see Managing Risk on page 5 »

Volume 23, Issue 22. © 2019 CenterWatch. All rights reserved.

see Broaden Criteria on page 5 »

June 10, 2019

Industry Briefs…2

Up and Coming…4

Drug & Device Pipeline News…7Twenty-five drugs and devices have entered a new trial phase this week.

Research Center Spotlight…9

Join the CenterWatch Community!

CenterWatchWeekly

By John Mitchell

C linical trials can’t focus on everything when it comes to process improve-ment, so sponsors and sites need to

focus on critical success factors, such as data reliability and protecting subjects.

Sponsors need to follow data end-to-end, from subject to final database, and look for weak spots, said Keith Dorricott of Dorricott Metrics and Process Improvement at a WCG-sponsored webinar. Think about, for example, what processes data go through, whether vendors or subcontractors are involved, and whether there is any data transfer.

Once critical success factors are defined, said Linda Sullivan, president of Metrics Cham-pion Consortium (MCC), you need to identify key performance questions for each factor to

tell you whether you are on track to achieve those success factors.

It’s often a challenge to decide what level of metrics you need to analyze, Dorricott said. He noted four basic levels:

}} Portfolio – Measures across multiple stud-ies, which are useful for vendor oversight;

}} Study – Measures across a single study, which also are useful for drill-down of portfolio-level metrics;

}} Country – Measures across a country, which are useful for oversight of coun-try-specific challenges and drill-down of study-level results; and

}} Investigative Site – Measures site perfor-mance against a target or compares against other sites in the same country or study.

Managing Risk Means Measuring the Right Things, Experts Say

By Leslie Ramsey

Sponsors should think about loosening their exclusion criteria to allow more diverse patient populations — especially

when recruiting for later stage trials, the FDA says in new draft guidance published last week.

The agency says that part of the low re-cruitment problem may be that sponsors are stuck on finding patients who only suffer from a given disease and no others. Perhaps worse, they exclude populations such as elders, kids, obese (or overly thin) patients, and HIV-posi-tive patients.

“For example, if there are unreason-able risks to participants with advanced heart failure, but enrollment of those with a milder disease would be appropriate, the exclusion criteria should specifically define

the population of heart failure participants that should be excluded,” the agency said in the 18-page document.

This is especially true of Phase II trials as they tend to be more restrictive. Sponsors should consider eliminating or modifying certain criteria when they move to Phase III.

For trials focused on rare diseases or condi-tions, the FDA advises sponsors to consider en-gaging with patient advocacy groups early in the process, planning to re-enroll participants from early-phase trials into later-phase trials and conducting open-label extension studies to ensure that all study participants will have access to the investigational treatment.

The agency offers several examples of trial design and methodologies to broaden

Broaden Criteria to Maximize Trial Results, FDA Says

PipelineNews

FDA Actions

Company name Drug name Indication FDA action

Lumendi, LLC DiLumen C2 second-generation endoscopic accessory indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment

510(k) clearance granted

Varian Calypso Anchored Beacon transponder

tumor detection 510(k) clearance granted

Conavi TM Medical Inc. Novasight Hybrid System simultaneous imaging of coronary arteries with both intravascular ultrasound (VUS) and Optical Coherence Tomography (OCT)

510(k) clearance granted

Prisyna, the oral care division of Synedgen

Moisyn product line xerostomia 510(k) clearance granted

C4 Imaging LLC HDR MRI Marker use prior to high dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for the treatment of multiple cancers

510(k) clearance granted

Amerigen Pharmaceuticals Limited and Dipharma S.A.

Miglustat 100 mg capsules Adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option

aNDA � led

Sage Therapeutics intravenous formulation of brexanolone (SAGE-547)

postpartum depression (PPD) NDA � led

Veloxis Pharmaceuticals A/S

de novo indication of ENVARSUS XR (tacrolimus extended-release tablets)

Prophylaxis of organ rejection in kidney transplant patients

sNDA � led

Jazz Pharmaceuticals Xyrem (sodium oxybate) oral solution

cataplexy and Excessive Daytime Sleepiness (EDS) in pediatric narcolepsy patients

sNDA � led

Abeona Therapeutics Inc. ABO-102 AAV-mediated gene therapy for the treatment of San� lippo syndrome Type A (MPS IIIA)

RMAT Designation granted

Immusoft Corporation Immune System Programming MPS I (Mucopolysaccharidosis type I) Orphan Drug Designation granted

Stealth Biotherapeutics elamipretide Leber’s hereditary optic neuropathy (LHON) Orphan Drug Designation granted

P� zer Inc. TRUMENBA (Meningococcal Group B Vaccine)

Active immunization to prevent invasive disease caused by Neisseria meningitides group B (MenB) in children ages 1 through 9 years

Breakthrough Therapy Designation granted

MeiraGTx Limited AAV-RPGR X-linked retinitis pigmentosa (SLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene

Fast Track Designation granted

The following is a sampling of FDA regulatory actions taken during the previous month, compiled from CenterWatch and third-party sources including the FDA and company press releases. For more information on FDA approvals, visit www.centerwatch.com/drug-information/fda-approvals/.For custom drug intelligence reports, email marketresearch@centerwatch.com. Join the LinkedIn Drug Research Updates group!

9:45 AMiPad3

Addressing Barriersto Entry and Retention

By Sony Salzman

B eing a principal investigator (PI) is tough. So tough, in fact, that more than half of new investigators give up er

thei rst FDA-regulated drug trial.Studies by the T s Center for the Study of

Drug Development (CSDD) have revealed a variety of challenges for rst-time investigators.

e rst — and some would say worst — challenge is that the path to success for PIs is murky, said Gerrit Hamre, project manager of CTTI and co-author of the group’s paper on the study. Although there are training programs and resources for investigators, most new investigators are unaware of their existence (outside of GCP training), and un-derestimate the infrastructure, st ng, bud-geting, contracting, and operational skills necessary to succeed.

e second overwhelming obstacle for edgling investigators is administra-

tive burden. Complex protocols, rigorous reporting demands and multiple technol-ogy platforms place a huge strain on inves-tigators and sta .

e third major obstacle new PIs face is the lack of accolades and/or s cient nancial reward to make all of that e ort worthwhile.

With mounting evidence that the prob-lem isn’t getting better, sponsors and CROs are rethinking the site selection process and trying to develop new ways to support inex-perienced investigators.

Sponsors and CROs are doubling-down on their top-performing sites — a trend that has helped fuel industry consolidation, says Ken Getz, director and associate professor of CSDD.

“At the same time that sponsors are look-ing for scaled, experienced sites and site networks, the CROs are buying them,” said Getz.

He predicts that in the short term, the in-dustry will continue to see the largest and most expensive sites and site networks build more share of the market.

Yet sponsors can’t rely solely on vetted academic medical centers and large com-mercial sites for all of their study partici-pants; the burgeoning elds of rare disease and oncology research in particular require them to cast a wider net for patients.

Experts agree that rst time investiga-tors can take some steps to bolster success — including nding a mentor, hiring an ex-perienced research coordinator, learning to budget appropriately and being technologi-cally savvy and platform-agnostic — but most also agree that ultimately, sponsors and CROs need to step up if they want their PIs to thrive.

“I’m sympathetic to investigators because you don’t know what you’re getting into,” says Hamre, adding, “I do think investiga-tors very en bite o more they can chew, but they don’t realize it. In that regard, I think it’s the sponsors and the CROs that have a bit more responsibility.”

Getz added that sponsors must “take ownership for site selection practices that

Industry Tries to Stem Investigator Dropout

© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited.

CRA/CRC Shortages Slow Clinical Trial Pace

June 2018 A CenterWatch Publication Volume 25, Issue 06

see CRA/CRC on page 8

Industry DevelopingStandardized TrainingBy Daphne Butas

As clinical trials continue to change, the evolving roles of CRAs and CRCs are exacerbating the problems sponsors and

CRO nding well-trained candidates.“What’s going to really get interesting is how

much these roles are going to evolve as more new initiatives come forward, like eConsent,

ePRO and risk-based monitoring,” said Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). As risk-based monitoring has taken hold and more monitors are analyzing data from a central loca-tion rather than traveling to the sites, sponsors and CROs are looking for CRCs with more of a robust math background, he said. And as the sponsors’ and CROs’ relationships with sites becomes ever more important, sponsors and CROs are looking for CRAs who excel at forg-ing friendly, supportive connections with sites.

“I think we’re going to see a morphing of these role into subspecialties — a data analyst and site-relationship manager type of CRA, along with the traditional role that the CRA has always had,” said Kremidas. “With CRCs, I think we’ll begin to see a quality assurance focus, someone who oversees the input of the data into the eCRFs. I think we’ll see a tech-nology type of specialist for patients to call in order to get help logging on. And I think the traditional role will be there, too.”

see Investigator Dropout on page 6

The CenterWatch Monthly provides in-depthand data-rich insights on key trends impactingthe clinical resarch landscape.

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Industry Briefs

FDA Advises on Phase III Trials for NASH with Symptom-Free CirrhosisThe FDA last week issued a draft guidance on Phase III trials of treatments for nonalco-holic steatohepatitis (NASH) with symptom-free cirrhosis, including recommendations on enrollment criteria, trial design, efficacy endpoints and safety considerations.

The draft guidance says sponsors should enroll only patients whose cirrhosis is secondary to NASH, using histological criteria. The agency also will accept non-histological criteria if they are scientifically supported.

Sponsors should consider using end-points such as complication of ascites, variceal hemorrhage, hepatic encepha-lopathy, worsening of condition to the point of requiring liver transplant or death from any cause.

In addition, the trial protocol should specify criteria for excluding patients with decompensated cirrhosis — where the cirrhosis has progressed and the liver is no longer fully functioning. Sponsors should not enroll patients listed for liver transplan-tation, the agency says.

Read the draft guidance here: https://bit.ly/2wEVuO2.

NIH Lays Out $42M for Genomic Medicine TrialsThe NIH will pay up to $42 million over the next five years for clinical trials on whether genomic medicine can help people with chronic diseases manage their care better.

The trials, scheduled to begin next year, represent the second phase of the agency’s Implementing Genomics in Practice (IGNITE) Network. The first trial will examine whether early access to patients’ genomic data will help them manage high blood pressure, hypertension and kidney disease.

The second trial will focus on pain and depression. It “seeks to test whether patients

with acute post-surgical pain, chronic pain and depression have better clinical out-comes if pharmacogenomics guide opioid and antidepressant prescriptions.”

The trials will be held at sites at the Universities of Florida and Indiana, Duke, Vanderbilt and the Icahn School of Medicine at Mount Sinai.

New Data Tool Available to Medical Device SponsorsMedical device sponsors now can access a data-driven benchmarking program to help accelerate study start-up.

WCG’s KMR Group has opened its Site Contracts Program to medical device companies for the first time, the company announced. Already in use by biopharma companies, the program has helped reduce trial start-up time by up to 20 percent and decrease costs by 15 percent.

“This program will give device compa-nies a rock-solid foundation of proprietary, independently verified data on which to build their study plans and implement per-formance improvements, as well as unique evidence-based insights to guide their decision-making,” says KMR president and founder Linda Martin.

England Claims Record Numbers in Clinical ResearchParticipation in clinical trials in England continues to grow at a record pace, according to a new report from the country’s National Institute for Health Research (NIHR).

More than 870,000 patients were en-rolled in English clinical research studies in the past 12 months, an increase of 140,000 over the previous 12-month period. Nearly 2,400 subjects per day were involved in a clinical trial, NIHR says.

And participation rates continue to grow year by year. The number of participants re-cruited for NIHR-supported studies annually has hit record levels for the past three years, with the 2018-2019 growth rate coming in at the highest ever, 20 percent.

Most patients this year were enrolled in children’s studies (81,892), followed by studies in primary care settings (78,533), reproductive health and childbirth (74,128), cancer (67,652) and mental health (65,645), the NIHR says.

Emerging Biotechs Lead the Way in 2018, Report SaysThe number of active clinical-stage pro-grams reached a record 6,984 in 2018, the Biotechnology Innovation Organization (BIO) says in a new report, with emerging biotech companies accounting for 73% of these programs.

BIO found that 45 percent of emerging companies partnered with other com-panies to pursue their pipelines. Half of oncology studies are being conducted by such partnerships, and 36 percent of car-diovascular and infectious disease studies are partnered.

The U.S. leads the world in the num-ber of emerging companies entering the

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continues on next page »

WCG | CWWeekly June 10, 2019 3 of 9

Industry Briefs (continued from page 2)

pipeline, with 44 percent, compared to 17 percent in Europe and 8 percent in Asia.

Read the report here: https://bit.ly/2WNoh1L.

Study Finds Lack of Faith in Randomized TestingEvidence-based research faces a challenge, according to one study that indicates a negative public view of comparison testing.

A study conducted by researchers at the Geisinger Health System’s Center for Transla-tional Bioethics and Healthcare Policy found evidence that A/B tests comparing the effectiveness of two treatments, practices or policies often are criticized as inappropriate despite people finding the untested imple-mentation of A or B to be appropriate.

Researchers examined 16 studies from sectors ranging from healthcare to public policy that involved 5,873 participants from three populations. Even when each of the options being compared are themselves unobjectionable, participants expressed disapproval of testing to prove superiority of one over the other.

Although participants’ reactions may be largely due to unfamiliarity with scientific methods, the study says, negative public perception may tend to lead researchers and policymakers away from randomized testing and may make it more difficult to recruit subjects.

Thorough evaluation of treatments through randomized trials could cause

greater opposition than simply imple-menting them without proper testing, the researchers conclude.

Read the report at: https://bit.ly/2I13uOQ.

Evidera to Acquire RWE Company MedimixEvidera, a business unit of PPD, will acquire real-world evidence data company Medimix International, the company announced last month.

The Medimix database, which includes 2.2 million clinicians in more than 60 countries, will support Evidera’s mission to provide evidence-based solutions that dem-onstrate the effectiveness, safety and value of healthcare products.

Network and problem solve with your peers by choosing one of two tracks, vendor oversight and risk-based quality management.

Come discover the secrets to implementing a successful metrics program. You’ll unlock the secrets to deciding what to measure; establishing your data requirements; aggregating reliable data; designing easy to understand metric reports; and using metrics to identify areas of concern and conduct root cause analysis.

Visit mcc-summit.com to learn more and REGISTER TODAY!

CLINICAL TRIAL RISK AND PERFORMANCEMANAGEMENT SUMMIT

SEPT. 4–5, 2019PHILADELPHIA, PA

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WCG | CWWeekly June 10, 2019 4 of 9

Up and Coming

This feature highlights changes in clinical research companies’ personnel.

Bristol-Myers SquibbFollowing the completion of the purchase of Celgene, Bristol-Myers Squibb has announced that the company will restructure around two core areas—research and early development (R&ED) and global drug development. Rupert Vessey, who currently serves as president of R&ED at Celgene, will assume the same role at the combined company. Samat Hirawat, current head of oncology development at Novartis, will join the combined company as chief medical of-ficer for global drug development. Chris Boerner will continue in his role as chief commercialization officer, and Nadim Ahmed, current president of global hematology and oncology at Celgene, will serve as president of hematology, to include cell therapy, at the combined company. David Elkins, who is currently chief financial officer of Celgene, will have the same role at the merged drugmaker.

SanofiSanofi has announced the appointment of Paul Hudson as CEO. Hudson was previously head of Novartis’ pharmaceuticals division. Current CEO Olivier Brandicourt will retire September 1.

NovartisMarie-France Tschudin has been named president of Novartis’ pharmaceuticals division. Tschudin is currently the president of the advanced accelerator applications company at Novartis.

GileadJohanna Mercier has been named commer-cial chief at Gilead, effective July 1. Mercier is currently the president of U.S. and large markets at Bristol Myers-Squibb.

AtaraT cell-focused biotech Atara has named Pascal Touchon as president and CEO of the company. Touchon was previously the head of oncology and global head of the cell and gene therapy

unit at Novartis. Atara’s global head of R&D, Di-etmar Berger, has resigned from the company to join Sanofi as head of development.

Audentes TherapeuticsSan Francisco-based Audentes Therapeutics has appointed Edward R. Conner as senior vice president and chief medical officer, replacing Suyash Prasad. Conner was previ-ously at Sangamo Therapeutics, where he led the clinical development of the company’s pipeline of genomic therapies. Fulvio Mavilio will move up to senior vice president of trans-lational science. The appointments will be ef-fective July 15. The company has announced the departure John Gray, current senior vice president and chief technology officer.

TheravanceTheravance Biopharma has named Andrew Hindman as senior vice president and chief financial officer. Hindman has held several se-nior executive-level positions in the biophar-maceutical industry, most recently as chief business officer of Acorda Therapeutics.

LabCorpAdam Schechter has been named CEO and president of LabCorp as David King is set to retire October 31. Schechter, a longtime Merck executive, is currently the president of global human health.

Casebia TherapeuticsStephen Kennedy has been named as senior vice president and head of technical operations at Casebia Therapeutics. Kennedy formerly served as the chief operating officer for Histogenics Corporation, a restorative cell therapy company.

DicernaDicerna Pharmaceuticals has announced the appointment of Rob Ciappenelli as chief commercial officer. Ciappenelli most recently held leadership roles at Momenta Pharmaceuticals, Shire Pharmaceuticals and Sunovion Pharmaceuticals.

EisaiEisai, Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., has announced the immedi-ate appointment of Patrick Coyle as vice president and chief financial officer. Coyle was formerly vice president of financial plan-ning and analysis at INSMED Inc.

PfizerPfizer has named Jeff Settleman senior vice president and group head of oncology research and development, effective July 1. Settleman was head of oncology research at Calico Life Sciences.

AGC BiologicsKasper Møller has been appointed chief tech-nical officer at AGC Biologics. Møller has held various roles over twelve years at AGC Biologics, most recently as the site head for Copenhagen.

BIORich Masters has been named executive vice president for public affairs at BIO, effective June 17. Masters previously held a position at Qorvis Communications.

ParexelParexel has announced the appointment of Makoto Sugita as senior vice president and general manager – Japan. Sugita most recently served as vice president and head, regional leader of the integrated team for medical, clinical and regulatory in Asia/Pa-cific medical devices at Johnson & Johnson.

LEO PharmaLEO Pharma has announced the appointment of Catherine Mazzacco as president and CEO, effective August 1. Mazzacco is currently the head of global commercial operations at GE Healthcare’s BioPharma division.

ImmunovantImmunovant has named Pete Salzmann, M.D., as CEO. Salzmann was most recently global clinical development leader for Eli Lilly’s recently approved Rheumatoid Arthritis drug, Olumiant.

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WCG | CWWeekly June 10, 2019 5 of 9

Features

Broaden Criteriacontinued from page 1 Part of the low recruitment

problem may be that sponsors are stuck on finding patients who only suffer from a given disease

and no others.

inclusion, including adaptive clinical trials, expansion cohorts that allow for dose modifi-cation in specific populations, the creation of pediatric development programs that stagger enrollment based on age and the inclusion of a broader participant group as part of the secondary efficacy and safety analyses.

The document also offers several recom-mendations for enrollment and retention practices that enhance inclusiveness, includ-ing working with communities to address

participant needs and gather valuable insights for trial design, and holding frequent recruitment events in nonclinical settings.

The draft guidance also urges drug spon-sors to think carefully about the logistical and financial obstacles to bringing people into clinical trials. It reiterates that regulators allow sponsors to reimburse recruits for “reasonable travel expenses” that include airline tickets, parking and hotels. It even suggests that it might be okay to pay patients to join a trial but “recognizes that payment for participation may raise difficult questions” that institutional review boards should examine carefully.

Read the draft guidance here: https://bit.ly/2ZgOinP.

After much discussion and repeated postponements, the updated Common Rule finally took effect on January 21, 2019.

In The Revised Common Rule report two prominent healthcare attorneys sift through the new rule to mark out every deletion—highlight every addition—interpret every rewording—that clinical research professionals and institutions will need to understand to be ready to comply.

The Revised Common RuleNew Requirements for Clinical Trials

A Report

ORDER TODAY!V I S I T store.centerwatch.com

CO N TAC T S A L E Ssales@centerwatch.com(617) 948-5100

“Sponsors need to follow data end-to-end, from subject to final

database, and look for weak spots.”

— Keith Dorricott, Dorricott Metrics and Process Improvement

Managing Riskcontinued from page 1

Sullivan likened metrics-based risk man-agement to a three-legged stool: trial success is the seat propped up by the legs of time, cost and quality. All three legs matter, she says. Too often, metrics focus on just one and neglect the others, unbalancing the stool.

“What you measure sends a signal about what you think is important, and it does, in

fact, influence behavior,” Sullivan said. “Using a balanced set of metrics provides those incen-tives for people to behave the way you want them to.”

For more information on metrics and risk management, register for MCC’s Clinical Trial Risk and Performance Management Summit scheduled for September 4-5 in Philadelphia.

Listen to the entire webinar here: https://bit.ly/2QX1XNR.

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WCG | CWWeekly June 10, 2019 6 of 9

Designed to Make Every Second of your Enrollment Period Count.

Achieve enrollment timelines with a customized, end-to-end recruitment plan from WCG Patient Engagement services. Backed by proven methods, a knowledge base of industry site enrollment performance, and our on-the-ground site support, we partner with you to enable your sites to achieve recruitment milestones on or ahead of schedule. These e�ciencies could amount to you saving two months in patient screening time, or 4,838,400 seconds.

wcgclinical.com

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WCG | CWWeekly June 10, 2019 7 of 9

Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor Contact

Cellenkos, Inc. CK0801 bone marrow failure syndromes, including aplastic anemia, hypoplastic myelodysplasia and primary myelofibrosis

Phase I trial initiated cellenkosinc.com

Xencor, Inc. XmAb22841 advanced solid tumors Phase I trial initiated xencor.com

Alnylam Pharmaceuticals, Inc.

ALN-AGT hypertension Phase I trial initiated enrolling 168 subjects

alnylam.com

UCBNeuropore Therapies, Inc.

UCB0599 Parkinson’s disease Phase Ib trial initiated ucb.comneuropore.com

Amphera B.V. MesoPher pancreatic cancer Phase II trial initiated enrolling 10 adult subjects with surgically resected pancreatic cancer who have received adjuvant standard of care treatment

amphera.nl

Immunovant IMVT-1401 moderate-to-severe active Graves' ophthalmopathy (GO)

Phase II trial initiated enrolling eight subjects

immunovant.com

Rejenevie Therapeutics

AR-100 immune restoration therapy

immunology Phase II trial initiated enrolling 20 healthy subjects 55 years of age or older in Freeport, Bahamas

rejenevie.com

Ironwood Pharmaceuticals, Inc. Allergan PLC

MD-7246 abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D)

Phase II trial initiated enrolling 400 subjects

ironwoodpharma.com

allergan.com

Verona Pharma PLC metered-dose inhaler formulation of ensifentrine (RPL554)

moderate-to-severe chronic obstructive pulmonary disease (COPD)

Phase II trial initiated enrolling 36 subjects at two sites in the UK

veronapharma.com

Minoryx Therapeutics

leriglitazone (MIN-102)

Friedreich’s Ataxia Phase II trial initiated enrolling 36 subjects 12 years of age or older at numerous sites across Europe

minoryx.com

GENFIT elafibranor nonalcoholic fatty liver disease (NAFLD)

Phase II trial initiated enrolling 16 subjects with NAFL as identified with magnetic resonance spectroscopy (H-MRS)

genfit.com

Arcutis, Inc. ARQ-151 atopic dermatitis Phase IIa trial initiated arcutis.com

Akero Therapeutics, Inc.

AKR-001 non-alcoholic steatohepatitis (NASH)

Phase IIa trial initiated enrolling 80 subjects

akerotx.com

Ansun Biopharma, Inc.

DAS181 lower respiratory tract parainfluenza virus

Phase III trial initiated enrolling immunocompromised subjects at sites in the U.S., Europe and Asia

ansunbiopharma.com

continues on next page »

For news on trial results, FDA approvals and drugs in development, Join the LinkedIn Drug Research Updates group!

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WCG | CWWeekly June 10, 2019 8 of 9

Drug & Device Pipeline News (continued from page 7)

Company Drug/Device Medical Condition Status Sponsor Contact

Eyenovia Inc. MicroPine pediatric progressive myopia Phase III trial initiated enrolling 400 subjects ages three to 12 years of age

eyenovia.com

Incyte pemigatinib (INCB54828)

cholangiocarcinoma Phase III trial initiated enrolling 432 subjects

incyte.com

Allergan plc Gedeon Richter PLC

VRAYLAR (cariprazine)

manic or mixed episodes associated with bipolar I disorder in adults

sNDA approval granted by the FDA

allergan.comrichter.hu

Cadent Therapeutics CAD-1883 spinocerebellar ataxia (SCA) Orphan Drug designation granted by the FDA

cadenttx.com

Bayer Aliqopa (copanlisib) marginal zone lymphoma (MZL) Breakthrough Therapy designation granted by the FDA

bayer.com

Imara, Inc. IMR-687 sickle cell disease Fast Track designation granted by the FDA

imaratx.com

NovoCure NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy

malignant pleural mesothelioma (MPM)

Approval granted by the FDA novocure.com

AveXis Inc. Zolgensma (onasemnogene abeparvovec-xioi)

spinal muscular atrophy (SMA) in children less than two years of age

Approval granted by the FDA avexis.com

Novartis Piqray (alpelisib) tablets in combination with the endocrine therapy fulvestran

hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer in postmenopausal women and men

Approval granted by the FDA novartis.com

Novartis Jakafi (ruxolitinib) steroid-refractory acute GVHD in adult and pediatric subjects 12 years and older

Approval granted by the FDA novartis.com

Celgene Corporation

REVLIMID (lenalidomide) in combination with a rituximab product (R²)

previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) in adults

Approval granted by the FDA celgene.com

Learn more at www.centerwatch.com/FinOps2019 BUY NOW

2019 Financial & Operating BenchmarksS E T YO U R S I T E A PA RTBenchmark report helps you know how to accelerate trial growth and maximize e� ciency using current industry trends.

Learn more at www.centerwatch.com/FinOps2019

COMPARISON OF SMALL AND LARGE SITES, 2018 16

Source: CenterWatch 2019 Financial & Operating Benchmark Survey

In the previous year, how long did it typically take for Sponsors and CROs to pay your investigative site for work that had been invoiced?

Sponsor/CRO Payment Frequency

> 120 days

90–120 days

60–90 days

45–60 days

30–45 days

Large Sites(n=86)

12%

20%

26%

26%

16%

Small Sites(n=79)

3%10%

41%

26%

18%

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WCG | CWWeekly June 10, 2019 9 of 9

Research Center Spotlight

Research Center Spotlight is a monthly selection of clinical research centers who have Research Center 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 expertise and services in conducting and managing clinical studies.

To learn more about becoming a Research Center Profile page subscriber, contact Sales at (617) 948-5100 or sales@centerwatch.com.

Phoenix, AZ(602) 788-3437debbie@eliteclinicalstudies.com

Elite Clinical Studies has an updated database with over 18,000 subjects and utilizes a central IRB.

Tampa, FL(813) 870-1292bkeskiner@crwf.com

Clinical Research of West Florida, Inc. provides improved and innovative healthcare opportunities to residents through clinical research studies. CRWF works with board certified/eligible community-based physicians to conduct Phase I-IV clinical research trials.

Cincinnati, OH(513) 931-0775 ext. 2bernsteincrc@bernsteincrc.com

Bernstein Clinical Research Center has been conducting clinical research studies since 1969. The center has conducted over 700 clinical trials in the adult and pediatric patients.

Las Vegas, NV(702) 527-7401info@altearesearch.com

Altea has conducted more than 250 studies, has 100+ active patients in the database and averages 20 total patients enrolled.

Escondido, CA(877) 567-2627info@amcrinstitute.com

AMCR Institute is a clinical research center engaged in Phase I-IV trials in the field of endocrinology and metabolism. It focuses on drug and medical device studies for diabetes type 1 and type 2 and other metabolic disorders.

Tulsa, OK(918) 392-4550iftikhar.hussain@aaicenter.net

Founded in 2007, Vital Prospects Clinical Research Institute has conducted several clinical studies with plans for continued expansion to conduct phase II, III and IV clinical studies in a variety of therapeutic areas.

New Hyde Park, NY (718) 289-2102lbreuer@parkerinstitute.org

From its beginning in 1907 as the Daughters of Israel shelter, Parker has evolved into one of the nation’s leading healthcare and rehabilitation centers for older adults.

Mobile, AL(251) 633-0793 x 250pangerholzer@mobileobgyn.com

Mobile Ob-Gyn maintains an active database of over 45,000 patients easily accessible through an electronic medical/health records system. The dedicated research department has been conducting investigational medication and device trials since 2004.

Berlin, NJ(856) 753-7335bd@hritrials.com

HRI has completed more than 700 studies. The center has more than 65,000 active patients in the database. The regulatory turnaround time is five business days.

San Diego, CA(619) 521-2841tchang@mccresearch.com

MCCR has successfully conducted over 350 clinical trials, with a focus on Phase II-IV research trials. An average of 95% of completed studies have met enrollment.

Hassman Research Institute, LLC

Medical Center for Clinical Research

Altea Research Institute

AMCR Institute

Bernstein Clinical Research Center, LLC

Vital Prospects Clinical Research Institute, P.C. Elite Clinical Studies, LLC

Mobile Ob-Gyn, P.C.

Clinical Research of West Florida, Inc. Parker Jewish Institute