join the centerwatch community centerwatch...proach towards collecting and using patient and...

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Volume 23, Issue 38. © 2019 CenterWatch. All rights reserved. Join the CenterWatch Community! October 7, 2019 Industry Briefs…2 Up and Coming…3 Drug & Device Pipeline News…7 Twenty drugs and devices have entered a new trial phase this week. JobWatch…9 see Owning Research Integrity on page 5 » see FDA Offers Methods on page 5 » CenterWatch Weekly By James Miessler T he FDA issued a 49-page draft guid- ance on how industry should go about asking patients what’s most important to them about how they are dealing with their disease and its treatment, to help companies better develop new drugs. The second in a series of four planned guidances on facilitating a systematic ap- proach towards collecting and using patient and caregiver input, the draft goes into detail on various research methods and notes how those methods can help in the development of clinical outcome assess- ments and the generation of patient prefer- ence information. For example, it offers considerations for the most common qualitative methods used for gathering patient input, including one-on- one interviews and focus groups, as well as how to go about asking effective questions. It also details survey research methods, which are frequently used for collecting quantita- tive data, and the accompanying instruments used to survey patients. Additionally, it includes a section on mixed methods — combinations of qualitative and quantitative research approaches — and aspects to consider when using social media to question patients. For example, the guid- ance points out that “different social media communities appeal to different segments of the population” and the level of anonymity af- forded by a community can affect how much a patient is willing to share. FDA Offers Methods, Research Practices for Pa- tient Input in Drug Development By Colin Stoecker D efending against research mis- conduct is the responsibility of everyone involved in a trial, from the principal investigator down to the low- est lab technician. Red flags can appear in any aspect of a trial, ranging from missing or altered data, significant omissions in published reports, investigators’ failure to disclose intellectual property interests or industry relationships, and generally results that seem too good to be true or apparently “perfect” protocol compliance, Donna Kessler, Duke Univer- sity research misconduct review officer, reminded attendees at the Society of Clini- cal Research Associates annual conference last week. Another warning sign, she said, is an inves- tigator’s refusal to share raw data or detailed methods. And serious or recurring episodes of non-compliance also bear a closer look. Kessler also noted that there are prac- tices that aren’t misconduct themselves but can create the environment for misconduct to flourish. For instance, unprofessional behavior — bullying, harassment and dis- crimination in the lab — can create a barrier to staff reports of misconduct. Trial staff actually identify more cases of misconduct than trial monitors do, said at- torney Debra Parrish. For example, a financial audit of a Stanford University trial turned up evidence of falsified data and led to a three-year Owning Research Integrity: Make It Everyone’s Obligation PRESENTS THE 14TH ANNUAL FDA INSPECTIONS SUMMIT 14TH ANNUAL FDA INSPECTIONS SUMMIT BETHESDA, MD OCTOBER 23–25, 2019 REGISTER NOW NEW WHITE PAPERS AVAILABLE An Actionable Approach to Decentralized Clinical Trials to Grow Enrollment and Retention From Symphony Clinical Research LEARN MORE An Actionable Approach to Decentralized Clinical Trials to Grow Enrollment and Retention Melissa Hawking Symphony Clinical Research June 2019 centerwatch.com/whitepapers FREE WEBINAR REGISTER Regulatory Binders: Your Path to Paperless Sponsored by MedPoint Digital OCT 9 ipelineNews FDA Actions Company name FDA action Lumendi, LLC second-generation endoscopic accessory indicated visualization, diagnosis and endoscopic treatment 510(k) clearance granted Varian 510(k) clearance granted Conavi TM Medical Inc. 510(k) clearance granted Prisyna, the oral care division of Synedgen 510(k) clearance granted C4 Imaging LLC to accurately locate the position of the applicators that guide the placement of radioac tive sources for 510(k) clearance granted Amerigen Pharmaceuticals Limited and Dipharma S.A. aND led Sage TND led Veloxis Pharmaceuticals A/S Prophylaxis of organ rejection in kidney transplant sND led Jazz Pharmaceuticals AbeoImmuStealth Biotherapeutics zer Inc. MeiraGTx Limited regulator (RPGR) gene efollowing is a sampling of FDA regulatory actions taken during the previous month, compiled from CenterWatch and third-party sources including e FDA and company press releases. For more information on FDA approvals, visit www.centerwatch.com/drug-information/fda-approvals/. r custom drug intelligence reports, email [email protected]. Join the LinkedIn Drug Research Updates group! Addressing Barriers to Entry and Retention B Industry Tries to Stem Investigator Dropout CRA/CRC Shortages Slow Clinical Trial Pace Industry Developing Standardized Training The CenterWatch Monthly provides in-depth and data-rich insights on key trends impacting the clinical resarch landscape. SUBSCRIBE TODAY » Valuable clinical study leads » Detailed drug intelligence » Key regulatory updates

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Page 1: Join the CenterWatch Community CenterWatch...proach towards collecting and using patient and caregiver input, the draft goes into detail on various research methods and notes how those

Volume 23, Issue 38. © 2019 CenterWatch. All rights reserved.

Join the CenterWatch Community!

October 7, 2019

Industry Briefs…2

Up and Coming…3

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

JobWatch…9

see Owning Research Integrity on page 5 »

see FDA Offers Methods on page 5 »

CenterWatchWeekly

By James Miessler

The FDA issued a 49-page draft guid-ance on how industry should go about asking patients what’s most important

to them about how they are dealing with their disease and its treatment, to help companies better develop new drugs.

The second in a series of four planned guidances on facilitating a systematic ap-proach towards collecting and using patient and caregiver input, the draft goes into detail on various research methods and notes how those methods can help in the development of clinical outcome assess-ments and the generation of patient prefer-ence information.

For example, it offers considerations for the most common qualitative methods used for

gathering patient input, including one-on-one interviews and focus groups, as well as how to go about asking effective questions. It also details survey research methods, which are frequently used for collecting quantita-tive data, and the accompanying instruments used to survey patients.

Additionally, it includes a section on mixed methods — combinations of qualitative and quantitative research approaches — and aspects to consider when using social media to question patients. For example, the guid-ance points out that “different social media communities appeal to different segments of the population” and the level of anonymity af-forded by a community can affect how much a patient is willing to share.

FDA Offers Methods, Research Practices for Pa-tient Input in Drug Development

By Colin Stoecker

Defending against research mis-conduct is the responsibility of everyone involved in a trial, from

the principal investigator down to the low-est lab technician.

Red flags can appear in any aspect of a trial, ranging from missing or altered data, significant omissions in published reports, investigators’ failure to disclose intellectual property interests or industry relationships, and generally results that seem too good to be true or apparently “perfect” protocol compliance, Donna Kessler, Duke Univer-sity research misconduct review officer, reminded attendees at the Society of Clini-cal Research Associates annual conference last week.

Another warning sign, she said, is an inves-tigator’s refusal to share raw data or detailed methods. And serious or recurring episodes of non-compliance also bear a closer look.

Kessler also noted that there are prac-tices that aren’t misconduct themselves but can create the environment for misconduct to flourish. For instance, unprofessional behavior — bullying, harassment and dis-crimination in the lab — can create a barrier to staff reports of misconduct.

Trial staff actually identify more cases of misconduct than trial monitors do, said at-torney Debra Parrish.

For example, a financial audit of a Stanford University trial turned up evidence of falsified data and led to a three-year

Owning Research Integrity: Make It Everyone’s Obligation

PRESENTS THE

14TH ANNUAL

FDA INSPECTIONS SUMMIT

14TH ANNUAL

FDA INSPECTIONS SUMMITBETHESDA, MD OCTOBER 23–25, 2019

REG ISTE R NOW

NEW WHITE PAPERS AVAILABLE

An Actionable Approach to Decentralized Clinical Trials to Grow Enrollment and RetentionFrom Symphony Clinical Research

LEARN MORE

An Actionable Approach to Decentralized Clinical Trials to Grow Enrollment and Retention

Melissa HawkingSymphony Clinical Research

June 2019

centerwatch.com/whitepapers

FREE WEBINAR

REGISTER

Regulatory Binders: Your Path to PaperlessSponsored byMedPoint Digital

O C T

9

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

aND led

Sage Therapeutics intravenous formulation of brexanolone (SAGE-547)

postpartum depression (PPD) ND led

Veloxis Pharmaceuticals A/S

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

Prophylaxis of organ rejection in kidney transplant patients

sND led

Jazz Pharmaceuticals Xyrem (sodium oxybate) oral solution

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

sND led

Abeona Therapeutics Inc. ABO-102 AAV-mediated gene therapy for the treatment of 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

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 [email protected]. 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.

SUBSCRIBE TODAY

» Valuable clinical study leads» Detailed drug intelligence» Key regulatory updates

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CenterWatch Weekly (ISSN 1528-5731)

Leslie Ramsey Editorial Director Colin Stoecker ReporterStephanie Akers ProductionRussell Titsch Business Development Director

© 2019 CenterWatch. All rights reserved. No part of this publication may be distributed or reproduced in any form or by any means without the express written consent of the publisher.

CenterWatch Main and Editorial Offices 300 N. Washington St., Suite 200, Falls Church, VA 22046 [email protected] / [email protected]

Permission requests can be emailed to [email protected].

Advertising packages and reprints are available:Email [email protected] or call (703) 538-7651.

WCG | CWWeekly October 7, 2019 2 of 9

Industry Briefs

White House Vets Potential Nominee for FDA CommissionerThe White House is vetting oncologist Stephen Hahn as a possible nominee for FDA commissioner, although there has been no official announcement.

Hahn, currently the chief medical executive at the MD Anderson Cancer Center, reportedly met with the president early in September and is now being vetted prior to his name be-ing sent to the Senate for approval.

Hahn has served as a professor, re-searcher, clinician and administrative head, as well as continuing to practice as a radia-tion oncologist.

The current acting commissioner, Ned Sharpless, who health organizations and former agency chiefs have praised as an outstanding candidate for the permanent po-sition, must step down by Nov. 1 (CenterWatch Weekly, Sept. 8, 2019).

Cincinnati Children’s to Coor-dinate Rare Diseases Research NetworkCincinnati Children’s Medical Center will be the new home of the Rare Diseases Clinical Research Network (RDCRN), thanks to a $28 million grant from the National Institute of Translational Sciences, which is part of NIH.

The hospital will lead studies involving thousands of scientists across the U.S. and 22 other nations, analyzing big data about rare diseases and generating data to spur clinical trials of new medicines.

23andMe Partners with Trial-Spark for RecruitmentThe gene testing company 23andMe has moved into clinical trial recruitment, establish-ing a partnership with TrialSpark to match customers with nearby trial sites based on their disease and demographic.

23andMe will identify potential research participants from its 10 million customers and refer them to TrialSpark, a technol-ogy infrastructure company that provides

support services and staff to community physicians who want to open their own study sites. The goal is to provide trial op-portunities to patients who can’t travel to large research sites.

The partnership is soliciting proposals from clinical researchers and will select up to three studies to work with first.

Veeva Provides Free Trial Man-agement SolutionVeeva Systems is offering sites a cloud-based trial management platform at no cost.

SiteVault eases sites’ administrative burden by handling such processes as electronic signatures, remote monitoring, certified copy workflows and reporting. Veeva will provide sites with unlimited user access and technical support from the company.

The free platform will launch in Decem-ber, but Veeva is accepting requests from sites in advance.

The fully customizable version, SiteVault Enterprise, currently is available and in use by multiple research organizations.

Firma Improves Training for Trial Home CareFirma Clinical Research is working to incor-porate the real-life experience of patients into training materials for trial personnel who provide in-home services.

Working with the Myositis Association, the CRO is surveying patients to learn more about their needs and attitudes and will use that information to improve home healthcare training for its trial nurses and investigators.

Forty percent of trials Firma currently supports require medical professionals to administer a drug in the patient’s home, and patient demand for in-home trial services is increasing, the company says.

Firma also is looking at implementing the program in other therapeutic areas.

QPS Expands GloballyQPS has opened new research facilities in the Netherlands, India and China.

The new Dutch clinical research site will be located at the Medical Center Leeuwar-den and will focus initially on early-stage research on Alzheimer’s and Parkinson’s diseases. A second clinical research facility in Hyderabad, India, will conduct phase 1 through phase 3 studies.

QPS’s new bioanalytical operation in Su-zhou, China, will focus on mass spectrometry.

The CRO also announced a three-fold ex-pansion of its translational medicine division at the company’s U.S. headquarters in February.

Percent of Sites Unable to Enroll a Single Patient, 2016-2018

Source: WCG Institute

30

25

20

15

10

5

2016 2017 2018

20.1%21.7%

29.1%

Data Point

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This feature highlights changes in clinical research organizations’ personnel.

Adaptimmune TherapeuticsAdaptimmune Therapeutics has added to its leadership with Michael Garone named in-terim chief financial officer. Garone previously served as the CFO and interim chief executive officer at Immunomedics in New Jersey.

Alphabet (Google)Former FDA commissioner Robert Califf has been named head of medical strategy and policy at Alphabet, a subsidiary of Google. He will head their Google Health and Verily units starting in mid-November.

AM PharmaAM Pharma has named Juliance Bernholz chief operating officer and Kristie Bass as vice president of clinical operations. Bernholz joined from Janssen Research and Development in New Jersey where she served as compound development team leader. Prior to joining AM Pharma, Bass served as senior director of project delivery at PRA Health Sciences, a North Carolina-based CRO.

Arix BioscienceArix Bioscience has appointed Marcus Karia to the position of group finance director. Karia was most recently with Arix Bioscience as the group financial controller.

Avidity BiosciencesSarah Boyce has been named president and chief executive officer at Avidity Biosci-ences. Boyce was previously president of Akcea Therapeutics.

BiogenBiogen has named Alfred Sandrock execu-tive vice president of research and develop-ment in addition to his role as chief medical officer and Alphonse Galdes executive vice president of pharmaceutical operations and

technology. Previously, Sandrock served as CMO at Biogen; Galdes was most recently at Biogen as senior vice president of asset devel-opment and portfolio management.

CURE PharmaceuticalCURE Pharmaceutical named Vered Gigi chief science officer. Gigi was previously vice president of strategy and business develop-ment at CURE.

Deciphera PharmaceuticalsDeciphera Pharmaceuticals has named Mat-thew Sherman executive vice president and chief medical officer. Previously, Sherman was CMO at Acceleron Pharma for 12 years.

Dyne TherapeuticsJoshua Brumm has been appointed chief ex-ecutive officer at Dyne Therapeutics. Brumm is the former chief operating officer and chief financial officer of Kaleido Biosciences.

HemoShear TherapeuticsBrian Johns has been named chief science officer at HemoShear Therapeutics. Previously, Johns served as a vice president of external discovery sciences in the GlaxoSmithKline-owned unit ViiV Healthcare, where he co-created one of the most widely used HIV drugs in the world.

ImmunoPrecise AntibodiesImmunoPrecise Antibodies has named Stefan Lang chief business officer. Previously, Lang served as vice president of business develop-ment with Aldevron.

InversagoInversago Pharma, Inc. named Caroline Fradette vice president, clinical research. Fra-dette was previously director, clinical research at ApoPharma.

Jnana TherapeuticsJnana Therapeutics has appointed Caro-line Stark Beer as chief business officer.

Beer was most recently vice president and head of business development at Alnylam Pharmaceuticals.

Nektar TherapeuticsNektar Therapeutics has appointed Jona-than Zalevsky chief research and develop-ment officer and Gil Labrucherie chief op-erating officer. Zalevsky was most recently chief science officer at Nektar. Labrucherie was promoted from his role of chief financial officer at the company.

Neurocrine BiosciencesNeurocrine Biosciences has named David Boyer as chief corporate affairs officer. Boyer most recently served as principal and head of the health and life sciences practice at the BGP Group.

NextCureTimothy Mayer was named chief operating officer at NextCure. Previously, Mayer was se-nior vice president of corporate development with the company.

Obsidian TherapeuticsErin Boyer has been named vice president, human resources at Obsidian Therapeutics. Boyer most recently served as global head of talent strategy and planning at Alnylam.

OcugenOcugen has named Sanjay Subramanian chief financial officer. Subramanian was most recently CFO at Aralez Pharmaceuticals.

PACT PharmaTim Moore was named president and chief technical officer at PACT Pharma. Previously, Moore was executive vice president of techni-cal operations at Kite, a Gilead Company.

Precision BioSciencesNicholas Riddle has been named vice president of financial strategy and investor

WCG | CWWeekly October 7, 2019 3 of 9

Up and Coming

continues on next page »

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WCG | CWWeekly October 7, 2019 4 of 9

Up and Coming (continued from page 3)

relations with Precision BioSciences. Riddle most recently served as an executive director in J.P. Morgan’s healthcare investment bank-ing group.

PulmotectPulmotect has appointed Colin Broom chief executive officer. Broom was most recently CEO with Nabriva Therapeutics.

Rafael PharmaceuticalsWendy McDermott was named the first ever chief people officer at Rafael Pharmaceuticals. Previously, McDermott was vice president of human resources at Sanofi.

Sangama TherapeuticsBettina Cockroft has been named senior vice president and chief medical officer at Sangama Therapeutics. Cockroft is a former

member of the senior leadership team responsible for clinical development at Cytokinetics.

Sonoma PharmaceuticalsSonoma Pharmaceuticals has named Amy Trombly interim chief executive officer and promoted John Dal Poggetto to chief financial officer. Trombly previously served as corporate and securities counsel for Sonoma Pharmaceuticals; Dal Poggetto served as Sonoma’s executive vice presi-dent of finance.

TevaIsrael-based Teva Pharmaceutical Industries has appointed Eric Drapé as executive vice president, global operations. Drapé was most recently group EVP, global quality and biolog-ics operations with the company.

Torque TherapeuticsTorque Therapeutics has named John Cox chief executive officer. Cox was most recently CEO at Bioverativ.

VertexCarmen Bozic has been appointed executive president of global medicines development and medical affairs at Vertex Pharmaceuticals. Bozic previously served as senior vice presi-dent of global development at Biogen.

Vor BiopharmaSadik Kassim has been named chief technol-ogy officer and Tirtha Chakraborty has been named vice president of research at Vor Biopharma. Kassim is the former executive director at Kite Pharma; Chakraborty most re-cently served as vice president of cell therapy research with Sana Biotechnology.

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WCG | CWWeekly October 7, 2019 5 of 9

Features

Owning Research Integritycontinued from page 1 “Cultivate good citizens,

managers and mentors, not just good researchers.”

—Donna Kessler, Research Misconduct Review Officer, Duke University

disqualification for the principal investiga-tor. In another instance at the University of Vermont, a lab technician suspected the investigator had falsified data. The tech’s report eventually led to the investigator’s admission that he had committed research misconduct in multiple cases.

It’s important to create an environ-ment in which reporters feel protected, Kessler said. Research institutions should normalize the process with such policies as anonymous reporting options, ombudsman services and prohibition of retaliation. They also can provide their investigators with role models, peer counseling and mentoring of professional behavior.

“Cultivate good citizens, managers and mentors, not just good researchers,” she said.

Although research integrity is a universal obligation, the ultimate responsibility is on the principal investigator’s shoulders. “Some places take the position that the PI is the cap-tain of the ship,” said Parrish. “If the ship goes down, the captain goes down.”

Research scientists need to practice more transparency, Kessler said, explaining their

methods, outlining results obtained and sharing source data. Investigators also need to provide better oversight, supervision and men-toring of the trial staff. Frequent discussions about ethics and integrity in research can help keep the ideas fresh in their minds, she said.

PIs should set expectations for data man-agement and conduct routine reviews, Kessler said, recommending giving staff tools to im-prove record-keeping and reporting, such as auditable systems and electronic notebooks.

Research is not flawless, she said, and researchers need to acknowledge that errors and experimental failure are a normal part of science. Deal with problems transparently and ethically.

“Make the error occur the right way,” she said, and learn from it.

“When possible, social media research should examine a variety of social media net-works and communities to obtain data that can be most generalized to the population of interest,” the guidance says.

The guidance also lists special consid-erations to keep in mind when studying specific populations — children, cognitively

impaired patients and patients with rare dis-eases. For example, a patient’s health status is important to consider, as fatigue due to illness or travel could negatively impact data quality. Similarly, the emotional burden of both the patient (anxieties or discomfort, potential for heightened emotions) and the interviewer (potential for emotional distress during the interview) could affect responses as well.

The agency issued a first draft guidance on this topic in June 2018, which offers sampling methods for researchers to use in collecting patient experience information that can assist in drug development and evaluation (Center-Watch Weekly, June 18, 2018).

Comments on the draft guidance are due by Dec. 30.

Read the full guidance here: https://bit.ly/2 p0F0zi.

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WCG | CWWeekly October 7, 2019 6 of 9

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WCG | CWWeekly October 7, 2019 7 of 9

Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor ContactThemis Bioscience and ZIKAVAX

Second-generation Zika vaccine

Zika virus Phase 1 study initiated enrolling 48 healthy subjects

themisbio.com

Noveome Biotherapeutics, Inc.

ST266 intraocular hypertension Phase 1 trial initiated enrolling subjects at the University of Pennsylvania who have been diagnosed with intraocular hypertension who have not yet developed optic nerve damage

noveome.com

Clover Biopharmaceuticals

SCB-313 malignant ascites Phase 1 trial initiated enrolling subjects in China

cloverbiopharma.com

Oncternal Cirmtuzumab in combination with Ibrutinib

Mantel cell lymphoma (MCL) Phase 1b expansion cohort trial initiated to confirm the RDR

oncternal.com

AVEO Oncology

AstraZeneca

Tivozanib (FOTIVDA) and Durvalumab (IMFINZI)

hepatocellular carcinoma (HCC) Phase 1b/2 trial initiated enrolling 50 subjects with hepatocellular carcinoma (HCC) who have not received prior systemic therapy

aveooncology.com

astrazeneca.com

Checkmate Pharmaceuticals Inc.

CMP-001 in combination with BAVENCIO (avelumab), utomilumab (4-1BB agonist) and PF-04518600 (OX40 agonist)

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 1b/2 trial initiated enrolling 60 subjects with Squamous Cell Cancer of the Head and Neck (SCCHN)

checkmatepharma.com

Adrenomed Adrecizumab septic shock Phase 2 trial initiated enrolling 300 subjects with early septic shock and elevated blood levels of Adrenomedullin

adrenomed.com

Oncopeptides AB melflufen with dexamethasone

relapsed/refractory multiple myeloma (RRMM)

Phase 2 trial initiated enrolling 150 subjects

oncopeptides.se/en/

North Sea Therapeutics

Icosabutate NASH (Non-alcoholic Steatohepatitis)

Phase 2b trial initiated enrolling 264 subjects

northseatherapeutics.com

Immutep eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA(R) (or pembrolizumab, an anti-PD-1 therapy)

Non-small cell lung cancer (NSCLC) Phase 2 expansion cohort trial initiated enrolling 19 subjects with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line in 13 study centers across the U.S., Europe and Australia

immutep.com

Cortexyme COR388 Alzheimer’s Disease Phase 2/3 trial initiated enrolling 570 subjects in U.S. and Europe

cortexyme.com

Incyte ruxolitinib cream vitiligo Phase 3 trial initiated enrolling 300 adolescent and adult subjects ages 12 and older who have been diagnosed with non-segmental vitiligo

incyte.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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Drug & Device Pipeline News (continued from page 7)

Galmed Pharmaceuticals Ltd.

SCD1 modulator Aramchol

nonalcoholic steatohepatitis ("NASH") and fibrosis

Phase 3/4 trial initiated enrolling 2,000 subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes at 185 sites in the U.S., Europe, Latin America and Asia.

galmedpharma.com

Luminex Corporation

ARIES MRSA Assay methicillin-resistant Staphylococcus aureus (MRSA)

510 (k) clearance granted by the FDA

luminexcorp.com

Exogenesis Corporation

Exogenesis Hernia Mesh

soft tissue repair, abdominal wall hernias and abdominal wall deficiencies

510 (k) clearance granted by the FDA

exogenesis.us

(LAS) Laser Associated Sciences

FlowMet-R peripheral artery disease (PAD) 510 (k) clearance granted by the FDA

laserassociatedsciences.com

Janssen Pharmaceuticals

INVOKANA (canagliflozin)

Heart failure in patients with type 2 diabetes (T2D) and DKD

Approval granted by the FDA janssen.com

Janssen Pharmacuticals

Darzalex multiple myeloma Approval granted by the FDA janssen.com

AbbVie MAVYRET (glecaprevir/pibrentasvir)

naïve chronic hepatitis C (HCV) with cirrhosis or with compensated cirrhosis

Approval granted by the FDA abbvie.com

Genentech Rituxan (rituximab) injection

granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones)

Approval granted by the FDA gene.com

Elizabeth Weeks-Rowe

SECOND EDITION

The PI’s Guideto Conducting Clinical Research

It’s your guide to understanding how to:

n Secure new clinical studies, assess feasibility and create study budgets

n Recruit and retain study volunteers

n Comply with changing federal regulatory guidelines

n Prepare for sponsor or IRB audits

n Prepare for certification exams

n Implement and adhere to strict standard operating procedures

n Conduct informed consent and protect human subjects

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