August 12, 2019
WCG Clinical has acquired clinical trial services organization PharmaSeek LLC, including its PFS Clinical and PatientWise subsidiaries, WCG announced last week.
Madison, Wisconsin-based PharmaSeek provides trial administration support and consulting as well as patient recruitment and training services. The company serves trial sites, multi-specialty practices, integrated health systems and academic medical centers.
Probability Platform Helps Predict Trials’ Regulatory Success
Evaluate Ltd. has developed an algorithm to predict the regulatory success of investigational drug products by combining industry and market data with individual products’ specific characteristics.
Called Product Specific PTRS, the tool aims to help sponsors evaluate the viability of their drug candidates and determine those that are not likely to make it through regulatory approval.
The tool is integrated with the company’s EvaluatePharma Vision service, which provides forecasting data, clinical timelines and sales predictions.
Javara Teams with Local Practice to Bring Trials to Patients
North Carolina-based clinical research organization Javara is teaming with a local medical practice to involve it in clinical trials that meet its patients’ needs.
Javara will place trial coordinators in Charlotte, N.C.-area Tryon Medical Partners clinics to help identify specific trials Tryon patients can participate in. Beginning in two of Tryon’s eight locations next month, Javara initially will focus on trials in endocrinology, internal medicine and dermatology and hopes to grow to 35 to 45 trials in the next 18 months.
Tryon’s 89 internists and specialists serve approximately 110, 000 patients.
FDA Releases Guidance on Drug Development for Fabry Disease
The FDA has okayed the use of a single trial to prove efficacy of any drug developed to treat Fabry Disease, according to a draft guidance the agency issued last week.
Sponsors should think about combining multiple clinical outcomes in their assessments given FD’s multi-systemic nature, highly variable rate of progression and heterogeneity, advises the guidance which focuses on trial design, efficacy endpoints and eligibility criteria.
If the drug is meant to slow or arrest disease progression but not reverse it, the trial should last long enough to observe disease progression in the control group, the guidance says.
Eligible patients should have the diagnosis confirmed through both biochemical testing and molecular genetic testing, and sponsors should think about enrolling pediatric patients in trials as early as possible.
Comments on the draft guidance are due by October 7.
Read the draft guidance here: https://bit.ly/2ZEHbWK.
Sarepta’s “Erroneous” AER Proves Costly
Sarepta Therapeutics’ stock plummeted 12.6 percent Thursday following an adverse event report (AER) of a serious side effect during a phase 2 gene therapy trial – but the company says the AER was wrongly submitted.
The sponsor says that neither it nor the trial’s principal investigator reported an adverse event involving a participant who experienced rhabdomyolysis. The participant in Sarepta’s trial, which is testing a micro-dystrophin gene therapy candidate for Duchenne muscular dystrophy, was hospitalized for observation and determined to be asymptomatic.
“While Sarepta and its principal investigator remain blinded to the study,” the company says, “the study drug safety monitoring board is unblinded to the event and has reviewed the issue and recommends the study continue uninterrupted.”
The submitter of the AER has not been identified.
Veristat Opens Office in Taiwan
Veristat has opened a new facility in Taipei, Taiwan, for its clinical trial, biostatistics and programming operations.
The new location will house a team of statistical programmers and clinical trial professionals to meet the increasing demand for local and international regulatory submission support in the region.