When Jigar left Constellation Pharmaceuticals he had just brokered a much-publicized three-year deal with a big pharma company. When he returned to Constellation almost five years later, the company was in a different place financially and its reputation had suffered a setback. He reevaluated the company’s clinical development work and opted to move into new disease areas.
In August 2019 Clinical Leader Live was proud to feature Bari Kowal, Jonathan Cohen, and Reb Tayyabkhan of Regeneron Pharmaceuticals to discuss “Developing a Benchmark Pricing Model for CROs.” During the presentation the team covered several topics, including implementing the model, the effects of company size, why the sudden interest in these models, and the feedback from CROs. In this video, the three executives discuss why the size of your company could impact your ability to implement a benchmark pricing model.
This study helps further understand the current processes related to reconciling payments at research sites, the level of satisfaction at research sites around receivables, as well as the impact that reconciling payments from sponsors/CROs has on the site’s ability to conduct a clinical trial.
Even measured against the vast scientific mystery that defines the biotech industry, gene therapy poses extraordinary challenges. This paper explores the history of gene therapy trials, as well as the types of gene therapy vectors and delivery strategies. Also discussed are the regulatory and operational challenges associated with gene therapy trials, including start-up regulations, site selection, recruitment, and retention.
Due to its complex nature, designing a study that effectively measures pain intensity and/or relief can be challenging. Health Decisions offers these considerations based on previous experience managing pain trials.
Targeted oncology therapies are found only in a small fraction of patients, making it extremely difficult to identify eligible participants for clinical studies. Just-in-time site activation is an approach that has proven successful in studies of targeted therapies/rare diseases and is worth considering as a solution.
A biologics company needed a CRO with a dedicated oncology team to manage its Phase 1 multicenter study to evaluate the safety and pharmacokinetic (PK) profile of an immunotherapeutic drug in subjects with advanced solid tumors. They found a clinical trial partner with oncology experience that could support protocol design and accelerate the start-up process to meet a quick first-patient-in (FPI) milestone.
ISR will review findings from two recent high-profile pieces of market research. One details the performance of specific IRBs (institutional review boards) in the clinical development space across such metrics as timeliness and responsiveness of protocol review and local IRB/regulatory knowledge. This report also highlights trends impacting how companies interact with IRBs — mainly the need for improved use of technology.