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Defending against research misconduct is the responsibility of everyone involved in a trial, from the principal investigator down to the lowest lab technician. Red flags can appear in any aspect of a trial, ranging from missing or altered data, significant omissions in published reports, investigators’ failure to disclose intellectual property interests or industry relationships, and […]
The FDA issued a 49-page draft guidance on how industry should go about asking patients what’s most important to them about how they are dealing with their disease and its treatment, to help companies better develop new drugs. The second in a series of four planned guidances on facilitating a systematic approach towards collecting and […]
This feature highlights changes in clinical research organizations’ personnel. Adaptimmune Therapeutics Adaptimmune Therapeutics has added to its leadership with Michael Garone named interim chief financial officer. Garone previously served as the CFO and interim chief executive officer at Immunomedics in New Jersey. Alphabet (Google) Former FDA commissioner Robert Califf has been named head of medical […]
Company Drug/Device Medical Condition Status Themis Bioscience and ZIKAVAX Second-generation Zika vaccine Zika virus Phase 1 study initiated enrolling 48 healthy subjects Noveome Biotherapeutics, Inc. ST266 intraocular hypertension Phase 1 trial initiated enrolling subjects at the University of Pennsylvania who have been diagnosed with intraocular hypertension who have not yet developed optic nerve damage Clover [...]
To help increase the number of effective trials of regenerative medicine therapies, the FDA will work with researchers and sponsors to focus on the populations, endpoints and designs best suited to prove success. Approximately 5,000 regenerative medicine trials are being conducted under the watch of the Center for Biologics Evaluation and Research (CBER) and Center […]
Diane Carozza, WCG vice president of clinical strategic services, and Danya Kaye, director of business development for R&D and innovation at Inspire, share their thoughts on a variety of issues related to successful site feasibility practices. Question: What are the pros and cons of conducting blinded versus unblinded initial site feasibility studies? Carozza: When we […]
Sponors of trials using complex innovative designs (CID) should carefully consider the statistical approaches they will use and discuss them with the FDA, a new draft guidance issued last week says. The benefits and risks of using novel statistical approaches — especially Bayesian analysis — in CID trials must be weighed carefully. “The use of […]
This feature highlights changes in clinical research organizations’ personnel. AGC Biologics Naofumi Kagami was named site head and general manager of the Chiba, Japan facility at AGC Biologics. Previously, Kagami was head of bioprocess solution sales with Sartorius Stedim Japan and marketing manager with Roche. Adicet Adicet has appointed Francesco Galimi senior vice president and […]
Company Drug/Device Medical Condition Status BioLineRx Ltd. AGI-134 solid tumors Phase 1/2a trial initiated enrolling subjects at 15 sites in the U.S., U.K. and Israel Neuralstem Inc. NSI-566 chronic ischemic stroke Phase 2 trial initiated enrolling 22 subjects with sustained chronic motor deficits due to an ischemic stroke Oragenics, Inc. AG013 severe oral mucositis Phase [...]
The most pressing compliance problem clinical trials have, data from the FDA show, continues to be following their protocols to the letter. The agency’s report on inspection findings in fiscal year 2019 places “failure to follow investigational plan” at the top of the list of most frequently cited observations, a spot it has held for […]
Florida-based Beacon of Hope is the first CRO to focus solely on right-to-try activities. Launched this month, Beacon of Hope will help companies provide safe, ethical and legal patient access to their investigational treatments outside of traditional clinical trials. The CRO also will work with patients, support advocacy groups and educate the community on right-to-try […]
This feature highlights changes in clinical research organizations’ personnel. Adamas Pharmaceuticals Neil McFarlane was named chief executive officer at Adamas Pharmaceuticals. McFarlane most recently was chief operating officer at Retrophin. AIM ImmunoTech AIM ImmunoTech has appointed Ellen Lintal chief financial officer. Lintal was previously senior vice president of finance and control for Hemispherx BioPharma, Inc. […]
Company Drug/Device Medical Condition Status Clover Biopharmaceuticals, Inc. SCB-313 peritoneal carcinomatosis Phase 1 trial initiated enrolling subjects in China Immunic IMU-935 various inflammatory and autoimmune diseases Phase 1 trial initiated Benitec Biopharma BB-301 Oculopharyngeal Muscular Dystrophy (OPMD) Phase 1 trial initiated Transgene TG4050 HPV negative, squamous cell carcinoma of the head and neck (SCCHN) Phase [...]
CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on 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 […]
Drug manufacturers are making progress toward the FDA’s goal of increasing access to investigational drugs outside clinical trials, the GAO says in a report released last week. Of 29 manufacturers GAO surveyed, 23 companies reported having an expanded access policy and only four stated they would not consider expanded access requests. One of the four […]
This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. To ask a question of WCG’s experts, click here: Question: In case of an unscheduled visit, or a serious adverse event that occurred and was treated outside the study site, should a protocol deviation be […]
Biogen and Eisai announced this week that they are pulling the plug on three additional phase 3 Alzheimer’s trials of investigational oral beta amyloid therapies (BACE inhibitors) over safety concerns. The companies previously had halted two phase 3 trials of anti-beta amyloid drug aducanumab after a data safety monitoring board (DSMB) review of interim data […]
This feature highlights changes in clinical research organizations’ personnel. AbCellera AbCellera Biologics Inc. has appointed Andrew Booth chief financial officer. Previously, Booth was vice president of instrumentation, chief financial officer and chief commercial officer at STEMCELL Technologies. Alpha Tau Medical Alpha Tau Medical has named Robert Den chief medical officer. Den is currently an associate […]

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