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Vol. 25, Issue 21. Copyright © 2021 by WCG CenterWatch Join the CenterWatch Community! see Participant Compensation on page 5 » see Use of Master Protocols on page 6 » May 24, 2021 Industry Briefs…3 FCRI Update…4 Drug & Device Pipeline News…8 Twenty-five drugs and devices have entered a new trial phase this week. Research Center Spotlight…10 Weekly By Charlie Passut T he use of master protocols in the U.S. will likely increase and expand into more treatment areas now that the FDA has signaled support for the prac- tice in a new final guidance for COVID-19 trials last week. Pamela Tenaerts, former executive direc- tor of the Clinical Trials Transformation Initia- tive (CTTI) and current chief scientific officer at Medable, said she was not surprised that the guidance emerged from an FDA with Acting FDA Commissioner Janet Woodcock at the helm. “She is very keen, and I think the FDA is in general, to make clinical trials more efficient,” Tenaerts told CenterWatch Weekly. “That’s not to say that this is a panacea for how every research trial should be done, but there are situations — especially when you’re talking about things like repurposed drugs — where it makes good sense to have a clinical trial with one control arm and then multiple treatment arms.” Lindsay McNair, chief medical officer at WCG, echoed Tenaerts’ sentiments. “While the startup timelines of new clinical trials for COVID-19 therapies have been remarkable, the FDA guidance rightly points out that master protocols are a rigorous and highly efficient way to answer multiple important study questions while reducing infrastruc- ture effort and administrative time and effort,” McNair says. “We’ve certainly seen this in the example of the UK-run RECOVERY Use of Master Protocols Expected to Grow in Wake of FDA Guidance By Charlie Passut C ompensating clinical trial partici- pants for their time, effort and risk is a practice commonly accepted by regulators and IRBs, although regulations do not specifically mention the concept. Instead, they require only that a trial’s informed consent process be free of any coercion or undue influence although many questions remain about what’s allowed and what isn’t. The words “payment” and “incentive” do not appear in either FDA regulations for clinical trials or in the Common Rule, said David Borasky, vice president of IRB compli- ance for WCG IRB. “But what you are going to find is language that says informed consent must be obtained under circumstances ‘that minimize the possibility of coercion or undue influence,’” he said. Because the issues are complex and there is little guidance for sponsors, sites or IRBs, sites and sponsors should work out compensation details before the budget is finalized or the clinical trial agreement is signed, making sure that all questions of influence are answered. Only then should the site begin work on the informed consent for the trial, says Jennifer Peterson, execu- tive director for site startup and regulatory for the Americas at Syneos Health. Peterson offered some “Do” and “Don’t” pointers to attendees at a recent WCG webinar on participant compensation. “Dos” include: Sites Look to Compensate Trial Participants While Avoiding Undue Influence CenterWatch Holiday Notification In observance of Memorial Day in the U.S., CWWeekly will not be published Monday, May 31. The next issue will be published Monday, June 7. GCP Questions, FDA Answers 2021 Edition ORDER TODAY More than 100 responses to questions posed to OGCP, curated and segmented by category FREE WEBINAR REGISTER Accelerate the Startup of Your Clinical Trials Without Sacrificing Quality: Common Pitfalls that Cause Delays and How to Avoid Them Sponsored by Diligent Pharma, LLC JUNE 17 NEW WHITE PAPERS AVAILABLE The Essential Guide to a Fourth-Generation eTMF From Agatha centerwatch.com/whitepapers LEARN MORE

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Page 1: Weekly Join the CenterWatch Community

Vol. 25, Issue 21. Copyright © 2021 by WCG CenterWatch

Join the CenterWatch Community!

see Participant Compensation on page 5 »

see Use of Master Protocols on page 6 »

May 24, 2021

Industry Briefs…3

FCRI Update…4

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

Research Center Spotlight…10

Weekly

By Charlie Passut

The use of master protocols in the U.S. will likely increase and expand into more treatment areas now that

the FDA has signaled support for the prac-tice in a new final guidance for COVID-19 trials last week.

Pamela Tenaerts, former executive direc-tor of the Clinical Trials Transformation Initia-tive (CTTI) and current chief scientific officer at Medable, said she was not surprised that the guidance emerged from an FDA with Acting FDA Commissioner Janet Woodcock at the helm.

“She is very keen, and I think the FDA is in general, to make clinical trials more efficient,” Tenaerts told CenterWatch Weekly. “That’s not to say that this is a panacea for

how every research trial should be done, but there are situations — especially when you’re talking about things like repurposed drugs — where it makes good sense to have a clinical trial with one control arm and then multiple treatment arms.”

Lindsay McNair, chief medical officer at WCG, echoed Tenaerts’ sentiments. “While the startup timelines of new clinical trials for COVID-19 therapies have been remarkable, the FDA guidance rightly points out that master protocols are a rigorous and highly efficient way to answer multiple important study questions while reducing infrastruc-ture effort and administrative time and effort,” McNair says. “We’ve certainly seen this in the example of the UK-run RECOVERY

Use of Master Protocols Expected to Grow in Wake of FDA Guidance

By Charlie Passut

Compensating clinical trial partici-pants for their time, effort and risk is a practice commonly accepted by

regulators and IRBs, although regulations do not specifically mention the concept. Instead, they require only that a trial’s informed consent process be free of any coercion or undue influence although many questions remain about what’s allowed and what isn’t.

The words “payment” and “incentive” do not appear in either FDA regulations for clinical trials or in the Common Rule, said David Borasky, vice president of IRB compli-ance for WCG IRB. “But what you are going to find is language that says informed consent must be obtained under circumstances

‘that minimize the possibility of coercion or undue influence,’” he said.

Because the issues are complex and there is little guidance for sponsors, sites or IRBs, sites and sponsors should work out compensation details before the budget is finalized or the clinical trial agreement is signed, making sure that all questions of influence are answered. Only then should the site begin work on the informed consent for the trial, says Jennifer Peterson, execu-tive director for site startup and regulatory for the Americas at Syneos Health. Peterson offered some “Do” and “Don’t” pointers to attendees at a recent WCG webinar on participant compensation.

“Dos” include:

Sites Look to Compensate Trial Participants While Avoiding Undue Influence

CenterWatch Holiday Notification

In observance of Memorial Day in the U.S., CWWeekly will not be published Monday, May 31. The next issue will be published Monday, June 7.

GCP Questions, FDA Answers2021 Edition

ORDER TODAY

More than 100 responsesto questions posed to OGCP, curated and segmented by category

FREE WEBINAR

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Accelerate the Startup of Your Clinical Trials Without Sacrificing Quality: Common Pitfalls that Cause Delays and How to Avoid ThemSponsored byDiligent Pharma, LLC

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NEW WHITE PAPERS AVAILABLE

The Essential Guide to a Fourth-Generation eTMF

From Agatha

centerwatch.com/whitepapers

LEARN MORE

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Copyright © 2021 by WCG CenterWatch CWW2521

CenterWatch Weekly May 24, 2021 2 of 10

Features

By Charlie Passut

D espite the pandemic, clinical trial activity remained historically high in 2020, especially in oncology,

according to a new report by IQVIA. Clinical trial starts increased 8 percent in 2020, an annual growth rate on par with those observed since 2017.

A surge in clinical trials focused on COVID-19 vaccines and therapies resulted in 866 industry-sponsored interventional studies, yielding 12 vaccines and four novel therapeutics to date, as well as a robust pipeline for additional ongoing studies, IQVIA said.

The annual growth rate includes a recov-ery that began in mid-2020 to levels higher than the corresponding period in 2019 — even excluding new COVID-19 trials. Of those 866 trials, 51 were subsequently termi-nated; the remaining 815 trials account for 61 percent of infectious disease trials started from 2020 through early April 2021. Overall, 49 percent of COVID-19 trials remain active, 15 percent are planned but not active and 30 percent are either closed or completed.

There were a total of 4,686 clinical trials started in 2020 — including 1,821 phase 1

studies, 1,880 phase 2 studies and 985 phase 3 studies. By comparison, there were 4,325 studies started in 2019 — including 1,856 phase 1 studies, 1,590 phase 2 studies and 879 phase 3 studies. IQVIA said oncology and rare disease studies were less impacted by disruptions caused by the pandemic.

Although subsequent waves of COV-ID-19 cases have persisted, the clinical trial industry has not seen parallel disruptions to trial starts, compared to the first wave. IQVIA said adaptations and adjustments made by hospitals, investigators and spon-sors helped shield the industry from more devastating disruption.

“While there has been a rebound in trial starts, the overall capacity of sponsors and investigators to conduct trials, along with continued reduced patient volumes in health systems, may be contributing to lower numbers of trial starts,” IQVIA said.

Oncology trial starts reached historically high levels in 2020, hitting a mark more than 60 percent higher than studies started in 2015, IQVIA said, reflecting “strong momen-tum in this area and especially in rare oncol-ogy indications.” There was also significant overlap between oncology and rare dis-

eases, with rare oncology trials representing 63 percent of oncology trials overall and 64 percent of rare disease trials overall — sig-naling a trend toward precision medicine.

Clinical trial starts in eight other therapy areas — specifically, dermatology, neurol-ogy, endocrinology, immunology, cardiovas-cular disease, women’s and sexual health, respiratory disease and ophthalmology — declined slightly in 2020 but remained high in most cases and were only temporarily disrupted, IQVIA said. More of the declines were in phase 1 trials, as the pandemic hampered sponsors and investigators from initiating new trials.

IQVIA also found that clinical trial complexity continued a two-year decline in 2020, a consequence of the reduced number of sites and countries performing research due to the pandemic, and slight decreases in endpoints and eligibility criteria in trials.

The length of trials has been increasing across all phases and now averages 1.5 years for phase 1, almost three years for phase 2 and 2.5 years for phase 3, as measured from trial start to primary completion.

Read the report here: https://bit.ly/3ft wQ9n.

Clinical Trial Activity Stayed Historically High in 2020 Despite Pandemic, Especially in Oncology, IQVIA Says

Total Number of Clinical Trial Starts by Phase, 2010 to 2020

Source: Citeline Trialtrove, April 2021; IQVIA Institute, April 2021

Phase 2 Phase 3Phase 1

1,202 1,267 1,099 1,134 1,352 1,241 1,253 1,429 1,574 1,856 1,821

1,220 1,222 1,205 1,1251,182 1,272 1,332

1,4781,550

1,5901,880919 924 903 890

859 929 821799

852879

985

3,341 3,413 3,207 3,1493,393 3,442 3,406

3,7063,976

4,3254,686

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

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Copyright © 2021 by WCG CenterWatch CWW2521

CenterWatch Weekly May 24, 2021 3 of 10

Industry Briefs

CVS Launches Clinical Trial Services, Plans Trials in Stores and Homes

CVS Health says it plans to conduct phase 3 and phase 4 clinical trials from some of its stores and will work with sponsors and others to boost patient recruitment and generate real-world evidence (RWE) through its new business, Clinical Trial Services.

The new business will initially focus on patient recruitment, using its footprint and local community connections to help customers learn about upcoming relevant clinical trial opportunities, Woonsocket, R.I.-based CVS Health said.

Clinical Trial Services will support more than 200 in-home clinical trials, as well as retrospective and prospective studies for generating RWE.

The new company also plans to use some of its more than 800 CVS HealthHUB locations in 34 states to support clinical trials. CVS Health has worked with 15 of the 20 largest pharmaceutical companies through two of its businesses, Healthagen and Coram, as well as Aetna. CVS Health has already been helping with clinical trials in a pilot program from HealthHUB locations in three states.

FDA Updates Guidance on Form 1572 Waivers for Foreign Investigators

The FDA has updated its guidance on Form 1572, the FDA’s Statement of

Investigator, to clarify what sponsors can or should do if a foreign investigator is unable or unwilling to sign the form.

The guidance was developed in response to sponsor questions on how to proceed if regional, national or local laws or regulations prohibit a foreign investigator from signing the form. One option is to request a waiver from the FDA. Another is to have the foreign site operate as a noninvestigational new drug (IND) site.

The FDA also recommended that sponsors obtain signed, written state-ments from investigators acknowledg-ing their commitment to comply with any applicable regional, national or local laws.

For sponsors that choose to conduct a foreign clinical study or to operate non-U.S. sites in a multinational study under an IND, the FDA says the foreign investigators would still be in compliance with U.S. regulations if they follow Inter-national Council for Harmonization (ICH) E6 Good Clinical Practice guidelines, with two exceptions:

} FDA requirements for IRBs differ slightly under ICH E6, so sponsors would need to request an additional waiver; and

} Informed consent requirements for IRBs are more extensive under ICH E6 than under FDA regulations.

Comments on the draft guidance are due by July 19.

Read the FDA guidance here: https://bit.ly/3u79ICC.

Proposed ICH E6 Update Nets 1,300 Comments, Likely Delayed Until 2022

The International Council on Harmo-nization (ICH) said the third revision of its good clinical practice guideline will likely be delayed into 2022 as the group wades through 1,300 comments from the public about the revision.

Lisbeth Bregnhøj, GCP inspector at the Danish Health and Medicines Authority, said comments received indicate stake-holders want the ICH to identify ways in which clinical trial participants can take a more active role in trials; to consider sharing trial results with participants; and to clarify or update adverse event report-ing recommendations.

She said stakeholders also want ICH E6(R3) to address new technologies, clini-cal trial designs and data types, such as from wearables and artificial intelligence. Stakeholders also complained that some areas of the proposed guidance lack detail — including in data management, the review of safety data, the use of data monitoring or adjudication committees, and informed consent.

The ICH gave a peek into its E6(R3) draft last month (CenterWatch Weekly, April 26). The public will have another chance to comment when the draft guideline is released.

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Copyright © 2021 by WCG CenterWatch CWW2521

CenterWatch Weekly May 24, 2021 4 of 10

FCRI Update

Eight FCRI stocks gained. Significant gainers included IQVIA Holdings (+22%), Syneos Health (+12%) and ICON (+10%). There were no significant decliners.

NOTES ON INDICES

First Clinical Research Index (FCRI). Calculated as the mean average percentage change from baseline, dividends excluded, adjusted for stock splits. In other words, the indices are not weighted for stock price or market capitalization. Prices are in local currencies. Index components may change from time to time based on new listings, mergers and other factors. Components include 8 publicly traded clinical research stocks: CMIC (2309:JP), EPS (4282:JP), Hangzhou Tigermed Consulting (300347:CH), ICON (ICLR:US), IQVIA Holdings (IQV:US), Medpace Hold-ings (MEDP:US), PRA Health Sciences (PRAH:US), and Syneos Health (SYNH:US).

S&P 500 Index (SPX). Capitalization-weighted representative sample of 500 mostly large-capitalization companies in leading industries of the U.S. economy.

S&P 500 Pharmaceutical Index (S5PHARX). Capitalization-weighted S&P 500 companies engaged in research, development or production of pharmaceuticals.

S&P 500 Biotechnology Index (S5BIOTX). Capitalization-weighted S&P 500 companies primarily involved in development, manufacturing or marketing of products based on advanced biotechnology research.

Stock and index prices are available at http://www.bloomberg.com/ and http://bigcharts.marketwatch.com/industry/bigcharts-com/industry chart.asp.

FCRI58%

S&P 50055%

Pharma51%

Biotech54%

This Month’s FCRI, a Stock Index of 8 Publicly Traded Clinical Trials Companies Here is this month’s First Clinical Research Index (FCRI), a stock index of eight publicly traded clinical research companies. Each month, Center-Watch Weekly will publish the calculation of the FCRI, based on the closing stock prices on the last trading day of the prior month, to show how the industry’s publicly traded stocks are faring compared to three other widely followed indices: the Standard & Poor’s (S&P) 500 index, the S&P Pharmaceutical Index and the S&P Biopharmaceutical Index. For more information about the index, read on.

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CenterWatch Weekly May 24, 2021 5 of 10

Features

} Do negotiate the payment compensa-tion line item in the trial budget first whenever possible;

} Do communicate the agreed com-pensation amount to the regulatory staff that will work on informed consent preparation;

} Do consult with the IRB for any ques-tions or concerns related to compensa-tion and reimbursement;

} Do take population, age, demograph-ics and other factors into account when determining the amount of compensation because it costs more to incentivize some participants than others and the effort to enroll as di-verse a population as possible can lead to different rates or forms of compen-sation; and

} Do pay similar amounts to participants involved in similar activities but be flexible enough to allow variation when it is based on indications or procedures that some participants undergo while others don’t.

On the list of things not to do, Peterson included:

} Don’t finalize the review of informed consent documents before the site’s budget is set;

} Don’t submit informed consent docu-ments — or any documents — to the IRB without making sure that everyone involved in the trial is in agreement on the details of the compensation scheme; and

} Don’t frontload or backload compen-sation — providing payments either before the trial starts or after it has concluded — to avoid any appearance of coercion.

Peterson says compensation for loss of wages is variable but offered some payment ranges for specific trial participant activities, including $75 to $100 for an office visit, $75 for completion of an online questionnaire, $250 for a liver biopsy and $50 for an MRI.

The clinical trials industry has seen many changes to participant compensation over the years. Compensation for caregivers in addition to participants is one idea that is gaining traction. Sites are more aware of the financial impact on those who assume the role of an elderly, pediatric or spousal partici-pant caregiver, Peterson said. Compensation to such caregivers is being made to cover for loss of wages and for transportation costs. “Loss of wages is something kind of new to the U.S.,” she said. “It had been used more significantly in Europe.”

Borasky says caregiver compensation presents no problem for IRBs. “There is no prohibition on compensating caregivers,” he told CenterWatch Weekly, “particularly when a subject’s ability to participate is dependent on caregiver assistance or even obtaining in-formation/data via the caregiver. It would be reasonable for the IRB to examine proposed caregiver compensation to ensure that it would not lead to the caregiver putting pressure on the potential subject, but I think that this is rare in reality.”

Peterson added that sites have been getting more creative in compensating pediatric participants, with games, gift cards and electronics, for example. And concierge services for adult participants, such as sites providing transportation and making travel and hotel arrangements as part of a com-pensation package, became very popular during the pandemic.

According to site partners and trial partic-ipants she has talked to, Peterson said most independent sites pay their trial participants on the day of a particular procedure or visit or on a designated day of the week, while participants at academic sites could be wait-ing upward of a few weeks for payment.

But some transactions can be almost im-mediate, she said. “I talked to one participant in a clinical trial who had just completed a visit, and by the time he got to his car he had already received a text that said his debit card had been loaded with funding for his participation,” she said. “There aren’t any true regulations or guidances governing the pay-ment schedule, but it is recommended that it’s within at least a business week.”

Participant Compensation(continued from page 1) “There is no prohibition on

compensating caregivers, particularly when a subject’s

ability to participate is dependent on caregiver assistance or even obtaining information/data via

the caregiver.”

—David Borasky, vice president of IRB compliance for WCG IRB

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CenterWatch Weekly May 24, 2021 6 of 10

Features

clinical trial master protocol, which has ran-domized almost 40,000 participants, tested multiple potential therapies and generated important and well-controlled data on sev-eral interventions for COVID-19 treatment.

“This guidance gives a lot more muscle to master protocols,” Tenaerts adds, “which is very encouraging. That’s not to say we weren’t using master protocols. We were. We just weren’t quite as orga-nized as the UK.”

While the guidance is directed at single sponsors, McNair points out that there are few sponsors who have multiple products in development for COVID-19 solutions. According to data from WCG’s Knowledge Base, 73 percent of sponsors involved in COVID-19 research are conducting only one trial, 22 percent are conducting two to four trials and only 5 percent are conduct-ing five or more studies.

“Collaboration between sponsors to use the same master protocol is certainly pos-sible,” she adds, “and hopefully some of the collaborations and partnerships we have seen developing in the past year could contribute to this.”

In its May 17 guidance, the FDA said master protocols, when designed and executed effectively, can accelerate drug development by evaluating multiple drugs at the same time and maximizing the amount of information gained during research compared to standalone trials.

They can also save drugmakers time and money in study startup and can increase data quality and efficiency through shared and reusable infrastructure.

“In a one-off, one-arm clinical trial, every time the trial is done it gets ripped up,” Tenaerts says. “The next person who wants to come in with a new treatment has to build up the sites and set up the whole infrastructure again. Part of the master protocol system is that you create this ongoing activity — where study drugs can come in and out — so you lose having to set all that study startup time aside every single time because the center is already engaged. It creates a continuous learning environment and it’s a lot more efficient.”

While the FDA’s guidance only covers COVID-19 trials, Tenaerts says she believes the door is open to expanded use of master protocols. “At CTTI, we had a lot

of patient organizations come to us that were looking at the effectiveness of the clinical trial system. They were interested in learning how to do master protocols in areas that hadn’t typically had master pro-tocols. The areas where master protocols were happening were in oncology. These patient groups asked ‘How can we do this better? What should we think about master protocols?’”

In its guidance, the FDA advised spon-sors using master protocol designs to meet with the agency before making a change where a drug evaluated under a master protocol is incorporated into a trial as either background therapy or as part of the control arm. The FDA also advised sponsors to meet with them to discuss endpoint selection in cases where drugs intended to affect different aspects of a disease — such as anticoagulants and antivirals — may have multiple endpoints specific to the intervention.

The FDA said it may be appropriate, under certain circumstances and with agency concurrence, for sponsors to take a selective approach to safety data collec-tion for repurposed drugs being studied for use against COVID-19. The agency said sponsors should also use a central IRB to review the master protocol and should appoint an independent, third-party data monitoring committee or similar entity to assess safety and efficacy data.

Read the guidance here: https://bit.ly/ 3eReoYY.

Use of Master Protocols(continued from page 1) “The FDA guidance rightly points

out that master protocols are a rigorous and highly efficient way

to answer multiple important study questions while reducing

infrastructure effort and administrative time and effort.”

—Lindsay McNair, chief medical officer at WCG

The issue of proper documentation in IRB liabilityBy Sue Coons, MA

T he guidance Minutes of Institutional Review Board (IRB) Meetings in

Federal Register describes the requirements for IRB meet-ing minutes and provides recommenda-tions for meeting applicable regulatory

Protections (OHRP) and Food and Drug Administration (FDA). It is intended for institutions and IRBs responsible for oversight of human subject research under HHS and FDA regulations.

However, a court case from the early -

ing IRB meeting activity not only puts IRBs in violation of regulatory standards, but also could put them in legal cross-hairs if research participants are harmed or perceive harm in a clinical trial.

Inadequate documentation in IRB

during FDA inspections, the guidance

FDA’s website for bioresearch monitor-ing (www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm -cies found during IRB inspections to be: inadequate initial and/or continuing review; inadequate written procedures; inadequate meeting minutes and mem-

bership rosters; quorum issues; prompt reporting of noncompliance, suspension/termination; Subpart D issues; and lack of or incorrect risk determination.

Learning Objectives:

1. List some of the documentation deficiencies FDA is finding in its IRB inspections.

2. Describe the claims plaintiffs in Robertson v McGee made against IRB members.

3. Explain the importance of proper documentation of IRB activities.

4. Discuss the concept of individual liability in IRB decisions.

2 CE program information

3 Regulatory update

6 IRB meeting minutes

16 CE post-test

In this issue:

see IRB liability on page 4

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CenterWatch Weekly May 24, 2021 7 of 10

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CenterWatch Weekly May 24, 2021 8 of 10

Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor ContactCOVID-19 Trials and ActionsLaurent Pharmaceuticals

LAU-7b hospitalized patients with COVID-19

recruitment complete in phase 2 trial

laurentpharma.com

Kintor Pharmaceutical

proxalutamide hospitalized patients with COVID-19

approval received from the FDA to proceed with a phase 3 trial

en.kintor.com.cn

LabCorp Pixel COVID-19 PCR test home collection kit for ages two to 17

COVID-19 test Emergency Use Authorization (EUA) granted by the FDA

labcorp.com

Roche Cobas SARS-CoV-2 test asymptomatic COVID-19 testing EUA granted by the FDA roche.comOther Trials and ActionsGammaDelta Therapeutics

GDX012 hematological malignancies IND approved by the FDA gammadeltatx.com

ImmunityBio m-ceNK platform combined with Anktiva (N-803)

locally advanced or metastatic solid tumors

IND approved by the FDA immunitybio.com

DiaMedica DM199 (recombinant human tissue kallikrein-1or KLK1)

acute ischemic stroke IND approved by the FDA for a phase 2/3 trial

diamedica.com

PharmaTher Holdings

ketamine levodopa-induced dyskinesia in patients with Parkinson’s disease

IND approved by the FDA for a phase 2 trial

pharmather.com

Propella Therapeutics

PRL-02 (abiraterone decanoate)

metastatic prostate cancer IND approved by the FDA propellatx.com

InnoCare oral ICP-332 autoimmune diseases IND approved by China's National Medical Products Administration

innocarepharma.com

Altasciences

SiteOne Therapeutics

ST-2427 management of moderate-to-severe pain

initiation of phase 1 trial altasciences.com

siteonetherapeutics.com

Crescendo Biologics CB307 patients with advanced and/or metastatic PSMA-positive solid tumors

first patient enrolled in phase 1 trial

crescendobiologics.com

GoldFinch Bio GFB-024 severe insulin-resistant diabetic nephropathy

first patients dosed in phase 1 trial

goldfinchbio.com

Mustang Bio

City of Hope

MB-101 (autologous IL13Rα2-CAR T cells)

leptomeningeal brain tumors (e.g., glioblastoma, ependymoma or medulloblastoma)

first patients dosed in phase 1 trial

mustangbio.com

cityofhope.orgPyramid Biosciences PBI-100 mild-to-moderate psoriasis first patients dosed in phase

1 trialpyramidbio.com

Catalyst Biosciences marzeptacog alfa (activated); MarzAA

bleeding in FVII deficiency, Glanzmann thrombasthenia and hemophilia A with inhibitor patients receiving Hemlibra prophylaxis

first patient dosed in phase 1/2 trial

catalystbiosciences.com

GeneTx Biotherapeutics

Ultragenyx Pharmaceuticals

intrathecally administered GTX-102

Angelman syndrome clearance from Health Canada to initiate phase 1/2 trial

genetxbio.com

ultragenyx.com

continues on next page »

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CenterWatch Weekly May 24, 2021 9 of 10

Drug & Device Pipeline News (continued from page 8)

Company Drug/Device Medical Condition Status Sponsor ContactXalud Therapeutics XT-150 patients with radicular

neuropathic pain due to lumbar disc disease

first patient dosed in phase 1/2a trial

xaludthera.com

Galera Therapeutics GC4711 in combination with stereotactic body radiation therapy (SBRT)

locally advanced pancreatic cancer

first patient dosed in phase 2b trial

galeratx.com

Xalud Therapeutics XT-150 moderate-to-severe pain due to osteoarthritis of the knee

recruitment complete in phase 2b trial

xaludthera.com

Endogena Therapeutics

EA-2353 ophthalmic suspension

retinitis pigmentosa Orphan Drug designation granted by the FDA

endogena.com

GammaDelta Therapeutics

GDX012 acute myeloid leukemia Orphan Drug designation granted by the FDA

gammadeltatx.com

Bridge BioPharma BBP-631 congenital adrenal hyperplasia Fast-Track designation granted by the FDA

bridgebio.com

Palisade Bio LB1148 reduction of adhesions following abdominal or pelvic surgery

Fast-Track designation granted by the FDA

palisadebio.com

Apellis Pharmaceuticals

Empaveli (pegcetacoplan)

adults with paroxysmal nocturnal hemoglobinuria

approved by the FDA apellis.com

Learn more at www.centerwatch.com/crctrainer

The CRC TrainerAn Interactive Companion to The CRC’s Guide to CoordinatingClinical Research.

The CRC Trainer is an interactive course built to support learners in a self-paced journey through the complex material of the guide. It covers all essential aspects of the coordinator role and focuses on the most important material in the guide.

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CenterWatch Weekly May 24, 2021 10 of 10

Research Center Spotlight

Research Center Spotlight is a 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 [email protected].

Hollywood, [email protected]

Infinity Clinical Research is the research division of a consortium of single and multispecialty, multidisciplinary medical practices throughout Broward County, Florida.

Cincinnati, [email protected]

Bernstein Clinical Research Center has been conducting clinical research since 1969 in adult and pediatric patients. The center has contributed to the development of new therapies for asthma, allergic rhinitis and chronic obstructive pulmonary disease.

Torrance, [email protected]

Advanced Dermatology Institute has been conducting clinical research in dermatology for more than 35 years.

Toms River, [email protected]

Advanced Memory Research Institute of New Jersey specializes in identifying memory prob-lems, reviewing currently approved treatments and clinical research opportunities.

Wheat Ridge, [email protected]

Western States Clinical Research consists of an independent study coordinating group working with a select group of principal investi-gators in several therapeutic areas. We participate in phase 2 to 4 trials for the pharmaceutical industry.

Las Vegas, [email protected]

Sierra Clinical Research is a dedicated research site in the greater Las Vegas area conducting studies in a variety of therapeutic areas, including pulmonology, gastroenterology, cardiology, pediatrics, dermatology and neurology.

Philadelphia, [email protected]

Paddington Testing Company is a center devoted to clinical research as part of a dermatologic practice. The clinical trials center conducts both in- and outpatient studies related to the skin, hair and nails.

Renton, [email protected]

Rainier Clinical Research Center is a privately owned, independent research clinic conducting phase 1 through phase 4 clinical trials of both drugs and devices.

Paddington Testing Company

Rainier Clinical Research Center

Advanced Dermatology Institute

Advanced Memory Research Institute of New Jersey

Bernstein Clinical Research Center Sierra Clinical Research

Infinity Clinical Research Western States Clinical Research

300 N. Washington St., Suite 200 • Falls Church, VA 22046-3431 Phone: 866.219.3440 or 617.948.5100 Customer Service: [email protected]

Editorial Director: Beth Belton, 703.538.7641, [email protected] Reporter: Charlie Passut, 703.538.7664, [email protected]: Russ Titsch, 813.767.6463, [email protected]

Copyright © 2021 by WCG CenterWatch. All rights reserved. CenterWatch Weekly (ISSN 1528-5731), an executive news briefing for the clinical trials industry, is published 48 times a year and is available for free. Photocopying or reproducing in any form is a violation of federal copyright law and is strictly prohibited without the publisher’s permission.

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