CenterWatch Join the CenterWatch Community! Weekly October 5, 2020 COVID-19 Update…2 Industry Briefs …4 Trend of Longer Trial Timelines is Likely Up and Coming…6 Drug & Device Pipeline News…11 to Continue Thirty-eight drugs and devices have By Charlie Passut formance will really come from our ability to entered a new trial phase this week. linical trial timelines have been best manage complexity, customization and JobWatch…13 lengthening since 2014 and with fragmentation,” Getz said last week at the C COVID-19 conditions forcing adap- Outsourcing in Clinical Trials USA virtual con- tation and adoption of new technologies ference. “These macro trends are inevitable.” 15TH ANNUAL and processes, the trend is likely to continue, But other complications “are actually FDA INSPECTIONS vSUMMIT if not accelerate. challenging and conspiring against our bold While the primary response to the development ambitions. They all suggest Tuesday, Nov. 17 – Wednesday, Nov. 18, 2020 pandemic represented important, and that our programs are actually getting lon- Please join us in celebrating 15 years of bringing together industry and the FDA in sometimes transformational, changes in ger. If you look at individual tasks and phase- harmonious collaboration. trials, those changes “will likely contribute specific cycle times, you’ll see that they’re all REGISTER TODAY to even greater complexity and increased increasing in length and we’re seeing high levels of customization and operating frag- levels if not higher levels of variation, that is mentation,” says Kenneth Getz, director one of the macro trends that we’re seeing. FREE WEBINAR of the Tufts Center for the Study of Drug Protocol complexity and customization OCTOBER Development (CSDD). and fragmented operating activity — are “Long term, we believe that develop- the primary factors that are impacting our 14 ment speed, efficiency and optimized per- see Trend of Longer Trials on page 8 » Make Real-Time, Real-World Data Work for You: How to Accelerate Clinical T Cells Could Play Crucial Role in COVID-19 Trials and Enhance Market Access Vaccine and Treatment Trials, Experts Say Sponsored by InterSystems REGISTER By Leslie Ramsey especially in older populations with reduced he first wave of COVID-19 vaccine de- immune capacity.” NEW WHITE PAPERS AVAILABLE velopment has not monitored the re- Rothman was joined in a WCG Clini- Clincierge – Patient Travel Management | Let’s talk about your trial today! 888.458.8579 / [email protected] PATIENT SUPPORT SOLUTIONS IN RARE DISEASE DURING THE COVID -19 PANDEMIC Keep Your Participants Safe And Your Study On Time With Clincierge’s Travel & Logistics Coordinators sponse of T cells to the virus, a missed cal webinar by former FDA commissioner Patient Support Solutions 38+ Countries Optimized Patient Travel Itineraries T 170+ Trials Supported Strategic Travel Solutions in Rare Disease During opportunity that should be addressed in Scott Gottlieb, who acknowledged the NAVIGATE THE RISKS OF TRAVEL DURING COVID-19 Chartered ights, long-distance drivers professionally trained to work with study patients, and more. Work with a Clincierge Coordinator who understands all of a patient’s travel options. the COVID-19 Pandemic the next wave of COVID-19 research, two potential of T cells to contribute to efforts ENHANCED GROUND TRANSPORTATION Beth is a patient with a rare disease needed to y to Spain for her study visits, but air travel and public transportation were no longer viable options due to From Clincierge COVID-19. To ensure she made it to her appointments, her STRATEGIC TRAVEL Clincierge Coordinator scheduled two extended private SOLUTIONS car trips, with overnight accommodations for both Beth • Convert Air to Ground and her driver. experts said last week. to vanquish the virus but questioned Transportation • Coordinate Overnight Accommodations • Enhanced Safety & CHARTERED FLIGHTS Sanitation Protocols Meredith is immuno-suppressed and had only two visits left to complete her study visits. Potential exposure to COVID-19 made airports and commercial ights too risky for her. Her Clincierge Coordinator chartered “Ongoing vaccine trials do not appear whether vaccines were the proper applica- private ights to transport Meredith to her visits safely. LEARN MORE to monitor the T cell response in detail, if tion. He said they could possibly be used in at all,” said James Rothman, chair of the COVID-19 treatments. centerwatch.com/whitepapers Department of Cell Biology at Yale University It’s pretty well established, Gottlieb School of Medicine and winner of the 2013 said, that a large percentage of people FREE WEBINAR Nobel Prize for medicine. have in their immune systems T cells OCTOBER The robust response of these cells was that could react with and kill the SARS- discovered after most COVID-19 vaccine CoV2 virus. 27 trials began, he said, adding that “T cell “What we don’t know is whether that responses need to be assessed after the first confers any protection,” he said. “If it’s going Bringing ClinOps Technology wave of approvals [of vaccines] to improve to confer protection, it wouldn’t be against to the Clinical Site Stories from the Frontlines and compare products and their utility, see T Cells Could Play Crucial Role on page 9 » Sponsored by Agatha, Inc. REGISTER Volume 24, Issue 38. © 2020 CenterWatch WCG | CWWeekly October 5, 2020 2 of 13 COVID-19 Update COVID-19 Drug Research are receiving oxygen or ventilator support. patients with COVID-19 who reside in com- Roundup The monoclonal antibody will be adminis- munity care homes. The trial will inves- COVID-19 Therapies: tered via a single one-hour infusion and will tigate the drug’s anti-inflammatory and The NIH’s National Institute for be compared with placebo plus standard prophylaxis effects against the disease. Allergy and Infectious Diseases has of care in terms of its ability to reduce the Recruitment of 750 patients across the UK halted enrollment of severely ill COVID-19 effects of the infection on the lungs. The will begin in late October. The Wellcome patients in a phase 3 trial of Merck’s Rebif primary endpoint will be the proportion initiative’s COVID-19 Therapeutics Acceler- (interferon beta-1a) with Gilead Sciences’ of patients who are alive and free of lung ator, in addition to the Bill & Melinda Gates remdesivir due to serious adverse events. failure at 28 days. Foundation and Mastercard, is sponsoring An interim review of safety data found Regeneron Pharmaceuticals has the trial. more adverse events among patients on released early data from its 275-patient COVID-19 Vaccines: high-flow oxygen/noninvasive mechanical phase 1/2/3 COVID-19 trial, which show Two leading COVID-19 vaccine develop- ventilation who received Rebif compared that antibody therapy REGN-COV2 ers, AstraZeneca and Moderna, have hit to those who did not receive the drug. reduced the proportion of patients new speed bumps that could delay their No concerns existed among patients who with COVID-19 who required additional promising COVID-19 vaccine candidates, had less severe COVID-19, and the trial will medical visits compared with placebo. reducing the possibility of a vaccine being continue to enroll patients on low-flow Approximately 7.7 percent and 4.9 per- ready ahead of the U.S. presidential elec- oxygen and those not requiring supple- cent of patients given the high and low tion on Nov. 3. The FDA has broadened mental oxygen. dose of the drug, respectively, required its already-significant investigation into The FDA has approved a phase 2 study additional visits, while 15.2 percent of the halted phase 3 trial of AstraZeneca’s of FSD Pharma’s investigational COVID-19 patients assigned to placebo required AZD1222 after a participant in the UK signature drug, FSD201. The primary ob- additional medical attention. A phase 2/3 experienced a serious adverse event. The jective of the randomized, multicenter trial portion of this trial is set to enroll up to agency is reportedly asking for data from will be to determine whether the therapy 1,300 patients who will be followed for 29 previous studies of similar vaccines that improves time to symptom relief faster days to examine the association between the same researchers worked on. Mean- than standard of care alone in 352 hospi- treatment and viral shedding in the upper while, Moderna CEO Stéphane Bancel talized patients with COVID-19. Dosing of respiratory tract. Three other late-stage said this week that he doesn’t expect the the trial’s first patients is expected some trials are also investigating REGN-COV2 for company to ask the FDA for an Emergency time in October 2020. COVID-19. Currently, a U.S.-based phase Use Authorization (EUA) for its vaccine The FDA has also greenlighted Stemed- 3 trial is testing the therapy in hospital- before Nov. 25 at the earliest. He had previ- ica Cell Technologies’ phase 2 trial, which ized patients with COVID-19, and another ously indicated that the vaccine could be will study the company’s intravenous study is testing the therapy for infection ready by early November. Bancel says the ischemic-tolerant mesenchymal stem-cell prevention in people who live with indi- company just does not have enough sup- treatment in patients with moderate- to- viduals who have been infected. porting data to file for an EUA yet. severe COVID-19. Patients in the trial will The University of Oxford is getting Moderna’s COVID-19 vaccine candi- be randomized to receive either the stem- ready to launch a phase 2 trial of AbbVie’s date, mRNA-1273, generated an immune cell therapy plus placebo or placebo with anti-inflammatory drug adalimumab in continues on next page » standard treatment. In emergency use and expanded use programs, Stemedica’s treatment was shown to reduce oxygen requirements within just one to two days CenterWatch Weekly of treatment initiation in 14 critically ill (ISSN 1528-5731) CenterWatch Main and Editorial Offices 300 N.