Volume 24, Issue 05. © 2020 CenterWatch

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see Clinical Inspection Summary on page 6 »

see Recruitment Rates Rising on page 6 »

February 3, 2020

Industry Briefs…2

Up and Coming…4

Drug & Device Pipeline News…8Nineteen drugs and devices have entered a new trial phase this week.

JobWatch…9

CenterWatchWeekly

By Leslie Ramsey

When a site undergoes an FDA inspection, just because its poli-cies and procedures pass muster

doesn’t mean the agency won’t ask for more proof of data reliability.

No Action Indicated (NAI) or Voluntary Action Indicated (VAI) classifications aren’t always the end of the enforcement activity. It’s the Clinical Inspection Summary (CIS) that determines whether the agency will take ac-tion on data integrity issues.

In addition to delivering a Form 483 listing compliance issues at the end of a site inspection, FDA field investigators prepare a CIS for review by the agency’s Center for Drug Evaluation and Research (CDER), closely examining any data issues found and

how they affect the integrity of the trial’s findings. If the CIS suggests any concerns about the reliability or safety of a trial’s data, a site can find itself facing a number of corrective or preventive actions levied by CDER’s Office of Compliance (OC), according to former OC Director Cynthia Schnedar.

The agency “has been very clear that you could have an NAI or a VAI classification, and you could still get an active recommenda-tion in the clinical inspection summary,” says Schnedar, executive vice president of regula-tory compliance at Greenleaf Health.

Actions could range from requiring a repeat inspection or inspection of other trial sites, to requiring the trial to exclude ques-tionable datasets or bringing in a third-party

Clinical Inspection Summary Reports Call Out Data Integrity Problems

By Leslie Ramsey

G lobal trial recruitment rates have been on an upward swing over the past seven years, thanks to new tech-

niques designed to make patient participation easier, but the benefits have not translated to trials’ ability to retain patients.

Patient involvement in protocol develop-ment, mobile data collection devices and virtual trials all have contributed to improved recruitment metrics since 2012, says the Tufts Center for the Study of Drug Develop-ment (CSDD) in its latest impact report. CSDD collected data on 87 trials from four top-20 pharma companies and one global CRO.

The study found that actual enrollment exceeded planned enrollment in 2019 by 113 percent, compared to 2012 when trials

achieved an average of only 96 percent of planned enrollment. And sites are recruit-ing faster, the report says, with 77 percent of trials hitting or beating planned timelines, compared to only 47 percent in 2012.

“These findings may suggest that orga-nizations have more effective recruitment strategies or could be setting less ambitious targets,” lead study author Mary Jo Lam-berti, CSDD associate director of sponsored research, told CenterWatch Weekly.

The study also found that recruitment approaches were fairly traditional. The three most effective strategies cited by respondents were patient outreach through traditional or digital media, chart reviews and trial-match-ing services.

Recruitment Rates Rising, but Retention Rates Fall, According to New Study

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Caution for NIH's single IRB policy for multi-site researchBy Sue Coons, MA

A tions had to comply with the National Institutes of Health’s (NIH’s) Final

NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Researchpolicy established the expectation that a single institutional review board (sIRB) of record would be used in the ethical review of non-exempt human subjects research protocols funded by NIH that are carried out at more than one site in the United States.

It does not apply to career development, research training, or fellowship awards.

However, some institutions continue to be concerned about their ability to adhere to the policy and the cost of doing so. IRB executives say it is wise to be cautious. Some institutions could spend millions of dollars to upgrade their IRB infrastructure, while some IRBs already have many of the policy requirements in place. In addition, one IRB executive worries that past NIH actions

show that the agency could revise its policy

Emerging trends in clinical research: The need for changeBy John W. Mitchell, MS

T by emerging trends in the clinical trial research sector, consider insight from

a business author and a businessman/politi-cian. In his groundbreaking book, Good to Great: Why Some Companies Make the Leap…And Others Don’t,” Jim Collins wrote:

“Good is the enemy of great. And that is one of the key reasons why we have so little that becomes great. We don’t have great schools, principally because we have good schools. We don’t have great government, principally because we have good govern-ment.”

Secretary Donald Rumsfeld noted that one of the biggest threats to security was driven by factors that fell under the category of “we

don’t know what we don’t know.” In recent issues, Research Practitioner has

explored individual key emerging trends in clinical research, including patient centricity, eMobile advances, and precision medicine. As stand-alone trends, these innovations hold great promise and excitement.

But what insight is gained when all emerg-ing trends are considered in totality? What

clinical research? As Rumsfeld alluded, what might we not know that we don’t know? Are current advancements in clinical research, as Collins asserted, relevant enough to power (great) the sector beyond the status quo (good), given the rapidly evolving medical

ligence (AI), and the expectation of patients?

results on the use of electronic-sourced data, Hugo Stephenson, executive chairman of DrugDev and a physician investigator, observed: “I’m surprised and disappointed there hasn’t been much improvement in the entire clinical trial process, including the

© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited. Volume 19, Number 3

Learning Objectives/Outcomes:1. Explain the need for change in clinical research.

2. List key drivers of transformation in clinical trials.

3. Describe examples of clinical trial research trends in action.

4. Discuss why the clinical trial sector will make the jump from trends to practice.

Learning Objectives/Outcomes:1. List the details that local IRBs may know about their

study populations as opposed to a single IRB.2. Describe NIH’s reasoning for going to a single IRB

policy for multi-site research.3. Discuss the impact of using a single IRB on a study’s

direct costs.4. Explain the concern about NIH’s history of choosing

the lowest-cost provider.

42 CE program information

43 Issues in research management

52 SMART IRB

55 CE post-test

May–June 2018

see Emerging trends on page 44

see Single IRB on page 49

ruary 2017 CenterWatch article about survey

s of Jan. 25, 2018, research institu-

© 2020 CenterWatch CWW2405

CenterWatch Weekly (ISSN 1528-5731)

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Advertising packages and reprints are available:Email russ.titsch@centerwatch.com or call 703.538.7651.

WCG | CWWeekly February 3, 2020 2 of 9

Industry Briefs

Human Gene Therapy Guidances Focus on Efficacy in Early-Stage TrialsA suite of FDA final guidances issued last week suggests that early-phase trials of gene therapies to treat rare diseases and other genetic disorders focus on efficacy as well as safety to maximize results from small patient populations.

The guidance on rare disease gene therapies recommends sponsors consider designing their first-in-human studies to have the potential to provide evidence of effectiveness without progressing through phase 2 and 3 trials.

“Alternative trial designs and statisti-cal techniques that maximize data from a small and potentially heterogeneous group of subjects (including genetic heterogeneity) should be considered,” the guidance adds.

The guidance on therapies for retinal disor-ders recommends early-phase trials focus on dose-ranging and in a third guidance, the FDA says early-phase trials of gene therapies for hemophilia “should not only evaluate safety and feasibility, but also gauge bioactivity and preliminary efficacy.”

Read the guidance on retinal disorders here: https://bit.ly/31cIbmF.

Read the guidance on rare diseases here: https://bit.ly/37YcxeY.

Read the guidance on hemophilia here: https://bit.ly/37HvUsN.

FDA Drug Center Releases 2020 Clinical Trial Guidance AgendaSeveral new FDA clinical trial-related guid-ances are in the works for 2020, accord-ing to the Center for Drug Evaluation and Research (CDER) guidance agenda released last week.

CDER announced plans for new or revised guidances on decentralized clinical trials, using multiple endpoints in clinical trials, use of data monitoring committees in controlled trials, digital health technologies

for remote data acquisition and postmarket-ing studies.

Other topics on the list include adjust-ment for covariates in randomized clinical trials using nonlinear models, civil monetary penalties for failure to meet accelerated postmarketing requirements and frequently asked questions about FDA’s statement of investigator form.

CDER did not specify when it will issue the guidances.

In addition to the FDA, the International Council on Harmonization (ICH) continues to work on a revision of its ICH E8 – Gen-eral Considerations in Clinical Trials, which it plans to release in June (CenterWatch Weekly, March 11, 2019). ICH also has begun work on revising its guideline for optimizing safety data collection for pub-lication in 2021, as well as a new guideline on adaptive clinical trials, which has not yet been drafted.

Read CDER’s guidance agenda here: https://bit.ly/2OiAPIZ.

Administration Pledges to Expedite Coronavirus Vaccine Trial but NIH Not OptimisticThe White House said last week that it hopes to have a vaccine for the coronavirus (2019-nCoV) ready for an early-stage clinical trial within the next three months, but it could take a year or more before a product is ready.

NIH is working with biotech company Mod-erna to develop a vaccine candidate, accord-ing to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Too Few Patients Enrolling in Cancer Trials, Study ShowsA study from Penn State Cancer Institute found that of 12 million patients in the National Cancer Database between 2004

continues on next page »

Source: Tufts CSDD and WCG Clinical

Number of weeks from siteidentification to study start-up

completion

Percentage of trials that willmeet their enrollment goals iforiginal timelines are doubled

Percent of all clinical studies thatclose because they fail to meet

enrollment goals

Data Point

© 2020 CenterWatch CWW2405

WCG | CWWeekly February 3, 2020 3 of 9

Industry Briefs (continued from page 2)

and 2015, only 11,600 patients — or 0.1 percent — enrolled in a clinical trial after their cancer diagnosis.

The study also found that a sizeable proportion of patients who enroll in cancer trials as a first form of therapy are white males with private insurance.

Those who enrolled in clinical trials had a median survival rate of 7.5-months longer than those who did not participate, the study found.

To read the study, click here: https://bit.ly/ 2S8mW15.

CROs and Sponsors Plan to Ramp Up eConsent Use, Survey ShowsA new survey from Signant Health says 71 percent of sponsors and 76 percent of CROs will implement an eConsent solution for most of their studies within the next three years.

Approximately 65 percent of CRO respon-dents and 85 percent of sponsor respondents say they will adopt eConsent for at least some studies the next 12 months, according to the survey from Signant, a clinical research technology firm.

To read the survey, click here: https://bit.ly/ 2RLpNOz.

UK’s MHRA Releases Updated Guidance on Clinical Investigation of Medical DevicesThe UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released an updated guidance for devicemakers, outlin-ing the necessary clinical data needed to gain CE-mark approval.

In this fifth version of the guidance, the MHRA provides information on when a clinical investigation may be required for medical de-vices. Also presented in the guidance are seven factors manufacturers should consider when deciding whether to conduct a clinical investi-gation for a nonCE-marked medical device.

The guidance is included in a group of additional documents from the MHRA that discuss compiling a submission, clinical investigation fees and assessment timelines.

India’s Regulatory Body Increases Oversight of Clinical TrialsFollowing the implementation of its New Drugs and Clinical Trial Rules 2019, India’s regulatory agency has increased the number of trial approvals to 185 from 30 the prior year.

On the inspection front, the Central Drugs Standard Control Organization (CDSCO) in In-dia has inspected 115 biological product and 30 new drug trial sites the past three years.

In 2017, the number of CDSCO inspec-tions of biological product trials was 16. This number increased to 53 inspections by 2018. Through October 2019, CDSCO had inspected 47 biological product trials.

There were only five CDSCO inspections of new drug trials in 2017, compared with 21 in 2018. Only two inspections of new drug trial sites were reported in 2019.

Researchers Introduce the World of Clinical Trials in New Children’s BookElementary and middle school children can learn about clinical trials at their own level with a new book from a team of University of Buffalo professors and researchers.

“Sofia Learns About Research” is an activity book that describes the journey of a child with asthma considering participating in a clinical trial. Teresa Quattrin, professor of pediatrics and senior associate dean of research integration, co-authored the book with another researcher and an undergradu-ate student at the university to make the topic of clinical research accessible to youth and their parents across cultures, learning and literacy levels.

To learn more about the book, click here: https://bit.ly/2Ueetw3.

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This feature highlights changes in clinical trial organizations’ personnel.

Avacta GroupPaul Fry will now serve as non-executive director of Avacta Group. Most recently, Fry was the interim CEO and chief financial officer at Vectura Group.

Bardy DiagnosticsEd Vertatschitsch has been named chief operating officer of Bardy Diagnostics. Most recently, Vertatschitsch was vice president of global portfolio solutions at Varian Medi-cal Systems.

Bavarian NordicBavarian Nordic has named Laurence De Moerlooze the firm’s newest executive vice president and chief medical officer. Prior to this appointment, De Moerlooze was vice president and global program lead for vac-cines at Takeda Vaccines.

BayerBijoy Sagar has been named Bayer’s new chief information technology and digital transformation officer. Most recently, Sagar was the chief technology officer at Stryker.

Beam TherapeuticsGiuseppe Ciaramella, chief scientific officer of Beam Therapeutics, has been promoted to president of the company. Since February 2018, Ciaramella has served as Beam’s chief scientific officer. Ciaramella was chief scientif-ic officer of Moderna Therapeutics’ infectious disease division prior to joining Beam.

CatalentCatalent has announced the appointment Ricci Whitlow to the role of president of clinical supply services, succeeding Paul Hegwood who will retire in March 2020. Most recently, Whitlow was senior vice presi-dent of technical and corporate operations at OptiNose.

CBD EmporiumCBD Emporium, a retailer of cannabidiol products, has named Paul Steinberg as the company’s new chief operating officer. Previously, Steinberg held roles at Abraxis Bioscience (acquired by Celgene), Novella Clinical, PPD and Simbec-Orion.

Centrient PharmaceuticalsRex Clements has been named CEO of Centri-ent Pharmaceuticals, replacing Karl Rotthier who will step down from the role after leading the company for nearly 10 years.

CytoDynCytoDyn has announced the hiring of Maura Fleming as the firm’s vice president, general counsel and corporate secretary. Fleming previously held a counsel role at Holland & Hart.

Decibel TherapeuticsLaurence Reid is now CEO of Decibel Therapeutics, joining the company after spending three years at Warp Drive Bio prior to its takeover by Revolution Medi-cines in 2018.

Dermavant SciencesDermavant Sciences has announced the ap-pointment of Chris Chapman to the position of chief commercial officer. Recently, Chap-man was vice president and general manager of Galderma.

Disc MedicineJohn Quisel, Acceleron Pharma’s executive vice president and chief business officer, is leaving his role to become CEO of Disc Medi-cine , a venture-backed biotech startup.

Hollister Hollister has appointed Abinash Nayak the company’s newest vice president of Americas. Prior, Nayak was the vice presi-dent of marketing, strategy and business development at Hill-Rom.

Horizon TherapeuticsHorizon Therapeutics has announced the departure of executive vice president of research and development and chief scien-tific officer Shao-Lee Lin. Several members of leadership within the company will now report directly to Timothy Walbert, president and CEO at Horizon. Members now reporting to Walbert include Elizabeth H.Z. Thompson, group vice president of clinical development and external search; Srini Ramanathan, group vice president of development sciences and San Francisco site head; and Melanie Gloria, senior vice president of R&D operations.

Ivenix Jørgen Hansen is now CEO of Ivenix, after serving for six years as CEO and president of Cantel Medical.

JanOneAmol Soin has been named JanOne’s new chief medical officer. Soin will continue his pain practice from his office in Centerville, Ohio.

Kura OncologyAntonio Gualberto is stepping down as head of development and chief medical officer at Kura Oncology. Vice president of clinical de-velopment Bridget Martell has been named acting chief medical officer until Kura hires a permanent replacement.

Lantheus Medical ImagingLantheus Medical Imaging has announced the hiring of Istvan Molnar, who will take over as the company’s new chief medical officer. Before joining Lantheus, Molnar was chief medical officer at Fusion Pharmaceuticals.

Myriad GeneticsThomas Slavin has been named senior vice president of medical affairs at Myriad Genetics. Slavin is assistant professor of medical oncology and therapeutic research

WCG | CWWeekly February 3, 2020 4 of 9

Up and Coming

continues on next page »

© 2020 CenterWatch CWW2405

WCG | CWWeekly February 3, 2020 5 of 9

Up and Coming (continued from page 4)

and population sciences at the City of Hope National Medical Center.

NeuroneticsNeuronetics has named Andrew Macan as the company’s chief compliance officer and senior vice president, general counsel and corporate secretary. Macan previously served as senior vice president, general counsel and corporate secretary at US Silica Holdings.

OxStem Ian Churcher has been appointed to the role of chief scientific officer at OxStem. Pre-viously, Churcher was senior vice president of drug discovery at BenevolentBio. He also spent 11 years at GlaxoSmithKline as direc-tor and head of the protein degradation discovery performance unit.

Passage BioPassage Bio has named Bruce Goldsmith as the company’s newest CEO. Most recently, Goldsmith was CEO of Civetta, a cancer startup.

Polyphor Gökhan Batur, chief commercial officer of Polyphor, will now serve as the company’s CEO, succeeding recently retired Giacomo Di Nepi. Prior to Polyphor, Batur served as executive director and global brand leader of antibiotics at Merck.

PoxelPoxel has announced the appointment of David E. Moller to the role of chief sci-entific officer. Before joining Poxel, Moller was the chief scientific officer at Sigilon Therapeutics.

Summit TherapeuticsDavid Roblin has resigned as the chief operating officer, chief medical officer and president of R&D at Summit Therapeutics.

Verrica PharmaceuticalsVerrica Pharmaceuticals has appointed Gerard DiGirolamo to the position of vice president of sales. Previously, DiGirolamo held various executive roles at GSK’s Stiefel. Sheila Kennedy was announced Verrica’s newest vice president of marketing, joining the company after serving as vice president of marketing at Onset Dermatologics.

Vyaire MedicalGaurav Agarwal has been appointed to the role of CEO at Vyaire Medical. Most recently, Agarwal was president and chief operating officer at KCI.

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

Conduct better, safer and more efficient clinical trialsThis new edition of The PI’s Guide is packed with information regarding your responsibilities including practical and ethical study conduct, site and financial management, and responsibilities imposed by ICH E6(R2).

Order today at www.centerwatch.com/piguide

© 2020 CenterWatch CWW2405

WCG | CWWeekly February 3, 2020 6 of 9

Features

Recruitment Rates Risingcontinued from page 1

Trials in North America had the highest planned-to-actual enrollment ratio, and both North American and Asia/Pacific trials achieved an activation rate of more than 85 percent. Of all sites studied, 87 percent of proposed early-stage trials and 85.7 percent of late-stage trials were able to begin recruiting.

Respondents’ average number of sites activated in 2019 was 30.5 in North America, 30.1 in Eastern Europe, 27 in Western Europe and 12.5 in Asia/Pacific.

But despite all the gains in enrollment, patient retention took a serious hit as the trial dropout rate rose to 19.1 percent in late-stage trials globally in 2019 from 15.3 percent in 2012, with the highest rates oc-curring in central nervous system (CNS) and

oncology trials. CNS trial dropout rates grew to 25.9 percent in 2019 from 19.2 percent in 2012, and oncology trial rates grew to 19.3 percent from 18.2 percent. Vaccine trials experienced a 12.3 percent dropout rate in 2019. Cardiovascular and rare disease trials fared best, with rates of 7 percent and 6.5 percent respectively.

To purchase the report, click here: https://bit.ly/36MhA0S.

Mean Dropout and Completion Rates in Late Development Studies

*Excludes rare disease indicationsSource: Tufts CSDD

Clinical Inspection Summarycontinued from page 1

auditor. “They may have concerns that are so grave they think they need another set of eyes,” she says. “They may even ask you to conduct some additional studies or conduct additional analyses.”

Although not as severe as an Official Ac-tion Indicated (OAI) inspection classification, which can carry severe penalties, an active recommendation resulting from a CIS is a signal from the FDA that more needs to be done to ensure the reliability of the trial’s data. Between 2015 and 2017, 19 percent of CIS reports resulted in active recommendations.

To avoid active recommendations, Schnedar recommends informing the FDA as soon as an issue is discovered and asking the agency for help in resolving it. “FDA has been actively encouraging early engagement when you have a data integrity issue arise during your trial,” she says.

She points to one case in which a spon-sor found an issue with their data — losing the audit trails due to a change of systems — and reported it to the agency. The FDA guided the sponsor through the process of fixing the problem, Schnedar says. “But they also mentioned that it would have been easier if the sponsor had disclosed

earlier on when it discovered this problem, and that they probably could have ad-dressed it more efficiently than they had to in the end.”

Rules for when to report data integ-rity issues are not clearly laid out by the agency, but she points out that involving the agency as you are working to resolve the problem helps ensure that you don’t affect or jeopardize the reliability of your data.

“So I think what’s important to keep in mind is that it’s always important that you maintain your trust in your relationship with FDA.”

© 2020 CenterWatch CWW2405

WCG | CWWeekly February 3, 2020 7 of 9

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WCG | CWWeekly February 3, 2020 8 of 9

Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor Contact

ORIC Pharmaceuticals ORIC-101 in combination with XTANDI (enzalutamide)

metastic prostate cancer phase 1b trial dosing first patient

oricpharma.com

Syros Pharmaceuticals

SY-5609 select solid tumors phase 1 trial dosing first patient

syros.com

Ikena Oncology IK-175 (formerly KYN-175)

advanced solid tumors phase 1 trial dosing first patient

ikenaoncology.com

Rubius Therapeutics RTX-134 phenylketonuria phase 1b trial dosing first patient

rubiustx.com

Cerevel Therapeutics CVL-936 substance use disorder phase 1 trial initiated cerevel.com

GlycoMimetics GMI-1359 advanced breast cancer phase 1b trial dosing first patient

glycomimetics.com

Epygenix Therapeutics

EPX-100 Dravet Syndrome phase 1 trial completed epygenix.com

Hansa Biopharma imlifidase Anti-GBM antibody disease phase 2 investigator-initiated trial enrolling 15 patients

hansabiopharma.com

Anavex Life Sciences ANAVEX 2-73 (blarcamesine)

Parkinson’s Disease phase 2 trial enrolling 120 patients at 20 sites across Spain and three sites in Australia

anavex.com

Cassava Sciences PTI-125 Alzheimer’s Disease phase 2b trial enrolling 64 patients

cassavasciences.com

Isofol Medical arfolitixorin metastatic colorectal cancer phase 1/2 trial completed isofolmedical.com

VistaGen Therapeutics

AV-101 oral NMDAR (N-methyl-D-aspartate receptor)

dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy

phase 2 IND cleared by the FDA

vistagen.com

NuCana Acelarin (NUC-1031) biliary tract cancer phase 3 trial dosing first patients in U.S. and Europe

nucana.com

Abbott Infinity Deep Brain Stimulation system

Parkinson’s Disease approved by the FDA for new indication

abbott.com

Epizyme Tezverik (tazemetostat)

metastatic or locally advanced epithelioid sarcoma not eligible for complete resection

approved by the FDA epizyme.com

Merck Dificid (fidaxomicin) Clostridioides difficile-associated diarrhea in children ages six months and older

approved by the FDA merck.com

Teva Pharmaceuticals USA

AJOVY (fremanezumab-vfrm) autoinjector

migraine approved by the FDA tevausa.com

Boehringer Ingelheim

Eli Lilly

Trijardy XR type 2 diabetes approved by the FDA us.boehringer-ingelheim.com

lilly.com

Pharmacosmos Therapeutics

Monoferric (ferric derisomaltose) injection

iron deficiency anemia approved by the FDA pharmacosmos.com

© 2020 CenterWatch CWW2405

WCG | CWWeekly February 3, 2020 9 of 9

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