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COVID-19 Update…2 Industry Briefs …3 Up and Coming…4 Complex Safety Reporting Processes Drug & Device Pipeline News…8 Overburden Sites, Experts Say Thirty-five drugs and devices have entered a new trial phase this week. By Charlie Passut safety issues with little or no evidence of cau- Research Center Spotlight…10 linical trial safety reporting proce- sality or relevance to the site, leaving trial staff dures have always been a challenge to investigate and determine if they need C for sites, taking a disproportionate to report the issues to their IRBs. Without VIRTUAL WORKSHOP amount of time and money, but three fac- causality, “most sponsors will take the most DATA INTEGRITY FOR GCP tors are making the task even more difficult conservative approach and call it related,” says PROFESSIONALS: CORE and lengthy for today’s sites: sponsors that Leslie Williams of Pharmacovigilance Consult- REQUIREMENTS, EXPECTATIONS AND CHALLENGES over-report, lack of global harmonization of ing. “That’s usually outlined in the protocol.” Tuesday, Dec. 1 and Thursday, Dec. 3, 2020 reporting rules and the pressures of a global “Many companies still distribute all safety Presented by WCG-CenterWatch and pandemic that require rapid response. reports to all sites and ethics committees Cerulean Associates LLC Safety reporting is one of the largest hid- due to a literal interpretation of [good clini- REGISTER TODAY den costs in drug development. And staying cal practice rules],” a practice that Steven on top of dozens of countries’ rules is a Beales, senior vice president for WCG Clini- daunting task, but it is essential to streamlin- cal’s scientific and regulatory division, refers ing the reporting process and alleviating the to as “brute force distribution.” burden on sites. Beales says one of the largest reporting Part of the problem lies with sponsors costs he has ever seen for a single clinical that pepper sites with unnecessary reports of see Complex Safety Reporting on page 5 » Questions of Cost, Accountability Dominate Discussion of Trials’ Post-Pandemic Future By Leslie Ramsey changed, said Karri Venn, CEO of site NEW WHITE PAPERS AVAILABLE s the industry moves beyond the network HyperCORE International. On the pandemic, sites and sponsors must other hand, Venn said, some innovations People Behind A ask themselves which practices de- that lessen the need for on-site operations the Platform veloped to meet the needs of remote opera- actually can save money. From LMK Clinical tions should carry forward and, ultimately, “I think there’s a nervousness, even Research Consulting who will cover the cost of new technology as you add in virtual telemedicine, that LEARN MORE and methods. the budgets will actually decrease,” she The telemedicine and home patient told attendees at the 2020 MAGI Clinical centerwatch.com/whitepapers visits, remote monitoring, electronic Research vConference last week. “These consent systems and direct-to-patient are real things that we have to think FREE WEBINAR delivery arrangements that have proven about” when deciding how to continue so successful in keeping trials operating and survive. NOVEMBER during the crisis all come with additional Still, many sites say they are ready to expenses that may not be covered in cur- take on the challenge of new methods. rent site budgets. Asked who should manage direct-to-home Vendor Oversight New methods and technology can visits, for example, 56 percent of attendees Ensuring Regulatory Compliance by Assessing Study Risks be expensive, and site budgets haven’t see Questions of Cost on page 6 » Sponsored by Oracle Health Sciences REGISTER Volume 24, Issue 43. © 2020 CenterWatch WCG | CWWeekly November 9, 2020 2 of 10 COVID-19 Update

COVID-19 Drug Research the vaccine, and Chile’s president has also An interim analysis of data from No- Roundup said the country should have access to 7.6 vartis’ canakinumab trial shows it failed COVID-19 Vaccines: million doses through the World Health to meet its primary endpoint, indicat- The Coalition for Epidemic Prepared- Organization’s COVAX initiative. The Astra- ing that canakinumab plus standard of ness Innovations (CEPI) has agreed to Zeneca trial will follow a COVID-19 vaccine care did not demonstrate a significantly invest up to $328 million to help China’s trial in Chile by Johnson & Johnson, which greater chance of survival for patients Clover Biopharmaceuticals develop SCB- is currently under way, as well as another without the need for invasive mechani- 2019, a COVID-19 vaccine candidate. The trial by Sinovac. cal ventilation compared with placebo CEPI funding will support a global phase Anvisa, Brazil’s health regulator, has plus standard of care. The trial also did 2/3 study and will also finance licensing said Johnson & Johnson’s clinical trial of not meet its key secondary endpoint of and distribution. The late-stage study of its COVID-19 vaccine can resume after it reducing the COVID-19-related death the vaccine is planned to start before the was paused in mid-October following an rate during the four-week period after end of the year and will enroll vulner- unexplained illness in one participant. The treatment. The results do not affect any able patients, including autoimmune and planned 60,000-person phase 3 trial is be- other ongoing trials for canakinumab, immunocompromised patients, as well as ing conducted in 11 states in Brazil and is the company says, including investiga- children and pregnant women. expected to enroll up to 7,560 adults. tions for the treatment of nonsmall-cell A phase 1 trial of CureVac’s COVID-19 The first doses of CanSino Biologics’ lung cancer. vaccine candidate CVnCoV shows the vac- COVID-19 vaccine have been delivered A data monitoring committee review- cine generates immune responses and is to Mexico for a late-stage trial. The trial ing safety and efficacy data from the generally well-tolerated in healthy volun- is set to enroll between 10,000 and UK-based RECOVERY trial evaluating teers. The early-stage trial included more 15,000 volunteers. Regeneron’s REGN-COV2 in hospitalized than 250 healthy patients between the COVID-19 Treatments: patients has given the trial the go-ahead ages of 18 and 60 and studied CVnCoV Vancouver-based Algernon Pharma- to continue recruitment of eligible doses ranging from 2µg to 12µg. Accord- ceuticals plans to conduct a late-stage patients to all study arms. Researchers in ing to the company, the positive interim study to evaluate an orally delivered drug, the trial are also planning to test whether results support the move to assess the NP-120 (ifenprodil), as a COVID-19 treat- aspirin can reduce the risk of blood clots highest dose level, 12µg, in a pivotal ment. The drug was originally developed in COVID-19 patients. More than 2,000 phase 2b/3 trial. Currently, CureVac’s vac- in the 1990s by Sanofi to treat peripheral patients will receive a daily 150mg aspi- cine is being tested in a phase 2a trial in circulatory disorders and it is still used in rin dose in addition to standard of care to Peru and Panama. generic form in Japan. Participants in the see if the drug improves mortality rates A COVID-19 vaccine candidate devel- phase 3 study will receive either standard after four weeks compared to standard of oped jointly by the Chinese Academy of of care, standard of care plus ifenprodil 60 care alone. Sciences and Chongqing Zhifei Biological mg or standard of care plus ifenprodil 120 Eli Lilly has received permission to Products has been proven safe and ca- mg. The researchers hope to determine conduct phase 3 trials of baricitinib in pable of generating immune responses in whether the drug improves blood oxygen India. The trials will compare the effect of a healthy participants, according to findings levels and reduces mortality, as well as daily 4mg dose of the drug to placebo on from phase 1 and 2 trials. time spent in an intensive care unit. disease progression. Symvivo has dosed the first healthy volunteer in the company’s phase 1 clinical trial of oral COVID-19 vaccine candidate bacTRL-Spike. The phase 1 trial is being CenterWatch Weekly conducted in Australia with Symvivo’s (ISSN 1528-5731) CenterWatch Main and Editorial Offices 300 N. Washington St., Suite 200, Falls Church, VA 22046 Beth Belton Editorial Director partner Nucleus Network. Tel: 866.219.3440 • 617.948.5100 Stephanie Akers Production [email protected] / [email protected] Chile’s health regulators have given Russell Titsch Business Development Director Permission requests can be emailed to [email protected]. AstraZeneca the green light to conduct © 2020 CenterWatch. No part of this publication may be distributed clinical trials of its COVID-19 vaccine. Previ- or reproduced in any form or by any means without the express Advertising packages and reprints are available: written consent of the publisher. Email [email protected] or call 703.538.7651. ously, Chile reserved 14.4 million doses of

RWD in Randomized Trials Industry Backs Direct-to-Patient inventory management. In addition, around Must Apply Conventional Trial Clinical Supply in Remote Trials 21 percent of respondents indicated that Standards, UK Says Clinical trial sites are backing the concept of using a central pharmacy could help reduce Randomized clinical trials (RCT) in the UK offering direct-to-patient (DTP) options for the number of needed sites/pharmacies. can use real-world data (RWD) as long as delivering clinical supplies in a remote or The survey also found that a signifi- they apply the same data standards used home-based study, a new survey shows. cant majority of sponsors perceive clinical in conventional trials, according to a draft In a joint Catalent and FiercePharma packaging and distribution companies with guidance the Medicines and Healthcare survey of 234 site staff involved in clinical in-house DTP capabilities as more desirable products Regulatory Agency (MHRA) pub- supply and operations, approximately 63 partners compared to companies that sub- lished in late October. percent of respondents said it’s “important” contract the service to third-party providers. Sponsors should describe the tools and or “very important” to offer DTP options for On a scale of one to five, 33 percent rated a methods to be used for the handling of RWD supplies in trials. direct service as a five, or “very important.” in their trial application to the MHRA, the But the model is more popular in the U.S. Another 32 percent rated a direct service on guidance says. than in Europe. Approximately 41 percent of the scale as a level-four importance. The guidance says the protocol standards respondents in the U.S. said DTP options are To read the survey, click here: https://bit. for a trial using RWD should be the same as “very important” for future studies compared ly/3mZSZht. used in a conventional RCT. to 26 percent of respondents from the EU. While the guidance says RWD is most Nearly 60 percent of EU respondents par80 Launches Research likely to be used in trials involving approved said they limit their reliance on DTP, possibly Network to Improve Diversity products, the agency does not rule out the because the EU requires individual country in Clinical Trials use of RWD in RCTs of new products. approval for DTP distribution, the survey says. par8o has launched a new clinical trial The draft of RCT requirements is the The survey also asked respondents recruitment service that analyzes elec- first of a set of planned guidances on using about the perceived benefits of the use of tronic health record data to identify and RWD in different trial designs. MHRA has not central pharmacies instead of individual site connect eligible health center patients specified the focus or release date for future pharmacists or standalone off-site central with nearby trials. RWD guidances. pharmacies to dispense DTP patient kits. par80 is a provider of referral manage- Comments on the guidance are due by Approximately 34 percent of survey respon- ment technologies for health systems and Dec. 11. dents said that using central pharmacies lo- self-insured employers and serves more than Read the draft guidance here: https://bit. cated within the same facilities that package 130 health center clients in 34 U.S. states and ly/2U41T1b. their clinical supplies could lead to better represents more than 7 million patients.

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This feature highlights changes in clinical Eagle Pharmaceuticals ProMIS Neurosciences trial organizations’ personnel. Eagle Pharmaceuticals has appointed four David Wishart has been appointed to Pro- new members to its clinical, formulations MIS Neurosciences’ scientific advisory board. Acousia Therapeutics and commercialization team, including Ju- Wishart is a professor in the departments of Jonas Dyhrfjeld-Johnsen has been dith Ng-Cashin to executive vice president biological sciences and computing science named chief development officer of Acou- and chief medical officer, John Kimmet to at the University of Alberta. sia Therapeutics. Most recently, Dyhrfjeld- executive vice president of oncology and Johnsen was head of pharmacology at acute care marketing, Valentin Curt to QurAlis Rewind Therapeutics. senior vice president of clinical drug devel- QurAlis has appointed Angela Genge to opment and Gaozhong Zhu to senior vice the role of chief medical officer. Genge Adaptate Biotherapeutics president of pharmaceutical development. previously served as the director of the Stewart Kay has been appointed to the Prior to these appointments, Ng-Cashin neuromuscular disease clinic and the role of chief business officer of Adaptate was the chief medical officer of AoBiome neuropathic pain clinic at the Montreal Biotherapeutics. Formerly, Kay was the chief Therapeutic, Kimmet was head of strategic Neurological Hospital and currently serves business officer of Crescendo Biologics. planning and decision analysis at Bristol as the executive director of the hospital’s Myers Squibb, Curt was executive medical clinical research unit. American Injectables director of clinical R&D at Imbrium Thera- American Injectables has hired Ben Boling peutics and Zhu was vice president and Silence Therapeutics to assume the role of chief operating officer. head of pharmaceutical development and Marie Wikström Lindholm has been Boling was most recently chief operating manufacturing at Corvidia Therapeutics. appointed to the role of senior vice officer of Bio-Concept Laboratories. president of molecular design at Silence Horizon Therapeutics Therapeutics. Lindholm was most recently Ascendis Pharma Karin Rosén has been named executive vice the company’s vice president and head of Ascendis Pharma has appointed Mark president of R&D and chief scientific officer technology innovation. Bach senior vice president of clinical de- of Horizon Therapeutics. Prior to joining velopment and medical affairs for endocri- Horizon, Rosén was the senior vice president SparingVision nology rare diseases. Bach most recently of U.S. medical affairs at GlaxoSmithKline. Paris-based genomics medicine company served as head of Asia Pacific medical SparingVision has named Florence Lorget sciences at Janssen Pharmaceuticals. LogicBio Therapeutics as chief development sciences officer and Mariana Nacht has been named chief Rajiv Gangurde as chief technology of- Boehringer Ingelheim scientific officer of LogicBio Therapeutics. ficer. Most recently, Lorget served as senior Boehringer Ingelheim has named Yew Looi Prior to this appointment, Nacht was chief director of nonclinical safety evaluation at Liew president of U.S. human pharma. scientific officer of Cereius. LogicBio has also Sangamo Therapeutics. Gangurde previ- Liew was formerly the corporate senior vice promoted Kyle Chiang, the company’s vice ously served as senior director and head of president and head of human pharma for president of product strategy, to the role of chemistry, manufacturing and controls at the company’s emerging markets region. chief operating officer. Voyager Therapeutics.

DevaCell Oryzon Genomics Trillium Therapeutics David Pyrce, former senior vice president Torsten Hoffmann has been appointed Trillium Therapeutics has hired Ingmar of strategy and chief commercial officer of global R&D director of Oryzon Genomics. Pre- Bruns to the role of chief medical officer. NantKwest, has been named CEO of DevaCell. viously, Hoffmann was the senior vice presi- Formerly, Bruns was senior vice president dent of drug discovery at Taros Chemicals. and head of clinical development at DURECT Pieris Pharmaceuticals. Biopharmaceutical company DURECT has Polyplus found its newest chief medical officer in Polyplus has named Mario Philips as the X4 Pharmaceuticals Norman Sussman, a former associate pro- company’s newest CEO. Philips joins Polyp- Art Taveras, former chief scientific officer of fessor of medicine and surgery at the Baylor lus from French biotech Polyneuros, where CoMET Therapeutics, is now the chief scien- College of Medicine. he also served as CEO. tific officer of X4 Pharmaceuticals. © 2020 CenterWatch CWW2443 WCG | CWWeekly November 9, 2020 5 of 10 Features

Complex Safety Reporting the past three years, for whom a single requirements. “For each of these scenarios, (continued from page 1) successful compound now has more safety we see how much we’re over-distributing by trial was $7.8 million for a four-year trial. distribution than almost the rest of their not following countries’ laws,” he said. “These costs are often hidden in other bud- compounds combined.” A number of high-profile sponsors have get line items, so we don’t know what the Kendra Hayden, WCG’s director for prod- banded together to help create databases real cost is,” he said. “As an industry, we have uct strategy and governance, added that of all the safety reporting requirements not fully tackled this.” safety reporting was an even more urgent globally, Beales noted, some of which use Sixty-one percent of sites are spending matter because of the pandemic. She said artificial intelligence (AI) to provide sponsors more than 80 hours of staff time per month a recent search of the website ClinicalTrials. with reporting guidance. processing safety reports; time that is taken gov revealed there are currently about 1,300 AI is key to this approach, Beales said. “A away from patients, Beales notes. And there interventional clinical trials that are open rules-based approach,” he said, “will always is money to be saved, too. Safety reports, on to recruitment and collectively looking to perform better than a probabilistic one. We average, cost about $26 each to produce and enroll more than 628,000 patients. use machine learning when we’re not smart the average budgeted cost per report is $45, “That’s a lot of patients in a lot of studies,” enough to work out the rules ourselves and so reducing the amount of safety reporting Hayden said. “What this actually means is need to derive them from big data.” can free up funds to be used elsewhere. that there is extra weight and urgency on Beales said he advises drug safety profes- A principal investigator (PI) involved in making sure that we’ve really got our pro- sionals to review safety report distribution more than one trial can expect to receive an cesses, policies and systems really working costs in their contracts. “You will be stunned average of 170 reports per quarter, Beales together so we can deliver on this informa- at the inconsistency,” he said. “In some said, and 80 percent of individual sites re- tion. There is an urgency of finding out and studies, the costs are per site, sometime per ceive more than 20 reports per month. As a getting those insights into how to better safety letter, sometimes there’s a flat fee. result, he estimates 20 percent of more than manage a global pandemic.” Study teams may understand how much 2,000 sites WCG has worked with end up And the multinational nature of today’s you would pay to recruit a patient, but they refusing to act on some sponsor reports. trials makes it difficult to know how and really do not understand how much safety For example, the FDA says that 86 per- what to report in different countries. The distribution should cost for a particular cent of sponsor reports of suspected, unex- timing of reporting requirements is espe- trial. Even on the same compound with the pected, serious adverse reactions (SUSARs) cially difficult to reconcile. same provider, we see a dramatic variation in a recent oncology trial did not meet the Generally, sites must report serious between studies.” criteria for reporting to the agency. adverse events to a sponsor within 24 hours, Beales also recommends that sites “You may be thinking ‘we don’t have while sponsors must deliver SUSARs to regu- consider centralizing safety reporting 170 SUSARs a quarter for any of our stud- latory authorities, IRBs or investigators within within their organization to help elimi- ies,’” Beales told attendees at a recent WCG either seven or 15 days, according to severity. nate overspending. “Safety reporting is a webinar. “But it is the cross-reporting where But Beales said 36 percent of countries have compound-level activity and it best belongs every SUSAR needs to be reported to every reduced their 15-day reporting requirements. in drug safety operations,” he said. “It is not a other study on that compound that causes “If you’re sending out your 15-day safety study-level activity, and study-level distribu- these numbers to rise. We’ve worked with reports to every country, you’re not doing it tion just results in over-distribution when several companies that have seen a five-fold correctly,” he said. He added that 62 percent sites are working on multiple studies with increase in safety report distribution over of countries have no seven-day reporting that same compound.”

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Questions of Cost remote approach, she acknowledged, but Another issue weighing on both sites’ (continued from page 1) if sponsors can provide flexibility in some and sponsors’ minds is who should be said it was the site’s job, 32 percent would areas and be a little more strict or careful responsible for providing new technology, hand off responsibility to a third party and in others, they can give sites more leeway such as electronic regulatory and data only 13 percent said sponsors and CROs in how they manage their trials. management systems. When asked this should have control. “If we, as sponsors, can be clear what question, attendees’ responses were di- At the same time sites take on more the ultimate goal is that we are trying to vided evenly between sites and sponsors. responsibility, there’s a new accountability achieve, that then allows all of our part- That discussion is still in its early days, for sponsors, and not just on the cost side, ners and stakeholders to be more flexible the three speakers agreed. said Kathryn King, senior vice president of in places where that flexibility is needed,” “I don’t know if we have enough data clinical development at Aptinyx. she said. right now to be able to go to that space “One of the things we as sponsors But the responsibility for change isn’t completely,” said Correa. “But I do think need to do is really be clear on what are all on the side of the sponsors, said Karen that we have the opportunity for commu- the aspects of either data collection or Correa, vice president and head of global nication and relationship-building on what data integrity that are most important,” clinical operations at Takeda. Sites need to that would look like so that it’s appropriate King says. educate their sponsors about the day-to- when it gets out there.” “I think perhaps in the past … we day issues they face. “People are working “It is a process,” Venn said, “but we’re tended to be a bit rigid about all aspects at the site level, working with the patients investing in it. We feel like this will help us of a clinical trial,” she said. Sponsors would … and we really need to hear from them,” ultimately go forward.” provide sites with the protocol and specify Correa said. “We need for you guys to be King also is optimistic about the future. where and when visits had to happen, for able to give us feedback.” “We have great tools from a technology point instance, not leaving sites many choices in That kind of communication from sites of view. We have the possibility of collaborat- how to conduct their trials. helps sponsors form the best protocols, ing with all of the stakeholders who are part “Maybe what we really need to do establish the right processes and select the of this process — sites, patients, sponsors, now is to think about what are the most correct vendors, she said, “so that we can regulators — and I think that enhanced col- important data to be collected and how be able to recruit the patients and com- laboration really can be leveraged right now.” much flexibility can or can’t be provided plete our trial. But we really need to hear “We can either get back to work or around the collection of that data,” King from you all of the challenges that you’re begin to work in a way that really propels said. Some assessments, procedures and dealing with and how we can be able to our industry forward. And I’m hopeful that examinations don’t lend themselves to the mitigate together.” we can do just that.”

Unique content, critical analysis & Septemer Centeratch ulication Volume ssue expert market research Start-up Costs Can Be an Uphill Slog in Need of Change By John W Mitchell

rustration about clinical trial start-up - sponsors. When each sponsor uses their sley, CEO at IACT Heal costs is not unlike Sisyphus’ dilemma. th. His company own networks and devices for patient-re- uscre to the nustrs lean loal nes source. A host of long-standing expense and ported outcomes, it adds to site workload InR and time. eview In this issue such uphill headwinds for the clinical trial - “We have no ability to standardize tech- ger, and there are more p 3-4 In Review sector. According to some sources, such rocedures per pa- nology,” Kingsley says “We have to do so tient per day. So, you’re eulator ate problems even threaten the viability of the doing loads more many trials with so many sponsors, and work, but you’re only pa 5 Action I sector. Sites complain they inRcur meoreg oveur- latory Upid when you put they have their own decision-making… tems d a a rt 4 t o e to Ie head costs driven by regulatory documen- - nt Canate rauulen themselves ce arl n he ec Subscribe Today! tation, antiquated data collec — you put fewer patients in tri- bia (standardization between sponsor rutment Ccle www.cen t erwatch.com/cwmonthly tion and t s and he By Angela Roberts dema als today.” sites).” nds of precision medicine to name a license is held by Progenics Pharmaceutica Rare, Adrenal GlaAnd Tumors ls. o Conseratons or sn tal few — all without incr ccording to Kingsley, the only way to As an example, he cites the ad eased compensation vantagesealt of h eces n Clncal rals from sponsors and CROs. A recent study - sites adopting electronic platforms such Bays V icki Gashwiler drug pate in three times as many cJonapcaunrr Genrte terin-ligehStosu Parkinson’s Trial supports this concern. ResearcheArsz eadt rtah feo r rare cancers of the adre- rce. Using such a platform could savse ase ualt anaement - billions compared to the aggregate cost ohef e ormal opment therapy OK’d for tfrom an overhead standpoint to have one By Brion Regan found that the study start-up phase hese tumors. scientists have won approval from Japanese Ineth analtcal reorts on e trens trial that places eight patients, rather than documents. C 10-11 Pipeline Ne » - re linically, an electronic plat- ws gulators to test adult stem cells a s a possible apy d three trials that place eight patients. form remained unchanged for the pastr udge cthadaet .a ttacks tumors with a high, treatment for Parkinson’sa dlsisoe apsere. vents errors such as entering ctons Also, at a time when technology is con- a blood pressure - Induced pluriopotent stem ce lilns co(irPrSe)c tly or performing ing inve a patient proced stments in technology are getting are derived from skin or blood cuerlles oauntd o f order from the trials do with inoperable l technology is compounding problems in test protocol. e reulator uates ne faster. None of this bodes well ocally advanced or metas- induced back into an embryonic-like plu- » th for smal tic cancers call e clinical trial sector. In each of the three “We’re trying ler, independent players. ed phenochromocytoma ripotent state that can divide in ttoo mcoonrvei nce the industry and pa studies he cites above, it’s likely that three The CenterWatch Monthly “Sites are doing more work forr a[fgeawnegrl]i oma. stem cells or become any type of cell in the ISSN 1556-3367 patients. We used to enroll aboPuhte eoicghrto mocytoma forms inside and bo pa- dy, leading to a potentially unseelim Staitedrt-up Costs on ae paraganglioma grows outside the adrenal source of any type of human cell needed itorial irector » uscrtons start at 3 gland(s). rouction - Both tumor ty Status Quo is Not apes Vreleaisea hoblrmoene sO that ered promising for regenerative research © 2018 CenterWatch, LLC. All rights reserved. can cause sympt ption: No part of this publication may be distributed or oms including high blood - reproduced in any form or by any means without the pressure, rapid heartbeat and anxiety. man cells and A Host of Challenges Stra , also, avoid controversy sur- express written consent of the publisher. Permission University of in Clinical Trial Site Viability Pennsylvania research- rounding stem cells from human embryos. requests can be obtained via fax at (617) 948-5101 or By John W emailed at [email protected]. Single-use Mitchell gish payments, contract viabiliRtye, spearerchers plan to transplant iPS cells r CONTACT SALES: [email protected] m | 617.948.5100 wwwfer.rced enterwatch.coman-nual subscript ions sta rt at $399. into site status, interconnectivity and stohme ebtrhainings ofr yP caarrkei nsistoesn i’sn pCaatnaiendta.s in percent who received at le or inuiries on ultireaer an corporate roblem less tangaibslte o—ne a d laocske oafn cdo nsitdheer ahtoiopne inth tehye will help repair or replace © 2020 CenterWatch CWW2443 WCG | CWWeekly November 9, 2020 7 of 10

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Company Drug/Device Medical Condition Status Sponsor Contact COVID-19 Trials and Actions OncoSec Medical CORVax12 DNA-encodable vaccine against IND approved by the FDA oncosec.com SARS-CoV-2 Equillium itolizumab hospitalized COVID-19 patients IND approved by FDA for equilliumbio.com with acute respiratory distress phase 3 trial syndrome (ARDS) Symvivo bacTRL-spike oral prevention of COVID-19 first patient dosed in phase symvivo.com Corporation vaccine 1 trial RevImmune CYT107 patients critically ill with COVID-19 patient enrollment initiated revimmune.com (recombinant in the U.S. in phase 2 trial human Interleukin-7) Humanigen lenzilumab prevention of cytokine storm first patient dosed in phase humanigen.com in hospitalized patients with 3 trial COVID-19 Other Trials and Actions enGene EG-70 Bacille Calmette-Guerin (BCG)- IND approved by the FDA engene.com unresponsive nonmuscle-invasive bladder cancer InnoCare Pharma orelabrutinib multiple sclerosis IND approved by the FDA innocarepharma.com Neuraly NLY01 Alzheimer’s disease IND approved by the FDA neuralymed.com OliX OLX10010 adjunct therapy to reduce the IND approved by the FDA olixpharma.com Pharmaceuticals recurrence of hypertrophic scars after scar revision surgery TaiGen TG-1000 influenza A and B IND approved by the FDA taigenbiotech.com Biotechnology Aligos Therapeutics ALG-000184 chronic hepatitis B virus first patient dosed in phase aligos.com 1a/1b trial BiomX BX002 inflammatory bowel disease first patient dosed in phase biomx.com 1a trial Synlogic SYNB8802 enteric hyperoxaluria first patient dosed in phase synlogictx.com 1 trial MindMed LSD microdose and anxiety disorders completion of phase 1 trial mindmed.co experiential doses Q32 Bio ADX-914 autoimmune diseases first patient dosed in phase Q32bio.com 1 trial ADC Therapeutics camidanlumab select advanced solid tumors first patients dosed in adctherapeutics.com tesirine (ADCT-301) combination arm of phase in combination with 1b trial pembrolizumab Gritstone Oncology GRANITE and SLATE historically cold (or non- first patients dosed in phase gritstoneoncology.com (neoantigen-based immunogenic) tumor types 2 expansion cohorts of immunotherapies) phase 1/2 trials Rubius Therapeutics RTX-240 acute myeloid leukemia first patient dosed in phase rubiustx.com 1/2 trial Novus Therapeutics AT-1501 amyotrophic lateral sclerosis first patient enrolled in novustherapeutics.com phase 2a trial AIVITA Biomedical AV-GBM-1 glioblastoma patient dosing complete in aivitabiomedical.com phase 2 trial continues on next page »

Company Drug/Device Medical Condition Status Sponsor Contact Amino Technology PalinGen Flow adults with chronic ulcers of the initiation of phase 2 trial amniotechnology.com lower extremities due to venous stasis or diabetic etiologies NanOlogy NanoPac (sterile prostate cancer first patient enrolled in nanology.us nanoparticulate phase 2 trial paclitaxel) for suspension via intratumoral injection PolyActiva latanoprost-free-acid glaucoma initiation of phase 2 trial in polyactiva.com sustained-release Australia ocular implant Enlivix Allocetra sepsis approval received from the enlivex.com Israeli Ministry of Health for a phase 2b trial Pfizer vupanorsen (AKCEA- patients with elevated nonhigh- initiation of phase 2b trial pfizer.com ANGPTL3-LRx) density lipoprotein cholesterol (nonHDL-C) and triglycerides Asieris APL-1202 nonmuscle-invasive bladder cancer approval granted by the asieris.cn Pharmaceuticals Center for Drug Evaluation of the China National Medical Products Administration to initiate phase 3 trial Cerevel Therapeutics tavapadon Parkinson’s disease first patients dosed in three cerevel.com phase 3 trials Concert CTP-543 moderate-to-severe alopecia areata initiation of phase 3 trial concertpharma.com Pharmaceuticals Daiichi Sankyo Enhertu (fam- adjuvant therapy in patients with initiation of phase 3 trial daiichisankyo.com trastuzumab HER2-positive early breast cancer AstraZeneca deruxtecan-nxki) with high risk of disease recurrence astrazeneca.com who have residual invasive disease in the breast or axillary lymph nodes after receiving neo-adjuvant therapy GW Pharmaceuticals nabiximols multiple sclerosis-associated initiation of phase 3 trial gwpharm.com spasticity Greenwich greenwichbiosciences.com Biosciences LianBio infigratinib locally advanced or metastatic approval granted by the lianbio.com unresectable cholangiocarcinoma Center for Drug Evaluation of with FGFR2 gene fusions the China National Medical Products Administration to initiate phase 3 trial Logic Bio LB-001 methylmalonic acidemia Fast-Track designation logicbio.com granted by the FDA Rafael CPI-613 (devimistat) soft tissue sarcoma Orphan Drug designation rafaelpharma.com Pharmaceuticals granted by the FDA Boston Scientific Ranger drug-coated patients with peripheral artery approved by the FDA bostonscientific.com balloon disease in the superficial femoral artery and proximal popliteal artery Chiesi, USA Bronchitol add-on maintenance therapy to approved by the FDA chiesiusa.com (mannitol) improve pulmonary function in inhalation powder cystic fibrosis patients 18 years of age and older

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].

ActivMed Practices & Research Direct Helpers Research Center Methuen, MA Hialeah, FL 978.655.7155 305.828.3555 [email protected] [email protected]

ActivMed Practices & Research is a woman-owned company operat- Direct Helpers Research Center is a dedicated medical institute that ing in Massachusetts and New Hampshire since 1994. The CEO has combines a network of committed and experienced personnel to 24+ years of clinical research experience, and her staff and physicians conduct an array of clinical research trials in phases 1 through 4. have up to 22 years working in clinical trials. Advanced Biomedical Research of America Heartland Research Associates Las Vegas, NV Wichita, KS 702.898.2088 316.689.6629 [email protected] [email protected]

Advanced Biomedical Research of America is a clinical research or- Heartland Research Associates, founded in 1991, consists of four sites, ganization conducting phase 2, 3 and 4 clinical research trials for the five medical directors and more than 60 staff conducting trials in all pharmaceutical industry. areas of multispecialty research.

AMCR Institute IMIC Escondido, CA Palmetto Bay, FL 877.567.2627 786.310.7477 [email protected] [email protected]

AMCR has directed phase 1-4 endocrine and metabolic The center was established in 2012 as a continuation of successful clinical trials for many of the world’s leading pharmaceu- completion of more than 63 trials in previous research clinics. tical and biotech companies.We have special expertise in the evaluation of medical software, both embedded and standalone. California Allergy and Asthma Medical Group Research Center Oklahoma Heart Hospital Research Foundation Los Angeles, CA Oklahoma City, OK 310.966.9022 405.608.1281 [email protected] [email protected]

California Allergy and Asthma Research is an independent clinical OHHRF and its for-profit subsidiary, Oklahoma Cardiovascular research facility with more than 20 years of expertise in conducting Research Group, provide cardiovascular trial management services to phase 2 to phase 4 clinical trials for the pharmaceutical industry. pharma, medical device and biotech companies. CAMC Institute The Rockefeller University Hospital Charleston, WV New York, NY 304.388.9960 800.783.2737 [email protected] [email protected]

CAMC Institute is a centralized clinical research center affiliated with The Rockefeller University Hospital is a key West Virginia University. CAMC is experienced in conducting phase component of the Rockefeller University Center 2-4 clinical trials evaluating a myriad of therapeutic areas. for Clinical and Translational Science, which is devoted to the research of human biology and disease.