ARTICLES BY ED MISETA
A Small Biotech’s 3 Steps To Recruitment Success
Millendo Therapeutics has a pipeline of products addressing endocrine diseases. One of the company's trials, ZEPHYR, enrolled over 150 patients at 38 sites worldwide. Recruitment was nothing short of a success story. Millendo began recruiting patients for that study well after its main competitors yet was the first to meet its enrollment target.
A Small Biopharma That Doesn't Use CROs
When it comes to conducting clinical trials, most emerging companies choose to access external resources through partnering with CROs. Martin Lehr, CEO of Context Therapeutics, does not use CROs, preferring instead to take part in investigator-sponsored trials (ISTs).
A New AI Collaboration Eliminates Tedious Research Reviews
In recent years, biomedical research has faced a daunting challenge. A bottleneck, caused by knowledge creation, blocks scientists and physicians from staying up to date on specific genomic advances and quickly matching patients with treatment options and clinical trials. AI could be the solution.
Stem Cell Therapy Trial Offers Hope To Osteoarthritis Patients
Cynata Therapeutics is producing products called mesenchymal stem cells (MSCs), which have huge therapeutic potential for numerous unmet medical needs. The company’s Cymerus technology addresses many of the challenges and complexities of manufacturing stem cells at commercial scale.
ISR Projects Growth In eTMF Market
In December 2019, ISR Reports released the 2nd edition of its eTMF Market and Service Provider Dynamics report. The 118-page report collected data from 110 respondents who worked for sponsor companies and CROs and who had direct, recent experience with eTMF software systems.
Technology Advancements Spur Adoption Of Virtual Trials
Patient recruitment and retention in clinical trials has long been an issue for pharma companies. This results in many trials being delayed and even canceled. One recent advancement that could help with both recruitment and retention is virtual (decentralized) trials.
Teva Develops First FDA-Approved Digitally-Integrated Inhaler
Two challenges have plagued asthma sufferers and researchers for year. The first is patients not adhering to their maintenance medication. The other is patients not using proper inhaler technique. A new digitally-integrated inhaler from Teva hopes to eliminate both problems.
Patient Diversity Starts With Community Connections
When it comes to clinical trials, the pharmaceutical industry still has a patient diversity problem. The face of patients in clinical trials is not representative of the face of America or the individuals projected to be most in need of the medications being developed.
Janssen Uses Geofencing To Monitor Clinical Trial Patients
A new patient-facing technology being tested by Janssen will be used to passively track hospitalization events based on the location services available from the smartphone of a patient.
Master Trial Protocols: Better For Pharma, Better For Sites
Over the last few years there have been increased discussions in the industry around a master protocol approach to clinical trials. Those discussions have really accelerated over the past year, spurred on by the FDA, which in September 2018 released draft guidelines on this topic for the industry.