
Genentech Hemlibra Hemophilia A patients without factor VIII inhibitors Granted approval by the FDA
Leadiant Biosciences, Inc. Revcovi™ (elapegademase-lvlr) injection Adenosine deaminase severe combined immune deficiency (ADA-SCID) in children and adults Granted approval by the FDA
Breckenridge Pharmaceutical, Inc. Roflumilast Tablets, 500mcg (generic for Daliresp® Tablets) COPD Abbreviated New Drug Application approved by the FDA
Valneva USA XIARO® (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Japanese encephalitis Accelerated dosing regimen approved by the FDA
Eidos Therapeutics, Inc. AG10 amyloidosis (ATTR) Granted Orphan Drug designation by the FDA
Paratek Pharmaceuticals, Inc. NUZYRA™ (omadacycline) Community-acquired bacterial pneumonia; acute skin infections (ABSSSI) in adults Granted approval by the FDA
Poxel SA Imeglimin, an investigational therapeutic agent Type 2 diabetes Patient enrollment completed in the TIMES 2 trial of the Phase III registration program
Chugai Pharmaceutical Co., Ltd HEMLIBRA® (US generic name: emicizumab-kxwh) Hemophilia A without factor VIII inhibitors in newborns, children and adults Granted approval by the FDA
Genentech baloxavir marboxil Influenza type A/H3N2 and type B Phase III CAPSTONE-2 trial showed symptoms improved significantly faster in patients at high risk of serious flu who took the drug v. a placebo
Zealand Pharma A/S Glepaglutide Short bowel syndrome (SBS) First patient enrolled in a global Phase III trial
JobWatch

October 15: Job openings, upcoming industry conferences, webinars and training programs

October 15, 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.
Jobs via Kelly Services
More Jobs

Clinical Research Coordinator
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio

Associate Clinical Trial Supply Manager
Novartis
East Hanover, NJ

Clinical Research Coordinator
Children’s Hospital Los Angeles
Los Angeles, CA

Clinical Trials Manager
Mallinckrodt
Bedminster, NJ

Clinical Research Coordinator II
Emory University
Atlanta, GA

Sr. Director, Quality Assurance
IQVIA
Research Triangle Park, NC

Pharmaceutical Teaching Positions (April 2019)
International Education Services
Tokyo, Japan

Study Concierge, Virtual Trials
IQVIA
Research Triangle Park, NC

Upcoming Conference

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

NOVEMBER 1-2, 2018
SOPs and Policies for the 21 st Century: Why Less is More
Washington, DC

NOVEMBER 14-15, 2018
Conducting Advanced Root Cause Analysis & CAPA Investigations
Princeton, NJ

NOVEMBER 14-15, , 2018
Clinical Trial Risk and Performance Management Summit
Princeton, NJ

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

Training Programs

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