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Volume 23, Issue 27. © 2019 CenterWatch. All rights reserved.
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Real World Evidence and Data A Tufts Study of 30 Pharma Companies
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15
July 22, 2019
Up and Coming…2
Industry Briefs…3
Drug & Device Pipeline News…7Seventeen drugs and devices have entered a new trial phase this week.
CWMarketPlace…8
CenterWatchWeekly
Are you like too many other clinical trial sites? Not getting paid what you think you’re owed, getting checks
that you can’t tie to a study or spending too much time resubmitting invoices?
Then you should think about conducting regular financial audits, says David Rus-sell, director of site strategy at PFS Clinical. “Sponsors and CROs are typically not going to remind you to send them invoices or to request the funds that you’ve already agreed to.”
And while it may seem like a lot of work, conducting financial audits can “reap very large rewards in making sure that every-thing is collected,” Russell told a Center-Watch webinar.
In his experience, payments are made on time and in accordance with the CTA only about 72 percent of the time. And even when they’re paid on time, they often aren’t accurate. “Only about 70 percent of payments are actually paid correctly. That’s a high number, but that means three out of every 10 invoices that you send in, or visit checks that you’re seeing, are inaccurate.”
“This is not saying that sponsors or CROs intentionally are paying inaccurately. Oftentimes I think they’re doing the best that they can. All I can say is, look at it from their perspective. As a sponsor, as a CRO, if there’s a study that’s going on, and we’ll just generalize and say it’s at 40 sites, what that typically means is that there’s 40 different
Sites: Make Financial Audits Work for You
By Elizabeth Hinkle
Despite more than six years of regu-lators’ encouragement to adopt risk-based monitoring (RBM) of
trials, the industry still has concerns about compliance.
Attendees at a recent FDA workshop question whether RBM is appropriate for small and complex studies, the appropriate-ness of sampling techniques for source data review (SDR) and source data verification (SDV) and how data privacy regulations might impact transmission and review of trial subject data.
But RBM has been shown to improve data quality, David Burrow, director of CDER’s Office of Scientific Investigations, told attendees at the workshop, also
sponsored by Duke University. With com-panies that have implemented true RBM programs, Burrow said, the FDA has seen a great correlation between issues caught by those plans and problems often flagged in new drug applications.
But challenges — such as customization of RBM to individual trials and regulatory consistency — remain, leaving the industry lukewarm, industry speakers and workshop attendees agreed.
One problem that comes up frequently is a lack of understanding of what RBM means from the FDA’s perspective. RBM is part of an overall quality management plan, not just a component of study monitoring, Burrow said. Companies need to look at
Regulators, Industry Still Have Not Reached Consensus on Risk-Based Monitoring
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Up and Coming
This feature highlights changes in clinical research organizations’ personnel.
GileadExecutive shakeup continues at Gilead, where chief scientific officer and R&D head John McHutchison will leave the company next month. Hutchison, a nine-year veteran of the company, stepped into his current position a little more than a year ago. Gilead did not specify a reason for his departure and has not named a successor. Also leaving next month is chief patient officer Gregg Alton, who will serve in an advisory capacity until the end of the year.
MODAGMODAG has announced the appointment of Torsten Matthias as chief executive officer and Armin Giese as chief scientific officer. Matthias is the owner, CEO and CSO of world-wide operating group Aesku.Group. Giese was formerly the acting head of department at the Center for Neuropathology and Prion Research at Ludwig Maximilian University of Munich.
ObsEvaElizabeth Garner has been named chief medical officer at Switzerland-based ObsEva SA. Garner most recently served as CMO and head of clinical development at Agile Therapeutics.
RAPT TherapeuticsDirk Brockstedt has been promoted to chief scientific officer and David Wustrow to senior vice president for drug discov-ery and preclinical development at RAPT Therapeutics. Brockstedt was previously the senior vice president of biology at RAPT. Wustrow was most recently vice president of discovery at FLX Bio.
CTDCTD Holdings has named Michael Lisjak as global head of regulatory affairs and senior vice president for business development.
Lisjak most recently served as head of global regulatory affairs for established products and global health at Sanofi.
NeptuneMichael Cammarata has been appointed chief executive officer at Neptune Wellness Solutions Inc. Camarata is co-founder and previous chief executive officer of Schmidt’s Naturals, now a division of Unilever. He is also the founder of Random Occurrence.
Lyra TherapeuticsLaura M. Edgerly-Pflug has been named senior vice president of technical operations at Lyra Therapeutics. Edgerly-Pflug was most recently vice president of technical opera-tions at Adgero Biopharmaceuticals Holdings.
ProgenicsProgenics Pharmaceuticals has announced the appointment of Huw Jones as vice president, commercial. Jones was previously vice president of marketing and sales at Advanced Accelerator Applications.
Sunesis PharmaceuticalsSunesis Pharmaceuticals has announced two key promotions. Judy Fox has been named chief scientific officer and executive vice president for research & development; Parvinder Hyare has been appointed senior vice president, commercial. Fox was previously chief scientific officer and senior vice president; Par was previously vice presi-dent of global oncology operations.
Health Enterprise PartnersHealth Enterprise Partners has announced the promotion of Elizabeth Colonna to vice president. Jessie Laurash has been named senior associate. Colonna was promoted from the position of senior associate with the company. Laurash most recently served as director of operations for MediQuire.
AnikaAnika Therapeutics has named James Loerop to the newly created position of ex-ecutive vice president of business develop-ment and strategic planning. Loerop most recently served as chief corporate develop-ment officer at Lupin Pharmaceuticals.
EIP PharmaNoel Donnelly has been appointed chief financial officer at EIP Pharma. Donnelly was most recently vice president of R&D busi-ness operations at Shire.’
SkyhawkTai Wong has been named vice president of oncology biology at Skyhawk Therapeutics. Wong was most recently vice president of biology at Peloton Therapeutics.
Sheppard Pratt Health SystemTodd Peters has been named vice president and chief medical officer at Sheppard Pratt Health System. Peters joined Sheppard Pratt in 2018 and served as its medical director of child and adolescent services and chief medical information officer.
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Industry Briefs
FDA Recommends Endpoint for Hormone Analogs for Prostate Cancer Testerone level should be used as a sur-rogate endpoint in phase 3 trials of gonad-otropin-releasing hormone (GnRH) analogs for treating advanced prostate cancer, the FDA says in a new draft guidance.
Sponsors should conduct single-arm trials that measure attainment and main-tenance of castrate testosterone (T) levels, according to the draft guidance released last week. Trials should look at T levels main-tained until the end of a dosing interval as well as immediately after later doses — not the first dose — of the study drug.
“To demonstrate these effects of the study drug on T levels, the treatment period should be at least twice as long as the dos-ing interval,” the agency advises. Products that act over shorter periods, such as one month, should have treatment periods ex-tending over three to four dosing intervals.
Trial participants should have normal, age-adjusted T levels and metastatic disease in order to produce a more accurate safety profile of the intended population, the FDA says. It recommends documenting information about patients’ prostate cancer history, including the diagnosis date, current stage, prior therapies and the extent of metastatic disease at baseline.
Any indications besides treating ad-vanced prostate cancer should be discussed with the agency before a sponsor begins a trial, the draft guidance says. Random-ized designs for supporting efficacy and/or safety among GnRH analogs also should be discussed with the agency.
The draft guidance also provides recom-mendations for dose selection; trial proce-dures and timing of assessments; pharmaco-kinetics and pharmacodynamics; statistical suggestions and labeling considerations.
Read the guidance here: https://bit.ly/32zoyVU.
Heart Failure Trial Uses Biosensors to Gauge Patient-Centric EndpointsA joint clinical study of patients with heart failure is using wearable biosensors to evalu-ate the viability and significance of patient-centric endpoints such as physical function and quality of life.
The multicenter study is being conducted by the Mayo Clinic and Yale University with assistance from the FDA in what is called a CERSI (Center of Excellence in Regulatory Science and Innovation), a collaboration be-tween the agency and academic institutions.
The study follows a draft guidance the FDA released in June that would allow
endpoints based on a treatment’s effect on patient-reported symptoms and experi-ences even if the treatment has no favorable effect on survival or risk of hospitalization (CenterWatch Weekly, July 1, 2019).
Researchers will use two different mobile devices to monitor discharged heart failure patients for 60 days, then analyze the data to measure the correlation between patient-reported outcomes and clinical endpoints, such as lab tests and physical examinations.
MHRA Issues Survey on Patient EngagementThe UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking public feedback on how the agency involves pa-tients in its work, including in clinical trials.
The goal is to find out how patients would like the MHRA to communicate with them and how patients would prefer to communi-cate with the MHRA to raise concerns.
“We want to adopt a more systematic ap-proach to listening to and involving patients — ensuring that the patient voice is heard when safety issues, concerning medicines or medical devices, are identified and in the licensing of new medicines,” the agency says.MHRA’s “con-sultation” survey will be open until Oct. 7.
Take the MHRA survey here: https://bit.ly/32rGemB.
CLINICAL TRIAL RISK AND PERFORMANCEMANAGEMENT SUMMIT
SEPT. 4–5, 2019PHILADELPHIA, PA
Network and problem solve with your peers by choosing one of two tracks, vendor oversight and risk-based quality management.
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Features
Risk-Based Monitoringcontinued from page 1 “On-site monitoring likely will
always have a role, but RBM strategies will need to involve greater use of centralized and
remote tools, as well as various analytical tools...”
—David Burrow, director, CDER Office of Scientific Investigations
RBM as both a whole system and as part of an overall quality-by-design approach to clinical trial development and conduct. He outlined a three-stage approach to develop-ing an RBM plan:}} Risk assessment for each discrete clinical
trial;}} An appropriate and well-articulated study
protocol that considers the identified risks; and}} An RBM plan that focuses on the highest
study-specific risks.Monitoring activities should focus on
processes and procedures deemed most critical for protection of trial subjects and ensuring data integrity, Burrow said.
Most EU regulators have adopted risk-based quality standards and encourage RBM, said EMA scientific administrator Camelia Mihaescu. Aside from minor language differ-ences, the EMA approach under EU regula-tion 536/2014 is very similar to the FDA’s. The EMA, like the FDA, encourages sponsors to position their RBM strategy within the broader quality concept, Mihaescu said.
One area that has proven confusing to sponsors is how centralized or remote monitoring should relate relative to the more traditional on-site monitoring. SDR and SDV,
for instance, traditionally have been conducted via on-site visits, and it is unclear whether a sampling approach, which could be conducted under a more centralized monitoring scheme, would be acceptable for these activities.
Nicole Stansbury, vice president of global centralized monitoring at CRO Syneos Health Clinical Solutions noted that SDR and SDV have been combined with medical re-views over the years, but the items have not been tightly connected. The FDA could help drug sponsors by providing clearer guidance on how to achieve that balance.
On-site monitoring likely will always have a role, Burrow added, but RBM strategies will need to involve greater use of central-ized and remote tools, as well as various analytical tools to identify trends, missing or
inconsistent data, variable data or outliers, protocol deviations and systemic errors. The idea is that RBM can better target risks to the most critical data elements and pro-cedures of a trial, including SDV, SDR and evaluation of study conduct.
Sampling alone does not qualify as an RBM plan, Burrow cautioned. Sampling can be an important part of RBM, but must be included as part of a broader risk mitigation system.
Another key factor is change manage-ment. RBM is not a “set it and forget it” process, Burrow said. Because risk is com-plex and can change as a study progresses, companies must not consider RBM as a single risk assessment, but a continuous improvement concept.
And regulators, sponsors, CROs and sites all agree that companies cannot take a blanket monitoring approach to all studies regardless of design and risk factors. RBM must be tailored to match the specific risks of each individual study.
The FDA issued draft guidance, A Risk-Based Approach to Monitoring of Clinical Investigations — Questions and Answers, on March 19 and is currently reviewing com-ments on the guidance. There is no date set to make the draft guidance final.
Read the FDA guidance and public com-ments here: https://bit.ly/2JHPtYN.
By John W Mitchell
Frustration about clinical trial start-up costs is not unlike Sisyphus’ dilemma. A host of long-standing expense and
inefficiency realities continues to create such uphill headwinds for the clinical trial sector. According to some sources, such problems even threaten the viability of the sector. Sites complain they incur more over-head costs driven by regulatory documen-tation, antiquated data collection and the demands of precision medicine to name a few — all without increased compensation from sponsors and CROs. A recent study supports this concern. Researchers at the Tufts Center for the Study of Drug Devel-opment found that the study start-up phase of five to six months for clinical trials has remained unchanged for the past decade. The study also concluded that CROs mak-ing investments in technology are getting trials done faster. None of this bodes well for smaller, independent players.
“Sites are doing more work for [fewer] patients. We used to enroll about eight pa-
tients per study 10 years ago, and today the number is less than three,” says Jeff King-sley, CEO at IACT Health. His company operates 13 locations in Georgia and a few outside the state in a network of about 100 clinical specialists. “The protocols are lon-ger, and there are more procedures per pa-tient per day. So, you’re doing loads more work, but you’re only paid when you put patients in trials. The averages speak for themselves — you put fewer patients in tri-als today.”
According to Kingsley, the only way to continue this financial model is to partici-pate in three times as many concurrent tri-als. However, he says it’s far more efficient from an overhead standpoint to have one trial that places eight patients, rather than three trials that place eight patients.
Also, at a time when technology is con-quering inefficiencies in other industries, technology is compounding problems in the clinical trial sector. In each of the three studies he cites above, it’s likely that three different electronic health records, tablets
and wearables are used by the different sponsors. When each sponsor uses their own networks and devices for patient-re-ported outcomes, it adds to site workload and time.
“We have no ability to standardize tech-nology,” Kingsley says “We have to do so many trials with so many sponsors, and they have their own decision-making… Our industry suffers from adoptive pho-bia (standardization between sponsors and sites).”
As an example, he cites the advantages of sites adopting electronic platforms such as eSource. Using such a platform could save billions compared to the aggregate cost of monitors flying to sites to review source documents. Clinically, an electronic plat-form also prevents errors such as entering a blood pressure incorrectly or performing a patient procedure out of order from the test protocol.
“We’re trying to convince the industry it’s a huge benefit, but the sites can’t afford
Start-up Costs Can Be an Uphill Slog in Need of Change
© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited.
Status Quo is Not a Viable Option: A Host of Challenges Strain Clinical Trial Site Viability
September 2018 A CenterWatch Publication Volume 25, Issue 09
see Site Viability on page 7
By John W Mitchell
C linical trial site finances are a problem that keeps getting bigger. While there’s agreement improvements are on the
horizon — and at least one sponsor is work-ing to shake things up — there’s also a lot of frustration about the slow pace of reinven-tion. A host of longstanding challenges are intensifying. These issues range from slug-
gish payments, contract viability, preferred site status, interconnectivity and something less tangible — a lack of consideration in the relationship.
Payments, which have traditionally ar-rived quarterly, are often now even later. And sites are hiring extra staff to chase down payments— and medical doctors to keep up with the regulatory requirements, says Karri Venn, president of research at LMC Mann
Research, which operates 19 trial and prima-ry care sites in Canada.
According to recent data, 80 percent of sites prefer monthly payments — with 59 percent in-dicating that quarterly payments have a nega-tive impact on trials. Given a choice, they said they’d choose studies that reimburse monthly.
“We learned very quickly that we had to have a floating line-of-credit...[or] we would
see Start-up Costs on page 6
rustration about clinical trial start-up costs is not unlike Sisyphus’ dilemma. A host of long-standing expense and
inefficiency realities continues to create such uphill headwinds for the clinical trial sector. According to some sources, such problems even threaten the viability of the sector. Sites complain they incur more over-head costs driven by regulatory documen-tation, antiquated data collection and the demands of precision medicine to name a few — all without increased compensation from sponsors and CROs. A recent study supports this concern. Researchers at the Tufts Center for the Study of Drug Devel-opment found that the study start-up phase of five to six months for clinical trials has remained unchanged for the past decade. The study also concluded that CROs mak-The study also concluded that CROs mak-The study also concluded that CROs making investments in technology are getting trials done faster. None of this bodes well for smaller, independent players.
“Sites are doing more work for [fewer] patients. We used to enroll about eight pa-
tients per study 10 years ago, and today the number is less than three,” says Jeff King-sley, CEO at IACT Health. His company operates 13 locations in Georgia and a few outside the state in a network of about 100 clinical specialists. “The protocols are lon-ger, and there are more procedures per pa-tient per day. So, you’re doing loads more work, but you’re only paid when you put patients in trials. The averages speak for themselves — you put fewer patients in tri-als today.”
According to Kingsley, the only way to continue this financial model is to partici-pate in three times as many concurrent tri-als. However, he says it’s far more efficient from an overhead standpoint to have one trial that places eight patients, rather than three trials that place eight patients.
Also, at a time when technology is con-quering inefficiencies in other industries, technology is compounding problems in the clinical trial sector. In each of the three studies he cites above, it’s likely that three different electronic health records, tablets
and wearables are used by the different sponsors. When each sponsor uses their own networks and devices for patient-re-ported outcomes, it adds to site workload and time.
“We have no ability to standardize tech-nology,” Kingsley says “We have to do so many trials with so many sponsors, and they have their own decision-making… Our industry suffers from adoptive pho-bia (standardization between sponsors and sites).”
As an example, he cites the advantages of sites adopting electronic platforms such as eSource. Using such a platform could save billions compared to the aggregate cost of monitors flying to sites to review source documents. Clinically, an electronic plat-form also prevents errors such as entering a blood pressure incorrectly or performing a patient procedure out of order from the test protocol.
“We’re trying to convince the industry it’s a huge benefit, but the sites can’t afford
Status Quo is Not a Viable Option: A Host of Challenges Strain Clinical Trial Site ViabilityBy John W Mitchell
linical trial site finances are a problem
gish payments, contract viability, preferred site status, interconnectivity and something less tangible — a lack of consideration in the
Research, which operates 19 trial and prima-ry care sites in Canada.
see Start-up Costs on page 6
In this issue3-4 In Review
Regulatory Update
5 Action Items
Part 4: How to Identify Candidate Fraudulence Early in The Recruitment Cycle By Angela Roberts
Top Considerations for Using Digital Health Devices in Clinical Trials By Vicki Gashwiler
Risk-based Quality Management: The New Normal By Brion Regan
10-11 Pipeline NewsFDA Actions
The CenterWatch MonthlyISSN 1556-3367
Editorial Director Lisa SteinProduction Renee Breau
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The CenterWatch Monthly September 2018 3
InReview
FDA Signs Off on Treatment for Rare, Adrenal Gland Tumors
The FDA has approved the injectable drug Azedra for rare cancers of the adre-nal glands — the first ever non-surgical therapy OK’d for these tumors.
Azedra (iobenguane I131) is a radiother-apy drug that attacks tumors with a high, specifically targeted dose. It’s designed to treat adults and children (12 and older) with inoperable locally advanced or metas-tic cancers called phenochromocytoma and paraganglioma.
Pheochromocytoma forms inside and paraganglioma grows outside the adrenal gland(s).
Both tumor types release hormones that can cause symptoms including high blood pressure, rapid heartbeat and anxiety.
University of Pennsylvania research-ers gave 68 patients in a trial at least one therapeutic dose of Azedra. The results: 25 percent who received at least one dose and 32 percent of those who received two doses saw their blood pressure drop enough to cut their hypertension meds in half.
“This is a true breakthrough. Until to-day, there were no anti-tumor therapies available for patients with these tumors who were not candidates for surgery,” said principal investigator Daniel Pryma, an associate professor of Radiology and Ra-diation Oncology.
“This therapy not only controls the tu-mors but also the debilitating symptoms caused by their excess hormone produc-tion, meaning it provides dual benefit to patients,” added Pryma, also chief of Penn’s Nuclear Medicine and Clinical Mo-lecular Imaging.
Reported side effects include low white blood cell and platelet counts, fatigue and anemia.
The FDA gave Azedra an Orphan Drug designation, Fast Track status and Break-
through Therapy designation in the U.S. Its license is held by Progenics Pharmaceuticals.
Japan Greenlights Parkinson’s TrialIn the first trial of its kind, Kyoto University
scientists have won approval from Japanese regulators to test adult stem cells as a possible treatment for Parkinson’s disease.
Induced pluriopotent stem cells (iPS) are derived from skin or blood cells and induced back into an embryonic-like plu-ripotent state that can divide into more stem cells or become any type of cell in the body, leading to a potentially unlimited source of any type of human cell needed for therapeutic purposes. They’re consid-ered promising for regenerative research because they can become different hu-man cells and, also, avoid controversy sur-rounding stem cells from human embryos.
Researchers plan to transplant iPS cells into the brains of Parkinson’s patients in the hope they will help repair or replace damaged nerve cells. This is the first trial of its kind to use iPS cells.
Scientists say they’re cautiously optimis-tic after testing the process in monkeys, who showed improvement and didn’t de-velop brain tumors — a much-feared po-tential side effect.
FDA: Focus on Hardest to Treat in Cohort Cancer Trials
The FDA says sponsors considering adaptive studies for early phase cancer treatments should focus on patients with no other options.
The agency notes that so-called expan-sion cohort trials — which start out rela-tively small but expand if a potential treat-ment shows promise--can be a way to get a treatment to market more quickly.
Regulatory Update
see Regulatory Update on page 4
sector. According to some sources, such problems even threaten the viability of the sector. Sites complain they incur more overhead costs driven by regulatory documentation, antiquated data collection and the demands of precision medicine to name a few — all without increased compensation from sponsors and CROs. A recent study supports this concern. Researchers at the Tufts Center for the Study of Drug Devel
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sector. According to some sources, such problems even threaten the viability of the sector. Sites complain they incur more overhead costs driven by regulatory documentation, antiquated data collection and the demands of precision medicine to name a few — all without increased compensation from sponsors and CROs. A recent study supports this concern. Researchers at the
sector. According to some sources, such problems even threaten the viability of the sector. Sites complain they incur more overhead costs driven by regulatory documentation, antiquated data collection and the demands of precision medicine to name a few — all without increased compensation from sponsors and CROs. A recent study supports this concern. Researchers at the
sector. According to some sources, such problems even threaten the viability of the sector. Sites complain they incur more overhead costs driven by regulatory documentation, antiquated data collection and the demands of precision medicine to name a few — all without increased compensation from sponsors and CROs. A recent study supports this concern. Researchers at the
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Features
Financial Auditscontinued from page 1 “Sponsors and CROs are
typically not going to remind you to send them invoices
or to request the funds that you’ve already agreed to.”
—David Russell, director of site strategy, PFS Clinical
CTAs, 40 different budgets, 40 different pay-ment terms,” Russell said.
To explain the value of a financial audit, Russell talked about a site he worked with that had 600 open studies. Out of the 600 studies Russell audited 12. “What we found was a little over $75,000 was not even invoiced. And there was $31,000 that was invoiced but it wasn’t collected,” he said.
“So there was a total of $106,000 that was owed to the sites from those 12 studies. So it averages about $8,852 per study that is owed,” he said.
A second site had 250 studies and he chose only five studies to audit. “A little over $102,000 was not invoiced and nearly $34,000 was invoiced but not collected,” he said. “This aver-aged actually $27,174 per study,” he said.
“Don’t wait too long after the closeout visit to complete your final reconciliation. I’ve seen a lot of sites lose a lot of money because six months after the closeout visit they realize, oh, there’s $30,000 worth of unpaid invoices that they didn’t get to us,” Russell said.
Russell has some dos and don’ts:
Do:}} Conduct routine financial audits;}} Understand the payment terms for your
studies;}} Maintain a reconciliation log to tie out all
payments;}} Assure you are keeping up with all in-
voiceable items.
Don’t:}} Assume your CTMS will accurately track
your receivables;}} Entrust the receivables management
process to a study coordinator;}} Assume that the sponsor/CRO will pay
you correctly;}} Presume that if you send an invoice you
will be paid;}} Wait too long after your close-out visit to
complete the final reconciliation.
STANDARD OPERATING PROCEDURES
FOR GOOD CLINICAL PRACTICE BY SPONSORS OF CLINICAL TRIALS: DRUGS AND BIOLOGICS
Highlights include:
New requirements established in the 2016 revision of ICH E6New FDA guidances, including new data integrity expectations
Processes addressing the use of new technology in conducting clinical trialsThe increased use of centralized institutional review boards (IRBs)
3 3 VISIT STORE.CENTERWATCH.COMTO ORDER store.centerwatch.com CONTACT SALES [email protected] (617) 948-5100
UPDATED FOR 2019
33 individual SOPs to use as is or customize to meet your organization’s specific needs and in all aspects of your trials — from general administration and regulatory compliance, to trial design, operation and analysis.
This is the industry’s most comprehensive, customizable and easy-to-use set of SOPs.
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Protocol design • Study design • Patient engagementGenetic testing & counseling
Together, we’re helping our partners deliver on the promise of precision medicine.
Genetics-oriented solutions to support clinical trials
The Center for Genetics and Precision Medicine in Clinical Trials
www.wcgclinical.com
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Drug & Device Pipeline News For news on trial results, FDA approvals and drugs in development, Join the LinkedIn Drug Research Updates group!
Company Drug/Device Medical Condition Status Sponsor ContactCompass Therapeutics
CTX-471 metastatic or locally advanced solid cancers
Phase 1 trial initiated compasstherapeutics.com
Cyxone T20K multiple sclerosis (MS) Phase 1 trial initiated cyxone.com/en/SOTIO SO-C101 advanced/metastatic solid tumors Phase 1/1b trial initiated sotio.comTARIS Bio TAR-200 in
combination with Opdivo (nivolumab)
muscle-invasive bladder cancer (MIBC)
Phase 1b trial initiated enrolling 25 subjects with MIBC who are scheduled for radical cystectomy
tarisbio.com
Metacrine, Inc. MET409 non-alcoholic steatohepatitis (NASH) Phase 1b trial initiated metacrine.comIDEAYA Biosciences, Inc.
IDE196 solid tumors that harbor GNAQ/11 mutations or PRKC fusions
Phase 1/2 trial initiated ideayabio.com
Trovagene, Inc. onvansertib in combination with FOLFIRI and Avastin (bevacizumab)
metastatic colorectal cancer (mCRC) with a KRAS mutation (NCT03829410)
Phase 1b/2 trial initiated trovageneoncology.com
EIP Pharma, Inc. neflamapimod Huntington's disease Phase 2 trial initiated enrolling 16 subjects at a site in Cambridge UK
eippharma.com
Cara Therapeutics, Inc.
Oral KORSUVA (CR845/difelikefalin)
pruritus in subjects with atopic dermatitis (AD)
Phase 2 trial initiated enrolling 240 adult subjects with AD
caratherapeutics.com
Dilafor AB tafoxiparin pregnant women planned for labor induction
Phase 2b trial initiated karolinskadevelopment.com
NeuroRx, Inc. NRX-101 Severe Bipolar Depression and Acute Suicidal Ideation and Behavior (ASIB)
Phase 2b/3 trial initiated enrolling 140 subjects with Severe Bipolar Depression and ASIB who are stabilized following a single IV infusion of ketamine JPS Health Network in Fort Worth, Texas
neurorxpharma.com
Mirum Pharmaceuticals
maralixibat progressive familial intrahepatic cholestasis (PFIC) in pediatric subjects
Phase 3 trial initiated enrolling 30 subjects with residual BSEP function (PFIC2 non-truncating) aged one to 17 years
mirumpharma.com
CStone Pharmaceuticals
avapritinib gastrointestinal stromal tumors (GIST)
Phase 3 trial initiated cstonepharma.com/en/
Sensorion SENS-401 Sudden Sensorineural Hearing Loss (or SSNHL)
IND approval granted by the FDA
sensorion-pharma.com
Karyopharm Therapeutics
selinexor in combination with dexamethasone
relapsed refractory multiple myeloma in subjects who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD38 monoclonal antibody
Approval granted by the FDA karyopharm.com
ConTIPI Medical, Ltd. ProVate pelvic prolapse in women Approval granted by the FDA contipi.comAzurity Pharmaceuticals
Katerzia (amlodipine) Oral Suspension, 1 mg/mL
hypertension (high blood pressure) in adults and pediatric patients six years of age and older and coronary artery disease in adults
Approval granted by the FDA azurity.com
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CWMarketPlace
CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at (617) 948-5100 or [email protected] on any provider to view the company’s complete online profile or click here to search more profiles.
SDC Tempe, AZ (480) 344-5443 [email protected]
With biostatistics and clinical data management services, SDC also offers scalable full service clinical trial solutions via strategic partnerships that are diverse and complementary.
Lotus Clinical Research, LLC Pasadena, CA (626) 568-8727 [email protected]
Since 2001, Lotus has honed its study design and conduct methodology, interacts on behalf of clients with the FDA’s Analgesics Division and under-stands how to efficiently navigate the agency’s regulatory framework.
DZS Clinical Services Bound Brook, NJ (732) 764-6970 [email protected]
DZS combines a unique brand of flexibility from its services division with its proprietary ClinPlus eClinical Platform. They provide services to global pharmaceutical companies and small biotech start-ups.
Criterium, Inc. Saratoga Springs, NY(518) [email protected]
Founded in 1991, Criterium offers a mix of clinical research services, real-time data acquisition and management and personalized communication processes.
CROMSOURCE Waltham, MA(617) [email protected]
CROMSOURCE was among the first CROs to become active in Central & Eastern Europe and Russia. Their successful growth over has been built on stability, integrity, high levels of customer satisfaction and repeated business.
Palm Beach Research Center West Palm Beach, FL (561) 689-0606 [email protected]
Palm Beach Research Center is a fully dedicated, modern, spacious, multi-specialty research facility for the purpose of conducting phase 1-4 clinical trials. They are committed to bringing state of the art medical treatment to patients.
Consolidated Clinical Trials, Inc. Monroeville, PA (412) 273-9100 [email protected]
Consolidated Clinical Trials, Inc., established in 2000, has focused on independent physician practices located throughout the Pittsburgh region and surrounding counties.
Summit Research Network Management, Inc. Portland, OR (503) 972-9818 [email protected]
Since 1976, Summit Research, an independent medical research organiza-tion with an outpatient facility, has worked in cooperation with pharmaceu-tical companies to develop medical treatments for a variety of conditions.
PMG Research, Inc. Winston-Salem, NC(919) [email protected]
PMG Research is an Integrated Site Network (ISN) of 12 clinical research facilities. Since its founding in 1979, PMG has conducted over 7,700 research studies.
Evolution Research Group, LLC Watchung, NJ [email protected]
ERG represents Thievon-Wright Consulting Group and specializes in the placement and management of clinical trials for a network of 10 owned and 12 affiliated clinical research sites across the U.S. and Puerto Rico.
CONTRACT RESEARCH ORGANIZATION INVESTIGATIVE SITE NETWORKS
INVESTIGATIVE SITE NETWORKS (NON SMO)
SITE MANAGEMENT ORGANIZATION
TRIAL MANAGEMENT ORGANIZATION